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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