Amendment No. 2 - FBO.pdf

Amendment #2 Solicitation Number

RFP-NIAID-DMID-NIHAI2011122

AMENDMENT Two (2)

OFFICE OF ACQUISITONS

National Institute of Allergy and Infectious Diseases (NIAID) 6700-B Rockledge Drive, Room 3220, MSC7612 Bethesda, MD 20892-7612

Solicitation Number: RFP-NIAID-DMID-NIHAI2011122

Date of Solicitation Issuance: 05/31/2012

Date of Amendment No.1 Issuance: 07/19/2012

Number of Pages 3

NIAID Point of Contact: PRIMARY:

Alexandra J. Buck, Contract Specialist Email: alexandra.buck@nih.gov Phone: 301-402-9396

SECONDARY:

George W. Kennedy, Contract Specialist Email: kennedyg@mail.nih.gov Phone: 301-451-2607

Purpose of Solicitation Amendment: The above numbered Solicitation is amended as set forth below.

The hour and date specified for receipt of proposals remains unchanged – until 4:00 PM Eastern Prevailing Time on August 23, 2012.

Offerors must acknowledge receipt of this Amendment (as well as the other amendments) on each copy of the proposal submitted. Failure to receive your acknowledgement of this Amendment may result in rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The Purpose of Amendment No. 2 is to respond to questions received regarding this solicitation, and to provide a final date for the submission of questions, after which questions will no longer be answered.

Our intention is to post at least one more Q&A amendment to this solicitation. Any questions that have been submitted but not yet addressed will be answered in the next amendment.

mailto:alexandra.buck@nih.gov mailto:kennedyg@mail.nih.gov

A. Final date to submit questions regarding this solicitation:

The last day to submit questions regarding this solicitation is July 31, 2012.

B. Below is the Government’s response to questions received regarding this solicitation:

1. Question 1 – Are foreign institutions eligible to apply?

Response 1 – Yes.

2. Question 2 – Do we have to generate our own research projects, or will we be simply implementing studies/trials instructed by an STI network?

Response 2 – Both. For purposes of preparing your proposal, please refer to the Proposal Instructions found in Section L and Attachments # 5, 6 and 7 of the RFP.

Task Orders placed under any resulting awards will involve both the generation of research Projects, as well as implementing studies. As noted in the solicitation, investigators will “identify concepts through 1) semi-annual meetings of the clinical site investigators from the STI CTG; and 2) from sources outside the semi-annual meetings as promising investigational products, devices and strategies become available and develop, review, and recommend (to the COR) Concept Proposals for STI-CTG clinical trials and clinical studies”.

3. Question 3 - We are in the process of applying for an NIH-CTU grant. Will this affect the success of our application for the STI-CTG solicitation?

Response 3 – No. The success of a proposal is dependent upon its scientific and technical merit, as determined through the peer review process.

4. Question 4 – With regard to statistical and data management support, are we correct in our assumption that NIAID will provide this (based on Attachment 4 page 2 paragraph 1 – last sentence of the solicitation)?

Response 4 – Yes, as noted in the Base Contract SOW: “NIAID contractors will provide statistical and data management support for all trials and studies conducted through this program”.

5. Question 5 – In Attachment 6 page 5 on page 124 of the RFP (Task Area 2), the sample Task Order in the Technical Proposal Instructions requesting a protocol for “A Phase III Clinical Trial to Evaluate the Safety and Efficacy of a New Antibiotic for the Treatment of Gonococcal Infection”, the specified drug comparison is cefixime. Does this remain the preferred comparison drug for this sample protocol, despite recent changes in preferred drugs for gonorrhea treatment?

Response 5 – Offerors should respond to the sample task as written. This is a sample task order used for proposal evaluation purposes, and will not be an actual order placed under any resultant contract.

PLEASE NOTE: In the questions/responses above, specific organizational names have been removed or replaced where possible as well as other minor adjustments.

ALL OTHER TERMS AND CONDITIONS OF THIS SOLICITATION REMAIN

UNCHANGED.