Amendment 1 - BAA-NIAID-DAIT-NIHAI2009061.pdf

Amendment #1 to BAA-NIAID-DAIT-NIHAI2009061 Population Genetics Analysis Program

Amendment to Solicitation No.: BAA-NIAID-DAIT-NIHAI2009061

Amendment No.: 1 (1st posting)

Issue Date: June 25, 2009

Effective Date:

Proposal Due Date:

June 25, 2009

July 30, 2009, at 3:00 P.M. local time

Issued By: David T. Lisle Contracting Officer

NIH/NIAID

Office of Acquisitions 6700 B Rockledge Drive Room 3112 Bethesda, Maryland 20892-7612

Point of Contact: Albert Nguyen, Contract Specialist nguyenal@niaid.nih.gov

Name and Address of Offeror: To All Potential Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals HAS NOT been extended. Offerors must acknowledge receipt of this amendment. Failure to receive your acknowledgement of this amendment may result in the rejection of your offer.

SECTION 1 – QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to this Amendment # 1 for additional Questions & Answers.

Question 1: "What criteria is NIAID looking for as basis for choice of genetic variants to study?"

Answer to Question 1: The strongest scientific criteria should be the basis for this choice and those criteria might be statistical, biological, or other convincing data that establish the genotype-phenotype association in the already completed discovery study that will be replicated and/or further studied in the proposed project.

As indicated in the BAA Attachment 5, "Offerors should be well positioned to perform the genotyping studies and other assays proposed; manage and analyze the data; conduct both primary and alternative experimental approaches; and define clear criteria for progressing from early to late stages of the work proposed. Offerors should already have on hand, or have ready sources from which to obtain, relevant samples and clinical or phenotypic data sufficient to appropriately power the studies proposed. All proposed assays and appropriate statistical and informatics capability should be available without the need for developmental support."

In Attachment 7.5.A, we state "Provide a strong rationale for selecting the genotype-phenotype association(s) to be studied, and present and discuss the preliminary data supporting all proposed studies."

Question 2: "What are the expectations in terms of the number of candidate genes to be proposed for replication?"

Answer to Question 2: I am not sure if he is really asking what budget he can propose, but we didn't give them that information in the BAA so it's all up to him.

Specifically in answer to the question asked, I can only say that we have not stated any expectations except in Attachment 5 that "This BAA requires that preliminary data from discovery studies that link human genetic polymorphisms with relevant phenotypes already be available from at least one study population and that these data correlate with positive or negative outcomes of vaccination against or infection by one or more of the agents..." It also allows deletion of Research Area 1 if "convincing replication studies have already been completed."

Again, in Attachment 7.5.A, we state "Provide a strong rationale for selecting the genotype-phenotype association(s) to be studied, and present and discuss the preliminary data supporting all proposed studies." This indicates that one association to be studied is acceptable, and more than one association to be studied is also acceptable.

The expectation is that offerors will propose to study one or more genotype-phenotype associations, and they should choose the number based on their best judgment of the supporting data and the feasibility of conducting whatever work is proposed.