Document ID: FDA-2016-D-3548-0013
Agency: fda
Document Type: Notice
Title: Public Warning and Notification of Recalls; Guidance for Industry and FDA Staff; Availability
Posted Date: 2019-02-08T05:00Z

[Federal Register Volume 84, Number 27 (Friday, February 8, 2019)]
[Notices]
[Pages 2876-2877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01603]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3548]

Public Warning and Notification of Recalls; Guidance for Industry 
and FDA Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a final guidance for industry and FDA staff entitled 
``Public Warning and Notification of Recalls.'' The guidance 
establishes guidance for industry and FDA staff regarding the use, 
content, and circumstances for issuance of public warnings and public 
notification of recalls under federal regulations. The intent of the 
guidance is to increase and expedite the appropriate and accurate use 
of public warnings and public notification and to increase public 
health protection by better informing the public about violative 
products being recalled. The guidance clarifies and supplements 
existing policy for industry and FDA staff regarding the use of public 
warnings and public notification.

DATES: The announcement of the guidance is published in the Federal 
Register on February 8, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or

[[Page 2877]]

confidential business information, such as a manufacturing process. 
Please note that if you include your name, contact information, or 
other information that identifies you in the body of your comments, 
that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-3548 for ``Public Warning and Notification of Recalls '' 
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.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on this guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the 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 guidance 
document.

FOR FURTHER INFORMATION CONTACT: For questions or information regarding 
this document, contact Chris Henderson, Office of Regulatory Affairs, 
Office of Strategic Planning and Operational Policy, Human and Animal 
Food Policy Branch, Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20857, 240-402-8186, Christopher.henderson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry and 
FDA staff entitled ``Public Warning and Notification of Recalls under 
21 CFR part 7, subpart C.'' We are issuing this guidance consistent 
with our good guidance practices regulation (21 CFR 10.115). The 
guidance represents the current thinking of FDA on this topic. 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.
    In the Federal Register of January 19, 2018 (83 FR 2758), we made 
available a draft guidance for industry and FDA Staff entitled ``Public 
Warning and Notification of Recalls under 21 CFR part 7, subpart C, 
Draft Guidance for Industry and FDA staff'' and gave interested parties 
an opportunity to submit comments by March 20, 2018, for us to consider 
before beginning work on the final version of the guidance. We received 
comments on the draft guidance. We considered every comment and made 
changes, where appropriate. The guidance announced in this notice 
finalizes the draft guidance dated January 17, 2018.
    The guidance establishes official guidance for industry and FDA 
staff regarding the use, content, and circumstances for issuance of 
public warnings and public notification of recalls under 21 CFR part 7, 
subpart C. The intent of the guidance is to increase and expedite the 
appropriate and accurate use of public warnings and public notification 
and to increase public health protection by better informing the public 
about violative products being recalled. The guidance clarifies and 
supplements existing policy for industry and FDA staff regarding the 
use of public warnings and public notification.

II. Paperwork Reduction Act of 1995

    This 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, such as a firm's public warning 
(21 CFR 7.42(b)(2)), has 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/Safety/Recalls/default.htm or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01603 Filed 2-7-19; 8:45 am]
 BILLING CODE 4164-01-P