[Federal Register Volume 68, Number 211 (Friday, October 31, 2003)]
[Notices]
[Pages 62090-62091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27387]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0476]


Guidance for Industry on Product Recalls, Including Removals and 
Corrections; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document for industry entitled ``Product 
Recalls, Including Removals and Corrections.'' This document provides 
members of industry regulated by FDA with guidance for handling all 
aspects of product recalls, including removals and corrections. The 
guidance applies to the recalls of all FDA-regulated products.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of ``Product 
Recalls, Including Removals and Corrections'' to the Food and Drug 
Administration, Office of Enforcement, Division of Compliance 
Management and Operations (HFC-210), 1350 Piccard Dr., Rockville, MD 
20850. Requests should be identified with the docket number found in 
brackets in the heading of this document. For documents without a 
docket number, include the title of the guidance document. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. You may fax your request to 301-827-0342. Submit written 
comments on the guidance to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Comments may be submitted at any time. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: Willie R. Bryant, Jr., Senior Recall 
Officer, Division of Compliance Management and Operations (HFC-210), 
Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 
301-827-0391.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance document that 
provides the agency's recommendations to members of FDA-regulated 
industry for the handling of product recalls. This document sets forth 
the agency's existing practices in recommending procedures for 
addressing all aspects of product recalls, including removals and 
corrections. The cooperation of manufacturers and distributors in 
expediting recall activities is vital. The recalling firm's 
notification of the local FDA District Recall Coordinator and 
submission of recall information outlined in the guidance allows FDA 
the opportunity to review, comment, offer assistance, and monitor the 
recall process.

II. Significance of Guidance

    This is a level 2 guidance issued consistent with FDA's good 
guidance practices regulation (Sec.  10.115 (21 CFR 10.115)). The 
agency is implementing this guidance document immediately in accordance 
with Sec.  10.115(g)(4)(i)(B) and inviting public comment in accordance 
with Sec.  10.115(g)(4)(i)(C). This guidance represents the agency's 
current thinking on product recalls, including removals and 
corrections. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternate 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining an electronic copy of the guidance 
may do so using the Internet. ORA maintains an entry on the Internet 
for easy access to information, including recent publications, consumer 
information references, compliance and inspection references, and 
recall information (model recall letters and press releases) that may 
be downloaded to a personal computer with Internet access. The ORA home 
page may be accessed at http://www.fda.gov/ora/. A search capability 
for all ORA guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available at http://www.fda.gov/ohrms/dockets.

[[Page 62091]]

IV. Paperwork Reduction Act

    The information collection requirements in this guidance have been 
approved under 21 CFR part 7, Office of Management and Budget (OMB) 
control number 0910-0249, which expires on October 31, 2004.

V. Comments

    Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. For 
documents without a docket number, include the title of the guidance 
document. The guidance and received comments are available for public 
examination in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

VI. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/ora or http://www.fda.gov/ohrms/dockets/default.

    Dated: October 22, 2003.
John R. Marzilli,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 03-27387 Filed 10-30-03; 8:45 am]
BILLING CODE 4160-01-S