Sol_75N98026R00074.pdf
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- Solicitation number
- 75N98026R00074
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This is a Request for Proposal (RFP) solicitation document for a Study Coordinating Center (SCC) to expand the Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study into the Southern Plains region of the United States. The National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), seeks a contractor to recruit and examine up to 2,000 new participants across two to four rural Southern Plains counties using methods and protocols comparable to the RURAL Original cohort. The primary objectives include establishing an expansion cohort that enables valid statistical comparisons of cardiopulmonary risk and resilience factors across population subgroups, conducting baseline clinical examinations via mobile examination units consistent with the original cohort baseline exam, and integrating resulting data and biospecimens with the RURAL Original cohort repository. Scientific aims include recruiting and examining up to 2,000 participants in rural, underserved areas to enhance understanding of risk factor progression, providing statistical power for analyses across population groups defined by sex, race, and ethnicity, studying CVD and pulmonary disease progression, and identifying new risk factors informing disease pathophysiology.
This is an Indefinite-Quantity contract with a minimum contract value of $1,410,783.00 and a maximum of $16,209,115.00, covering the period from June 1, 2027 through August 31, 2031, with five option periods to be negotiated. The Government will issue Task Orders based on work described in Section C. Proposals are due November 5, 2026, by 3:00 PM EST through the NIH electronic Contract Proposal Submission (eCPS) website, with price-cost proposals submitted separately from technical proposals. A Proposal Intent Response Form must be submitted by September 1, 2026, by 3:00 PM EST, and Offerors may submit no more than ten clarification questions by the same deadline, with anticipated written responses issued by September 14, 2026. The RFP includes requirements for protection of human subjects, data sharing, clinical trial registration, inclusion of women and racial/ethnic minorities, and reporting on investigator financial conflicts of interest. Non-small business offerors must submit a subcontracting plan through the HHS Small Business Customer Experience (SBCX) system as part of the proposal submission. Invoices must be submitted to the Department of Treasury's Invoice Processing Platform (IPP), and the contractor is responsible for periodic transition updates as NIH transitions from the Office of Financial Management system.
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SOLICITATION/CONTRACT
BIDDER/OFFEROR TO COMPLETE
BLOCKS 11, 13, 15, 21, 22, and 27
1. This Contract is a Rated Order under the Defense Priorities and Allocations System (DPAS) - Code of Federal Regulations - at
15 CFR 700.
RATING PAGE
2. CONTRACT NUMBER 3. AWARD/EFFECTIVE
DATE
4. SOLICITATION NUMBER 5. SOLICITATION TYPE
SEALED BIDS (IFB)
INVITATION FOR
BID
NEGOTIATED
(RFP) REQUEST
FOR PROPOSAL
6. SOLICITATION
ISSUE DATE
8. THIS ACQUISITION IS
9. (Agency Use)
11. IF OFFER IS ACCEPTED BY THE GOVERNMENT WITHIN
CALENDAR DAYS (60 CALENDAR DAYS UNLESS OFFEROR INSERTS A
DIFFERENT PERIOD) FROM THE DATE SET FORTH IN BLOCK 9 ABOVE, THE
CONTRACTOR AGREES TO HOLD ITS OFFERED PRICES FIRM FOR THE
ITEMS SOLICITED HEREIN AND TO ACCEPT ANY RESULTING CONTRACT
SUBJECT TO THE TERMS AND CONDITIONS STATED HEREIN.
12. ADMINISTERED BY CODE
13. CONTRACTOR
OFFEROR
FACILITY
CODECODE
TELEPHONE NUMBER UNIQUE ENTITY
IDENTIFIER
CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER
15. PROMPT PAYMENT DISCOUNT
14. PAYMENT WILL BE MADE BY
SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK:
16. AUTHORITY FOR USING OTHER
THAN FULL AND OPEN COMPETITION
UNDER THE UNITED STATES CODE AT:
10 U.S.C. 3204(a)
17.
ITEM NUMBER
18.
SCHEDULE OF
SUPPLIES/SERVICES
19.
QUANTITY
20.
UNIT
21.
UNIT PRICE
22.
AMOUNT
23. ACCOUNTING AND APPROPRIATION DATA 24. TOTAL AWARD AMOUNT
(For Government Use Only)
25. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN COPIES TO
ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET FORTH OR
OTHERWISE IDENTIFIED ABOVE AND ON ANY CONTINUATION SHEETS SUBJECT TO THE TERMS
AND CONDITIONS SPECIFIED HEREIN.
NUMBER SHOWN IN BLOCK 4 INCLUDING ANY ADDITIONS OR
CHANGES WHICH ARE SET FORTH HEREIN, IS ACCEPTED AS TO
ITEMS:
26. AWARD OF CONTRACT:
27. SIGNATURE OF OFFEROR/CONTRACTOR
NAME AND TITLE OF SIGNER (Type or Print) DATE SIGNED
28. UNITED STATES OF AMERICA (Signature of Contracting Officer)
NAME OF CONTRACTING OFFICER DATE SIGNED
STANDARD FORM 1447 (REV. 12/2022)
Prescribed by GSA - FAR (48 CFR) 53.214(d)
7. ISSUED BY
NO COLLECT CALLS
10. ITEMS TO BE PURCHASED (Brief Description)
SUPPLIES SERVICES
41 U.S.C. 253
CODE
AUTHORIZED FOR LOCAL REPRODUCTION
PREVIOUS EDITION NOT USABLE
NORTH AMERICAN INDUSTRY CLASSIFICATION
SYSTEM (NAICS):
SIZE STANDARD:
% FOR:
SMALL BUSINESS
HISTORICALLY UNDERUTILIZED
BUSINESS ZONE
(HUBZone) SMALL BUSINESS
SERVICE-DISABLED VETERAN-
OWNED SMALL BUSINESS
8(A)
OF
UNRESTRICTED SET ASIDE:
WOMEN-OWNED SMALL BUSINESS (WOSB)
ELIGIBLE UNDER THE WOSB PROGRAM
ECONOMICALLY DISADVANTAGED
WOMEN-OWNED SMALL BUSINESS (EDWOSB)
CODE
OR
PAGES
YOUR OFFER ON SOLICITATION
75N98026R00074
National Institutes of Health Div. Simplified Acq. Policy & Services, OALM 6701 Rockledge Drive, RK II, 4th floor Bethesda, MD 20817
National Heart, Lung, and Blood Institute Bethesda, MD 20892-7511
08/19/2026
OD/OALM
541715
1,000
NHLBI
ELIZABETH R. BULGER
Title: Risk Underlying Rural Areas
Longitudinal (RURAL) Heart and Lung Study -
Expansion Cohort
Please see the attached Request for Proposal
(RFP) Number 75N98026R00074 and the accompanying attachments as identified in
SECTION J of this solicitation.
1 160
NO RESPONSE FOR REASONS CHECKED
CANNOT COMPLY WITH SPECIFICATIONS
UNABLE TO IDENTIFY THE ITEM(S)
CANNOT MEET DELIVERY REQUIREMENT
DO NOT REGULARLY MANUFACTURE OR SELL THE TYPE
OF ITEMS INVOLVED
OTHER (Specify)
WE DO WE DO NOT, DESIRE TO BE RETAINED ON THE MAILING LIST FOR FUTURE PROCUREMENT OF THE TYPE
OF ITEMS INVOLVED
NAME AND ADDRESS OF FIRM (Include ZIP Code) SIGNATURE
TYPE OR PRINT NAME AND TITLE OF SIGNER
FROM: AFFIX
STAMP
HERE
TO:
DATE AND LOCAL TIME
SOLICITATION NUMBER
STANDARD FORM 1447 (REV. 12/2022) BACK
Div. Simplified Acq. Policy & Services, OALM
SOLICITATION/CONTRACT
BIDDER/OFFEROR TO COMPLETE
BLOCKS 11, 13, 15, 21, 22, and 27
1. This Contract is a Rated Order under the Defense Priorities and Allocations System (DPAS) - Code of Federal Regulations - at
15 CFR 700.
RATING PAGE
2. CONTRACT NUMBER 3. AWARD/EFFECTIVE
DATE
4. SOLICITATION NUMBER 5. SOLICITATION TYPE
SEALED BIDS (IFB)
INVITATION FOR
BID
NEGOTIATED
(RFP) REQUEST
FOR PROPOSAL
6. SOLICITATION
ISSUE DATE
8. THIS ACQUISITION IS
9. (Agency Use)
11. IF OFFER IS ACCEPTED BY THE GOVERNMENT WITHIN
CALENDAR DAYS (60 CALENDAR DAYS UNLESS OFFEROR INSERTS A
DIFFERENT PERIOD) FROM THE DATE SET FORTH IN BLOCK 9 ABOVE, THE
CONTRACTOR AGREES TO HOLD ITS OFFERED PRICES FIRM FOR THE
ITEMS SOLICITED HEREIN AND TO ACCEPT ANY RESULTING CONTRACT
SUBJECT TO THE TERMS AND CONDITIONS STATED HEREIN.
12. ADMINISTERED BY CODE
13. CONTRACTOR
OFFEROR
FACILITY
CODECODE
TELEPHONE NUMBER UNIQUE ENTITY
IDENTIFIER
CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER
15. PROMPT PAYMENT DISCOUNT
14. PAYMENT WILL BE MADE BY
SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK:
16. AUTHORITY FOR USING OTHER
THAN FULL AND OPEN COMPETITION
UNDER THE UNITED STATES CODE AT:
10 U.S.C. 3204(a)
17.
ITEM NUMBER
18.
SCHEDULE OF
SUPPLIES/SERVICES
19.
QUANTITY
20.
UNIT
21.
UNIT PRICE
22.
AMOUNT
23. ACCOUNTING AND APPROPRIATION DATA 24. TOTAL AWARD AMOUNT
(For Government Use Only)
25. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN COPIES TO
ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET FORTH OR
OTHERWISE IDENTIFIED ABOVE AND ON ANY CONTINUATION SHEETS SUBJECT TO THE TERMS
AND CONDITIONS SPECIFIED HEREIN.
NUMBER SHOWN IN BLOCK 4 INCLUDING ANY ADDITIONS OR
CHANGES WHICH ARE SET FORTH HEREIN, IS ACCEPTED AS TO
ITEMS:
26. AWARD OF CONTRACT:
27. SIGNATURE OF OFFEROR/CONTRACTOR
NAME AND TITLE OF SIGNER (Type or Print) DATE SIGNED
28. UNITED STATES OF AMERICA (Signature of Contracting Officer)
NAME OF CONTRACTING OFFICER DATE SIGNED
STANDARD FORM 1447 (REV. 12/2022)
Prescribed by GSA - FAR (48 CFR) 53.214(d)
7. ISSUED BY
NO COLLECT CALLS
10. ITEMS TO BE PURCHASED (Brief Description)
SUPPLIES SERVICES
41 U.S.C. 253
CODE
AUTHORIZED FOR LOCAL REPRODUCTION
PREVIOUS EDITION NOT USABLE
NORTH AMERICAN INDUSTRY CLASSIFICATION
SYSTEM (NAICS):
SIZE STANDARD:
% FOR:
SMALL BUSINESS
HISTORICALLY UNDERUTILIZED
BUSINESS ZONE
(HUBZone) SMALL BUSINESS
SERVICE-DISABLED VETERAN-
OWNED SMALL BUSINESS
8(A)
OF
UNRESTRICTED SET ASIDE:
WOMEN-OWNED SMALL BUSINESS (WOSB)
ELIGIBLE UNDER THE WOSB PROGRAM
ECONOMICALLY DISADVANTAGED
WOMEN-OWNED SMALL BUSINESS (EDWOSB)
CODE
OR
PAGES
YOUR OFFER ON SOLICITATION
Div. Simplified Acq. Policy & Services, OALM
National Heart, Lung, and Blood Institute Bethesda, MD 20892-7511
08/19/2026
541715
1,000
NHLBI
ELIZABETH R. BULGER
Title: Risk Underlying Rural Areas
Longitudinal (RURAL) Heart and Lung Study -
Expansion Cohort
Please see the attached Request for Proposal
(RFP) Number 75N98026R00074 and the accompanying attachments as identified in
SECTION J of this solicitation.
1 160
NO RESPONSE FOR REASONS CHECKED
CANNOT COMPLY WITH SPECIFICATIONS
UNABLE TO IDENTIFY THE ITEM(S)
CANNOT MEET DELIVERY REQUIREMENT
DO NOT REGULARLY MANUFACTURE OR SELL THE TYPE
OF ITEMS INVOLVED
OTHER (Specify)
WE DO WE DO NOT, DESIRE TO BE RETAINED ON THE MAILING LIST FOR FUTURE PROCUREMENT OF THE TYPE
OF ITEMS INVOLVED
NAME AND ADDRESS OF FIRM (Include ZIP Code) SIGNATURE
TYPE OR PRINT NAME AND TITLE OF SIGNER
FROM: AFFIX
STAMP
HERE
TO:
DATE AND LOCAL TIME
SOLICITATION NUMBER
STANDARD FORM 1447 (REV. 12/2022) BACK
Div. Simplified Acq. Policy & Services, OALM
RFP No. 75N98026R00074
RFP TABLE OF CONTENTS
PART I - THE SCHEDULE
SOLICITATION
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
SECTION D - PACKAGING, MARKING AND SHIPPING
SECTION E - INSPECTION AND ACCEPTANCE
SECTION F - DELIVERIES OR PERFORMANCE
SECTION G - CONTRACT ADMINISTRATION DATA
SECTION H - SPECIAL CONTRACT REQUIREMENTS
PART II - CONTRACT CLAUSES
SECTION I - CONTRACT CLAUSES
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
SECTION J - LIST OF ATTACHMENTS
PART IV - REPRESENTATIONS AND INSTRUCTIONS
SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS
SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS
SECTION M - EVALUATION FACTORS FOR AWARD
PART I - THE SCHEDULE
THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.
ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A -
SOLICITATION/CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION
APPLICABLE TO THE CONTRACT AWARD.
THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED
IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE
ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY
INFORMATION TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.
SOLICITATION
SECTION A - SOLICITATION/CONTRACT FORM
Proposal Submission Proposals in response to this solicitation are due on November 5, 2026, by 3:00 PM EST. Proposals must be submitted through the NIH electronic Contract Proposal Submission (eCPS) Website. See Attachment 1, Packaging and Delivery of Proposals, for instructions. The Price-Cost Proposal shall be submitted separately from the Technical Proposal. Please provide searchable electronic copies only.
Proposal Intent Potential Offerors are asked to review this Request for Proposal (RFP) and complete the form in Attachment 2, Proposal Intent Response Form, and submit it by e-mail to Elizabeth Bulger, elizabeth.bulger@nih.gov and Melissa K. Ramos, melissa.ramos@nih.gov no later than September 1, 2026, by 3:00 PM EST only if the intent is to submit a proposal.
Requests for Clarification
1. Requests for clarification shall be submitted by e-mail to Elizabeth Bulger, elizabeth.bulger@nih.gov and Melissa K. Ramos, melissa.ramos@nih.gov no later than September 1, 2026, by 3:00 PM EST.
2. When submitting requests for clarification, Offerors must cite the relevant section, paragraph, and page number of the RFP. Questions should be written in a way that enables clear understanding of the Offeror’s issues or concerns. Statements expressing opinions, sentiments, or conjectures are not considered valid inquiries and will not be provided a response.
Furthermore, Offerors are reminded that the Contracting Officer will not address hypothetical questions aimed at receiving a potential “evaluation decision.”
3. Offerors may submit no more than ten (10) questions for clarification.
4. The Government anticipates providing written responses to questions to all Offerors on or about September 14, 2026, by 4:00 PM EST; however, this date is a target only and is not binding on the Government. The Government reserves the right to adjust the date and time by which responses will be provided, and is under no obligation to respond to any or all questions submitted. The Government further reserves the right to determine the form and content of any response, including the right to consolidate, paraphrase, or decline to identify the source of a question. Responses will not disclose proprietary information of any Offeror. Responses, as provided, will be issued as an amendment to this solicitation.
mailto:elizabeth.bulger@nih.gov mailto:melissa.ramos@nih.gov mailto:elizabeth.bulger@nih.gov mailto:melissa.ramos@nih.gov
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The National Heart, Lung, and Blood Institute (NHLBI), Division of Cardiovascular Sciences (DCVS), requires a Study Coordinating Center (SCC) to expand the Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study into the Southern Plains region of the United States. The goal of this acquisition is to increase the representation of the U.S. rural population within the RURAL cohort by recruiting and examining up to 2,000 new participants across two (2) to four (4) rural Southern Plains counties, using methods and protocols comparable to the RURAL Original cohort. The primary objectives are to: (1) establish an expansion cohort that enables valid statistical comparisons of cardiopulmonary risk and resilience factors across key population subgroups; (2) conduct a baseline clinical examination via mobile examination unit(s) consistent in scope with the RURAL Original cohort baseline exam; and (3) integrate the resulting data and biospecimens with the RURAL Original cohort repository to support ongoing and future scientific analysis. The scientific aims of the RURAL Expansion cohort are to: (1) recruit and examine up to 2,000 participants in rural, underserved areas of the Southern Plains to enhance understanding of risk factor progression and resilience factors related to cardiopulmonary health; (2) provide sufficient statistical power for analyses of biological, social, and behavioral predictors of subclinical disease across population groups defined by sex, race, and ethnicity; (3) study progression from subclinical to clinical CVD and pulmonary complications; and
(4) identify new risk factors or interactions informing disease pathophysiology.
ARTICLE B.2. PRICES/COSTS
a. This is an Indefinite-Quantity contract as contemplated by RFO 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $1,410,783.00 (minimum) nor more than a total of $16,209,115.00 (maximum) for successful performance of this contract.
b. The costs set forth in this ARTICLE will cover the contract period June 1, 2027 through August 31, 2031.
c. The Government will issue Task Orders based on the work described in SECTION C of this contract.
ARTICLE B.3. ESTIMATED COST – OPTION
*This Article is applicable to Task Area A only. The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.
a. The estimated cost of the Base Period of this contract is to be determined.
b. The total estimated amount of the Task Order, represented by the sum of the estimated cost for the Base Period plus option periods, if exercised, is to be determined.
c. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government’s total estimated contract amount represented by the sum of the estimated cost will be increased as follows:
Estimated Cost ($)
Base Period: June 1, 2027 – May 31, 2028 To be negotiated
Option Period 1: June 1, 2028 – May 31, 2029 To be negotiated
Option Period 2: June 1, 2029 – May 31, 2030 To be negotiated
Option Period 3: June 1, 2030 – May 31, 2031 To be negotiated
Option Period 4: June 1, 2031 – August 31, 2031 To be negotiated
TOTAL (Base and Option Periods) To be negotiated
ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS
This Article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable: 1) Conferences & Meetings; 2) Food for Meals, Light Refreshments & Beverages; 3) Promotional Items; 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property;
12) Printing costs; and 13) Research Funding.
ARTICLE B.5. ADVANCE UNDERSTANDINGS
Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurring the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.
Invoice Processing Platform (IPP)
NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). This award will transition to IPP in the future. The Contractor/Vendor shall use the attached NIH OFM Electronic Invoice Submission Instructions until the Contractor/Vendor has transitioned to IPP as specified on the OALM IPP website at https://oalm.od.nih.gov/IPP. It is the Contractor/Vendor’s responsibility to periodically check the OALM IPP website and be prepared to transition to IPP on the designated transition date. Questions concerning the transition to IPP should be directed to NIH-https://oalm.od.nih.gov/IPP mailto:NIH-IPPinvoicing@mail.nih.gov
IPPinvoicing@mail.nih.gov. Questions concerning this award should be directed to the NIH Contracting Officer.
All IPP invoices must contain a Unique Entity Identifier (UEI), which is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.
This award is a parent Indefinite-Delivery award and HHSAR 352.232-71 applies to all Task Orders issued under this award.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF WORK
a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated 8/18/2026, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).
ARTICLE C.2. REPORTING REQUIREMENTS
All reports shall be submitted electronically to the Contracting Officer.
These reports shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: https://www.hhs.gov/web/section-508/index.html and at:
https://www.section508.gov/create/documents , "Create Accessible Documents."
a. Technical Progress Reports In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]
For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s), no hard copies of these reports will be required.
[ ] Monthly [ ] Quarterly [ ] Semi-Annually [ X ] Annually mailto:NIH-IPPinvoicing@mail.nih.gov https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents https://www.section508.gov/create/documents
[ ] Annually (with a requirement for a Draft Annual Report) [ ] Final - Upon final completion of the contract [ X ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)
Summary of Salient Results
The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.
Annual Technical Progress Report for Clinical Research Study Populations
The Contractor shall submit information about the inclusion of women and members of racial and/or ethnic minority groups and their subpopulations (when appropriate) for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, “Cumulative Inclusion Enrollment Report,” which is set forth in SECTION J of this contract. The Contractor shall also use this format, modified to indicate that it is a final report, for reporting purposes in the final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative Inclusion Enrollment Reports.
The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.
In addition, the “NIH Policy and Guidelines on the Inclusion of Women and Members of Racial and/or Ethnic Minority Groups as Subjects in Clinical Research”, effective August 16, 2025, also applies. If this contract is for Phase III clinical trials, see Section B of these guidelines. The Guidelines may be found at the following website: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-131.html
For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex, racial, and/or ethnic groups, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex, racial, and/or ethnic groups.
b. Other Reports/Deliverables
1. Reporting of Financial Conflict of Interest (FCOI)
All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm submitted to the Contracting Officer in electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94. 45 CFR Part 94 is available at:
https://www.ecfr.gov/current/title-45/part-94.
See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.
(Reference the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)
2. Section 508 Annual Report
The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer’s Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: https://www.hhs.gov/sites/default/files/web/508/contracting/technolog y/section_508_annual_report.doc.
3. NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological
Studies
The Contractor must provide data sets for the study with full documentation.
The data set and documentation shall be prepared in accordance with the NHLBI's Data Set policy at: https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing-from-clinical-trials-and-epidemiological-studies.
SECTION D - PACKAGING, MARKING AND SHIPPING
All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.
b. For the purpose of this SECTION, the Contracting Officer's Representative (COR) is the authorized representative of the Contracting Officer.
https://www.ecfr.gov/current/title-45/part-94 https://www.ecfr.gov/current/title-45/part-94 https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing-from-clinical-trials-and-epidemiological-studies https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing-from-clinical-trials-and-epidemiological-studies https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing-from-clinical-trials-and-epidemiological-studies
c. Inspection and acceptance will be performed at:
Office of the Director Office of Acquisition and Logistics Management (OALM) 6701 Rockledge Drive Rockledge Building II Bethesda, MD 20892-7902
d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.
RFO Clause 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE
a. The period of performance of this contract shall be from June 1, 2027 through August 31, 2031.
*Paragraph b. is only applicable to Task Area A.
b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in SECTION H of this contract, the period of performance will be increased as follows:
Option Option Period
Option Period 1 June 1, 2027 – May 31, 2028 Option Period 2 June 1, 2028 – May 31, 2029 Option Period 3 June 1, 2029 – May 31, 2030 Option Period 4 June 1, 2030 – May 31, 2031 Option Period 5 June 1, 2031 – August 31, 2031
ARTICLE F.2. DELIVERIES
Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:
a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in RFO 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below:
Item Description Quantity Delivery Schedule
(1) See SECTION J –
Attachment 2
(2) (3)
b. The above items shall be addressed and delivered to:
Addressee Deliverable Item No. Quantity
See SECTION J – Attachment 2
ARTICLE F.3. NOTIFICATION OF COMPLETION OF REPORTING IN ELECTRONIC RESEARCH
ADMINISTRATION (eRA) SYSTEM
The Contractor shall submit data relevant to Human Subjects and Clinical Trial Information, including any required Inclusion Enrollment Reporting, into the NIH Electronic Research Administration (eRA) system. These requirements are described further in SECTION H - REPORTING IN ELECTRONIC RESEARCH ADMINISTRATION (eRA) SYSTEM.
The Contractor shall submit the data within the NIH eRA system within fifteen (15) calendar days of receiving a prompt from the NIH to complete these activities, or sooner as instructed by the Contracting Officer (CO).
Following submission of data within the NIH eRA system as instructed, the Contractor shall send an e-mail notification verifying completion to the CO and the Contracting Officer’s Representative (COR).
ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, RFO 52.252-2 (FEB 1998).
This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.
REVOLUTIONARY FAR OVERHAUL (RFO) (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (August 1989).
Alternate I (April 1984) is applicable to this contract.
https://www.acquisition.gov/?q=browsefar
SECTION G – CONTRACT ADMINISTRATION DATA
ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR)
The following Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract:
[To be determined at the time of award]
The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.
The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the Statement of Work; (2) modify or extend the period of performance; (3) change the delivery schedule;
(4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract.
The Government may unilaterally change its COR designation.
ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015).
The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the Contractor voluntarily diverting any of the specified individuals to other programs or contracts, the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the Contractor is terminated for cause or separates from the Contractor voluntarily with less than thirty days' notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.
(End of clause).
The following individual[(s)] [is/are] considered to be essential to the work being performed hereunder:
Name Title To Be Determined
ARTICLE G.3. TASK ORDER PROCEDURE
This contract provides for the issuance of Task Orders on a negotiated basis as follows:
a. General
Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.
No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.
b. Requesting Task Order Proposals.
The Contracting Officer or a designated individual may solicit responses to requirements from Contractors within a technical area covered by a Task Order requirement in writing. A Task Order Request for Proposal (TORFP) will be prepared and issued for each task order requirement.
Generally, the Task Order Request for Proposal (TORFP) will include but is not limited to the following:
1. Statement of Work;
2. Reporting Requirements and Deliverables;
3. Proposal Due Date and Location to Deliver Proposals;
4. Period of Performance of Task Order;
5. Anticipated type of Task Order;
6. Technical Proposal Instructions;
7. Business proposal Instructions
8. Evaluation Factors for Award
c. All contract clauses contained in this contract shall be incorporated in the TORFP and the resultant Task Order. If conflicts exist between the contract clauses and the information outlined in the Task Order, the contract language takes precedence over the information in the Task Order.
Competitive Ordering Process.
1. All Contractors within a technical area will receive e-mail notification advising of the availability of each proposed Task Order requirement. All proposed Task Orders will incorporate all terms of this contract unless otherwise specified in the proposed Task Order.
2. Contractors will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed Task Order. Responses will not be considered a proposal as defined in RFO Part
15. However, the Contractor shall provide information sufficient for consideration in accordance with RFO Part 16. Each TORFP will indicate the criteria for the evaluation of proposals. The responses shall demonstrate capability for each criterion to be evaluated. Generally, the Contractor will be asked to demonstrate the following as appropriate:
Understanding of the requirements;
Experience and capability on similar tasks;
Technical approach, methods, and procedures for satisfying the requirements with a discussion of potential problems to be encountered and proposed solutions and/or risk mitigation strategies;
Procedures for assuring quality of work, products, and deliverables;
Plan for managing the Task Order, including meeting requirements and schedules, and performance measures (if applicable);
Staffing plan with skill levels and level of effort for each individual proposed.
Generally, resumes will be required for proposed personnel (if not previously submitted);
References to evaluate past performance; and Cost/Price to perform the Task Order.
d. Evaluation and Award of Task Order Proposals
The Government will evaluate the Task Order proposals against the requirements of the TORFP. Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a Contractor for award. Generally, technical factors will be significantly more important than cost or price. However, each TORFP will specify how the award decision will be made.
Upon completion of evaluations, the Contracting Officer will issue a Task Order to the Contractor.
The Contracting Officer will notify the Contractor of the selection decision in writing.
ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST
a. Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost- Reimbursement Contracts, NIH(RC)-4 are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.
1. The Contractor must submit invoices to the Department of Treasury's Invoice Processing
Platform (IPP) at https://www.ipp.gov with a copy of the invoice to the approving official, as directed below and in accordance with the definitions of timeliness set forth in the invoice instructions included as an attachment in SECTION J of this Solicitation.
https://www.ipp.gov/
The Contractor’s failure to submit timely invoice(s) to the Government waives the Contractor’s rights to receive payment pursuant to this contract. In the event of this waiver, the Government is not obligated to make such payment, and the Contracting Officer shall have the authority to unilaterally deobligate the funds in accordance with the requirements at 31 U.S.C. 1552(a) and downwardly adjust the total amount of the award by the amount of the deobligation. The Contractor shall be given an opportunity to request the excusal of a late invoice from the Contracting Officer. If excused, the Contracting Officer will respond in writing to confirm that the Contactor’s right to receive payment has not been waived.
The Contractor must submit a copy of the electronic invoice to the following Approving Official: the Contracting Officer and the Contracting Officer’s Representative (COR):
Official: Contracting Officer - TBD Contracting Officer’s Representative - TBD
For inquiries regarding the status of invoices, contact OFM Customer Service via e-mail at ofm_customer_service@mail-cmp.niceincontact.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx .
Note: The OFM Customer Service is open Eastern Standard Time, Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed daily between 12:00 p.m. to 1:00 p.m.
2. In addition to the requirements specified in RFO 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:
a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is the Office of Acquisition and Logistics Management (OALM).
b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer. Note: The Contractor shall not include the TIN if it is a Social Security Number.
c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the System for Award Management (SAM). If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.
mailto:ofm_customer_service@mail-cmp.niceincontact.com mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx
d. Invoice Matching Option. This contract requires a two-way match.
e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.
f. The Contract Title is: Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study – Expansion Cohort
g. Contract Line Items as follows:
Line Item # Line Item Description
To Be Determined
h. Inquiries regarding payment of invoices shall be directed to the designated billing office,
(301) 496-6452.
i. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:
"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."
ARTICLE G.5. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, RFO
52.232-40 (Mar 2023).
(a) (1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.
(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.
(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.
(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.
(End of clause).
https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801
ARTICLE G.6. INDIRECT COST RATES
In accordance with Revolutionary FAR Overhaul (RFO) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the Cognizant Federal Agency Official (CFAO) responsible for negotiating provisional and/or final indirect cost rates is identified as follows:
Director, Division of Financial Advisory Services (DFAS) Office of Acquisition Management and Policy National Institutes of Health 6701 Rockledge Drive 4th Floor, MSC-7786 Bethesda, MD 20892-7786
These rates are hereby incorporated without further action of the Contracting Officer. Go to the Indirect Cost Submission web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for electronic copies of the DFAS Indirect Cost Branch's information package documents.
Billing (Provisional) Rates:
In accordance with RFO 42.504, billing (provisional) rates must be established by the CFAO on the basis of information resulting from recent reviews, previous rate audits or experience, or similar reliable data or experience of other contracting activities.
The Contractor is required to submit a billing rate proposal to the CFAO identified above for the purpose of establishing and/or renewing expiring billing rates. As an administrative requirement, such submission shall be made no later than five (5) business days following the expiration of each of the Contractor's fiscal years.
Failure to submit a timely billing rate proposal to the CFAO may result in establishment of billing rates unilaterally by the CFAO, based on audited historical data or other available data with unallowable costs excluded.
The Contractor shall have an opportunity to request reasonable extensions in writing at least 30 days prior to the expiration of the active billing rate agreement. Requests may be granted in writing by the
CFAO.
The Contractor shall notify the CFAO if/when the current billing (provisional) rates are no longer representative of current conditions and need to be renegotiated. This notification should include a revised indirect cost proposal and complete financial documentation to support a significant change in circumstances that warrants renegotiation of the rates.
The Contractor shall utilize the IDC Submission Checklist found at: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for preparing the billing rate proposal.
https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission%C2%A0 https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission%C2%A0 https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission
Final Indirect Rates:
In accordance with RFO Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in PART II, SECTION I of this contract, the Contractor shall submit an adequate final indirect cost rate proposal to the Contracting Officer (or cognizant Federal agency official) and auditor within the 6-month period following the expiration of each of its fiscal years. Reasonable extensions, for exceptional circumstances only, may be requested in writing by the Contractor and granted in writing by the Contracting Officer.
RFO Clause 52.216-7 (d)(2) lists the full requirements for submission of an adequate final indirect cost rate proposal. In accordance with RFO 42.503-2(a), the Government must not accept a proposal or agree to establish final indirect cost rates unless the contractor certifies the costs are allowable. Failure to submit a certified final indirect rate proposal to the CFAO may result in establishment of final indirect rates unilaterally by the Government, based on audited historical data or other available data with unallowable costs excluded. These unilateral rates established by the Government shall be set low enough to ensure that unallowable costs will not be reimbursed (RFO 42.503-2(c)).
ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
a. Contractor Performance Evaluations
Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with RFO Subpart 4211. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows on the anniversary date of the contract.
Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted sixty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.
Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.
b. Electronic Access to Contractor Performance Evaluations
Contractors may access evaluations through a secure Web site for review and comment at the following address: https://www.cpars.gov .
End of clause.
https://www.cpars.gov/
ARTICLE G.8. GOVERNMENT PROPERTY
If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the pre-award negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," Appendix Q, which can be found at:
https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%2 0of%20Government%20Property-Appendix%20Q.pdf
SECTION H - SPECIAL CONTRACT REQUIREMENTS
ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.235-71 (MAR 2026) (RFO DEVIATION).
(a) The Contractor must—
(1) Protect the rights and welfare of human subjects involved in research under this contract in accordance with 45 CFR part 46 and with the Contractor's current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services;
(2) Provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance; and
(3) Ensure that other agencies or institutions the Contractor involves in activities considered to be engaged in research involving human subjects—
(i) Obtain their own FWA if they are routinely engaged in research involving human subjects; or
(ii) Are covered by the Contractors' FWA via designation as agents of the institution or via individual investigator agreements (see OHRP Web site at:
http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf [PDF, 76 KB]).
(b) The Contractor—
(1) Bears full responsibility for the performance of all work and services involving the use of human subjects under this contract and must ensure that work is conducted in a proper manner and as safely as is feasible.
(2) Retains the right to control and direct the performance of all work under this contract. Nothing in this contract must create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever.
https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf…
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