Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Public Meeting; Request for Comments, 57435-57437 [2021-22474]
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Federal Register / Vol. 86, No. 197 / Friday, October 15, 2021 / Notices
this screening tool will help ensure the
health and safety of children and staff
at care provider facilities by helping to
identify and reduce potential exposure
to COVID–19.
57435
Respondents: Staff and visitors at
ORR care provider facilities.
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of
respondents
Annual
responses per
respondent
Average
burden hours
per response
Annual
burden hours
COVID–19 Verbal Screening and Temperature Check ..................................
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Authority: 6 U.S.C. 279.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–22477 Filed 10–14–21; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1004]
Enhanced Drug Distribution Security at
the Package Level Under the Drug
Supply Chain Security Act; Public
Meeting; Request for Comments
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of public meeting;
request for comments.
AGENCY:
The Food and Drug
Administration (FDA or the Agency) is
announcing a virtual public meeting
entitled ‘‘Enhanced Drug Distribution
Security at the Package Level Under the
Drug Supply Chain Security Act
(DSCSA).’’ This public meeting is
intended to provide members of the
pharmaceutical distribution supply
chain and other interested stakeholders
an opportunity to discuss enhanced
drug distribution security requirements
of the DSCSA related to system
attributes necessary to enable secure
tracing of product at the package level.
DATES: The public meeting will be held
on November 16, 2021, from 9 a.m. to
4 p.m., and will take place virtually.
Submit either electronic or written
comments on this public meeting by
January 18, 2022.
ADDRESSES: The public meeting will be
held virtually and hosted by FDA.
Registration to participate in this
meeting and other information can be
found at https://www.fda.gov/drugs/
news-events-human-drugs/publicmeeting-enhanced-drug-distributionsecurity-package-level-under-drugsupply-chain-security. See the
SUPPLEMENTARY INFORMATION section for
registration date and other information.
SUMMARY:
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Comments: To permit the widest
possible opportunity to obtain public
comment, FDA is soliciting either
electronic or written comments on all
aspects of the public meeting topics.
You may submit comments as follows.
Please note that late, untimely filed
comments will not be considered.
Please note that the deadline for
submitting either electronic or written
comments is 60 days after the meeting,
January 18, 2022, to which the
comments relate. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
the specified 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’’).
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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–
2021–N–1004 for ‘‘Enhanced Drug
Distribution Security at the Package
Level Under the Drug Supply Chain
Security Act; 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
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Federal Register / Vol. 86, No. 197 / Friday, October 15, 2021 / Notices
‘‘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.
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 build an electronic, interoperable
system by 2023 to identify and trace
certain prescription drugs as they are
distributed within the United States.
This system will 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 the enhanced drug distribution
security that go into effect on November
27, 2023. Additionally, 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. Section
582(h)(3) of the FD&C Act directs FDA
to conduct a public meeting and issue
guidance addressing the system
attributes necessary to enable secure
tracing of product at the package level.
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II. Topics for Discussion at the Public
Meeting
FDA will hold a virtual public
meeting on November 16, 2021, on
enhanced drug distribution security at
the package level. The purpose of this
public meeting is to provide members of
the pharmaceutical distribution supply
chain and other interested stakeholders
an opportunity to provide input to FDA
on the implementation of the enhanced
drug distribution security provisions of
the DSCSA that go into effect in 2023.
FDA requests that stakeholders prepare
comments responding to the following
questions for one or more of the topics
listed below:
• How is implementation of the 2023
enhanced system requirements
progressing for your organization?
• What challenges are your
organization facing?
• Are the proposed recommendations
in FDA’s draft guidance entitled
‘‘Enhanced Drug Distribution Security at
the Package Level Under the Drug
Supply Chain Security Act’’ (June 2021)
helpful to achieve compliance with
2023 enhanced system requirements? If
not, what additional information would
be useful?
• Are there areas in which FDA could
provide more clarity?
Topics
1. Enhanced Drug Distribution Security
• System Attributes
• Aggregation, Inference, and
Physical Security Features
2. System Structure
• Data Architecture
• Adoption of Data and System
Security
• Protecting Confidential Commercial
Information and Trade Secrets
• System Access and Data Retrieval
3. Enhanced Product Tracing
• Serialized Transaction Information
and Data Exchange (Incorporation
of the Product Identifier into
Product Tracing Information)
• Responsibilities of the Selling and
Buying Trading Partners in Regard
to the Product Tracing Information
• Handling Aggregation Errors and
Other Discrepancies
4. Gathering of Relevant Product
Tracing Information
5. Enhanced Verification
• Verification of Distributed Product
• Verification of Saleable Return
Product
• Alerts for Illegitimate Product
6. Trading Partner Readiness
• Your organization’s Overall
Readiness for Implementation of the
Enhanced Drug Distribution
Security Provisions of the DSCSA
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That Go into Effect in 2023
• Components That Your
Organization Is Furthest Along in
Developing, Including the
Components Being Prioritized and
the Components That Are Easier or
More Challenging to Implement:
i. Technical Components
ii. Technical Infrastructure
iii. Business Processes
iv. Employee Training
FDA may include additional
discussion topics. Materials for the
public meeting will be provided on
FDA’s website at https://www.fda.gov/
drugs/news-events-human-drugs/publicmeeting-enhanced-drug-distributionsecurity-package-level-under-drugsupply-chain-security 7 days before the
public meeting.
III. Participating in the Public Meeting
Registration: This will be a virtual
public meeting and attendance is free.
Individuals who wish to attend must
register on or before October 26, 2021.
To register for the public meeting,
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://
dscsapublicmeeting
2021.eventbrite.com. There will be no
onsite or same-day registration. If
registration reaches maximum capacity,
FDA will post a notice closing
registration for the meeting on FDA’s
website at https://www.fda.gov/drugs/
news-events-human-drugs/publicmeeting-enhanced-drug-distributionsecurity-package-level-under-drugsupply-chain-security.
Request for Oral Presentations: This
public meeting will include public
comment sessions. Individuals who
wish to present during a public
comment session during this meeting
must register as noted at https://
www.fda.gov/drugs/news-eventshuman-drugs/public-meeting-enhanceddrug-distribution-security-packagelevel-under-drug-supply-chain-security
and identify the topics (see section II)
they wish to address in their
presentation and the stakeholder group
they best associate with, if any, to help
FDA organize the presentations.
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
presentations and request time for a
joint presentation. Presenters should
submit an electronic copy of their
presentation to CDERODSIRPublic
Meetings@fda.hhs.gov on or before
November 2, 2021.
FDA will do its best to accommodate
requests to present during the public
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Federal Register / Vol. 86, No. 197 / Friday, October 15, 2021 / Notices
comment session and will determine the
amount of time allotted for each oral
presentation and the approximate time
that each oral presentation is scheduled
to begin. FDA will notify registered
presenters of their scheduled times and
make available an agenda and
background material at https://
www.fda.gov/drugs/news-eventshuman-drugs/public-meeting-enhanceddrug-distribution-security-packagelevel-under-drug-supply-chain-security
on or before November 5, 2021.
If you need special accommodations
due to a disability, please contact Kristle
Green (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of
the public meeting.
IV. Post-Public Meeting Materials
FDA will provide a recording of the
public meeting and materials from the
meeting at https://www.fda.gov/drugs/
news-events-human-drugs/publicmeeting-enhanced-drug-distributionsecurity-package-level-under-drugsupply-chain-security after the public
meeting.
Dated: October 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–22474 Filed 10–14–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Cybersecurity and Infrastructure
Security Agency
[Docket No. CISA–2021–0016]
Notice of President’s National Security
Telecommunications Advisory
Committee Meeting
Cybersecurity and
Infrastructure Security Agency (CISA),
Department of Homeland Security
(DHS).
ACTION: Notice of Federal Advisory
Committee Act (FACA) meeting; request
for comments.
AGENCY:
CISA is publishing this notice
to announce the following President’s
National Security Telecommunications
Advisory Committee (NSTAC) meeting.
This meeting will be partially closed to
the public.
DATES: Meeting Registration:
Registration to attend the meeting is
required and must be received no later
than 5:00 p.m. Eastern Time (ET) on
October 26, 2021. For more information
on how to participate, please contact
NSTAC@cisa.dhs.gov.
SUMMARY:
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16:50 Oct 14, 2021
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Speaker Registration: Registration to
speak during the meeting’s public
comment period must be received no
later than 5:00 p.m. ET on October 26,
2021.
Written Comments: Written comments
must be received no later than 5:00 p.m.
ET on October 26, 2021.
Meeting Date: The NSTAC will meet
on November 2, 2021, from 10:00 a.m.
to 3:15 p.m. ET. The meeting may close
early if the committee has completed its
business.
ADDRESSES: The November 2021 NSTAC
Meeting’s open session is set to be held
in person at 1717 H Street NW,
Washington, DC. Capacity and location
are subject to change based on DHS
protocol regarding COVID–19 pandemic
restrictions at the time of the meeting.
Due to pandemic restrictions, members
of the public may only participate via
teleconference. Requests to participate
will be accepted and processed in the
order in which they are received. For
access to the conference call bridge,
information on services for individuals
with disabilities, or to request special
assistance, please email NSTAC@
cisa.dhs.gov by 5:00 p.m. ET on October
26, 2021.
Comments: Members of the public are
invited to provide comment on issues
that will be considered by the
committee as listed in the
SUPPLEMENTARY INFORMATION section
below. Associated materials that may be
discussed during the meeting will be
made available for review at https://
www.cisa.gov/nstac on October 18,
2021. Comments should be submitted
by 5:00 p.m. ET on October 26, 2021
and must be identified by Docket
Number CISA–2021–0016. Comments
may be submitted by one of the
following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Please follow the
instructions for submitting written
comments.
• Email: NSTAC@cisa.dhs.gov.
Include the Docket Number CISA–2021–
0016 in the subject line of the email.
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and the Docket
Number for this action. Comments
received will be posted without
alteration to www.regulations.gov,
including any personal information
provided.
Docket: For access to the docket and
comments received by the NSTAC,
please go to www.regulations.gov and
enter docket number CISA–2021–0016.
A public comment period is
scheduled to be held during the meeting
from 2:40 p.m. to 2:50 p.m. ET. Speakers
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57437
who wish to participate in the public
comment period must email NSTAC@
cisa.dhs.gov to register. Speakers should
limit their comments to 3 minutes and
will speak in order of registration.
Please note that the public comment
period may end before the time
indicated, following the last request for
comments.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Gauthier, 202–821–6620,
NSTAC@cisa.dhs.gov.
SUPPLEMENTARY INFORMATION: The
NSTAC was established by Executive
Order (E.O.) 12382, 47 FR 40531
(September 13, 1982), as amended and
continued under the authority of E.O.
13889, dated September 27, 2019.
Notice of this meeting is given under
FACA, 5 U.S.C. Appendix (Pub. L. 92–
463). The NSTAC advises the President
on matters related to national security
and emergency preparedness (NS/EP)
telecommunications and cybersecurity
policy.
Agenda: The NSTAC will meet in an
open session on Thursday, November 2,
2021, to discuss current NSTAC
activities and the Government’s ongoing
cybersecurity and NS/EP
communications initiatives. This open
session will include: (1) A keynote
address on fortifying the Nation’s
cybersecurity posture; (2) an update on
Administration actions to NSTAC and
joint NS/EP communications; (3) a
deliberation and vote on the NSTAC
Report to the President on Software
Assurance in the Information and
Communications Technology and
Services Supply Chain; and (4) a status
update from the NSTAC Zero-Trust and
Trusted Identity Management
Subcommittee.
The committee will also meet in a
closed session from 10:00 a.m. to 12:00
p.m. during which time senior
Government intelligence officials will
provide a threat briefing concerning
threats to NS/EP communications and
engage NSTAC members in follow-on
discussion.
Basis for Closure: In accordance with
section 10(d) of FACA and 5 U.S.C.
552b(c)(9)(B), The Government in the
Sunshine Act, it has been determined
that a portion of the agenda requires
closure, as the disclosure of the
information that will be discussed
would not be in the public interest.
This agenda item is the classified
threat briefing and discussion, which
will provide NSTAC members the
opportunity to discuss information
concerning threats to NS/EP
communications with senior
Government intelligence officials. The
briefing is anticipated to be classified at
E:\FR\FM\15OCN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 197 (Friday, October 15, 2021)]
[Notices]
[Pages 57435-57437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22474]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1004]
Enhanced Drug Distribution Security at the Package Level Under
the Drug Supply Chain Security Act; Public Meeting; Request for
Comments
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a virtual public meeting entitled ``Enhanced Drug
Distribution Security at the Package Level Under the Drug Supply Chain
Security Act (DSCSA).'' This public meeting is intended to provide
members of the pharmaceutical distribution supply chain and other
interested stakeholders an opportunity to discuss enhanced drug
distribution security requirements of the DSCSA related to system
attributes necessary to enable secure tracing of product at the package
level.
DATES: The public meeting will be held on November 16, 2021, from 9
a.m. to 4 p.m., and will take place virtually. Submit either electronic
or written comments on this public meeting by January 18, 2022.
ADDRESSES: The public meeting will be held virtually and hosted by FDA.
Registration to participate in this meeting and other information can
be found at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security. See the SUPPLEMENTARY INFORMATION section for
registration date and other information.
Comments: To permit the widest possible opportunity to obtain
public comment, FDA is soliciting either electronic or written comments
on all aspects of the public meeting topics. You may submit comments as
follows. Please note that late, untimely filed comments will not be
considered. Please note that the deadline for submitting either
electronic or written comments is 60 days after the meeting, January
18, 2022, to which the comments relate. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of the specified 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-2021-N-1004 for ``Enhanced Drug Distribution Security at the
Package Level Under the Drug Supply Chain Security Act; 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
[[Page 57436]]
``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 build an
electronic, interoperable system by 2023 to identify and trace certain
prescription drugs as they are distributed within the United States.
This system will 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 the
enhanced drug distribution security that go into effect on November 27,
2023. Additionally, 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. Section 582(h)(3) of the FD&C Act
directs FDA to conduct a public meeting and issue guidance addressing
the system attributes necessary to enable secure tracing of product at
the package level.
II. Topics for Discussion at the Public Meeting
FDA will hold a virtual public meeting on November 16, 2021, on
enhanced drug distribution security at the package level. The purpose
of this public meeting is to provide members of the pharmaceutical
distribution supply chain and other interested stakeholders an
opportunity to provide input to FDA on the implementation of the
enhanced drug distribution security provisions of the DSCSA that go
into effect in 2023. FDA requests that stakeholders prepare comments
responding to the following questions for one or more of the topics
listed below:
How is implementation of the 2023 enhanced system
requirements progressing for your organization?
What challenges are your organization facing?
Are the proposed recommendations in FDA's draft guidance
entitled ``Enhanced Drug Distribution Security at the Package Level
Under the Drug Supply Chain Security Act'' (June 2021) helpful to
achieve compliance with 2023 enhanced system requirements? If not, what
additional information would be useful?
Are there areas in which FDA could provide more clarity?
Topics
1. Enhanced Drug Distribution Security
System Attributes
Aggregation, Inference, and Physical Security Features
2. System Structure
Data Architecture
Adoption of Data and System Security
Protecting Confidential Commercial Information and Trade
Secrets
System Access and Data Retrieval
3. Enhanced Product Tracing
Serialized Transaction Information and Data Exchange
(Incorporation of the Product Identifier into Product Tracing
Information)
Responsibilities of the Selling and Buying Trading
Partners in Regard to the Product Tracing Information
Handling Aggregation Errors and Other Discrepancies
4. Gathering of Relevant Product Tracing Information
5. Enhanced Verification
Verification of Distributed Product
Verification of Saleable Return Product
Alerts for Illegitimate Product
6. Trading Partner Readiness
Your organization's Overall Readiness for Implementation
of the Enhanced Drug Distribution Security Provisions of the DSCSA That
Go into Effect in 2023
Components That Your Organization Is Furthest Along in
Developing, Including the Components Being Prioritized and the
Components That Are Easier or More Challenging to Implement:
i. Technical Components
ii. Technical Infrastructure
iii. Business Processes
iv. Employee Training
FDA may include additional discussion topics. Materials for the
public meeting will be provided on FDA's website at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security 7
days before the public meeting.
III. Participating in the Public Meeting
Registration: This will be a virtual public meeting and attendance
is free. Individuals who wish to attend must register on or before
October 26, 2021. To register for the public meeting, 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://dscsapublicmeeting2021.eventbrite.com. There
will be no onsite or same-day registration. If registration reaches
maximum capacity, FDA will post a notice closing registration for the
meeting on FDA's website at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security.
Request for Oral Presentations: This public meeting will include
public comment sessions. Individuals who wish to present during a
public comment session during this meeting must register as noted at
https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security and identify the topics (see section II) they wish to
address in their presentation and the stakeholder group they best
associate with, if any, to help FDA organize the presentations.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations and request time for a
joint presentation. Presenters should submit an electronic copy of
their presentation to [email protected] on or before
November 2, 2021.
FDA will do its best to accommodate requests to present during the
public
[[Page 57437]]
comment session and will determine the amount of time allotted for each
oral presentation and the approximate time that each oral presentation
is scheduled to begin. FDA will notify registered presenters of their
scheduled times and make available an agenda and background material at
https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security on or before November 5, 2021.
If you need special accommodations due to a disability, please
contact Kristle Green (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the public meeting.
IV. Post-Public Meeting Materials
FDA will provide a recording of the public meeting and materials
from the meeting at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security after the public meeting.
Dated: October 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22474 Filed 10-14-21; 8:45 am]
BILLING CODE 4164-01-P
