Source: https://www.federalregister.gov/documents/2018/01/19/2018-00918/public-warning-and-notification-of-recalls-under-21-cfr-part-7-subpart-c-draft-guidance-for-industry
Timestamp: 2019-10-15 23:38:19
Document Index: 267475261

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Federal Register :: Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
A Proposed Rule by the Food and Drug Administration on 01/19/2018
83 FR 2758
2758-2759 (2 pages)
2018-00918
FDA-2016-D-3548
https://www.federalregister.gov/d/2018-00918 https://www.federalregister.gov/d/2018-00918
This PDF is the current document as it appeared on Public Inspection on 01/18/2018 at 8:45 am.
Start Preamble Start Printed Page 2758
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA Staff.” The draft guidance, when finalized, establishes official guidance for industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notification of voluntary recalls under Federal regulations. The intent of the draft guidance is to increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about violative products being recalled. The draft guidance clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.
Instructions: All submissions received must include the Docket No. FDA-2016-D-3548 for “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA Staff.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Submit written requests for single copies of the draft guidance to the Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Building, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.
Chris Henderson, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240-402-8186, Christopher.henderson@fda.hhs.gov.
FDA is announcing the availability of a draft guidance for industry and FDA staff entitled “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C.” The draft guidance, when finalized, will establish official guidance for industry and FDA staff regarding the use, content, and timing of public warnings and public notification of recalls under part 7 (21 CFR part 7). 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.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on public warnings and notification of recalls. It does not establish any rights for any person and is not binding on Start Printed Page 2759FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866.
This draft guidance refers to previously approved collections of information that 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). Any collection of information, including a firm's public warning (§ 7.42(b)(2)), has been approved under OMB control number 0910-0249.
Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/​Safety/​Recalls/​default.htm or https://www.regulations.gov.
Dated: January 16, 2018.
[FR Doc. 2018-00918 Filed 1-18-18; 8:45 am]