The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; Request for Comments, 68342-68344 [2020-23838]
Download as PDF
<![CDATA[
68342
Federal Register / Vol. 85, No. 209 / Wednesday, October 28, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
introduced or delivered for introduction
into interstate commerce. The FD&C Act
establishes three pathways to market for
new tobacco products:
• Submission of a PMTA under
section 910(b) of the FD&C Act (21
U.S.C. 387j(b)) and receipt of a
marketing order under section
910(c)(1)(A)(i),
• Submission of a SE report under
section 905(j)(1)(A) (21 U.S.C.
387e(j)(1)(A)) and receipt of an SE
marketing order, or
• Submission of a request for an
exemption from the requirements of
demonstrating SE under section
905(j)(3) and receipt of an exemption
from FDA (implemented at § 1107.1 (21
CFR 1107.1)).
To introduce or deliver for
introduction into interstate commerce a
modified risk tobacco product, there
must be in effect an order under section
911(g) of the FD&C Act (21 U.S.C.
387k(g)) and the applicant must satisfy
any applicable premarket review
requirements under section 910 of the
FD&C Act.
The draft guidance is intended to
assist applicants design and conduct
TPPI studies that may be submitted as
part of an MRTPA, a PMTA, or a SE
report. Conducting TPPI studies can
assist applicants submitting tobacco
product applications demonstrate that
their product meets applicable
requirements to receive marketing
authorization under the appropriate
pathway. For example, TPPI studies can
be used to assess, among other things,
individuals’ perceptions of tobacco
products, understanding of tobacco
product information, and intention to
use tobacco products. The draft
guidance is intended to address a
variety of scientific issues applicants
may consider as they design and
conduct TPPI studies to support tobacco
product applications.
II. Significance of Draft Guidance
FDA is issuing this draft guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on designing and conducting tobacco
product perception and intention
studies. 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.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
VerDate Sep<11>2014
18:29 Oct 27, 2020
Jkt 253001
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in § 1107.1(b) and (c)
have been approved under OMB control
number 0910–0684. The collections of
information under section 910 of the
FD&C Act have been approved under
OMB control number 0910–0768. The
collections of information in section
905(j) of the FD&C Act have been
approved under OMB control number
0910–0673.
IV. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
draft guidance at either https://
www.regulations.gov or https://
www.fda.gov/tobacco-products/
products-guidance-regulations/rulesregulations-and-guidance.
Dated: October 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–23840 Filed 10–27–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The Drug Supply Chain Security Act
Pilot Project Program and Enhanced
Drug Distribution Security; Public
Meeting; Request for Comments
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the following virtual public
meeting entitled ‘‘The Drug Supply
Chain Security Act Pilot Project
Program and Enhanced Drug
Distribution Security.’’ The purpose of
the public meeting is to provide
members of the pharmaceutical
distribution supply chain and other
interested stakeholders an opportunity
to discuss with FDA and provide input
on strategies and issues related to the
enhanced drug distribution security
provisions of the Drug Supply Chain
Security Act (DSCSA) and the results of
FDA’s DSCSA Pilot Project Program.
DATES: The public meeting will be held
on December 8 and 9, 2020, from 9 a.m.
to 4 p.m., Eastern Time, each day, and
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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/drug-supplychain-security-act-pilot-projectprogram-and-enhanced-drugdistribution-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.
Electronic and written comments must
be submitted on or before December 28,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 28, 2020.
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.
ADDRESSES:
Electronic Submissions
[Docket No. FDA–2020–N–1862]
AGENCY:
will take place virtually (by webcast
only). Submit either electronic or
written comments on this public
meeting by December 28, 2020.
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’’).
E:\FR\FM\28OCN1.SGM
28OCN1
Federal Register / Vol. 85, No. 209 / Wednesday, October 28, 2020 / Notices
jbell on DSKJLSW7X2PROD 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
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–
2020–N–1862 for ‘‘The Drug Supply
Chain Security Act Pilot Project
Program and Enhanced Drug
Distribution Security; 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.
VerDate Sep<11>2014
18:29 Oct 27, 2020
Jkt 253001
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
for building 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(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360eee–1(j)), which was added by the
DSCSA, directs FDA to establish one or
more pilot projects, in coordination
with authorized manufacturers,
repackagers, wholesale distributors, and
dispensers, to explore and evaluate
methods to enhance the safety and
security of the pharmaceutical
distribution supply chain. 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 product tracing of product at the
package level.
II. Topics for Discussion at the Public
Meeting
FDA will hold a virtual public
meeting on December 8 and 9, 2020, on
FDA’s DSCSA Pilot Project Program and
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
68343
related enhanced drug distribution
security issues. The purpose of this
public meeting is to provide members of
the pharmaceutical distribution supply
chain and other interested stakeholders
an opportunity to discuss with FDA,
and provide input on, strategies and
issues related to the enhanced drug
distribution security provisions of the
DSCSA and FDA’s DSCSA Pilot Project
Program. The public meeting will focus
on the following topics for discussion:
• Findings and lessons learned from
FDA’s DSCSA Pilot Project Program.
• Other piloting or piloted activities
related to DSCSA implementation.
• System attributes necessary for
enabling secure product tracing of
product at the package level. Examples
of discussion topics include, but are not
limited to, the system attributes,
circumstances, and processes necessary
for facilitating:
Æ Interoperability among trading
partners in the pharmaceutical
distribution supply chain, FDA, and
other appropriate Federal or State
official(s);
Æ enhanced product tracing activities
involving the exchange of data in a
secure manner, including management
and maintenance of the data;
Æ the use of aggregation and inference
for product tracing and/or verification;
and
Æ enhanced verification activities
involving communications between
trading partners and FDA and exchange
of data in a secure manner, including
management and maintenance of the
data.
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-eventshuman-drugs/drug-supply-chainsecurity-act-pilot-project-program-andenhanced-drug-distribution-security 7
days before the public meeting.
III. Participating in the Public Meeting
Registration: To request registration
for the public meeting, provide your
information, including name, company
or organization, address, telephone
number, and email address, to FDA at
https://www.fda.gov/drugs/news-eventshuman-drugs/drug-supply-chainsecurity-act-pilot-project-program-andenhanced-drug-distribution-security.
FDA may limit attendance to ensure
manageability of the virtual public
meeting and breakout sessions. In
addition, FDA may limit the number of
participants from each organization to
help ensure that meeting participants
represent the diversity of the
pharmaceutical supply chain and other
stakeholders. FDA recommends that
E:\FR\FM\28OCN1.SGM
28OCN1
68344
Federal Register / Vol. 85, No. 209 / Wednesday, October 28, 2020 / Notices
each organization determine who
should register for the public meeting to
represent his/her organization.
Registrants will receive confirmation of
participation for the meeting from FDA
within 14 days before the meeting.
There is no registration fee for the
public meeting, and there will be no
onsite 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-eventshuman-drugs/drug-supply-chainsecurity-act-pilot-project-program-andenhanced-drug-distribution-security.
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.
Streaming Webcast of the Public
Meeting: Portions of the public meeting
will be recorded and webcast on the day
of the meeting. Information on how to
access the webcast will be available at
https://www.fda.gov/drugs/news-eventshuman-drugs/drug-supply-chainsecurity-act-pilot-project-program-andenhanced-drug-distribution-security
within 7 days before the public meeting.
The webcast will be conducted in
listening mode only.
Dated: October 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–23838 Filed 10–27–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
for previously cleared accessories
necessary to the operation of automated
external defibrillator (AED) systems.
DATES: The announcement of the
guidance is published in the Federal
Register on October 28, 2020.
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
Food and Drug Administration
[Docket No. FDA–2020–D–1877]
Necessary Automated External
Defibrillator Accessories: Policy
Regarding Compliance Date;
Immediately in Effect Guidance for
Industry, Stakeholders, Health Care
Professionals, and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Necessary
Automated External Defibrillator
Accessories: Policy Regarding
Compliance Date.’’ FDA is issuing this
guidance to revise its compliance policy
regarding the deadline for filing
premarket approval (PMA) applications
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:29 Oct 27, 2020
Jkt 253001
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–
2020–D–1877 for ‘‘Necessary Automated
External Defibrillator Accessories:
Policy Regarding Compliance Date.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Necessary
Automated External Defibrillator
Accessories: Policy Regarding
Compliance Date’’ to the Office of
Policy, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
E:\FR\FM\28OCN1.SGM
28OCN1
]]>Agencies
[Federal Register Volume 85, Number 209 (Wednesday, October 28, 2020)]
[Notices]
[Pages 68342-68344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23838]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1862]
The Drug Supply Chain Security Act Pilot Project Program and
Enhanced Drug Distribution Security; 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 or the Agency) is
announcing the following virtual public meeting entitled ``The Drug
Supply Chain Security Act Pilot Project Program and Enhanced Drug
Distribution Security.'' The purpose of the public meeting is to
provide members of the pharmaceutical distribution supply chain and
other interested stakeholders an opportunity to discuss with FDA and
provide input on strategies and issues related to the enhanced drug
distribution security provisions of the Drug Supply Chain Security Act
(DSCSA) and the results of FDA's DSCSA Pilot Project Program.
DATES: The public meeting will be held on December 8 and 9, 2020, from
9 a.m. to 4 p.m., Eastern Time, each day, and will take place virtually
(by webcast only). Submit either electronic or written comments on this
public meeting by December 28, 2020.
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/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-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. Electronic and written comments must be submitted on or
before December 28, 2020. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. Eastern Time at the
end of December 28, 2020. 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.
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'').
[[Page 68343]]
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-2020-N-1862 for ``The Drug Supply Chain Security Act Pilot Project
Program and Enhanced Drug Distribution Security; 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 for building 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(j) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360eee-1(j)), which was added by the DSCSA,
directs FDA to establish one or more pilot projects, in coordination
with authorized manufacturers, repackagers, wholesale distributors, and
dispensers, to explore and evaluate methods to enhance the safety and
security of the pharmaceutical distribution supply chain. 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 product tracing of product at the package
level.
II. Topics for Discussion at the Public Meeting
FDA will hold a virtual public meeting on December 8 and 9, 2020,
on FDA's DSCSA Pilot Project Program and related enhanced drug
distribution security issues. The purpose of this public meeting is to
provide members of the pharmaceutical distribution supply chain and
other interested stakeholders an opportunity to discuss with FDA, and
provide input on, strategies and issues related to the enhanced drug
distribution security provisions of the DSCSA and FDA's DSCSA Pilot
Project Program. The public meeting will focus on the following topics
for discussion:
Findings and lessons learned from FDA's DSCSA Pilot
Project Program.
Other piloting or piloted activities related to DSCSA
implementation.
System attributes necessary for enabling secure product
tracing of product at the package level. Examples of discussion topics
include, but are not limited to, the system attributes, circumstances,
and processes necessary for facilitating:
[cir] Interoperability among trading partners in the pharmaceutical
distribution supply chain, FDA, and other appropriate Federal or State
official(s);
[cir] enhanced product tracing activities involving the exchange of
data in a secure manner, including management and maintenance of the
data;
[cir] the use of aggregation and inference for product tracing and/
or verification; and
[cir] enhanced verification activities involving communications
between trading partners and FDA and exchange of data in a secure
manner, including management and maintenance of the data.
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/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security 7 days before the
public meeting.
III. Participating in the Public Meeting
Registration: To request registration for the public meeting,
provide your information, including name, company or organization,
address, telephone number, and email address, to FDA at https://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security. FDA
may limit attendance to ensure manageability of the virtual public
meeting and breakout sessions. In addition, FDA may limit the number of
participants from each organization to help ensure that meeting
participants represent the diversity of the pharmaceutical supply chain
and other stakeholders. FDA recommends that
[[Page 68344]]
each organization determine who should register for the public meeting
to represent his/her organization. Registrants will receive
confirmation of participation for the meeting from FDA within 14 days
before the meeting. There is no registration fee for the public
meeting, and there will be no onsite 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/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security.
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.
Streaming Webcast of the Public Meeting: Portions of the public
meeting will be recorded and webcast on the day of the meeting.
Information on how to access the webcast will be available at https://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security
within 7 days before the public meeting. The webcast will be conducted
in listening mode only.
Dated: October 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23838 Filed 10-27-20; 8:45 am]
BILLING CODE 4164-01-P
