[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
