RFP_75N95024R00086_Amnd_0003_0003.pdf

(x)

75N95024R00086 x x

0 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.

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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

08/19/20240003

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

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10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

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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

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4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

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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

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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.

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

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RIEKA N. PLUGGE

STANDARD FORM 30 (REV. 11/2016)

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14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this Amendment is to provide responses to additional vendor-submitted questions.

All other terms and conditions remain unchanged.

Attachment 1: Questions and Answers (addendum)

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

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 .

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Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics Solicitation number 75N95024R00086 Questions and Answers (addendum)

Question Number

Question to Government Government Response

99. Can the Government confirm that “organizations” include the prime and subcontractors?

Unless expressly stated otherwise, references to “organization(s)” within the RFP generally refer only to the prime offeror’s organization and do not include the offeror’s proposed subcontractors. As stated in the RFP’s “evaluation factors” section, a prime offeror’s historical relationship with any proposed subcontractors and the adequacy of their oversight are considered important elements of the “Organizational Capabilities and Resources” technical factor. Proposed subcontractors’ technical capabilities and personnel qualifications are likewise considered important aspects of the “Technical Approach” and “Personnel Qualifications” factors.

However, the expectation is that the work described in the SOW will be performed primarily in-house.

100. Can the Government confirm that “organizations” may include a team formed by two or more businesses that form the Contractor Teaming Arrangements?

Yes, as stated in Federal Acquisition Regulation (FAR) Provision 52.207-6, which is incorporated by reference into the RFP, the Government will consider offers from any responsible source, including responsible small business concerns and offers from Small Business Teaming Arrangements or joint ventures of small business concerns.

101. Can the Government provide guidance related to minimum insurance requirements?

Please see paragraph (e) of the IDIQ contract SOW’s “Special Requirements” section (pg. 7) for insurance requirements. It is the offeror’s responsibility to determine and obtain the level of malpractice insurance and indemnification for trial-related injuries that they believe is sufficient based on the information provided in the SOW and draft protocol for individual TORFPs.

102. We request that the government consider extending the due date of the response by 3 weeks from the time the Q&A’s are released.

The proposal submission deadline was extended after the previous amendment to October 11, 2024 at 5 pm ET. The Government does not anticipate granting additional extensions but reserves the right to do so if it determines it be in its’ best interest.

103. Is there an incumbent currently performing these services, if so please provide the contract number and name of the incumbent.

Yes, the incumbent contract numbers for these services are HHSN271201600004I and HHSN271201600005I. These contracts are being performed, respectively, by Duke University and PPD Development.

Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics Solicitation number 75N95024R00086 Questions and Answers (addendum)

104. Will the contractor be responsible for delivering the final data files in CDISC format?

The required format will be described in the SOWs for individual TOFRPs issued after award of the parent contract vehicle. For the purposes of this RFP, please describe your organization’s related capabilities in its’ technical proposal as future TORFPs could have different requirements.

105. Does the program anticipate in-person Investigator Meetings as required?

Most likely virtual meetings will be sufficient but details will be provided in the SOWs for future TORFPs. For the purposes of this RFP, please describe your organization’s related capabilities in its’ technical proposal as future TORFPs could have different requirements.

106. Will organization of a DSMB be in the scope of this project?

No. Per page 6 of the IDIQ Contract SOW (Base Requirement, Section V.e), these trials will use an Independent Safety Monitor.

107. Will the contractor be responsible for the entirety of the TMF?

Most likely yes. Details will be provided in the SOWs for future TORFPs. For the purposes of this RFP, please describe your organization’s related

108. Will the contractor be responsible for clinical monitoring? Will a clinical monitoring plan be required by the contractor?

Yes, this is described on page 6 of the IDIQ Contract SOW (Base Requirement, Section V.e).

109. Does the bioanalytical laboratory need to be in the USA or can a Canadian facility be used?

It isn't required that subawards be domestic.

However, as with any subaward, please describe plans to ensure outsourcing doesn't cause delays or issues.

110. Where will the reference standard be sourced from? Purchased or from a CDMO?

Both are possible. Details will be provided in the SOWs for future TORFPs. For the purposes of this RFP, please describe your organization’s related