[Federal Register Volume 73, Number 197 (Thursday, October 9, 2008)]
[Notices]
[Pages 59633-59634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23910]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0314]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recall Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 10, 2008.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to [email protected]. All comments
should be identified with the OMB control number 0910-0249. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
FDA Recall Regulations--21 CFR Part 7--(OMB Control Number 0910-0249--
Extension)
Section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371) and part 7, subpart C (21 CFR part 7, subpart C), set forth the
recall regulations (guidelines) and provide guidance to manufacturers
on recall responsibilities. The guidelines apply to all FDA regulated
products (i.e., food, including animal feed; drugs, including animal
drugs; medical devices, including in vitro diagnostic products;
cosmetics; and biological products intended for human use). These
responsibilities include: (1) developing a recall strategy that
requires time by the firm to determine the actions or procedures
required to manage the recall (Sec. 7.42); (2) providing FDA with
complete details of the recall including reason(s) for the removal or
correction, risk evaluation, quantity produced, distribution
information, firm's recall strategy, a copy of any recall
communication(s), and a contact official (Sec. 7.46); (3) notifying
direct accounts of the recall, providing guidance regarding further
distribution, giving instructions as to what to do with the product,
providing recipients with a ready means of reporting to the recalling
firm (Sec. 7.49); (4) submitting periodic status reports so that FDA
may assess the progress of the recall (status report information may be
determined by, among other things, evaluation return reply cards,
effectiveness checks, and product returns) (Sec. 7.53); and (5)
providing the opportunity for a firm to request in writing that FDA
terminate the recall (Sec. 7.55).
A search of the FDA database was performed to determine the number
of recalls that took place during fiscal year 2007. The resulting
number of recalls from this database search (2,166) is used in
estimating the current annual reporting burden for this report. FDA
[[Page 59634]]
estimates the total annual industry burden to collect and provide the
previous information to 216,600 burden hours.
Table 1 of this document is a summary of the estimated annual
burden hours for recalling firms (manufacturers, processors, and
distributors) to comply with the voluntary reporting requirements of
FDA's recall regulations.
In the Federal Register of June 3, 2008 (73 FR 31696), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Recognizing that there may be a vast difference in the information
collection and reporting time involved in different recalls of FDA's
regulated products, FDA estimates on average the burden of collection
for recall information to be as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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Recall 2,166 1 2,166 20 43,320
strategy 7.42
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Firm initiated 2,166 1 2,166 30 64,980
recall and
recall
communication
s 7.46 and
7.49
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Recall status 2,166 4 8,664 10 86,640
reports and
followup 7.53
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Termination of 2,166 1 2,166 10 21,660
a recall
7.55(b)
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Total 216,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The annual reporting burdens are explained as follows:
Reporting
A. Recall Strategy
Request firms develop a recall strategy including provision for
public warnings and effectiveness checks. Under this portion of the
collection of information, the agency estimates it will receive 2,166
responses annually.
B. Firm Initiated Recall and Recall Communications
Request firms voluntarily remove or correct foods and drugs (human
or animal), cosmetics, medical devices, and biologicals to immediately
notify the appropriate FDA district office of such actions. The firm is
to provide complete details of the recall reason, risk evaluation,
quantity produced, distribution information, firms' recall strategy and
a contact official as well as requires firms to notify their direct
accounts of the recall and to provide recipients with a ready means of
reporting to the recalling firm. Under these portions of the collection
of information, the agency estimates it will receive 2,166 responses
annually for each.
C. Recall Status Reports
Request that recalling firms provide periodic status reports so FDA
can ascertain the progress of the recall. This collection of
information will generate approximately 8,664 responses annually.
D. Termination of a Recall
Provide the firms an opportunity to request in writing that FDA end
the recall. The agency estimates it will receive 2,166 responses
annually.
Dated: October 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23910 Filed 10-8-08; 8:45 am]
BILLING CODE 4160-01-S