[Federal Register Volume 66, Number 84 (Tuesday, May 1, 2001)]
[Notices]
[Pages 21767-21768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10707]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0174]


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 
(guidelines) and provides guidances to manufacturers on recall 
responsibilities.

DATES: Submit written or electronic comments on the collection of 
information by July 2, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
via the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. Submit written comments on the collection of 
information to the Dockets Management Branch (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: 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 set forth in this document.
    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 (Subpart C) (21 CFR Part 7 (Subpart 
C))--(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 sets 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 
(Sec. 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, 
copy of any recall communication(s), and a contact official 
(Sec. 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 (Sec. 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, evaluating 
return reply cards, effectiveness checks and product returns 
(Sec. 7.53); and 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 2000. The resulting 
number of recalls from this database search (1,933) is used in 
estimating the current annual reporting burden for this report. FDA 
estimates the total annual industry burden to collect and provide the 
above information to 84,665 burden hours.
    The following is a summary of the estimated annual burden hours for 
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 as follows:

[[Page 21768]]



                                 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                                1,933               1           1,933               1.8         3,479
7.46 and 7.49                       1,933               1           1,933               4.0         7,732
7.53                                1,933               1           1,933              36.0        69,588
7.55(b)                             1,933               1           1,933               2.0         3,866
                                                                                                 ---------------
  Total                                                                                            84,665
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: April 24, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-10707 Filed 4-30-01; 8:45 am]
BILLING CODE 4160-01-S