Proposed Rule2022-09232
The Accredited Third-Party Certification Program: Questions and Answers; Draft Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 29, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "The Accredited Third-Party Certification Program: Questions and Answers." The draft guidance, when finalized, will answer frequently asked questions relating to the requirements of the Accredited Third- Party Certification Program, and is intended to assist accreditation bodies', third-party certification bodies', and eligible entities' understanding of the regulation and program requirements.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 83 (Friday, April 29, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Proposed Rules]
[Pages 25432-25433]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09232]
[[Page 25432]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2022-D-0370]
The Accredited Third-Party Certification Program: Questions and
Answers; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``The Accredited Third-Party Certification Program: Questions and
Answers.'' The draft guidance, when finalized, will answer frequently
asked questions relating to the requirements of the Accredited Third-
Party Certification Program, and is intended to assist accreditation
bodies', third-party certification bodies', and eligible entities'
understanding of the regulation and program requirements.
DATES: Submit either electronic or written comments on the draft
guidance by July 28, 2022 to ensure that the Agency considers your
comment on the draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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-2022-D-0370 for ``The Accredited Third-Party Certification Program:
Questions and Answers.'' 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 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 draft guidance to
the Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Doriliz De Leon, Center for Food
Safety and Applied Nutrition (HFS-607), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 240-402-2772.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``The Accredited Third-Party Certification Program: Questions
and Answers.'' We are issuing the draft guidance consistent with our
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent 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 alternate approach if it
satisfies the requirements of the applicable statutes and regulations.
The FDA Food Safety Modernization Act (Pub. L. 111-353) added
section 808 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 384d), which directs FDA to establish a program for
accreditation of third-party certification bodies to conduct food
safety audits and to certify that eligible foreign food entities
(including registered foreign food facilities) and food produced by
such entities meet applicable FDA requirements for purposes of sections
801(q) (21 U.S.C. 381(q)) and 806 (21 U.S.C. 384b) of the FD&C Act. On
November 27, 2015, FDA issued the final rule, ``Accreditation of Third-
Party Certification Bodies to Conduct Food Safety Audits and to Issue
Certifications'' (also referred to as the TPP regulation) (80 FR 74569;
21 CFR part 1, subpart M). This draft guidance,
[[Page 25433]]
when finalized, will answer frequently asked questions relating to the
requirements of the Accredited Third-Party Certification Program
established in 21 CFR part 1, subpart M (21 CFR 1.600 through 1.695, 21
CFR 1.700 through 1.725), and is intended to assist the accreditation
bodies', third-party certification bodies', and eligible entities'
understanding of the TPP regulation and program requirements.
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. The previously approved collections of information are
subject to review by OMB under the PRA. The collections of information
under the TPP regulation in 21 CFR part 1, subpart M have been approved
under OMB control number 0910-0750.
III. Electronic Access
Persons with access to the internet may obtain the draft 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>. Use the FDA website
listed in the previous sentence to find the most current version of the
guidance.
Dated: April 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09232 Filed 4-28-22; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on April 29, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.