[Federal Register Volume 64, Number 172 (Tuesday, September 7, 1999)]
[Notices]
[Pages 48661-48662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23220]
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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: 06/00.
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
[[Page 48662]]
office staff. The annual reporting burden is as follows:
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Estimated Estimated
Estimated number of Average total annual
Type of respondents number of responses per burden hours burden hours
respondents respondent per response requested
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OS Participants................................. 82,044 .96876 .4557 36,219
Next-of-kin..................................... 2,741 1 .0835 229
Physician's Office Staff........................ 226 1 .0835 19
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Total................................... .............. .............. .............. 36,467
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The annualized cost burden is $365,428.
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 you request, including your address to:
Linda__Pottern@nih.gov.
Comments Due Date
Comments regarding this information collection are best assured of
having their full effect if received on or before November 8, 1999.
Dated: August 27, 1999.
Donald P. Christoferson,
Executive Officer, National Heart, Lung, and Blood Institute.
[FR Doc. 99-23220 Filed 9-3-99; 8:45 am]
BILLING CODE 4140-01-M
