[Federal Register Volume 69, Number 109 (Monday, June 7, 2004)]
[Notices]
[Pages 31827-31828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12789]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

[[Page 31828]]

    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 (301) 435-6669 (not a toll-
free number) or E-mail your request, including your address to: 
[email protected].
    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.
[FR Doc. 04-12789 Filed 6-4-04; 8:45 am]
BILLING CODE 4140-01-M