RFP 75N93026R00003 w attachments.pdf

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 81-692, as amended

2. Request for Proposal Number:

75N93026R00003

3. Issue Date:

03/30/2026

4. Set Aside:

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

5. TITLE: Clinical Research Products Management Center (CRPMC)

6. ISSUED BY:

Office of R&D and Professional Services Contracts Office of Acquisition & Logistics Management 6701 Rockledge Drive, Room 412-G Bethesda, MD 20817-1816

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

Any solicitation questions must be submitted on or before 04/30/2026.

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 3:00 pm Eastern Time on 06/01/2026. 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 the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Shawnice Williams

PHONE: 301-761-5431

e-MAIL:shawnice.williams@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

We strongly suggest that any questions regarding the solicitation be submitted by 3:00 PM EST, on April 30, 2026, so that we can provide timely responses before proposals are due.

Shawnice Williams Contracting Officer Office of R&D and Professional Services Contracts Office of Acquisition & Logistics Management http://www.sam.gov/ mailto:shawnice.williams@nih.gov

RFP Number: 75N93026R00003

SECTION A - SOLICITATION/CONTRACT FORM

PART I - THE SCHEDULE

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D – PACKAGING AND MARKETING

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 Documents, Exhibits and Other Attachments

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV – REPRESENTATIONS AND INSTRUCTIONS

SECTION K – REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS TO

OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST FAR 52.233-2 (Sep 2006)

INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. Certification Regarding Tax Matters, FAR 52.209-12 (Oct 2020)

14. Past Performance Information

15. Electronic and Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

16. Solicitation Provisions Incorporated by Reference, FAR 52.252-1 (Feb 1998)

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Enhancing Reproducibility through Rigor and Transparency

5. Obtaining and Disseminating Biomedical Research Resources

6. Management and Sharing of Research Data

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Data Other than Certified Cost or Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor-Protégé Program, HHSAR 352.219-70 (December 2015)

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Adequate Accounting System

12. Facilities Capital Cost of Money, FAR 52.215-16, (Jun 2003)

13. Qualifications of the Offeror

14. Subcontractors

15. Travel Costs/Travel Policy

SECTION M - Evaluation Factors for Award

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. EVALUATION OF DATA MANAGEMENT AND SHARING PLAN

5. PRE-AWARD SITE VISIT OR SITE AUDIT

6. TECHNICAL EVALUATION FACTORS

7. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY -

SECTION 508

8. PAST PERFORMANCE FACTOR

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.

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This contract is for the management and operation of the CRPMC to support NIAID sponsored clinical research trials, with a core focus of HIV/AIDS and its co-morbidities. The Contractor shall provide cGMP-compliant facilities for the receipt, storage, handling, shipping, and disposition of study products. All functions must be conducted in accordance with all federal, local and other applicable regulations governing study product including but not limited to, the CFR, ICH GCP, cGMP, Good Distribution Practices (GDP), Good Documentation Practices and all applicable regulation or guidance.

ARTICLE B.2. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ .

b. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ .

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost ($)

Fixed Fee ($)

Estimated Cost Plus Fixed Fee ($)

Base Period Option Period(s):

Total [Base Period and Option(s)]

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 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.

1. INVOICES – COST AND PERSONNEL REPORTING AND VARIANCES FROM THE

NEGOTIATED BUDGET

The Contractor agrees to provide a detailed breakdown on invoices of the following cost categories:

1. Direct Labor – List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.

2. Fringe Benefits – Cite rate and amount.

3. Materials & Supplies – Include detailed breakdown when total amount is over $1,000.

4. Travel – Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

5. Consultant Fees – Identify individuals and amounts.

6. Subcontracts – Attach subcontractor invoice(s).

7. Equipment – Cite authorization and amount.

8. Facilities and Administrative Costs (F&A) – Cite rate and amount.

9. Total Cost

Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the amount allotted to the contract, and the reasons for the variance. Also refer to the requirement of Limitation of Cost Clause in the contract.

2. INVOICE PROCESSING PLATFORM (IPP)

NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). This award will transition to IPP in the future. The Contractor/Vendor shall use the attached NIH OFM Electronic Invoice Submission Instructions until the Contractor/Vendor has transitioned to IPP as specified on the OALM IPP website at https://oalm.od.nih.gov/IPP. It is the Contractor/Vendor’s responsibility to periodically check the OALM IPP website and be prepared to transition to IPP on the designated transition date. Questions concerning the transition to IPP should be directed to NIH-IPPinvoicing@mail.nih.gov. Questions concerning this award should be directed to the NIH Contracting Officer.

All IPP invoices must contain a Unique Entity Identifier (UEI) which is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

3. Protection of Proprietary Data

All materials, data and other information supplied by third-party providers or laboratories under this contract or the Contracting Officer's Representative (COR) shall be assumed to be confidential unless specifically identified as not confidential in writing by the COR.

https://oalm.od.nih.gov/IPP mailto:NIH-IPPinvoicing@mail.nih.gov mailto:NIH-IPPinvoicing@mail.nih.gov

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

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 February 12, 2026, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

REPORTING REQUIREMENTS FOR USE WITH THE ELECTRONIC REPORT DELIVERABLE

SUBMISSION (eRDS) SITE

All reports required herein must be submitted in electronic format. All electronic contract deliverables must be submitted via the NIAID electronic Report Deliverable Submission (eRDS) Site, available at the following website: https://erds.niaid.nih.gov/. 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.]

The Contractor shall submit to the CO and to the COR technical progress reports covering the work accomplished during each reporting period. These reports are subject to technical inspection and requests for clarification by the COR. These reports shall be brief and factual and prepared in accordance with the format described below.

Format of Cover Page: All reports shall include a cover page prepared in accordance with the following format:

• Contract Number and Project Title

• Period of Performance Being Reported

• Contractor’s Name and Address

• Author(s)

• Date of Submission

• Delivery Address https://erds.niaid.nih.gov/ https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents https://www.section508.gov/create/documents

1. Monthly Progress Report

This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month. The report must include:

a) Progress report: A section consisting of a detailed description of overall progress for each task or segment of work as per the Statement of Work (SOW) that was conducted during the reporting period.

b) Personnel changes: A section describing any changes in personnel or level of effort during the reporting period.

c) Deviations and problems: A section describing technical and process deviations encountered and corrective action taken to resolve any issues.

d) Financial report: A section describing the financial status of the contract. This should include trending of the previous month(s) within the contract year and anticipated costs for the next reporting period. Identification of potential high budget items should also be included. A graph to compare expected expenditure and actual expenditure must be included.

e) Maintenance of facilities, inventory, supplies and equipment: A section describing problems encountered and corrective actions within the reporting period.

f) Projected Resources Impact Analysis Report: Include a summary of this report (see SOW, paragraph 3.B.7).

g) Study Product Evaluations (SPEs): A summary of the SPEs completed during the month shall be included (see SOW paragraph 3.B.3).

h) Clinical Supply Plan (CSP): Include a summary of new CSPs or updates (see SOW paragraph 3.B.2).

i) Pharmacy Establishment Plan (PEP): Include a summary of the PEPs or all PEP reviews (see SOW paragraph 3.C.4).

j) Outcome of Quality Assessment: Provide outcomes of Quality Assessments as described in SOW paragraph 3.D.9).

k) Samples of Packaging, auxiliary (secondary) labels and Kits: Provide a summary of the samples, packaging, auxiliary (secondary) labels and kits that were provided for COR review (see SOW paragraph 3.A.2.h).

l) Protocol Specific notifications: Provide a summary of protocol specific notifications (see SOW paragraph 3.B.8 and 3.B.9).

m) Shipping Preparation Procedures and Equipment: Provide a summary of shipping preparation procedures and equipment (see SOW paragraph 3.A.3.a)

n) Inventory Report: Provide a summary of the Inventory Report (see SOW 3.A.5.a and 3.A.5.g)).

o) Provide an evaluation/measurement of 5 predetermined metrics related to the deliverables in the SOW or activities related to the CRPMC. These topics shall be discussed with the COR.

2. Annual Progress Report

This report includes a summation of the results of the entire contract work for the period covered. An Annual Progress Report will not be required for the period when the Final Report is due. A Monthly Progress Report shall not be submitted when an Annual Progress Report is due.

The Contractor shall provide the Contracting Officer’s Representative and Contracting Officer with an electronic copy of the Annual Progress Report in draft form in accordance with the DELIVERIES Article in SECTION F of this contract 30 calendar days prior to the delivery date for the Final Version of the Annual Progress Report. The Contracting Officer’s Representative will review the draft report and provide the Contracting Officer with comments within 15 calendar days after receipt. The Annual Progress Report shall be corrected by the Contractor, if necessary and the final version delivered as specified in the above paragraph.

This report includes a summation of the results of the entire contract work for the period covered, with an emphasis on activities completed after submission of the semi-annual report. An Annual Progress Report will not be required for the period when the Final Report is due. A Semi-Annual Progress Report shall not be submitted when an Annual Progress Report is due. The annual report should not exceed 100 pages. Appendices are allowed.

3. Final Report

This report shall consist of the work performed and results obtained for the entire contract period of performance as stated in SECTION F of this contract. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted on or before the last day of the contract performance period. An Annual Progress Report and Monthly Progress Report will not be required for the period when the Final Report is due.

The Contractor shall provide the Contracting Officer’s Representative and Contracting Officer with [2] copies of the Final Report in draft form in accordance with the DELIVERIES Article in SECTION F of this contract 30 calendar days prior to the completion date of this contract. The Contracting Officer’s Representative will review the draft report and provide the Contracting Officer with comments within 15 calendar days after receipt. The Final Report shall be corrected by the Contractor, if necessary and the final version delivered as specified in the above paragraph.

4. 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 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. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

3. 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/technology/section_508_annua l_report.doc.

4. Other Reports and Deliverables Required by the Contract and Statement of Work

Item Deliverables SOW Reference Recipient Delivery Schedule

1. Projected Resources Impact Analysis Report (PRIAR)

SOW

paragraph 3.B.7.

1 electronic copy to COR

Make available to the COR within 3 business days of request via email and add a summary to the monthly report.

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.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc

Reference Recipient Delivery Schedule

2. Study Product Evaluation (SPE)

SOW

paragraph 3.B.3.

1 electronic copy to the

COR

Study Product Evaluations shall be provided to the COR within 5 business days after receipt of the protocol, unless requested sooner by the COR. A summary of the SPEs completed during the month should be included in the monthly report.

3. Clinical Supply Plan

(CSP)

SOW

paragraph 3.B.2.

1 electronic copy to COR

Email to the COR within 3 business days of request and include a summary of new plans and updates in the monthly report.

4. Summary and Recommendations from Site Pharmacy Monitoring

SOW

paragraph 3.C.1 and 3.I.3.

1 electronic copy to COR

Monthly and Quarterly, 1 week prior to Pharmacy Monitoring Working Group Meeting

5. PEP Review Summary SOW paragraph 3.C.4.

1 electronic copy to COR

Provide a summary email to the COR after 5 business days.

Include a summary of all PEP reviews in the monthly report.

6. Clinical Site Pharmacy Visit

SOW

paragraph 3.C.2.

1 electronic copy to COR

Within 10 business days after completion of each visit

7. Clinical Site Pharmacy Guidance Activities Summary

SOW

paragraph 3.C.3.

1 electronic copy to COR

10 business days after completion of activities.

8 Protocol and Study Products Status Worksheet

SOW

paragraph 3.I.2.

Electronic copy and a summary of weekly changes resulting from the meeting to COR and all attendees

Make worksheet readily available to the COR and provide a summary of changes weekly with those indicated by the COR.

Include a summary of changes by week in the monthly report.

Reference Recipient Delivery Schedule

9. Outcome of Quality Assessment

SOW

paragraph C.1.l.3.

Include in Monthly Report

Provide as a section in the Monthly report

10. Quality Management Plan

SOW

paragraph 3.D.5.

1 electronic copy to COR

Draft to the COR within 30 business days of the contract effective date

11. Inventory Reports SOW paragraph 3.A.5.a. and 3.A.5.g.

1 electronic copy to COR

Include a copy in the monthly or provide to the COR within 2 hours as needed prior to submitting to product manufacturer.

12. TMF Audit Reports SOW paragraph 3.A.7.b.

Include in Annual Report

Copy of the results to be included in the Annual Report.

13. Destruction Reports SOW paragraph 3.A.6.k.

1 electronic copy to the

COR

Include a summary of final destructions in the monthly report in the month immediately following receipt of final destruction report

14. CoA Review SOW paragraph 3.A.3.j.

1 electronic copy to the

COR

Provide as directed by the COR for review with each new batch within 3 business days of receipt

15. cGMP Audit Reports of Manufacturer

SOW

paragraph 3.J.

1 electronic copy to the

COR

Copy to the COR for review with each new batch within 15 business days after completion

16. Samples of packaging, auxiliary (secondary) or mock labels and kits

SOW

paragraph 3.A.2.h.

1 electronic copy to the COR and

NIAID

assigned Pharmacist

Email copy to the COR for review within 2 business days of preparation. Provide a summary in monthly report

Reference Recipient Delivery Schedule

17. Protocol specific notification

SOW

paragraph 3.B.8. and 3.B.9.

1 electronic copy to the COR and

NIAID

assigned Pharmacist

Email copy to the COR for review within 3 business days of receipt of study products. Provide a summary in monthly report.

18. Shipping preparation procedures and equipment

SOW

paragraph 3.A.2 and 3.A.3.

1 electronic copy to the COR and

NIAID

assigned Pharmacist

Provide a summary in the monthly report.

19. Section 508 Annual Report

1 electronic copy to CO

Due on/before the 30th of the month following each anniversary date of the contract.

20. Annual Utilization Report

ARTICLE

C.3.

1 electronic copy to CO

Due on/before the 30th of the month following each anniversary date of the contract.

21. Final Invention Statement

ARTICLE

C.3.

1 electronic copy to CO

Due on/before completion date of the contract.

22. All reports and documentation including the invention disclosure report, the confirmatory license, and the government support certification

ARTICLE

C.3.

1 electronic copy to CO

As required by FAR Clause 52.227-11.

23. Information Security Reporting Requirements

NA 1 electronic copy to CO

As required by Article Information Security and/or Physical Access Security

24. Source Code and Object Code

NA 1 electronic copy to CO

As required by Electronic and Information Technology Accessibility Article in Section H of the contract.

Reference Recipient Delivery Schedule

25. Standard Operating Procedure (specified at the time of request)

3.K.1. 1 Electronic Copy to CO and COR

Copy to the COR or CO for review within one business day of request or upon revision

ARTICLE C.3. INVENTION REPORTING REQUIREMENTS

All reports and documentation required by FAR 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 FAR 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 April 15, 2028. Thereafter, reports shall be due on or before the 30th calendar day following the reporting period. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer Office of R&D and Professional Services Contracts Office of Acquisition & Logistics Management 6701 Rockledge Drive, Room 412-G Bethesda, MD 20817-1816

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.

http://www.iedison.gov/

SECTION D – PACKAGING AND MARKETING

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.

ARTICLE D.1. PACKAGING

The Contractor shall be responsible for packaging of products/shipments in accordance with the attached Statement of Work under Paragraph C.1.d. - Labeling, Packaging and Repackaging of Study Products, and Paragraph C.1.e. - Shipping and Distribution of Study Products.

ARTICLE D.2. MARKING

The Contractor shall be responsible for marking of products/shipments in accordance with the attached Statement of Work, under Paragraph C.1.d. - Labeling, Packaging and Repackaging of Study Products, and Paragraph C.1.e. - Shipping and Distribution of Study Products.

ARTICLE D.3. SHIPPING

The Contractor shall ship in accordance with the attached Statement of Work, under Paragraph C.1.d. - Labeling, Packaging and Repackaging of Study Products, and Paragraph C.1.e. - Shipping and Distribution of Study Products.

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:

Pharmaceutical Affairs Branch Office of Clinical Site Oversight Division of AIDS National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services 5601 Fishers Lane Bethesda, MD 20852

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.

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

Alternate I (April 1984) is not applicable to this contract.

SECTION F – DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from March 16, 2027 through March 15, 2028.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period

Option 1 (Contract Year 2) March 16, 2028 – March 15, 2029

Option 2 (Contract Year 3) March 16, 2029 – March 15, 2030

Option 3 (Contract Year 4) March 16, 2030 – March 15, 2031

Option 4 (Contract Year 5) March 16, 2031 – March 15, 2032

Option 5 (Contract Year 6) March 16, 2032 – March 15, 2033

Option 6 (Contract Year 7) March 16, 2033 – March 15, 2034

ARTICLE F.2. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide _____ direct labor hours. The labor hours include vacation, holiday, and sick leave. These labor hours include subcontractor labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Labor Category Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7

Professional

Other Professional

Support

Totals

b. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than

110% of the total direct labor hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

c. In the event fewer hours than the minimum specified number of direct labor hours in the total categories are used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost- Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of hours by which the number of direct labor hours furnished is less than the number of direct labor hours specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 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.

52.247-35, F.o.b. Destination Within Consignees Premises (April 1984).

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

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

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or

(6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days' notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of clause).

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title To be specified prior to award

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, 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.

1. The Contractor must submit invoices to the Department of Treasury's Invoice Processing

Platform (IPP) at https://www.ipp.gov with a copy of the invoice to the approving official, as directed below.

2. Until the Contract has transitioned to IPP as specified on the OALM IPP website, the Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract. The invoice submitted to the NIH/OFM must be transmitted as an attachment via email to the address listed above in one of the following formats:

Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

3. 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.

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

Approving Official: Contracting Officer Name: TBD, Email Address: TBD

Contracting Officer’s Representative Name: TBD, Email Address: TBD

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.

4. In addition to the requirements specified in FAR 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 National Institute of Allergy and Infectious Diseases (NIAID).

https://www.ipp.gov/ https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx

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 Contract Title is: “Virology Quality Assurance”

g. Contract Line Items as follows:

Line Item #

Line Item Description

Period of Performance

Funded Amount

b. Inquiries regarding payment of invoices shall be directed to the designated billing office,

(301) 496-6452.

c. 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.4. FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS (MAR 2023)

a. 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.

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.

ARTICLE G.5. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer Representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

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 Branch's information package documents.

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

ARTICLE G.6. 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 FAR Subpart 42.15. 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.

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.

ARTICLE G.7. 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%20Contra ct%20of%20Government%20Property-Appendix%20Q.pdf https://www.cpars.gov/ 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

SECTION H – SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. CERTIFICATE OF CONFIDENTIALITY

Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act.

Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of the NIH Policy for Issuing Certificate of Confidentiality (CoC) NOT-OD-17-109, the Contractor shall protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act as a term and condition of the contract. The certificate will not be issued as a separate document.

NIH considers research in which identifiable, sensitive information is collected or used, to include:

• Human subjects research as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46), including exempt research (except for human subjects' research that is determined to be exempt from all or some of the requirements of 45 CFR 46) if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects);

• Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;

• Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or

• Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods,…