Drug Supply Chain Security Act Implementation and Readiness Efforts for 2023; Public Meeting; Request for Comments, 67047-67049 [2022-24212]
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Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
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 the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
khammond on DSKJM1Z7X2PROD with NOTICES
Jessica Gillum, 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 document entitled ‘‘Studying Multiple
Versions of a Cellular or Gene Therapy
Product in an Early-Phase Clinical Trial;
Guidance for Industry.’’ The guidance
document provides recommendations to
sponsors interested in studying multiple
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versions of a cellular or gene therapy
product in an early phase clinical trial
for a single disease. Sponsors have
expressed interest in gathering
preliminary evidence of safety and
activity using multiple versions of a
cellular or gene therapy product in a
single clinical trial, where each version
of the product is distinct and is
generally submitted to FDA in a
separate IND. The objective of these
early phase clinical studies is to guide
which version(s) of the product to
pursue for further development in later
phase studies. Thus, these studies are
not intended to provide primary
evidence of effectiveness to support a
marketing application and generally are
not adequately powered to demonstrate
a statistically significant difference in
efficacy between the study arms. The
guidance provides recommendations for
conducting such studies, including how
to organize and structure the INDs,
submit new information, and report
adverse events.
In the Federal Register of September
30, 2021 (86 FR 54207), FDA announced
the availability of the draft guidance
entitled ‘‘Studying Multiple Versions of
a Cellular or Gene Therapy Product in
an Early Phase Clinical Trial.’’ FDA
received several comments on the draft
guidance and those comments were
considered as the guidance was
finalized. Changes to the guidance
include clarifying how to continue the
umbrella trial after a study arm has been
closed and adding examples of changes
that result in multiple versions of a
cellular or gene therapy product. In
addition, editorial changes were made
to improve clarity. The guidance
announced in this notice finalizes the
draft guidance of the same title dated
September 2021.
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 ‘‘Studying Multiple
Versions of a Cellular or Gene Therapy
Product in an Early-Phase Clinical
Trial.’’ 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.
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67047
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 and
Form FDA 1572 have been approved
under OMB control number 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24112 Filed 11–4–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2671]
Drug Supply Chain Security Act
Implementation and Readiness Efforts
for 2023; Public Meeting; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following virtual
public meeting entitled ‘‘Drug Supply
Chain Security Act Implementation and
Readiness Efforts for 2023’’ to allow
supply chain stakeholders an
opportunity to share their perspectives.
The topics to be discussed are
stakeholder experiences with
implementation and overall readiness
regarding implementation of enhanced
drug distribution security requirements
that will go into effect on November 27,
2023, standards for the interoperable
data exchange of product tracing
information, requests for product tracing
information or verification from FDA for
the purpose of investigating suspect or
illegitimate products or for recalls, steps
taken to build capacity for package-level
tracing, pharmaceutical distribution
supply chain best practices, and, in
general, the impact that the Drug Supply
Chain Security Act (DSCSA)
requirements would have on public
health, including patient safety and
access to prescription drugs, and on
SUMMARY:
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Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
stakeholders, in terms of costs, benefits,
and regulatory burden.
DATES: The public meeting will be held
on December 7 and 8, 2022, from 10
a.m. to 3 p.m. eastern time and will take
place virtually. Either electronic or
written comments on this public
meeting must be submitted by February
6, 2023. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public meeting will be
held virtually and hosted by FDA.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. eastern time
at the end of February 6, 2023.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
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’’).
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
16:45 Nov 04, 2022
Jkt 259001
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–N–2671 for ‘‘Drug Supply Chain
Security Act Implementation and
Readiness Efforts for 2023; Public
Meeting; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
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.
PO 00000
Frm 00042
Fmt 4703
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FOR FURTHER INFORMATION CONTACT:
Kristle Green, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave. Silver Spring, MD 20993, 301–
796–3130, CDERODSIRPublicMeetings@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On November 27, 2013, the DSCSA
(title II, Pub. L. 113–54) was signed into
law. The DSCSA outlines critical steps
to achieve electronic, interoperable
tracing at the package level by 2023 to
identify and trace certain prescription
drugs as they are distributed within the
United States. DSCSA requirements
enhance FDA’s ability to protect U.S.
consumers from exposure to drugs that
may be counterfeit, diverted, stolen,
intentionally adulterated, or otherwise
harmful by improving the detection and
removal of potentially dangerous drugs
from the drug supply chain.
Section 582(g)(1) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360eee–1(g)(1)) imposed
requirements for enhanced drug
distribution security that go into effect
on November 27, 2023. Section 582(i) of
the FD&C Act directs FDA to hold
public meetings to enhance the safety
and security of the pharmaceutical
distribution supply chain and provide
opportunities for comment from
members of the pharmaceutical
distribution supply chain and other
interested stakeholders. Since
enactment of the law, FDA has held
multiple public meetings that address
specific topics as they relate to
implementation of DSCSA
requirements. As the capabilities of the
pharmaceutical distribution supply
chain have progressed and matured, this
public meeting will be used to gather
stakeholder perspectives on DSCSA
implementation.
II. Topics for Discussion at the Public
Meeting
• Stakeholder experiences with
implementation and overall readiness
regarding implementation of enhanced
drug distribution security requirements
that will go into effect on November 27,
2023.
• DSCSA standards for the
interoperable data exchange of product
tracing information for enhanced
product tracing and verification.
• FDA requests to trading partners for
product tracing information, verification
for the purpose of investigations of
suspect or illegitimate products, or
recalls to support enhanced drug
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
distribution requirements under section
582(g) of the FD&C Act.
• Steps taken by the pharmaceutical
distribution supply chain to build
capacity for package-level tracing,
including the ability of the healthcare
system to maintain patient access to
medicines, scalability of DSCSA
requirements, and best practices.
• Technical capabilities and legal
authorities, if any, needed to establish
interoperable, electronic product tracing
at the package level.
• General impact that the DSCSA
requirements would have on public
health, including patient safety and
access to prescription drugs, and on
stakeholders, in terms of costs, benefits,
and regulatory burden.
If other topics are identified as
appropriate, FDA will post these on the
designated public meeting web page
prior to the meeting.
same-day registration for oral
presentations. FDA will do its best to
accommodate requests for oral
presentations. Individuals and
organizations with common interests are
encouraged to consolidate or coordinate
their presentations and can submit a
single request to present. Time allotted
for each presentation will depend on the
number of requests received and may be
limited.
FDA has verified the website
addresses in this document, as of the
date this document publishes in the
Federal Register, but websites are
subject to change over time.
Other Issues for Consideration: FDA
will provide a recording of the public
meeting and materials from the meeting
at https://www.fda.gov/drugs/drugsupply-chain-security-act-dscsaimplementation-and-readiness-efforts2023-12072022 after the public meeting.
III. Participating in the Public Meeting
Registration: This will be a virtual
public meeting and there are no fees for
this meeting. FDA may limit registration
once the meeting capacity is reached.
Individuals who wish to attend the
general session of the public meeting
must register by December 2, 2022, and
provide the following information on
the public meeting registration page:
Your name, organization name,
stakeholder type, email address, and
telephone number to FDA at https://
dscsapublicmeeting2022.
eventbrite.com. Meeting information for
virtual participation will be emailed by
December 5, 2022, to those that
registered.
If you need special accommodations
due to a disability, please contact Kristle
Green (see FOR FURTHER INFORMATION
CONTACT) no later than 7 days before the
public meeting.
Breakout Sessions: Any person
interested in participating in small
group discussions must register by
November 28, 2022, following the
instructions above, and indicate your
request for breakout session
participation. There will be no same-day
registration for breakout sessions. FDA
will organize breakout sessions based on
registration and interest to help ensure
varied stakeholder representation,
including across the pharmaceutical
distribution supply chain. FDA may
limit the number of participants from
each organization if interest exceeds
breakout session capacity.
Request for Oral Presentations: Any
person interested in presenting during
the public meeting must register by
November 28, 2022, following the
instructions above, and indicate your
request to present. There will be no
Dated: November 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
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16:45 Nov 04, 2022
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[FR Doc. 2022–24212 Filed 11–4–22; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Pathway to Independence Awards (K99/R00).
Date: December 2, 2022.
Time: 9:30 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Nicholas Gaiano, Ph.D.,
Review Branch Chief, Division of Extramural
Activities, National Institute of Mental
Health, National Institutes of Health,
PO 00000
Frm 00043
Fmt 4703
Neuroscience Center/Room 6150/MSC 9606,
6001 Executive Boulevard, Bethesda, MD
20892–9606, 301–443–2742, nick.gaiano@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: November 1, 2022.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–24115 Filed 11–4–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; NCI Genomic Data Commons
(GDC) Data Submission Request Form
(National Cancer Institute)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide an
opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Zhining Wang, Ph.D., Project
Officer, Center for Cancer Genomics
(CCG), National Cancer Institute,
Building 31, Room 3A20, 31 Center
Drive, Bethesda, MD 20814 or call nontoll-free number 301–402–1892 or Email
your request, including your address to:
zhining.wang@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and suggestions from the
public, and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
SUMMARY:
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67047-67049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24212]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2671]
Drug Supply Chain Security Act Implementation and Readiness
Efforts for 2023; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following virtual public meeting entitled ``Drug Supply
Chain Security Act Implementation and Readiness Efforts for 2023'' to
allow supply chain stakeholders an opportunity to share their
perspectives. The topics to be discussed are stakeholder experiences
with implementation and overall readiness regarding implementation of
enhanced drug distribution security requirements that will go into
effect on November 27, 2023, standards for the interoperable data
exchange of product tracing information, requests for product tracing
information or verification from FDA for the purpose of investigating
suspect or illegitimate products or for recalls, steps taken to build
capacity for package-level tracing, pharmaceutical distribution supply
chain best practices, and, in general, the impact that the Drug Supply
Chain Security Act (DSCSA) requirements would have on public health,
including patient safety and access to prescription drugs, and on
[[Page 67048]]
stakeholders, in terms of costs, benefits, and regulatory burden.
DATES: The public meeting will be held on December 7 and 8, 2022, from
10 a.m. to 3 p.m. eastern time and will take place virtually. Either
electronic or written comments on this public meeting must be submitted
by February 6, 2023. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be held virtually and hosted by FDA.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. eastern
time at the end of February 6, 2023. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or before that date.
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-2022-N-2671 for ``Drug Supply Chain Security Act Implementation and
Readiness Efforts for 2023; Public Meeting; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at 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.
FOR FURTHER INFORMATION CONTACT: Kristle Green, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave. Silver Spring, MD 20993, 301-796-3130,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On November 27, 2013, the DSCSA (title II, Pub. L. 113-54) was
signed into law. The DSCSA outlines critical steps to achieve
electronic, interoperable tracing at the package level by 2023 to
identify and trace certain prescription drugs as they are distributed
within the United States. DSCSA requirements enhance FDA's ability to
protect U.S. consumers from exposure to drugs that may be counterfeit,
diverted, stolen, intentionally adulterated, or otherwise harmful by
improving the detection and removal of potentially dangerous drugs from
the drug supply chain.
Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360eee-1(g)(1)) imposed requirements for enhanced drug
distribution security that go into effect on November 27, 2023. Section
582(i) of the FD&C Act directs FDA to hold public meetings to enhance
the safety and security of the pharmaceutical distribution supply chain
and provide opportunities for comment from members of the
pharmaceutical distribution supply chain and other interested
stakeholders. Since enactment of the law, FDA has held multiple public
meetings that address specific topics as they relate to implementation
of DSCSA requirements. As the capabilities of the pharmaceutical
distribution supply chain have progressed and matured, this public
meeting will be used to gather stakeholder perspectives on DSCSA
implementation.
II. Topics for Discussion at the Public Meeting
Stakeholder experiences with implementation and overall
readiness regarding implementation of enhanced drug distribution
security requirements that will go into effect on November 27, 2023.
DSCSA standards for the interoperable data exchange of
product tracing information for enhanced product tracing and
verification.
FDA requests to trading partners for product tracing
information, verification for the purpose of investigations of suspect
or illegitimate products, or recalls to support enhanced drug
[[Page 67049]]
distribution requirements under section 582(g) of the FD&C Act.
Steps taken by the pharmaceutical distribution supply
chain to build capacity for package-level tracing, including the
ability of the healthcare system to maintain patient access to
medicines, scalability of DSCSA requirements, and best practices.
Technical capabilities and legal authorities, if any,
needed to establish interoperable, electronic product tracing at the
package level.
General impact that the DSCSA requirements would have on
public health, including patient safety and access to prescription
drugs, and on stakeholders, in terms of costs, benefits, and regulatory
burden.
If other topics are identified as appropriate, FDA will post these
on the designated public meeting web page prior to the meeting.
III. Participating in the Public Meeting
Registration: This will be a virtual public meeting and there are
no fees for this meeting. FDA may limit registration once the meeting
capacity is reached. Individuals who wish to attend the general session
of the public meeting must register by December 2, 2022, and provide
the following information on the public meeting registration page: Your
name, organization name, stakeholder type, email address, and telephone
number to FDA at https://dscsapublicmeeting2022.eventbrite.com. Meeting
information for virtual participation will be emailed by December 5,
2022, to those that registered.
If you need special accommodations due to a disability, please
contact Kristle Green (see FOR FURTHER INFORMATION CONTACT) no later
than 7 days before the public meeting.
Breakout Sessions: Any person interested in participating in small
group discussions must register by November 28, 2022, following the
instructions above, and indicate your request for breakout session
participation. There will be no same-day registration for breakout
sessions. FDA will organize breakout sessions based on registration and
interest to help ensure varied stakeholder representation, including
across the pharmaceutical distribution supply chain. FDA may limit the
number of participants from each organization if interest exceeds
breakout session capacity.
Request for Oral Presentations: Any person interested in presenting
during the public meeting must register by November 28, 2022, following
the instructions above, and indicate your request to present. There
will be no same-day registration for oral presentations. FDA will do
its best to accommodate requests for oral presentations. Individuals
and organizations with common interests are encouraged to consolidate
or coordinate their presentations and can submit a single request to
present. Time allotted for each presentation will depend on the number
of requests received and may be limited.
FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
Other Issues for Consideration: FDA will provide a recording of the
public meeting and materials from the meeting at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa-implementation-and-readiness-efforts-2023-12072022 after the public meeting.
Dated: November 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24212 Filed 11-4-22; 8:45 am]
BILLING CODE 4164-01-P
