[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