Amendment NO 1.docx

Amendment NO. 1. NIAID SOLICITATION NO.

BAA-NIAID-DAIT-NIHAI2009074

MODELING IMMUNITY for BIODEFENSE

NIAID, NIH, DHHS Office of Acquisitions, DEA 6700-B Rockledge Drive Room 3214, MSC 7612 Bethesda, Maryland 20892-7612

The purpose of this amendment is to make changes to the solicitation 1) To clarify the definition of clinical trials in the context of this BAA and 2) Update the broken Web link of Attachment 5 page 3, the definitions of clinical research versus clinical trials.

The date specified for receipt of proposals is unchanged.

Offerors must acknowledge receipt of this Amendment by identifying this amendment number and date of the amendment on each copy of the offer submitted. 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.

1) For the purposes of this BAA, NIAID defines a clinical trial as a prospective study of human subjects designed to answer questions about the safety and effectiveness of biomedical or behavioral interventions.

All clinical studies that require an Investigational New Drug (IND) application from the U. S. Food and Drug Administration (FDA) to conduct a clinical investigation WOULD be considered clinical trials.

Studies using FDA approved interventions (e. g. licensed vaccines), that are prescribed for use as described in the intervention’s product label and are exempt per regulation from needing an IND for a clinical investigation, for the purposes of studying detailed immune response to that intervention, WOULD NOT be considered clinical trials. Applicants should contact the FDA directly to discuss the possible need for an IND application.

Examples to further clarify the definition of a clinical trial, for the purposes of this BAA, are given below:

1. a study of a seasonal influenza vaccine that is given at the appropriate time for seasonal influenza immunization and to approved populations, as indicated in the product label of the influenza vaccine to be used in the study, WOULD NOT be considered a clinical trial;

1. a study of a seasonal influenza vaccine that is given at the appropriate time for seasonal influenza immunization but is given to subjects outside of the approved indication age range (e. g. infants<6 months of age) WOULD be considered a clinical trial;

1. a study of a seasonal influenza vaccine that is given at the appropriate time for seasonal influenza immunization but uses a novel adjuvant WOULD be considered a clinical trial;

NIAID reserves the right to decide whether a proposed clinical study is, or is not, a clinical trial based on the definitions and guidance provided above for purposes of determining whether the proposed study is responsive to the BAA.

2) On Attachment 5, page 3, the correct link to the definitions of clinical research versus clinical trials is found on the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm#_Toc54600040.