[Federal Register Volume 68, Number 218 (Wednesday, November 12, 2003)]
[Notices]
[Page 64111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28281]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Obstetrician-Gynecologists' 
Knowledge and Practice Patterns With Regard to Hormone Therapy

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) 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 National Institutes of Health (NIH) will 
publish periodic summaries of proposed projects to be submitted to the 
Office of Management and Budget (OMB) for review and approval.
    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 therapy. 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. The revised view of the value of hormone therapy to 
prevent chronic diseases has had a major impact on obstetrician-
gynecologists, who are among the principal health care providers for 
women and who now account for the majority of prescriptions for 
postmenopausal hormones. The investigators propose to survey fellows of 
ACOG over a four and a half year period. Objectives of the study are to 
evaluate the extent to which the WHI findings for estrogen plus 
progestin have been accepted by ACOG members, and what the effect has 
been on their prescription patterns. The initial two surveys will also 
form a baseline for two further surveys subsequent to the anticipated 
publication of the WHI estrogen-only trial results in 2005. The 
findings 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 from past 
practice, their concerns and informational and educational needs. The 
proposed surveys, performed over a period, will allow the investigators 
to track changes in knowledge, attitudes, and practice over a period of 
evolving knowledge among a representative sample of obstetrician-
gynecologists. The finding 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: 1825; Estimated Number of 
Responses per Respondent: 1; Average Burden Hours Per Response: 25, and 
Estimated Total Annual Burden Hours Requested: 456, The annualized 
costs to respondents is estimated at: $34,200. There are no Capital 
Costs to report. There are no Operating 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 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 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.

FOR FURTHER INFORMATION CONTACT: 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, NHLBI, NIH, Rockledge 1 Building, Suite 300, 6705 
Rocklege Drive, Bethesda, MD 20892, or call (301) 435-6669 (not a toll-
free number) or E-mail you 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 60-days 
of the date of this publication.

    Dated: October 28, 2003.
Jacques Rossouw,
NHLBI, National Institutes of Health.
[FR Doc. 03-28281 Filed 11-10-03; 8:45 am]
BILLING CODE 4140-01-M