RFP 75N95024R00045 Amendment 1.pdf

(x) 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-EXEC

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

3/20/2024

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.

75N95024R00045

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)

N01DA-24-8950

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

2/26/2024

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.)

PURPOSE: To respond to formal questions submitted in response to the solicitation.

PROPOSAL DUE DATE: 04:00 p.m. (Eastern time) on April 11, 2024 (UNCHANGED).

Note: The offeror should acknowledge on the cover page or first page of its business and technical proposals receipt of the RFP and this Amendment.

All other terms and conditions of the RFP remain unchanged.

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)

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

Robert Bailey, Jr.

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 .

To All Potential Offerors

RFP No. 75N95024R00045

Request for Proposal (RFP) No. 75N95024R00045 is amended as follows:

PURPOSE: The purpose of this amendment is to include questions from offerors and responses in reference to the solicitation.

QUESTIONS/ANSWERS:

1. Question:

Is the additional procedure listed in Attachment 03 of the RFP, Statement of Work II.B.1 Task 4 bullet 3) a. regarding random sampling of materials prepared for shipment necessary if it is demonstrated that specific requirements to ensure accurate identification and preparation of materials prepared for shipment are in place including those listed for bullet 3) b. and c.? It is feared that integrity of samples prepared for shipment would be compromised by the random sampling.

Response:

The Statement of Work (Attachment 3) is updated to replace the language provided on Section II. B, Task 4, Subsection 3a which states “A procedure for selecting and checking analytical samples, on a random basis, from materials prepared for shipment to qualified researchers. The Contractor shall select at least twelve (12) samples per year at random and analyze them for chemical composition or as directed by the COR. The Contractor shall document the outcome of these analyses and report such to the COR within 2 days of testing.” This language is replaced with the following language: “A procedure for selecting and checking analytical samples on a random basis from prepared active pharmaceutical ingredient (API). The Contractor selects at least twelve samples per year at random and analyzes them for chemical composition as directed by the COR. The Contractor shall document the outcome of these analyses and report such to the COR within 2-days of testing.”

2. Question:

Please confirm that only Data Other than Certified Cost or Pricing Data is required for this submission.

Response:

Only Data Other than Certified Cost or Pricing Data will be required with the submission of an offeror’s proposal.

ALL OTHER TERMS AND CONDITIONS OF THE RFP REMAIN UNCHANGED AND IN

FULL FORCE AND EFFECT

Amendment 1 p. 2