Amendment_1.pdf

Amendment #1 Solicitation HHS-NIH-NIAID-BAA2019-1

AMENDMENT ONE (1)

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-BAA2019-1

Date of Solicitation Issuance: 02/22/2019

Date of Amendment No.1 Issuance: 05/01/2019

Number of Pages: 5

Points of Contact:

Division of Allergy, Immunology, and Transplantation (DAIT)

Research Area 001: Development of Radiation/Nuclear Medical Countermeasures (MCMs)

Liem Nguyen, Contracting Officer Phone: (240) 669-5144; E-mail: liem.nguyen@nih.gov

Division of Microbiology and Infectious Diseases (DMID)

Research Area 002: Development of Therapeutic Products for Antibiotic Resistant Bacteria;

Research Area 003: Advanced Development of Vaccine Candidates for Antibiotic Resistant Bacteria

Julie Rodriguez, Contract Specialist Phone: (301) 761-7735; Email: julie.rodriguez@nih.gov

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

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.

mailto:liem.nguyen@nih.gov mailto:julie.rodriguez@nih.gov mailto:kennedyg@mail.nih.gov

PURPOSE OF SOLICITATION AMENDMENT

The purpose of this amendment is to provide responses 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. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

SPECIFIC RESEARCH AREA QUESTIONS

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

Division of Allergy, Immunology, and Transplantation (DAIT)

Research Area 001: Development of Radiation/Nuclear Medical Countermeasures (MCMs)

Question 1: On page 6, the BAA says the base period budget is limited to $2M. Is the base period year 1 of the grant? The BAA says more funds can be awarded for option years. Are the budgets for the option years also $2M? Does this mean the budget for 3 years can be up to $6M?

Answer 1: As stated on page 6 of the solicitation, the budget for the base period is up to $2M per contract. The Base period is Year 1 of the contract. This is not a grant. The contract performance includes one base period (or year 1) plus two (2) one-year optional periods. Budget for each option year is up to $2M for a total of up to $6M for a 3-year period, depending on the offeror’s technical approach and proposed milestones.

Question 2: I cannot find the specific RFA on the NAID website (https://www.niaid.nih.gov/grants-contracts/opportunities). Would you be able to let me know where I find this information?

Answer 2: The Broad Agency Announcement HHS-NIH-NIAID-BAA2019-1 is for contract, not for grant. All requirements are stated in the BAA which posted in the Fedbizopps website.

Question 3: Do I have to create an account on the Fedbizopps site to have access to the submission guidelines?

Answer 3: You don’t have to create an account in Fedbizopps site to submit your proposal.

Please refer to section 4.3. Instruction to Offerors, page 54/143, and go through the whole section for specific instruction. Specifically, section 4.3.2.1.2. – Online submission of Electronic Proposals provides instruction on submitting proposals online via the electronic Contract Proposal Submission (eCPS) website: https://ecps.nih.gov.

Question 4: Is it allowable for a multiple PI submission on this announcement?

Answer 4: It is permitted to have multiple PIs. With Multiple Principal Investigators, you are requested to submit a Multiple Principal Investigator Leadership Plan. If two PIs are not from the https://ecps.nih.gov/ same company/institute, the company or person with the intellectual property should be the one developing the drug.

Question 5: Under Section 2 page 91- Cost or Price Support, should we include all the pricing information in the attached excel sheet? Would this meet the minimum requirements for cost data and all cost related support?

Answer 5: Please refer to pages 94-95 of the solicitation for specific instruction to complete the cost elements of your proposal.

Question 6: Section 4.3.3.1.3- under the general instructions-states A. “you must include an index, appropriately referenced, of all the certified cost or pricing data and information accompanying or identified in the proposal”. Is this “index” referring to the attached excel sheet or should we include some other type of index which we create?

Answer 6: In addition to the excel spreadsheet, offerors are requested to provide in the business proposal a narrative/justification for each proposed cost category listed in the excel sheet.

Question 7: Is it acceptable to include documents that are unrelated to the study description (e.g. biographical sketches, past experiences, IP details, etc.) in the appendix and not in the body of the technical proposal to increase clarity?

Answer 7: Please see page 62 of the BAA. Technical Proposal is limited to 150 pages, inclusive of CV’s. The information should be included in Section 5: Scientific and Technical Personnel, of your Technical Proposal.

Question 8: Is it expected that the complete development plan is discussed up to NDA filing (beyond the scope of BAA proposal)?

Answer 8: Please refer to page 10 of the solicitation.

As appropriate to the Statement of Work: 3.1.3.1 - Experimental Plan (Include the following in SECTION 4: TECHNICAL DISCUSSIONS, of your Technical Proposal) NIAID recognizes that the regulatory path to licensure for products within the scope of this BAA may not have been previously defined. The regulatory requirements are likely to be defined in an iterative decision-making process with the FDA based on product-specific data as it emerges.

Provide an Experimental Plan that details the specific tasks and stages that the Offeror proposes to perform with a proposed budget that can reasonably be completed in three years.

Question 9: Is it possible to exchange individual studies included currently in the application after funding has been granted, given that justification would be provided, and changes are cost-neutral?

Answer 9: Any changes should not deviate significantly from the Peer-Reviewed body of work unless strongly justified and approved by the Contracting Officer.

Question 10: In the description of the base and option periods, is it advisable to use the dates (e.g. July 1, 2020 to June 30, 2021) or is it enough to indicate the duration of the periods?

Answer 10: As stated on page 6 of the solicitation, awards are anticipated to be made in or around May 2020. It is advisable to use the dates, e.g. May 1, 2010 to April 30, 2021 and so on for the subsequent option periods.

Question 11: The proposals should be submitted online via the electronic Contract Proposal Submission (eCPS) website. Is eRA commons registration required for the submission?

Answer 11: No eRA commons registration is required for submission of proposal. Please refer to page 62 of the solicitation, section 4.3.2.1.2 – Online Submission of Electronic Proposals for information and instructions to submit an online proposal.

Question 12: Is it predicted to fund 1-2 awards for a maximum of 3 years? The total award sum is 4 mln $ per year for all awards. Would that mean that we are able to propose the base and option period for the total of to 6 mln $ (base period being 2 mln $ and option periods up to 4 mln $)? Is the duration of the base period defined?

Answer 12: The total budget for the base period and two (2) option periods is up to $6M, depending upon the proposed technical objectives and the availability of funds. In general, each period is 12 months, but it depends upon the proposed project and technical objectives.

Question 13: Would an offeror, as a small business that would subcontract animal efficacy studies, have to submit such subcontracting plan? And would such proposal have to be negotiated with the Contracting Officer before the submission of the proposal?

Answer 13: Small business is not required to submit a Small Business Subcontracting Plan.

However, if a prime offeror subcontracts the animal efficacy studies to a large business and the total amount of the subcontract is over $700,000 then the subcontractor who is large business is required to prepare and submit a Small Business Subcontracting Plan (SBSP).

Question 14: Historically, mouse and NHP was a model of choice to show efficacy in ARS.

However, rabbit (small animal) and minipig or dog (large animal) may be of interest to other agencies like BARDA and FDA. Would you be able to advise us on the animal models we should consider for this application?

Answer 14: According to the FDA’s 2015 Guidance, the animal models that are chosen should have data from the literature or historical studies showing the model’s relevance to radiation injury in humans and should model the recovery from radiation injury from a given product.

https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm 399217.pdf p.16 https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm399217.pdf%20p.16 https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm399217.pdf%20p.16

Division of Microbiology and Infectious Diseases (DMID)

General Questions

Question 1: Can you please confirm that the above referenced opportunity is open to United Kingdom entities, i.e. foreign applicants?

Answer 1: This BAA is being solicited using full and open competition. All offerors, including foreign institutions/investigators/subcontractors, not otherwise prohibited by law are eligible to respond.

Question 2: In review of BAA2019-1 and the associated attachments, we were not able to determine a submission date for the Proposal Intent Response Form for a project that is due for submission on 05/20/2019. Is there a date that the Proposal Intent Response Forms should be submitted?

Answer 2: Unlike proposal submission, the intent notice does not have a specified date. We use the intent notice as a planning tool and appreciate your submitting as early as possible before the closing date of the solicitation.

Research Area 002 – Development of Therapeutic Products for Antibiotic Resistant Bacteria

Question 1: Is Clostridium difficile infection an appropriate problem to address in this funding mechanism?

Answer 1: Yes.

Research Area 003 - Advanced Development of Vaccine Candidates for Antibiotic Resistant Bacteria

Question 1: We have developed a small number of lead candidates and will not have identified a single lead candidate by the application deadline. Are we eligible for funding?

Answer 1: Based on Section 3.2.2.2.4 of the Solicitation, only a proposal with a single lead candidate will be considered.

Question 2: Would a multi-valent adjuvant vaccine, with no protein, be considered responsive to this BAA?

Answer 2: A protein component is not a requirement for the lead candidate.