[Federal Register Volume 78, Number 104 (Thursday, May 30, 2013)]
[Notices]
[Pages 32406-32407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12815]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day 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 National Heart, Lung, and Blood Institute
(NHLBI), 0020, the National Institutes of Health, 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 February
5, 2013 on pages 8152-8153 and allowed 60-days for public comment. One
comment was received and an appropriate response was made. The purpose
of this notice is to allow an additional 30 days for public comment.
The NHLBI, 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.
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: NIH Desk Officer.
[[Page 32407]]
DATES: Comment 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.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, or request more information on the
proposed project 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 (301)
402-2900 or Email your request, including your address to:
[email protected]. Formal requests for additional plans and
instruments must be requested in writing.
Proposed Collection: Women's Health Initiative Observational Study.
Revision- OMB No. 0925-0414, Expiration Date: 07/31/2013. National
Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health
(NIH).
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 history update forms will provide
essential data for outcomes assessment for this population of aging
women.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time, which is estimated at $308,218 for
all respondents. The total estimated annualized burden hours are
13,927.
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Number of Average burden
Type of respondent* Number of responses per per response Total annual
respondents response (in hours) burden hours
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OS Participants................................. 41,495 1 20/60 13,832
Next of kin..................................... 936 1 6/60 94
Physician/Office Staff.......................... 17 1 5/60 1
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* 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.
Dated: May 14, 2013.
Michael S. Lauer,
Director, Division of Cardiovascular Sciences, NHLBI, National
Institutes of Health.
Lynn W. Susulske,
Government Information Specialist, Freedom of Information and Privacy
Act Branch, NHLBI, National Institutes of Health.
[FR Doc. 2013-12815 Filed 5-29-13; 8:45 am]
BILLING CODE 4140-01-P