Amendment_4_-_Q&A_-_Research_Areas_001_and_002.pdf

Amendment #4

Solicitation HHS-NIH-NIAID-BAA2018

AMENDMENT FOUR (4)

OFFICE OF ACQUISITONS

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, Room 3D32, MSC 9821 Rockville, MD 20852

Solicitation Number: HHS-NIH-NIAID-BAA2018

Date of Solicitation Issuance: 06/01/2018

Date of Amendment No.1 Issuance: 07/03/2018

Date of Amendment No.2 Issuance: 07/03/2018

Date of Amendment No.3 Issuance: 07/20/2018

Date of Amendment No.4 Issuance: 07/24/2018

Number of Pages: 3

Issued By:

George W. Kennedy, Contracting Officer Email: kennedyg@mail.nih.gov Phone: 240-669-5170

The hour and date specified for receipt of Offers remains unchanged.

Offerors must acknowledge receipt of the amendment by Amendment number(s) and date of the amendment. Include a statement of acknowledgement in your proposal submission. Failure of acknowledgement may result in rejection of your offer.

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

PURPOSE OF SOLICITATION AMENDMENT

The purpose of this amendment is to provide responses to questions received regarding Research Areas 001 and 002 of this solicitation.

SOLICITATION QUESTIONS AND RESPONSES

This section provides the Government’s responses to questions received regarding this solicitation. The responses are offered for information only and do not modify or become part of this solicitation.

RESEARCH AREA 001 QUESTIONS

The Government’s responses to questions received regarding Research Area 001 are as follows:

Question 1: In reference to the list in section 3.1.2.1.5 – “Contracts awarded under this

Research Area will NOT support”… The list includes a bullet excluding development of serum-derived products.

Is this exclusion intended only for human serum derivatives, or does it apply to animal plasma as well?

Answer 1: Any serum-derived products will not be supported under this solicitation.

Question 2: We would like to gain clarity on the in-vivo data expectation for lead candidates. Our question is whether or not in-vivo data from surrogate antibodies would be sufficient to meet the criteria for this call.

Answer 2: In vivo data for one or more in a lead series would qualify the lead series for consideration in this solicitation, provided that in vivo data includes evidence of acceptable preliminary pharmacokinetic, safety and toxicology, as well as in vivo evidence of efficacy against pathogens identified under Section

3.1.2.1.3. Additionally, proposals that describe lead series should provide clear plans for selecting a single clinical candidate therapeutic by the end of the second year of funding to enable completion of IND-enabling activities and submission of the IND within a 5-year period of performance.

Question 3: Can one apply for this Research Area for compounds active against drug resistant Mycobacterium Tuberculosis?

Answer 3: Mycobacterium Tuberculosis is considered a NIAID Category C Priority

Pathogen and is thus eligible for this Research Area.

Question 4: Are submissions for the development of devices to detect pharmaceutical quality eligible for submission?

Answer 4: Consistent with solicitation Section 3.1.2.1.5 which delineates the topics that will not be supported, the development of devices for detection of pharmaceutical quality will not be supported in this Research Area.

RESEARCH AREA 002 QUESTIONS

The Government’s responses to questions received regarding Research Area 002 are as follows:

Question 1: Would development of vaccine against cryptosporidiosis be considered within the scope of Research Area 002?

Answer 1: Yes, development of a vaccine against cryptosporidiosis is considered eligible.

Question 2: Would development of a vaccine against Francisella be considered within the scope of Research Area 002?

Answer 2: Yes, development of a vaccine against Francisella is considered eligible.

Question 3: Are vector vaccine platforms against Tier 1 Select Agents such as tularemia, anthrax, plague, and melioidosis eligible under Research Area 002?

Answer 3: Yes, single vector vaccine platforms against tularemia, plague, and/or melioidosis would be eligible. Note that Section 3.1.2.2.5 of the solicitation excludes from eligibility the development of Anthrax vaccines.

Question 4: Please confirm that this Research Area does not include funding for clinical trials.

Answer 4: Clinical trials are permitted under this Research Area. When developing your proposal, please note the budget and project duration information contained in solicitation Section 3.1.2.2.1 – Budget and Award Information.

Question 5: Please confirm that vaccine candidates developed against AMR are eligible for submission under this Research Area.

Answer 5: Antimicrobial resistance, excluding research on sexually transmitted organisms, (unless the resistance is newly emerging) is considered a NIAID Category C Priority Pathogen (Please refer https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens ), which would thus be considered eligible.