04-12789. Submission for OMB Review; Comment Request; Obstetrician-Gynecologists' Knowledge and Practice Patterns With Regard to Hormone Therapy

Summary: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung and Blood Institute (NHLBI), the Office of Research on Women's Health (ORWH), the National Institutes of Health (NIH) and the Health Resources and Services Administration (HRSA) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. The proposed information collection was previously published in the Federal Register on November 12, 2003, page 64111 and allowed 60 days for public comment. A public comment was received from Wyeth Ayerst Pharmaceuticals. No other public comment was received. 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 currently valid OMB number.

Proposed Collection: Title: Obstetrician-Gynecologists' Knowledge and Practice Patterns with Regard to Hormone Therapy. Type of Information Collection Request: New. Need and Use of Information Collection: This study will evaluate and track the effect of results from the Federally-funded Women's Health Initiative (WHI) trials of estrogen plus progestin and estrogen alone, and of updated guidelines provided by Federal agencies and professional bodies, on the knowledge, attitudes and prescription behavior of members of the American College of Obstetricians and Gynecologists (ACOG) in regard to the use of postmenopausal hormone threapy. The publication of the WHI trial findings for estrogen plus progestin in 2002 generated massive media coverage and revisions to the guidelines for the use of hormones, including revisions of the package insert by the Food and Drug Administration (FDA). The findings for estrogen alone published in April 2004 further contributed to the revised view of the value of hormone therapy to prevent chronic diseases. The WHI findings led to a marked decrease in the prescriptions for hormone therapy on a national level. They are thought to have had a major impact on obstetrician-gynecologists, who are among the principal health care providers for women and who prescribe hormones more frequently than any other health care provider specialty group. However, the impact obstetrician-gynecologists have not been studied systematically. The investigators propose to survey fellows of ACOG over a four and a half year period starting in 2004. Objectives of the study are to evaluate the extent to which the WHI findings for estrogen alone and for estrogen plus progestin have been accepted by ACOG members, what the effect has been on their prescription patterns, and to track changes over time as new guuidelines continue to appear. The initial survey will provide valuable information concerning ACOG members' knowledge of current and past research findings regarding hormone therapy, their awareness of ACOG and Federal guidelines for the use of hormone therapy, their own current practice and changes for past practice, their concerns and informational and educational needs. Two subsequent annual will allow the investigators to track changes in knowledge, attitudes, and practice over a period of evolving knowledge among a representatiave sample of obstetrician-gynecologists. The findings will assist the Government and professional bodies in evaluating the degree of translation of research findings into practice, and with developing educational materials for physicians to assist with translation. Frequency of Response: On occasion. Affected Public: Individuals or households; Businesses or other for-profit. Type of Respondents: Physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 1875; Estimated Number of Responses Per Respondent: 1; Average Burden Hours Per Response: .33, and Estimated Total Annual Burden Hours Requested: 619. The annualized costs to respondents is estimated at: $46,425. There are no Capitol Costs to report. There are no Operating or Maintenanace 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 used; (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 informatijon 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. Jacques E. Rossouw, Project Officer, Women's Health Initiative, NIH, NHLBI, 6101 Rockledge Drive Ste 8204 MSC 7935, Bethesda, MD 20892-7935, or call [phone] (not a toll-free number) 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: May 18, 2004.

Barbara Alvin,

Director, Women's Health Initiative, National Institutes of Health.