75A50125R00005 Amendment 0002.pdf

(x)

75A50125R00005 x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

ASPR/DAAPPO/BARDA/DC

WASHINGTON DC 20024

CONSTITUTION CENTER OFFIE BLDG

US DEPT OF HEALTH & HUMAN SERVICES

ASPR/DAAPO/BARDA/DCMA

07/13/20250002

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

07/13/2025

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purposes of Amendment 0002 are to answer questions and amend the RFP. See the attached sheets for more details.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

ERIN W. GRENINGER

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

The purposes of Amendment 0002 are to answer questions and update the RFP.

1. QUESTION: Section I, Page 49 of the RFP references FAR clause 52.219-6 Notice of Total Small Business Set-Aside. However, SAM.gov notes that this is not a small business set-aside. Can you confirm that this opportunity is NOT limited to Small Business Concerns?

ANSWER: This is not a small business set aside. Accordingly, Under Section I – CONTRACT CLAUSES, I.3. ADDITIONAL CONTRACT CLAUSES, I.3.2. Additional Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clauses – In Full Text, page 49 of the RFP delete 52.219-6 Notice of Total Small Business Set-Aside (Nov 2020) in its entirety.

2. QUESTION: Please confirm the following referenced solicitation attachment corrections:

Topic/Item

RFP

Page #

Attachment Referenced

(within Body of RFP)

Assumed Correction

(in Attachments section)

Security Plan 60 Attachment #17 Attachment #8

Risk Mitigation Plan

61 Attachment #14 Attachment #5

Vendor Payment Enrollment Form

61 Attachment #12 Not Included (needs to be provided)

Excel Spreadsheet 59 Attachment #10 Attachment #3

Past Performance Questionnaire(s) 65

Attachment #15 Attachment #6

Protection of Human Subjects

61 Attachment #8 Not Included (needs to be provided)

Security and Information Technology Requirements

62 Section J Attachments 7 and 8

ANSWER: Yes the attachments are correct except for Vendor Payment Enrollment Form and Protection of Human Subjects. A Vendor Payment Enrollment Form is not needed.

Vendors are not required to specify how human subjects will be protected at this time.

The RFP has been updated to reflect these changes.

Under Section L.4.2. Appendices to Technical Proposal, 1), delete “(Attachment #17)” and replace with “(Attachment #8)”.

Under Section L.4.2. Appendices to Technical Proposal, 3), delete “(Attachment #14)” and replace with “(Attachment #5)”.

Under Section L.4.2. Appendices to Technical Proposal, delete 5) in its entirety.

Under Section L.2.4 PACKAGING OF PROPOSAL, D. BUSINESS PROPOSAL, delete “Attachment #10” and replace with “Attachment #3”.

Under Section Section L.5.3. Business Proposal – Other Information, (3) Past performance information, third paragraph delete “(Attachment #15)” and replace with “(Attachment #6)”.

Under Section Section L.4.2. Appendices to Technical Proposal, delete 4) in its entirety.

Under Section L.5.1 Business Proposal Instructions, paragraph CLIN-0002 (BARDA security requirements, onshoring commercial manufacturing, & shelf-life extension program activities for HABP/VABP or BSI indications) delete “SECTION J” replace with “Attachments 7 & 8”

Under Section L.5.1 Business Proposal Instructions, paragraph CLIN-0003 (Continued BARDA security requirements, onshoring commercial manufacturing, & shelf-life extension program activities for HABP/VABP or BSI indications) delete “SECTION J” replace with “Attachments 7 & 8”

3. QUESTION: Can you please confirm if FAR 52.222-11 applies to this solicitation? It does not appear that this is DBA covered work.

ANSWER: This is no longer required. 52.222-11 has been deleted from the RFP.

Accordingly, under Section I – CONTRACT CLAUSES, I.1. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR Chapter 1) CLAUSES, delete FAR 52.222-11 May 2014 Subcontracts (Labor Standards) (Deviation Feb 2025) from the table.

4. QUESTION: Please clarify the due date for this RFP. Page 2 of the RFP states August 25, 2026; Section L.2.3 Delivery of Proposal (page 58) states August 26, 2025 at 12:00pm EST; SAM.gov states August 26, 2025 12:00pm EDT.

ANSWER: The due date for proposals is August 26, 2025. The RFP has been updated.

Accordingly, on Page 2 of the RFP delete “August 25, 2025” next to Proposal Responses Due and replace with “August 26, 2025”.

5. QUESTION: The RFP identifies certain CLINs as being cost reimbursable. Can offerors propose these CLINs as firm fixed price instead?

ANSWER: No, research and development CLINs must be cost reimbursable.

6. QUESTION: For electronic submission via email, is there a recommended nomenclature for sending multiple emails with multiple documents attached to ensure all aspects of our proposal stay together?

ANSWER: There is no current required nomenclature however if multiple emails are required please ensure you indicate there are multiple emails and the number of emails being submitted e.g. “email 1 of 4”.

7. QUESTION: The security plan requirements and template, as referred to in the RFP as “Attachments 16 and 17” (see page 9), are not included. Are these the same as attachments #7 and #8, or are there version updates?

ANSWER: Yes they are the same. See the answer to Question 2. The RFP has been updated to reflect these changes.

8. QUESTION: The risk mitigation plan, as referred to in the RFP as “Attachment #14” (see page 61), is not included. Is this the same as attachment #5, or is there a version update?

ANSWER: Yes they are the same. See the answer to Question 2. The RFP has been updated to reflect these changes.

9. QUESTION: The attachment for the “Protection of Human Subjects,” as referred to in the RFP as “Attachment #8” (see page 61), is not included. Can you please provide this attachment?

ANSWER: Yes they are the same. See the answer to Question 2. The RFP has been updated to reflect these changes.

10. QUESTION: The attachment for the past performance questionnaire, as referred to in the RFP as “Attachment #15” (see page 65), is not provided. Is this questionnaire the same as attachment #6 or is there a version update?

ANSWER: Yes they are the same. See the answer to Question 2. The RFP has been updated to reflect these changes.

11. QUESTION: The attachment for the disclosure of lobbying activities, as referred to in the RFP as “Attachment #4,” is not included as the link is broken (see page 76). Can you provide this attachment or correct link?

ANSWER: The link should work. Once the link is clicked you can download the file by clicking the download file button or right clicking the download file and saving the link.

In order to ensure access a copy of the form has been added to Attachment 4 of the RFP.

12. QUESTION: The RFP states “The USG is seeking to procure and maintain an antibiotic for the treatment of BSI or HABP/VABP and, if feasible, the treatment and/or PEP of a biothreat indication (Y. pestis, F. tularensis, or B. pseudomallei).” Please clarify if products under development for a biothreat indication are eligible for award if the product has an existing (e.g., CABP) indication, but does not have a BSI or HABP/VABP indication and is not planned for development of a BSI or HABP/VABP indication.

ANSWER: Products under development for a biothreat indication must have approval for HABP/VABP or BSI (or be under development for these indications). A CABP indication would not be responsive to the RFP.

13. QUESTION: Throughout the RFP, when discussing the requirements for an antibiotic with a planned biotreat indication, it states that the development plan must include the conduct of a Phase 3 clinical trial for a pneumonic indication if the product is not already approved for such an indication. Would an FDA-approved product indicated for Community-Acquired Bacterial Pneumonia (CABP) satisfy this requirement?

ANSWER: “The United States Government (USG) seeks an antibiotic that treats bloodstream infections (BSI) or hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by drug-resistant bacteria.” An FDA-approved product indicated for CABP would not satisfy this requirement.

14. QUESTION: The RFP states “The product/candidate must be FDA-approved within the last 15 years, or the program completed an end-of-Phase 2 meeting with the FDA and have a Phase 3 development plan that has been favorably reviewed by the FDA for an HABP/VABP and/or BSI indication.” Are products/candidates approved within the last 15 years only eligible if approved for a HABP/VABP and/or BSI indication?

ANSWER: That is correct, only products/candidates approved for a HABP/VABP and/or BSI indication within the last 15 years are eligible.

15. QUESTION: Evaluation Criteria 1.10 states that proposals will be evaluated for “Adequacy of the proposed timelines/milestone schedule(s) for meeting late-stage product development objectives (marketing authorization in no more than five years).”

Please confirm if all late-stage development activities for any proposed new indications (including biodefense) must be completed within 5 years.

ANSWER: Late-stage development activities for a single indication (HABP/VABP or BSI or biothreat) must be completed within 5 years. If Offeror proposes multiple indications (e.g. HABP/VABP and biothreat), the commercial indication should be completed within 5 years and the biothreat indication may take longer than 5 years.

16. QUESTION: Please clarify if proposed periods of performance must be within the periods of performance outlined in Section B.2.1 Base Period and B.2.2 Option Periods?

ANSWER: Offeror may propose their own periods of performance.

17. QUESTION: If a product’s API is produced outside of the U.S., but processing of FDP occurs domestically and therefore meets the definition of a U.S.-made end product, according the Trade Agreements Act, will this meet the requirement of Mandatory Evaluation Criteria M.3.g?

ANSWER: Yes, domestic processing of FDP meets the requirement of Mandatory Evaluation Criteria M.3.g.

18. QUESTION: Should storage and distribution be priced separately from the product price?

ANSWER: Yes, please separate storage and distribution costs from product cost. When budgeting distribution costs from VMI assume the longest route for delivery within the continental United States.

19. QUESTION: Would one application for multiple products be considered or will each proposed product be considered as part of an independent application?

ANSWER: Each product needs its own independent application/proposal.

20. QUESTION: Please provide details on the total budget available for contracts awarded under this RFP.

ANSWER: We cannot provide this information. Offerors should submit complete and best pricing in the proposal.

21. QUESTION: Given the FDA’s timelines for requesting regulatory meetings and the 45 days turnaround time of this RFP, would BARDA be open to amending mandatory criterion B.1 to:

“If proposing a biothreat indication, Offerors must propose a biodefense development plan including nonclinical, clinical, and CMC activities that aligns with FDA Guidance for Product Development Under the Animal Rule or that has been discussed with the FDA, and that if successful will achieve marketing authorization for the treatment and, if feasible, PEP of a biothreat indication(s). If the FDA is not able to meet with Offerors prior to the proposal submission deadline, Offerors must commit to meeting with the FDA within 120 days of submission.”

ANSWER: No, the mandatory criterion B.1 cannot be amended