ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM FOR AIDS

Release Date:  October 16, 1998

RFA:  AI-98-013

P.T.

National Institute of Allergy and Infectious Diseases

Release Date:  July 29, 1998
Letter of Intent Receipt Date:  September 11, 1998
Pre-application Conference Date:  September 18, 1998
Application Receipt Date:  January 15, 1999

PURPOSE

On September 18, 1998, a pre-application conference was held in Rockville, MD. 
This amendment announces the availability of the results of that meeting and
amends the instructions for application submission.

PRE-APPLICATION MEETING RESULTS

Full information about this RFA including the results of the pre-application
meeting are available at URL:
http://www.niaid.nih.gov/daids/adulttrialsrfa.htm

APPLICATIONS

With the one following addition concerning the structure of grant
applications, all provisions of RFA AI-98-013 as published on July 29, 1998
apply.

SPECIAL INSTRUCTIONS

APPLICATION PACKAGE

The following two options for structuring applicant organizations and
applications were presented in the RFA of July 29, 1998.

1.  A Principal Investigator who proposes to form a Group and assume the role
as Group Leader is responsible for coordinating the preparation of a package
that will include the following applications: One (1) Coordinating and
Research Operations Center; One (1) Statistical and Data Management Center;
and One (1) proposal for each individual Clinical Site [The number of clinical
sites should be based on the scope of the research agenda].

2.  If the Group Leader chooses to use a Coordinating Center for both
operational and statistical and data management support, a single application
should be submitted for both components.

Based on the pre-application meeting, a new third option for structuring the
application is acceptable.

3.  A Principal Investigator who proposes to form a group with a scientific
agenda limited to a small number of defined protocols may submit a single
application that combines (1) the Coordinating and Research Operations Center,
(2) the Statistical and Data Management Center, and (3) the Clinical Sites.
For applicants combining all activities into a single application, the
Research Plan is not subject to the page limitations in the PHS Form 398, item
a-d.  This section may not exceed 450 Pages.  The applicant must address all
requirements of the RFA and will be assessed using the review criteria
presented in the RFA.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.  The
opportunity to clarify any issues or questions from potential applicants is
welcome.

Direct inquiries regarding programmatic issues to:

Frederick Batzold, Ph.D.
Clinical Research Management Branch
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 2B27
Bethesda, MD  20892-7620
Bethesda, MD  20852 (for express/courier service)
Telephone:  (301) 402-0143
FAX:  (301) 480-4582
Email:  fb10c@nih.gov

Direct inquiries regarding review issues and special instructions for
application preparation; address the letter of intent; and mail two copies of
the application and five sets of appendices to:

Peter Jackson, Ph.D.
Scientific Review Program
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4C10
Bethesda, MD  20892-7610
Bethesda, MD  20852 (for express/courier service)
Telephone:  (301) 496-8426
FAX:  (301) 402-2638
Email:  pj8v@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Ann Devine
Grants Management Branch
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4B23
Bethesda, MD  20892-7610
Bethesda, MD  20852 (for express/courier service)
Telephone:  (301) 496-5601
FAX:  (301) 480-3780
Email:  ad22x@nih.gov

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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