[Federal Register Volume 68, Number 58 (Wednesday, March 26, 2003)]
[Notices]
[Page 14669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; 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 September 20, 2002, page 59294 and allowed 60-
days for public comment. No public comments were received. The purpose 
of this notice is to allow an additional 39 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: 05/31/2003. 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. 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 as 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.................................          86,886          1.4084         0.17042          20,855
Next-of-kin.....................................           2,916               1          0.0835             243
Physician's Office Staff........................              43               1          0.0835               4
                                                 -----------------
    Total.......................................          89,845  ..............  ..............          21,102
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    The annualized cost burden to respondents is estimated at $211,180. 
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 time, 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, 6705 Rockledge Drive, 1 Rockledge 
Centre, Suite 300, MSC 7966, Bethesda, MD 20892-7966, or call (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 13, 2003.
Jacques E. Rossouw,
Lead Project Officer, Women's Health Initiative.
[FR Doc. 03-7154 Filed 3-25-03; 8:45 am]
BILLING CODE 4140-01-M