Sol_75N94026R00008.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: FAR 15.204-2(a)(2)

2. Request for Proposal (RFP) Number:

75N94026R00008

3. Issue Date:

November 3, 2026

4. Set Aside:

[X] No [ ] Yes See Part IV Section L

5. Title : Best Pharmaceuticals for Children Act Data Coordination Center

6. ISSUED BY:

Office of Acquisitions and Logistics Management (OALM), NIH R&D Professional Services, Division B on behalf of Eunice Kennedy Shriver Institute of Child Health & Human Development National Institutes of Health 6710B Rockledge Drive First Floor MSC 7000 Bethesda, Maryland 20892-7000

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal"

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 4:00 PM EST local time on December 18, 2026. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access SAM at http://www.sam.gov.

11. Primary Contact: Theresa Ranjit Email: Theresa.Ranjit@nih.gov Proposals due by 4:00pm (Eastern)

December 18, 2026

Technical Proposal Page Limitations: See “Packaging and Delivery of the Proposal,” Section J – Attachment 1.

See Attachment 4 entitled “Additional Proposal Information” for additional proposal instructions.

Secondary Contact Alice Pagan, Contracting Officer Email: Alice.Pagan@nih.gov

Questions must be submitted in writing via email by November 20, 2026.

http://www.sam.gov/ mailto:Theresa.Ranjit@nih.gov mailto:Alice.Pagan@nih.gov

SECTION B - Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

2. PRICES/COSTS

3. PROVISIONS APPLICABLE TO DIRECT COSTS

4. ADVANCE UNDERSTANDINGS

SECTION C - Description/Specifications

1. REPORTING REQUIREMENTS

2. INVENTION REPORTING REQUIREMENT

SECTION D - Packaging and Marking

SECTION E - Inspection and Acceptance

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

2. DELIVERIES

3. NOTIFICATION OF COMPLETION OF REPORTING IN ELECTRONIC RESEARCH ADMINISTRATION

(eRA) SYSTEM

4. CLAUSES INCORPORATED BY REFERENCE, RFO 52.252-2 (FEB 1998)

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

2. TASK ORDER PROCEDURE

3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

4. INDIRECT COST RATES

5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

6. GOVERNMENT PROPERTY

7. HHSAR 352.237-75 Key Personnel. (DEC 2015)

SECTION H - Special Contract Requirements

1. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

2. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

3. GOOD CLINICAL PRACTICE TRAINING FOR NIH AWARDEES INVOLVED IN NIH-FUNDED CLINICAL

TRIALS

4. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION SUBMISSION PLAN

5. POSTING CLINICAL TRIAL INFORMED CONSENT FORMS TO CLINICALTRIALS.GOV

6. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN

CLINICALTRIALS.GOV

7. RESEARCH AND DEVELOPMENT DATA IN ELECTRONIC RESEARCH ADMINISTRATION (eRA) SYSTEM

8. HUMAN MATERIALS

9. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

10. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

11. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-

FUNDED RESEARCH

12. ACKNOWLEDGEMENT OF FEDERAL FUNDING

13. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

14. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

15. GUN CONTROL

16. OPTION PROVISION

17. SUBCONTRACTING PROVISIONS

18. INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE, HHSAR 352.239-78

(FEB 2024) (DEVIATION)

19. INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-79 (FEB

2024) (DEVIATION)

20. CONFIDENTIALITY OF INFORMATION

21. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF

INTEREST

22. Article H.71 PUBLICATION AND PUBLICITY

23. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

24. SHARING RESEARCH DATA

25. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

26. CONSTITUTION DAY

27. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

28. USE OF FUNDS FOR PROMOTIONAL ITEMS

SECTION I - Contract Clauses

1. GENERAL CLAUSES

2. AUTHORIZED SUBSTITUTION OF CLAUSES

3. ADDITIONAL CONTRACT CLAUSES IN FULL TEXT

SECTION J - List of Documents, Exhibits and Other Attachments

SECTION K - Representations, Certifications, and Other Statements of Bidders

1. SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - Instructions,Conditions, and Notices to Bidders

SECTION M - Evaluation Factors for Award

1. COST/PRICE EVALUATION

2. EVALUATION OF OPTIONS

3. TECHNICAL EVALUATION FACTORS

4. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY - SECTION 508 . 134

SECTION B – Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this contract is to provide continued Data Coordinating Center (DCC) services for the Best Pharmaceuticals for Children Act (BPCA) Clinical Program, including data management, data storage, statistical analysis, safety monitoring, and regulatory support for BPCA clinical trials and other NICHD high-priority studies.

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 $2,500 (minimum) nor more than a total of $90,000,000 (maximum) for successful performance of this contract.

b. The ordering period of the IDIQ contract is May 29, 2027 through May 28, 2037. Costs and/or prices will be established at the individual task order level.

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

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.

4. ADVANCE UNDERSTANDINGS

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

SECTION C - Description/Specifications

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, dated September 18, 2026, attached hereto and made a part of this Solicitation (See SECTION J-List of Attachments).

Note: Please be advised that the Contractor shall perform work under this contract only as directed in Task Order(s) issued by the Contracting Officer.

1. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format, via the NICHD Contracts Portal. All electronic contract deliverables shall be submitted via the NICHD Contracts Portal. Access to the NICHD Contracts Portal will be provided to the successful offeror following contract award.

All electronic reports submitted 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 under "Create Accessible Documents." The Contractor must provide to the Contracting Officer/Contract Specialist the name of the person(s) submitting electronic reports via the NICHD Contracts Portal in order to initiate access to the Portal.

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order. Deliverables shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract and with the requirements of Task Orders issued.

a. Technical Reports

See Attachment 3 of this RFP for a list of all Reporting Requirements and Deliverables.

1. In addition to the required report 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, in any technical progress report submitted, the applicable PubMed Central (PMC) 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 versions of these reports will be required as follows:

https://www.hhs.gov/web/section-508/index.html

[ ] Monthly [ ] Quarterly [X] Semi-Annually [X] Annually [ ] 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)

2. Summary of Salient Results

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

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/Hard Copy] 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. INVENTION REPORTING REQUIREMENT

All reports and documentation required by [RFO Clause 52.227-11, Patent Rights-Ownership by the Contractor/RFO Clause 52.227-13, Patent Rights-Ownership by the Government] 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.

https://www.ecfr.gov/current/title-45/part-94

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. 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 Contracting Officer (CO) at following email address:

Theresa Ranjit Theresa.Ranjit@nih.gov

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected.

Interagency Edison and information relating to the capabilities of the system can be obtained from the Web (http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

mailto:Theresa.Ranjit@nih.gov http://www.iedison.gov/

SECTION D – Packaging and Marking

A. 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.

Note: Packaging and Marking Instructions will be specified, as necessary, in individual task order(s).

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.

c. Inspection and acceptance will be performed at:

National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development 6710B Rockledge Drive Bethesda, MD 20892

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt. If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

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.

FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

FAR Clause 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

SECTION F – Deliveries or Performance

1. PERIOD OF PERFORMANCE

The ordering period of this IDIQ contract shall be from May 29, 2027 through May 28, 2037.

2. DELIVERIES

a. Satisfactory performance of this 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 Services specified in the Delivery Schedule which are described in SECTION C of this contract.

b. Deliveries required by the Contractor shall be made F.o.b. destination as set forth in RFO Clause 52.247-35, F.o.b. Destination, Within consignees Premises (April 1984) and any specifications stated in SECTION D, PACKAGING AND MARKING AND SHIPPING, of this contract.

3. NOTIFICATION OF COMPLETION OF REPORTING IN ELECTRONIC RESEARCH

ADMINISTRATION (eRA) SYSTEM

The Contractor shall provide a written notification of completion of research and development data entry, as required in section H of this contract, in eRA Commons to the NIH COR within fifteen (15) calendar days of being notified by the eRA Commons system. [The notification will come in the form of an eRA Commons system-generated email, sent to the Contractor's registered user(s) under the contract].

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:

5. RFO 52.242-15 Stop-Work Order. (AUG 1989) - Alternate I (APR 1984)

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

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

To be specified prior to 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 alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

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.

2. 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 each proposal.

3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

a. Invoice Submission/Contract Financing Request, NIH(RC)-1 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.

a. The Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official for approval, 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'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 shall submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Official: Contracting Officer

Name- [ ] Email Address- [ ]

Contracting Officer Representative

Name- [ ] Email Address- [ ]

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.

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:

c. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is OALM Professional Services Division B, Branch 3.

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.

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 Task Order Title is:

To be specified in each individual task order

g. Contract Line Items as follows:

Line Item # Line Item Description To be specified in each individual task order

4. 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.

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.

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)).

5. 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 as follows on [Insert Dates].

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.

6. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the 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

7. HHSAR 352.237-75 Key Personnel. (DEC 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 specified at the time of award Principal Investigator

SECTION H - Special Contract Requirements

1. 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.

2. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

The Contractor is directed to the full text of the NIH Policy regarding Data and Safety Monitoring and Reporting of Adverse Events, which may be found at the following web sites:

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

The Contractor must comply with the NIH Policy cited in these NIH Announcements and any other data and safety monitoring requirements found elsewhere in this contract.

Data and Safety Monitoring shall be performed in accordance with the approved Data and Safety Monitoring Plan.

The Data and Safety Monitoring [Board/Plan/Board and Plan/Board and/or Plan] shall be established and approved prior to beginning the conduct of the clinical trial.

3. 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 clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2). GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. GCP training should be refreshed at least every three years to remain current with regulations, standards and guidelines. The Contractor shall provide completion of training documentation to the Contracting Officer's Representative (COR).

Investigator: The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Clinical Trial Staff: Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

4. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION SUBMISSION PLAN

The special terms and conditions in the Contract Award that include a clinical trial:

1. The clinical trial(s) supported by this award is subject to the plan dated [DATE] submitted to NIH and the NIH policy on Dissemination of NIH-Funded Clinical Trial Information. The plan must state that the clinical trial(s) funded by this award will be registered in ClinicalTrials.gov not later than 21 calendar days after enrollment of the first participant. The plan also must state that primary summary results shall be reported in ClinicalTrials.gov, including adverse event information, not later than one year after the primary completion date of the trial. The reporting of summary results is required by this term of award.

2. This award is subject to reporting requirements with each submission of the annual report.

Contractor shall agree to the following annual certification. By affirming this annual certification:

The Contractor hereby certifies that all investigators conducting NIH-funded clinical trials under the NIH contract number [ ] are in compliance with the Contractor's plan addressing compliance with the NIH policy on Dissemination of NIH-Funded Clinical Trial Information. Any clinical trial funded wholly or partially under this award has been registered in ClinicalTrials.gov or will be registered not later than 21 calendar days after enrollment of the first participant. Primary summary results have been submitted to ClinicalTrials.gov or will be submitted not later than one year after the primary completion date of the trial.

5. POSTING CLINICAL TRIAL INFORMED CONSENT FORMS TO CLINICALTRIALS.GOV

The Revised Common Rule sections 46.102(b) and 46.116(h) requires Contractors to post one IRB-approved version of an Informed Consent Form that has been used to enroll participants on a public federal website designated for posting such Consent Forms. Contractors shall post the Informed Consent Form to the National Institutes of Health's (NIH's) clinical trials registry and results database ClinicalTrials.gov . Note: ClinicalTrials.gov only accepts Informed Consent Forms written in English; non- English language forms must be submitted to Regulations.gov . The Informed Consent Form must be posted after recruitment closes, and no later than 60 days after the final study visit. The Contracting Officer (CO) and/or Contracting Officer Representative (COR) may permit or require redactions as appropriate.

6. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN

CLINICALTRIALS.GOV

The Food and Drug Administration Amendments Act of 2007 (FDAAA) at: PUBLIC Law 110-085.PS, Title VIII, expands the National Institutes of Health's (NIH's) clinical trials registry and results database known as ClinicalTrials.gov and imposes new requirements that apply to specified "applicable clinical trials," including those supported in whole or in part by NIH funds. FDAAA requires:

• the registration of certain "applicable clinical trials" (see Definitions at:

https://grants.nih.gov/grants/policy/nihgps/html5/section_1/1.2_definition_of_terms.htm ) in ClinicalTrials.gov no later than 21 days after the first subject is enrolled; and

• the reporting of summary results information (including adverse events) no later than 1 year after the completion date (See Definitions at link above) for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of FDCA.

In addition, the Contractor shall notify the Contracting Officer's Representative (COR), with the trial registration number (NCT number), once the registration is accomplished. This notification may be included in the Technical Progress Report covering the period in which registration occurred, or as a stand-alone notification.

The [Contractor is the Sponsor, therefore/Government is the Sponsor and delegates the Contractor's Principal Investigator as/Government is the Sponsor, therefore] the "Responsible Party" for the purposes of compliance with FDAAA which includes registration (and results reporting, if required) of applicable clinical trial(s) performed under this contract in the Government database, ClinicalTrials.gov ( https://www.ClinicalTrials.gov). The Contractor shall provide the "Responsible Party" with all essential data for timely compliance with ClinicalTrials.gov reporting requirements.

Additional information is available at: https://prsinfo.clinicaltrials.gov/.

7. RESEARCH AND DEVELOPMENT DATA 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.

More information is available at https://www.era.nih.gov/help-tutorials/era-training-hss.htm.

System Access

The eRA system website may be accessed at: https://public.era.nih.gov/commonsplus.

Please note that if your organization does not currently have an account in eRA Commons, you will first need to register your organization at https://public.era.nih.gov/commonsplus/public/registration/initRegistration.era.

Once your organization is registered, your signing official is then able to create new eRA system user accounts (such as for a Project Director/Principal Investigator).

For information on how to create/manage accounts in the eRA system, please refer to:

https://www.era.nih.gov/register-accounts/create-and-edit-an-account.htm . [Note: You must be logged into the eRA system with appropriate role(s), in order to complete these activities.]

Refer to SECTION F - NOTIFICATION OF COMPLETION OF RESEARCH AND DEVELOPMENT DATA ENTRY IN ELECTRONIC RESEARCH ADMINISTRATION (eRA) SYSTEM for schedule and notification requirements related to data submission in the NIH eRA system.

8. HUMAN MATERIALS

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

9. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

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

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for

Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

Provision by the Contractor to the Contracting Officer of a properly completed "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 from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self-designated form, provided that it contains the information required by the "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263(formerly Optional Form 310).

10. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND

TRANSPARENCY

Contractors shall adhere to the NIH policy of enhancing reproducibility through rigor and transparency by addressing each of the four areas of the policy in performance of the Statement of Work and in publications, as applicable: 1) Scientific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables, including Sex; and 4) Authentication of Key Biological and/or Chemical Resources.

This policy applies to all NIH funded research and development, from basic through advanced clinical studies. See NIH Guide Notice, NOT-OD-15-103 , "Enhancing Reproducibility through Rigor and Transparency" and NOT-OD-15-102, "Consideration of Sex as a Biological Variable in NIH-funded Research" for more information. More information is available at https://grants.nih.gov/policy/reproducibility/index.htm, including FAQs and a General Policy

11. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS

RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) electronic versions of all Author Accepted Manuscripts arising from this contract in whole or in part, upon acceptance for publication. NIH defines the Author Accepted Manuscripts as the author's final version that has been accepted for journal publication and includes all revisions resulting from the peer review process, including all associated tables, graphics, and supplemental material. NIH-funded investigators shall notify their Contracting Officers and Contracting Officer Representatives upon the acceptance of an Author Accepted Manuscript resulting from the contract, even if co-authored with those not using contract funds. Through execution of this contract, contractor, and through implementation of this provision by contractor to each of contractor's investigators and subcontractor, and through implementation of this provision to each of subcontractor's investigators, conducting work under this contract or a subcontract, respectively, hereby grants to NIH a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use for federal purposes and to authorize others to do so, all Author Accepted Manuscripts that result from this contract, which includes making Author Accepted Manuscripts publicly available in PubMed Central upon the Official Date of Publication, in accordance with the 2024 NIH Public Access Policy. Upon receipt of a PMCID, investigators should report the PMCID to their Contracting Officers and Contracting Officer Representatives to demonstrate compliance with this term of the contract. The PMC archive will permanently preserve and retain these manuscripts for use by the public, health care providers, educators, scientists, and NIH. NIH Policy directs electronic submissions to the NIH/NLM/PMC:

https://www.ncbi.nlm.nih.gov/pmc/.

Additional information is available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25- 047.html and https://grants.nih.gov/policy-and-compliance/policy-topics/public-access

12. ACKNOWLEDGEMENT OF FEDERAL FUNDING

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

13. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

14. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

15. GUN CONTROL

The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

16. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to [RFO Clause 52.217-6, Option for Increased Quantity/RFO Clause 52.217-7, Option for Increased Quantity-Separately Priced Line Item/RFO Clause Article H.51, Option to Extend Services/RFO Clause 52.217-9, Option to Extend the Term of the Contract] set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract.