RFP_75N95022R00012_Amendment 01 - Response to Questions.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

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)

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)

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

SCR

Joshua T. Lazarus

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 and extend the solicitation period to February 25th, 2022. All other terms and condition of the Request for Proposal (RFP) remain unchanged.

Quote Due Date: 3:00 p.m. (Eastern) on February 25, 2022 (CHANGED) Note: The Offeror should acknowledge on the cover page or first pages on its Business or Technical Quotes receipt of this RFQ and its 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.

NIDA Section, Contracts Management Office of Acquisition, NIDA c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

75N95022R00012

1 4

See Block 16C

9B. DATED (SEE ITEM 11)

01/28/2022

X

01/28/2022

Request for Proposal Amendment No. 01 RFP No. 75N95022R00012 Page 2 of 4

RESPONSE TO QUESTIONS

1. In Attachment 21 (Task Order A) it states that “…clinical signs shall be recorded every 25 min…” whereas in Attachment 22 (Task Order B) it states that “Clinical signs shall be recorded every 30 min…” Is it correct that the timing of recording clinical signs varies between these two Task Orders?

Response: Task Order A and B should read: “Clinical signs shall be recorded every 30 min…”

2. Is there a page limit for this application?

Response: There are no page limits or restrictions, Offerors are encouraged to provide a complete description addressing all requirements and criteria as stated in the RFP. The description must be cohesive and include sufficient information to allow evaluation by reviewers and NIH staff. However, Offerors are also encouraged to be economical when preparing a response and can reference duplicative information addressed in various sections of Technical Proposal when practicable and the Technical Proposal and Business Proposal shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other.

3. The RFP indicates that a period of performance of 7/19/22 – 7/18/27 should be used for the Sample Tasks which is not in alignment with the base agreement POP. Can you please confirm that the sample task orders should follow the base agreement POP of 7/26/22 – 7/25/27?

Response: As stated in: Section B, Article B.2.c Prices/Costs on page 5 of the RFP;

Section F, Article F.1.a on page 12; and Section I, Article I.4a.5. FAR Clause 52.216-18, Ordering (October 1995) on page 39, the Ordering Period of the Contract is 7/26/22 – 7/25/27. However, the estimated period of performances for the Sample Task Orders should be corrected as follows:

• Task Order A - 7/26/22 – 1/25/23

• Task Order B - 7/26/22 – 1/25/23

• Task Order C - 7/26/22 – 1/25/23

• Task Order D - 7/26/22 – 1/25/23

• Task Order E - 7/26/22 – 1/25/23

• Task Order F - 7/26/22 – 7/25/23

The estimated period of performance for each Sample Task Order A - E should be 6 months and 12 months for Sample Task Order F. The Sample Task Orders (A, B, C, D, and E) represent compound evaluations which should only last a few months, once the protocols are developed. Multiple task orders may be issued in any given year, but there is no guarantee that any particular task order will be issued in any given year, other than Sample Task Order F - Annual Administrative Activities.

4. Please confirm the intended source of potential treatments to be assessed. Will the intended potential treatments be coming from industry, academia, etc., or is there also an assumption that we are to develop potential treatments (as well as their assessment)?

Response: The potential treatment compounds will come from industry and academia through NIDA and will be delivered with a blinding number. The Contractor will do the

RFP No. 75N95022R00012 Page 3 of 4 required testing and prepare a report which will be returned to the compound submitter through NIDA. There will be no direct interaction of the compound submitter with the Contractor.

5. Statement of Work, Attachment 3, page 4 of 5: Instructions as follows: “For purposes of proposal preparation, offerors are to provide a technical proposal and cost estimates for each of the Sample Task Orders described below. The Sample Task Order technical proposal shall include a general description of approach, timelines, staff, supplies, animals, facilities, etc. (as applicable) required to support each individual requirement.”

It is our understanding, based on these instructions, that the government is seeking a technical volume that consists of all sections outlined on pages 68-70 for each task order. We have not found direction/instructions that indicate the government wants a full/general IDIQ level technical approach section, or the same supplies, animals, facilities sections at the IDIQ level. Can the government please confirm or correct this understanding?

Response: Please refer to Section G, Article G.3 Task Order Procedures on pages 14 -16 for instructions on responding specifically to the Sample Task Orders.

6. We respectfully request that the proposal due date is extended to March 4, 2022. Given staff absences due to COVID and general capacity constraints, an extension will allow additional time to put together the most complete and high-quality proposal possible.

Response: The solicitation period shall be extended to February 25, 2022.

7. Please note that the title on Attachment 21 for Sample Task Order A is as listed in the RFP SOW

(Attachment 3, pages 4-5), but the STO A title is repeated for the STOs B – F, Attachments 22-

26. Can we assume in our response that we can update the titles in Attachments 22-26 with the varying titles listed in the SOW?

Response: Correct, the Sample Task Orders should match the titles listed Attachment 3, Statement of Work. The title for the Sample Task Orders should be as follows:

Sample Task Order A - Evaluation of potential respiratory stimulantΦ Sample Task Order B - Evaluation of compound that may block the respiratory depressant effect of an opioid administered as a pretreatment.

Sample Task Order C - Evaluation of a potential reversal agent of opioid-induced respiratory depression.

Sample Task Order D - Collection, preparation, storage, and shipping of plasma samples.

Sample Task Order E - Protocol development and pharmacology studies involving behavioral observation of methamphetamine toxicity and reversal by ƛΦv. administration of reversal agent.

Sample Task Order F - Annual administrative activities.

8. We understand that the budget is for 5 years. Is there a direct cost budget limit yearly? Overall?

Response: The financial proposals should be based on the Sample Task Orders and not on the potential costs over the term of the contract.

9. We intend to further characterize the efficacy of our novel thiolester drugs against fentanyl-induced respiratory depression and arterial blood-gas chemistry in freely-moving male and female Sprague- Dawley rats. Should we incorporate analgesia studies as well?

RFP No. 75N95022R00012 Page 4 of 4

Response: No, NIDA will provide the compounds to be tested under this contract. This contract does not support evaluation of compounds selected by the contractor and does not support analgesia studies. NIDA only intends to issue task orders for specific compounds that have been submitted to the program for evaluation of their effects related to their potential use as respiratory stimulants, or for their potential to prevent or reverse opioid induced respiratory depression. There are no tasks related to the contractor developing potential treatments; this is program-directed research, not investigator-initiated research.

10. Is there a checklist, other than the announcement that was sent around, detailing how the application should be put together and if there are page limitations (like with R01 applications)?

Response: The Technical Proposal Instruction begin on page 68 (Part IV, Section L, 2.b) of the RFP and page 73 (Part IV, Section L, 2.c) of the RFP includes additional details on the business submission requirements. Section J, starting on page 53, include the list of required Attachments for the process. For page requirements, please refer to Question 2.