RFP_75N92026R00008_Lung_Health_Cohort.pdf

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

75N92026R00008

National Institutes of Health National Heart, Lung, and Blood Institutes Bethesda MD 20892-7511

05/04/2026

IO-NHLBI

541715

1,000

LYNN M. FURTAW

Title: Study Coordinating Center the Lung

Health Cohort

Please see attached Request for Proposals

(RFP).

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

National Institutes of Health National Heart, Lung, and Blood Institutes Bethesda MD 20892-7511

75N92026R00008

IO-NHLBI

RFP No. 75N92026R00008

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

IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST :

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 June 18, 2026, by 3:00PM ET. Proposals must be submitted through the NIH electronic Contract Proposal Submission (eCPS) Website. See Attachment 1, Packaging and Delivery of Proposals, for instructions.

Proposal Intent Offerors are asked to review this RFP and complete the form in Attachment 2, Proposal Intent Response Sheet, and submit it by email to Lynn Furtaw, lynn.furtaw@nih.gov and Jessica Williams, jessica.williams3@nih.gov no later than May 15, 2026, by 3:00PM ET only if the intent is to submit a proposal.

Requests for Clarification

Requests for clarification shall be submitted by email to Lynn Furtaw, lynn.furtaw@nih.gov and Jessica Williams, jessica.williams3@nih.gov no later than May 15, 2026, by 3:00PM ET.

When submitting requests for clarification, offerors must cite the relevant section, paragraph, and page number. 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 with a response. Further, offerors are reminded that the Contracting Officer will not address hypothetical questions aimed at receiving a potential “evaluation decision.”

Contractors may submit no more than ten (10) questions for clarification.

Written responses to questions will be provided to all contractors by May 22, 2026, by 3:00PM ET.

Responses will not disclose proprietary information of the offerors.

mailto:lynn.furtaw@nih.gov mailto:jessica.williams3@nih.gov mailto:jessica.williams3@nih.gov

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Lung Health Cohort (LHC) is a longitudinal study that will enroll up to 4,000 community-dwelling adults aged 25–35 years from 17 metropolitan regions across the United States. The study was designed to examine a large cohort of healthy young adults to better define and characterize the constructs of “ideal” versus “impaired” lung health. The study is currently supported through a single NHLBI cooperative agreement (U01), first awarded in 2019 and expected to end in early 2027, which supports the LHC study coordinating center. The cooperative agreement supports study enrollment, data coordination, human subjects regulation, imaging oversight, environmental surveillance, and other functions. Study procedures for the baseline visit include physical assessment, spirometry, chest computed tomography (CT) scan, accelerometry, and collection of nasal epithelial lining fluid, nasal epithelial cells, blood, and urine. Additionally, medically related participant questionnaires are being recorded such as sociodemographic characteristics, home address histories and exposures, work history and exposures, medical histories, lung health, and health behaviors and activity. While baseline visits are ongoing, the full cohort of 4,000 participants is expected to have been enrolled and complete a baseline visit by early 2027 under the current cooperative agreement.

The objective of this requirement is to procure the services of a study coordinating center to support the continuation of the LHC. The contractor shall complete a second in-person visit of the full LHC cohort, to be completed approximately five years after the baseline visit, as well as other data to be collected remotely, all to be conducted through the ACRC network. Data and biospecimens shall be assessed for quality, stored, analyzed, and distributed as appropriate. Finally, the study shall be managed in a manner consistent with NIH and NHLBI policies with oversight from a single Institutional Review Board (IRB) and an NHLBI-managed Observational Study Monitoring Board (OSMB). The objective of this contract is to exploit the unique characteristics of the LHC to clarify how potential factors might alter ideal lung health and increase risk for future diseases such as chronic obstructive pulmonary disease.

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 $50,000 (minimum) nor more than a total of $49,400,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period March 01, 2027 through February 28, 2033.

c. The Government will issue Task Orders based on the work described in SECTION C of this contract.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. 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.4. 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.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. DESCRIPTION-SPECIFICATION- 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 4/30/2026, 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 [ X ] Semi-Annually [ ] Annually 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 also shall 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.

In addition, the UPDATED “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, racial, and/or 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 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.

https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-131.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-131.html https://www.ecfr.gov/current/title-45/part-94 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 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.

c. Invention Reporting

All reports and documentation required by RFO Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see RFO 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The first annual utilization report shall be due on or before the anniversary date of the contract.

Thereafter, reports shall be due on or before the 10th calendar day following the reporting period. The final invention statement (see RFO 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

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

Lynn Furtaw lynn.furtaw@nih.gov National Institutes of Health National Heart, Lung, and Blood Institute, Office of Acquisition Rockledge ll, 6701 Rockledge Dr., Bethesda, Maryland 20892 -7902

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 is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institutes of Health National Heart, Lung, and Blood Institute, Office of Acquisitions Rockledge I 6705 Rockledge Drive Bethesda, MD20892-7902 Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

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 52.246-8 Inspection of Research and Development - Cost- Reimbursement. (MAY 2001) - Alternate I (APR 1984)

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from March 01, 2027, through February 28, 2033.

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 items listed in Attachment 5 in accordance with the stated delivery schedule.

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.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) Alternate I (April 1984) is applicable to this contract.

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

TBD 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 https://www.acquisition.gov/?q=browsefar 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

TBD

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 Proposals (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

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.

c. 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 the proposal.

Upon completion of evaluation, the Contracting Officer will issue a task order if the proposal is in the best interest of the government.

The Contracting Officer will notify the Contractor of the selection decision in writing.

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

a. Invoice Submission, Invoice Submission, NIH(RC)-4 for NIH Cost-Reimbursement Type Contracts 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.

b. 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/Contract.

The Contractor must submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Official: Contracting Officer - TBD Contracting Officer Representative - TBD https://www.ipp.gov/

One courtesy copy of the original invoice shall be submitted electronically as follows:

The Central Point of Distribution: NHLBI Branch A - NHLBIContractsBranchA@mail.nih.gov

Invoices shall be submitted in accordance with Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract

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.

For inquiries regarding the status of invoices, contact OFM Customer Service via email 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 between 12:00 p.m. to 1:00 p.m.

c. 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 NHLBI Office of Acquisitions.

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 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 Central Contractor Registration (CCR) database. 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:%20ofm_customer_service@mail-cmp.niceincontact.com mailto:%20ofm_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: Study Coordinating Center for the Lung Health Cohort

g. Contract Line Items as follows:

Line Item # Line Item Description

h. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301)

496-6088.

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).

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 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801

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.

DFAS accepts only electronic submissions of indirect cost proposals. Go to the New Online Submission Guidance web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/new%20-online-submission-guidance for guidance on submitting indirect cost rate proposals electronically to DFAS.

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.

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 https://oamp.od.nih.gov/division-of-financial-advisory-services/new%20-online-submission-guidance https://oamp.od.nih.gov/division-of-financial-advisory-services/new%20-online-submission-guidance

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.

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.

FAR 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 42.11. 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 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://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 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 preaward 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. NOTICE TO OFFERORS - PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-70 (MAR 2026).

(a) The Department of Health and Human Services (HHS) regulations for the protection of human subjects, 45 CFR part 46, are available on the Office for Human Research Protections (OHRP) website at: http://www.hhs.gov/ohrp/index.html.

(1) These regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of human subjects participating in research activities supported or conducted by HHS.

(b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data or identifiable public information through intervention or interaction with the individual, or identifiable private information.

In most cases, the regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. 45 CFR part 46 does not directly regulate the use of autopsy materials; instead, applicable state and local laws govern their use.

(c) Activities which involve human subjects in one or more of the categories set forth in 45 CFR 46.104(d)(1)-(8) are exempt from complying with 45 CFR part 46. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

(d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal.

(e) In accordance with 45 CFR part 46, Offerors considered for award must file an acceptable Federal-wide Assurance (FWA) of compliance with OHRP specifying review procedures and assigning responsibilities for the protection of human subjects. The FWA is the only type of assurance that OHRP accepts or approves. The initial and continuing review of a research project by an institutional review board must ensure that: The risks to subjects are minimized; risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result; selection of subjects is equitable; and informed consent will be obtained and documented by methods that are adequate and appropriate. Depending on the nature of the research, additional requirements may apply; see 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 https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf http://www.hhs.gov/ohrp/index.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111 for additional requirements regarding initial and continuing review. HHS regulations for the protection of human subjects (45 CFR part 46), information regarding OHRP registration and assurance requirements/processes, and OHRP contact information is available at the OHRP Web site (at http://www.hhs.gov/ohrp/assurances/index.html).

(f) Offerors may consult with OHRP only for general advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects.

ONLY the contracting officer may offer information concerning a solicitation.

(g) The Offeror must document in its proposal the approved or active FWA from OHRP, related to the designated Institutional Review Board (IRB) reviewing and overseeing the research.

(1) If the Offeror does not have an approved FWA from OHRP, the Offeror must obtain an FWA before the deadline for proposal submission.

(h) When possible, the Offeror must also certify the IRB's review and approval of the research. If the Offeror cannot obtain this certification by the time of proposal submission, they must include an explanation in their proposal.

(i) Never conduct research covered by 45 CFR part 46 prior to receiving certification of the research's review and approval by the IRB.

(End of provision)

Alternate I (MAR 2026) (RFO DEVIATION).

As prescribed in HHSAR 335.7004(a), substitute the following paragraph (g)(1) for paragraph (g)(1) of the basic clause.

(1) If the Offeror does not have an active FWA from OHRP, the Offeror must take all necessary steps to obtain an FWA prior to the proposal submission deadline. If the Offeror cannot obtain an FWA before the proposal submission deadline, the proposal must indicate the steps/actions the Offeror will take to obtain OHRP approval within (Contracting Officer insert a time period in which the FWA must be obtained). Upon obtaining FWA approval, submit the approval notice to the Contracting Officer.

ARTICLE H.2. HUMAN SUBJECTS

Research involving human subjects shall not be conducted under this contract until the protocol developed in Phase I has been approved by NHLBI, written notice of such approval has been provided by the Contracting Officer, and the Contractor has provided to the Contracting Officer a properly completed "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly Optional Form 310) certifying IRB review and approval of the protocol. The human subject certification can be met by submission of the Contractor's self-designated form, provided that it contains the information required by the "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990- 0263 (formerly Optional Form 310).

http://www.hhs.gov/ohrp/assurances/index.html

When research involving Human Subjects will take place at collaborating sites or other performance sites, the Contractor shall obtain, and keep on file, a properly completed "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990- 0263 (formerly Optional Form 310) certifying IRB review and approval of the research.

ARTICLE H.3. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement dated August 25, 2000 at the following website:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

The information below is a summary of the NIH Policy Announcement:

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

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

ARTICLE H.4. DATA AND SAFETY MONITORING IN CLINICAL TRIALS AND EPIDEMIOLOGICAL STUDIES

For informational purposes, the Contractor is directed to the full text of the NHLBI policies regarding Data and Safety Monitoring Boards (DSMBs) and Observational Study Monitoring Boards (OSMBs), which may be found at:

https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-data-and-safety-monitoring-extramural-clinical-studies

a. Establishing Data and Safety Monitoring Boards and Observational Study Monitoring Boards.

b. Data Quality Assurance in Clinical Trials and Observational Studies-Guidelines.

c. Responsibilities of DSMBs Appointed by the NHLBI.

d. Responsibilities of OSMBs Appointed by the NHLBI.

ARTICLE H.5. GOOD CLINICAL PRACTICE TRAINING FOR NIH AWARDEES INVOLVED IN NIH-FUNDED

CLINICAL TRIALS

All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of…