
[Federal Register Volume 88, Number 149 (Friday, August 4, 2023)]
[Notices]
[Pages 51842-51844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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This guidance finalizes the draft guidance of the same title issued on 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:
     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-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]]

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 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 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, 
[email protected]; 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 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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


