Sol_75N95024R00002_Amd_0002.pdf

(x)

75N95024R00002 x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

NIDA

Bethesda, MD 20892-7511 National Institute on Drug Abuse National Institutes of Health

NIDA-EXEC

Bethesda, MD 20892-7511 National Institute on Drug Abuse National Institutes of Health

04/10/20240002

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

04/09/2024

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

NINDS Human Genetic Resource Center

The above numbered RFP is amended as set forth below. The hour and the date specified for receipt of proposals remains unchanged. Offerors must acknowledge receipt of the amendment prior to the hour and the date specified in the RFP or as amended, by one of the following methods:

I. By acknowledging receipt of this amendment on each copy of the proposal submitted.

Please note that this is the preferred method.

II. By separate letter or email which includes a reference to the RFP and amendment number.

Continued ...

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

SNEHA V. SINGH

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 5

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75N95024R00002/0002

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT

THE PLACE DESIGNATED FOR THE RECEIPT OF PROPOSALS

PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT

IN REJECTION OF YOUR PROPOSAL. If by virtue of this amendment you desire to change a proposal already submitted, such change may be made by letter, provided each letter makes reference to the RFP and this amendment, and is received prior to the opening hour and date specified.

The purpose of this amendment is to: 1) make changes to the RFP (sections H, L and M) and 2) provide responses to questions received concerning the RFP.

See continuing pages and attachments for additional information.

Period of Performance: 09/30/2024 to 09/29/2025

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

The following sections are hereby amended to add Data Management and Sharing information as follows:

SECTION H - SPECIAL CONTRACT REQUIREMENTS

28. SHARING RESEARCH DATA

The Contractor's Data Management and Sharing Plan, dated [TBD], is hereby incorporated by reference herein. The Contractor agrees to adhere to its Data Management and Sharing Plan and shall request the prior written approval of the Contracting Officer for any changes in its Data Management and Sharing Plan.

NIH encourages, to the maximum extent practicable, the sharing of final research data to serve public health for the common good and this contract is expected to generate research data that must be shared with the public and other researchers. NIH's Data Management and Sharing policies may be found at the following websites:

▪ NOT-OD-14-124 – NIH Genomic Data Sharing Policy;

▪ NOT-OD-21-013 - Final NIH Policy for Data Management and Sharing;

▪ NOT-OD-21-014 - Supplemental Information to the NIH Policy for Data Management and Sharing:

Elements of an NIH Data Management and Sharing Plan;

▪ NOT-OD-21-015 - Supplemental Information to the NIH Policy for Data Management and Sharing:

Allowable Costs for Data Management and Sharing; and

▪ NOT-OD-21-016 - Supplemental Information to the NIH Policy for Data Management and Sharing:

Selecting a Repository for Data Resulting from NIH-Supported Research.

NIH recognizes that data sharing may be complicated or limited, in some cases, by institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including but not limited to the Privacy Act of 1974 (2020 Edition), the Privacy Rule (see HHS-published documentation on the Privacy Rule at http://www.hhs.gov/ocr/), the Health Insurance Portability & Accountability Act of 1996 (HIPAA), and the Health IT for Economic & Clinical Health (HITECH) Act, which was enacted as part of the American Recovery & Reinvestment Act of 2009 (ARRA).

As per NIH Notice NOD-OD-21-013, “Final NIH Policy for Data Management and Sharing,” respect for participant autonomy and maintenance of participant privacy and confidentiality can be consistent with data sharing. The rights and privacy of people who participate in NIH-funded research shall be protected at all times and Contractors shall anonymize and aggregate (or otherwise fully protect from release) any personally identifiable information (PII), HIPAA-protected personal health information (PHI), and/or HITECH-protected electronic health information which they receive, use, and/or reference; thus, data intended for broader use should be free of any and all personal identifiers that would permit linkages to individual research participants and/or variables that could lead to any disclosure of the identity of individual subjects, direct or deductive, for which the Government shall have no liability whatsoever.

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-014.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-014.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-015.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-015.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-016.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-016.html http://www.hhs.gov/ocr/

n. Management and Sharing of Research Data

[Note: This policy applies to all NIH contracts, regardless of dollar value or level or type of funding, degree of funding (whole or partial), or type of NIH funding mechanism, that are expected to generate research data.]

NIH encourages, to the maximum extent practicable, the sharing of final research data to expedite the translation of research results into knowledge, products, services, and/or procedures to improve the human health condition. This contract is anticipated to generate such research data. Therefore, the Offeror shall submit a plan in its technical proposal for data management and sharing or state why such data sharing is not possible. If data sharing is limited, the Offeror shall explain the rationale and nature of such limitations in its Data Management and Sharing Plan. NIH's Data Management and Sharing Policy may be found at the following Web site:

NOT-OD-21-013: Final NIH Policy for Data Management and Sharing.

NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources are found at: https://grants.nih.gov/policy/sharing.htm.

[If the resultant contract is part of a collaborative program involving multiple sites, all data management and sharing shall be governed by a data management, sharing, and dissemination plan to be jointly developed prior to award. A Coordinating Center’s proposal shall describe the methods by which to coordinate such data management, sharing, and dissemination planning and implementation efforts. In its proposal the Coordinating Center shall include a budget with all proposed costs and justification for/of any costs of such collaborative effort(s).]

SECTION M - EVALUATION FACTORS FOR AWARD

8. EVALUATION OF DATA MANAGEMENT AND SHARING PLAN OR ANY EXCEPTIONS

The Offeror's plan for the management and sharing of final research data, or, if data sharing is not possible, the Offeror's documentation of its inability to share research data, with justified limitations or exceptions, shall be assessed for appropriateness, adequacy, and reasonableness.

9. EVALUATION OF DATA MANAGEMENT AND SHARING PLAN

An Offeror's plan for the management and sharing of final research data (Data Management and Sharing Plan) shall be assessed for appropriateness, adequacy, and reasonableness.

If an Offeror’s proposal does not include a Data Management and Sharing Plan (Plan) or if the Plan in an Offeror’s proposal is considered "unacceptable," and the Government includes Offeror’s proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html https://grants.nih.gov/policy/sharing.htm source (for sole source acquisitions), the Offeror will be afforded the opportunity to further discuss, clarify, and/or modify its Plan during discussions and in its Final Proposal Revision (FPR). However, if the Plan is still considered "unacceptable" by the Government after discussions, the Offeror may not be further considered for award.