Notice2023-16645
Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry; Availability
Primary source
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Published
August 4, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Waivers, Exceptions, and Exemptions from the Requirements of section 582 of the Federal Food, Drug, and Cosmetic Act." This guidance describes the process an authorized trading partner or other stakeholder should use to request a waiver, exception, or exemption from the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as the factors FDA intends to consider when evaluating such requests from an authorized trading partner or other stakeholder, and when determining FDA-initiated exceptions and exemptions. Additionally, this guidance describes the process the FDA intends to follow once every 2 years to review and make determinations on the appropriateness of renewing a previously approved waiver, exception, or exemption, where applicable. This guidance finalizes the draft guidance of the same title issued on May 9, 2018.
Full Text
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<title>Federal Register, Volume 88 Issue 149 (Friday, August 4, 2023)</title>
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[Federal Register Volume 88, Number 149 (Friday, August 4, 2023)]
[Notices]
[Pages 51842-51844]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16645]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1434]
Waivers, Exceptions, and Exemptions From the Requirements of
Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Waivers,
Exceptions, and Exemptions from the Requirements of section 582 of the
Federal Food, Drug, and Cosmetic Act.'' This guidance describes the
process an authorized trading partner or other stakeholder should use
to request a waiver, exception, or exemption from the requirements of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as the
factors FDA intends to consider when evaluating such requests from an
authorized trading partner or other stakeholder, and when determining
FDA-initiated exceptions and exemptions. Additionally, this guidance
describes the process the FDA intends to follow once every 2 years to
review and make determinations on the appropriateness of renewing a
previously approved waiver, exception, or exemption, where applicable.
This guidance finalizes the draft guidance of the same title issued on
May 9, 2018.
DATES: The announcement of the guidance is published in the Federal
Register on August 4, 2023.
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-1434 for ``Waivers, Exceptions, and Exemptions from the
Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act
Guidance for Industry.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at
[[Page 51843]]
<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 this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. 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: Lysette Deshields, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130,
<a href="/cdn-cgi/l/email-protection#6c081e190b181e0d0f070d0208181e0d0f092c0a080d4204041f420b031a"><span class="__cf_email__" data-cfemail="88ecfafdeffcfae9ebe3e9e6ecfcfae9ebedc8eeece9a6e0e0fba6efe7fe">[email protected]</span></a>; or Anne Taylor, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Waivers, Exceptions, and Exemptions from the Requirements of
section 582 of the Federal Food, Drug, and Cosmetic Act.'' The Food
Drug and Cosmetic Act, as amended by the Drug Supply Chain Security Act
(DSCSA), outlines critical steps to enhance drug distribution security.
These steps will ultimately allow tracing of certain human finished
prescription drugs in an electronic, interoperable manner as they are
distributed within the United States. Section 582 of the FD&C Act (21
U.S.C. 360eee-1), as amended by the DSCSA, applies to manufacturers,
repackagers, wholesale distributors, and dispensers (collectively
referred to as ``trading partners'') who engage in transactions of
product, and outlines requirements related to product tracing,
verification, product identification, and authorized trading partners.
Section 582(a)(3)(A) of the FD&C Act requires FDA to issue a
guidance that: (1) establishes a process by which an authorized
manufacturer, repackager, wholesale distributor, or dispenser may
request a waiver from any of the requirements set forth in section 582
of the FD&C Act, which the Secretary of HHS (Secretary) may grant if
the Secretary determines that such requirements would result in an
undue economic hardship or for emergency medical reasons, including a
public health emergency declaration pursuant to section 319 of the
Public Health Service Act; (2) establishes a process by which the
Secretary determines exceptions, and a process through which a
manufacturer or repackager may request such an exception, to the
requirements relating to product identifiers if a product is packaged
in a container too small or otherwise unable to accommodate a label
with sufficient space to bear the information required for compliance
with section 582 of the FD&C Act; and (3) establishes a process by
which the Secretary may determine other products or transactions that
shall be exempt from the requirements of section 582 of the FD&C Act.
Additionally, section 582(a)(3)(B) of the FD&C Act requires the FDA
to issue guidance that includes a process describing how the FDA
intends to review and renew granted waivers, exceptions, and
exemptions.
This guidance finalizes the draft guidance entitled ``Waivers,
Exceptions, and Exemptions from the Requirements of Section 582 of the
Federal Food, Drug, and Cosmetic Act'' issued on May 9, 2018 (83 FR
21297). FDA considered comments received on the draft guidance as the
guidance was finalized. Changes from the draft guidance to the final
guidance include: (1) recommending that a requestor submit a request
for a waiver, exception, or exemption to FDA electronically; (2)
recommending additional information a requestor should provide to FDA
in a request for waiver, exception, or exemption; (3) recommending that
recipients of a waiver, exception, or exemption notify the Agency of
any material change in circumstances that formed the basis for granting
the initial request for regulatory relief as soon as possible; (4)
recommending that recipients of a waiver, exception, or exemption
notify affected entities that a product and/or transaction is subject
to a waiver, exception, or exemption; (5) describing how an authorized
trading partner and other stakeholder may submit a request to FDA to
reconsider the scope of a waiver, exception, or exemption that has been
granted; (6) describing how an authorized trading partner and other
stakeholder may submit a request to FDA to reconsider and re-evaluate a
denied waiver, exception, or exemption request; and (7) recommending
that recipients of a waiver, exception, or exemption notify affected
entities upon termination of a waiver, exception, or exemption. In
addition, editorial changes were made to improve clarity.
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 ``Waivers, Exceptions, and Exemptions from
the Requirements of Section 582 of the Federal Food, Drug, and
Cosmetic.'' 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
[[Page 51844]]
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 ``Waivers, Exceptions, and Exemptions from the
Requirements of section 582 of the Federal Food, Drug, and Cosmetic
Act'' have been approved under OMB control number 0910-0806.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>,
<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: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16645 Filed 8-3-23; 8:45 am]
BILLING CODE 4164-01-P
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