Amendment_NO_1.pdf

Amendment Number: 1

ADJUVANT DEVELOPMENT PROGRAM

Solicitation Number: BAA-NIAID-DAIT-NIHAI2012146

Amendment Number: One (1)

Amendment Issue Date: November 20, 2012

Amendment Effective Date: November 20, 2012

Proposal Due Date: January 17, 2013 [3pm Eastern]

Issued By: Tom Bahrami Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3109 Bethesda, MD 20892-7612

Point of Contact: George Ralis Contract Specialist ralisg@niaid.nih.gov

The purpose of this amendment is to 1) clarify language in the BAA and 2) provide responses to questions which may be useful to all potential offerors.

Offerors must acknowledge receipt of this amendment by identifying the amendment number and date of the amendment in the proposal. Failure to receive your acknowledgement may result in the rejection of your offer. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

QUESTION/ISSUE 1:

Will the Program fund preclinical preparations for the clinical trials beyond the pre-clinical testing (i.e.

conducting a pre-IND meeting, GMP manufacturing, and drafting and filing of an IND)?

RESPONSE:

Yes. The BAA supports some IND-enabling activities such as conducting a pre-IND meeting, GMP manufacturing, and drafting and filing of an IND. The BAA does not support the design or conduct of clinical trials (see Attachment 5, pages 2 - 3 and below):

“(C) NOTE: Contracts awarded under this solicitation will NOT support:

• The design and conduct of clinical trials (see http://www.niaid.nih.gov/researchfunding/glossary/pages/c.aspx#clintrial for the NIH definition of a clinical trial).”

mailto:ralisg@niaid.nih.gov http://www.niaid.nih.gov/researchfunding/glossary/pages/c.aspx#clintrial

QUESTION/ISSUE 2:

Should the target pathogens be selected from each of the three lists or can all be selected from List III only?

There are no restrictions or limitations regarding which lists/pathogens within NIAID Emerging and Re-emerging Pathogens can be addressed.

QUESTION/ISSUE 3:

Are there specific disease areas which NIAID is interested in evaluating with the adjuvant?

No. Offerors should address NIAID Emerging and Re-emerging Pathogens or HIV/AIDS. The offeror is free to choose among these.

QUESTION/ISSUE 4:

Is it necessary for the applicant to be the adjuvant developer?

No. The Adjuvant Development BAA does not prohibit a subcontractor from developing the adjuvant in collaboration with a primary offeror.

QUESTION/ISSUE 5:

Does this contract include development of adjuvants which have previous clinical experience (but are not in licensed products) for application to HIV Envelope?

Yes. The Adjuvant Development BAA includes development of adjuvants which have previous clinical experience (but are not in licensed products) for application to HIV Envelope. Only adjuvants previously licensed with a vaccine are excluded (see Attachment 5, page 2 and below):

“(C) NOTE: Contracts awarded under this solicitation will NOT support:

• The further development of an adjuvant that has been previously licensed for use with any vaccine.”

QUESTION/ISSUE 6:

In Section K of the solicitation, it states that prospective offerors must “Go to the Online Representations and Certifications Application (ORCA) at: https://orca.bpn.gov/ and complete the Representations and Certifications”.

ORCA has been consolidated under the System for Award Management (SAM) website. Please access SAM to perform tasks such as registering/updating your ORCA information.

SAM is a Federal Government owned and operated free website. SAM can be accessed at https://www.sam.gov/portal/public/SAM/

QUESTION/ISSUE 7:

Is the submission for this BAA paper or electronic? [Attachment 1 (‘Packaging and Delivery of the Proposal’) of the solicitation indicates a paper submission, but Attachment 2 (‘Proposal Intent Response Sheet’) indicates it will be an electronic submission.]

Follow the submission instructions as written in Attachment 1 (‘Packaging and Delivery of the Proposal’).

As noted in Attachment 1, “PAPER SUBMISSION: The paper copy is the official copy for recording timely receipt of proposals.”

Attachment 1 also instructs offerors to submit a separate CD-Rom containing both the Technical Proposal and Business Proposal information.

On Attachment 2, disregard the following text…“Since your proposal will be submitted electronically, please include the name and e-mail of the individual to whom the electronic proposal instructions, login code, and password should be provided.” This text should not have been included in this BAA.

QUESTION/ISSUE 8:

The section on page 83 of the solicitation entitled “Section 508 accessibility standards for HHS Web Site Content and Communications Materials” ends with the following unfinished sentence: “The following Section 508 accessibility standards apply to the content or communications material identified in this Statement of Work:” However, no text follows this sentence. Can NIAID please clarify?

https://www.sam.gov/portal/public/SAM/

The following Section 508 accessibility standards apply to the content or communications material identified in the offerors Statement of Work.

Information regarding Section 508 accessibility standards can be found at:

http://www.hhs.gov/web/508/checklists/index.html

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