ADDENDUM TO RFA-DK-03-022: ANCILLARY STUDIES TO OBESITY RELATED CLINICAL TRIALS RELEASE DATE: June 24, 2004 NOTICE: NOT-DK-04-007 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov/) This addendum is to inform potential applicants of two changes in RFA-DK-03-022: a change in the handling of fiscal and administrative costs on subcontracts and the readiness of three networks to accept ancillary studies. CHANGE TO HANDLING OF FISCAL AND ADMINISTRATIVE COSTS. The original RFA INCLUDED fiscal and administrative costs on subcontracts towards the $1 million per year direct cost funding limitation. This policy will be changed beginning with the next receipt date for the RFA, consistent with new NIH policy (see April 30, 2004 NIH Guide, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html). For applications to the November 19, 2004 and July 19, 2005 receipt dates, an applicant may request a project period of up to 5 years and a budget for direct costs of up to $1 million per year, EXCLUDING fiscal and administrative costs on subcontracts. As before, you are strongly encouraged to discuss proposed budgets with the IC program official for the parent trial or network prior to extensive preparation of your application. Applications funded in FY 2004 will be subject to the original RFA cost limitations; however, any revised and resubmitted applications originally submitted to the March 19, 2004 receipt date will be subject to the new policy. NETWORKS AND TRIALS READY TO ACCEPT ANCILLARY STUDIES. This addendum also announces the readiness of three trials or networks to conduct ancillary studies: 1) The Longitudinal Assessment of Bariatric Surgery (LABS) study, formerly know as the Bariatric Surgery Clinical Research Consortium. http://www.niddklabs.org 2) The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN). http://www.nashcrn.com 3) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) http://www.todaystudy.org Applications for ancillary studies to these trials or networks may be accepted for the remaining receipt dates, November 19, 2004, and July 19, 2005. All other aspects of the RFA remain unchanged, and the other trials and networks listed in the original RFA continue to be available for ancillary studies. The full text of the RFA, which was published October 22, 2003, can be accessed at the following location: https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-03-022.html. An earlier addendum announcing a name change for the PRIDE study may be found at: https://grants.nih.gov/grants/guide/notice-files/NOT-DK-04-002.html. Inquiries regarding this notice may be directed to: Barbara Harrison, M.S. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Room 661 Bethesda, MD 20892-5450 (for express/courier service: Bethesda, MD 20817) Telephone: (301)594-8858 FAX: (301)480-8300 E-mail: bh72k@nih.gov Chhanda Dutta, PhD Geriatrics and Clinical Gerontology Program National Institute on Aging Gateway Building, Suite 3C-307 7201 Wisconsin Avenue Bethesda, MD 20892-9205 Telephone: (301)435-3048 FAX: (301)402-1784 E-mail: cd23z@nih.gov Marguerite Klein National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 (for express mail, use 20817) Telephone: (301)402-5860 Fax: (301)480-3621 E-mail: mk443s@nih.gov
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