Notice Number: NOT-AI-05-025

Key Dates
Release Date: February 17, 2005
Release Date of RFA-AI-05-001: November 19, 2004
Letters of Intent Receipt Date(s): April 11, 2005
Application Receipt Date(s): May 11, 2005
Peer Review Date(s): October, 2005
Council Review Date(s) : January, 2006
Earliest Anticipated Start Date: March, 2006
Expiration Date: May 12, 2005

The National Institute of Allergy and Infectious Diseases (NIAID) is amending RFA-AI-05-001, Leadership for HIV/AIDS Clinical Trials Network, as follows.

1. The list of collaborating NIH Institutes and Centers is revised to indicate that the National Institute of Nursing Research (NINR) will not be participating in this RFA.

2. The application instructions have been modified with regard to budget development and presentation as a result of questions received from potential applicants. Specifically,

a) The requirements for describing plans for transition of clinical research and activities have been clarified. Recognizing that the description of ongoing studies and phase out activities in incumbent Networks with numerous ongoing studies may be lengthy, NIAID has revised the suggested budget tables that can be used to present this information succinctly and has determined that these tables will not count against the page limit for the CORE component. The suggested Table 4: Transition of Clinical Research Activities and Components, has been expanded to include 5 parts: 4A: Protocols Closed to Enrollment, 4B: Protocols Open to Enrollment, 4C: Protocols Pending Enrollment, 4D: Phase-Out Network Infrastructure and 4E: Transition of Clinical Trial Materials. These tables allow applicants to estimate the total budgetary needs for each Network component per protocol as well as the total required at performance sites for the first budget period and budget periods two through seven.

b) All clinical research activities (clinical trials as well as relevant epidemiologic investigations and other observational studies) newly proposed in the Network application should be summarized in Table 5: Proposed Clinical Research Activities. Table 5 also will not count against the page limit. This table allows applicants to estimate the total budgetary needs for each Network component per protocol as well as the total required at performance sites for the first budget period and budget periods two through seven. The difference between the Table 5 total cost and the Core Costs for each Network component and the Clinical Research Sites for the first year only should be included in the PHS 398 Page 4 or Page 5 budgets.

c) The description of the CORE PHS 398 Page 4: Detailed Budget for Initial Budget Period and CORE PHS 398 Page 5: Budget for the Entire Proposed Period of Support now includes a 4 th breakdown budget: (iv) Transition of Clinical Research Activities and Components. This breakdown budget should include the first year total transition costs for all ongoing clinical protocols as derived in the suggested Table 4 (Total budget for all ongoing protocols at CORE, SDMC, NL and sites). Costs from Table 4 and Table 5 for continuing clinical research beyond the first year are not to be included in either the PHS 398 Page 4 or Page 5 budgets.

d) The following note has been added to the application instructions for the Page 4 budgets for all components (CORE, NL and SDMC): The budget for each Network component should be developed based on the volume of clinical research activity equivalent to Clinical Research Capacity Requirements Core Costs for the Clinical Research Sites. That is, the type and volume of activity should reflect the capacity requirement that each Clinical Research Site maintain an average of 20 participants on study' per month over a 12-month period. It is planned that additional resources required for each Network component to implement the proposed research plan in its entirety will be disbursed by the Network through the Protocol Implementation Fund administered by the CORE. Costs to complete ongoing studies, known as transition costs' for each Network component, should be included only in the Transition Costs budget in the CORE application.

The revised application instructions are available at the application website (http://www.niaid.nih.gov/daids/rfa/network06).

3. The correct website for the Partnership for AIDS Vaccine Development (PAVE) is http://www.hivpave.org.

4. Scientific Research Contacts. The telephone number for contacting DAIDS with inquiries has been changed from (301) 496-0545 to (301) 451-2729.

Inquiries

For questions or further information, contact:

Office of the Director
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4142, MSC-7620
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: 301-451-2729
FAX: 301-402-1505
Email: FY06UNITRFA@niaid.nih.gov

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