RFP_Q&A_FINAL.pdf

RFP-19-100-SOL-00011: Questions and Responses

1. Offeror Question: Our current product manufacturing is done outside of the United States. Is there any aspect of manufacturing that must be done inside the United States for security purposes? The process has been transferred and a process transfer could be proposed to another manufacturer inside the United States and the budget could be provided as part of the proposal. Is that something that would be worthwhile? Is there any limitation to manufacturing outside the US?

USG Response: The product must be manufactured at a facility approved by the U.S. Food and Drug Administration (FDA) under current good manufacturing practice. If the current product manufacturing is performed outside of the United States, the Offeror’s proposal shall include a detailed evaluation of U.S.-based manufacturing facilities with potential to support the current product manufacturing. The evaluation shall include a plan to transition manufacturing to the United States and if not feasible, justification is required. There are specific aspects of U.S.

manufacturing that the Product Sponsor should consider as outlined in recent Presidential orders and strategic documents referencing the need for companies to focus on domestic manufacturing:

i. 2019-01-31 Presidential Executive Order 13858 / Strengthening Buy-American Preferences for Infrastructure Projects

ii. 2018-10 Strategy for American Leadership in Advanced Manufacturing (National Science & Technology Council)

iii. 2018-09 Executive Order 13806 / Assessing and Strengthening the Manufacturing and Defense Industrial Base and Supply Chain Resiliency of the United States

iv. 2018-09-08 The National Biodefense Strategy (White House)

v. 2017-04-18 Presidential Executive Order 13788 / Buy American and Hire American

2. Offeror Question: In the case where additional information related to the project is obtained after the submission deadline but before award notification is made, will there be a mechanism to add this information to the application?

USG Response: No extensions will be granted at this time for additional information after the submission deadline, before award notification is made. All proposal submissions are due by the June 21, 2019 deadline listed in the RFP.

3. Offeror Question: Will documented FDA EUA eligibility be required/in place for RFP reward this year? Alternatively, Will FDA discussions about EUA eligibility need to be in place, this year, for the reward, even if all requirements are not initiated/completed?

USG Response: FDA documentation or discussions do not need to have occurred prior to award yet FDA discussion and documentation must occur after award. There are specific aspects of EUA eligibility that the Product Sponsor should consider as outlined in the December 13, 2016, 21st Century Cures Act (H.R. 34; PL: 114-255) and recent FDA guidance:

i. 2017-01 Emergency Use Authorization of Medical Products and Related Authorities, Guidance for Industry and Other Stakeholders

ii. 2018-11-08 Summary of Process for EUA Issuance

As well, Product Sponsor must consider the following Request for Proposal Section M.3.

Mandatory Evaluation Criteria Emergency Use Authorization requirements: (a) The antibiotic(s) must have FDA marketing authorization for a pulmonary indication or in Phase 3 clinical development for a pulmonary indication and be eligible for Emergency Use Authorization (EUA) pre-approval by FDA for a biothreat indication. (b) If the antibiotic does not have FDA marketing authorization for a pulmonary indication, the Offeror must indicate they will seek development and FDA marketing authorization for a pulmonary indication that could support EUA pre-approval or marketing authorization of a biothreat indication. (c) The Offeror must indicate they will seek development and EUA or FDA marketing authorization for treatment of infections due to one of the following biothreat pathogens: Y. pestis (plague), B. anthracis (anthrax), F. tularensis (tularemia), B. mallei (glanders) or B. pseudomallei (melioidosis).

4. Offeror Question: Will a product be awarded the RFP, if no discussion has yet taken place with

FDA regarding a development for a pneumonia indication and/or EUA eligibility?

USG Response: FDA documentation or discussions do not need to have occurred prior to award yet FDA discussion and documentation must occur after award. There are specific aspects of EUA eligibility that the Product Sponsor should consider as outlined in the December 13, 2016, 21st Century Cures Act (H.R. 34; PL: 114-255) and recent FDA guidance:

i. 2017-01 Emergency Use Authorization of Medical Products and Related Authorities, Guidance for Industry and Other Stakeholders

ii. 2018-11-08 Summary of Process for EUA Issuance

As well, Product Sponsor must consider the following Request for Proposal Section M.3.

Mandatory Evaluation Criteria Emergency Use Authorization requirements: (a) The antibiotic(s) must have FDA marketing authorization for a pulmonary indication or in Phase 3 clinical development for a pulmonary indication and be eligible for Emergency Use Authorization (EUA) pre-approval by FDA for a biothreat indication. (b) If the antibiotic does not have FDA marketing authorization for a pulmonary indication, the Offeror must indicate they will seek development and FDA marketing authorization for a pulmonary indication that could support EUA pre-approval or marketing authorization of a biothreat indication. (c) The Offeror must indicate they will seek development and EUA or FDA marketing authorization for treatment of infections due to one of the following biothreat pathogens: Y. pestis (plague), B. anthracis (anthrax), F. tularensis (tularemia), B. mallei (glanders) or B. pseudomallei (melioidosis).

3. Offeror Question: Will EUA eligibility be required before purchase?

USG Response: Purchase of antibiotic treatment courses will occur once the antibiotic(s) is acceptable for use under an EUA or upon FDA marketing authorization for a biothreat indication.

When the antibiotic(s) are acceptable for use under an EUA as authorized by the FDA or upon FDA marketing authorization for a biothreat indication, the USG will procure sufficient product to meet some or its entire requirement. Acceptance of the antibiotic(s) into the ASPR/SNS requires that the finished drug product meet, at a minimum, specifications determined by the FDA. The antibiotic(s) must be developed for potential use during a declared emergency under EUA pre-approval or FDA marketing authorization for the treatment of a biological threat. The Offeror(s) shall provide an initial shipment of product manufactured using a validated process in accordance with cGMP, up to 2,500 treatment courses of antibiotic(s) when acceptable for use under EUA, in accordance with all federal, state and local regulations, as well as international regulations if applicable.

4. Offeror Question: Will any purchase be made before 60 month stability data are available?

USG Response: The product shall have a minimum of five years stability at the intended storage temperature with a plan for the shelf-life extension. In consideration of marketing authorization of the biothreat indication and inclusion in the ASPR/SNS, the Offeror shall propose extended product stability studies for bulk drug substance (BDS) and final drug product (FDP) of at least five years and an ongoing stability program agreed upon by FDA.

5. Offeror Question: Will “manufacture at release” be required (with 60 month expiry) at time of purchase?

USG Response: Documented capabilities for storage and release of the product for either storage as vendor managed inventory OR subsequent delivery to the Strategic National Stockpile are required. The product shall have a minimum of five years stability at the intended storage temperature with a plan for the shelf-life extension. In consideration of marketing authorization of the biothreat indication and inclusion in the ASPR/SNS, the Offeror shall propose extended product stability studies for bulk drug substance (BDS) and final drug product (FDP) of at least five years and an ongoing stability program agreed upon by FDA.

6. Offeror Question: What RFP activities must be completed to initiate a purchase?

USG Response: Purchase of antibiotic treatment courses will occur once the antibiotic(s) is acceptable for use under an EUA or upon FDA marketing authorization for a biothreat indication.

Acceptance of the antibiotic(s) into the ASPR/SNS requires that the finished drug product meet, at a minimum, specifications determined by the FDA. The antibiotic(s) must be developed for potential use during a declared emergency under EUA pre-approval or FDA marketing authorization for the treatment of a bio threat.

7. Offeror Question: Attachment #6, Protection of Human Subjects. Please clarify if Attachment #6 is to be provided in both the Technical Volume [L.4.2.4] and in the Business Proposal [L.5.3(4)2] USG Response: Yes. The Human Subject Protection regulations should be included in both the Technical Proposal and in the Business Proposal.

8. Offeror Question: Manufacturing is asked to addressed in three (3) SOW sections [C.1.4.1.6 – Product Manufacturing; C.4.5 – CMC; and C.1.4.5.2 – Manufacturing Plan], but only evaluated according to two (2) sections [M.4.3 – Product Manufacturing; M.4.1 – CMC]. Please clarify if the Manufacturing Plan will be evaluated. Also, please clarify if the Manufacturing Plan can be provided as an Appendix.

USG Response: The initial manufacturing plan will be evaluated and may be provided as an Appendix. Please reference the manufacturing plan when responding to Section 4.5.2 Chemistry, Manufacturing, and Control Objectives. The Offeror shall submit a comprehensive manufacturing plan for review and approval no later than 60 days from the date of award.

9. Offeror Question: Is a Cost Proposal spreadsheet intended to be completed for each CLIN, or one spreadsheet to account for all 10 CLINs?

USG Response: Each CLIN must be accounted for in the Cost Proposal spreadsheet. In addition, the Offeror may include a summation tab totaling all 10 CLINs.

10. Offeror Question: Our understanding is that the Cost Proposal spreadsheet is relevant to the cost-reimbursable CLINs (0001, 0003 – 0007), but not for the Fixed Price CLINs (0002, 0008 – 0010). Please confirm or correct our understanding.

USG Response: The Cost Proposal spreadsheet must include both the Cost-Reimbursable and Fixed Price CLINs. The Fixed Price CLINs can be on a separate tab than the buildup for Cost- Reimbursable CLINs. As described in Section L.5 Business Proposal, “Please propose costs for each CLIN in Section B separately (different tabs or separate spreadsheets).”

11. Offeror Question: Is Section 508 applicable to this bid given that there is no software or IT deployed to the Government as part of the RFP?

USG Response: Correct – Section 508 is not applicable to this requirement.

12. Offeror Question: The submission date for Proposals is June 21, 2019. We would like to request an extension to the submission date, ideally a 4-week extension, to facilitate our submission. Please advise whether you are able to grant an extension, without prejudice to the review, at your earliest convenience.

USG Response: No extensions will be granted at this time. All proposal submissions are due by the June 21, 2019 deadline listed in the RFP.