[Federal Register Volume 61, Number 236 (Friday, December 6, 1996)]
[Notices]
[Page 64750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31050]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0429]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Reinstatement
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 notice in the Federal Register
concerning each proposed collection of information, including each
proposed reinstatement of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on requirements for parties seeking an advisory
opinion from the Commissioner of Food and Drugs (the Commissioner).
DATES: Submit written comments on the collection of information by
February 4, 1997.
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: Denver Presley, 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: Under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520), Federal agencies must obtain approval from the
Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. ``Collection of information'' is
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the Paperwork Reduction Act (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, including
each proposed reinstatement of an existing collection of information,
before submitting the collection to OMB for approval. 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.
Advisory Opinions--21 CFR 10.85 (OMB Control Number 0910-0193--
Reinstatement)
Section 10.85 (21 CFR 10.85), issued under section 701(a) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(a),
provides that an interested person may request an advisory opinion from
the Commissioner on a matter of general applicability. Section 10.85
sets forth the format and instructions for making an advisory opinion
request. When making a request, the petitioner must provide a concise
statement of the issues and questions on which an opinion is requested
and a full statement of the facts and legal points relevant to the
request. An advisory opinion represents the formal position of FDA on a
matter of general applicability.
Respondents to this collection of information are parties seeking
an advisory opinion from the Commissioner on the agency's formal
position for matters of general applicability.
FDA estimates the burden of the collection of information
provisions for these regulations as follows:
Estimated Annual Reporting Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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10.85 8 1 8 16 128
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There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this collection of information is based on
agency data received on this administrative procedure for the past 3
years. Agency personnel responsible for the processing of requests for
an advisory opinion, estimate approximately eight requests are received
annually by the agency, each requiring an estimated 16 hours of
preparation time.
Dated: November 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31050 Filed 12-5-96; 8:45 am]
BILLING CODE 4160-01-F
