Food and Drug Administration, HHS.
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.
Submit written or electronic comments on agency guidances at any time.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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 (§ 10.115 (21 CFR 10.115)). The agency is implementing this guidance document immediately in accordance with § 10.115(g)(4)(i)(B) and inviting public comment in accordance with § 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.Start Printed 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.
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 AccessStart Signature
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