Proposed Pilot Project(s) Under the Drug Supply Chain Security Act; Public Workshop; Request for Comments, 7807-7809 [2016-02977]
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
MD 20993–0002, Audrey.Thomas@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
purpose of this public workshop is to
discuss the scientific progress being
made in harnessing evidence generated
from the real-world use of medical
devices to improve device safety and
effectiveness. The role that unique
device identification plays in improving
device evaluation, to support more
informed clinical and patient decisionmaking, and device innovation will also
be discussed.
The foundation (strategy and steps)
for the development of a national
evaluation system for medical devices
has been developed by FDA’s Center for
Devices and Radiological Health
(available at
www.pharmacy.umaryland.edu/
DeviceEval). In 2015, two
multistakeholder groups issued reports
that develop the science and provide
recommendations that further the
establishment of this system: ‘‘Building
an Effective National Medical Device
Surveillance System’’ and
‘‘Recommendations for a National
Medical Device Evaluation System:
Strategically Coordinated Registry
Networks to Bridge the Clinical Care
and Research’’ (available at
www.pharmacy.umaryland.edu/
DeviceEval).
To successfully harness relevant
information from the diverse set of realworld evidence, the United States must
develop the necessary infrastructure
which is not yet in place today. We
continue to explore ways to improve the
efficiency and cost-effectiveness of data
generation in traditional medical device
clinical trials while maintaining data
quality. The goal is to streamline the
process and restore the United States to
the country of first choice to conduct
clinical research for medical technology
innovation and ultimately bring their
products first to U.S. patients.
Limitations of current postmarket
surveillance tools, such as passive
reporting, also constrain ability to
rapidly address safety concerns. A
national evaluation system for medical
devices, which leverages real-world
evidence, can help FDA more efficiently
strike the right balance between
premarket and postmarket data
collection, facilitate access to medical
devices, and more quickly and robustly
identify safety signals that may arise in
the postmarket period. The promise of
using real-world evidence to promote
the safety and effectiveness of medical
devices can only be achieved through
robust public-private partnerships and
new approaches to informatics,
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7807
epidemiology, biostatistics, and
healthcare data systems integration.
This workshop will provide
clinicians, researchers, and others from
the medical device industry,
professional societies, health care
delivery systems groups, patient
advocacy groups, and FDA the
opportunity to discuss this important
topic.
Agenda: The agenda is located at
www.pharmacy.umaryland.edu/
DeviceEval.
Registration: There is a registration fee
to attend this public workshop. The
registration fee is charged to help defray
the costs for facilities, materials, and
food. Seats are limited and registration
will be on a first-come, first-served
basis.
To register, please complete
registration online at:
www.pharmacy.umaryland.edu/
DeviceEval. The costs of registration for
the different categories of attendees are
as follows:
Pilot Project(s) under the Drug Supply
Chain Security Act (DSCSA).’’ This
public workshop will provide a forum
for discussing proposed design
objectives of pilot projects that will
explore and evaluate methods to
enhance the safety and security of the
pharmaceutical distribution supply
chain. FDA would like to obtain
information and input from interested
pharmaceutical distribution supply
chain members about issues related to
utilizing the product identifier for
product tracing, improving the technical
capabilities of the supply chain, and
identifying the system attributes that are
necessary to implement the
requirements established under the
DSCSA. The information gathered from
the workshop and the public comments
submitted to the docket will further
inform FDA’s development of its pilot
project program.
DATES: The public workshop will be
held on April 5, 2016, from 9 a.m. to 5
p.m. and April 6, 2016, from 9 a.m. to
12:15 p.m. The deadline for submitting
Category
Cost
either electronic or written comments
on this workshop is April 21, 2016. See
Industry Representative ........
$50
the SUPPLEMENTARY INFORMATION section
Charitable Nonprofit and
for registration date and information.
Academic Other Than University of Maryland ............
50 ADDRESSES: The public workshop will
University of Maryland, Colbe held at FDA’s White Oak Campus,
lege Park and Baltimore ...
0 10903 New Hampshire Ave., Bldg. 31
Government ..........................
0 Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993–0002.
Accommodations: Attendees are
Entrance for the confirmed public
responsible for their own hotel
workshop participants (non-FDA
accommodations. If you need special
employees) is through Building 1 where
accommodations due to a disability,
routine security check procedures will
please contact Ann Anonsen (see FOR
be performed. For parking and security
FURTHER INFORMATION CONTACT).
information, please refer to https://
Dated: February 9, 2016.
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
Leslie Kux,
WhiteOakCampusInformation/
Associate Commissioner for Policy.
ucm241740.htm.
[FR Doc. 2016–02966 Filed 2–12–16; 8:45 am]
You may submit comments as
BILLING CODE 4164–01–P
follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0407]
Proposed Pilot Project(s) Under the
Drug Supply Chain Security Act;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘Proposed
SUMMARY:
PO 00000
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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
E:\FR\FM\16FEN1.SGM
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7808
Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–N–0407 for ‘‘Proposed Pilot
Project(s) under the Drug Supply Chain
Security Act; Public Workshop; Request
for Comments.’’ 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
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• 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 Division of Dockets
Management. 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
VerDate Sep<11>2014
22:15 Feb 12, 2016
Jkt 238001
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–3130,
CDERODSIRpublicmeetings@
fda.hhs.gov (include ‘‘DSCSA pilot
projects’’ in the subject line).
SUPPLEMENTARY INFORMATION:
I. Background
On November 27, 2013, the Drug
Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113–54) was signed
into law. The DSCSA outlines critical
steps to build an electronic,
interoperable system by November 27,
2023, which will identify and trace
certain prescription drugs as they are
distributed within the United States.
Section 202 of the DSCSA added the
new sections 581 and 582 to the Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360eee and 360eee–1). Under
section 582(j), FDA is required 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.
FDA intends to establish a pilot
project program to implement section
582(j) of the FD&C Act. The overarching
goals of this program include assessing
the ability of supply chain members to
satisfy the requirements of section 582
and to identify, manage, and prevent the
distribution of suspect and illegitimate
drugs; identifying the system attributes
needed to implement the requirements
of section 582, particularly the
requirement to utilize a product
PO 00000
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Sfmt 4703
identifier for product tracing purposes;
and demonstrating the electronic,
interoperable exchange of product
tracing information across the
pharmaceutical distribution supply
chain. FDA intends to coordinate its
pilot project program efforts with
stakeholders that reflect the diversity of
the pharmaceutical distribution supply
chain, including large and small entities
from all industry sectors.
II. Purpose of the Public Workshop
This public workshop is intended to
provide an opportunity for interested
persons to provide comments on and
discuss the proposed design objectives
of pilot projects that will explore and
evaluate methods to enhance the safety
and security of the pharmaceutical
distribution supply chain. FDA would
like to obtain information and input
from interested pharmaceutical
distribution supply chain members
about issues related to utilizing the
product identifier for product tracing,
improving the technical capabilities of
the pharmaceutical distribution supply
chain, and identifying the system
attributes that are necessary to
implement the requirements under
section 582. FDA would also like to
learn more about the practices,
processes, and systems that supply
chain stakeholders currently use or plan
to use to meet the requirements under
section 582, particularly the product
tracing and verification requirements.
These practices, processes, and systems
may include those that supply chain
stakeholders would consider using in
pilot projects or those that supply chain
stakeholders have already used in other
previous pilot projects.
By March 29, 2016, FDA will post the
workshop agenda and other relevant
materials under the DSCSA section of
its Web site at https://www.fda.gov/
Drugs/NewsEvents/ucm481767.htm.
Supply chain stakeholders that might be
interested in attending the public
workshop include manufacturers,
repackagers, wholesale distributors,
dispensers, State and Federal
authorities, solution providers, and
standards organizations. Participants at
the workshop will not be asked to
develop consensus opinions during the
discussion, but rather to provide their
individual perspectives.
Regardless of attendance at the public
workshop, interested stakeholders may
submit comments to the public docket
related to any of the public workshop
materials, including the agenda and
other posted materials on FDA’s Web
site, in addition to comments specific to
the design of pilot projects that will
explore and evaluate methods to
E:\FR\FM\16FEN1.SGM
16FEN1
Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
enhance the safety and security of the
pharmaceutical distribution supply
chain. Stakeholders may comment on
utilizing the product identifier for
product tracing and the technical
capabilities of the pharmaceutical
distribution supply chain and the
system attributes that are necessary to
implement the requirements under
section 582. The information gathered
from the workshop participants and
from the comments submitted to the
docket for the public workshop will
further inform FDA’s development of its
pilot project program under section
582(j) of the FD&C Act.
Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
III. Registration for the Public
Workshop
AGENCY:
To request registration for the public
workshop, provide your information
including name, company or
organization, address, telephone
number, and email address to FDA at
https://www.fda.gov/Drugs/NewsEvents/
ucm481767.htm. Registration requests
should be received by March 11, 2016.
FDA is limiting workshop attendance
due to limited space. FDA may limit the
number of participants from each
organization based on space limitations.
FDA recommends that each
organization determine who should
register for the workshop to represent
his/her organization. This will help
ensure that the workshop will have
broad and varied representation across
the pharmaceutical distribution supply
chain. Registrants will receive
confirmation of participation for the
workshop from FDA by March 18, 2016.
There is no registration fee for the
public workshop. There will be no
onsite registration. If registration
reaches maximum capacity, FDA will
post a notice closing registration for the
workshop on FDA’s Web site at https://
www.fda.gov/Drugs/NewsEvents/
ucm481767.htm. If you need special
accommodations due to a disability,
please contact Daniel Bellingham (see
FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the public
workshop.
ACTION:
mstockstill on DSK4VPTVN1PROD with NOTICES
Portions of this public workshop will
be recorded and Webcasted on the day
of the workshop. Information for how to
access the Webcast will be available at
https://www.fda.gov/Drugs/NewsEvents/
ucm481767.htm by March 29, 2016. The
Webcast will be conducted in listeningmode only.
22:15 Feb 12, 2016
Jkt 238001
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0437]
Evaluation of the Safety of Drugs and
Biological Products Used During
Lactation; Public Workshop; Request
for Comments
Food and Drug Administration,
HHS.
IV. Webcasting of the Public Workshop
VerDate Sep<11>2014
[FR Doc. 2016–02977 Filed 2–12–16; 8:45 am]
Notice of public workshop;
request for comments.
The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘Evaluation of
the Safety of Drugs and Biological
Products used during Lactation.’’ The
purpose of this workshop is to provide
a forum to discuss the current state and
future directions of the collection of
data on the potential risks to breastfed
infants with maternal use of
medications during lactation. The
workshop will review current
approaches to the collection of data
when drugs are used or expected to be
used during lactation. The workshop
will also discuss and consider novel
approaches to improve the quality and
quantity of data, to inform of the
potential risks of medication use during
lactation, and to raise awareness and
engage stakeholders about
communication of safety information
related to maternal use of medications
during lactation.
DATES: The public workshop will be
held on April 27, 2016, from 8 a.m. to
5 p.m.; and April 28, 2016, from 8 a.m.
to 1 p.m. Registration closes on April 8,
2016. Submit electronic or written
comments to the public docket by May
28, 2016.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993–0002.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
SUMMARY:
PO 00000
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Fmt 4703
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7809
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public submit the comment as a written/
paper submission and in the manner
detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–N–0437 for ‘‘Evaluation of the
Safety of Drugs and Biological Products
used during Lactation; Public
Workshop; Request for Comments.’’
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
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available submit your
E:\FR\FM\16FEN1.SGM
16FEN1
]]>Agencies
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7807-7809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02977]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0407]
Proposed Pilot Project(s) Under the Drug Supply Chain Security
Act; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Proposed Pilot Project(s) under the Drug Supply
Chain Security Act (DSCSA).'' This public workshop will provide a forum
for discussing proposed design objectives of pilot projects that will
explore and evaluate methods to enhance the safety and security of the
pharmaceutical distribution supply chain. FDA would like to obtain
information and input from interested pharmaceutical distribution
supply chain members about issues related to utilizing the product
identifier for product tracing, improving the technical capabilities of
the supply chain, and identifying the system attributes that are
necessary to implement the requirements established under the DSCSA.
The information gathered from the workshop and the public comments
submitted to the docket will further inform FDA's development of its
pilot project program.
DATES: The public workshop will be held on April 5, 2016, from 9 a.m.
to 5 p.m. and April 6, 2016, from 9 a.m. to 12:15 p.m. The deadline for
submitting either electronic or written comments on this workshop is
April 21, 2016. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the confirmed
public workshop participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments 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
[[Page 7808]]
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-0407 for ``Proposed Pilot Project(s) under the Drug Supply
Chain Security Act; Public Workshop; Request for Comments.'' 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 Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3130, CDERODSIRpublicmeetings@fda.hhs.gov (include ``DSCSA
pilot projects'' in the subject line).
SUPPLEMENTARY INFORMATION:
I. Background
On November 27, 2013, the Drug Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113-54) was signed into law. The DSCSA outlines
critical steps to build an electronic, interoperable system by November
27, 2023, which will identify and trace certain prescription drugs as
they are distributed within the United States. Section 202 of the DSCSA
added the new sections 581 and 582 to the Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360eee and 360eee-1). Under section 582(j), FDA
is required 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.
FDA intends to establish a pilot project program to implement
section 582(j) of the FD&C Act. The overarching goals of this program
include assessing the ability of supply chain members to satisfy the
requirements of section 582 and to identify, manage, and prevent the
distribution of suspect and illegitimate drugs; identifying the system
attributes needed to implement the requirements of section 582,
particularly the requirement to utilize a product identifier for
product tracing purposes; and demonstrating the electronic,
interoperable exchange of product tracing information across the
pharmaceutical distribution supply chain. FDA intends to coordinate its
pilot project program efforts with stakeholders that reflect the
diversity of the pharmaceutical distribution supply chain, including
large and small entities from all industry sectors.
II. Purpose of the Public Workshop
This public workshop is intended to provide an opportunity for
interested persons to provide comments on and discuss the proposed
design objectives of pilot projects that will explore and evaluate
methods to enhance the safety and security of the pharmaceutical
distribution supply chain. FDA would like to obtain information and
input from interested pharmaceutical distribution supply chain members
about issues related to utilizing the product identifier for product
tracing, improving the technical capabilities of the pharmaceutical
distribution supply chain, and identifying the system attributes that
are necessary to implement the requirements under section 582. FDA
would also like to learn more about the practices, processes, and
systems that supply chain stakeholders currently use or plan to use to
meet the requirements under section 582, particularly the product
tracing and verification requirements. These practices, processes, and
systems may include those that supply chain stakeholders would consider
using in pilot projects or those that supply chain stakeholders have
already used in other previous pilot projects.
By March 29, 2016, FDA will post the workshop agenda and other
relevant materials under the DSCSA section of its Web site at https://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. Supply chain stakeholders
that might be interested in attending the public workshop include
manufacturers, repackagers, wholesale distributors, dispensers, State
and Federal authorities, solution providers, and standards
organizations. Participants at the workshop will not be asked to
develop consensus opinions during the discussion, but rather to provide
their individual perspectives.
Regardless of attendance at the public workshop, interested
stakeholders may submit comments to the public docket related to any of
the public workshop materials, including the agenda and other posted
materials on FDA's Web site, in addition to comments specific to the
design of pilot projects that will explore and evaluate methods to
[[Page 7809]]
enhance the safety and security of the pharmaceutical distribution
supply chain. Stakeholders may comment on utilizing the product
identifier for product tracing and the technical capabilities of the
pharmaceutical distribution supply chain and the system attributes that
are necessary to implement the requirements under section 582. The
information gathered from the workshop participants and from the
comments submitted to the docket for the public workshop will further
inform FDA's development of its pilot project program under section
582(j) of the FD&C Act.
III. Registration for the Public Workshop
To request registration for the public workshop, provide your
information including name, company or organization, address, telephone
number, and email address to FDA at https://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. Registration requests should be received by
March 11, 2016. FDA is limiting workshop attendance due to limited
space. FDA may limit the number of participants from each organization
based on space limitations. FDA recommends that each organization
determine who should register for the workshop to represent his/her
organization. This will help ensure that the workshop will have broad
and varied representation across the pharmaceutical distribution supply
chain. Registrants will receive confirmation of participation for the
workshop from FDA by March 18, 2016. There is no registration fee for
the public workshop. There will be no onsite registration. If
registration reaches maximum capacity, FDA will post a notice closing
registration for the workshop on FDA's Web site at https://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. If you need special accommodations due
to a disability, please contact Daniel Bellingham (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in advance of the public workshop.
IV. Webcasting of the Public Workshop
Portions of this public workshop will be recorded and Webcasted on
the day of the workshop. Information for how to access the Webcast will
be available at https://www.fda.gov/Drugs/NewsEvents/ucm481767.htm by
March 29, 2016. The Webcast will be conducted in listening-mode only.
Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02977 Filed 2-12-16; 8:45 am]
BILLING CODE 4164-01-P
