BAA-NIAID-DMID-NIHAI2010104 - Amendment 1.docx

BAA-NIAID-DMID-NIHAI2010104

Amendment #1

“VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES”

Proposal Due Date/Time:

December 20, 2011 at 3:00 P.M., local time [Unchanged]

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214, Bethesda, Maryland 20892-7612

mansouryb@niaid.nih.gov Bijan Mansoury, Contract Specialist Phone: 301-594-4573

SECONDARY:

andersondj@niaid.nih.gov Deborah J. Anderson, Contract Specialist Phone: 301-402-2234

Offerors must acknowledge receipt of this Amendment on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

The hour and date specified for receipt of proposals HAS NOT been extended.

This amendment is to provide clarification to questions below:

Question 1: Will HHS indemnify contractors, through authorization of the PREP Act or any other indemnification coverage, for the use of their products in the performance of this contract?

Answer 1: No.

Question 2: In Attachment 4, page 8 of 11, item #6, there is the following statement:

"preparing and executing written Quality Agreements with each subcontractor".

What is meant by “each subcontractor”?

Answer 2: Any sub-contract for GXP compliant work should clearly delineate roles, responsibilities, expectations and deliverables regarding compliance from a quality standpoint, including what the prime contractor plans to do to ensure that these expectations are met (frequency, timing of oversight audits, review/approval of documents, etc.). Quality Agreements may be used as appropriate to ensure subcontractors meet USG expectations regarding quality work. Transfer of Regulatory Obligations is separate from the prime contractor obligations to ensure subcontractors maintain GCP compliance in terms of fiduciary responsibility. Relying on Transfer of Regulatory Obligations for ensuring GCP compliance would not be appropriate. For example, any prime contractor is expected to have an active role in oversight monitoring visits/audits with an independent Clinical Research Associate.

Question 3: We would like to get clarification about whether a proposal for a single vaccine component, but including a definitive comparison of two alternate forms of the technology component prior to choosing one for development, would require two separate applications. If a single integrated proposal was submitted, would it be rejected prior to review on the grounds that it did not follow the specified format?

Answer 3: It is acceptable to submit a proposal in which one vaccine component is evaluated in conjunction with different technology components or alternatively a proposal in which one technology component is evaluated in conjunction with different vaccine components. Activities should be clearly defined for each proposed stage of each proposed vaccine component-technology component with tasks and sub-tasks identifying "Go/No Go" decision points allowing down selection and further development of a final candidate product.

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