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

HHS-NIH-NIAID-BAA2023-1

Page 1 of 5 Amendment Seven (7)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2023 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2023-1

Solicitation Amendment Seven (7)

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 Seven Issuance: March 03, 2023

Number of Pages: Five (5)

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 5 Amendment Seven (7)

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 SEVEN (7)

The purpose of Amendment Seven (7) 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.

I. GOVERNMENT’S RESPONSES TO QUESTIONS RECEIVED REGARDING THIS

SOLICATION ARE AS FOLLOWS:

A. General Questions applicable to all Research Areas:

Question 1: Would it be possible for me to receive a sample of a past successful proposal submission?

Response: No. In general, federal regulations prohibit federal agencies from disclosing information that is exempt from disclosure under the Freedom of Information Act. (FOIA). With respect to contractor proposals, Exemption 3 statutes, with few exceptions, prohibit federal agencies from releasing under the FOIA, any proposal “submitted by a contractor in response to the requirements of a solicitation for a competitive proposal.” Accordingly, the NIAID is unable to provide a sample of a successful proposal. It is the NIAID’s expectation that Offerors will carefully review the BAA solicitation and amendments in their entirety and use their professional judgment when preparing their proposals.

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

Page 3 of 5 Amendment Seven (7)

Question 2: Can we acknowledge Amendment numbers and dates via email to the POC?

Response: No. Acknowledgement of Amendment numbers and dates must be provided in your

Business Proposal.

Question 3: The suggested individual page limits for sections 2-9 add up to the total 75-page limit, but the following are also described as being part of the “technical proposal”.

Can you please confirm that the following are outside the page limit?

• product development plan (p. 27, 3.6.1) – required

• work plan (p. 27, 3.6.2) - required

• human subjects narratives (4.3.2.3) - as applicable

• vertebrate animals (p. 68, 4.3.2.5)

• select agents (p. 69, 4.3.2.6) - required (if none, so state)

• rigor and transparency (p. 70, 4.3.2.7) - required

• dual use research (p. 71, 4.3.2.8) – required

• research data sharing (p. 72, 4.3.2.9.1) - required

• model organism sharing (p. 72, 4.3.2.9.2) - as applicable

• genomic data sharing (p. 73, 4.3.2.9.3 and 4.3.2.9.4) - as applicable

Response: No, these items are within the page limit. The Product Development Plan (PDP) and

Work Plan are required parts of the technical proposal only for Research Area (RA) 004 (see section 3.6). For RA 001, 002 and 003, the PDP and Work Plan are part of the post-award

Reporting Requirements and Deliverables (see section 3.5). These items may fit within the aforementioned sections, for example, rigor and transparency within Section 6, dual research within Section 9, etc. The rest of the list, as applicable, is part of the 75-page limit, inclusive of

CVs/biosketches, for the Technical Proposal. See section 4.3.2 of the BAA. The page numbers for

Sections 2-9 are suggestions and may be revised; pages in excess of this 75-page limitation will be removed from the proposal.

Question 4: We understand that one of the requirements to apply is for our organization to have an active SAM.gov account. Our organization’s SAM.gov account expired in

November 2022, and we are actively working to renew the registration. Will we still be allowed to apply if our renewal is not complete by March 13, 2023?

Please note that our organization has been awarded an NIH grant and we have seen other notices that allow for a grace period for SAM.gov renewals that are in process, such as the one provide here: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-119.html

Response: FAR 4.1102(a) requires offerors to be registered in SAM at the time an offer or quotation is submitted. Section 4.2.1 of the BAA states that if you intend to submit a proposal, you must:

a) Go to the System for Award Management (SAM) and complete the Representations and

Certifications. The SAM website may be accessed at http://www.sam.gov; and

b) Complete, and INCLUDE, the Representations and Certifications as part of your Business

Proposal.

Processing time should be taken into consideration when registering. Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-119.html https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fsam.gov%2Fcontent%2Fhome&data=05%7C01%7Cannie.gersch%40nih.gov%7Ce3d549b2d4174fa18b2108db1a56ccd9%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638132732328090475%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=IvUWoD8W93RiDve5Rz8n7%2FVUD6ZFtigvlSX3XSy4jgA%3D&reserved=0

Page 4 of 5 Amendment Seven (7) solicitation. Please understand that this solicitation will result in the award of a contract, not a grant. The NOT-OD-22-119 applies to grants and cooperative agreements only.

Question 5: Would it be possible to get a copy of the contract template that will be used for the BAA solicitation?

Response: The NIAID is unable to provide the contract template as the organizational structure of the successful offeror(s) will determine the specific language to be used in the contract award.

However, an offeror should review Section 5 of the BAA as it identifies special contract requirements and provides the general clause listing that may be applicable to an offeror’s proposed project.

B. RESEARCH AREA 001

Question 1: Would it be acceptable to include in the proposal, as part of the product development plan scope, demonstration that the candidate vaccine for SARS-COV-2 variants of concern elicits mucosal immunity and conduct study(ies) for preclinical efficacy showing reduction of viral replication in the upper respiratory tract (including success of these demonstrations as early Go/No-Go criteria), or would preliminary data for elicitation of mucosal immunity and preclinical efficacy as shown by reduction of viral replication in the upper respiratory tract be required at time of submission?

Response: Under Section 3.3.1.1 - Technical Objectives, it is stated that Research Area 001

(Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases) is restricted to the following pathogens:

• SARS-CoV-2 variants of concern vaccine that elicits mucosal immunity and has demonstrated preclinical efficacy as shown by reduction of viral replication in the upper respiratory tract.

This means that preclinical efficacy as shown by reduction of viral replication in the upper respiratory tract must be part of the preliminary dataset in the proposal. Similarly, the SARS-

CoV-2 variants of concern vaccine must be shown to elicit mucosal immunity as part of the preliminary dataset in the proposal.

Question 2: Would a proposal aimed at combining an approved recombinant mpox vaccine with a novel skin patch delivery system be eligible for the BAA under discussion?

Response: Please refer to Section 3.3.1.1 - Technical Objectives: Orthopoxviruses: Especially next generation vaccines for smallpox (must also protect against mpox and excludes Modified

Vaccinia Ankara (MVA)-based technologies) suitable for all ages and the immunocompromised.

A proposal aimed at combining an approved recombinant mpox vaccine with a novel skin patch delivery system would be eligible for the BAA under Research Area 001 if it is not an MVA-based vaccine platform. Only MVA-based technologies are excluded.

C. RESEARCH AREA 002

Question 1: This year’s solicitation seems to imply that if the “products or closely related entity, such as a prodrug or salt form, has ever been in a Phase 3 clinical trial for any indication in any jurisdiction worldwide”, then such product is not eligible. Developing a pediatric indication for a novel antibacterial requires a successfully completed Phase 3

Page 5 of 5 Amendment Seven (7) trial as the trigger to initiate the pediatric clinical development. Does the above-mentioned restriction for compounds in phase 3 place pediatric development of NDA-ready antibiotics out of scope for this solicitation?

Response: A proposal to develop a product previously approved by the FDA or which has previously entered into a Phase 3 clinical trial would not comply with the requirements of

Research Area 002. See Section 3.3.2.4 Item 6. The intent of NIAID BAA contracts is to advance products through early clinical trials, thereby reducing risk and becoming eligible for advanced clinical and manufacturing development funding. If the proposed pediatric trial is to occur after start of Phase 3 clinical trials for the product, it falls outside the explicit scope of Research Area

002 as well as the stated intent of the solicitation. See Section 3.1 paragraph 4.

Question 2: In reference to Research Area 2 (Development of Therapeutic Candidates for

Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases) for the Broad

Agency Announcement HHS-NIH-NIAID-BAA2023-1, would it be acceptable to submit a product proposal comprising a drug molecule that may have been approved earlier by the FDA, albeit for a different (non-infectious disease) indication, or is it not eligible per clause 6 of section

3.3.2.4?

Response: A proposal to develop a product previously approved by the FDA would not comply with the requirements of Research Area 002. See Section 3.3.2.4 Item 6.

Question 3: Would this topic include studies to identify therapeutics against biodefense and emerging viruses? The insertion of the AMR into the topic head is giving us pause as to whether or not it’s bacterial agent specific or not.

Response: The objective of Research Area 002 is the development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and

C priority pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens) and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic

Resistance Threats Report (Antibiotic Resistance Threats in the United States, 2019 (cdc.gov))

See Section 3.3.2.1of the BAA.

D. RESEARCH AREA 003

Question 1: In reference to Research Area 3 (Antiviral Program for Pandemics: Development of

Antivirals for RNA Viral Families of Pandemic Potential) for the Broad Agency Announcement

HHS-NIH-NIAID-BAA2023-1, would it be acceptable to submit a product proposal that enables a novel method of use for an antiviral drug that had been approved earlier by the FDA, or is it not eligible per clause 7 of section 3.3.3.4?

Response: A proposal to develop an agent previously approved by the FDA would not comply with the requirements of Research Area 003. See Section 3.3.3.4 Item 7.

https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf