[Federal Register Volume 63, Number 177 (Monday, September 14, 1998)]
[Notices]
[Pages 49130-49131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24496]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0373]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; FDA Recall Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by
October 14, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
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: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
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 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
that 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.
In the Federal Register of June 9, 1998 (63 FR 31502), the agency
requested comments on the proposed collections of information. No
significant comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden 1
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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 1 1,712 1.8 3,082
7.46 and 7.49 1,712 1 1,712 4 6,848
7.53 1,712 1 1,712 36 61,632
7.55(b) 1,712 1 1,712 2 3,424
Totals 74,986
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\1\ There are no capital costs associated with this collection of information.
[[Page 49131]]
Due to a typographical error, the ``Annual Frequency per Response''
for 21 CFR 7.42, 7.46 and 7.49, 7.53, and 7.55(b) were reported as
``4'' in FDA's June 9, 1998, notice providing 60 days for public
comment on this collection of information. Therefore, the totals for
``Total Annual Responses'' and ``Total Hours'' were reported
incorrectly. Table 1 of this document reflects the correct annual
frequency per response, total annual responses and total burden hours.
Dated: September 3, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-24496 Filed 9-11-98; 8:45 am]
BILLING CODE 4160-01-F
