E9-5521. Submission for OMB Review; Comment Request; Women's Health Initiative Observational Study

Summary: Under the provisions of Sec tion 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, the National Heart, Lung, and Blood Institute (NHLBI), 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 December 30, 2008, page 79889-79890 and allowed 60-days for public comment. One comment was received and appropriate response was made. 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, and 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 current valid OMB control number.

Proposed Collection: Title: Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: REVISION: OMB No. 0925-0414, Expiration date: 05/31/2009. Need and Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up years for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: Annually. Affected Public: Individuals and physicians. Type of Respondents: Women, next-of-kin, and physician's office staff. The annual reporting burden is as follows:

Estimate of Annual Hour Burden

Type of response	Number of respondents	Frequency of response	Average hours per response	Annual hour burden
Observational Study Participants	63,230	1.1	.3383	23,509
Next of Kin1	1,163	1	.083	97
Health Care Providers1	9	1	.083	.77
Total	64,402			23,607
1 Annual burden is placed on health care providers and respondent relatives/informants through requests for information which will help in the compilation of the number and nature of new fatal and nonfatal events.

The annualized cost burden to respondents is estimated at $377,725. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report.

Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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, [e-mail] or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plan and instruments, contact: Shari Eason Ludlam, Project Officer, Women's Health Initiative Program Office, 6701 Rockledge Drive, 2 Rockledge Centre, Suite 10018, MSC 7936, Bethesda, MD 20892-7936, or call [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: March 2, 2009.

Michael S. Lauer,

Director, Division of Prevention and Population Sciences, NHLBI, National Institutes of Health.

Dated: March 3, 2009.

Suzanne Freeman,

Chief, FOIA, NHLBI, National Institutes of Health.