Amendment Four 5.5.22.pdf
PDF 156 KB Posted
- Solicitation number
- RFP-NIH-AI-75N93022R00004
About this file
This amendment to a request for proposals seeks preclinical services for biopharmaceutical product development. The National Institute of Allergy and Infectious Diseases is creating multiple award indefinite delivery/indefinite quantity contracts to provide comprehensive preclinical development support for promising therapeutic candidates and diagnostics for human infectious diseases. Services will include activities required for regulatory submissions such as investigational new drug applications, biologics license applications, and 510(k) and investigational device exemption applications. This resource is intended to support a diverse range of biopharmaceutical candidates and diagnostics at various stages of development for academia, private sector, and other sources to acquire additional funding, form partnerships, and complete studies needed to enter clinical trials or gain regulatory approvals. Proposals are due by June 13, 2022.
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Other files
| File | Type | Posted |
|---|---|---|
| Amendment Six 5.24.22.pdf | ||
| Amendment Five 5.16.22.pdf | ||
| Amendment Three 3_25_22.pdf | ||
| Amendment Two 3_22_2022.pdf | ||
| Amendment One 2_10_22.pdf | ||
| RFP-NIH-AI-75N93022R00004.pdf |
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RFP-NIAID-75N93022R00004 Page 1 of 2
AMENDMENT #4
RFP-NIAID-75N93022R00004
“PRECLINICAL SERVICES FOR BIOPHARMACEUTICAL PRODUCT DEVELOPMENT”
AMENDMENT No. 4
Amendment Number: Four (4)
Amendment Issue Date: May 5, 2022
Proposal Due Date: June 13, 2022, 3:00PM EST (UNCHANGED)
Issued By:
Tasha Lee
Contracting Specialist
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:
Tasha Lee, Contracting Specialist
Email: tasha.lee@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 RFP 75N93022R00004.
Question 1: Please confirm that a list of citations or references may include links to internet web site addresses (URLs).
Answer 1: As stated in Attachment 1, Page 2 “Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information”.
Question 2: How will the Government provide the information listed under item #4?
Answer 2: The items will be provided via email or a secured file transfer method.
Question 3: Please confirm that a complete CMC draft is not needed for Sample Task E as not all the information is available to draft it.
mailto:tasha.lee@nih.gov.
RFP-NIAID-75N93022R00004 Page 2 of 2
AMENDMENT #4
Answer 3: The Sample Task Orders are for guidance. Offerors can provide task orders of past projects or products.
Question 4: Please confirm that Sample task includes just the proposed plan, processes, and procedures for compiling the CMC and finalizing it for submission.
Answer 4: The Offeror can describe how they would perform a task order in Task Areas with examples based on past projects and products.
Question 5: Please confirm that offerors are allowed to submit Data other than certified cost or pricing data.
Answer 5: Yes, as specified in C3-Business Proposal Instructions (Page 91).
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