[Federal Register Volume 63, Number 110 (Tuesday, June 9, 1998)]
[Notices]
[Pages 31502-31503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15339]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0373]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 Recall Regulations under 
21 CFR part 7. Recall guidelines set forth procedures to be used by 
manufacturers and distributors or other responsible persons in 
notifying or alerting health professionals or other persons of an 
unreasonable risk of substantial harm to the public's health and 
describe the procedures used or required by FDA in the recall process.

DATES: Submit written comments on the collection of information by 
August 10, 1998.
ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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 listed below.
     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 (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

[[Page 31503]]

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 which 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.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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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               4           6,848               1.8        12,326       
7.46 and 7.49                       1,712               4           6,848               4          27,392       
7.53                                1,712               4           6,848              36         246,528       
7.55(b)                             1,712               4           6,848               2          13,696       
Total                                                                                             299,942       
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 3, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15339 Filed 6-8-98; 8:45 am]
BILLING CODE 4160-01-F