[Federal Register: October 31, 2003 (Volume 68, Number 211)]
[Notices]
[Page 62090-62091]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc03-71]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/ A search capability for all ORA guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/.
guidance.html. Guidance documents are also available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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