[Federal Register Volume 63, Number 110 (Tuesday, June 9, 1998)]
[Notices]
[Pages 31502-31503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15339]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0373]
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
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on FDA Recall Regulations under
21 CFR part 7. Recall guidelines set forth procedures to be used by
manufacturers and distributors or other responsible persons in
notifying or alerting health professionals or other persons of an
unreasonable risk of substantial harm to the public's health and
describe the procedures used or required by FDA in the recall process.
DATES: Submit written comments on the collection of information by
August 10, 1998.
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: JonnaLynn P. Capezzuto, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: Under the PRA (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 PRA (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 extension 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.
FDA Recall Regulations--Part 7 (21 CFR Part 7), Subpart C--(OMB
Control Number 0910-0249--Extension)
These regulations were established to provide guidance to
manufacturers on recall responsibilities. These responsibilities
include development of a recall strategy; providing complete details of
the recall reason, risk evaluation, quantity produced, distribution
information, firm's recall
[[Page 31503]]
strategy and a contact official; notifying direct accounts of the
recall and to provide recipients with a ready means of reporting to the
recalling firm; provide periodic status reports so FDA can assess the
progress of the recall. The recall provisions provide the information
necessary for FDA to monitor recalls and assess the adequacy of a
firm's efforts in a recall. It also permits FDA to evaluate whether a
recall has been completed in a manner which assures that unreasonable
risk of substantial harm to the public health has been eliminated. The
guidelines apply to all regulated products (i.e., food, including
animal feed; drugs, including animal drugs; medical devices, cosmetics;
and biological products intended for human use.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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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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7.42 1,712 4 6,848 1.8 12,326
7.46 and 7.49 1,712 4 6,848 4 27,392
7.53 1,712 4 6,848 36 246,528
7.55(b) 1,712 4 6,848 2 13,696
Total 299,942
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 3, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15339 Filed 6-8-98; 8:45 am]
BILLING CODE 4160-01-F