Federal Register, Volume 73 Issue 107 (Tuesday, June 3, 2008)

[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31696-31697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12339]

[[Page 31696]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0314]

Agency Information Collection Activities; Proposed Collection;
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 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's recall regulations and
provides guidance to manufacturers on recall responsibilities.

DATES: Submit written or electronic comments on the collection of
information by August 4, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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 set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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--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 21 CFR part 7, subpart C, set forth the recall regulations
(guidelines) and provides 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 development of a recall strategy that requires time by the firm
to determine the actions or procedures required to manage the recall
(21 CFR 7.42); 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 (21 CFR
7.46); 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 (21 CFR 7.49); 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 (21 CFR 7.53);
and providing the opportunity for a firm to request in writing that FDA
terminate the recall (21 CFR 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
estimates the total annual industry burden to collect and provide the
previous information to 216,600 burden hours.
The following table 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.
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 Strategy 2,166 1 2,166 20 43,320
7.42
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Firm Initiated 2,166 1 2,166 30 64,980
Recall and
Recall
Communications
7.46 and 7.49
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[[Page 31697]]

Recall Status 2,166 4 8,664 10 86,640
Reports and
Follow-up 7.53
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Termination of a 2,166 1 2,166 10 21,660
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:

I. 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 the
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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12339 Filed 6-2-08; 8:45 am]
BILLING CODE 4160-01-S