FINAL_Amendment_1_RFP_NIAID-DAIDS-NIHAI2015029.pdf

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015029 1

Amendment No. 1

NIAID-DAIDS-NIHAI2015029

“Comprehensive Resources for HIV Microbicides and Biomedical Prevention”

Solicitation Number: NIAID-DAIDS-NIHAI2015029

Amendment Number: One (1)

Amendment Issue Date: August 6, 2015

Proposal Due Date/Time: Thursday, September 24, 2015 at 3:00 PM, Local Time

(Unchanged)

Issued By: John R. Manouelian

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY cornorj@mail.nih.gov Robert Corno, Contract Specialist Phone: 240.669.5151

SECONDARY

manouelj@mail.nih.gov John R. Manouelian, Contracting Officer Phone: 240.669.5152

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. Failure to receive your acknowledgement may result in the 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 1 is to provide responses to questions from potential offerors regarding the solicitation.

mailto:cornorj@mail.nih.gov mailto:manouelj@mail.nih.gov

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015029 2

Question 1

Should offerors responding to multiple task areas submit one technical and one business proposal that covers multiple task areas rather than separate proposals for each task area? Related experience, facilities and personnel may apply equally to multiple task areas and would be considered redundant if separate proposals are required.

Response to Question 1

No; as stated in the second paragraph under Technical Proposal – Additional Instructions, on page 1 of Attachment 9, Additional Technical Proposal Instructions, Offerors may submit proposals in response to one or more Task Area(s) of their choosing, and are not expected to respond to all Task Areas. Offerors responding to multiple Task Areas must provide separate Technical and Business Proposals for each Task Area. Proposals for each Task Area will be reviewed independently.

Question 2

Section 3.2.B of Attachment 9 asks offerors to “describe performance of three (3) studies: 1) an initial dose-ranging PK study to be used for selection of the dose(s) for the transmission studies, and (2) a transmission study for each challenge route.” Please confirm that the third study referenced refers to the safety assessment referenced in Attachment 9, Section 3.2.B.2.

Response to Question 2

No, the third study is not the "safety assessment." For clarification purposes, the three studies that should be described include: 1) an initial dose-ranging PK study to be used for selection of the dose(s) for the transmission studies, 2) a transmission study for the vaginal challenge route, and 3) a transmission study for the rectal challenge route. It is our expectation that sufficient measures to assess systemic and local toxicities (i.e., "a safety assessment") will be incorporated into each of the studies.