Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry; Availability, 51842-51844 [2023-16645]
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Federal Register / Vol. 88, No. 149 / Friday, August 4, 2023 / Notices
determining this patent’s eligibility for
patent term restoration. In a letter dated
July 14, 2020, FDA advised the USPTO
that this medical device had undergone
a regulatory review period and that the
approval of VERCISE DBS SYSTEM
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
ddrumheller on DSK120RN23PROD with NOTICES1
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
VERCISE DBS SYSTEM is 393 days. Of
this time, 0 days occurred during the
testing phase of the regulatory review
period, while 393 days occurred during
the approval phase. These periods of
time were derived from the following
dates:
1. The date an exemption for this
device, under section 520(g) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(g)), became
effective: Not Applicable. The applicant
claims no investigational device
exemption for the regulatory review
period.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): December 22,
2017. FDA has verified the applicant’s
claim that the premarket approval
application (PMA) for VERCISE DBS
SYSTEM (PMA P150031 Supplement
002 (S002)) was initially submitted
December 22, 2017.
3. The date the application was
approved: January 18, 2019. FDA has
verified the applicant’s claim that PMA
P150031 S002 was approved on January
18, 2019.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 392 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
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comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16610 Filed 8–3–23; 8:45 am]
BILLING CODE 4164–01–P
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
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
AGENCY:
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,
SUMMARY:
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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
E:\FR\FM\04AUN1.SGM
04AUN1
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Federal Register / Vol. 88, No. 149 / Friday, August 4, 2023 / Notices
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-201509-18/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
VerDate Sep<11>2014
18:51 Aug 03, 2023
Jkt 259001
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–3130,
drugtrackandtrace@fda.hhs.gov; 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
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51843
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
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Federal Register / Vol. 88, No. 149 / Friday, August 4, 2023 / Notices
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/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
ddrumheller on DSK120RN23PROD with NOTICES1
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Novel and Exceptional
Technology and Research Advisory
Committee.
The meeting will be held as a virtual
meeting and will be open to the public
as indicated below. Individuals who
plan to view the virtual meeting and
need special assistance or other
reasonable accommodations to view the
meeting should notify the Contact
Person listed below in advance of the
meeting. The meeting will be videocast
and can be accessed from the NIH
Videocasting and Podcasting website
(https://videocast.nih.gov/).
Name of Committee: Novel and
Exceptional Technology and Research
Advisory Committee.
Date: August 29, 2023.
Time: 2:00 p.m. to 4:30 p.m.
Agenda: The Novel and Exceptional
Technology and Research Advisory
Committee meeting will include
presentation, discussion, and possible
finalization of the Draft Report of the
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Working Group on Data Science and
Emerging Technology and will include
discussion of next steps for the Committee.
Place: National Institutes of Health, 6705
Rockledge Drive, Suite 630, Bethesda, MD
20892 (Virtual Meeting Link will be available
at https://osp.od.nih.gov/policies/novel-andexceptional-technology-and-researchadvisory-committee-nextrac#tab4/).
Contact Person: Jessica Tucker, Ph.D.,
Office of Science Policy, National Institutes
of Health, 6705 Rockledge Drive, Suite 630,
Bethesda, MD 20892, 301–496–9838,
SciencePolicy@od.nih.gov.
Members of the public may request to
make an oral public comment or may submit
written public comments. To sign up to make
an oral public comment, please submit your
name, affiliation, and short description of the
oral comment to the Contact Person listed on
this notice at least two business days prior
to the meeting date. Once all time slots are
filled, only written comments will be
accepted. Any interested person may file
written comments by forwarding the
statement to the Contact Person listed on this
notice at least two business days prior to the
meeting date. The statement should include
the name, address, telephone number and,
when applicable, the business or professional
affiliation of the interested person. Other
than name and contact information, please
do not include any personally identifiable
information or any information that you do
not wish to make public. Proprietary,
classified, confidential, or sensitive
information should not be included in your
comments. Please note that any comments
NIH receives may be posted unredacted to
the Office of Science Policy website.
Information is also available on the NIH
Office of Science Policy website: https://
osp.od.nih.gov/policies/novel-andexceptional-technology-and-researchadvisory-committee-nextrac#tab4, where an
agenda, link to the webcast meeting, and any
additional information for the meeting will
be posted when available. Materials for this
meeting will be posted prior to the meeting.
Please check this website for updates.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: August 1, 2023.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–16685 Filed 8–3–23; 8:45 am]
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Substance Abuse and Mental Health
Services Administration
Tribal Listening Session and Tribal
Consultation; Notice of Meeting
Change
Substance Abuse and Mental
Health Services Administration
(SAMHSA).
ACTION: Notice of change to tribal
consultation.
AGENCY:
Notice is given that the
August 29, 2023, virtual meeting
SAMHSA Tribal Consultation that was
published in the Federal Register on
July 11, 2023, (Document Number 2023–
14638; pages 44134–4135), will now be
a Tribal Listening Session. SAMHSA
will host American Indian and Alaska
Native (AI/AN) Federally Recognized
Tribes for a virtual Tribal listening
session on the BEHAVIORAL HEALTH
AND SUBSTANCE USE DISORDER
RESOURCES FOR NATIVE
AMERICANS PROGRAM.
DATES: The virtual SAMHSA Tribal
Listening Session will be held on
August 29, 2023, from 4:00 p.m.–6:00
p.m. EDT. Registration is required at:
https://www.zoomgov.com/meeting/
register/vJItfuitqDIvGJb7z8G5vUTNjXjFDxOG8U. Individuals
must register to obtain the call-in
number, access code, and/or web access
link or request special accommodations
for those with disabilities.
Instructions to access the Zoom
virtual consultation will be provided in
the above link following registration.
FOR FURTHER INFORMATION CONTACT:
CAPT Karen Hearod, MSW, LCSW,
Director, Office of Tribal Affairs and
Policy, Substance Abuse and Mental
Health Services Administration,
Telephone: (202) 868–9931, Email:
otap@samhsa.hhs.gov.
SUMMARY:
Dated: July 6, 2023.
Carlos Castillo,
Committee Management Officer.
[FR Doc. 2023–16666 Filed 8–3–23; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2023–0247]
Certificates of Alternative Compliance
for the Eighth Coast Guard District
AGENCY:
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Coast Guard, DHS.
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]]>Agencies
[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.
-----------------------------------------------------------------------
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
