RFP No. 75N95023R00047 - Amendment 1.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 3

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

01 See Block 16C

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

National Institute on Drug Abuse, NIH NIDA Section, Contracts Management Branch Red Office of Acquisition, NIDA 6001 Executive Blvd, Room 4211 - MSC 9559 Bethesda, MD 20892-9559

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

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION

NO. 75N95023R00047

9B. DATED (SEE ITEM 11)

June 28, 2023

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 ACKNOWLEDG- MENT 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 amend the Request for Proposal (RFP) to incorporate responses to vendor questions. All other terms and conditions of the RFP remain unchanged.

Proposal Due Date: Wednesday, August 7, 2023, 2:00 PM EST (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.

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)

Josh Lazarus, Contracting Officer, NIDA Section, CMB Red

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) x

Questions for 75N95023R00047

• In Attachment 3 (page 7), the protocol specifications for Task 2 states that “Eight rhesus monkeys (Macaca mulatta) will serve as subjects”. Is this eight monkeys as a maximum per group or does the RFP require 8 monkeys per group? We ask this because the RFP also acknowledges that rhesus monkeys may be difficult to purchase.

Response: Ideally, 8 monkeys should be trained and available for testing; however, for a given compound, a group may consist of 4 monkeys.

As for the availability of rhesus monkeys, page 2 of Attachment 3 specifies that

“At the time of award, all monkeys used for Task 3 shall be rhesus monkeys (Macaca mulatta); however, over the life of the contract, if it becomes increasingly difficult for the Contractor to obtain virus-free rhesus monkeys, the NIDA Contracting Officer’s Representative (COR) may authorize the use of a different type of monkey (e.g., cynomolgous Macaca fascicularis monkeys).”

This text provides flexibility in the type of monkey to be used in Task 2, although rhesus monkeys are to be used at the time of award.

• In Attachment 3 (page 8), the RFP calls for 3 session components, i.e., a drug component preceded and followed by food components. This raises the following question: Is the drug component expected to be a drug only or drug v. food (choice) component?

Response: The procedure described in Task 2 outlines a multiple schedule of food and drug self-administration, with drug and food available in isolation during discrete components. That being said, the evaluation of drug-versus-food choice may be desirable during the evaluation of certain compounds. The offeror should propose a protocol based upon the rationale of testing choice behavior and also lever pressing for food as a control for sedation and/or motor impairment.

• The next paragraph of Attachment 3 (page 8) calls for subjects to work for food pellets outside the daily session, both for enrichment and to reveal health problems that may have arisen following drug treatment. However, our IACUC and USDA inspector have notified us that this behavior does not serve as enrichment. This leads us to the question: Is “working” for food a requirement or can we monitor food intake outside the session in the absence of operant behavior, i.e., when technical staff are present to record and report food intake, allowing us to intervene promptly as necessary.

Response: The inclusion of food self-administration outside of the daily three component self-administration provides an additional quantifiable opportunity to observe behavioral disruption and should be included at the time of contract award. If the USDA and local IACUC require additional enrichment for the monkeys, this enrichment plan should be discussed with the COR at the time of award. In addition, changes to the enrichment plan should be minimized throughout the life of the contract as to avoid disruption in drug- and food-maintained responding.

• In view of market instability, does the government provide a guideline for calculating the expected inflation rate in the contract periods?

Response: Offerors should develop any proposed escalation based on their own budget projections and expected actual costs for the periods of performance. NIDA cannot specify a methodology, but notes that the Department of Labor does post its projections for expected inflation rates in different industries.

• In the description of Protocol Specifications for Task 1 and under Discrimination Testing, the number of subjects listed for the Substitution Protocol is 4 monkeys but the number of subjects listed for the Antagonism Pretreatment Protocol is at least two monkeys. I am surprised by the difference so I wanted to check whether that is correct as written.

The protocol requires that four monkeys are trained in the discrimination procedure.

The language regarding the testing for antagonism of discriminative-stimulus effects in “at least two monkeys” is related to only testing a small number of subjects if the test drug is ineffective or of limited programmatic interest.