[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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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