RFP NHLBI-HC-98-36

Coronary Artery Disease Risk Development in Young Adults (CARDIA) Study Computed Tomography Reading Center (CTRC)

Request for Proposal (RFP) Number: NHLBI-HC-98-36
Issue Date: June 02, 1999
Issued by: William M. Stevens
Contracting Officer
NIH/NHLBI
Contracts Operations Branch
II Rockledge Centre
6701 Rockledge Dr., MSC 7902
Bethesda, MD 20892-7902
Purchase Authority: Public Law 95-83, as amended
Small Business Set-Aside: No; SIC 8733
Proposal Due Date: July 19, 1999, 4:30 P.M. (Eastern Time)

Ladies and Gentlemen:

You are invited by The National Heart, Lung, and Blood Institute (NHLBI) to submit a proposal for the services of a Computed Tomography Reading Center (CTRC) to read scans performed as part of the renewal for the Coronary Artery Disease Risk Development in Young Adults (CARDIA) Study. The NIH anticipates a cost-reimbursement contract will be awarded for a period of 3 years and 11 months. This Streamlined Technical Request For Proposal (RFP) consists of this combined solicitation form and cover letter (PART A), and three additional components, as follows:

  1. Work Statement;
  2. Reports/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. The section entitled "Specific RFP Instructions and Provisions" contains, for example, the address for delivery of your proposal. The section 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.

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 WILLIAM M. STEVENS, CONTRACTING OFFICER, AT THE FOLLOWING INTERNET ADDRESS: ws69s@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 fifteen (15) copies of your technical proposal, the original and six (6) copies of your business proposal and one Electronic Business Proposal Spread Sheet (EXCEL Spread Sheet) on disk must be received by the Contracting Office no later than July 19, 1999, 4:30 P.M. (Eastern Time) at the address listed in the item entitled "Packaging and Delivery of Proposals". Also, please complete the form entitled "Proposal Intent Response Sheet" and send it to the address indicated therein on or before June 28, 1999. This will allow us to expedite preparations for the peer review of proposals. Your proposal must be organized and submitted in accordance with the "Technical Proposal Table of Contents." These items are found under the "Specific RFP Instructions and Provisions" portion of this RFP, which follows the technical evaluation criteria section.

You are reminded that the "Technical Proposal Cover Sheet" must be completed in full detail and used as the cover sheet for each copy of your technical proposal. (This form is contained in the NIH WEB site under the FORMS, FORMATS, AND ATTACHMENTS file found in STREAMLINED RFP REFERENCES.) This information will be used to ensure that there will be no conflict of interest when selecting review committee members.

Your offer 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" also located at the site for FORMS, FORMATS, AND ATTACHMENTS.

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 THE PHS CLAUSE 352.215-10 ENTITLED, "LATE PROPOSALS, MODIFICATIONS OF PROPOSALS, AND WITHDRAWALS OF PROPOSALS". The full text is in the Optional RFP Instructions and Provisions file of the Streamlined RFP References Directory.

If you have any additional questions regarding this RFP, please contact Mr. William M. Stevens (ws69s@NIH.GOV) through the Internet using the electronic mail address or phone (301) 435-0345, fax (301) 480-3430. Collect calls will not be accepted.

The submission of the proposal using facsimile or electronic 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,

"REPRESENTATIONS AND CERTIFICATIONS" to download and complete the representations and certifications that must be submitted with your proposal, and

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

Sincerely,
    /s/
Mr. William M. Stevens
Contracting Officer

  1. WORK STATEMENT

    STATEMENT OF WORK FOR CORONARY ARTERY DISEASE RISK DEVELOPMENT IN YOUNG ADULTS (CARDIA) STUDY - Computed Tomography Reading Center (CTRC)

    SPECIFIC REQUIREMENTS AND TASKS

    Independently, and not as an agent of the Government, the contractor shall furnish the necessary services, qualified personnel, equipment, facilities, and materials, not otherwise provided by the Government, to perform the following work:

    1. Specifically, the Contractor shall:

      1. Coordinate, at the direction of the Steering Committee and in collaboration with the Coordinating Center and Field Centers, the development of protocols for computed tomography (CT) examinations for coronary calcium at each Field Center, and CT reading and information abstraction at the Reading Center, in accordance with the study design.

      2. Train and certify Field Center technicians according to the scanning protocol. This will include initial training and certification and training and certification of new technicians due to turnover. It will also include orientation training to scanning protocol methods for professional staff from the Coordinating Center with quality assurance and quality control responsibilities.

      3. Train and certify CT readers at the Reading Center according to the reading and information abstraction protocol. This will include initial training, certification, and orientation in the pilot testing phase and training, certification, and orientation of new readers and quality assurance staff due to turnover. It will also include orientation of professional staff from the Coordinating Center with quality assurance and quality control responsibilities

      4. Conduct a pilot test of the CT protocols, including Quality Control activities, during the protocol development/pilot testing phase, in collaboration with Field Centers and the Coordinating Center.

      5. Perform readings and information abstractions of CT measurements on approximately 3,320 studies during the 12-month examination period.

      [Note: It is expected that 3,890 CARDIA participants will undergo the Year 15 examination and that 80% (3,112) will undergo CT examinations during the 12-month examination period, from June 1, 2000 to May 31, 2001. Plan for a pilot study to include approximately 10 scans per site. Plan to reread all scans by the same and by a second reader for 5% rereads by a second reader.]

      1. Participate in various other activities to include, including visiting the four Field Centers as needed in support of quality Control activities of the Coordinating Center, participating in the Steering Committee and subcommittees as necessary, and participating in data analysis and preparation of reports and manuscripts using the CT data.

    2. Specific Requirements and Tasks:

      1. Develop and implement protocols for CT scanning.

        1. Develop methods for ensuring quality and standardization of scanning procedures and scans among Field Centers. Include recommendations about whether dual scanning should be performed, according to whether the scanning technology is electron-beam CT, helical CT, or some other form of subsecond CT. Develop written standard operating procedures (SOPs) for scanning procedures; documentation and records keeping; for logs of incidents reflecting unusual circumstances related to measurements, readings, errors, or any other information that may be of utility in providing perspective; for measurement quality control activities; and for any other relevant activity.

      [Note: In response to the RFP, recommended deletions from or additions to the protocol for obtaining other measurements may be suggested, along with scientific justification. It is anticipated that two of the four Field Centers will utilize electron-beam computed tomography using Imatron C-150 scanners, one Field Center will utilize a Siemens subsecond CT scanner, and one Field Center will utilize a helical CT scanner. Include a discussion regarding the advantages and disadvantages of performing dual scanning.]

        1. In collaboration with Coordinating Center staff as part of an overall quality assurance program, train and oversee quality control monitoring of measurements from the Field Centers' CT technicians in details of the CT examination, optical disk handling, and/or electronic data transfer, and data management. Training may include a meeting at the CT Reading Center with all Field Center technicians. Train and certify initially, and retrain and recertify technicians as needed during the entire study period. Train and certify new technicians when turnover occurs, as necessary.

      [Note: In the proposal, discuss the advantages and disadvantages of Field Center technician training and recommend whether or not the offeror considers it worthwhile.]

      1. Design and implement protocols for reading CT studies

        1. Develop a protocol for reading cardiac CT examinations for coronary calcium quantification. Include the development of written SOPs.

        2. Develop quality control procedures and performance standards to ensure that measurements from each reader conform to protocol requirements. This includes assessment, monitoring, and control of inter- and intra-reader variability. In conjunction with the Quality Control committee, define the limits of acceptability and plan for its continual assessment.

        3. As part of an overall quality assurance program in collaboration with Coordinating Center staff, train and certify the CT readers in interpretation of studies and reading conventions developed in the final CT protocol.

      2. In collaboration with Coordinating Center staff, oversee and evaluate a pilot series of approximately 10 CT studies at each Field Center during the pilot testing phase.

        1. Assist in the oversight of the pilot study.

        2. Identify and recommend remedial action prior to the start of the full examination for problems revealed in any aspects of scanning, data handling or reading as a result of the pilot test.

      3. Perform readings, information abstractions, and interpretations at a capacity of approximately 64 per week during the examination (approximately 3,268 total studies, including repeat readings) and transfer data to the Coordinating Center.

        1. Conduct readings in accordance with the protocol approved by the Steering Committee.

        2. Perform rereads, in accordance with a quality Control program developed in collaboration with the Coordinating Center.

        3. Assist the Coordinating Center in analysis and interpretation of data on accuracy and reliability, including summary of findings and recommendations for any further re-readings or analyses to the Steering Committee, as appropriate.

        4. Utilize calcium phantoms in the scanning and reading procedures to standardize readings of density.

      [Note: The proposal should detail the proposed method of performing information abstraction (i.e., "reading" the CT studies). The proposal should describe any analysis systems to be used, and should provide data on validity and reproducibility of proposed reading methods.]

      1. Other Tasks

        1. Receive scans from the Field Centers and, after reading, using transmission procedures developed in cooperation with the Coordinating Center, transmit the information to the Coordinating Center within 14 days of receipt of the images. Detailed methods must be described to assure accurate tracking of scans between the Field Center and the CT Reading Center and accurate transmission of all data to the Coordinating Center. Describe procedures for tracking down missing data and for replacing data, if necessary.

        2. Participate in the Steering Committee and its subcommittees as needed.

      [Note regarding travel: Plan to attend a site visit at each of the 4 Field Centers, two Steering Committee meetings in Bethesda annually, one Review Board meeting annually in Bethesda, and one scientific meeting per year.]

        1. Participate in maintaining a publications and presentations data base managed by the Coordinating Center.

        2. Participate in ancillary studies and substudies, as desired, feasible, and recommended by the Steering Committee.

      [Note: Investigators may propose ancillary studies and substudies to be conducted in one or more study Centers. A substudy is an investigation which, although not part of the core exam protocol, will yield additional information related to study objectives. An ancillary study is a substudy not funded by contract funds. Substudies and ancillary studies may include all or a subgroup of the cohort at a given center, and may involve additional interviews or examinations of study subjects as well as analysis of blood or tissue samples, tapes, or images collected previously.

      Ancillary studies and substudies are subject to the same policies, reviews and approvals as the core protocol. Substudies involving additional participant burden will require OMB clearance. Investigators proposing substudies will also prepare a request for OMB clearance for the substudy; or, for case-control studies, a request for exemption from OMB review, as appropriate.

      Ancillary studies and substudies will be evaluated by the Steering Committee. Highest priority will be given to studies which: 1) do not interfere with the main study objectives, 2) have the highest scientific merit, 3) produce the least burden on participants, 4) have objectives directly related to the study, and 5) require the unique characteristics of the cohort.

      For all substudies and ancillary studies, the contractor shall define the hypotheses to be investigated and the methodology to be used, and should estimate the cost and burden on participants. Study data collection must not interfere with the conduct of the core examination. All studies in the proposal should be distinctly identified, with separate descriptions and estimates of costs. Ancillary studies and substudies may be proposed before and/or after contract award as scientific opportunities arise. All studies must be approved by the Steering Committee, the Monitoring Board and the NHLBI Project Office before initiation.]

        1. Participate in analysis and publication of CT and other related data.

      [Note: Provide discussion of expertise and commitment to this activity, and the scientific questions believed to be most important. Make specific reference to types of information already collected or proposed for collection in the overall study, and describe relations to be explored between these data and the CT information. With your proposal, please submit ideas for three data analysis projects that the CT Reading Center might pursue in this study.]

    PROJECT PHASING

    The contractors's activities shall be accomplished in a timely mamner in order to fulfill thecollaborative phases, as follows:

    Phase Period

    I. Planning, pilot testing, cohort follow-up: 01/01/2000-05/31/2000
    II. Cohort Examination 06/01/2000-05/31/2001
    III. Close-out and Final Data Analysis 06/01/2001-11/30/2003

  1. REPORTS/ DELIVERABLES

    Satisfactory performance of this contract shall be deemed to occur upon delivery and acceptanceby the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule.

    DELIVERABLES - ELECTRON BEAM COMPUTED TOMOGRAPHY READING CENTER

    Item # Description Quantity Schedule Delivery
    Information
    1. Draft Field
    Center Manual
    of Operations    		 13 March 1, 2000 Field Centers (2 copies each)
    Center Manual Coordinating Center (2 copies)
    Of Operations Project Office (2 copies)
    Contracts Office (1 copy)
    2. Field Center
    Manual of
    Operations    		 13 April 1, 2000 Same as 1. Above
    3. Draft Reading
    Center Manual
    of Operations    		 13 March 1, 2000 Same as 1. Above
    4. Reading Center
    Manual of
    Operations    		 13 April 1, 2000 Same as 1. Above
    5. Training
    Materials for
    Field Centers    		 13 April 1, 2000 Same as 1. Above
    6. Reading Center
    Results    		 1 30 days after
    Receipt of
    Field Center Data    		 Coordinating Center;
    Project Office
    as requested
    7. Orientation
    Materials on
    Field Center
    Procedures for
    Coordinating Center    		 4 April 1, 2000 Coordinating Center (2 copies)
    Project Office (2 copies)
    8. Quality Assurance
    Data    		 1 Quarterly Coordinating Center
    9. Site Visit
    Report    		 5 30 days after
    Site Visit    		 Coordinating Center (2 copies)
    Project Office (2 copies)
    Contracts Office (1 copy)
    10. Raw Data 1 As requested Project Office
    11. Manuscripts As needed 4 weeks before
    Submission    		 Publications Committee
    (1 copy per Member)
    Project Office (2 copies)
    12. Abstracts As needed 2 weeks before
    Submission    		 Same as 9. Above
    13. Semi-annual
    Progress
    Report    		 3 January 15 and
    July 15 of each
    year of the contract    		 Project Office (2 copies)
    Contract Office (1 copy)
    14. Financial
    Reports    		 3 Monthly
    Invoice    		 Contract Office (3 copies)
    15. Final Report
    and Summary    		 10 November 30, 2003 Project Office (2 copies)
    Contract Office (1 copies)

    The items above shall be addressed and delivered to:

    Project Officer
    Epidemiology and Biometry
    Program Division of Epidemiology
      and Clinical Applications
    Bethesda, MD 20892

    Contracting Officer
    Contracts Operations Branch
    National Heart, Lung, and
      Blood Institute
    6701 Rockledge Dr. MSC 7902
    Bethesda, MD 20892-7902

    Steering Committee as per the Manual of Operations

    Coordinating Center as per the Manual of Operations

  1. EVALUATION FACTORS FOR AWARD WITH TECHNICAL EVALUATION CRITERIA

    GENERAL:

    Proposals submitted in response to this RFP will be reviewed by (1) a primary technical review group using peer review procedures under the auspices of Review Branch, DEA and (2) a secondary review group composed primarily of members of the DECA, NHLBI professional staff.

    The technical proposal will receive paramount consideration in the selection of the Contractor(s) for this acquisition. All technical evaluation factors, when combined, are significantly more important that cost/price and small disadvantaged business participation. However, cost/price and small disadvantaged business participation may become critical factors in source selection in the event that two or more offerors are determined to be essentially equal following the evaluation of all technical evaluation factors. Cost/Price is significantly more important than small disadvantaged business participation. In any event, the Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered.

    Award of this RFP will be made only to offerors located in the United States of America. Proposals from offerors outside the United States will not be considered for award.

    The offeror's Small Disadvantaged Business (SDB) Participation Plan will be evaluated after determination of the competitive range. Only those offerors included in the competitive range will be evaluated.

    The evaluation will be based on information obtained from the plan provided by the offeror (Reference Standard RFP Instructions and Provisions), the realism of the proposal, other relevant information obtained from named SDB concerns, and any information supplied by the offeror concerning problems encountered in SDB participation. Evaluation of the SDB Participation Plan will be a subjective assessment 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 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. Thus, an offeror with an exceptional record of participation with SDB concerns may receive a more favorable evaluation than another whose record is acceptable, even though both may have acceptable technical proposals.

    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 most advantageous to the Government.

    Technical Evaluation Criteria

    The following criteria and weight factors will utilized in the technical evaluation of the proposal. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes.

    1. Adequacy of plans for fulfilling the ECT Reading Center functions outlined in the statement of work (with the exception of quality assurance). These include plans and protocols for ECT scanning at the Field Centers; for information processing, coding, and interpretation at the Reading Center; for data management, including detailed plans assuring accurate transmission of data from Field Centers to the ECT Reading Center and from the ECT Reading Center to the Coordinating Center.

      (35 points)

    2. Expertise and experience of ECT Reading Center senior staff in cardiac ECT, and their willingness and ability to take appropriate leading roles in protocol development, collaboration and coordination among centers, quality assurance activities, scientific data analysis, data management, and publication. Adequacy of availability and time commitments of proposed key staff.

      (35 points)

    3. Adequacy of plans for developing, maintaining, and modifying quality assurance activities in collaboration with the Coordinating Center. This includes development of written standard operating procedures; appropriate training and certification of all Field Center, Coordinating Center, and ECT Reading Center staff to implement the ECT measurement protocol; and monitoring of reliable and accurate measurement performance at Field Centers and the Reading Center.

      (20 points)

    4. Adequacy of the administrative structure, support staff, and institutional support. This includes the availability of adequate facilities and equipment, including technical hardware; the ability of staff to develop, maintain, and modify technical software and hardware and operations, as necessary.

      (10 points)

THE REMAINDER OF THIS RFP CONSISTS OF THE FOLLOWING SECTIONS:

  1. Specific RFP Instructions and Provisions, and

  2. Applicable RFP References

  1. 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 III. 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. SIC Code and Small Business Size Standard
    5. Number and Type of Award(s)
    6. Estimate of Effort
    7. Service of Protest
    8. Technical Proposal Table of Contents
    9. Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns
    10. Other Provisions

  1. PROPOSAL INTENT RESPONSE SHEET

    RFP No. NHLBI-HC-98-36

    TITLE OF RFP: Coronary Artery Disease Risk Development in Young Adults (CARDIA) Study Computed Tomography Reading Center (CTRC)

    FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY June 28, 1999. 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
    NIH, NHLBI
    6701 ROCKLEDGE DR MSC 7924
    BETHESDA MD 20892-7924
    Attention: Dr. James Scheirer
    or FAX TO: Dr. James Scheirer at (301) 480-3541.

  1. 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.

    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 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.)

  1. PACKAGING AND DELIVERY OF THE PROPOSAL

    Shipment and marking shall be as follows:

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

    "RFP NO. NHLBI-HC-98-36
    TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

    The number of copies required of each part of your proposal are:
    TECHNICAL PROPOSAL: ORIGINAL* AND Fifteen (15) COPIES
    BUSINESS PROPOSAL: ORIGINAL* AND Six (6) COPIES
    One Electronic Business Proposal Spread Sheet (EXCEL Spread Sheet) on disk

    DELIVER PROPOSAL TO:
    If hand delivered or delivery service:

    Review Branch
    Division of Extramural Affairs
    National Heart, Lung, and Blood Institute
    I Rockledge Centre, Room 7091
    6701 Rockledge Drive MSC 7924
    Bethesda, MD 20817-7924

    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.

  2. SIC CODE AND SMALL BUSINESS SIZE STANDARD

    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 standard industrial classification (SIC) code for this acquisition is 8733.

    The small business size standard is $5,000,000 average annual receipts over the three preceding fiscal years.

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

  3. NUMBER AND TYPE OF AWARD

    It is anticipated that one award will be made from this solicitation and that award will be made in January 2000.

    It is anticipated that the award from this solicitation will be a multiple-year cost reimbursement, completion type contract with a period of performance of three years and 11 months, and that incremental funding will be used.

  4. ESTIMATE OF EFFORT AND PROJECTED TRAVEL:

    To assist you in the preparation of your proposal, the Government considers the effort to be approximately as follows. This information is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes.

    Period
    Labor Category 01/01/00
    11/30/00    		 12/01/00
    11/30/01    		 12/01/01
    11/30/02    		 12/01/02
    11/30/03
    Investigators 40% 40% 10% 10%
    Staff 85% 85% 0% 0%
    Total 125% 125% 10% 10%

    All staffing levels proposed should be accompanied by specific justifications as to the type and hours of work expected to be performed by all personnel. Offerors will be required to propose levels of commitment whether compensated or donated effort, necessary to complete the work described in their proposals. It is expected that realistic levels of effort will be proposed such that an offeror's understanding of the work will be apparent.

    TRAVEL: Anticipated average number of trips per year is as follows:

    Period
    Travel Category 01/01/00
    11/30/00    		 12/01/00
    11/30/01    		 12/01/01
    11/30/02    		 12/01/02
    11/30/03
    Steering Committee 2 2 2 2
    Review Board 1 1 1 1
    Site Visits 4
    Scientific Meetings 1 1 1 1
    TOTAL 8 4 4 4

  5. SERVICE OF PROTEST

    In accordance with FAR 52.233-2 SERVICE OF PROTEST (NOV 1988):

    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 R. Carlsen
      Hand-Carried Address:
      National Institutes of Health
      National Heart, Lung, and Blood Institute
      Contracts Operations Branch
      II Rockledge Center, Room 6122
      6701 Rockledge Drive, MSC 7902
      Bethesda, MD 20817

      U.S. Postal Service:
      National Institutes of Health
      National Heart, Lung, and Blood Institute
      Contracts Operations Branch
      II Rockledge Center
      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. 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 (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 (approximately 25 PAGES for part 4, sections a.- d.)
      Refer to Technical Proposal Instructions located in the Standard RFP Instructions and Provisions under Streamlined RFP References for more detail.
      1. WORK STATEMENT
        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--Page #

        PROVIDE NARRATIVE FOR:

        1. Principal Investigator/Project Director--Page #
        2. Other Investigators--Page #
        3. Professional Personnel--Page #
        4. Support Staff--Page #
          [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." 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.

  1. 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.

  1. 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. Please submit a computer disc with the cost proposal in Excel 5.0 (or 97) format. For your convenience, a standard cost proposal format in Excel format will be provided by NHLBI contracts office.

    2. NHLBI PUBLIC USE DATA CLAUSE - EPIDEMIOLOGY (This clause will be made a part of the contract.)

      Public use data will be released under this observational epidemiology study. After completion of the closing date of each examination cycle, the coordinating center will prepare the data from the examination component and will deliver it to the NHLBI. The data will be prepared in a format suitable for use by the public. Such release is expected to occur no later than five years after the closing date of each examination cycle. The coordinating center will provide the data to the NHLBI within four years of the closing date of each examination cycle so that the NHLBI can check the data before release. This will provide time for NHLBI review, discussion of the data and opportunity for any changes needed in content or presentation prior to release.

      The public use data set will include all of the examination data obtained in the examination cycle, and/or all of the follow up information available up to the cutoff time. Inclusion of raw data that has been processed into summary information shall be discussed with the Project Officer prior to submission. Data prepared for release will not contain personal identifiers. The coordinating center will coordinate preparation of the data with the NHLBI to assure patient confidentiality. Ancillary study data(not funded under this contract) are not required to be included in the public use data set, though the data may be included if agreed upon by the ancillary study investigator.

      The study investigators will be expected to answer basic questions regarding data set characteristics, format and content, during the study. Documentation is expected to be of the highest quality so that such questions will be minimized.

      Data will not be prepared for public use if the investigators and NHLBI believe that they are unreliable or invalid. These exceptions must be justified in writing through the coordinating center to the NHLBI and will be reviewed and, if the NHLBI concurs, approved in writing by the Director of the Division that sponsored the study.

    3. INTRODUCTION BACKGROUND AND GENERAL OBJECTIVES OF STUDY -

      1. INTRODUCTION - BACKGROUND

        The origins of cardiovascular disease are in childhood, adolescence, and young adulthood, manifest as early atherosclerotic lesions, including fatty streaks and fibrous plaque. Prevention of the initial formation of atherosclerosis would be likely to prevent the development of clinical atherosclerosis in later life. However, there have been relatively few studies of the risk factors for the initial development of atherosclerosis, particularly in free-living populations.

        The Coronary Artery Risk Development in Young Adults (CARDIA) Study, which has existed as a study of the distribution and change in risk factors during young adulthood in black and white men and women, has the potential to address important new questions related to the early development of atherosclerosis, including its genetic origins. The study, which began recruitment in 1985, has completed 10 years of examinations in a cohort of 5,115 men and women aged 18-30 years in four communities. Participants were initially selected from the total population, selected census tracts or, in the case of one Center, the membership of a large health plan. The original cohort had approximately equal representation by blacks and whites, men and women, those aged 18-24 and 25-30, and those with no more than a high school education and more than a high school education.

        The study has four Field Centers and a Coordinating Center, which subcontracts for a central laboratory and other essential functions. Principal Investigators from each of the Field Centers and the Coordinating Center plus the NHLBI Project Officer form the Study Steering Committee. The chairman of the Steering Committee serves through a subcontract with the Coordinating Center.

        The baseline examination (Year 0) was conducted over a 14-month period during 1985-86. The examination consisted of questionnaires on sociodemographic characteristics, health behaviors, and psychological factors; an exercise treadmill test; resting electrocardiography; a quantitative food frequency assessment; anthropometry; pulmonary function testing; and resting blood pressure. Fasting blood measurements included total cholesterol and its subfractions, insulin, glucose, liver enzymes and other serum chemistry measurements, and hematology.

        Four additional examinations have been completed every 2-3 years, including a Year 10 examination, completed in 1996. Repeat measurements on traditional risk factors, including plasma lipids, blood pressure, anthropometry, smoking behavior, physical activity, and pulmonary function testing (except Year 7) have used the same methods at each examination to assess cohort changes and secular trends in these factors during young adulthood. In selected years, additional measurements have been made, including a treadmill exercise test and quantitative food frequency questionnaire at baseline and Year 7; cardiovascular reactivity measurements in Year 2; echocardiography and ambulatory blood pressure monitoring (in a subset) at Year 5; skin reflectance and assessment of the experience of discrimination and other psycho social measures and urine sodium and creatinine in Year 7; and echocardiography (in a subset), glucose tolerance testing, and micro albuminuria in Year 10.

        Retention of the surviving cohort was 91, 86, 81 and 78 percent at each of the respective follow-up examinations.

        Cohort members are contacted every six months to obtain information on vital status and current residence. Every other contact includes contact with the individual to ascertain information on current smoking status, major illness or injury, and hospitalizations. Investigators currently have 123 papers published or in press.

        Having largely completed several major objectives of the original contracts, including a description of the cross-sectional and longitudinal relationships between age, race and risk factors during young adulthood, the study is poised to contribute in new areas related to the early development of atherosclerosis. This contribution is possible because of the previously collected data in this cohort and new scientific opportunities presented by evolving technologies in subclinical atherosclerosis measurement, genetics, and assessment of inflammatory response.

        Plans to take advantage of this unique cohort and new scientific opportunities have been developed by the CARDIA Steering Committee, in accordance with recommendations from the NHLB Advisory Council. The Council, at its February 1998 meeting, recommended that the investigators and the Institute develop specific plans to change the scientific focus and direction of the study, to address new areas of research, and to broaden the expertise among the investigators to assure that new objectives can be addressed. In response, the Steering Committee developed a plan that was endorsed by the Council in May 1998. The plan outlined new research questions and specific data to be collected in Year 15. New measures included a measure of subclinical disease, immortalized lymphocytes which will serve as a plentiful supply of DNA for genetic studies, genomic screening, markers of endothelial cell damage, hemostatic and thrombotic factors, and markers of inflammation and infection. The plan also called for the creation of an "Emerging Science Committee," with interested scientists specifically named. The Steering Committee has since proceeded to establish this committee and involve them in planning for the Year 15 examination and in data analysis and manuscript preparation.

      2. OBJECTIVES

        The objectives of the five year renewal are:

        1. Measure early atherosclerosis, using noninvasive means, in persons aged 33-45.

        2. Identify and quantify risk factors for the early development of atherosclerosis measured noninvasively.

        3. Identify and quantify gene-environment interactions that contribute to the development of cardiovascular risk factors and to early atherosclerosis.

        4. Determine whether significant race or gender differences exist in the risk factors for early atherosclerosis or in the gene-environment interactions that lead to the development of atherosclerosis.

  1. SCHEDULE OF CARDIA COMPONENTS, SUBSTUDIES AND ANCILLARY STUDIES BY EXAMINATION, INCLUDING TENTATIVE YEAR 15 COMPONENTS -

    Table 1. Schedule of CARDIA components, substudies and ancillary studies by examination, including tentative Year 15 components

    Year/Exam
    Components 85
    0    		 87
    2    		 90
    5    		 92
    7    		 95
    10    		 00
    15
    BLOOD PRESSURE
      Resting X X X X X X
      Standing - X - - - -
      Reactivity - X - - - -
    CHEMISTRIES
      Lipids X X X X X X
      Lipoproteins X X X X X X
      Apoproteins X X - - - -
      Triglycerides via ultracentrifugation - - - - - -
      Cotinine X - - - X -
      SMAC 12 X - - - - -
      Fasting Insulin X - - X X X
      Fasting Glucose X - - X X X
      Oral Glucose Tolerance Test - - - - X -
      CBC X - - - - -
      Lp(a) - - X - - -
      Fibrinogen - - X - - X
      DNA Storage - - X - X -
      Stored Cells for Cell Immortalization - - - - - X
      Cell Immortalization - - - - - X
      ApoE Phenotype - - - X - -
      Stored Plasma - X X X X X
      Stored Serum X X X X X X
      GGT, Uric Acid X - - - X -
      Creatinine X - - - X X
      Small Dense LDL - - - - - X
      Homocysteine, Folate, Pyridoxine - - - - - X
      Carotenoids, Tocopherols, Selenium - - - - - X
      TNF-a - - - - - X
      Interleukin-6 - - - - - X
      C-reactive Protein - - - - - X
      Amyloid A - - - - - X
      Chlamydia Pneumoniae, CMV HSV Type I Antibody - - - - - X
      PAI-1 - - - - - X
      Factor VIII - - - - - X
      Isoprostanes - - - - - X
      Paraoxanase - - - - - X
      Platelet - Aggregating Factor Aceylhydrolase - - - - - X
      sICAM-1 - - - - - X
      Micro albuminuria - - - - X X
      Urinary Oxidative DNA Damage Products - - - - - X
    ANTHROPOMETRY
      Height X X X X X -
      Weight X X X X X X
      Skinfolds X X X X X -
      Chest Circumference - X X - - -
      Waist Circumference X X X X X X
      Hip Circumference X X X X X X
      Thigh Circumference - - - - X -
      Elbow Breadth X X - - - -
      Shoulder Breadth - X - - - -
      Sitting Height - X - - - -
      Toenails - X - - - -
      Eye Color - - X - - -
      Skin Reflectance - - - X - -
    MEDICAL HISTORY
      Personal History X X X X X X
      Drug History X X X X X -
      Mortal Events - - - X X X
      Safety Questionnaire - X - - - -
      Interim Hospitalization - X X X X X
      Chest Pain/Palpitations - - X - X -
      Oral Contraceptive History - - - - X -
      Hypertension in Pregnancy - - - - X -
    FAMILY HISTORY
      Questionnaire X - X - X -
      Extended Interview - - - - - -
    PHYSICAL ACTIVITY/FITNESS
      7 Day Physical Activity X - - - - -
      Physical Activity History X X X X X X
      Graded Exercise Test X - - X - -
      Baecke Questionnaire - - X - X -
      Household Chores - - - X X -
    PSYCHO SOCIAL
      Cook-Medley X - X - - -
      Life Events X X - - - -
      Social Support X X - - - -
      Framingham Type A X X - - - -
      John Henryism X - - - - -
      Tobacco X X X X X X
      Alcohol X X X X X X
      Weight History X X - - - -
      Type A-B Interview X - - - - -
      Karasek - X - - X -
      Sociodemographic X X X X X X
      CES-D Depression - - X - X -
      Anger-In, Speilberger Trait Anxiety - - X - - -
      Discrimination - - - X - -
      Selected Psycho social Measures - - - - - X
    NUTRITION
      CARDIA Diet History X - - X - -
      Food Frequency - X - - - -
    PULMONARY FUNCTION
      Testing X X X - X X
      Questionnaire X X - - X X
    ECHOCARDIOGRAPHY
      LV Mass - - X - - -
      Systolic, Diastolic Function - - X - - -
    OBESITY QUESTIONNAIRES
      Knowledge, Attitude, Behavior - - X - - -
      Self Image - - - X - -
      Weight Change - - - X X -
      Dietary Practices, Behaviors and Attitudes - - - X X -
      Self-Efficacy for Eating Behavioral Scale - - - - X -
      Binge Eating Disorder - - - - X -
    GENETIC STUDIES
      Genotyping - - - - - X
    SUBSTUDIESa
      Urinary Na, K, Mg, Creatinine - - X - -
      24 Hour Blood Pressure - - X - -
      Urinary Catecholamines - - - X -
      Echocardiography - - X - X
      Homocysteine X - - X -
      Toenail Lead Levels - X - - -
      Hypertension in Pregnancy (HIP) - - - - X
      Vascular Resistance/Arterial Complianceb - - - - X
      Dual Energy X-Ray Absorptiometry - - - - X
    Plasma Renin Activityb - - - - X
      Sympathetic Nervous Systemb - - - - X
      Apolipoprotein B - - X - X
      EBCT - - - - X
      Cotinine - - - - X
    ANCILLARY STUDIESa
      Na-Li Countertransport - X - - -
      AIDS Study - X - - -
      Injury Risk Assessment - - X - -
      Bioelectrical Impedance - - X - -
      Clotting Factors - X X X -
      Bone Mass - - - X X
      Seismocardiography - - - X X
      Lp(a) Isoforms - - - X -
      Serum Antioxidants X - - X X
      Visceral Fat - - - - X
      Apo(a) Genotype - - - - X
      ACE/AGT Genotyping - - X - -
      Leptin - - X - X

    aYear of study indicates when original data collection occurred; assay or coding may occur later.
    bSubstudies will be conducted in same subsample of participants.

  1. APPLICABLE RFP REFERENCES
    This section identifies the items located in the Streamlined RFP References that are applicable to this Request For Proposal (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.

    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 provisions which apply to this specific RFP:

    1. Notice: This requirement is Not Set-Aside for Small Business
    2. Late Proposals, Modifications of Proposal, and Withdrawal of Proposals, PHS 352.215-10
    3. Small Business Subcontracting Plan (JAN 1999)
    4. Facilities Capital Cost of Money
    5. "Just in Time"

    6. 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
      2. Summary of Current and Proposed Activities
      3. Technical Proposal Cost Information

      SUBMIT WITH BUSINESS PROPOSAL:

      1. Contract Pricing Proposal Cover Sheet, SF-1411, or equivalent, with every copy of business proposal.
      2. Proposal Summary and Data record, NIH-2043, with every copy of business proposal.
      3. Disclosure of Lobbying Activities, OMB SF-LLL, only one completed and signed original.
      4. Representations and Certifications, only one completed and signed original.
      5. Attached Electronic Business Proposal Spread Sheet (Attached EXCEL 5.0 or 97 file)
      6. Supporting documentation for staff salaries, consultants, subcontracts, supplies and equipment.
      7. Small Disadvantaged Business (SDB) Participation Plan ( This plan is different from the Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan. Please see Streamlined RFP References - Standard RFP Instructions and Provisions - G. General Instructions - paragraph number 19)

      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 Requests Instructions for NIH Cost Reimbursement Type Contracts,
      2. NIH(RC)-2Procurement of Certain Equipment, NIH(RC)-7
      3. Privacy Act System of Records

      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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