[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Notices]
[Pages 34846-34847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16884]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0158]

Agency Information Collection Activities; Proposed Collection; 
Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995, 
Federal agencies are required to publish a notice in the Federal 
Register concerning each collection of information and to allow 60 days 
for public comment in response to the notice. This notice solicits 
comments on a survey of hormone replacement therapy (HRT) among women 
with a previous diagnosis of endometrial cancer.

DATES: Submit written comments on the collection of information by 
September 3, 1996.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information. ``Collection of information'' 
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information listed below.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
Survey of HRT Among Women With A Previous Diagnosis of Endometrial 
Cancer
    Under FDA's statutory authority to conduct and sponsor research (21 
U.S.C.

[[Page 34847]]

393(b)(2)(C) and 42 U.S.C. 300u-1), FDA and the Fred Hutchinson Cancer 
Research Center in Seattle, WA, have jointly designed a study involving 
a written survey to be completed by women with a previous diagnosis of 
endometrial cancer. The study will evaluate the occurrence of 
menopausal vasomotor symptoms (``hot flashes'') among these women, and 
the extent to which they have used HRT, either as therapy for 
menopausal symptoms or for other reasons. (``Hormone replacement 
therapy'' means treatment with estrogen alone or with a combination of 
estrogen and progestogen.)
FDA estimates the burden of this survey as follows:

                                        ESTIMATED ANNUAL REPORTING BURDEN                                       
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                        Annual Frequency per       Total Annual                                                 
  No. of Respondents          Response              Responses          Hours per Response        Total Hours    
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575..................            1                    575                       .5                 288          
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There are no capital costs or operating and maintenance costs associated with this collection.                  


    Dated: June 26, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-16884 Filed 7-2-96; 8:45 am]
BILLING CODE 4160-01-F