[Federal Register Volume 64, Number 172 (Tuesday, September 7, 1999)]
[Notices]
[Pages 48661-48662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23220]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; Proposed Collection; 
Comment Request; Women's Health Initiative Observational Study

SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, Office of the Director, the 
National Heart, Lung, and Blood Institute (NHLBI), the National 
Institutes of Health (NIH) will publish periodic summaries of proposed 
projects to be submitted to the Office of Management and Budget (OMB) 
for review and approval.

Proposed collection

    Title: Women's Health Initiative (WHI) Observational Study. Type of 
Information Collection Request: Revision OMB #0925-0414 exp: 06/00. 
Need for 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

[[Page 48662]]

office staff. The annual reporting burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                                                     Estimated                       Estimated
                                                     Estimated       number of        Average      total annual
               Type of respondents                   number of     responses per   burden hours    burden hours
                                                    respondents     respondent     per response      requested
----------------------------------------------------------------------------------------------------------------
OS Participants.................................          82,044          .96876           .4557          36,219
Next-of-kin.....................................           2,741         1                 .0835             229
Physician's Office Staff........................             226         1                 .0835              19
                                                 ---------------------------------------------------------------
        Total...................................  ..............  ..............  ..............          36,467
----------------------------------------------------------------------------------------------------------------

    The annualized cost burden is $365,428.
    There are no annual 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.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans 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 you request, including your address to: 
Linda__P[email protected].

Comments Due Date

    Comments regarding this information collection are best assured of 
having their full effect if received on or before November 8, 1999.

    Dated: August 27, 1999.
Donald P. Christoferson,
Executive Officer, National Heart, Lung, and Blood Institute.
[FR Doc. 99-23220 Filed 9-3-99; 8:45 am]
BILLING CODE 4140-01-M