[Federal Register Volume 71, Number 39 (Tuesday, February 28, 2006)]
[Notices]
[Page 10039]
From the Federal Register Online via the Government Publishing 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:

----------------------------------------------------------------------------------------------------------------
                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total annual
               Type of respondents                   number of     responses per     hours per     burden hours
                                                    respondents     respondent       response        requested
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    Total.......................................          87,273  ..............  ..............          18,319
----------------------------------------------------------------------------------------------------------------

    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: [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: 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