Amendment: NIAID Clinical Trial Implementation Cooperative Agreement (U01) (PAR-11-234)

Notice Number: NOT-AI-11-053

Release Date:  August 26, 2011

National Institute of Allergy and Infectious Diseases (NIAID)

The purpose of this Notice is to amend and clarify wording in NIAID Clinical Trail Implementation Cooperative Agreement (U01), https://grants.nih.gov/grants/guide/pa-files/PAR-11-234.html.  Located in:

Part 2; Section I; Scope; in Paragraph beginning with – “Applicants must propose a time-sensitive….”  Sentence “The trial must be hypothesis –driven, include a randomized design…” 

We have removed “include a randomized design” from this sentence.

Section IV; Research Strategy; Last bullet of this part – “Milestones” should be disregarded.

Section IV; 6. Other Submission Requirements…. – Paragraph beginning with – “Applicants may submit a resubmission…” - after PAR-05-113 we added “and PAR-10-186.”

All other aspects of this FOA remain unchanged.

Please direct all inquiries to:

Matthew J. Fenton, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 6
503, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-8973
Fax: (301) 480-5824
Email: fentonm@niaid.nih.gov

Mr. Martin Gutierrez
Division of Acquired Immunodeficiency Syndrome
National Institute of Allergy and Infectious Diseases
Room 4258, MSC-7620
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 451-2703
Fax: (301) 402-1506
Email: mgutierrez@niaid.nih.gov

Ms. Elizabeth Holloman
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 4504, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 402-8339
Fax: (301) 480-0728
Email: hollomone@niaid.nih.gov