[Federal Register Volume 62, Number 75 (Friday, April 18, 1997)]
[Notices]
[Pages 19121-19122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9993]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission of OMB Review; Comment Request; Women's Health
Initiative Observational Study
SUMMARY: Under the provisions of Section 3506(c)(2)(A) of the Paperwork
[[Page 19122]]
Reduction Act of 1995, the Office of the Director (OD), National
Institutes of Health (NIH), has submitted to the Office of Management
and Budget (OMB) a request for review and approval of the information
collection listed below. This proposed information collection was
previously published in the Federal Register on November 4, 1996
(Volume 61, Number 214, Page 56696) and allowed 60-days for public
comment. No public comments were received. The purpose of this notice
is to allow an additional 30 days for public comment. 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 control number.
PROPOSED COLLECTION: Title: Women's Health Initiative (WHI)
Observational Study. Type of Information Collection Request: Revision
of OMB #0925-0414. Exp: 6/30/97. Need for Use of Information
Collection: This study will be used by 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 cause of frailty, disability and health 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 physicians. The annual reporting burden is as
follows:
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Estimated Estimated
Estimated number of Average total
Type of respondents number of responses burden hours annual
respondents per per response hours
respondent requested
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OS Participants........................................... 100,000 1.06667 .819 87,360
Next-of-Kin............................................... 2,682 1 .0835 224
Physician................................................. 166 1 .0835 14
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Total............................................... ........... ............ ............ 87,598
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The annualized cost to respondents is: $876,525.
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 functions 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 through 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 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, D.C. 20503, Attention: Desk
Officer for NIH. to request more information on the proposed project or
to obtain a copy of the data collection plan and instruments, contact:
Dr. Loretta Finnegan, Women's Health Initiative Program Office, 7550
Rockville Pike, Room 6A09, Bethesda, Maryland 20892-9110 or call non-
toll-free number (301) 402-2900, or E-mail your request, including your
address to: .
COMMENTS DUE DATE: Comments regarding this information collection are
best assured of having their full effect if received on or before May
19, 1997.
Dated: March 11, 1997.
Stephen Benowitz,
Executive Officer, Office of the Director, NIH.
[FR Doc. 97-9993 Filed 4-17-97; 8:45 am]
BILLING CODE 4140-01-M
