International Research Registry Network for Sjögren's Syndrome

Request for Proposal Under BAA-DR-03-01

Broad Agency Announcement: NIDCR-BAA-DR-03-01
Issue Date: July 15, 2002
Issued By: Kristiane E. Cooper, Contracting Officer
NIH/NHLBI
Contracts Operations Branch
6701 ROCKLEDGE DR MSC 7902
BETHESDA MD 20892-7902
Telephone Number: (301) 402-6462
FAX Number: (301) 480-3432
E-Mail: kc116y@nih.gov
Purchase Authority: 42USC201, Public Health Service Act
Small Business Set-Aside: No; NAICS 541710
Proposal Intent Due Date: October 15, 2002 (See Proposal Instructions and Information)
Proposal Due Date: November 15, 2002, 4:00 PM (Eastern Time)


COMBINED SOLICITATION FORM AND COVER LETTER

Ladies and Gentlemen:

The National Heart, Lung, and Blood Institute (NHLBI) is issuing this Request for Proposal (RFP) for a Broad Agency Announcement (BAA) on behalf of the National Institute for Dental and Craniofacial Research (NIDCR). Offerors are invited to submit a proposal in accordance with the requirements of this BAA entitled "International Research Registry Network for Sjögren's Syndrome."

The Broad Agency Announcement is authorized by Federal Acquisition Regulation (FAR) 6.102. BAAs are used by 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 work statement.

The Government anticipates that it will make one award based on this announcement. It is expected that this award will be a multi-year, cost-reimbursement, completion type contract. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The NIDCR estimates that the award under this solicitation will be for five (5) years. The total estimated costs for this contract award under this solicitation is estimated to be $10,000,000. An award is expected to be made on or about September 30, 2003. An award document will be tailored to the final negotiations with the selected offeror and modified, as necessary, for the type of organization, cost or price arrangements, and other elements as negotiated prior to award.

This BAA includes this combined solicitation form and cover letter (PART A), and three additional components as follows:

  1. Background/Research and Technical Objectives/Additional Technical Proposal Instructions
  2. Reporting Requirements/Deliverables
  3. Evaluation Factors for Award with Technical Evaluation Criteria

These components contain the technical information required for the submission of a proposal for this acquisition. In addition, there are two other sections in this specific RFP. Section I entitled "Specific RFP Instructions and Provisions" contains, for example, the address for delivery of your proposal. Section II entitled "Applicable RFP References" lists those items in the STREAMLINED RFP REFERENCES directory that apply to this RFP, including forms for submission of the proposal. The Streamlined RFP References directory is located at URL: http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm

The information contained in this streamlined electronic RFP represents all the necessary information required for the submission of a proposal for this acquisition. Following proposal submission and review, additional information will be requested by the Contracting Officer during discussions (if applicable).

Although these documents contain sufficient information for you or your organization to submit a proposal, if you intend to submit a proposal in response to this RFP, IT IS ESSENTIAL THAT YOU IMMEDIATELY NOTIFY KRISTIANE E. COOPER, CONTRACTING OFFICER, AT THE FOLLOWING E-MAIL ADDRESS: kc116y@nih.gov

IF YOU DO NOT NOTIFY THE CONTRACTING OFFICE 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 original and twenty-five (25) copies of your technical proposal and the original and six (6) copies of your business proposal must be received by the Contracting Office no later than November 15, 2002, 4:00 P.M. (Eastern Standard Time) at the address listed in the item entitled "Packaging and Delivery of Proposals". Offers will be valid for 120 days unless a different period is specified by the offeror on the form entitled, "Proposal Summary and Data Record, NIH 2043" (Adobe PDF document Microsoft Word document) also located at the site for FORMS, FORMATS, AND ATTACHMENTS.

Also, please complete the form entitled "Proposal Intent Response Sheet" and send it to the address indicated therein on or before October 15, 2002. This will allow us to expedite preparations for the review of proposals.

The Business and Technical Proposals must be separate from one another in the proposal package, as the peer review panel will only receive the Technical Proposal. The Business Proposal must be signed by an authorized official of your organization and must contain a detailed breakdown of costs by year for each cost category/element. The basis for all costs must be explained and supporting documentation must be submitted with the proposal. See "Standard RFP Instructions and Provisions" in the NIH RFP Home Page for more details on the Business Proposal requirements. As part of this electronic RFP, we have included a template cost spreadsheet in Microsoft Excel. Information relevant to the cost spreadsheet is located in this RFP, under Specific RFP Instructions, "Other Provisions," Item K. Offerors are requested to complete this spreadsheet and include it with their business proposal.

You are reminded that the "Technical Proposal Cover Sheet" (NIH Web Site Microsoft Word document) must be completed in full detail and used as the cover sheet for each copy of your technical proposal. It is very important that you list all professional personnel and organizations named in the proposal that have any role in the proposed work, including staff of the primary organization (offeror), subcontractors, collaborating organizations, and consultants. This information will be used to ensure that there is no conflict of interest when selecting review committee members. BE ADVISED THAT YOUR TECHNICAL PROPOSAL IS SUBJECT TO PAGE LIMITATIONS. The format and content of your technical proposal along with page limitation information is detailed in the Technical Proposal Table of Contents/Format under Specific RFP Instructions, item G.

Please note that one copy of the Representations and Certifications (Adobe PDF document Corel WordPerfect document Microsoft Word document) must be submitted with the offeror's proposal.

NOTE: IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR DESIGNEE AT THE PLACE AND TIME SPECIFIED, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH HHSAR 352.215-70, see Section II of this RFP, Applicable RFP References, Item 1.E, "Late Proposals, HHSAR 352.215-70."

If you have any additional questions regarding this RFP, please contact Ms. Kristiane E. Cooper through the Internet using the electronic mail address kc116y@nih.gov, or by phone (301) 402-6462, or fax (301) 480-3432. Collect calls will not be accepted.

SUBMISSION OF PROPOSALS USING FACSIMILE OR E-MAIL IS NOT AUTHORIZED.

NOTE: DIRECTIONS FOR ACCESSING THE "STREAMLINED RFP REFERENCES" REFERRED TO THROUGHOUT THIS RFP ARE AS FOLLOWS:

After reviewing this Request For Proposal, type in URL: "http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm". In this directory, entitled "NIH Request For Proposals Directory", following the list of NIH Institutes by name, is the section entitled "STREAMLINED RFP REFERENCES". Select (click on) each section you wish to review:

"STANDARD RFP INSTRUCTIONS AND PROVISIONS" for proposal preparation instructions and other standard provisions,

"OPTIONAL RFP INSTRUCTIONS AND PROVISIONS" for the special provisions identified in this specific RFP,

"FORM, FORMATS, AND ATTACHMENTS" to download the forms listed in this specific RFP that you will need to submit a proposal, and

"SAMPLE CONTRACT FORMAT-GENERAL" to view some of the clauses that are typical for inclusion in a Research and Development type contract issued by NIH.

Sincerely,
/s/
Ms. Kristiane E. Cooper
Contracting Officer


  1. BACKGROUND, RESEARCH AND TECHNICAL OBJECTIVES, ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

    BACKGROUND

    This section presents the background for this solicitation and the technical objectives that the Government seeks to achieve through this BAA. Proposals should explain how the offeror shall contribute to these overall objectives. Any contract awarded as a result of this BAA shall incorporate the statement of work proposed by the offeror and negotiated and accepted by the Government.

    The NIDCR supports research on the etiology, pathogenesis, prevention and treatment of Sjögren's syndrome through investigator-initiated research projects. However, it has become evident that the major hurdles in making progress in understanding this disorder are the lack of standardized diagnostic criteria, large and well-characterized patient populations, and sufficient high quality biological specimens, particularly those for genetic information and other assays. The availability of such information and materials will allow researchers and clinicians to make scientific progress regarding the etiology, prevalence or incidence, and pathogenesis of Sjögren's syndrome and will promote the development of novel preventative and therapeutic strategies for these patients.

    Therefore, the NIDCR plans to award a contract for an International Research Registry Network for Sjögren's syndrome to establish standardized diagnostic criteria and to collect, store and process clinical data and specimens from patients for further studies. The proposed contract would support the collection of clinical data from Sjögren's syndrome patients and their families. It is expected that the information to be collected by the registries will facilitate future research projects on the etiology, pathogenesis, prevention, and treatment of Sjögren's syndrome. Collection of patient materials, including saliva, blood, tissues, and other samples for research purposes, will be included as part of the International Research Registry Network.

    RESEARCH AND TECHNICAL OBJECTIVES

    RESEARCH OBJECTIVES

    Independently, and not as an agent of the Government, the Contractor shall 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 as set forth below.

    The NIDCR is seeking to establish an International Research Registry Network that will: 1) develop a set of standardized diagnostic criteria for Sjögren's syndrome which will be used for the purpose of research, prevention, diagnosis, and treatment of Sjögren's syndrome, 2) collect, process and store patients' clinical data and specimens, and 3) provide these resources to researchers who are interested in basic and clinical studies on this disease. The offeror is expected to address all the technical objectives described below. As part of the proposal, the offeror should describe the proposed structure of the International Research Registry Network among different countries, present a plan for developing and testing the diagnostic criteria and explain how these criteria will be used to identify patients with Sjögren's syndrome. The offeror should also present a plan for collecting, processing, shipping and storing clinical information and biological specimens from such patients and their families.

    TECHNICAL OBJECTIVES

    [NOTE 1 TO OFFERORS: Offerors should submit one proposal that addresses all technical objectives (A-D). The proposal should be submitted in one volume. The proposal will be reviewed as a whole].

    1. To design and implement an International Research Registry Network for Sjögren's syndrome.

      This project will focus on the establishment of an International Research Registry Network for Sjögren's syndrome. Collaborations with existing Sjögren's syndrome research groups such as local research institutions or organizations or individual research projects are encouraged.

      1. Structure and Locations of the International Research Registry Network:

        The International Research Registry Network for Sjögren's syndrome shall consist of four to five Research Groups located in different countries and one central Coordinating Center. The prime contractor shall establish both a Research Group and a Coordinating Center in the United States. It is envisioned (though not mandated) that the Coordinating Center will be established at the same site as the U.S. based Research Group. The International Research Groups will likely participate as subcontracts to the prime contract. The participation of international Research Groups in different geographical areas, such as Europe, Asia (Japan or China), and Australia will allow for a study of the influence of different ethnicities, races, and geographical locations on the etiology of Sjögren's syndrome, and facilitate in the development of diagnostic criteria that are universally acceptable. A Principal Investigator shall be designated for the Coordinating Center and each Research Group. The Principal Investigators will be responsible for overseeing and managing their respective components of the International Research Registry Network.

        The Research Groups must have appropriate facilities for storing biological specimens. All clinical data shall be stored at the Coordinating Center while biological specimens collected by the participating Research Groups shall be stored in established repositories at the respective subcontractor sites or at a repository established in the United States.

        The Research Groups shall be established at locations where the following conditions are met: 1) availability of fully or partially characterized Sjögren's syndrome populations; 2) availability of a team of well-trained and experienced Sjögren's syndrome professionals, including physicians, nurses, data-processors and staff knowledgeable in biological specimen-collection; 3) sufficient laboratory space well-equipped with computers, software, and other necessary equipment; and 4) appropriate facilities for storing biospecimens.

      2. The Responsibility of the Research Groups

        The Research Groups shall work with the Coordinating Center in developing the protocol used for the study. The Research Groups shall be responsible for adhering to the procedures that are part of the protocol, i.e., patient recruitment, data and specimen collection, informed consent materials, etc. The Research Groups shall provide technical and administrative oversight and transmit accurate clinical data to the Coordinating Center as required by the protocol.

      3. The Responsibility of the Coordinating Center

        The Coordinating Center shall have overall responsibility for the operation of the International Research Registry Network. The Coordinating Center shall coordinate the development of and finalization of the protocol used for the study, prepare statistical and other reports as needed, and monitor the study progress, quality of data and participating centers' performance, etc. The Coordinating Center shall coordinate all aspects of data collection and data management, conduct site visits, and advise the NIDCR Project Officer on the progress of the study.

    2. To establish a set of standardized diagnostic criteria for Sjögren's syndrome.

      The contractor shall establish and deliver a set of diagnostic criteria not later than the end of second year of the contract. The criteria shall meet the following standards:

      1. High specificity and accuracy for Sjögren's syndrome diagnosis for the purpose of patient recruitment. The new criteria may be established by modification of one set or several sets of current criteria, or by development of a completely new set of criteria. The newly established criteria must be demonstrated by one or more studies designed specifically to test the specificity and accuracy of the diagnostic criteria, which may be tested on newly recruited patients or on previously recruited patient populations.

      2. Acceptance of the newly established diagnostic criteria by all participating Research Groups and clinicians. These criteria should be discussed and recommended for approval by the Sjögren's Syndrome Advisory Committee (SSAC). The NIDCR shall have final approval of the recommended standardized diagnostic criteria. The committee shall consist of a group of independent reviewers that will be designated by NIDCR and will be made up of a) a chairperson, and b) approximately three-five scientists with experience in Sjögren's syndrome research.

    3. To collect, process, store, ship, and analyze clinical information and biological specimens from patients and families with Sjögren's syndrome.

      The International Research Registry Network shall select and characterize patient populations to accomplish the following technical goals:

      1. Collect patients' clinical data including personal information (such as age, sex, race, birth date and place, education, occupation, address, height, weight), medical history, genetic background of the patients and their families, health status of family members, current health status, medications, and results of laboratory tests. The Research Registry Network shall also be able to register newly diagnosed patients as they are accrued.

      2. Store and maintain patients' information in a data base at the Coordinating Center using appropriate commercially available hardware and software which provide the capability to search the database with various parameters. Access to this information should be securely controlled in order to protect the privacy of the patient information.

      3. Collect biological specimens (e.g., DNA samples, saliva, blood, and other tissues) from patients and their families. These specimens shall be processed according to procedures specified in the protocol.

      4. Store and maintain the specimens collected from patients in appropriate facilities in established repositories to ensure the proper conditions to preserve the quality of the specimens. Access to these samples should be strictly controlled in order to protect the privacy of the patient information.

      5. Register and process the data of the specimens and analysis results, and store this information in the database for patients' information. Access to this information should be securely controlled in order to protect the privacy of the patient information.

    4. To disseminate to researchers clinical information and biological specimens from patients with Sjögren's syndrome and their families.

      The International Research Registry Network shall develop dissemination procedures for the purpose of providing clinical data and biological specimens to investigators for basic and clinical research. A Dissemination Plan will be approved by the Sjögren's Syndrome Advisory Committee (SSAC), and become part of the protocol prior to any dissemination of clinical information or biological specimens to researchers. The Principal Investigators of the International Research Registry Network shall develop qualification requirements as well as a review mechanism for providing clinical data and specimens stored in the International Research Registry Network to investigators interested in using such materials. Beginning in the fourth year of the contract, the International Research Registry Network will begin disseminating clinical information and biological specimens to researchers. The application form requesting information and /or materials stored in the International Research Registry Network will need to include:

      1. a description of the purpose/use of the International Research Registry Network information and specimens;

      2. a description of the assurance that the use of the data and specimens will not lead to violation of the privacy of the patient information;

      3. a description of the demonstrated capabilities of the proposed researcher(s) to conduct high quality research in the Sjögren's syndrome area, and documentation if applicable that the institution's IRB approves of the planned use of data and specimens;

      4. a description of the research projects which represent cutting-edge studies that will potentially move the research field forward or have a high impact on the prevention and/or treatment of Sjögren's syndrome;

      In addition, the application form shall include an agreement that all results derived from studies using the clinical data and/or biological specimens shall be reported to the International Research Registry Network. An acknowledgment to the International Research Registry Network shall be included in all publications which contain any results from studies based on data obtained from the network. The following materials are considered to be publications: a) articles in journals, b) abstracts and presentations in meetings, conferences, and symposia, and c) book chapters.

    ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

    Each proposal shall include:

    1. A discussion of the significance of the proposed International Research Registry Network and the impact the network would have in: a) enhancing Sjögren's syndrome research leading to a resolution or better understanding of the etiology, pathogenesis, and potential treatment; b) facilitating the diagnosis, prevention and treatment of this disease; and c) stimulating research on other similar autoimmune diseases.

    2. A background section briefly reviewing the following: a) the current diagnostic criteria used for Sjögren's syndrome (e.g., a discussion on the strength and weakness of each set of criteria, and what modifications should be made); b) the current research status of etiology, pathogenesis, prevention and treatment of Sjögren's syndrome; and c) future studies that will become feasible because of the availability of the proposed research registry.

    3. A detailed description of the research plan, which shall clearly state the following:

      1. the location, structure, and operation of the Coordinating Center and of the international Research Groups;

      2. a full justification of the criteria by which these locations are selected, such as the availability of a fully or partially characterized patient population;

      3. a list and justification of the personnel proposed for the International Research Registry Network. A biosketch including publication list of each key person with an advanced degree shall also be included;

      4. a detailed description of laboratory and office space, research facilities, and equipment which are available for the use by the registry network. These shall be separately described according to the qualification categories of the Coordinating Center, and each Research Group;

      5. the organization and collaboration mechanisms including how the entire International Research Registry Network will be supervised, how communications between the Principal Investigator at the Coordinating Center and the Principal Investigators at the Research Groups will be conducted, and how information will be exchanged between research groups;

      6. a plan for collecting, processing, shipping of biological specimens, and storing clinical data.

    4. A detailed description of the plan for patient recruitment. Such a plan should include the following:

      1. the number of patients to be recruited and a justification to support this number;

      2. what clinical data will be collected and how the goal(s) will be accomplished;

      3. a detailed quality control plan for collecting, processing, and communicating clinical data;

      4. a discussion of anticipated problems and resolutions;

      5. a description of the computer programs which will be used to store clinical data;

    5. A description of the plan for collecting, processing, shipping, and storing biological specimens. The plan shall include:

      1. a detailed description of the methods and procedures which will be used in collecting, processing, shipping and storing biological specimens;

      2. information about the training, expertise, and experience of the personnel participating in registering, collecting, processing, and storing biological specimens

      3. a detailed quality control plan for collecting, processing, and storing biological specimens;

      4. a detailed discussion of anticipated pitfalls and problems in methodology and procedures, and potential resolutions;

      5. a description of the database which will be used to register and store the data associated with biological specimens.

    6. A proposed plan for providing clinical data and biological specimens to researchers. A plan for disseminating clinical data and biological specimens from Sjögren's syndrome patients and their families to researchers. A description of future research projects that would become feasible because of the availability of the proposed research registry. Note: This information should be included as part of the proposal. However, a separate requirement for a finalized Dissemination Plan will be required as part of any resulting contract and will be become a Deliverable during the contract. The following considerations should be included in the plan:

      1. a plan for receiving, registering, and processing requests for clinical data and specimens. A description of the procedures and equipment used for this purpose should be included;

      2. a description of the staff who will be responsible for this process should also be included;

      3. a qualification standard for the investigators interested in using the clinical data and specimens stored in the repository;

      4. a review and approval procedure for providing clinical data and specimens stored in the repository. The procedure should include a description of the review committee and the review and approval procedures;

      5. a follow up plan for monitoring the use of the clinical data and biological specimens.

    7. A description of the plan to establish the following two committees

      1. A Sjögren's Syndrome Advisory Committee (SSAC). The committee shall include a group of independent reviewers that will be designated by NIDCR and will include a chairperson, and approximately three-five scientists with experience in Sjögren's syndrome research. The proposal should include the plan for assembling this committee, but the offeror should not recruit any specific scientists for this committee and should not name specific individuals in the proposal. The responsibilities of the SSAC shall include but not be limited to: reviewing, suggesting revisions as necessary, and recommending for approval a set of standardized diagnostic criteria for Sjögren's syndrome; and monitoring the progress of the International Research Registry Network. The Sjögren's Syndrome Advisory Committee shall meet annually.

      2. A Steering Committee that will include the Project Officer, the Principal Investigator from the Coordinating Center and the Principal Investigators from each Research Group. The Steering Committee shall correspond at least monthly and as often as is necessary to plan the study, develop and finalize the protocol, and assess periodic evaluation and progress of the contract.

    [NOTE 2 TO OFFERORS: Your proposal should include cost information to support the SSAC. For budgetary purposes, assume $10,000 per year for the annual meeting]


  1. REPORTING REQUIREMENTS/DELIVERABLES

    REPORTING REQUIREMENTS

    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 periods. For proposal preparation purposes only, it is estimated that reports will be required as follows:

    1. Program Plan—A program plan shall be submitted 90 days after contract award for review and approval. The plan shall identify critical decision points that are expected to result, and include when the key milestones of the International Research Registry Network will be met. Any revisions to the approved plan shall be submitted to the NIDCR Project Officer for review and approval.

    2. 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 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, objectives, and milestones of the Statement of Work;
          4. A brief overview of any problems (technical or financial) that occurred during the current reporting period and their resolution or status.

        2. A summary of activities planned for the next reporting period;

        3. 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 resulting from this work must cite the support received from this contract.

          The initial report shall be submitted for the first full twelve months of performance including any fractional part of the initial month. Annual reports thereafter shall be submitted at 12 month intervals. An annual report is not required for the period when the final report is due.

    3. Final Technical Report—This report shall cover the entire period of contract performance and shall be in sufficient detail to describe comprehensively the results achieved. Edited data tapes and documentation shall be provided to NIDCR as part of the Final Technical Report. The final report shall be submitted on or before the last day of the contract performance period.

    4. Annual Technical Progress Report for Clinical Research Study Populations—The contractor shall submit information about the inclusion of women, and members of minority groups and their subpopulations for the work being performed under this requirement.

    5. Standardized Diagnostic Criteria—The Contractor shall submit a set of standardized diagnostic criteria for Sjögren's syndrome by the end of the second year of the contract.

    6. Protocol—The Contractor shall deliver a final protocol as part of the contract.

    7. Dissemination Plan—The Contractor shall provide a plan for disseminating clinical data and biological specimens from Sjögren's syndrome patients and their families to researchers.

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

    9. A plan for future long-term support of the program through additional sources other than the Government.

    10. Other Reports as required by the contract, i.e. electronic data available in a secured format.

    DELIVERABLES

    Copies of reports shall be sent to the following addresses:

    Item Description Quantity Delivery Schedule
    1 Program Plan 3 90 days after contract start
    2 Annual Technical Reports 3 Annually
    3 Final Report 3 Contract expiration date
    4 Annual Technical Progress Report for Clinical Research Study Populations 3 Annually
    5 Standardized Diagnostic Criteria 3 The end of the second year
    6 Protocol 3 As required in the contract
    7 Dissemination Plan 3 As required in the contract
    8 Abstracts and Manuscripts 2 As required in the contract
    9 Plan for Future Support 3 As required in the contract
    10 Other Reports 3 As required in the contract
    11 Subcontracting Report for Individual Contracts (294) 1 April 30 and October 31 annually
    12 Summary Contracting Report (295) 1 October 31 annually
    13 Human Subject Assurances OF-310 1 Annually
    14 Data and Specimens Collected TBD To be specified

    The items above shall be delivered to the following addresses:

    Addressee Deliverable Item # Quantity
    Contracting Officer
    Contracts Operations Branch, DEA, NHLBI
    Two Rockledge Center, Room 6136
    6701 Rockledge Drive, MSC 7902
    Bethesda, MD 20892-7902
    1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13 1
    Project Officer
    National Institute of Dental
      and Craniofacial Research
    45 Center Drive, Room 4an18a
    Bethesda, MD 20892-6401
    1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14 2


  1. EVALUATION FACTORS FOR AWARD WITH TECHNICAL EVALUATION CRITERIA

    The Government will make an award to the responsible offeror whose proposal provides the best value to the Government. The evaluation will be based on the demonstrated capabilities of the prospective offerors in relation to the evaluation criteria as set forth herein. Each proposal must document the feasibility of successful implementation of the requirements of the BAA. The estimated cost of an offer must be reasonable for the tasks to be performed, and in accordance with FAR 15.305, will be subject to a cost realism analysis by the Government.

    All technical proposals will undergo evaluation by a peer review group also known as the Technical Evaluation Panel (TEP). The merits of each proposal will be evaluated carefully against the technical evaluation criteria below. Proposals will not be evaluated against each other since they are not submitted in accordance with a common work statement.

    The primary basis for selecting proposals for award shall be technical, importance to agency programs, and the availability of funds which the NIDCR determines to exist at the time of award selection. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price.

    It is anticipated that technical discussions will be held with all offerors whose proposals remain under consideration after the TEP evaluation. Cost negotiations may be necessary as well.

    The NIDCR reserves the right to make awards for only certain portions of proposed work.

    Past performance is not an evaluation factor but will be considered in determining the offerors responsibility in accordance with FAR 9.104-3(b) (Reference Applicable RFP References, Optional RFP Instructions and Provisions).

    The offeror's Small Disadvantaged Business (SDB) Participation Plan (see Section I, Specific RFP Instructions and Provisions, Item K) will be evaluated after the initial technical evaluation. Only those offerors being considered further for award, will be evaluated.

    TECHNICAL EVALUATION CRITERIA

    The technical evaluation criteria below are to be used by the Technical Evaluation Panel when reviewing technical proposals. The criteria below are listed in order of relative importance with weights assigned for evaluation purposes.

    1. Scientific and Technical Merit 50 Points
    Adequacy, feasibility and technical merit of the proposed methods and approaches for establishing and maintaining an International Research Network for Sjögren's syndrome, proposed methods for establishing standardized diagnostic criteria for Sjögren's syndrome, and the adequacy of the proposed plan to collect the appropriate information from patients and their families, including access to patient populations, and method of quality assurance and updating data. Adequacy of the proposed plan for disseminating clinical and biological specimens to researchers.
    2. Staff Experience 40 Points
    Demonstrated expertise and experience of the Principal Investigators and other staff related to patient recruitment, case ascertainment, information dissemination, diagnosis, and follow-up for the proposed International Research Registry Network. Demonstrated expertise and capability to compile information/data for the research network and the ability to interact with the research community interested in the evaluation of Sjögren's syndrome. Documented experience with managing projects with similar complexity. Demonstrated familiarity with the basic science that relates to the disease.
    3. Facilities/Equipment/Resources 10 Points
    Availability of adequate facilities, equipment and resources necessary to support the technical objectives. Adequacy of computer systems for the input and maintenance of data files and of proposed measures taken to assure security of the data.
    TOTAL: 100 Points

THE REMAINDER OF THIS RFP CONSISTS OF THE FOLLOWING SECTIONS:

  1. Specific RFP Instructions and Provisions, and

  2. Applicable RFP References


SECTION I. SPECIFIC RFP INSTRUCTIONS AND PROVISIONS

NOTICE TO OFFEROR: This section contains proposal instructions and information which are specifically related to this acquisition. The information provided below is only a portion of the instructions and notices required for the submission of a proposal. References to additional, more general, information and forms regarding proposal preparation are contained under Section II. Applicable RFP References.

The following specific RFP instructions and provisions apply to this Request For Proposal:

  1. Proposal Intent Response Sheet
  2. Government Notice for Handling Proposals
  3. Packaging and Delivery of Proposal
  4. NAICS Code and Small Business Size Standard
  5. Number and Type of Award
  6. Service of Protest
  7. Technical Proposal Table of Contents
  8. Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns
  9. Privacy Act
  10. Safety and Health
  11. Other Provisions


  1. PROPOSAL INTENT RESPONSE SHEET

    RFP No. NIDCR BAA-DR-03-01

    TITLE OF BAA/RFP: International Research Registry Network for Sjögren's Syndrome

    FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY October 15, 2002. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT WILL ASSIST US IN PLANNING FOR PROPOSAL EVALUATION.

         I INTEND TO SUBMIT A PROPOSAL


         COMPANY/INSTITUTION NAME:


         ADDRESS:



         PROJECT DIRECTOR'S NAME:

         TITLE:

         TELEPHONE NUMBER:

         NAMES OF COLLABORATING INSTITUTIONS AND INVESTIGATORS
         (include Subcontractors and Consultants):





         RETURN TO:
         Review Branch
         Attention: Dr. Anne Clark
         NIH, NHLBI
         6701 ROCKLEDGE DR RM 7178 MSC 7924
         BETHESDA MD 20892-7924          or FAX TO: Dr. Anne Clark at (301) 480-0730


  1. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

    NOTE: This Notice is for the Technical Evaluation Review Group who 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.

    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 paragraph 315.608-72.

    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.)

  2. PACKAGING AND DELIVERY OF THE PROPOSAL

    Your proposal shall be organized in accordance with the guidelines provided in "Standard RFP Instructions and Provisions." Shipment and marking shall be as follows:

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

    "RFP/BAA NO. NIDCR-BAA-DR-03-01
    TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

    The number of copies required of each part of your proposal are:
    TECHNICAL PROPOSAL: ORIGINAL* AND Twentyfive (25) COPIES
    BUSINESS PROPOSAL: ORIGINAL* AND Six (6) COPIES

    *DELIVER PROPOSAL TO:
    If courier delivery service:
    Review Branch
    Division of Extramural Affairs
    National Heart, Lung, and Blood Institute
    Rockledge Building, Room 7091
    6701 ROCKLEDGE DRIVE MSC 7924
    BETHESDA, MD 20817-7924

    *(Note: Proposals delivered in person will not be accepted)

    If using U.S. Postal Service:
    Review Branch, Division of Extramural Affairs
    National Institutes of Health
    National Heart, Lung, and Blood Institute
    6701 ROCKLEDGE DRIVE MSC 7924
    BETHESDA, MD 20892-7924

    *THE ORIGINAL PROPOSAL MUST BE READILY ACCESSIBLE FOR DATE STAMPING.

  3. NAICS CODE AND SIZE STANDARD

    THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS. However, the FAR requires in every solicitation (except for foreign acquisitions) the inclusion of the NAICS code and corresponding size standard which best describes the nature of the requirement in the solicitation.

    NOTE: The following information is to be used by the offeror in preparing its Representations and Certifications, specifically in completing the provisions entitled, SMALL BUSINESS PROGRAM REPRESENTATIONS, FAR 52.219-1:

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

    The small business size standard is 500 employees.

  4. NUMBER AND TYPE OF AWARD

    It is anticipated that one award will be made from this solicitation and that the award will be made on or about September 30, 2003.

    It is anticipated that an award made from this solicitation will be a multiple-year cost reimbursement, completion type contract with a period of performance of five years, and that incremental funding will be used.

  5. SERVICE OF PROTEST

    In accordance with FAR 52.233-2 SERVICE OF PROTEST (AUG 1996):

    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:

      Mr. Robert Best
      Chief, Contracting Operations Branch
      National Heart, Lung, and Blood Institute
      National Institutes of Health
      6701 Rockledge Drive, MSC 7902
      Bethesda, MD 20892-7902
      The copy of any protest shall be received in the office designated above within one day of filing a protest with GAO.

  6. TECHNICAL PROPOSAL TABLE OF CONTENTS

    Please number each page of text. The technical proposal, excluding resumes, biosketches and appendices, is limited to 100 pages. Type density and size must be 10-12 points If constant spacing is used, there should be no more than 15 cpi, 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. The technical proposal should be organized as follows:

    1. TECHNICAL PROPOSAL COVER SHEET NIH Web Site Microsoft Word document (Form is located in the Streamlined RFP References under "FORMS, FORMATS, ATTACHMENTS")—Page 1

    2. TECHNICAL PROPOSAL TABLE OF CONTENTS—Page 2

    3. ABSTRACT—Page 3
      State the proposal's broad, long-term objectives and specific aims. Briefly and concisely describe the research design and methods for achieving these goals. DO NOT EXCEED one page in providing the abstract. Identify the RFP Number, Institution and Principal Investigator on the abstract.

    4. TECHNICAL PLAN—Refer to Technical Proposal Instructions located in the Standard RFP Instructions and Provisions under Streamlined RFP References for more detail.

      1. Statement of Work
        1. Objectives—Page #
        2. Approach—Page #
        3. Methods—Page #
        4. Schedule—Page #

      2. PERSONNEL
        List of all Personnel in the project including Subcontractors, Consultants/Collaborators, by name, title, department and organization

        PROVIDE NARRATIVE FOR:

        1. Principal Investigator/Project Director
        2. Other Investigators
        3. Professional Personnel
        4. Support Staff
          [NOTE: For all personnel except support staff, include a two-page biosketch under APPENDICES below.]

      3. FACILITIES, EQUIPMENT AND OTHER RESOURCES—Page #
        List/describe all facilities, equipment and other resources available for this project.

      4. OTHER CONSIDERATIONS—Page #
        (Use specifically titled subparagraphs, as applicable.)

    5. OTHER SUPPORT—Page #
      Complete the Form "Summary of Current and Proposed Activities" (NIH Web Site Microsoft Word document). All key personnel must be listed on this form. The form is located in the Streamlined RFP References under "FORMS, FORMATS, & ATTACHMENTS."

    6. TECHNICAL PROPOSAL COST INFORMATION—Page #
      (Form located in the Streamlined RFP References under "FORMS, FORMATS, & ATTACHMENTS.")

    7. LITERATURE CITED—Page #

    8. APPENDICES—Page #
      List each Appendix and identify the number of pages for each one. Appendices must be clear and legible, and easily located. Include biosketches here. Provide in appendices, letters of commitment for proposed consultants.

    9. Human Subjects and Minority Gender issues not otherwise addressed (if applicable)—Page #

  7. 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.
  8. PRIVACY ACT SYSTEM OF RECORDS

    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 09-25-0200, Clinical, Epidemiology and Biometric Studies of the NIH. The notice was published in the Federal Register, Volume 64, number 229 on November 30, 1999 (http://www.access.gpo.gov/su_docs/aces/PrivacyAct.shtml).

  9. SAFETY AND HEALTH DEVIATION PHS 352.223-70 (AUGUST 1997)

    To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State and local laws and regulations applicable to the work being performed under this contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration and other agencies at the Federal, State and local levels (Federal, State and local regulatory/enforcement agencies).

    Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer, in conjunction with the project or other appropriate officer, determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, an equitable adjustment will be made in accordance with the applicable "Changes" Clause set forth in this contract.

    The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contract and all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

    If the Contractor fails or refuses to comply promptly with the Federal, State or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor. The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor.

  10. OTHER PROVISIONS

    1. COST/PRICING INFORMATION

      The offeror's business proposal shall include the basic cost/pricing information specified in the Standard RFP Instructions and Provisions, under the Streamlined RFP References Directory referenced in this RFP. Please include information to substantiate the proposed costs or prices, including payroll documentation, vendor quotes, invoice prices, and/or any other information relevant to aid the Government in evaluating the reasonableness of the price or to determine cost realism. Before award, submission and certification of cost or pricing data may be required. The cost spreadsheets should be in Microsoft Excel using the format located at http://ocm.od.nih.gov/contracts/rfps/buscost.htm. A diskette or CD Rom containing the Microsoft Excel spreadsheets should be attached to the original proposal. As an alternative to submitting the file on diskette, you may send the Microsoft file by electronic mail to kc116y@nih.gov.

    2. Uniform Resource Locators (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.

    3. Small Disadvantaged Business Participation Plan

      Evaluation of Small Disadvantaged Business (SDB) Participation Plans will be made based on a consideration of all relevant facts and circumstances. It will not be based on absolute standards of acceptable performance. The Government is seeking to determine whether the offeror has demonstrated their commitment and capability to use SDB concerns for the work that it intends to perform as the prime contractor.

      1. Evaluation of the Plan will be performed only on those offerors being considered for award. 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. The SDB Participation Plan should address 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 plan:

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


SECTION II. APPLICABLE RFP REFERENCES

This section identifies the items located in the Streamlined RFP References that are applicable to this Request For Proposal (RFP). The files identified below must be retrieved, in whole or in part, in order to submit a proposal in response to this RFP. The entire file entitled "STANDARD RFP INSTRUCTIONS AND PROVISIONS" is applicable to this RFP, except as modified by the inclusion of items from the "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS" below. Note: all references to "competitive range"contained in the standard RFP instructions are hereby deleted because this is a BAA and not a conventional RFP.

  1. The following items are applicable from the file entitled "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS." The full text of the provisions is available in the file.

    List of optional provisions which apply to this specific RFP:

    1. Notice: This requirement is Not Set-Aside for Small Business
    2. Late Proposals, HHSAR 352.215-70
    3. Human Subjects
    4. Inclusion of Women and Minorities in Research Involving Human Subjects
    5. Facilities Capital Cost of Money
    6. Inclusion of Children in Research Involving Human Subjects

  2. The following items are applicable to this specific RFP and are located in the file entitled "FORMS, FORMATS, AND ATTACHMENTS", under Streamlined RFP References:

    SUBMIT WITH TECHNICAL PROPOSAL (with original and every copy of technical proposal)

    1. Technical Proposal Cover Sheet (NIH Web Site Microsoft Word document)
    2. Government Notice for Handling Proposals (See Section I of this RFP, Specific RFP Instructions and Provisions, Item B)
    3. Summary of Current and Proposed Activities (NIH Web Site Microsoft Word document)
    4. Technical Proposal Cost Information

    SUBMIT WITH BUSINESS PROPOSAL:

    1. Proposal Summary and Data record, NIH-2043 (Adobe PDF document Microsoft Word document), with every copy of business proposal.
    2. Disclosure of Lobbying Activities Adobe PDF document, OMB SF-LLL, only one completed and signed original. This form is not required if there are no lobbying activities to disclose.
    3. Representations and Certifications (Adobe PDF document Corel WordPerfect document Microsoft Word document), only one completed and signed original.
    4. Electronic Business Proposal Spreadsheet located at: http://ocm.od.nih.gov/contracts/rfps/buscost.htm.
    5. Supporting documentation for staff salaries, consultants, subcontracts, supplies and equipment.
    6. Small Disadvantaged Business (SDB) Participation Plan—See Section 1, Specific RFP Instructions and Provisions, Item K. (This plan is different from the Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan).
OTHER—TO BE SUBMITTED WITH THE FINAL PROPOSAL REVISION:

  1. Certificate of Current Cost or Pricing Data, NIH-1397, to be submitted with Final Proposal Revision.
  2. Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan, only one completed and signed original.

ANTICIPATED TO BE INCLUDED AS CONTRACT ATTACHMENTS:

  1. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts Adobe PDF document, NIH(RC)-1
  2. NIH 2706, Financial Report for Individual Project/Contract Instructions
  3. NIH 2706, Financial Report for Individual Project/Contract Form Adobe PDF document
  4. Procurement of Certain Equipment, NIH(RC)-7
  5. Research Patient Care Costs, NIH(RC)-11

The "SAMPLE CONTRACT FORMAT-GENERAL" under the Streamlined RFP References is applicable to this RFP. Selected clauses, applicable to this acquisition, will be included in the contract.


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