Notice Number: NOT-AI-09-051

Key Dates
Release Date:  August 6, 2009

Issued by
National Institute of Allergy and Infectious Diseases (NIAID), (www.niaid.nih.gov)

Purpose

This Notice amends the Funding Opportunity Announcement (FOA), RFA-AI-09-040, to clarify the definition of clinical trials in the context of this FOA.

For the purposes of this FOA, 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 RFA, are given below:

• 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;
• 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;
• 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;
• a study of a pandemic influenza vaccine in any age group WOULD be considered a clinical trial as there is no such vaccine approved for use by the FDA at this time. 

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 FOA.  If there are any questions, applicants are strongly encouraged to contact one of the NIAID staff listed below: 

Helen R. Quill, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases, NIH
6610 Rockledge Drive, Room 3013, MSC-6601
Bethesda, MD 20892-6601
Telephone: (301) 435-4416
Fax: (301) 480-2381
Email:  hquill@niaid.nih.gov

Matthew J. Fenton, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases, NIH
6610 Rockledge Drive, Room 3105, MSC-6601
Bethesda, MD 20892-6601
Telephone: (301)946-8974
Fax: (301) 402-0175
Email: mailto:fentonm@niaid.nih.gov

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