Rule2022-04704
Initiation of Voluntary Recalls; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
March 4, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 This guidance finalizes the draft guidance of the same title issued on April 24, 2019.
Full Text
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<title>Federal Register, Volume 87 Issue 43 (Friday, March 4, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#f6a693829384d8b0998eb6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="4010253425326e062f38002624216e2828336e272f36">[email protected]</span></a>.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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