Amendment01_75N95024R00058.pdf

NSN 7540 - 01 - 152 – 8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48CFR) 53.243

OMB No. 0990-0115 AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

1 2

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

01 4/11/2024

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

National Institutes of Health National Institute on Drug Abuse Office of Acquisitions c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

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

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION NO.

75N95024R00058

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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 Offer is extended is not extended.

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 Item 8 and 15, and returning 1 copies of the amendment; (b) acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hours and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT/ORDER NO. 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, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

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

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. All other terms and conditions of the RFP remain unchanged.

PROPOSAL DUE DATE: May 3rd, 2024, 3:00 P.M. (Eastern Time) (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 REMAIN UNCHANGED

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.

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

Joshua Lazarus, Contracting Officer, NIDA Section

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

(Signature of person authorized to sign)

BY

(Signature of Contracting Officer) Joshua T. Lazarus -S Digitally signed by Joshua T. Lazarus - S Date: 2024.04.11 10:53:10 -04'00'

Solicitation Number # 75N95024R00058 “GMP Synthesis of Bulk Drug Substances”

Amendment 01

The purpose of this amendment # 01 is to clarify the RFP requirements by responding to questions submitted. Unless specifically noted, all other terms remain unchanged.

1) Question: Will LAAM and psilocybin split the batches between them (e.g., 50 - 1000 grams each per delivery) for a total of 12 batches? Or will each batch strictly refer to an individual molecule (e.g., 100 - 2000 grams of only LAAM OR psilocybin) that equals 12 but could be either product as requested?

Answer: LAAM and psilocybin are examples of compounds that may be requested under this contract but not the only two compounds. Other molecules not named in the solicitation may be requested depending on the government’s needs. A batch pertains to an individual molecule, amount, and grade (GMP or non GMP) and the individual molecule may be something other than LAAM or psilocybin.

2) The RFP refers to a PI, and "The report must be acceptable in format and substance for adaptation into a Chemistry, Manufacturing, and Control (CMC) section for each drug substance for submission to the FDA in support of Investigational New Drug (IND) and New Drug Application (NDA) applications." (Page 106 on Adobe Acrobat/labeled 6). Can you clarify if the manufacturer will be the investigator in this instance, or is the response producing a product for another manufacturer's IND and/or research within NIDA?

The Principal Investigator (PI) at the contractor site oversees the project and is the main scientific point of contact with NIDA. The contractor will produce material for research conducted by NIDA or a group supported by NIDA.

3) Can you help us understand the requirements for a small business subcontracting plan?

Benuvia is considered a small business under code 541715, per the North American Industry Classification System (NAICS).?

Small business subcontracting plan is not required from small business companies. Only other than small businesses should provide the subcontracting plan for this requirement IAW FAR Subpart 19.7.