RFP_75N95022R00012_Amendment 02.pdf
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- Attached to
- Assessment of Potential Treatments to Treat Drug-induced Respiratory Depression and Overdose Toxicity
- Solicitation number
- 75N95022R00012
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| File | Type | Posted |
|---|---|---|
| RFP_75N95022R00012_Amendment 01 - Response to Questions.pdf | ||
| RFP_75N95022R00012.pdf |
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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.
Quote Due Date: 3:00 p.m. (Eastern) on February 25, 2022 (UNCHANGED)
Note: The Offeror should acknowledge on the cover page or first pages on its Business or Technical Quotes receipt of this RFP 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 2
See Block 16C
9B. DATED (SEE ITEM 11)
02/11/2022
X
X
Request for Proposal Amendment No. 02 RFP No. 75N95022R00012 Page 2 of 2
RESPONSE TO QUESTIONS
1. Does the existing requirement mean offerors should submit one technical volume that contains complete write-ups for the individual Sample TOs, or should offerors submit separate documents for each Sample TO (i.e., each TO should be addressed separately in one of six individual technical volumes)?
Response: As stated in Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, subpart I.B.1, ”Create one PDF file of your Technical Proposal, including all attachments.” As stated in Attachment 3 – Statement of Work on page 4, “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.”
Each Sample Task Order can be included as attachments or appendices to the “Technical Volume”.
2. Does the government want an IDIQ-level description of the proposer’s general requirements, outside of those specific to each task order? If so, should each task order proposal stand alone, or can we refer back to a previous section for reference and ease of evaluator review? For example, if a specific write-up applies to all task orders (such as how we propose to staff the effort, or our response to the VAS requirement), should offerors repeat those sections in each applicable task order, or can we cross reference the common material in a previous section?
Response: Please refer to the response to Question 1.
3. There is a mandatory criterion regarding a DEA Research Registration for Schedules II to V (as per the language below).
MANDATORY CRITERIA:
Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that offerors possess, at the time of proposal submission, a DEA Research Registration for Schedules II to V to handle substances under the Controlled Substances Act of 1970. In addition, the successful offeror must either possess, or demonstrate the ability to obtain a DEA registration for Schedule I controlled substances prior to Award. The offeror must demonstrate its understanding and compliance with the NIH Guide for Care and Use of Laboratory Animals. The offeror shall submit evidence that its proposal was reviewed and approved by the Institution’s Animal Care and Use Committee (IACUC). The Assurance number shall be provided with the proposal.
Do you know if the abovementioned DEA Research Registration is relevant, or even possible, for non-US companies? Is the corresponding local European authorization sufficient?
Response: The DEA Research Registrations, as stated in Section M, 4, are critical to the qualification and evaluation of the Technical Proposal submissions. NIDA must comply with The Federal Comprehensive Drug Abuse Prevention and Control Act of 1970. Please refer to Part C – Registration Manufacturers, Distributors, and Dispensers of Controlled Substances, subsections 821-823.
| 2022-02-11T13:50:20-0500 | |
| Joshua T. Lazarus -S |
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