HHS-NIH-NIAID-BAA2023-1 - Amendment Two.pdf

HHS-NIH-NIAID-BAA2023-1

Page 1 of 3 Amendment Two (2)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2023 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2023-1

Solicitation Amendment Two (2)

Issuing Office: OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID)

5601 Fishers Lane, Room 3D38, MSC 9821

Bethesda, MD 20892-9821

Solicitation Number: HHS-NIH-NIAID-BAA2023-1

Date of Solicitation Issuance: January 11, 2023

Date of Amendment Two Issuance January 23, 2023

Number of Pages: Three (3)

Proposal Due Dates: The hour and date specified for receipt of offers for each

Research Area remains unchanged:

RESEARCH

AREA

TITLE PROPOSALS DUE*

Development of Vaccine Candidates for

Biodefense and Emerging Infectious

Diseases

April 11, 2023

Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant

(AMR) Infections and Emerging

Infectious Diseases

The Antiviral Program for Pandemics

(APP): Development of Antivirals for

Specific RNA Viral Families of

Pandemic Potential

March 13, 2023

Development of In Vitro Diagnostics for

Biodefense, Antimicrobial Resistant

Infections (AMR), and Emerging

Infectious Diseases

* Proposals must be received before 3:00 PM Eastern Time on the date specified herein.

Page 2 of 3 Amendment Two (2)

Contracting Office Points of Contact:

Primary Contact:

Swee L. Teo, Contracting Officer

Email: teosl@niaid.nih.gov

Phone: 240-669-5173

Secondary Contact:

Ebony Taylor, Contract Specialist

Email: ebony.taylor@nih.gov

Phone: 240-292-0668

Offerors MUST acknowledge receipt of the amendment by Amendment number(s) and date of the amendment. Failure to receive your acknowledgment of this amendment may result in the rejection of your proposal.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

PURPOSE OF AMENDMENT TWO (2)

The purpose of Amendment Two (2) is to:

I. Provide the NIAID’s response to questions received regarding the solicitation. The responses are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related responses.

Please note, in the questions/responses below, specific organizational names have been removed or replaced where possible as well as other minor adjustments.

GOVERNMENT’S RESPONSES:

The Government’s responses to questions received regarding this solicitation are as follows:

I. GENERAL QUESTIONS APPLICABLE TO ALL RESEARCH AREAS:

Question 1: Are there any limitations for organizations/institutes that already have been awarded contract(s) from NIH/NIAID? For example, is there a maximum number of contracts an organization can have, or is this defined by the level of effort of key personnel involved?

Response: An organization/institute may have multiple contracts awarded by NIAID; however, an offeror should assure that the principal investigator, and all other personnel proposed, shall not be committed on federal grants and contracts for more than a total of 100% of their time. If the situation arises where it is determined that a proposed employee is committed for more than 100% of his or her time, the government will require action on the part of the offeror to correct the time commitment.

See Section 4.3.2.2, Section 7 (page 50) of the BAA.

II. RESEARCH AREA SPECIFIC QUESTIONS:

1. RESEARCH AREA 001

mailto:teosl@niaid.nih.gov mailto:ebony.taylor@nih.gov

Page 3 of 3 Amendment Two (2)

Question 1: Is it preferred/required to do a clinical trial in the U.S.?

Response: A clinical trial can be conducted within the U.S. and/or globally. If successful, clearance by the State Department will be obtained prior to awarding a foreign contract, a foreign subcontract, or a domestic contract with a foreign component.

Question 2: Are human challenge clinical trials for SARS-CoV-2 eligible?

Response: All clinical trials funded through the NIAID BAA must be conducted in compliance with the U.S. Food and Drug Administration (FDA) regulations and guidance, see Section 3.4.1 of the BAA (page 19), an excerpt provided here:

“Human subjects research may be carried out under this contract with the approval of DMID.

Describe experience in the conduct of human subject research in accordance with DMID, NIAID, and NIH policies and guidelines and provide a statement acknowledging willingness to conduct clinical research according to these policies and in accordance with applicable ICH and FDA regulations and guidance.”

Any trials funded by this NIAID BAA - including a SARS-CoV-2 human challenge trial - must be conducted either (1) under FDA guidance or (2) in a manner that addresses and is in compliance with FDA guidance. Consequently, an offeror should include details of the proposed trial and rationale that addresses all relevant concerns. Given continued high rates of infection, justification of the need for a human challenge study should be included.

One area of concern is that NIAID is not aware of SARS-CoV-2 human challenge trials that have been conducted under FDA guidance. Therefore, it would be beneficial if a SARS-CoV-2 human challenge study was discussed with the FDA to help evaluate the risk and feasibility of conducting such a study.

An offeror should be aware of the following information:

• FDA Guidance from June 2020 on Development and Licensure of Vaccines to Prevent

COVID-19 has the following information, which has not been revised or superseded:

“If it is no longer possible to demonstrate vaccine effectiveness by way of conducting clinical disease endpoint efficacy studies, the use of a controlled human infection model to obtain evidence to support vaccine efficacy may be considered. However, many issues, including logistical, human subject protection, ethical, and scientific issues, would need to be satisfactorily addressed. At this time no controlled human infection models for SARS-CoV-2 have been established or characterized.”

• Scientific consensus on the use of human challenge material, such as: Controlled Human

Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain, Biologicals (2021) 74: 16-23 also available at https://www.sciencedirect.com/science/article/pii/S1045105621000737 https://www.fda.gov/media/139638/download https://www.fda.gov/media/139638/download https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.sciencedirect.com%2Fscience%2Farticle%2Fpii%2FS1045105621000737&data=05%7C01%7Cswee.teo%40nih.gov%7C6ca2a911c5cd430cf9e408dafb04b3d1%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638098294854353315%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=NsHJbwz1DlRfw40q78iUWsIkBZGqZHgyRDsgOs9Dgy0%3D&reserved=0