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Submission for OMB Review; Comment Request; Women's Health Initiative Observational Study

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Information about this document as published in the Federal Register.

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Under the provisions of Section 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 November 7, 2005, page 67494 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, 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: 4/30/2006.

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: On occasion.

Affected Public: Individuals and physicians.

Type of Respondents: Women, next-of-kin, and physician's office staff. The annual reporting burden is an follows:

Type of respondentsEstimated number of respondentsEstimated number of responses per respondentAverage burden hours per responseEstimated total annual burden hours requested
OS Participants85,7861.01.2118,195
Physician's Office Staff41.0835.33

The annualized cost burden to respondents is estimated at $293,112. 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 item(s) contained in this notice, especially regarding the estimated public burden and associated response item, 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 plan and instruments, contact: Dr. Linda Pottern, Project Officer, Women's Health Initiative Program Office, 6701 Rockledge Drive, 2 Rockledge Centre, Suite 8204, MSC 7935, Bethesda, MD 20892-7935, or call 301-402-2900 or E-mail your request, including your address to:

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.

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Dated: February 17, 2006.

Linda Pottern,

Project Officer, Women's Health Initiative Women Health Initiative Program Office National Institutes of Health.

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[FR Doc. 06-1844 Filed 2-27-06; 8:45 am]