Sol_75N95024R00086_Amd_0002.pdf

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Attached to
Request for Proposals - Phase I Clinical Trials Federal contract opportunity
Solicitation number
75N95024R00086
Issued by
Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse

About this file

This document is an amendment to a Request for Proposals (RFP) for Phase I Clinical Trials for the Development of Small Molecule and Biologics Therapeutics, solicitation number 75N95024R00086, issued by the National Institute on Drug Abuse (NIDA), part of the Department of Health and Human Services' National Institutes of Health.

The key details are:

  • The amendment provides responses to vendor-submitted questions, revises sections of the RFP, incorporates a new FAR clause, and revises the Statement of Work for two sample task orders.
  • The proposal submission deadline has been extended to October 11, 2024 at 5 pm ET.
  • The period of performance for the resulting contract is April 1, 2025 to March 31, 2035.
  • No other terms and conditions of the solicitation have been changed.

View the file

Other files for this federal contract opportunity

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Text version

(x)

75N95024R00086 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

NINDS

Bethesda, MD 20892-7511 Disorders and Stroke National Institute of Neurological National Institutes of Health

NIDA-EXEC

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

08/19/20240002

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

08/19/2024

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.)

The purpose of this Amendment is to:

1) Provide responses to vendor-submitted questions;

2) Revise pgs. 10 (Reporting Requirements), 96 (Page and Formatting Limitations), and 125

(Enhancing Reproducibility through Rigor and Transparency) of the RFP;

3) Incorporate FAR Clause 52.204-23 "Prohibition on Contracting for Hardware, Software, and

Services Developed or Provided by Kaspersky Lab Covered Entities (DEC 2023)" by reference into Section I of the RFP;

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)

RIEKA N. PLUGGE

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 2

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

75N95024R00086/0002

4) Revise Attachment 9 - Sample Task Order #2

Statement of Work, Pages 6-7 ("Plasma for PK,"

"IP Administration in CRU," and "Issue Drug for

Home Use");

5) Revise Attachment 10 - Sample Task Order #3

Statement of Work, Pages 6-11, (Plasma for PK);

and

6) Extend the proposal submission deadline to

October 11, 2024, at 5 pm ET.

All other terms and conditions remain unchanged.

Attachment 1: Questions and Answers

Attachment 2: Attachment 9 - Sample Task Order #2

Statement of Work (revised)

Attachment 3: Attachment 10 - Sample Task Order

#3 Statement of Work (revised)

Period of Performance: 04/01/2025 to 03/31/2035

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

Sponsored by GSA

FAR (48 CFR) 53.110

File details come from the government source that posted it. Updated .