Amendment Four.pdf

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Attached to
Interventional Agents Safety and Pharmacokinetic Services
Solicitation number
75N93024R00003
Issued by

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This document is Amendment Four to Solicitation 75N93024R00003 for "Interventional Agents Safety and Pharmacokinetic Services." The amendment addresses questions regarding the contract type, confirming that offerors may propose either cost-reimbursement or firm-fixed-price contracts for Task Area A. If a firm-fixed-price contract is proposed for Task Area A, the cost-reimbursement requirements will not apply.

The solicitation seeks to establish multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) contracts to provide preclinical and non-clinical development support for promising therapeutic candidates against agents of bioterrorism, drug-resistant pathogens, and emerging/re-emerging infectious diseases. The contract will include services across six technical Task Areas: Product Development Planning, Non-GLP Preclinical Safety Studies, Non-GLP Preclinical Microbiological/Safety/Toxicology/PK, GLP Preclinical Microbiological/Safety/Toxicology/PK, Commercial Off-the-Shelf ADME/Safety/PK Screening, and Contract Kick-Off Meeting. The anticipated contract start date is May 1, 2025, with a seven-year ordering period.

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Amendment Seven.pdf PDF
Amendment Six.pdf PDF
Amendment Five.pdf PDF
Amendment Three.pdf PDF
Amendment Two.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 #4

75N93024R00003

“INTERVENTIONAL AGENTS SAFETY AND PHARMACOKINETIC SERVICES”

AMENDMENT No. 4

Amendment Number: Four (4)

Amendment Issue Date: April 18, 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 #4, 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: Would NIAID consider proposals from offerors who propose either a cost-reimbursement or a firm fixed price type contract for Task Area A? If NAID is open to considering a firm fixed price proposal for Task Area A, would NIAID confirm that cost-reimbursement requirements (i.e., maintaining an adequate accounting system for cost-reimbursable contracts, providing breakdown direct and indirect costs and profit, direct labor rates, fringe benefits, overhead, and G&A expenses) will not apply?

Answer 1: Offerors are welcome to propose a firm fixed contract for Task Area A. Offerors are welcome to propose either a cost reimbursement or firm fixed for the Task Areas. If an offeror proposes a firm fixed price for a task area, the cost reimbursement requirements will not be required.

mailto:miranda.adams@nih.gov.

75N93024R00003 Page 2 of 2

AMENDMENT #4

End of Amendment 4

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