[Federal Register Volume 74, Number 48 (Friday, March 13, 2009)]
[Notices]
[Pages 10944-10945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5521]


-----------------------------------------------------------------------

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

[[Page 10945]]

listed below. This proposed information collection was previously 
published in the Federal Register on December 30, 2008, page 79889-
79890 and allowed 60-days for public comment. One comment was received 
and appropriate response was made. 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 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
------------------------------------------------------------------------
                                                                  Annual
    Type of         Number of      Frequency of    Average hours   hour
    response       respondents       response      per response   burden
------------------------------------------------------------------------
  Observational         63,230            1.1              .3383  23,509
           Study
    Participants
 Next of Kin\1\          1,163            1                 .083   97
    Health Care              9            1                 .083  .77
    Providers\1\
                --------------------------------------------------------
    Total......         64,402    ..............  ..............  23,607
------------------------------------------------------------------------
\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 $377,725. 
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, Suite 10018, MSC 7936, Bethesda, MD 20892-7936, 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 2, 2009.
Michael S. Lauer,
Director, Division of Prevention and Population Sciences, NHLBI, 
National Institutes of Health.

    Dated: March 3, 2009.
Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of Health.
 [FR Doc. E9-5521 Filed 3-12-09; 8:45 am]
BILLING CODE 4140-01-P