75N95023R00003 A00002 SF30 2.21.23.pdf

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 items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT 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.

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

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

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

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

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

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

00002

Michael Horn, Contract Specialist/Contracting Officer

The purpose of this amendment is to:

1) Clarify terms of the solicitation. Reference the attached A00002 Summary of Revisions document.

All other terms and conditions remain unchanged.

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

NIH-NIMH-75N95023R00003

1 1

02/21/2023

01/19/2023

Michael B. Horn -S Digitally signed by Michael B. Horn -S Date: 2023.02.21 12:57:54 -05'00'

Solicitation Number: NIH-NIMH-75N95023R00003

Amendment Number 00002 Summary of Revisions

SECTION B:

VARIOUS ARTICLES:

Corrected error from “8” to “B” (e.g. “B.1” instead of “8.1”).

ARTICLE B.2:

Re-titled OPTION FOR INCREASED QUANTITY Table to include Attachment 3: Statement of Work, Fee-for-Service Option for clarity.

ARTICLE B.4:

Added the following for clarity:

Human Materials

Any acquisition and/or supply of human specimen materials, requires advance written approval from the Contracting Officer.

Informed Consents

All informed consents related to human research materials shall be approved in writing and in advance by the COR.

SECTION C:

ARTICLE C.2

Revised first paragraph to remove the “hardcopy” requirement.

Removed reference to completion contract

SECTION F:

ARTICLE F.2

Corrected error from “Cop” to “Copy”

SECTION H:

Added the following Special Contract Requirement Clauses:

ARTICLE H.3. CERTIFICATE OF CONFIDENTIALITY

ARTICLE H.4. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH

INVOLVING HUMAN SUBJECTS

ARTICLE H.5 INCLUSION OF INDIVIDUALS ACROSS THE LIFESPAN AS

PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECT

ARTICLE H.6 POSTING CLINICAL TRIAL INFORMED CONSENT FORMS TO

CLINICALTRIALS.GOV

ARTICLE H.9. PUBLIC HEALTH SURVEILLANCE EXCLUSION

ARTICLE H.10 REMITTANCE PROCEDURES FOR SALE OF RESEARCH SUBSTANCES

AND LIVING ORGANISMS

ARTICLE H.11 NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR

AND TRANSPARENCY

SECTION I:

Added “Article I.1 General Clauses for a Cost Reimbursement Contract with Non-Profit Organizations”

SECTION J:

Attachments #24 through #27 have been added as follows:

Attachment 24 – PHS Human Subjects and Clinical Trial Information Form

Attachment 25 – Public Health Surveillance Exclusion Request

Attachment 26 – Commitment to Protect Non-Public Information Contractor Agreement

Attachment 27 – The Sale of Research Substances and/or Living Organisms

SECTION L:

Revised to state System for Award Management, FAR Provision 52.204-7 (Oct 2018) is applicable to this solicitation.

Added FAR 52.215-16 Facilities Capital Cost of Money (June 2003).

All other terms and conditions remain unchanged.