Amendment Two.pdf

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Attached to
Interventional Agents Safety and Pharmacokinetic Services
Solicitation number
75N93024R00003
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This document is Amendment Two to Solicitation 75N93024R00003, "Interventional Agents Safety and Pharmacokinetic Services". The amendment addresses questions related to the proposal requirements, including the need for a leadership plan, the inclusion of web links in biographies, and the page limits for technical proposals. The solicitation is for an Indefinite Delivery/Indefinite Quantity (IDIQ) contract to provide preclinical and non-clinical development support for promising therapeutic candidates against infectious diseases and bioterrorism agents. The contract has a seven-year ordering period with an anticipated start date of May 1, 2025. The solicitation includes six technical task areas covering product development planning, in vitro and in vivo preclinical safety and pharmacokinetic studies, and commercial off-the-shelf screening services. Offerors may need to utilize subcontractors or partners to fulfill the full scope of services. Proposal responses will include both technical and business proposals.

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Amendment Three.pdf PDF
Amendment One.pdf PDF
Attachment 23 - Electronic Invoicing Instructions.pdf PDF
Attachment 19 - NIH(RC)-4.pdf PDF
Attachment 16 - Certificate of Current Cost or Pricing Data.pdf PDF
Attachment 1 - Packaging and Delivery.pdf PDF
Attachment 3 - Statement of Work.pdf PDF
Attachment 11 - Acquisition Guidance on the Voluntary Product Accessibility Template (VPAT).pdf PDF
Attachment 21 - Instructions for NIH 2706.pdf PDF
Attachment 17 - Disclosure of Lobbying Activities.pdf PDF
RFP 75N93024R00003.pdf PDF
Attachment 18 - NIH(RC)-2.pdf PDF
Attachment 7 - Additional Business Proposal Instructions.pdf PDF
Attachment 14 - Breakdown of Proposed Estimated Costs.xlsx XLSX spreadsheet
Attachment 4 - REPRESENTATIONS CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS.pdf PDF
Attachment 9 - Summary Related Activities.pdf PDF
Attachment 15 - Offerors Point-of-Contact.pdf PDF
Attachment 2 - Intent Response Form.pdf PDF
Attachment 12 - Proposal Summary and Data Record NIH2043.pdf PDF
Attachment 8 - Techical Proposal Cost Summary.pdf PDF
Attachment 5 - Additional Technical Proposal Instructions.pdf PDF
Attachment 13 - HHS Subcontracting Plan Template.pdf PDF
Attachment 20 - NIH 2706.pdf PDF
Attachment 6 - Sample Task Orders.pdf PDF
Attachment 22 - HHSAR 352.223-70 Safety and Health.pdf PDF
Attachment 10 - Contract Proposal Vertebrate Animal Section Worksheet.pdf PDF
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75N93024R00003 Page 1 of 2

AMENDMENT #2

75N93024R00003

“INTERVENTIONAL AGENTS SAFETY AND PHARMACOKINETIC SERVICES”

AMENDMENT No. 2

Amendment Number: Two (2)

Amendment Issue Date: March 26, 2024

Proposal Due Date: May 24, 2024, 3:00PM EST (UNCHANGED)

Issued By:

Miranda Adams Contracting Officer Office of Acquisitions, DEA National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane

MSC 9821

Rockville, Maryland 20852-9821

Point of Contact:

Miranda Adams, Contracting Officer Email: miranda.adams@nih.gov.

Offerors must acknowledge receipt of the final posting of Amendment #2, on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

The hour and date specified for receipt of proposals HAS NOT been extended.

PURPOSE OF SOLICITATION AMENDMENT:

The purpose of this amendment is to address questions regarding 75N93024R00003.

Question 1: The RFP states a leadership plan is required as part of the proposal if multiple PIs are to be assigned. As we intend to assign a single PI per Task order (but different PIs for individual Task Orders), is the leadership plan required?

Answer 1: A leadership plan is only required if the base/parent IDIQ will have multiple PIs. It will also be required if each Task Order will have multiple PIs.

Question 2: Instructions for proposal formatting state: “Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.” The standard NIH-required format for biographies includes a link to the mailto:miranda.adams@nih.gov.

75N93024R00003 Page 2 of 2

AMENDMENT #2

NCBI Bibliography for each staff member. Should we assume that this NIH-mandated link is exempt from the URL rule, or should it be removed from all bios?

Answer 2: Please remove any internet web site links from the bios.

Question 3: Is the Sample Task Order included as part of the 50-page minimum for each Technical Proposal?

Answer 3: The offeror is afforded 50 pages maximum for each task area proposed. For each task area proposed you are to submit the proposal separately in eCPS. Do not combine all task areas proposed into one PDF document.

Task Area F, contract kick-off, does not require a technical proposal and will not be peer reviewed. Task Area F may be submitted as a business proposal.

Questions 4: The Statement of Work for Sample Task Area B requests metabolite identification (met ID) in human live microsomes, but then it includes line items for met ID in microsomes and hepatocytes. Should we cost for met ID in microsomes, only, or in both microsomes and hepatocytes?

*Note for the third line item: the use of industry standard software would be included in the cost of a met ID study.

Answer 4: The costs should be for in both microsomes and hepatocytes. It is understood that the use of industry standard software would be included in the cost of a met ID study.

End of Amendment 2

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