[Federal Register Volume 75, Number 65 (Tuesday, April 6, 2010)]
[Notices]
[Pages 17411-17412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7741]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Women's Health
Initiative Observational Study
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the Director, the National Heart,
Lung, and Blood Institute (NHLBI), the 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 January 20, 2010, page 3237 and allowed 60 days
for public comment. Two comments were received and appropriate
responses were given. 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
current valid OMB control number.
Proposed Collection: Title: Women's Health Initiative (WHI)
Observational Study. Type of Information Collection Request: REVISION:
OMB No. 0925-0414, Expiration date: 05/31/2009. Need and 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. Continuation of follow-up years for
ascertainment of medical
[[Page 17412]]
history update forms will provide essential data for outcomes
assessment for this population of aging women. Frequency of Response:
Annually. Affected Public: Individuals and physicians. Type of
Respondents: Women, next-of-kin, and physician's office staff. The
annual reporting burden is as follows:
Estimate of Annual Hour Burden
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Number of Frequency of Average hours Annual hour
Type of response respondents response per response burden
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Observational Study Participants................ 42,550 1.12 .4155 19,801
Next of Kin\1\.................................. 941 1 .083 78
Health Care Providers\1\........................ 8 1 .085 .68
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Total....................................... 43,499 .............. .............. 19,880
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\1\ Annual burden is placed on health care providers and respondent relatives/informants through requests for
information which will help in the compilation of the number and nature of new fatal and nonfatal events.
The annualized cost burden to respondents is estimated at $397,617.
There are no 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.
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, [email protected] or by fax to 202-395-6974,
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: Shari Eason Ludlam, Project Officer, Women's
Health Initiative Program Office, 6701 Rockledge Drive, 2 Rockledge
Centre, Room 9188, MSC 7913, Bethesda, MD 20892-7936, or call non-toll-
free number (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 30 days
of the date of this publication.
Dated: March 23, 2010.
Michael S. Lauer,
Director, Division of Cardiovascular Science, NHLBI, National
Institutes of Health.
Dated: March 24, 2010.
Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of Health.
[FR Doc. 2010-7741 Filed 4-5-10; 8:45 am]
BILLING CODE 4140-01-P