Request for Proposals Under BAA-HB-03-06
Somatic Cell Therapy Processing Facilities

Request for Proposals No.: BAA-HB-03-06
Issue Date: January 03, 2003
Issued By: Joanna Magginas, Contracting Officer
NIH/NHLBI
Contracts Operations Branch
6701 ROCKLEDGE DR MSC 7902
BETHESDA MD 20892-7902
Telephone Number: (301) 435-0360
FAX Number: (301) 480-3432
E-Mail: magginaj@nhlbi.nih.gov
Purchase Authority: 42USC201, Public Health Service Act of 1944, as amended
Just In Time: Yes; See Part IV Section L
Small Business Set-Aside: No; NAICS 541710
Proposal Intent Due Date: February 03, 2003
Proposal Due Date: March 03, 2003 4:00 PM (Eastern Time)

COMBINED SOLICITATION FORM AND COVER LETTER

The National Heart, Lung, and Blood Institute (NHLBI) is soliciting proposals under the subject Broad Agency Announcement (BAA). BAAs are used by federal agencies to fulfill their requirements for scientific study and experimentation directed toward advancing the state of the art or increasing knowledge or understanding rather than focusing on a specific system or hardware solution. Proposals received as a result of this BAA will be evaluated in accordance with the evaluation criteria specified herein through a peer review process. Proposals will not be evaluated against a specific Government requirement, as in the case of a conventional RFP, as they are not submitted in accordance with a common statement of work.

The NHLBI recognizes that scientific and technical staff of potential offerors may want to read portions of a RFP first. The RFP has four parts as follows:

Part I Contract Schedule
Part II Contract Clauses
Part III List of Documents, Exhibits, and other Attachments
Part IV Representations and Instructions

Attention is directed to Part I, Section C and, Part III, Section J, for the Statement of Work (general description of the required objectives and desired results, background information, research and technical objectives, and technical/cost information specific to this RFP). Attention also is directed to Part IV, Section L, which contains instructions for preparing technical and cost proposals. In Section L.1., please note paragraphs j., k., and l. which provide information specifically for this RFP. Finally, staff is referred to Part IV, Section M, for the Evaluation Factors for Award. These parts need to be integrated with the rest of the RFP since all portions must be considered when preparing a proposal.

To assist us in expediting preparations for review of proposals, completion and submittal of the Proposal Intent Response Sheet is extremely important and is due by February 3, 2003. See Section J, Attachment 15. If you intend to submit a proposal in response to this RFP, it is essential that you immediately notify Joanna Magginas, Contracting Officer, at the following internet address:

magginaj@nhlbi.nih.gov

If you do not notify the Contracting Officer of your intent to submit a proposal, you will not receive an individual notice of any amendments to the RFP, if any are issued. However, all amendments will be posted on the NIH web site. The due date for submittal of proposals is March 3, 2003, 4:00 p.m. (local time). The address for submittal of proposals and packaging instructions is sent forth in Part III, Section J, Attachment 1.


/s/
Joanna Magginas
Contracting Officer
Contract Operations Branch
National Heart, Lung, and Blood Institute


PART I—THE SCHEDULE

The contract schedule set forth in SECTIONS B through H, below, is NOT an exact representation of the contract that will result from this RFP. Rather, it is a sample that provides general information pertinent to many of the contracts awarded and should be reviewed as such. Specific contractual provisions pertinent to the offeror's organizational structure (e.g. Non-Profit, Commercial, Educational) and specific cost authorizations unique to the offeror's proposal will be discussed in the negotiation process and included in the resultant contract. This sample contract is meant to provide the offeror with an overview of the elements of a typical contract.



SECTION B—SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
This project is designed to develop novel somatic cellular therapies that will aid investigators by providing support in areas ranging from basic science to animal studies to proof-of-principle and eventually human trials. The somatic cell processing facilities are charged with implementing the rapid, safe, and equable transition of basic research ideas to clinical practice as well as supplying clinical grade products produced in a manner that is compliant with all regulatory requirements. The somatic cell administrative center will serve as the monitor and coordinator for organizational and regulatory aspects of the program.

ARTICLE B.2. PRICES/COSTS
The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer for: 1) Acquisition, by purchase or lease, of any interest in real property; 2) Special rearrangement or alteration of facilities; 3) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 4) Travel Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs; 8) Accountable Government Property; and 9) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS
Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

SECTION C—DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK
Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, SECTION J, ATTACHMENT 2, dated [to be inserted at time of contract award] , attached hereto and made a part of this Solicitation.
NOTE TO OFFERORS: Section J, Attachment 2 outlines the following three items:

General Description of the Required Objectives and Desired Results
Background Information
Research and Technical Objectives

ARTICLE C.2. REPORTING REQUIREMENTS

  1. Technical Progress Reports

    In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. For proposal preparation purposes only, it is anticipated that reports will be required as follows:

    Quarterly Progress Reports: This report shall document and summarize all work results for the period covered. This report shall be in sufficient detail to explain comprehensively the results achieved. The report shall be in letter form (2-3 pages) and include progress for the quarter, problems encountered during the quarter, goals met or missed, a summary of activities planned for the next quarter, manuscripts in progress, submitted or published.

    The first reporting period consists of the first full three months of performance and any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. A quarterly progress report is not required for the periods in which an annual or final report is due.

    Abstracts and Manuscripts: Copies of manuscripts (published or unpublished) derived from research under the contract and copies of all abstracts, manuscripts, preprints and publications that resulted from work conducted or any protocol or method developed specifically under this contract during the performance period. Manuscripts and publications will only be judged as resulting from this work if they cite the support received from this contract.

    Abstracts and manuscripts in progress and proposed for publication shall be provided to the NHLBI for review and comment 30 days prior to submission for publication.

    Annual Technical Reports: This report shall document and summarize all work results for the period covered. Specifically, the report shall include:

    1. Face page to include contract number, title, period of performance being reported, Contractor's name and address, telephone and facsimile numbers, and date of submission.

    2. An executive summary, to include:
      1. A statement of intended work for the reporting period;
      2. A brief overview of the work that was completed for the reporting period;
      3. A brief overview of any problems (technical or financial) that occurred during the current reporting period and their resolution of status;
      4. The advancements made in relation to any of the technical tasks set forth in the Statement of Work;
      5. A full description of data pertaining to:
        1. The work performed during the reporting period;
        2. The materials and methods pertaining to the work;
        3. The relationship between the accomplishments made relative to the goals and tasks of the Statement of Work;
        4. Problems encountered and their resolution.
      6. If applicable, full disclosure of any efforts to transfer the technology or receipt of support from outside entities interested in future access, partnering, or license to the developing technologies.

    3. The initial report shall be submitted for the first full twelve months of performance and any fractional part of the initial month. Annual reports thereafter shall be submitted at twelve month intervals. An annual report is not required for the period when the final report is due.

    Final Technical Report: This report shall consist of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The final report shall be submitted on or before the last day of the contract performance period.

  2. Summary of Salient Results

    The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

  3. Other Reports
    1. INVENTION REPORTING REQUIREMENT

      All reports and documentation required by FAR Clause 52.227-11 including, but not limited to, the invention disclosure report, the confirmatory license, and the government support certification, shall be directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 1040 A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of the annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer at the address listed below. The final invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted on the expiration date of the contract to the Contracting Officer, whose address will be identified in the resultant contract.

      Contracting Officer
      National Institutes of Health
      National Heart, Lung, and Blood Institute
      Rockledge Building (RKL2)
      6701 Rockledge Drive MSC 7902
      Bethesda, Maryland 20892-7902
      To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web (http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

SECTION D—PACKAGING, MARKING AND SHIPPING
All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. Specific details related to shipment of reagents to the NHLBI repository will be determined prior to award.

SECTION E—INSPECTION AND ACCEPTANCE

  1. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

  2. For the purpose of this SECTION, the Project Officer is the authorized representative of the Contracting Officer.

  3. Inspection and acceptance will be performed at the National Heart, Lung, and Blood Institute, Bethesda, MD.

    Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

  4. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

    FAR Clause No. 52.246-9, INSPECTION OF RESEARCH AND DEVELOPMENT (SHORT FORM) (APRIL 1984).

SECTION F—DELIVERIES OR PERFORMANCE

ARTICLE F.1. DELIVERIES
Satisfactory performance of the contract shall be deemed to occur upon performance of the work described in Article C.1. and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

  1. The items specified below as described in SECTION C, ARTICLE C.2 . will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the dates specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of the contract:

    Item Description Quantity Delivery Schedule
    (1) Quarterly Progress Reports 5 Quarterly
    (2) Annual Technical Reports 5 Annually
    (3) Final Technical Report 5 Expiration of Contract
    (4) Public Use Data set in accordance with NHLBI policy per Public Use Data Clause

  2. The above items shall be addressed and delivered to:

    [The specific information will be included in the resultant contract]

    Addressee Deliverable Item No. Quantity
         
         

ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.arnet.gov/far/.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).

SECTION G—CONTRACT ADMINISTRATION DATA

Any contract awarded from this RFP will contain the following:

ARTICLE G.1. PROJECT OFFICER
The following Project Officer(s) will represent the Government for the purpose of this contract:

[To be specified prior to award]

The Project Officer is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its Project Officer designation.

ARTICLE G.2. KEY PERSONNEL
Pursuant to the Key Personnel clause incorporated in this contract, the following individual(s) is/are considered to be essential to the work being performed hereunder:

NAME TITLE
[To be specified prior to award]]

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST

  1. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts NIH(RC)-1 (PDF format) are attached and made part of this contract. The instructions and the following directions for the submission of invoices/financing request must be followed to meet the requirements of a "proper" payment request pursuant to FAR 32.9.

    1. Invoices/financing requests shall be submitted as follows:

      An original and one copy to the following designated billing office:

      Contracting Officer
      Contracts Operations Branch
      National Heart, Lung, and Blood Institute, NIH
      Rockledge Building (RKL2)
      6701 Rockledge Drive MSC 7902
      BETHESDA MD 20892-7902

    2. Inquiries regarding payment of invoices should be directed to the designated billing office, (301)435-0355.

ARTICLE G.4. CONTRACT FINANCIAL REPORT

  1. Financial reports on the attached Form NIH 2706, Financial Report of Individual Project/Contract (PDF format), shall be submitted by the Contractor in accordance with the Instructions for Completing Form NIH 2706, which accompany the form, in an original and two copies, not later than the 30th working day after the close of the reporting period. The line entries for subdivisions of work and elements of cost (expenditure categories) which shall be reported within the total contract are listed in paragraph e., below. Subsequent changes and/or additions in the line entries shall be made in writing.

  2. Unless otherwise stated in that part of the Instructions for Completing Form NIH 2706, entitled "PREPARATION INSTRUCTIONS," all columns A through J, shall be completed for each report submitted.

  3. The first financial report shall cover the period consisting of the first full three calendar months following the date of the contract, in addition to any fractional part of the initial month. Thereafter, reports will be on a quarterly basis.

  4. The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record retention requirements in FAR Part 4.7.

  5. The following is a listing of expenditure categories to be reported:

    Expenditure Category
    Direct Labor
          Principal Investigator
    Co-Principal Investigator
    Key Personnel
    Other Professional Personnel
    Personnel—Other
    Fringe Benefits
    Accountable Personal Property
    Materials/Supplies
    Travel
    Consultant Costs
    Computer Costs
    Subcontract Costs
    Other Direct Costs
    Indirect Costs
    G&A Expense
    Total Cost
    Fee
    Total Cost Plus Fixed Fee

  6. The Government may unilaterally revise the NIH 2706 to reflect the allotment of additional funds.

ARTICLE G.5. INDIRECT COST RATES
In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7(d)(2), "Allowable Cost and Payment" incorporated by reference in this contract in Part II, Section I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services
Office of Acquisition Management and Policy
National Institutes of Health
6100 Building, Room 6B05
6100 EXECUTIVE BLVD MSC 7540
BETHESDA MD 20892-7540

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.6. GOVERNMENT PROPERTY
If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the DHHS Publication (OS) 686, entitled, Contractor's Guide for Control of Government Property, (1990) which can be found at http://knownet.hhs.gov/log/contractorsguide.htm

ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

  1. Contractor Performance Evaluations

    Interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work.

    Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

    Copies of the evaluations, contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

  2. Electronic Access to Contractor Performance Evaluations

    Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

    http://ocm.od.nih.gov/cdmp/cps_contractor.htm

    The registration process requires the contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the contractor will be required to identify an alternate contact who will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

SECTION H—SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS
As part of the work to be conducted under this contract, the contractor will assist investigators in developing and designing protocols for products to be used in clinical trials as well as developing, obtaining, and maintaining any INDs required for manufactured cellular therapies. For the performance of work related to clinical trials, research involving human subjects shall not be conducted under this contract until each protocol developed has been approved, written notice of such approval has been provided by the Contracting Officer, and the Contractor has provided to the Contracting Officer a properly completed Optional Form 310 (PDF format) certifying IRB review and approval of the protocol. The human subject certification can be met by submission of the Contractor's self designated form, provided that it contains the information required by the Optional Form 310.

ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the contractor should access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. The information below is a summary of the NIH Policy Announcement:

The contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

ARTICLE H.3. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)
The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

Provision by the Contractor to the Contracting Officer of a properly completed Optional Form 310 certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self designated form, provided that it contains the information required by the Optional Form 310.

ARTICLE H.4. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

  1. Pursuant to Public Law(s) cited in paragraph b., below, NIH is prohibited from using appropriated funds to support human embryo research. Contract funds may not be used for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

    Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

  2. Public Law and Section No.                         Fiscal Year                         Period Covered

    [Applicable information to be included at award]

ARTICLE H.5. NEEDLE EXCHANGE

  1. Pursuant to Public Law(s) cited in paragraph b., below, contract funds shall not be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

  2. Public Law and Section No.                         Fiscal Year                         Period Covered

    [Applicable information to be included at award]

ARTICLE H.6. PRIVACY ACT
This procurement action requires the Contractor to do one or more of the following: design, develop, or operate a system of records on individuals to accomplish an agency function in accordance with the Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 USC 552a) and applicable agency regulations. Violation of the Act may involve the imposition of criminal penalties. The Privacy Act System of Records applicable to this project is Number [to be included in contract]. This document is incorporated into this contract as an Attachment in SECTION J of the contract .

ARTICLE H.7. ANIMAL WELFARE ASSURANCE
The Contractor shall obtain, prior to the start of any work under this contract, an approved Animal Welfare Assurance from the Office of Extramural Research (OER), Office of Laboratory Animal Welfare (OLAW), Office of the Director, NIH, as required by Section I-43-30 of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. The Contractor shall maintain such assurance for the duration of this contract, and any subcontractors performing work under this contract involving the use of animals shall also obtain and maintain an approved Animal Welfare Assurance.

ARTICLE H.8. SUBCONTRACTING PROVISIONS

  1. Small Business Subcontracting Plan

    1. The Small Business Subcontracting Plan (PDF format), dated      is attached hereto and made a part of this contract.

    2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages-Subcontracting Plan."

  2. Subcontracting Reports

    1. Subcontracting Report for Individual Contracts, SF-294
      The Contractor shall submit the original and one (1) copy of Subcontracting Report for Individual Contracts, SF-294 in accordance with the instructions on the report as referenced in Public Law 95-507, Section 211. Regardless of the effective date of this contract, the Report shall be submitted on the following dates for the entire life of this contract:
      April 30th
      October 30th

      The Report shall be sent to the Contracting Officer at following address:

      Contracting Officer
      Contracts Operations Branch
      National Heart, Lung, and Blood Institute, NIH
      6701 Rockledge Drive MSC 7902
      BETHESDA MD 20892-7902

    2. Summary Subcontract Report, SF-295
      The Contractor shall submit two (2) copies of Summary Subcontract Report, SF-295 in accordance with the instructions on the report as referenced in Public Law 95-507, Section 211. The Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

      October 30th

      The first Report shall be submitted after the first full year of this contract in addition to any fractional part of the year in which this contract became effective.

      One copy of this report shall be sent to the Contracting Officer at the address above. One copy of this Report shall be mailed to the Office of Small and Disadvantaged Business Utilization, DHHS at the following addresses:

      Office of Small and Disadvantaged Business Utilization
      Department of Health and Human Services
      Hubert H. Humphrey Bldg., Room 517-D
      200 Independence Avenue, S.W.
      Washington, D.C. 20201

    3. The contractor shall also send an "Information Copy" of the SF-295 to the Cognizant Commercial Representative (CMR) at the address provided by the SBA. The Contractor should call SBA Headquarters in Washington, DC at (202) 606-4000, ext. 234 for the correct address if unknown.

ARTICLE H.9. SALARY RATE LIMITATION LEGISLATION PROVISIONS

  1. Pursuant to Public Law(s) cited in paragraph b., below, no NIH Fiscal Year funds may be used to pay the direct salary of an individual through this contract at a rate in excess of applicable amount shown for the fiscal year covered. Direct salary is exclusive of fringe benefits, overhead, and general and administrative expenses (also referred to as "indirect cost" or "facilities and administrative (F&A) costs"). Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the contractor pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the contractor. The per year salary rate limit also applies to individuals proposed under subcontracts. It does not apply to fees paid to consultants. If this is a multiple year contract, it may be subject to unilateral modifications by the Government if an individual's salary rate exceeds any salary rate ceiling established in future HHS appropriation acts.

b.   Public Law No. Fiscal Year Dollar Amount of
Salary Limitation*
[pending passage of legislation*]

  1. Direct salaries which will be paid with FY-03 funds are limited to the Executive Level rate which was in effect on the date(s) the expense was incurred.

* For contract expenditures using FY-03 funds, the period 10/1/02—12/31/02 the Executive Level rate is $        . Effective 1/1/03,for contract expenditures using FY-03 funds, the Executive Level rate may be increased by $ and will remain at that level until such time as it is determined to raise the Executive Schedule annual rates. See the web site listed below for Executive Schedule rates of pay.
LINK to EXECUTIVE LEVEL SALARIES: http://www.opm.gov/oca/PAYRATES/index.htm
(Click on "Executive Schedule" for the current Fiscal Year's salary rate or scroll down to the "General Schedule Salary Tables from Previous Years" to locate the Executive Level salary rates from previous years.)

ARTICLE H.10. PUBLICATION AND PUBLICITY
The contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

"This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, under Contract No.               .

ARTICLE H.11. PRESS RELEASES

  1. Pursuant to Public Law(s) cited in paragraph b., below, the contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

  2. Public Law and Section No.                         Fiscal Year                         Period Covered

    [Applicable information to be included at award]

ARTICLE H.12. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:

Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026

ARTICLE H.13. ANTI-LOBBYING

  1. Pursuant to Public Law(s) cited in paragraph c., below, contract funds shall not be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself.

  2. Contract funds shall not be used to pay salary or expenses of the contractor or any agent acting for the contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

  3. Public Law and Section No.                         Fiscal Year                         Period Covered

    [Applicable information to be included at award]

ARTICLE H.14. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES
Unique research resources arising from NIH-funded research are to be shared with the scientific research community. NIH provides guidance, entitled, "Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts," (Federal Register Notice, December 23, 1999 [64 FR 72090]), concerning the appropriate terms for disseminating and acquiring these research resources. This guidance, found at : http://ott.od.nih.gov/NewPages/64FR72090.pdf (PDF format) is intended to help contractors ensure that the conditions they impose and accept on the transfer of research tools will facilitate further biomedical research, consistent with the requirements of the Bayh-Dole Act and NIH funding policy.

Note: For the purposes of this Article, the terms, "research tools," "research materials," and "research resources" are used interchangeably and have the same meaning.


PART II—CONTRACT CLAUSES

SECTION I—CONTRACT CLAUSES

THE FOLLOWING PAGES CONTAIN A LISTING(S) OF GENERAL CLAUSES WHICH WILL BE APPLICABLE TO MOST CONTRACTS RESULTING FROM THIS RFP. HOWEVER, THE ORGANIZATIONAL STRUCTURE OF THE SUCCESSFUL OFFEROR(S) WILL DETERMINE THE SPECIFIC GENERAL CLAUSES LISTING TO BE CONTAINED IN THE CONTRACT(S) AWARDED FROM THIS RFP.


ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT—FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.arnet.gov/far/.

  1. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

    FAR
    CLAUSE NO.
    DATE TITLE
    52.202-1 Dec 2001 Definitions
    52.203-3 Apr 1984 Gratuities (Over $100,000)
    52.203-5 Apr 1984 Covenant Against Contingent Fees (Over $100,000)
    52.203-6 Jul 1995 Restrictions on Subcontractor Sales to the Government (Over $100,000)
    52.203-7 Jul 1995 Anti-Kickback Procedures(Over $100,000)
    52.203-8 Jan 1997 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over $100,000)
    52.203-10 Jan 1997 Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
    52.203-12 Jun 1997 Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
    52.204-4 Aug 2000 Printed or Copied Double-Sided on Recycled Paper (Over $100,000)
    52.209-6 Jul 1995 Protecting the Government's Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $25,000)
    52.215-2 Jun 1999 Audit and Records—Negotiation (Over $100,000)
    52.215-8 Oct 1997 Order of Precedence—Uniform Contract Format
    52.215-10 Oct 1997 Price Reduction for Defective Cost or Pricing Data
    52.215-12 Oct 1997 Subcontractor Cost or Pricing Data (Over $500,000)
    52.215-14 Oct 1997 Integrity of Unit Prices (Over $100,000)
    52.215-15 Dec 1998 Pension Adjustments and Asset Reversions
    52.215-18 Oct 1997 Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions
    52.215-19 Oct 1997 Notification of Ownership Changes
    52.215-21 Oct 1997 Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data—Modifications
    52.216-7 Feb 2002 Allowable Cost and Payment
    52.216-8 Mar 1997 Fixed Fee
    52.219-8 Oct 2000 Utilization of Small Business Concerns (Over $100,000)
    52.219-9 Jan 2002 Small Business Subcontracting Plan (Over $500,000)
    52.219-16 Jan 1999 Liquidated Damages—Subcontracting Plan (Over $500,000)
    52.222-2 Jul 1990 Payment for Overtime Premium (Over $100,000) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the contract.)
    52.222-3 Aug 1996 Convict Labor
    52.222-26 Apr 2002 Equal Opportunity
    52.222-35 Dec 2001 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans
    52.222-36 Jun 1998 Affirmative Action for Workers with Disabilities
    52.222-37 Dec 2001 Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans
    52.223-6 May 2001 Drug-Free Workplace
    52.223-14 Oct 2000 Toxic Chemical Release Reporting
    52.225-1 May 2002 Buy American Act—Supplies
    52.225-13 Jul 2000 Restrictions on Certain Foreign Purchases
    52.227-1 Jul 1995 Authorization and Consent, Alternate I (Apr 1984)
    52.227-2 Aug 1996 Notice and Assistance Regarding Patent and Copyright Infringement (Over $100,000)
    52.227-11 Jun 1997 Patent Rights—Retention by the Contractor (Short Form) (Note: In accordance with FAR 27.303(a)(2), paragraph (f) is modified to include the requirements in FAR 27.303(a)(2)(i) through (iv). The frequency of reporting in (i) is annual.
    52.227-14 Jun 1987 Rights in Data—General
    52.232-9 Apr 1984 Limitation on Withholding of Payments
    52.232-17 Jun 1996 Interest (Over $100,000)
    52.232-20 Apr 1984 Limitation of Cost
    52.232-23 Jan 1986 Assignment of Claims
    52.232-25 Feb 2002 Prompt Payment
    52.232-34 May 1999 Payment by Electronic Funds Transfer—Other Than Central Contractor Registration
    52.233-1 Jul 2002 Disputes
    52.233-3 Aug 1996 Protest After Award, Alternate I (Jun 1985)
    52.242-1 Apr 1984 Notice of Intent to Disallow Costs
    52.242-3 May 2001 Penalties for Unallowable Costs (Over $500,000)
    52.242-4 Jan 1997 Certification of Final Indirect Costs
    52.242-13 Jul 1995 Bankruptcy (Over $100,000)
    52.243-2 Aug 1987 Changes—Cost Reimbursement, Alternate V (Apr 1984)
    52.244-2 Aug 1998 Subcontracts, Alternate II (Aug 1998) *If written consent to subcontract is required, the identified subcontracts are listed in ARTICLE B, Advance Understandings.
    52.244-5 Dec 1996 Competition in Subcontracting (Over $100,000)
    52.245-5 Jan 1986 Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour Contract)
    52.246-23 Feb 1997 Limitation of Liability (Over $100,000)
    52.249-6 Sep 1996 Termination (Cost-Reimbursement)
    52.249-14 Apr 1984 Excusable Delays
    52.253-1 Jan 1991 Computer Generated Forms

  2. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:

    HHSAR
    CLAUSE NO.
    DATE TITLE
    352.202-1 Jan 2001 Definitions—with Alternate paragraph (h) (Jan 2001)
    352.216-72 Oct 1990 Additional Cost Principles
    352.228-7 Dec 1991 Insurance—Liability to Third Persons
    352.232-9 Apr 1984 Withholding of Contract Payments
    352.233-70 Apr 1984 Litigation and Claims
    352.242-71 Apr 1984 Final Decisions on Audit Findings
    352.270-5 Apr 1984 Key Personnel
    352.270-6 Jul 1991 Publications and Publicity
    352.270-7 Jan 2001 Paperwork Reduction Act

[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT—Rev. 9/2002].

ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES
Any authorized substitutions and/or modifications other than the General Clauses which will be based on the type of contract/Contractor will be determined during negotiations.

It is expected that the following clauses will be made part of the resultant contract:

FAR Clause 52.216-7, ALLOWABLE COST AND PAYMENT (FEBRUARY 2002), is modified in paragraph (a) to delete the words "subpart 31.2 of the Federal Acquisition Regulation (FAR)" and substitute the words "45 CFR part 74, appendix E."

FAR Clause 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR Clause 52.232-22, LIMITATION OF FUNDS (APRIL 1984) is substituted therefor. Note: When this contract is fully funded, FAR Clause 52.232-22, LIMITATION OF FUNDS will no longer apply and FAR Clause 52.232-20, LIMITATION OF COST will become applicable.

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
Additional clauses other than those listed below which are based on the type of contract/Contractor shall be determined during negotiations. Any contract awarded from this solicitation will contain the following:

This contract incorporates the following clauses by reference, (unless otherwise noted), with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

  1. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
    1. FAR 52.217-2, Cancellation Under Multiyear Contracts (JULY 1996).
    2. FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JANUARY 1999).
      "(c) Waiver of evaluation preference....
      [ ] Offeror elects to waive the evaluation preference."
    3. FAR 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (MAY 2001).
      "(b) Evaluation adjustment. (1) The Contracting Officer will evaluate offers by adding a factor of 10 percent to the price of all offers, except ..."
    4. FAR 52.224-1, Privacy Act Notification (APRIL 1984).
    5. FAR 52.224-2, Privacy Act (APRIL 1984).
    6. FAR 52.227-14, Rights in Data—General (JUNE 1987).
    7. FAR 52.230-2, Cost Accounting Standards (APRIL 1998).
    8. FAR 52.230-3, Disclosure and Consistency of Cost Accounting Practices (APRIL 1998).
    9. FAR 52.242-3, Penalties for Unallowable Costs (MAY 2001).
    10. FAR 52.243-2, Changes—Cost Reimbursement (AUGUST 1987), Alternate V (APRIL 1984).

  2. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER 3) CLAUSES:
    1. HHSAR 352.270-8, Protection of Human Subjects (JANUARY 2001).
      Note: The Office for Human Research Protections (OHRP), Office of the Secretary (OS), Department of Health and Human Services (DHHS) is the office responsible for oversight of the Protection of Human subjects and should replace Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH) wherever it appears in this clause.

  3. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
    The following clause is attached and made a part of this contract:
    1. NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin 81-16).

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
Additional clause other than those listed below which are based on the type of contract/Contractor shall be determined during negotiations. Any contract awarded from this solicitation will contain the following:

This contract incorporates the following clause in full text.

FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1) CLAUSES:

  1. FAR Clause 52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS (MAY 2002)
    (a) Definitions. As used in this clause—
    Commercial item, has the meaning contained in the clause at 52.202-1, Definitions.
    Subcontract, includes a transfer of commercial items between divisions, subsidiaries, or affiliates of the Contractor or subcontractor at any tier.
     
    (b) To the maximum extent practicable, the Contractor shall incorporate, and require its subcontractors at all tiers to incorporate, commercial items or nondevelopmental items as components of items to be supplied under this contract.
     
    (c) (1) The Contractor shall insert the following clauses in subcontracts for commercial items:
    (i) 52.219-8, Utilization of Small Business Concerns (OCT 2000) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $500,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.
    (ii) 52.222-26, Equal Opportunity (APR 2002) (E.O. 11246).
    (iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (DEC 2001) (38 U.S.C. 4212(a)).
    (iv) 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998) (29 U.S.C. 793).
    (v) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (JUN 2000) (46 U.S.C. Appx 1241) (flowdown not required for subcontracts awarded beginning May 1, 1996).
     
    (2) While not required, the Contractor may flow down to subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.
     
    (d) The Contractor shall include the terms of this clause, including this paragraph (d), in subcontracts awarded under this contract.


PART III—LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J—LIST OF ATTACHMENTS

  1. Packaging and Delivery of Proposal, September, 1997.
  2. Statement of Work.
  3. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-14 (PDF format), May, 1997.
  4. Financial Report of Individual Project/Contract, NIH 27064 (PDF format), May, 1997.
  5. Instructions for Completing Form NIH 27064, May, 1997.
  6. Protection of Human Subjects Assurance Identification/Certification/Declaration, Optional Form 3106 (PDF format), January, 1998.
  7. Subcontract Plan Format3 (PDF format), November, 2002.
  8. Procurement of Certain Equipment, NIH(RC)-7 (OMB Bulletin 81-16)4, April, 1984.
  9. Disclosure of Lobbying Activities, OMB Form SF-LLL2 (PDF format), December, 1989.
  10. Proposal Summary and Data Record, NIH-2043 (Rev. 6/82)2 (PDF format, MS Word format), June, 1982.
  11. Contact Points2, July, 1991.
  12. Technical Proposal Cost Information1 (HTML format, MS Word format), December, 1988.
  13. Breakdown of Proposed Estimated Cost (plus fee) and Labor Hours2, September, 1992.
  14. Summary of Related Activities1 (HTML format MS Word format), March, 1984.
  15. Proposal Intent Response Sheet5, March, 1984.
  16. Project Objectives, NIH 1688-11 (PDF format), September, 2002.
  17. Government Notice for Handling Proposals1, January, 2001.

Footnotes:

  1. These forms must be completed (where applicable) and submitted with the Technical Proposal.
  2. These forms must be completed (where applicable) and submitted with the Business Proposal.
  3. These forms are for informational purposes only.
  4. These forms will be attached to any contract resulting from this RFP.
  5. Complete this form as soon as possible and return as indicated on the form.
  6. If applicable, this form is to be completed and submitted with the Technical Proposal. ALL INSTITUTIONS MUST HAVE THE FORM REVIEWED AND APPROVED BY THEIR INSTITUTIONAL REVIEW COMMITTEE.


PART IV—REPRESENTATIONS AND INSTRUCTIONS

SECTION K—REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

Representations, Certifications, and Other Statements of Offerors or Quoters (Negotiated).

1. REPRESENTATIONS AND CERTIFICATIONS

The Representations and Certifications required by this particular acquisition can be accessed electronically from the INTERNET at the following URL:

http://rcb.nci.nih.gov/forms/rcneg.pdf (PDF format)

If you are unable to access this document electronically, you may request a copy from the Contracting Officer identified on the cover page of this solicitation.

IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST COMPLETE THE REPRESENTATIONS AND CERTIFICATIONS AND SUBMIT THEM AS PART OF YOUR BUSINESS PROPOSAL.


SECTION L—INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

  1. INSTRUCTIONS TO OFFERORS—COMPETITIVE ACQUISITION [FAR Clause 52.215-1 (May 2001)]

    (a) Definitions. As used in this provision—
     
    NOTE: All references to "competitive range" contained in Section L Instructions, Conditions and Notices to Offerors, are hereby deleted because this is a Broad Agency Announcement (BAA) and not a conventional Request for Proposals (RFP).
    Discussions are negotiations that occur after establishment of the competitive range that may, at the Contracting Officer's discretion, result in the offeror being allowed to revise its proposal.
     
    "In writing", "writing", or "written" means any worded or numbered expression that can be read, reproduced, and later communicated, and includes electronically transmitted and stored information.
     
    "Proposal modification" is a change made to a proposal before the solicitation's closing date and time, or made in response to an amendment, or made to correct a mistake at any time before award.
     
    "Proposal revision" is a change to a proposal made after the solicitation closing date, at the request of or as allowed by a Contracting Officer as the result of negotiations.
     
    "Time," if stated as a number of days, is calculated using calendar days, unless otherwise specified, and will include Saturdays, Sundays, and legal holidays. However, if the last day falls on a Saturday, Sunday, or legal holiday, then the period shall include the next working day.
     
    (b) Amendments to solicitations. If this solicitation is amended, all terms and conditions that are not amended remain unchanged. Offerors shall acknowledge receipt of any amendment to this solicitation by the date and time specified in the amendment(s).
     
    (c) Submission, modification, revision, and withdrawal of proposals. (1) Unless other methods (e.g., electronic commerce or facsimile) are permitted in the solicitation, proposals and modifications to proposals shall be submitted in paper media in sealed envelopes or packages (i) addressed to the office specified in the solicitation, and (ii) showing the time and date specified for receipt, the solicitation number, and the name and address of the offeror. Offerors using commercial carriers should ensure that the proposal is marked on the outermost wrapper with the information in paragraphs (c)(1)(i) and (c)(1)(ii) of this provision.
     
    (2) The first page of the proposal must show—
    (i) The solicitation number;
    (ii) The name, address, and telephone and facsimile numbers of the offeror (and electronic address if available);
    (iii) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and agreement to furnish any or all items upon which prices are offered at the price set opposite each item;
    (iv) Names, titles, and telephone and facsimile numbers (and electronic addresses if available) of persons authorized to negotiate on the offeror's behalf with the Government in connection with this solicitation; and
    (v) Name, title, and signature of person authorized to sign the proposal. Proposals signed by an agent shall be accompanied by evidence of that agent's authority, unless that evidence has been previously furnished to the issuing office.
     
    (3) Submission, modification, revision, and withdrawal of proposals. (i) Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that proposal or revision is due.
    (ii) (A) Any proposal, modification, or revision received at the Government office designated in the solicitation after the exact time specified for receipt of offers is "late" and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and—
    (1) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of proposals; or
    (2) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or
    (3) It is the only proposal received.
     
    (B) However, a late modification of an otherwise successful proposal that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.
     
    (iii) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the proposal wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.
     
    (iv) If an emergency or unanticipated event interrupts normal Government processes so that proposals cannot be received at the office designated for receipt of proposals by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation, the time specified for receipt of proposals will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.
     
    (v) Proposals may be withdrawn by written notice received at any time before award. Oral proposals in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile proposals, proposals may be withdrawn via facsimile received at any time before award, subject to the conditions specified in the provision at 52.215-5, Facsimile Proposals. Proposals may be withdrawn in person by an offeror or an authorized representative, if the identity of the person requesting withdrawal is established and the person signs a receipt for the proposal before award.
     
    (4) Unless otherwise specified in the solicitation, the offeror may propose to provide any item or combination of items.
     
    (5) Offerors shall submit proposals in response to this solicitation in English, unless otherwise permitted by the solicitation, and in U.S. dollars, unless the provision at FAR 52.225-17, Evaluation of Foreign Currency Offers, is included in the solicitation.
     
    (6) Offerors may submit modifications to their proposals at any time before the solicitation closing date and time, and may submit modifications in response to an amendment, or to correct a mistake at any time before award.
     
    (7) Offerors may submit revised proposals only if requested or allowed by the Contracting Officer.
     
    (8) Proposals may be withdrawn at any time before award. Withdrawals are effective upon receipt of notice by the Contracting Officer.
     
    (d) Offer expiration date. Proposals in response to this solicitation will be valid for the number of days specified on the solicitation cover sheet (unless a different period is proposed by the offeror).
     
    (e) Restriction on disclosure and use of data. (1) The proposal submitted in response to this request may contain data (trade secrets; business data, e.g., commercial information, financial information, and cost and pricing data; and technical data) which the offeror, including its prospective subcontractor(s), does not want used or disclosed for any purpose other than for evaluation of the proposal. The use and disclosure of any data may be so restricted; provided, that the Government determines that the data is not required to be disclosed under the Freedom of Information Act, 5 U.S.C. 552, as amended, and the offeror marks the cover sheet of the proposal with the following legend, specifying the particular portions of the proposal which are to be restricted in accordance with the conditions of the legend. The Government's determination to withhold or disclose a record will be based upon the particular circumstances involving the record in question and whether the record may be exempted from disclosure under the Freedom of Information Act. The legend reads:

    Unless disclosure is required by the Freedom of Information Act, 5 U.S.C. 552, as amended, (the Act) as determined by Freedom of Information (FOI) officials of the Department of Health and Human Services, data contained in the portions of this proposal which have been specifically identified by page number, paragraph, etc. by the offeror as containing restricted information shall not be used or disclosed except for evaluation purposes.

    The offeror acknowledges that the Department may not be able to withhold a record (data, document, etc.) nor deny access to a record requested pursuant to the Act and that the Department's FOI officials must make that determination. The offeror hereby agrees that the Government is not liable for disclosure if the Department has determined that disclosure is required by the Act.

    If a contract is awarded to the offeror as a result of, or in connection with, the submission of this proposal, the Government shall have right to use or disclose the data to the extent provided in the contract. Proposals not resulting in a contract remain subject to the Act.

    The offeror also agrees that the Government is not liable for disclosure or use of unmarked data and may use or disclose the data for any purpose, including the release of the information pursuant to requests under the Act. The data subject to this restriction are contained in pages (insert page numbers, paragraph designations, etc. or other identification).

    (2) In addition, the offeror should mark each page of data it wishes to restrict with the following statement:

    "Use or disclosure of data contained on this page is subject to the restriction on the cover sheet of this proposal or quotation."
    (3) Offerors are cautioned that proposals submitted with restrictive legends or statements differing in substance from the above legend may not be considered for award. The Government reserves the right to reject any proposal submitted with a nonconforming legend.
     
    (f) Contract award. (1) The Government intends to award a contract or contracts resulting from this solicitation to the responsible offeror(s) whose proposal(s) represents the best value after evaluation in accordance with the factors and subfactors in the solicitation.
     
    (2) The Government may reject any or all proposals if such action is in the Government's interest.
     
    (3) The Government may waive informalities and minor irregularities in proposals received.
     
    (4) The Government intends to evaluate proposals and award a contract without discussions with offerors (except clarifications as described in FAR 15.306(a)). Therefore, the offeror's initial proposal should contain the offeror's best terms from a cost or price and technical standpoint. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary. If the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals.
     
    (5) The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit cost or prices offered, unless the offeror specifies otherwise in the proposal.
     
    (6) The Government reserves the right to make multiple awards if, after considering the additional administrative costs, it is in the Government's best interest to do so.
     
    (7) Exchanges with offerors after receipt of a proposal do not constitute a rejection or counteroffer by the Government.
     
    (8) The Government may determine that a proposal is unacceptable if the prices proposed are materially unbalanced between line items or subline items. Unbalanced pricing exists when, despite an acceptable total evaluated price, the price of one or more contract line items is significantly overstated or understated as indicated by the application of cost or price analysis techniques. A proposal may be rejected if the Contracting Officer determines that the lack of balance poses an unacceptable risk to the Government.
     
    (9) If a cost realism analysis is performed, cost realism may be considered by the source selection authority in evaluating performance or schedule risk.
     
    (10) A written award or acceptance of proposal mailed or otherwise furnished to the successful offeror within the time specified in the proposal shall result in a binding contract without further action by either party.
     
    (11) The Government may disclose the following information in postaward debriefings to other offerors:
     
    (i) The overall evaluated cost or price and technical rating of the successful offeror;
    (ii) The overall ranking of all offerors, when any ranking was developed by the agency during source selection;
    (iii) A summary of the rationale for award; and
    (iv) For acquisitions of commercial items, the make and model of the item to be delivered by the successful offeror.
     
    Alternate I (October 1997). As prescribed in 15.209(a)(1), substitute the following paragraph (f)(4) for paragraph (f)(4) of the basic provision:
     
    (f) (4) The Government intends to evaluate proposals and award a contract after conducting discussions with offerors whose proposals have been determined to be within the competitive range. If the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals. Therefore, the offeror's initial proposal should contain the offeror's best terms from a price and technical standpoint.

  2. "JUST IN TIME"

    This RFP contains special procedures for the submission of business management proposals. These special procedures are designed to reduce the administrative burden on offerors without compromising the information during the initial evaluation of proposals. Certain documents will not longer be required to be submitted with initial proposals, but will be requested at a later stage in the competitive process. Specifically, the travel policy, the annual financial statement, the total compensation plan, the subcontracting plan, and certain types of cost/pricing information will only be required to be submitted from those offerors included in the competitive range, or the apparent successful offeror. The special procedures for submission of this documentation are set forth in detail below:

    Travel Policy. The offeror's (and any proposed subcontractor's) written travel policy shall not be submitted with the initial business proposal. All offerors included in the competitive range will be required to submit a travel policy as a part of their final proposal revision.

    Annual Report. The offeror's most recent annual report shall not be submitted with the initial business proposal. All offerors included in the competitive range will be required submit a copy of their most recent annual report as a part of their final proposal revision.

    Total Compensation Plan. The offeror's total compensation plan shall not be submitted with the initial business proposal. All offerors included in the competitive range will be required submit a total compensation plan as a part of their final proposal revision.

    Subcontracting Plan. The offeror's Small Business Subcontracting Plan shall not be submitted with the initial business proposal. Only the apparent successful offeror will be required to submit an acceptable subcontracting plan.

    Cost/Pricing Information. The offeror's business proposal shall include the basic cost/pricing information specified in Section L.2.c.(1) of this RFP. In addition, the Government may require offerors included in the competitive range to submit additional information substantiating their proposed costs or prices. This additional cost/pricing information will be requested after establishment of the competitive range, and potentially includes payroll documentation, vendor quotes, invoice prices, and/or any other information deemed necessary by the contracting officer to evaluate the reasonableness of the price or to determine cost realism. The information may also include submission and certification of cost or pricing data.

  3. NAICS CODE AND SIZE STANDARD

    Note: The following information is to be used by the offeror in preparing its Representations and Certifications (See Section K of this RFP), specifically in completing the provision entitled, SMALL BUSINESS PROGRAM FAR Clause 52.219-1.

    1. The North American Industry Classification System (NAICS) code for this acquisition is 541710.

    2. The small business size standard is 500 employees.

    THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS. However, the Federal Acquisition Regulation (FAR) requires in EVERY solicitation, (except for foreign acquisitions) the inclusion of the North American Industry Classification (NAICS) Code and corresponding size standard which best describes the nature of the requirement in the solicitation.

  4. NOTICE OF PRICE EVALUATION ADJUSTMENT FOR SMALL DISADVANTAGED BUSINESS CONCERNS

    In accordance with FAR Clause 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns, incorporated in Section I.3., offerors will be evaluated by adding a factor of 10 percent to the price of all offers, except offers from small disadvantaged business concerns that have not waived the adjustment. (Note: A listing of other offerors who are excepted and will not have this evaluation factor added to their offer may be found in subparagraph (b) of FAR Clause 52.219-23.

    A small disadvantaged business concern may elect to waive the adjustment, in which case the factor will be added to its offer for evaluation purposes. The agreements in paragraph (d) of FAR Clause 52.219-23 do not apply to offerors that waive the adjustment.

    AN OFFEROR WHO ELECTS TO WAIVE THIS EVALUATION ADJUSTMENT MUST SPECIFICALLY INDICATE WITH A STATEMENT TO THIS EFFECT ON THE COVER PAGE OF ITS BUSINESS PROPOSAL.

  5. TYPE OF CONTRACT AND NUMBER OF AWARDS

    It is anticipated that up to three awards will be made from this solicitation and that the award(s) will be made on/about September 30, 2003. It is anticipated that the award(s) from this solicitation will be a multiple-year cost reimbursement completion type with a period of performance of five years and that incremental funding will be used [see Section L.2.c. Business Proposal Instructions].

  6. COMMITMENT OF PUBLIC FUNDS

    The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed procurement. Any other commitment, either explicit or implied, is invalid.

  7. COMMUNICATIONS PRIOR TO CONTRACT AWARD

    Offerors shall direct all communications to the attention of the Contract Specialist or Contracting Officer cited on the face page of this RFP. Communications with other officials may compromise the competitiveness of this acquisition and result in cancellation of the requirement.

  8. RELEASE OF INFORMATION

    Contract selection and award information will be disclosed to offerors in accordance with regulations applicable to negotiated acquisition. Prompt written notice will be given to unsuccessful offerors as they are eliminated from the competition, and to all offerors following award.

  9. COMPARATIVE IMPORTANCE OF PROPOSALS

    The relative importance of the evaluation factors are specified in SECTION M of this solicitation.

  10. REFERENCE MATERIALS

    RFP NHLBI-HB-03-07; "Somatic Cell Therapy Processing—Administrative Center"

  11. LEVEL OF FUNDING

    Awards are expected to be made on or about September 30, 2003 for a period of performance of five years. The NHLBI anticipates awarding up to three contracts at an estimated total cost (direct and indirect costs) of $8 million per award.

  12. CLINICAL RESEARCH/HUMAN SUBJECTS

    This project involves research on human subjects. It is expected that final products from the cell processing facilities will be used in clinical trials. Therefore, the facilities will bear the responsibility of producing the clinical grade reagent and assuring compliance with all regulatory requirements, and they will also assist the investigator in designing studies to test the efficacy and safety of the reagent. Applicable clauses will be incorporated into any resultant contract. Human subject assurance certification by the institution's IRB must be obtained prior to participant contact.

  13. PREPARATION COSTS

    This RFP does not commit the Government to pay for the preparation and submission of a proposal.

  14. SERVICE OF PROTEST (AUGUST 1996)—FAR 52.233-2

    1. Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the General Accounting Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

      Robert Best
      Chief, Contracts Operations Branch
      National Heart, Lung, and Blood Institute
      Rockledge Building (RKL2)
      6701 Rockledge Drive MSC 7902
      Bethesda, Maryland 20892—7902

    2. The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

    (End of Provision)

  15. LATE PROPOSALS AND REVISIONS, HHSAR 352.215-70

    Notwithstanding the procedures contained in FAR 52.215-1(c)(3) of the provision of this solicitation entitled Instructions to Offerors-Competitive Acquisition, a proposal received after the date specified for receipt may be considered if it offers significant cost or technical advantages to the Government; and it was received before proposals were distributed for evaluation, or within five calendar days after the exact time specified for receipt, whichever is earlier.

    (End of provision)

2. INSTRUCTIONS TO OFFERORS

  1. GENERAL INSTRUCTIONS

    INTRODUCTION

    The following instructions will establish the acceptable minimum requirements for the format and contents of proposals. Special attention is directed to the requirements for technical and business proposals to be submitted in accordance with these instructions.

    1. Contract Type and General Clauses

      It is anticipated that a cost-reimbursement completion type contract will be awarded. (See General Information) Any resultant contract shall include the clauses applicable to the selected offeror's organization and type of contract awarded as required by Public Law, Executive Order, or acquisition regulations in effect at the time of execution of the proposed contract.

    2. Authorized Official and Submission of Proposal The proposal must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this RFP. Your proposal shall be submitted in the number of copies, to the addresses, and marked as indicated in the Attachment entitled, PACKAGING AND DELIVERY OF PROPOSAL, Part III, Section J hereof. Proposals will be typewritten, paginated, reproduced on letter size paper and will be legible in all required copies. To expedite the proposal evaluation, all documents required for responding to the RFP should be placed in the following order:

      1. COVER PAGE Include RFP title, number, name of organization, identification of the proposal part, and indicate whether the proposal is an original or a copy.

      2. TECHNICAL PROPOSAL

        It is recommended that the technical proposal consist of a cover page, a table of contents, and the information requested in the Technical Proposal Instructions and as specified in SECTION J, List of Attachments.

      3. BUSINESS PROPOSAL

        It is recommended that the business proposal consist of a cover page, a table of contents, and the information requested in the Business Proposal Instructions and as specified in SECTION J, List of Attachments.

    3. Proposal Summary and Data Record (NIH-2043)

      The Offeror must complete the Form NIH-2043 (PDF format, MS Word format), attached, with particular attention to the length of time the proposal is firm and the designation of those personnel authorized to conduct negotiations. (See Section J, Attachment entitled, PROPOSAL SUMMARY AND DATA RECORD.)

    4. Separation of Technical and Business Proposals

      The proposal must be prepared in two parts: a "Technical Proposal" and a "Business Proposal." Each of the parts shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other. The technical proposal must include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs so that the offeror's understanding of the project may be evaluated (See Attachment entitled, TECHNICAL PROPOSAL COST INFORMATION/SUMMARY OF LABOR AND DIRECT COSTS [HTML format, MS Word format]). However, the technical proposal should not include pricing data relating to individual salary information, indirect cost rates or amounts, fee amounts (if any), and total costs. The technical proposal should disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions.

    5. Alternate Proposals

      You may, at your discretion, submit alternate proposals, or proposals which deviate from the requirements; provided, that you also submit a proposal for performance of the work as specified in the statement of work. Such proposals may be considered if overall performance would be improved or not compromised and if they are in the best interests of the Government. Alternative proposals, or deviations from any requirements of this RFP, shall be clearly identified.

    6. Evaluation of Proposals

      The Government will evaluate technical proposals in accordance with the criteria set forth in Part IV, Section M of this RFP.

    7. Potential Award Without Discussions

      The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial prices are fair and reasonable and that discussions are not necessary.

    8. Use of the Metric System of Measurement

      It is the policy of the Department of Health and Human Services to support the Federal transition to the metric system and to use the metric system of measurement in all procurement, grants, and other business related activities unless such use is impracticable or is likely to cause significant inefficiencies.

      The offeror is encouraged to prepare their proposal using either "Hard Metric," "Soft Metric," or "Dual Systems" of measurement. The following definitions are provided for your information:

      Hard Metric—The replacement of a standard inch-pound size with an accepted metric size for a particular purpose. An example of size substitution might be: selling or packaging liquids by the liter instead of by the pint or quart (as for soft drinks), or instead of by the gallon (as for gasoline).

      Soft Metric—The result of a mathematical conversion of inch-pound measurements to metric equivalents for a particular purpose. The physical characteristics are not changed.

      Dual Systems—The use of both inch-pound and metric systems. For example, an item is designed, produced, and described in inch-pound values with soft metric values also shown for information or comparison purposes.

      IMPORTANT NOTE TO OFFERORS: The following 6 paragraphs [(9) through (14)] shall be addressed in a SEPARATE SECTION of the Technical Proposal entitled, "HUMAN SUBJECTS." While it is understood that much of the language DOES NOT apply for proposal purposes, some of the information contained in the following paragraphs may apply, after contract award, to those manufactured products which will be used in clinical trials. Attachments/tables need NOT be completed at this time.

    9. Human Subjects

      The following notice is applicable when contract performance is expected to involve risk to human subjects:

      Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects (JANUARY 2001)

      1. Copies of the Department of Health and Human Services (Department) regulations for the protection of human subjects, 45 CFR Part 46, are available from the Office of Protection from Research Risks (OPRR), National Institutes of Health (NIH), Bethesda, Maryland 20892*. The regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the Department.

      2. The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. The regulations extend to the use of human organs, tissue and body fluids from individually identifiable human subjects as well as to graphic, written or recorded information derived from individually identifiable human subjects. The use of autopsy materials is governed by applicable State and local law and is not directly regulated by 45 CFR, Part 46.

      3. Activities in which the only involvement of human subjects will be in one or more of the categories set forth in 45 CFR 46.101(b)(1-6) are exempt from coverage.

      4. Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal. The National Institutes of Health will make a final determination of whether the proposed activities are covered by the regulations or are in an exempt category, based on the information provided in the proposal. In doubtful cases, prior consideration with OPRR*, (telephone: 301-496-7014*), is recommended.

      5. In accordance with 45 CFR, Part 46, prospective Contractors being considered for award shall be required to file with OPRR* an acceptable Assurance of Compliance with the regulations, specifying review procedures and assigning responsibilities for the protection of human subjects. The initial and continuing review of a research project by an institutional review board shall assure that the rights and welfare of the human subjects involved are adequately protected, that the risks to the subjects are reasonable in relation to the potential benefits, if any, to the subjects and the importance of the knowledge to be gained, and that informed consent will be obtained by methods that are adequate and appropriate. Prospective Contractors proposing research that involves human subjects shall be contacted by OPRR* and given detailed instructions for establishing an institutional review board and filing an Assurance of Compliance.

      6. It is recommended that OPRR* be consulted for advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects. (End of Provision)

      *Note: The Office for Human Research Protections (OHRP), Office of the Secretary (OS), Department of Health and Human Services (DHHS) is the office responsible for oversight of the Protection of Human subjects and should replace Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH) wherever it appears in this provision. The phone number to reach this office is 301-496-7005. For more information, the OHRP website may be accessed at http://ohrp.osophs.dhhs.gov/. Copies of the DHHS Regulations for the Protection of Human Subjects, 45 CFR Part 46, are also available on line at http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html.

    10. Instructions to Offerors Regarding Protection of Human Subjects

      Offerors must address the following human subjects protections issues if this contract will be for research involving human subjects (note: under each of the following points below, the offeror should indicate whether the information provided relates to the primary research site, or to a collaborating performance site(s), or to all sites:

      1. Risks to the subjects

        Human Subjects Involvement and Characteristics:

        • Describe the proposed involvement of human subjects in response to the solicitation.

        • Describe the characteristics of the subject population, including their anticipated number, age range, and health status.

        • Identify the criteria for inclusion or exclusion of any subpopulation. Explain the rationale for the involvement of special classes of subjects, such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be vulnerable populations.

        Sources of Materials:

        • Identify the sources of research material obtained from individually identifiable living human subjects in the form of specimens, records, or data. Indicate whether the material or data will be obtained specifically for research purposes or whether use will be made of existing specimens, records, or data.

        Potential Risks:

        • Describe the potential risks to subjects (physical, psychological, social, legal, or other) and assess their likelihood and seriousness to the subjects.

        • Describe alternative treatments and procedures, including the risks and benefits of the alternative treatments and procedures, to participants in the proposed research, where appropriate.

      2. Adequacy of Protection Against Risks

        Recruitment and Informed Consent:

        • Describe plans for the recruitment of subjects and the procedures for obtaining informed consent. Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent. The informed consent document for the contractor and any collaborating sites should be submitted only if requested elsewhere in the solicitation. Be aware that an IRB-approved informed consent document for the contractor and any participating collaborative sites must be provided to the Government prior to patient accrual or participant enrollment.

        Protection Against Risk:

        • Describe the procedures for protecting against or minimizing potential risks, including risks to confidentiality, and assess their likely effectiveness.

        • Discuss provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects where appropriate.

        • In studies that involve interventions, describe the provisions for data and safety monitoring of the research to ensure the safety of subjects.

      3. Potential Benefits of the Proposed Research to the Subjects and Others

        • Discuss the potential benefits of the research to the subjects and others.

        • Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and others.

        • Describe treatments and procedures that are alternatives to those provided to the participants by the proposed research, where appropriate.

      4. Importance of the Knowledge to be Gained

        • Discuss the importance of the knowledge gained or to be gained as a result of the proposed research.

        • Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge that may reasonably be expected to result.

      Note: If a test article (investigational new drug, device, or biologic) is involved, name the test article and state whether the 30-day interval between submission of offeror's certification to the Food and Drug Administration (FDA) and its response has elapsed or has been waived and/or whether the FDA has withheld or restricted use of the test article.

      Collaborating Site(s)

      When research involving human subjects will take place at collaborating site(s) or other performance site(s), the offeror must provide in this section of its proposal a list of the collaborating sites and their assurance numbers. Further, if you are awarded a contract, you must obtain in writing, and keep on file, an assurance from each site that the previous points have been adequately addressed at a level of attention that is at least as high as that documented at your organization. Site(s) added after an award is made must also adhere to the above requirements.

    11. Required Education in the Protection of Human Research Participants

      NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for contracts for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. Offerors should review the policy announcement prior to submission of their offers. The following is a summary of the Policy Announcement:

      For any solicitation for research involving human subjects, the offeror shall provide in its technical proposal the following information: (1) a list of the names of the principal investigator and any other individuals proposed under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program completed (or to be completed prior to the award of the contract) for each named personnel; (3) a one sentence description of the program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

      Curricula that are readily available and meet the educational requirement include the NIH on-line tutorial, titled "Protection of Human Research Subjects: Computer-Based Training for Researchers," available at http://ohsr.od.nih.gov/cbt/. You may download the information at this site at no cost and modify it, if desired. In addition, the University of Rochester has made its training program available for individual investigators. Completion of this program will also satisfy the educational requirement. The University of Rochester manual can be obtained through Centerwatch, Inc. at http://www.centerwatch.com/order/pubs_profs_protect.html. If an institution already has developed educational programs on the protection of research participants, completion of these programs also will satisfy the educational requirement.

      In addition, prior to the substitution of the principal investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the contractor shall provide the contracting officer with the title of the education program and a one sentence description of the program that the replacement has completed.

    12. Inclusion of Women and Minorities in Research Involving Human Subjects

      It is NIH policy that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. The Director, NIH, may determine that exclusion under other circumstances is acceptable, upon the recommendation of an Institute/Center Director, based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43), and applies to research subjects of all ages.

      All investigators proposing research involving human subjects should read the UPDATED "NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended October 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 at the following web site:

      http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

      These guidelines contain a definition of clinical research adopted in June 2001, as: "(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) Epidemiologic and behavioral studies; and (3) Outcomes research and health services research" (http://www.nih.gov/news/crp/97report/execsum.htm).

      Information Required for ALL Clinical Research Proposals

      This solicitation contains a review criterion addressing the adequacy of (1) the offeror's plans for inclusion of women and minorities in the research proposed; or (2) the offeror's justification(s) for exclusion of one or both groups from the research proposed.

      Provide information on the composition of the proposed study population in terms of sex/gender and racial/ethnic groups and provide a rationale for selection of such subjects in response to the requirements of the solicitation. The description may include (but is not limited to) information on the population characteristics of the disease or condition being studied in the planned research, and/or described in the statement of work, national and local demography, knowledge of the racial/ethnic/cultural characteristics of the population, prior experience and collaborations in recruitment and retention of the populations and subpopulations to be studied, and the plans, arrangements and letters of commitment from relevant community groups and organizations for the planned research.

      The proposal must include the following information:

      • A description of the subject selection criteria
      • The proposed dates of enrollment (beginning and end)
      • A description of the proposed outreach programs for recruiting women and minorities as subjects
      • A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group
      • The proposed sample composition using the "Targeted/Planned Enrollment Table"(see Section J, Attachments)

      NOTE 1: For all proposals, use the ethnic and racial categories and complete the "Targeted/Planned Enrollment Table in accordance with the Office of Management and Budget (OMB) Directive No. 15, which may be found at: http://www.whitehouse.gov/OMB/fedreg/ombdir15.html.

      NOTE 2: If this is an Indefinite Delivery, Indefinite Quantity (IDIQ) or Requirements contract as defined in FAR 16.5, the proposal should describe in general terms how it will comply with each bulleted item above for each task order. When the Government issues a task order request for proposal, each of the bulleted information items must be fully and specifically addressed in the proposal.

      Standards for Collecting Data. When you, as a contractor, are planning data collection items on race and ethnicity, you shall use, at a minimum, the categories identified in OMB Directive No. 15. The collection of greater detail is encouraged. However, you should design any additional, more detailed items so that they can be aggregated into these required categories. Self-reporting or self-identification using two separate questions is the preferred method for collecting data on race and ethnicity. When you collect race and ethnicity separately, you must collect ethnicity first. You shall offer respondents the option of selecting one or more racial designations. When you collect data on race and ethnicity separately, you shall also make provisions to report the number of respondents in each racial category who are Hispanic or Latino. When you present aggregate data, you shall provide the number of respondents who selected only one category, for each of the five racial categories. If you collapse data on multiple responses, you shall make available, at a minimum, the total number of respondents reporting "more than one race." Federal agencies shall not present data on detailed categories if doing so would compromise data quality or confidentiality standards.

      In addition to the above requirements, solicitations for NIH defined Phase III clinical trials (See NIH Guide http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm for the Definition of an "NIH-Defined Phase III clinical trial) require that: a) all proposals and/or protocols provide a description of plans to conduct analyses, as appropriate, to detect significant differences in intervention effect (see NIH Guide:

      http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm, Definitions—Significant Difference),
      by sex/gender, racial/ethnic groups, and relevant subpopulations, if applicable; and b) all contractors to report annually cumulative subject accrual, and progress in conducting analyses for sex/gender and race/ethnicity differences.

      Offerors may obtain copies of the Updated Guidelines from the sources above or from the contact person listed in the solicitation.

      Also, the proposal must include one of the following plans:

      • Plans to conduct valid analysis to detect significant differences in intervention effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly support these significant differences among subgroups, OR

      • Plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups, OR

      • Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect between subgroups.

      Use the form in Section J, Attachments, entitled, "Targeted/Planned Enrollment Table," when preparing your response to the solicitation requirements for inclusion of women and minorities.

      Unless otherwise specified in this solicitation, the Government has determined that the work required by this solicitation does not involve a sex/gender specific study or a single or limited number of minority population groups. Therefore, the NIH believes that the inclusion of women and minority populations is appropriate for this project. (See Section M of this RFP for more information about evaluation factors for award.)

      Use the format for the Annual Technical Progress Report for Clinical Research Study Populations (See Section J—List of Documents, Exhibits and Other Attachments of the RFP) entitled, "Inclusion Enrollment Report," for reporting in the resultant contract.

    13. Inclusion of Children in Research Involving Human Subjects

      It is NIH policy that children (defined below) must be included in all human subjects research, including, but not limited to, clinical trials, conducted under a contract funded by the NIH, unless there are clear and compelling reasons not to include them. (See examples of Justifications for Exclusion of Children below). For the purposes of this policy, contracts involving human subjects include categories that would otherwise be exempt from the DHHS Policy for Protection of Human Research Subjects (sections 101(b) and 401(b) of 45 CFR 46), such as surveys, evaluation of educational interventions, and studies of existing data or specimens that should include children as participants. This policy applies to both domestic and foreign research contracts.

      For purposes of this policy, a child is defined as an individual under the age of 21 years.

      All offerors proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" which was published in the NIH Guide for Grants and Contracts on March 6, 1998 and is available at the following URL address:

      http://www.nih.gov/grants/guide/notice-files/not98-024.html

      Offerors also may obtain copies from the contact person listed in the RFP.

      Inclusion of children as participants in research must be in compliance with all applicable subparts of 45 CFR 46 as well as other pertinent laws and regulations whether or not such research is otherwise exempted from 45 CFR 46. Therefore, any proposals must include a description of plans for including children, unless the offeror presents clear and convincing justification for an exclusion. The "Human Subjects" section of your technical proposal should provide either a description of the plans to include children and a rationale for selecting or excluding a specific age range of child, or an explanation of the reason(s) for excluding children as participants in the research. This solicitation contains a review criterion addressing the adequacy of: (1) the plans for including children as appropriate for the scientific goals of the research; and/or (2) the justification of exclusion of children or exclusion of a specific age range of children.

      When children are included, the plan also must include a description of: (1) the expertise of the investigative team for dealing with children at the ages included; (2) the appropriateness of the available facilities to accommodate the children; and, (3) the inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose/objective of the solicitation.

      Justifications for Exclusion of Children

      It is expected that children will be included in all research involving human subjects unless one or more of the following exclusionary circumstances can be fully justified:

      • The objective of the solicitation is not relevant to children.

        • There are laws or regulations barring the inclusion of children in the research to be conducted under the solicitation.

        • The knowledge being sought in the research is already available for children or will be obtained from another ongoing study, and an additional study will be redundant. You should provide documentation of other studies justifying the exclusion.

        • A separate, age-specific study in children is warranted and preferable. Examples include:

          • The relative rarity of the condition in children, as compared with adults (in that extraordinary effort would be needed to include children); or
          • The number of children is limited because the majority are already accessed by a nationwide pediatric disease research network; or
          • Issues of study design preclude direct applicability of hypotheses and/or interventions to both adults and children (including different cognitive, developmental, or disease stages of different age-related metabolic processes); or
          • Insufficient data are available in adults to judge potential risk in children (in which case one of the research objectives could be to obtain sufficient adult data to make this judgment). While children usually should not be the initial group to be involved in research studies, in some instances, the nature and seriousness of the illness may warrant their participation earlier based on careful risk and benefit analysis; or
          • Study designs aimed at collecting additional data on pre-enrolled adult study subjects (e.g., longitudinal follow-up studies that did not include data on children);
          • Other special cases justified by the offeror and found acceptable to the review group and the Institute Director

      Definition of a Child

      For the purpose of this solicitation, a child is defined as an individual under the age of 21 years. The definition of child described above will pertain to this solicitation (notwithstanding the FDA definition of a child as an individual from infancy to 16 years of age, and varying definitions employed by some states). Generally, State laws define what constitutes a "child," and such definitions dictate whether or not a person can legally consent to participate in a research study. However, State laws vary, and many do not address when a child can consent to participate in research. Federal Regulations (45 CFR 46, subpart D, Sec.401-409) address DHHS protections for children who participate in research, and rely on State definitions of "child" for consent purposes. Consequently, the children included in this policy (persons under the age of 21) may differ in the age at which their own consent is required and sufficient to participate in research under State law. For example, some states consider a person age 18 to be an adult and therefore one who can provide consent without parental permission.

    14. Data and Safety Monitoring in Clinical Trials

      All offerors are directed to the full text of the NIH Policies regarding Data and Safety Monitoring and Reporting of Adverse Events that are found in the NIH Guide for Grants and Contracts Announcements at the following web sites:

      http://grants.nih.gov/grants/guide/notice-files/not98-084.html
      http://grants.nih.gov/grants/guide/notice-files/not99-107.html
      http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

      All offerors receiving an award under this solicitation must comply with the NIH Policy cited in these NIH Announcements and any other data and safety monitoring requirements found elsewhere in this solicitation.

      The following is a brief summary of the Data and Safety Monitoring and Adverse Event Reporting Requirements:

      Data and Safety Monitoring is required for every clinical trial. Monitoring must be performed on a regular basis and the conclusions of the monitoring reported to the Project Officer.

      The type of data and safety monitoring required will vary based on the type of clinical trial and the potential risks, complexity and nature of the trial. A plan for data and safety monitoring is required for all clinical trials. A general description of a monitoring plan establishes the overall framework for data and safety monitoring. It should describe the entity that will be responsible for the monitoring, and the policies and procedures for adverse event reporting. Phase III clinical trials generally require the establishment of a Data Safety Monitoring Board (DSMB). The establishment of a DSMB is optional for Phase I and Phase II clinical trials.

      The DSMB/Plan is established at the time the protocol is developed and must be approved by both the Institutional Review Board (IRB) and the Government and in place before the trial begins. If the protocol will be developed under the contract awarded from this solicitation, a general description of the data and safety monitoring plan must be submitted as part of the proposal and will be reviewed by the scientific review group (Technical Evaluation Panel, (TEP)) convened to evaluate the proposal. If the protocol is developed and is included as part of the submitted proposal, a complete and specific data and safety monitoring plan must be submitted as part of the proposal.

      Monitoring Plans, at a minimum, must include the prompt reporting of adverse events to the IRB, the NIH Office of Biotechnology Activities (OBA), and the Food and Drug Administration (FDA). Also, in the plan you should describe the frequency of reporting of the conclusions of the monitoring activities. The overall elements of each plan may vary depending on the size and complexity of the trial. The NIH Policy for Data and Safety Monitoring at http://grants.nih.gov/grants/guide/notice-files/not98-084.html describes examples of monitoring activities to be considered.

      The frequency of monitoring will depend upon potential risks, complexity, and the nature of the trial; therefore a number of options for monitoring trials are available. These can include, but are not limited to, monitoring by a:

      • Principal Investigator (required)
      • Independent individual /Safety Officer
      • Designated medical monitor
      • Internal Committee or Board with explicit guidelines
      • Data and Safety Monitoring Board (DSMB—required for multisite trials)
      • Institutional Review Board (IRB—required)

      For multi-site Phase I and Phase II trials, a central reporting entity that will be responsible for preparing timely summary reports of adverse events for distribution among sites and IRBs should be considered.

      Organizations with a large number of clinical trials may develop standard monitoring plans for Phase I and Phase II trials. In this case, such organizations may include the IRB-approved monitoring plan as part of the proposal submission.

    15. Obtaining and Disseminating Biomedical Research Resources

      As a public sponsor of biomedical research, the National Institutes of Health (NIH) has a dual interest in accelerating scientific discovery and facilitating product development. Intellectual property restrictions can stifle the broad dissemination of new discoveries and limit future avenues of research and product development. At the same time, reasonable restrictions on the dissemination of research tools are sometimes necessary to protect legitimate proprietary interests and to preserve incentives for commercial development. To assist NIH contractors achieve an appropriate balance, the NIH has provided guidance in the form of a two-part document, consisting of Principles setting forth the fundamental concepts and Guidelines that provide specific information to patent and license professionals and sponsored research administrators for implementation.

      The purpose of these Principles and Guidelines is to assist NIH funding recipients in determining: 1) Reasonable terms and conditions for making NIH-funded research resources available to scientists in other institutions in the public and private sectors (disseminating research tools); and 2) Restrictions to accept as a conditions of receiving access to research tools for use in NIH-funded research (acquiring research tools). The intent is to help recipients ensure that the conditions they impose and accept on the transfer of research tools will facilitate further biomedical research, consistent with the requirements of the Bayh-Dole Act and NIH funding policy.

      This policy, entitled, "Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts," (Federal Register Notice, December 23, 1999 [64 FR 72090] will be included in any contract awarded from this solicitation. It can be found at the following website: http://ott.od.nih.gov/NewPages/64FR72090.pdf (PDF format).

    16. Privacy Act—Treatment of Proposal Information

      The Privacy Act of 1974 (P.L. 93-579) requires that a Federal agency advise each individual whom it asks to supply information, the authority which authorizes the solicitation, whether disclosure is voluntary or mandatory, the principal purpose or purposes for which the information is intended to be used, the uses outside the agency which may be made of the information, and the effects on the individual, if any, of not providing all or any part of the requested information.

      The NIH is requesting the information called for in this RFP pursuant to the authority provided by Sec. 301(a)(7) of the Public Health Service Act, as amended, and P.L. 92-218, as amended

      Providing the information requested is entirely voluntary. The collection of this information is for the purpose of conducting an accurate, fair, and adequate review prior to a discussion as to whether to award a contract.

      Failure to provide any or all of the requested information may result in a less than adequate review.

      In addition, the Privacy Act of 1974 (P.L. 93-579, Section 7) requires that the following information be provided when individuals are requested to disclose their social security number.

      Provision of the social security number is voluntary. Social security numbers are requested for the purpose of accurate and efficient identification, referral, review and management of NIH contracting programs. Authority for requesting this information is provided by Section 301 and Title IV of the PHS Act, as amended.

      The information provided by you may be routinely disclosed for the following purposes:

      • the cognizant audit agency and the General Accounting Office for auditing.
      • to the Department of Justice as required for litigation.
      • to respond to congressional inquiries.
      • to qualified experts, not within the definition of Department employees, for opinions as a part of the review process.

    17. Selection of Offerors

      1. The acceptability of the scientific and technical portion of each research contract proposal will be evaluated by a technical review committee. The committee will evaluate each proposal in strict conformity with the evaluation criteria of the RFP, utilizing point scores and written critiques. The committee may suggest that the Contracting Officer request clarifying information from an offeror.

      2. The business portion of each contract proposal will be subjected to a cost and/or price analysis, management analysis, etc.

      3. If award will be made without conducting discussions, offerors may be given the opportunity to clarify certain aspects of their proposal (e.g., the relevance of an offeror's past performance information and adverse past performance information to which the offeror has not previously had an opportunity to respond) or to resolve minor or clerical errors.

      4. If the Government intends to conduct discussions prior to awarding a contract—

        1. Communications will be held with offerors whose past performance information is the determining factor preventing them from being placed within the competitive range. Such communications shall address adverse past performance information to which an offeror has not had a prior opportunity to respond. Also, communications may be held with any other offerors whose exclusion from, or inclusion in, the competitive range is uncertain.

          Such communications shall not be used to cure proposal deficiencies or omissions that alter the technical or cost elements of the proposal, and/or otherwise revise the proposal, but may be considered in rating proposals for the purpose of establishing the competitive range.

        2. The Contracting Officer will, in concert with program staff, decide which proposals are in the competitive range. The competitive range will be comprised of all of the most highly rated proposals. Oral or written discussions will be conducted with all offerors in the competitive range.

          While it is NHLBI's policy to conduct discussions with all offerors in the competitive range, NHLBI reserves the right, in special circumstances, to limit the number of proposals included in the competitive range to the greatest number that will permit an efficient competition. All aspects of the proposals are subject to discussions, including cost, technical approach, past performance, and contractual terms and conditions. At the conclusion of discussions, each offeror still in the competitive range shall be given an opportunity to submit a written Final Proposal Revision (FPR) with the reservation of the right to conduct finalization of details with the selected source in accordance with HHSAR 315.370.

      5. The process described in FAR 15.101-1 will be employed, which permits the Government to make tradeoffs among cost and/or price and non-cost factors and to consider award to other than the lowest price offeror or other than the highest technically rated offeror. This process will take into consideration the results of the technical evaluation, the past performance evaluation (if applicable) and the cost analysis.

      6. The NHLBI reserves the right to make a single award, multiple awards, or no award at all to the RFP. In addition, the RFP may be amended or canceled as necessary to meet NHLBI requirements. Synopses of awards exceeding $25,000 will be published in the Commerce Business Daily only if a determination has been made that subcontracting opportunities exist.

    18. Small Business Subcontracting Plan

      **** This document is INCLUDED in the "Just In Time" procedures. Specific instructions for the submission of this document are outlined in SECTION L.1.b. of this RFP. ****

      If the proposed contract exceeds a total estimated cost of $500,000 for the entire period of performance, the apparent successful offeror shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," FAR Clause No.52.219-9, incorporated herein by reference in the Solicitation, Attachment __ (PDF format) to this RFP is an example of such a plan.

      1. THIS PROVISION DOES NOT APPLY TO SMALL BUSINESS CONCERNS.

      2. The term "subcontract" means any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government prime contractor or subcontractor calling for supplies or services required for the performance of the original contract or subcontract. This includes, but is not limited to, agreements/purchase orders for supplies and services such as equipment purchase, copying services, and travel services.

      3. The offeror understands that:

        1. No contract will be awarded unless and until an acceptable plan is negotiated with the Contracting Officer which plan will be incorporated into the contract, as a material part thereof.

        2. An acceptable plan must, in the determination of the Contracting Officer, provide the maximum practicable opportunity for Small Businesses, Small Disadvantaged Businesses, Women-Owned Small businesses, HubZone Small Businesses, Veteran-Owned Small Businesses, and Service Disabled Veteran-Owned Small Businesses to participate in the performance of the contract.

        3. If a subcontracting plan acceptable to the Contracting Officer is not negotiated within the time limits prescribed by the contracting activity and such failure arises out of causes within the control and with the fault or negligence of the offeror, the offeror shall be ineligible for an award. The Contracting Officer shall notify the Contractor in writing of the reasons for determining a subcontracting plan unacceptable early enough in the negotiation process to allow the Contractor to modify the plan within the time limits prescribed.

        4. Prior compliance of the offeror with other such subcontracting plans under previous contracts will be considered by the Contracting Officer in determining the responsibility of the offeror for award of the contract.

        5. It is the offeror's responsibility to develop a satisfactory subcontracting plan with respect to Small Business Concerns, Small Disadvantaged Business Concerns, Women-Owned Small Business Concerns, HubZone Small Business Concerns, Veteran-Owned Small Business Concerns, and Service Disabled Veteran-Owned Small Business Concerns that each such aspect of the offeror's plan will be judged independent of the other.

        6. The offeror will submit, as required by the Contracting Officer, subcontracting reports in accordance with the instructions thereon, and as further directed by the Contracting Officer. Subcontractors will also submit these reports to the Government's Contracting Officer or as otherwise directed, with a copy to the prime Contractor's designated small and disadvantaged business liaison.

      4. Each plan must contain the following:

        1. Goals, expressed in terms of percentages of total planned subcontracting dollars, for the use of Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Business Concerns as subcontractors.

        2. A statement of total dollars planned to be subcontracted. A statement of total dollars to be subcontracted to each of the following type of small business concerns: Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses.

        3. A description of the principal types of supplies and services to be subcontracted with an identification of which supplies and services are expected to be subcontracted to Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and/or Service Disabled Veteran-Owned Small Business Concerns.

        4. A description of the method used to develop the subcontracting goals.

        5. A description of the method used to identify potential sources for solicitation purposes.

        6. A statement as to whether or not indirect costs were included in establishing subcontracting goals. If they were, a description of the method used to determine the proportionate share of indirect costs to be incurred with Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses.

        7. The name of the individual employed by the offeror who will administer the offeror's subcontracting program and a description of his/her duties.

        8. A description of the efforts the offeror will make to assure that Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses have an equitable chance to compete for subcontracts.

        9. Assurances that the offeror will include in all subcontracts the contract clause "Utilization of Small Business Concerns." Assure that all subcontractors, other than small businesses, in excess of $500,000 adopt a plan similar to the plan agreed upon by the offeror.

        10. Assurances that the offeror (and any required subcontractors) will cooperate in studies or surveys as required and submit required reports (SF 294 and SF 295) to the Government.

        11. List the types of records the offeror will maintain to demonstrate procedures that have been adopted to comply with the requirement and goals in the plan, including establishing source lists. Also, the offeror shall describe its efforts to locate Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses and award subcontracts to them.

        For additional information about each of the above elements required to be contained the subcontracting plan, see FAR Clause 52.219-9, Small Business Subcontracting Plan, and the Sample Subcontracting Plan (PDF format) which is provided as an attachment to this RFP in SECTION J.

        HHS expects each procuring activity to establish minimum subcontracting goals for all procurements. The anticipated minimum goals for this RFP will be determined at a later date.

        _____% for Small Business; _____% for Small Disadvtaged Business; _____%for Women-Owned Small Business; _____% for HubZone Small Business; and _____% for Veteran-Owned Small Business and Service-Disabled Veteran-Owned Small Business.

    19. HUBZone Small Business Concerns

      Small Business offerors located in underutilized business zones, called "HUBZones," will be evaluated in accordance with FAR Clause 52.219-4, NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZONE SMALL BUSINESS CONCERNS, which is incorporated by reference in ARTICLE I.3. of this solicitation. Qualified HUBZone firms are identified in the Small Business Administration website at http://www.sba.gov/hubzone.

    20. Extent of Small Disadvantaged Business Participation

      In accordance with FAR part 15.304(c)(4), the extent of participation of Small Disadvantaged Business (SDB) concerns in performance of the contract in the authorized SIC Major Groups will be evaluated in unrestricted competitive acquisitions expected to exceed $500,000 ($1,000,000 for construction) subject to certain limitations (see FAR 19.1202-1 and 19.1202-2(b). The dollar amounts cited above include any option years/option quantities that may be included in this solicitation. The definition of a "small disadvantaged business" is cited in FAR 19.001.

      NOTE: The SDB Participation Plan is a separate requirement from the Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan described elsewhere in this solicitation, if applicable. Offerors shall submit a Small Disadvantaged Business Participation Plan which includes the following information in one clearly marked section of their business proposal:

      A plan on the extent of participation of SDB concerns in performance of the contract. Participation in performance of the contract includes the work expected to be performed by SDB concern(s). This can include SDB (as prime contractor), joint ventures, teaming arrangements, and subcontracts. Include the following information in your SDB participation plans:

      1. The extent of an offerors commitment to use SDB concerns. Commitment should be as specific as possible, e.g., are subcontract arrangements already in place; are letters of commitment in place. Enforceable commitments will be weighted more heavily than non-enforceable ones;
      2. Specifically identify the SDB concerns with point of contact and telephone number;
      3. The complexity and variety of the work SDB concerns are to perform;.
      4. Realism for the use of SDB in the proposal;
      5. Past performance of the offeror in complying with subcontracting plans for SDB concerns;
      6. Targets expressed as dollars and percentage of total contract value, in each of the applicable authorized SIC Major Group(s). A total target for SDB participation by the prime contractor that includes any joint ventures and team members* shall be provided, as well as a total target for SDB participation by subcontractors. Targets may be incorporated into and become part of any resulting contract; and
      7. The extent of participation of SDB concerns in terms of the value of the total acquisition.

      *NOTE: FAR Subpart 9.6 defines "Contractor team arrangements" to include two or more companies forming a partnership or joint venture to act as a potential prime contractor, or a potential prime contractor who agrees with one or more companies to have them act as its subcontractors on a specific contract or acquisition program. For purposes of evaluation of the SDB participation factor, FAR 19.1202-4 requires that SDB joint ventures and teaming arrangements at the prime level be presented separately from SDB participation by subcontractors.

      SDB participation information furnished in the plan described above will be used as an evaluation factor (see Section M. Evaluation Criteria, Small Disadvantaged Business Participation Factor.) The Government will focus on information that demonstrates realistic commitments to use SDB concerns relative to the size and complexity of the acquisition under consideration. Also, references other than those identified by the offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the offeror's commitment to SDB participation.

      The Government is seeking to determine whether the offeror has demonstrated a commitment to use SDB concerns for the work that it intends to perform as the prime contractor. The assessment of the offeror's SDB Participation Plan will be used as a means of evaluating the relative capability and commitment of the offeror and the other competitors, e.g., an offeror with an exceptional record of participation with SDB concerns may receive a more favorable evaluation than another whose record of participation with SDB concerns is acceptable, even though both may have acceptable technical proposals.

      NOTE: Offers to rely on SDB concerns merely for such activities as provision of supplies and basic services such as travel arrangements, unless such supplies and arrangements are of significant value and are an integral part of contract performance, will be considered of negligible value for the purposes of evaluating the SDB participation plan.

    21. Reimbursement of Costs for Independent Research and Development Projects (Commercial Organizations Only)

      The primary purpose of the Public Health Service (PHS) is to support and advance independent research within the scientific community. This support is provided in the form of contracts and grants totaling approximately 7 billion dollars annually. PHS has established effective, time tested and well recognized and accepted procedures for stimulating and supporting this independent research by selecting from multitudes of proposals those research projects most worthy of support within the constraints of its appropriations. The reimbursement of independent research and development costs not incidental to product improvement, through the indirect cost mechanism, would circumvent this competitive process.

      To ensure that all research and development projects receive similar and equal consideration, all offerors may compete for direct funding for independent research and development projects they consider worthy of support by submitting those projects to the appropriate Public Health Service grant and/or contract office for review. Since these projects may be submitted for direct funding, the successful offeror agrees that no costs for any independent research and development project, including applicable indirect costs, will be claimed under any contract resulting from this solicitation.

    22. Salary Rate Limitation in Fiscal Year 2003*

      Offerors are advised that pursuant to P.L. *, no NIH Fiscal Year 2003 (October 1, 2002—September 30, 2003) funds may be used to pay the direct annual salary of an individual through any contract awarded as a result of this solicitation at a rate in excess of the Executive Schedule, Level I* (direct salary is exclusive of Overhead, Fringe Benefits and General and Administrative expenses, also referred to as "indirect cost" or "facilities and administrative (F&A) costs"). Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the contractor pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the contractor.

      This does not preclude the offeror from absorbing that portion of an employee's annual salary (plus the dollar amount for fringe benefits and associated indirect costs) that exceeds a rate of the Executive Schedule, Level I*. The salary rate limitation set by P.L. * applies only to Fiscal Year 2002 funds, however, salary rate ceilings for subsequent years may be included in future DHHS appropriation acts. Multi-year contracts awarded pursuant to this solicitation may be subject to unilateral modifications by the Government if an individual's annual salary exceeds any salary rate ceiling established in future appropriations acts. The Executive Schedule, Level I* annual salary rate limit also applies to individuals proposed under subcontracts, however it does not apply to consultants. P.L. * states in pertinent part:

      "None of the funds appropriated in this Act for the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Substance Abuse, and Mental Health Services Administration shall be used to pay the salary of an individual through a grant or extramural mechanism at a rate in excess of Executive Level I."

      Link to Executive Schedule Salaries: http://www.opm.gov/oca/PAYRATES/index.htm
      * pending passage of FY-2003 legislation

    23. Institutional Responsibility Regarding Conflicting Interests of Investigators

      EACH INSTITUTION MUST:

      1. Maintain an appropriate written, enforced policy on conflict of interest that complies with 42 CFR Part 50 Subpart F and/or 45 CFR Part 94 as appropriate and inform each investigator of the Institution's policy, the Investigator's reporting responsibilities, and the applicable regulations. If the Institution carries out the NIH funded research through subgrantees, contractors or collaborators, the Institution must take reasonable steps to ensure that Investigators working for such entities comply with the regulations, either by requiring those investigators to comply with the Institution's policy or by requiring the entities to provide assurances to the Institution that will enable the Institution to comply with the regulations.

      2. Designate an Institutional official(s) to solicit and review financial disclosure statements from each Investigator who is planning to participate in NIH-funded research.

      3. Require that by the time an application/proposal is submitted to the NIH each investigator who is planning to participate in the NIH-funded research has submitted to the designated official(s) a listing of his/her known Significant Financial Interests (and those of his/her spouse and dependent children): (i) that would reasonably appear to be affected by the research for which the NIH funding is sought; and (ii) in entities whose financial interests would reasonably appear to be affected by the research. All financial disclosures must be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained.

      4. Provide guidelines consistent with the regulations for the designated official(s) to identify conflicting interests and take such actions as necessary to ensure that such conflicting interests will be managed, reduced, or eliminated.

      5. Maintain records, identifiable to each award, of all financial disclosures and all actions taken by the institution with respect to each conflicting interest for: (1) in the case of grants, at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 CFR Part 74.53(b) and (2) in the case of contracts, 3 years after final payment or, where applicable, for the other time period specified in 48 CFR Part 4 Subpart 4.7, Contract Records Retention.

      6. Establish adequate enforcement mechanisms and provide for sanctions where appropriate.

      7. Certify, in each application/proposal for funding to which the regulations applies, that:

        1. there is in effect at the Institution a written and enforced administrative process to identify and manage, reduce or eliminate conflicting interests with respect to all research projects for which funding is sought from the NIH;

        2. prior to the Institution's expenditure of any funds under the award, the Institution will report to the awarding component the existence of a conflicting interest (but not the nature of the interest or other details) found by the Institution and assure that the interest has been managed, reduced or eliminated in accord with the regulations; and for any interest that the Institution identifies as conflicting subsequent to the expenditure of funds after award, the report will be made and the conflicting interest managed, reduced, or eliminated, at least on a temporary basis within sixty days of that identification;

        3. the Institution agrees to make information available, upon request, to the awarding component regarding all conflicting interests identified by the Institution and how those interested have been managed, reduced, or eliminated to protect the research from bias; and

        4. the Institution will otherwise comply with the regulations.

        Institutional Management of Conflicting Interests

        1. The designated official(s) must: (1) review all financial disclosures; and (2) determine whether conflict of interest exists, and if so, determine what actions should be taken by the Institution to manage, reduce or eliminate such conflict of interest. A conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.

          Examples of conditions or restrictions that might be imposed to manage actual or potential conflicts of interests include, but are not limited to:

          1. public disclosure of significant financial interests;
          2. monitoring of research by independent reviewers;
          3. modification of the research plan;
          4. disqualification of the Investigator(s) from participation in all or a portion of the research funded by the awarding component;
          5. divestiture of significant financial interests; or
          6. severance of relationships that create actual or potential conflicts of interests.

        2. An Institution may require the management of other conflicting financial interests in addition to those described in paragraph (a) of this section, as the Institution deems appropriate.

    24. ROTC Access and Federal Military Recruiting on Campus

      Section 514 of the FY 1997 Appropriations Act prohibits NIH from providing contract funds to educational institutions that the Secretary of Defense determines have a policy or practice (regardless of when implemented) that either prohibits or in effect prevents (1) the maintaining, establishing, or operation of a unit of the Senior Reserve Officer Training Corps at the covered education entity; or (2) a student at the covered educational entity from enrolling in a unit of the Senior Reserve Officer Training Corps at another institution of higher education.

      Further, contract funds may not be provided to educational institutions that have a policy or practice that prohibits or prevents (1) entry to campuses, or access to students (who are 17 years of age or older) on campuses, for purposes of Federal military recruiting; or (2) access by military recruiters for purposes of Federal military recruiting to information pertaining to students (who are 17 years or older) enrolled at the covered educational entity.

    25. Solicitation Provisions Incorporated by Reference, FAR 52.252-1 (February 1998)

      This Solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address: http://www.arnet.gov/far/.

      FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1):

      1. Facilities Capital Cost of Money, FAR Clause 52.215-16, (October 1997).
      2. Order of Precedence-Uniform Contract Format, FAR Clause 52.215-8, (October 1997).
      3. Preaward On-Site Equal Opportunity Compliance Evaluation, (Over $10,000,000), FAR Clause 52.222-24, (February 1999).

    26. Uniform Resource Locations (URLs) in Contract Proposals

      All proposals must be self-contained within the specific page limitations cited elsewhere in this solicitation. Unless otherwise specified, URLs/Internet addresses shall not be used to provide information necessary to the review because reviewers are under no obligation to review the Internet sites.

    27. Page and Formatting Limitations

      The Technical Plan (objectives, approach, methods and procedures, and schedule) of the Technical Proposal shall not exceed 40 single-sided pages or 20 double-sided pages. This page limitation does not apply to the cover sheet, abstract, table of contents, personnel, facilities, equipment and resources, other considerations, other support, cost information, and literature cited. Appendices shall be limited to 100 single-sided pages or 50 double-sided pages. Pages in excess of this will be deleted and will be neither read nor evaluated. Each page of the Technical Proposal must be numbered sequentially. Offerors are encouraged to limit the overall size of the Technical Proposal, inclusive of appendices, attachments, etc. Note that although no page limit has been placed on the Business Proposal, offerors are encouraged to limit its content to only those documents necessary to provide adequate support for the proposed costs.

      Type density and size must be 10 to 12 points. If constant spacing is used, 15 cpi (characters per inch) or fewer shall be used, whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch. Margins must be set to one inch around.

    28. Past Performance Information

      1. Offerors shall submit the following information as part of their business proposals (for both the offeror and proposed major subcontractors): A list of the contracts completed during the past two years and all contracts currently in progress for products or services similar to the solicitation workscope. Contracts listed may include those entered into with the Federal Government, agencies of state and local governments and commercial customers. Offerors that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. Include the following information for each contract or subcontract:
        1. Name of Contracting Organization
        2. Contract Number (for subcontracts, provide the prime contract number and subcontract number)
        3. Contract Type
        4. Total Contract Value
        5. Description of Requirement
        6. Contracting Officer's Name and Telephone Number
        7. Project Officer's Name and Telephone Number

      2. Each offeror will be evaluated on its performance under existing and prior contracts for similar products or services. Performance information will be used for responsibility determinations. The Government will focus on information that demonstrates quality of performance relative to the size and complexity of the acquisition under consideration. The Government is not required to contact all references provided by the offeror. References other than those identified by the offeror may be contacted by the Government to obtain additional information that will be used in the responsibility determination.

  2. TECHNICAL PROPOSAL INSTRUCTIONS

    A detailed work plan must be submitted indicating how each aspect of the statement of work is to be accomplished. Your technical approach should be in as much detail as you consider necessary to fully explain your proposed technical approach or method. The technical proposal should reflect a clear understanding of the nature of the work being undertaken. The technical proposal must include information on how the project is to be organized, staffed, and managed. Information should be provided which will demonstrate your understanding and management of important events or tasks.

    1. Technical Discussions

      The technical discussion included in the technical proposal should respond to the items set forth below:

      1. Project Objectives, NIH-1688-1

        The offeror shall insert a completed NIH Form 1688-1, Project Objective (PDF format), as provided in Section J, Attachments, behind the Title Page of each copy of the proposal, along with the "Government Notice for Handling Proposals." The NIH Form 1688-1 is to be completed as follows:

        • For an Institution of Higher Education: The form MUST be completed in its entirety.
        • For OTHER than an Institution of Higher Education: The starred items (Department, Service, Laboratory or Equivalent, and Major Subdivision) should be left blank.

        The information required under the "Summary of Objectives" portion of the form MUST meet the requirements set forth in the section of the form entitled, "INSTRUCTIONS:"

      2. Statement of Work

        1. Objectives

          State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and relation to comparable work in progress elsewhere. Review pertinent work already published which is relevant to this project and your proposed approach. This should support the scope of the project as you perceive it.

        2. Approach

          Use as many subparagraphs, appropriately titled, as needed to clearly outline the general plan of work. Discuss phasing of research and, if appropriate, include experimental design and possible or probable outcome of approaches proposed.

        3. Methods

          Describe in detail the methodologies you will use for the project, indicating your level of experience with each, areas of anticipated difficulties, and any unusual expenses you anticipate.

        4. Schedule

          Provide a schedule for completion of the work and delivery of items specified in the statement of work. Performance or delivery schedules shall be indicated for phases or segments, as applicable, as well as for the overall program. Schedules shall be shown in terms of calendar months from the date of authorization to proceed or, where applicable, from the date of a stated event, as for example, receipt of a required approval by the Contracting Officer. Unless the request for proposal indicates that the stipulated schedules are mandatory, they shall be treated as desired or recommended schedules. In this event, proposals based upon the offeror's best alternative schedule, involving no overtime, extra shift or other premium, will be accepted for consideration.

      3. Personnel

        Describe the experience and qualifications of personnel who will be assigned for direct work on this program. Information is required which will show the composition of the task or work group, its general qualifications, and recent experience with similar equipment or programs. Special mention shall be made of direct technical supervisors and key technical personnel, and the approximate percentage of the total time each will be available for this program.

        OFFERORS SHOULD ASSURE THAT THE PRINCIPAL INVESTIGATOR, AND ALL OTHER PERSONNEL PROPOSED, SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND CONTRACTS FOR MORE THAN A TOTAL OF 100% OF THEIR TIME. IF THE SITUATION ARISES WHERE IT IS DETERMINED THAT A PROPOSED EMPLOYEE IS COMMITTED FOR MORE THAN 100% OF HIS OR HER TIME, THE GOVERNMENT WILL REQUIRE ACTION ON THE PART OF THE OFFEROR TO CORRECT THE TIME COMMITMENT.

        1. Principal Investigator/Project Director

          List the name of the Principal Investigator/Project Director responsible for overall implementation of the contract and key contact for technical aspects of the project. Even though there may be co-investigators, identify the Principal Investigator/Project Director who will be responsible for the overall implementation of any awarded contract. Discuss the qualifications, experience, and accomplishments of the Principal Investigator/Project Director. State the estimated time to be spent on the project, his/her proposed duties, and the areas or phases for which he/she will be responsible.

        2. Other Investigators

          List all other investigators/professional personnel who will be participating in the project. Discuss the qualifications, experience, and accomplishments. State the estimated time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible.

        3. Additional Personnel

          List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis. The technical areas, character, and extent of subcontract or consultant activity will be indicated and the anticipated sources will be specified and qualified. For all proposed personnel who are not currently members of the offeror's staff, a letter of commitment or other evidence of availability is required. A resume does not meet this requirement. Commitment letters for use of consultants and other personnel to be hired must include:

          • The specific items or expertise they will provide.

          • Their availability to the project and the amount of time anticipated.

          • Willingness to act as a consultant.

          • How rights to publications and patents will be handled.

        4. Resumes

          Resumes of all key personnel are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications.

    2. Technical Evaluation

      Proposals will be technically evaluated in accordance with the factors, weights, and order of relative importance as described in the Technical Evaluation Criteria (Section M.___, hereof).

    3. Additional Technical Proposal Information

      1. Proposals which merely offer to conduct a program in accordance with the requirements of the Government's scope of work will not be eligible for award. The offeror must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives.

      2. The technical evaluation is conducted in accordance with the weighted technical evaluation criteria by an initial review panel. This evaluation produces a numerical score (points) which is based upon the information contained in the offeror's proposal only.

    4. Other Considerations

      Record and discuss specific factors not included elsewhere which support your proposal. Using specifically titled subparagraphs, items may include:

      1. Any agreements and/or arrangements with subcontractor(s). Provide as much detail as necessary to explain how the statement of work will be accomplished within this working relationship.

      2. Unique arrangements, equipment, etc., which none or very few organizations are likely to have which is advantageous for effective implementation of this project.

      3. Equipment and unusual operating procedures established to protect personnel from hazards associated with this project.

      4. Other factors you feel are important and support your proposed research.

      5. Recommendations for changing reporting requirements if such changes would be more compatible with the offeror's proposed schedules.

  3. BUSINESS PROPOSAL INSTRUCTIONS

    1. Basic Cost/Price Information

      The business proposal must contain sufficient information to allow the Government to perform a basic analysis of the proposed cost or price of the work. This information shall include the amounts of the basic elements of the proposed cost or price. These elements will include, as applicable, direct labor, fringe benefits, travel, materials, subcontracts, purchased parts, shipping, indirect costs and rate, fee, and profit.

    2. Cost and Pricing Data

      **** This document is INCLUDED in the "Just In Time" procedures. Specific instructions for the submission of this document are outlined in SECTION L.1.b. of this RFP. ****

      1. General Instructions

        1. You must provide the following information on the first page of your pricing proposal:

          1. Solicitation, contract, and/or modification number;
          2. Name and address of offeror;
          3. Name and telephone number of point of contact;
          4. Name of contract administration office (if available);
          5. Type of contract action (that is, new contract, change order, price revision/redetermination, letter contract, unpriced order, or other);
          6. Proposed cost; profit or fee; and total;
          7. Whether you will require the use of Government property in the performance of the contract, and, if so, what property;
          8. Whether your organization is subject to cost accounting standards; whether your organization has submitted a CASB Disclosure Statement, and if it has been determined adequate; whether you have been notified that you are or may be in noncompliance with your Disclosure Statement or CAS, and, if yes, an explanation; whether any aspect of this proposal is inconsistent with your disclosed practices or applicable CAS, and, if so, an explanation; and whether the proposal is consistent with your established estimating and accounting principles and procedures and FAR Part 31, Cost Principles, and, if not, an explanation;
          9. The following statement: This proposal reflects our estimates and/or actual costs as of this date and conforms with the instructions in FAR 15.403-5(b)(1) and Table 15-2. By submitting this proposal, we grant the Contracting Officer and authorized representative(s) the right to examine, at any time before award, those records, which include books, documents, accounting procedures and practices, and other data, regardless of type and form or whether such supporting information is specifically referenced or included in the proposal as the basis for pricing, that will permit an adequate evaluation of the proposed price;
          10. Date of submission; and
          11. Name, title and signature of authorized representative

        2. In submitting your proposal, you must include an index, appropriately referenced, of all the cost or pricing data and information accompanying or identified in the proposal. In addition, you must annotate any future additions and/or revisions, up to the date of agreement on price, or an earlier date agreed upon by the parties, on a supplemental index.

        3. As part of the specific information required, you must submit, with your proposal, cost or pricing data (that is, data that are verifiable and factual and otherwise as defined at FAR 15.401). You must clearly identify on your cover sheet that cost or pricing data are included as part of the proposal. In addition, you must submit with your proposal any information reasonably required to explain your estimating process, including—

          1. The judgmental factors applied and the mathematical or other methods used in the estimate, including those used in projecting from known data; and
          2. The nature and amount of any contingencies included in the proposed price.

        4. You must show the relationship between contract line item prices and the total contract price. You must attach cost-element breakdowns for each proposed line item, using the appropriate format prescribed in the "Formats for Submission of Line Item Summaries'' section of this table. You must furnish supporting breakdowns for each cost element, consistent with your cost accounting system.

        5. When more than one contract line item is proposed, you must also provide summary total amounts covering all line items for each element of cost.

        6. Whenever you have incurred costs for work performed before submission of a proposal, you must identify those costs in your cost/price proposal.

        7. If you have reached an agreement with Government representatives on use of forward pricing rates/factors, identify the agreement, include a copy, and describe its nature.

        8. As soon as practicable after final agreement on price or an earlier date agreed to by the parties, but before the award resulting from the proposal, you must, under the conditions stated in FAR 15.406-2, submit a Certificate of Current Cost or Pricing Data.

      2. Cost Elements

        Depending on your system, you must provide breakdowns for the following basic cost elements, as applicable:

        1. Materials and services. Provide a consolidated priced summary of individual material quantities included in the various tasks, orders, or contract line items being proposed and the basis for pricing (vendor quotes, invoice prices, etc.). Include raw materials, parts, components, assemblies, and services to be produced or performed by others. For all items proposed, identify the item and show the source, quantity, and price. Conduct price analyses of all subcontractor proposals. Conduct cost analyses for all subcontracts when cost or pricing data are submitted by the subcontractor. Include these analyses as part of your own cost or pricing data submissions for subcontracts expected to exceed the appropriate threshold in FAR 15.403-4. Submit the subcontractor cost or pricing data as part of your own cost or pricing data as required in paragraph 2.A(2) of this table. These requirements also apply to all subcontractors if required to submit cost or pricing data.

          1. Adequate Price Competition. Provide data showing the degree of competition and the basis for establishing the source and reasonableness of price for those acquisitions (such as subcontracts, purchase orders, material order, etc.) exceeding, or expected to exceed, the appropriate threshold set forth at FAR 15.403-4 priced on the basis of adequate price competition. For interorganizational transfers priced at other than the cost of comparable competitive commercial work of the division, subsidiary, or affiliate of the contractor, explain the pricing method (see FAR 31.205-26(e)).

          2. All Other. Obtain cost or pricing data from prospective sources for those acquisitions (such as subcontracts, purchase orders, material order, etc.) exceeding the threshold set forth in FAR 15.403-4 and not otherwise exempt, in accordance with FAR 15.403-1(b) (i.e., adequate price competition, commercial items, prices set by law or regulation or waiver). Also provide data showing the basis for establishing source and reasonableness of price. In addition, provide a summary of your cost analysis and a copy of cost or pricing data submitted by the prospective source in support of each subcontract, or purchase order that is the lower of either $10,000,000 or more, or both more than the pertinent cost or pricing data threshold and more than 10 percent of the prime contractor's proposed price. The Contracting Officer may require you to submit cost or pricing data in support of proposals in lower amounts. Subcontractor cost or pricing data must be accurate, complete and current as of the date of final price agreement, or an earlier date agreed upon by the parties, given on the prime contractor's Certificate of Current Cost or Pricing Data. The prime contractor is responsible for updating a prospective subcontractor's data. For standard commercial items fabricated by the offeror that are generally stocked in inventory, provide a separate cost breakdown, if priced based on cost. For interorganizational transfers priced at cost, provide a separate breakdown of cost elements. Analyze the cost or pricing data and submit the results of your analysis of the prospective source's proposal. When submission of a prospective source's cost or pricing data is required as described in this paragraph, it must be included along with your own cost or pricing data submission, as part of your own cost or pricing data. You must also submit any other cost or pricing data obtained from a subcontractor, either actually or by specific identification, along with the results of any analysis performed on that data.

        2. Direct Labor. Provide a time-phased (e.g., monthly, quarterly, etc.) breakdown of labor hours, rates, and cost by appropriate category, and furnish bases for estimates.

        3. Indirect Costs. Indicate how you have computed and applied your indirect costs, including cost breakdowns. Show trends and budgetary data to provide a basis for evaluating the reasonableness of proposed rates. Indicate the rates used and provide an appropriate explanation.

        4. Other Costs. List all other costs not otherwise included in the categories described above (e.g., special tooling, travel, computer and consultant services, preservation, packaging and packing, spoilage and rework, and Federal excise tax on finished articles) and provide bases for pricing.

        5. Royalties. If royalties exceed $1,500, you must provide the following information on a separate page for each separate royalty or license fee:

          1. Name and address of licensor.
          2. Date of license agreement.
          3. Patent numbers.
          4. Patent application serial numbers, or other basis on which the royalty is payable.
          5. Brief description (including any part or model numbers of each contract item or component on which the royalty is payable).
          6. Percentage or dollar rate of royalty per unit.
          7. Unit price of contract item.
          8. Number of units.
          9. Total dollar amount of royalties.
          10. If specifically requested by the Contracting Officer, a copy of the current license agreement and identification of applicable claims of specific patents (see FAR 27.204 and 31.205-37).

        6. Facilities Capital Cost of Money. When you elect to claim facilities capital cost of money as an allowable cost, you must submit Form CASB-CMF and show the calculation of the proposed amount (see FAR 31.205-10).

      3. Formats for Submission of Line Item Summaries

        The detailed breakdown shall be in the format as shown on the form Breakdown of Proposed Estimated Cost (plus fee) and Labor Hours (Section J, List of Attachments). For each separate cost estimate, the offeror must furnish a breakdown by cost element as indicated above. In addition, summary total amounts shall be furnished. In the event the RFP cites specific line items, by number, a cost breakdown for each line item must be furnished.

        To assist in the preparation of future cost estimates, the Projected Consumer Price Index may be accessed at: http://rcb.nci.nih.gov/forms/cpi.htm

      4. There is a clear distinction between submitting cost or pricing data and merely making available books, records, and other documents without identification. The requirement for submission of cost or pricing data is met when all accurate cost or pricing data reasonably available to the offeror have been submitted, either actually or by specific identification, to the Contracting Officer or an authorized representative. As later information comes into your possession, it should be submitted promptly to the Contracting Officer in a manner that clearly shows how the information relates to the offeror's price proposal. The requirement for submission of cost or pricing data continues up to the time of agreement on price, or an earlier date agreed upon between the parties if applicable.

      5. By submitting your proposal, you grant the Contracting Officer or an authorized representative the right to examine records that formed the basis for the pricing proposal. That examination can take place at any time before award. It may include those books, records, documents, and other types of factual information (regardless of form or whether the information is specifically referenced or included in the proposal as the basis for pricing) that will permit an adequate evaluation of the proposed price.

        **** (Please note that data substantiating the costs or prices proposed (i.e. payroll documentation, vendor quotes, invoice price, etc.) shall not be submitted with the initial proposal. This information will be requested from the offeror during the negotiation process. The initial proposal need only indicate from what source the proposed costs and prices are substantiated.) ****

    3. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data[FAR Clause 52.215-20 (October 1997)]

      1. Exceptions from cost or pricing data.

        1. In lieu of submitting cost or pricing data, offerors may submit a written request for exception by submitting the information described in the following subparagraphs. The Contracting Officer may require additional supporting information, but only to the extent necessary to determine whether an exception should be granted, and whether the price is fair and reasonable.

          1. Identification of the law or regulation establishing the price offered. If the price is controlled under law by periodic rulings, reviews, or similar actions of a governmental body, attach a copy of the controlling document, unless it was previously submitted to the contracting office.

          2. Commercial item exception. For a commercial item exception, the offeror shall submit, at a minimum, information on prices at which the same item or similar items have previously been sold in the commercial market that is adequate for evaluating the reasonableness of the price for this acquisition. Such information may include—

            1. For catalog items, a copy of or identification of the catalog and its date, or the appropriate pages for the offered items, or a statement that the catalog is on file in the buying office to which the proposal is being submitted. Provide a copy or describe current discount policies and price lists (published or unpublished), e.g., wholesale, original equipment manufacturer, or reseller. Also explain the basis of each offered price and its relationship to the established catalog price, including how the proposed price relates to the price of recent sales in quantities similar to the proposed quantities;

            2. For market-priced items, the source and date or period of the market quotation or other basis for market price, the base amount, and applicable discounts. In addition, describe the nature of the market;

            3. For items included on an active Federal Supply Service Multiple Award Schedule contract, proof that an exception has been granted for the schedule item.

        2. The offeror grants the Contracting Officer or an authorized representative the right to examine, at any time before award, books, records, documents, or other directly pertinent records to verify any request for an exception under this provision, and the reasonableness of price. For items priced using catalog or market prices, or law or regulation, access does not extend to cost or profit information or other data relevant solely to the offeror's determination of the prices to be offered in the catalog or marketplace.

      2. Requirements for cost or pricing data. If the offeror is not granted an exception from the requirement to submit cost or pricing data, the following applies:

        1. The offeror shall prepare and submit cost or pricing data and supporting attachments in accordance with Table 15-2 of FAR 15.408.

        2. As soon as practicable after agreement on price, but before contract award (except for unpriced actions such as letter contracts), the offeror shall submit a Certificate of Current Cost or Pricing Data, as prescribed by FAR 15.406-2.

        (End of provision)

      Alternate I (October 1997). As prescribed in 15.408(l), substitute the following paragraph (b)(1) for paragraph (b)(1) of the basic provision:

      (b)(1) The offeror shall submit cost or pricing data and supporting attachments in the following format:

      The format specified in Formats for Submission of Line Item Summaries above shall be used for the submission cost information. Submission of all other cost or pricing data shall be in accordance with Table 15-2 in FAR 15.408.

    4. Qualifications of the Offeror

      You are requested to submit a summary of your "General Experience, Organizational Experience Related to this RFP, Performance History and Pertinent Contracts."

      1. General Experience

        General experience is defined as general background, experience and qualifications of the offeror. A discussion of proposed facilities which can be devoted to the project may be appropriate.

      2. Organizational Experience Related to the RFP

        Organizational experience is defined as the accomplishment of work, either past or on-going, which is comparable or related to the effort required by this RFP. This includes overall offeror or corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work in this RFP.

      3. Performance History

        Performance history is defined as meeting contract objectives within delivery and cost schedules on efforts, either past or on-going, which is comparable or related to the effort required by this RFP.

      4. Pertinent Contracts

        Pertinent contracts is defined as a listing of each related contract completed within the last three years or currently in process. The listing should include: 1) the contract number; 2) contracting agency; 3) contract dollar value; 4) dates contract began and ended (or ends); 5) description of contract work; 6) explanation of relevance of work to this RFP; 7) actual delivery and cost performance versus delivery and cost agreed to in the contract(s). For award fee contracts, separately state in dollars the base fee and award fee available and the award fee actually received. The same type of organizational experience and past performance data should be submitted.

      5. Pertinent Grants

        List grants supported by the Government that involved similar or related work to that called for in this RFP. Include the grant number, involved agency, names of the grant specialist and the Science Administrator, identification of the work, and when performed.

      You are cautioned that omission or an inadequate or inaccurate response to this very important RFP requirement could have a negative effect on the overall selection process.

    5. Other Administrative Data

      1. Property

        1. It is DHHS policy that Contractors will provide all equipment and facilities necessary for performance of contracts. Exception may be granted to furnish Government-owned property, or to authorize purchase with contract funds, only when approved by the Contracting Officer. If the offeror is proposing that the Government provide any equipment, other than that specified under Government Furnished Property in the RFP, the proposal must include comprehensive justification which includes:

          1. An explanation that the item is for a special use essential to the direct performance of the contract and the item will be used exclusively for the purpose. Office equipment such as desks, office machines, etc., will not be provided under a contract except under very exceptional circumstances.

          2. No practical or economical alternative exists (e.g., rental, capital investment) that can be used to perform the work.

        2. The offeror shall identify Government-owned property in its possession and/or Contractor titled property acquired from Federal funds, which it proposes to use in the performance of the prospective contract.

        3. The management and control of any Government property shall be in accordance with DHHS Publication (OS) 686 entitled, "Contractor's Guide for Control of Government Property (1990)," a copy of which will be provided upon request.

      2. Submission of Electronic Funds Transfer Information with Offer, FAR Clause 52.232-38, (May 1999)

        The offeror shall provide, with its offer, the following information that is required to make payment by electronic funds transfer (EFT) under any contract that results from this solicitation. This submission satisfies the requirement to provide EFT information under paragraphs (b)(1) and (j) of the clause at 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration.

        1. The solicitation number (or other procurement identification number).
        2. The offeror's name and remittance address, as stated in the offer.
        3. The signature (manual or electronic, as appropriate), title, and telephone number of the offeror's official authorized to provide this information.
        4. The name, address, and 9-digit Routing Transit Number of the offeror's financial agent.
        5. The offeror's account number and the type of account (checking, savings, or lockbox).
        6. If applicable, the Fedwire Transfer System telegraphic abbreviation of the offeror's financial agent.
        7. If applicable, the offeror shall also provide the name, address, telegraphic abbreviation, and 9-digit Routing Transit Number of the correspondent financial institution receiving the wire transfer payment if the offeror's financial agent is not directly on-line to the Fedwire and, therefore, not the receiver of the wire transfer payment.

      3. Financial Capacity

        The offeror shall indicate if it has the necessary financial capacity, working capital, and other resources to perform the contract without assistance from any outside source. If not, indicate the amount required and the anticipated source.

      4. Incremental Funding

        An incrementally funded cost-reimbursement contract is a contract in which the total work effort is to be performed over a multiple year period and funds are allotted, as they become available, to cover discernible phases or increments of performance. The incremental funding technique allows for contracts to be awarded for periods in excess of one year even though the total estimated amount of funds expected to be obligated for the contract are not available at the time of the contract award. If this requirement is specified elsewhere in this RFP, the offeror shall submit a cost proposal for each year. In addition, the following provisions are applicable:

        HHSAR 352.232-75, Incremental Funding (January 2001)

        1. It is the Government's intention to negotiate and award a contract using the incremental funding concepts described in the clause entitled Limitation of Funds. Under the clause, which will be included in the resultant contract, initial funds will be obligated under the contract to cover the first year of performance. Additional funds are intended to be allotted to the contract by contract modification, up to and including the full estimated cost of the contract, to accomplish the entire project. While it is the Government's intention to progressively fund this contract over the entire period of performance up to and including the full estimated cost, the Government will not be obligated to reimburse the Contractor for costs incurred in excess of the periodic allotments, nor will the Contractor be obligated to perform in excess of the amount allotted.

        2. The Limitation of Funds clause to be included in the resultant contract shall supersede the Limitation of Cost clause found in the General Provisions.

        (End of provision)

      5. Facilities Capital Cost of Money, FAR 52.215-16, (October 1997)

        (This is applicable if you are a commercial organization.)

        1. Facilities capital cost of money [(see FAR 15.408(h)] will be an allowable cost under the contemplated contract, if the criteria for allowability in subparagraph 31.205-10(a)(2) of the Federal Acquisition Regulation are met. One of the allowability criteria requires the prospective Contractor to propose facilities capital cost of money in its offer.

        2. If the prospective Contractor does not propose this cost, the resulting contract will include the clause Waiver of Facilities Capital Cost of Money.

        (End of Provision)

        If the offeror elects to claim this cost, the offeror shall specifically identify or propose it in the cost proposal for the contract by checking the appropriate box below.

        [ ] The prospective Contractor has specifically identified or proposed facilities capital cost of money in its cost proposal and elects to claim this cost as an allowable cost under the contract. Submit Form CASB-CMF (see FAR 31.205-10).

        [ ] The prospective Contractor has not specifically identified or proposed facilities capital cost of money in its proposal and elects not to claim it as an allowable cost under the contract.

    6. Subcontractors

      If subcontractors are proposed, please include a commitment letter from the subcontractor detailing:

      1. Willingness to perform as a subcontractor for specific duties (list duties).

      2. What priority the work will be given and how it will relate to other work.

      3. The amount of time and facilities available to this project.

      4. Information on their cognizant field audit offices.

      5. How rights to publications and patents are to be handled.

      6. A complete cost proposal in the same format as the offeror's cost proposal.

      Note: Organizations that plan to enter into a subcontract with an educational concern under a contract awarded under this RFP should refer to the following Web Site for a listing of clauses that are required to be incorporated in Research & Development (R&D) subcontracts with educational institutions:
      http://ocm.od.nih.gov/contracts/rfps/FDP/FDPclausecover.htm

    7. Proposer's Annual Financial Report

      **** This document is INCLUDED in the "Just In Time" procedures. Specific instructions for the submission of this document are outlined in SECTION L.1.b. of this RFP. ****

      All offerors included in the competitive range will be required to submit a copy of the organization's most recent annual financial report.

    8. Representations and Certifications

      One copy of the Representations and Certifications attached as Section K shall be completed and be signed by an official authorized to bind your organization. Additionally, a completed copy of the Representations and Certifications shall be submitted from any proposed subcontractor.

    9. Travel Costs/Travel Policy

      1. Travel Costs—Commercial

        Costs for lodging, meals, and incidental expenses incurred by Contractor personnel shall be considered to be reasonable and allowable to the extent they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulations, General Services Administration (GSA). Therefore, if travel costs are applicable and proposed by offerors, please be advised that they shall be calculated using the per diem rate schedule as established by GSA. Reimbursement of travel costs under any contract awarded from this RFP shall be in accordance with FAR 31.205-46.

      2. Travel Policy

        **** This document is INCLUDED in the "Just In Time" procedures. Specific instructions for the submission of this document are outlined in SECTION L.1.b. of this RFP. ****

        All offerors included within the competitive range will be required to submit one copy of their written travel policy. A written travel policy for any proposed subcontractors shall also be submitted at that time. If an offeror (or any proposed subcontractor) does not have a written travel policy, the offeror shall so state.


SECTION M—EVALUATION FACTORS FOR AWARD

GENERAL

The primary basis for selecting proposals for award shall be technical, importance to agency programs, and fund availability which NHLBI determines to exist at the time of award selection, and small disadvantaged business participation. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Past performance is NOT an evaluation factor but will be considered in determining an offeror's responsibility in accordance with FAR 9.104-3(b). (Reference Section L.) All evaluation factors other than cost/price, when combined, are significantly more important than cost/price. The trade-off process described in FAR 15.101-1 will be employed. This process permits tradeoffs among cost/price and non-cost factors and allows the Government to consider award to other than the lowest priced or highest technically rated offeror. In any event, the Government reserves the right to make an award to that offeror whose proposal provides the best value to the Government.

The evaluation will be based on the demonstrated capabilities of offerors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed evaluation criteria/factors listed below.

The technical evaluation criteria are used by the technical evaluation committee when reviewing the technical proposals. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. Price analysis will be used to verify that the overall price offered is fair and reasonable. Cost/price analysis will be used to evaluate the reasonableness of individual cost elements when cost or pricing data are required. Cost analysis may be used to evaluate information other than cost or pricing data to determine cost reasonableness or cost realism. Subsequent awards.

TECHNICAL EVALUATION CRITERIA

SCIENTIFIC AND TECHNICAL MERIT 40 Points
Adequacy, feasibility, and technical merit of the proposed methods and approaches for establishing and maintaining a Somatic Cell Processing Facility, including plans for processing requests from investigators; suitability of the quality control and quality assurance plans.
STAFF EXPERIENCE 40 Points
Demonstrated expertise and experience of the Principal Investigators and other staff related to cell processing and/or transfusion medicine. Documented training, experience, expertise, and availability of the Principal Investigator for planning and directing the proposed cell processing facility. Evidence that the investigators work effectively together. Documented training, experience, and availability of all personnel in conducting the proposed technical procedures.
FACILITIES/RESOURCES 20 Points
Availability of adequate facilities and resources necessary to support the technical objectives. Demonstration that existing equipment is well-maintained, i.e. service contract. Adequacy of computer systems for the input and maintenance of data files.

Price Evaluation Adjustment for Small Disadvantaged Business Concerns
In accordance with FAR Clause 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns, offerors will be evaluated by adding a factor of 10 percent to the price of all offers, except offers from small disadvantaged business (SDB) concerns that have not waived the price evaluation adjustment. In addition, offerors that satisfy the exception requirements under subparagraph (b) of FAR Clause 52.219-23 will not have the price evaluation adjustment factor added to their offers.

A SDB concern may elect to waive the price evaluation adjustment, in which case the factor will be added to its offer for evaluation purposes. (The agreements in paragraph (d) of FAR Clause 52.219-23 do not apply to offerors that waive the price evaluation adjustment.) If the SDB concern elects to waive the price evaluation adjustment, it will be evaluated under the Small Disadvantaged Business Participation Factor cited in Section M, and participation in performance of the resultant contract shall include the work expected to be performed by SDB concerns at the prime contract level. Small businesses, other than SDB concerns, will also be evaluated under this factor. Any targets will be incorporated into and become part of the resulting contract.

Credit under the small disadvantaged business participation factor is not available to small disadvantaged business concerns that receive a price evaluation adjustment.

Small Disadvantaged Business Participation Factor
In accordance with FAR part 15.304(c)(4), the extent of participation of Small Disadvantaged Business (SDB) concerns in performance of the contract will be evaluated; however, the evaluation may take place after establishment of the competitive range. This evaluation will not be conducted on any offeror whose proposal would not be selected for award based on the results of the evaluation of factors other than SDB participation.

The evaluation will be based on information obtained from the Small Disadvantaged Business Participation Plan provided by the offeror (Reference Section L.), other relevant information obtained from named SDB concerns, any information supplied by the offeror concerning problems encountered in SDB participation, and other references available to the Government. Evaluation of the SDB Participation Plan will be based on consideration of all relevant facts and circumstances; it will not be based on absolute standards of acceptable performance.

SDB participation will not be scored, but the Government's conclusions about overall commitment and realism of the offeror's SDB Participation Plan will be considered in determining the relative merits of the offeror's proposal and in selecting the offeror whose proposal is considered to offer the best value to the Government.

The SDB Participation Plan is a separate requirement from the Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan.


PACKAGING AND DELIVERY OF THE PROPOSAL Your proposal shall be organized as specified in Section L.2., "Instructions to Offerors"—General Instructions. Shipment and marking shall be as indicated below.

EXTERNAL PACKAGE MARKING

In addition to the address cited below, mark each package as follows:

"RFP NO. NHLBI-HB-03-06
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

PLEASE READ THE FOLLOWING INFORMATION CAREFULLY:

NUMBER OF COPIES

TECHNICAL PROPOSAL: ORIGINAL* AND 25 COPIES TO:
BUSINESS PROPOSAL: ORIGINAL* AND 6 COPIES TO:

If hand-delivered or delivery service
 
 
If using U.S. Postal Service
 
 
Review Branch
Division of Extramural Affairs
National Institutes of Health
National Heart, Lung, and Blood Institute
6701 Rockledge Dr., MSC 7924 (Room 7091)
Bethesda, Maryland 20892-7924
Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge Building, Room 7091
6701 Rockledge Dr., MSC 7924
Bethesda, Maryland 20817-7924

*THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES.


STATEMENT OF WORK

Note to Offerors: To ensure that data analysis is conducted independently of data acquisition, the same institution may submit proposals for both a cell processing facility and the administrative center, but each proposal must not have the same investigators.

Contracts awarded as a result of this RFP will incorporate the Statement of Work proposed by the offeror and negotiated and accepted by the Government. The following description of required objectives and desired results, background information, and technical requirements are to assist offerors in the preparation of their proposals.

  1. General Description of the Required Objectives and Desired Results

    The project is designed to develop novel somatic cellular therapies that will aid investigators by providing support in areas ranging from basic science through animal studies to proof-of-principle and eventually human trials. The somatic cell processing facilities are charged with implementing the rapid, safe, and equable transition of basic research ideas to clinical practice as well as supplying clinical grade products produced in a manner that is compliant with all regulatory requirements. The somatic cell administrative center (SCAC) will serve as the monitor and coordinator for organizational and regulatory aspects of the program. It is anticipated that up to three somatic cell processing facilities will be awarded under separate contracts.

  2. Background Information

    The use of cells as more than replacement therapy has become a reality over the course of the last several years. While basic and clinical scientists are developing many new and promising strategies to improve immune reconstitution and transplant outcome, they are dependent on many others to implement these new therapies. Blood collection centers must collect the lymphocytes, hematopoietic progenitors, or other components. Clinical cell processing laboratories must scale up the processes developed in the research laboratory using reagents approved for use in humans and using good manufacturing practices (GMP). Immunology laboratories must establish techniques to monitor the outcome of the immune therapy. All of these processes must comply with local, state, national, and in some cases international regulations and standards. Implementation of procedures that were successful in the laboratory can be expensive and difficult to put through a scale-up process.

    To cope with these issues, many institutions have established specialized cell processing centers. However, a specialized cell processing lab and specially trained laboratory staff do not resolve all the problems associated with scaling a new procedure for a clinical trial. In some cases, equivalent reagents and processes suitable for clinical work are not available. Therefore, the establishment of cellular processing facilities is proposed as a method to combine the consulting, manufacturing, and regulatory duties that are necessary for the development of novel cellular therapies. It is envisioned that cell processing facilities will provide the actual product desired by an investigator along with the assurance that it is clinical grade and is produced in a manner that is compliant with all regulatory requirements.

    As translational research becomes a major focus in cellular therapies, cellular processing facilities can assume the responsibility of bridging the gap between basic and clinical research. Some of the preclinical tasks of a cell processing facility include the qualification and testing of reagents, scale-up of methods, development of Standard Operating Procedures (SOPs), ongoing process validation, and the provision of controlled GMP infrastructure. As a therapy moves from preclinical testing to clinical studies, a dialogue with the Food and Drug Administration (FDA) is necessary, and cell processing facilities are in a position to coordinate the assembly of an Investigational New Drug (IND) application.

    This purpose of this somatic cell project is to find a way whereby a focus is placed on translational work involving immunomodulation research and to address the lack of assistance in transporting cellular therapies from the bench to the bedside. For example, space and facilities to perform such work could be centralized and made readily available to many investigators, rather than having each one creating his or her own GMP-level, quality assurance facility.

  3. Research and Technical Objectives

    For proposal purposes, below are examples of areas in cellular therapy research that may be appropriate for support through this RFP. Examples include, but are not limited to, the development and application of:

    1. Innovations in the primary ex vivo culture and expansion of cell populations and subsets
    2. High throughput sorting of cells of interest
    3. Genetic modification of cells ex vivo with genes that will allow subsequent cell expansion or elimination under pharmacologic control in vivo
    4. Production, standardization, and distribution of immune-modulating cytokines or monoclonal antibodies
    5. Approaches for activation, isolation, and antigen-pulsing of antigen presenting cells (APCs)
    6. Therapeutic procedures for targeting APCs in vivo
    7. Animal models for the demonstration of safety and efficacy of novel cellular therapies
    8. Genetic engineering of cells to control growth, programmed cell death, and/or enhancement of cardiac contractile parameters.
    9. Production of in vitro cell expansion in doses appropriate for therapeutic use in humans
    10. Development of in vivo techniques to monitor survival, growth, and development of engrafted cells
    11. Development of methodology to track and monitor cell fates in vitro or in vivo
    12. Therapeutic procedures for targeting cells and progenitors in vivo with emphasis on the areas of interest of the NHLBI

Based on the proposed area of cellular therapy research, proposals shall address the following technical objectives (1.-4. below):

  1. To provide for rapid, safe, and equable transition of basic research ideas in clinical practice. For proposal purposes, the offeror shall give examples of products manufactured in the offeror's facility. Describe the development of these products and how they have been transitioned into clinical studies, including quality assurance and quality control plans. If no products have been manufactured, propose a sample plan for the production and development of a clinical grade therapeutic product.

  2. To develop and implement procedures for the evaluation, prioritization and processing of requests for service. For proposal purposes, a detailed description of monitoring plans for products beginning with production and progressing to compliance to regulatory requirements and advice and assistance in designing clinical studies shall be included in the proposal. [Note: The SCAC will have a regulatory specialist who will be involved in writing the plans for the implementation and maintenance of quality control and quality assurance procedures for manufacturing processes for each approved request for service.]

  3. To prepare programs or mechanisms to facilitate the training and development of junior investigators in areas of cell therapy clinical studies/manufacturing with a focus on clinical grade reagent production and FDA regulatory procedures. For proposal purposes, offerors shall propose various programs or mechanisms.

  4. To process, store, ship, and analyze reagents produced by the facility. For proposal purposes, costs for shipment of samples shall be borne by the cell processing facility. Assume up to $2000 per month for shipment of samples.

ADDITIONAL SOMATIC CELL PROCESSING FACILITY PROJECT REQUIREMENTS
For proposal purposes, technical proposals shall include a discussion of 1.-10. below:

  1. With the assistance of the SCAC, the cell processing facility shall develop and prepare protocols and standards of procedures (SOPs) for each request for service. The SCAC will obtain a customer satisfaction survey from the requester which addresses the quality and acceptability of each manufactured product. For proposal purposes, offerors shall provide examples of previous experience in supplying clinical grade biological products for specific requests from investigators. Examples shall include how requests were evaluated and associated cost information. [NOTE: Include associated cost information in the business proposal NOT in the technical proposal.]

  2. With the assistance of the SCAC, the cell processing facility shall develop, obtain, and maintain any investigation new drug (INDs) or investigation device exemptions (IDEs) required for manufactured cellular therapies.

  3. In conjunction with the SCAC, the cell processing facility shall participate in developing a manual of procedures (MOP) for the project. The facility shall be responsible for adhering to procedures that are outlined in the MOP and shall transmit accurate data to the SCAC as required. The MOP shall be completed and approved before any requests for products can be accepted by the facility. The first six months of the award period will be devoted to developing the MOP.

  4. The cell processing facility shall prepare reports, as needed, for use by the External Review Panel. For proposal purposes, assume 1 External Review Panel meeting/year to be held in Bethesda, Maryland to be attended by the Principal Investigator. [Note: The panel will evaluate the goals and progress of the cell processing facilities. It will act in an advisory capacity to the NHLBI and will consist of five members with consultants added as needed. The overall objective of the panel will be determine if the cell processing facilities are meeting the needs of the scientific community and, if so, how effectively are these needs being met.]

  5. With the assistance of the SCAC, the cell processing facility shall assure prompt accumulation, entry, and editing of product-related data in accordance with protocols.

  6. The cell processing facility shall report all adverse events associated with products manufactured to the SCAC and NHLBI Project Officer.

  7. For each manufactured product, the cell processing facility shall:
    1. provide complete protocol information to the SCAC, including quality control and quality assurance methods, to be maintained in the MOP;
    2. participate in the analysis and writing of study manuscripts and reports for publication and presentation; and,
    3. prepare archival samples from each lot manufactured to be sent to the NHLBI repository.

  8. The cell processing facility shall maintain inventories of reagents produced. [Note: The SCAC will assist the facility in sending archival samples to the NHLBI repository by developing labels and coordinating the timing and batching of the shipments.]

  9. The cell processing facility shall participate in yearly site visits to be conducted jointly by the SCAC and NHLBI staff.

  10. The cell processing facility shall participate as a member of the Steering Committee. For proposal purposes, assume 2 steering committee meetings/year to be held in Bethesda, Maryland to be attended by the Principal Investigator. [Note: The steering committee will be comprised of the Principal Investigator of the SCAC, the Principal Investigators from each cell processing facility, and the NHLBI Project Officer.]


CONTACT POINTS

Complete the following and return with the BUSINESS PROPOSAL.

Name, Title and Address* of Business Representative with whom daily contact is required.

_____________________________________________ ___________________________________
Name
 
 
Telephone Number
 
 
_____________________________________________ ___________________________________
Institutional Title
 
 
FAX Number
 
 
_____________________________________________ ___________________________________
Institutional Office
 
 
E-Mail Address
 
 
________________________________________________________________________________
Institution Name
 
 
________________________________________________________________________________
**Street Address
 
 
___________________________________ __________ ___________________________________
City
 
 
State
 
 
ZIP Code
 
 

Name, Institutional Title and Address of Proposed Principal Investigator
 
 
_____________________________________________ ___________________________________
Name
 
 
Telephone Number
 
 
_____________________________________________ ___________________________________
Institutional Title
 
 
FAX Number
 
 
_____________________________________________ ___________________________________
Institutional Office
 
 
E-Mail Address
 
 
________________________________________________________________________________
Institution Name
 
 
________________________________________________________________________________
**Street Address
 
 
___________________________________ __________ ___________________________________
City
 
 
State
 
 
ZIP Code
 
 

These exact addresses are necessary to ensure that contact can be made with the proper individual(s) in the most expeditious manner.

* May not necessarily be same as legal address of offeror.
**Please use actual street address, not P.O. Box.


PROPOSAL INTENT RESPONSE SHEET

RFP No. NHLBI-HB-03-06

PLEASE REVIEW THE ATTACHED REQUEST FOR PROPOSAL. FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY THE EARLIEST PRACTICABLE DATE. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT WILL GREATLY ASSIST US IN PLANNING FOR PROPOSAL EVALUATION.


[  ]
 
  DO INTEND TO SUBMIT A PROPOSAL
 
[  ]
 
  DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:
 


 


 

COMPANY/INSTITUTION NAME:

AUTHORIZED SIGNATURE:

TYPED NAME AND TITLE:

DATE:


RETURN TO:

National Institutes of Health
National Heart, Lung, and Blood Institute
Attention: Joanna Magginas
Fax: (301)480-3432


NOTE: This notice is for the Technical Evaluation Committee which will be reviewing the proposals submitted in response to this RFP. THE OFFEROR SHALL PLACE A COPY OF THIS NOTICE BEHIND THE TITLE PAGE OF EACH COPY OF THE TECHNICAL PROPOSAL.

GOVERNMENT NOTICE FOR HANDLING PROPOSALS

This proposal shall be used and disclosed for evaluation purposes only, and a copy of this Government notice shall be applied to any reproduction or abstract thereof. Any authorized restrictive notices which the submitter places on this proposal shall be strictly complied with. Disclosure of this proposal outside the Government for evaluation purposes shall be made only to the extent authorized by, and in accordance with, the procedures in HHSAR 352.215-1.

  1. If authorized in agency implementing regulations, agencies may release proposals outside the Government for evaluation, consistent with the following:
    1. Decisions to release proposals outside the Government for evaluation purposes shall be made by the agency head or designee;

    2. Written agreement must be obtained from the evaluator that the information (data) contained in the proposal will be used only for evaluation purposes and will not be further disclosed;

    3. Any authorized restrictive legends placed on the proposal by the prospective Contractor or subcontractor or by the Government shall be applied to any reproduction or abstracted information made by the evaluator;

    4. Upon completing the evaluation, all copies of the proposal, as well as any abstracts thereof, shall be returned to the Government office which initially furnished them for evaluation; and

    5. All determinations to release the proposal outside the Government take into consideration requirements for avoiding organizational conflicts of interest and the competitive relationship, if any, between the prospective Contractor or subcontractor and the prospective outside evaluator.

  2. The submitter of any proposal shall be provided notice adequate to afford an opportunity to take appropriate action before release of any information (data) contained therein pursuant to a request under the Freedom of Information Act (5 U.S.C. 552); and, time permitting, the submitter should be consulted to obtain assistance in determining the eligibility of the information (data) in question as an exemption under the Act. (See also Subpart 24.2, Freedom of Information Act.)


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