Proposed Rules. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2019-08198 · Docket No. FDA-2018-D-2074 · 21 CFR 7

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled “Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.” The draft guidance, if finalized, would establish guidance for industry and FDA staff regarding timely initiation of voluntary recalls of FDA-regulated products. The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations that firms in a distribution chain should consider making to ensure timely responses to a recall communication. In addition, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA.

Dates

Submit either electronic or written comments on the draft guidance by June 24, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Supplementary Information

I. Background FDA is announcing the availability of a draft guidance for industry and FDA staff entitled “Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.” The draft guidance, if finalized, would establish guidance for industry and FDA staff regarding timely initiation of voluntary recalls of FDA-regulated products under 21 CFR part 7, subpart C. The draft guidance is part of a larger effort FDA is undertaking to give additional guidance to industry and FDA staff regarding the execution and oversight of voluntary recalls under part 7, subpart C. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, if finalized, would represent the current thinking of FDA on “Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 7.45(c), 7.46(a), and 7.59 have been approved under OMB control number 0910-0249. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Dated: April 18, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019-08198 Filed 4-23-19; 8:45 am]