[Federal Register Volume 71, Number 39 (Tuesday, February 28, 2006)]
[Notices]
[Page 10039]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1844]
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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 November 7, 2005, page 67494 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 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: 4/30/2006.
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.
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 an 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
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OS Participants................................. 85,786 1.01 .21 18,195
Next-of-kin..................................... 1,483 1 .0835 124
Physician's Office Staff........................ 4 1 .0835 .33
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Total....................................... 87,273 .............. .............. 18,319
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The annualized cost burden to respondents is estimated at $293,112.
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 item(s) contained in
this notice, especially regarding the estimated public burden and
associated response item, should be directed to: The Office of
Management and Budget, Office of Regulatory Affairs, New Executive
Office Building, Room 10235, Washington, DC 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. Linda Pottern, Project Officer, Women's Health Initiative Program
Office, 6701 Rockledge Drive, 2 Rockledge Centre, Suite 8204, MSC 7935,
Bethesda, MD 20892-7935, or call 301-402-2900 or E-mail your request,
including your address to: pottern1@mail.nih.gov.
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: February 17, 2006.
Linda Pottern,
Project Officer, Women's Health Initiative Women Health Initiative
Program Office National Institutes of Health.
[FR Doc. 06-1844 Filed 2-27-06; 8:45 am]
BILLING CODE 4140-01-M