05-21649. Submission for OMB Review; Comment Request; Assessment of the Use of Special Funding for Research on Type 1 Diabetes Provided by the Balanced Budget Act of 1997, the FY 2001 Consolidated Appropriations Act, and the Public Health Service ...

Summary: Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 10, 2005, page 11994 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Proposed Collection

Title: Assessment of the Use of Special Funding for Research on Type 1 Diabetes Provided by the Balanced Budget Act of 1997, and the FY 2001 Consolidated Appropriations Act, and the Public Health Service Act Amendment for Diabetes. Type of Information Collection Requested: Revision, OMB control number: 0925-0503; expiration date: 06/30/2005. Need and Use of Information Collection: This survey will be one source of input into a statutorily mandated assessment and report to the Congress on special funding for research on type 1 diabetes provided by the Balanced Budget Act of 1997, (Pub. L. 105-33), the FY 2001 Consolidated Appropriations Act, (Pub. L. 106-554), and the Public Health Service Act Amendment for Diabetes, (Pub. L. 107-360). Collectively, these Acts provided $1.14 billion in special funds to the Department of Health and Human Services (HHS) for research aimed at understanding, treating, and preventing type 1 diabetes and its complications. The Secretary of HHS subsequently designated to the NIDDK the lead responsibility in the Department for developing a process for allocation of these funds. The primary objective of this study is to gain information, via a brief questionnaire, from NIH research grantees who were the primary recipients of these special funds, concerning their views on the impact of the type 1 diabetes research fundings with respect to: (1) Advancing scientific accomplishments involving innovative, clinically relevant, and multidisciplinary research on type 1 diabetes; (2) developing resources or reagents useful for type 1 diabetes research; and (3) increasing the number and quality of type 1 diabetes investigators. The responses will provide valuable information concerning how the funds have facilitated research as intended by these Acts of the Congress. The results will also help determine how research progress from these special congressional initiatives fits within the continuum of diabetes research, and how these funds have contributed to the field of type 1 diabetes research and NIH efforts to combat this challenging health problem. Information from this study will aid in evaluation of the process by which the research goals for use of the special type 1 diabetes funds have been developed and are being pursued. Responses already collected from this survey were analyzed as part of an interim program assessment that was published by the NIDDK in April, 2003 http://www.niddk.nih.gov/​federal/​planning/​type 1_specialfund/. This revised survey will contribute to a statutorily mandated report, due to the Congress on January 1, 2007, evaluating the process and efforts under this program and assessing research initiatives funded by these Act of Congress. Frequency of Response: The survey will require a one time response; though, respondents may be contacted again in the event of future congressionally mandated reports on the use of the special type 1 diabetes research funds. Affected Public: Research scientists who received the special funds about which the Congress has mandated in law the requirements for an evaluation report. Type of Respondents: Laboratory and clinical investigators who have received support from the special type 1 diabetes funds provided under the laws previously cited. The annual reporting burden is as follows: Estimated number of respondents: 500; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 1; and Estimated Total Burden Hours Requested: 500. The annualized total cost to respondents is estimated at: $25,000. It is expected that the respondents will be contacted and will return their responses via electronic mail. These measures will reduce the burden on the respondents and the overall costs of administering the study. Respondents will be asked to answer no more than sixteen questions, one-third of which will be answered with “yes” or “no” or a one-word response. There are no Capital Costs, Operating Costs or Maintenance Costs to report.

Request For Comments

Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions sued; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Direct Comments to OMB

Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Shefa Gordon, Presidential Management Fellow, Office of Scientific Program and Policy analysis, NIDDK, NIH, Building 31, Room 9A31, 9000 Rockville Pike, Bethesda, MD 20892, or call non-toll-free number [phone] or e-mail your request, including your address, to: [e-mail].

Comments Due Date

Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

Dated: October 19, 2005.

Barbara Merchant,

Executive Officer, NIDDK.