Document ID: FDA-2018-D-2074-0020
Agency: fda
Document Type: Rule
Title: Initiation of Voluntary Recalls; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2022-03-04T05:00Z

[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Rules and Regulations]
[Pages 12401-12402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04704]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 7

[Docket No. FDA-2018-D-2074]

Initiation of Voluntary Recalls; Guidance for Industry and Food 
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a final guidance for industry and FDA 
staff entitled ``Initiation of Voluntary Recalls Under 21 CFR part 7, 
subpart C.'' The guidance for industry and FDA staff provides guidance 
on timely initiation of voluntary recalls of FDA-regulated products. It 
also discusses preparations that firms in a distribution chain should 
consider making to ensure timely responses to a recall communication. 
In addition, the guidance 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 (FD&C Act) and other laws administered by FDA. This 
guidance finalizes the draft guidance of the same title issued on April 
24, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on March 4, 2022.

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 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-2018-D-2074 for ``Initiation of Voluntary Recalls Under 21 CFR part 
7, subpart C.'' 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, 240-402-7500.
     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

[[Page 12402]]

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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any 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 Bldg., Rm. 4141, Rockville, MD 20857. Send two self-addressed 
adhesive labels to assist that office in processing your request. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance.

FOR FURTHER INFORMATION CONTACT: Peter Fox, Office of Regulatory 
Affairs, Office of Strategic Planning and Operational Policy, Food and 
Drug Administration, 12420 Parklawn Dr., Element Bldg., Rm. 4146, 
Rockville, MD 20857, 240-402-1857, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Initiation of Voluntary Recalls Under 21 CFR part 
7, subpart C.'' The guidance for industry and FDA staff provides 
guidance on timely initiation of voluntary recalls of FDA-regulated 
products. The 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 recall communications. In addition, the guidance discusses 
how FDA assists firms with carrying out their recall responsibilities 
to protect the public health from distributed products in violation of 
the FD&C Act and other laws administered by FDA.
    This guidance finalizes the draft guidance of the same title issued 
on April 24, 2019 (84 FR 17112). FDA considered comments received on 
the draft guidance as the guidance was finalized. In addition to 
editorial changes made to improve clarity, changes from the draft to 
the final guidance include the addition of the terms correction and 
market withdrawal to the terminology section, the addition of language 
encouraging the use of electronic communications for conveying 
voluntary recall communications about FDA-regulated products, and the 
deletion of section IV (``References'').
    This guidance is being issued consistent with FDA's 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR 7.46, 7.49, and 7.59 have been approved under 
OMB control number 0910-0249; section 417 of the FD&C Act (21 U.S.C. 
350f) has been approved under OMB control number 0910-0643; section 761 
of the FD&C Act (21 U.S.C. 379aa-1) has been approved under OMB control 
number 0910-0291; 21 CFR 107.240 has been approved under OMB control 
number 0910-0188; 21 CFR part 117 has been approved under OMB control 
number 0910-0751; and 21 CFR part 507 has been approved under OMB 
control number 0910-0751.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov.

    Dated: February 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04704 Filed 3-3-22; 8:45 am]
BILLING CODE 4164-01-P