[Federal Register Volume 67, Number 183 (Friday, September 20, 2002)]
[Notices]
[Pages 59294-59295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23873]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; Proposed Collection; 
Comment Request; Women's Health Initiative Observational Study

    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, Office of the 
Director, 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: Women's Health Initiative (WHI) Observational Study.
    Type of Information Collection Request: Revision OMB 0925-
0414 Exp: 05/03.
    Need for 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.
    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 as follows:

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                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total annual
               Type of respondents                   number of     responses per     hours per     burden hours
                                                    respondents     respondent       response        requested
----------------------------------------------------------------------------------------------------------------
OS Participants.................................          86,886          1.4059           .173           21,133
Next-of-kin.....................................           2,916               1           .0835             243
Physician's Office Staff........................              43               1           .0835               4
                                                 -----------------
    Total.......................................  ..............  ..............  ..............          21,380
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    The annualized cost burden is $213,948.
    There are no annual 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.
    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. Linda Pottern, Project Officer, Women's 
Health Initiative Program Office, 6705 Rockledge Drive, 1 Rockledge 
Centre, Suite 300, MSC 7966, Bethesda, MD 20892-7966, or call (301) 
402-2900 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 60 days 
of the date of this publication.

    Dated: September 11, 2002.
Jacques E. Rossouw,
Acting Director, Women's Health Initiative.
[FR Doc. 02-23873 Filed 9-19-02; 8:45 am]
BILLING CODE 4140-01-M