Document ID: FDA-2008-N-0314-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recall Regulations
Posted Date: 2008-10-09T04:00Z

[Federal Register: October 9, 2008 (Volume 73, Number 197)]
[Notices]               
[Page 59633-59634]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09oc08-88]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 10, 2008.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0249. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT:  Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 part 7, subpart C (21 CFR part 7, subpart C), set forth the 
recall regulations (guidelines) and provide 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: (1) developing a recall strategy that 
requires time by the firm to determine the actions or procedures 
required to manage the recall (Sec.  7.42); (2) 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 (Sec.  7.46); (3) 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); (4) 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) (Sec.  7.53); and (5) 
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 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

[[Page 59634]]

estimates the total annual industry burden to collect and provide the 
previous information to 216,600 burden hours.
    Table 1 of this document 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.
    In the Federal Register of June 3, 2008 (73 FR 31696), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    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
----------------------------------------------------------------------------------------------------------------
Recall                      2,166                     1              2,166                 20             43,320
 strategy 7.42
----------------------------------------------------------------------------------------------------------------
Firm initiated              2,166                     1              2,166                 30             64,980
 recall and
 recall
 communication
 s 7.46 and
 7.49
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Recall status               2,166                     4              8,664                 10             86,640
 reports and
 followup 7.53
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Termination of              2,166                     1              2,166                 10             21,660
 a recall
 7.55(b)
----------------------------------------------------------------------------------------------------------------
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:

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 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.

    Dated: October 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23910 Filed 10-8-08; 8:45 am]

BILLING CODE 4160-01-S