Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act; Public Meetings; Request for Comments, 33505-33507 [2017-15204]
Download as PDF
Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices
which can be submitted to the Dockets
Management Staff (see ADDRESSES). For
context, please indicate if you are
commenting as a patient with HAE or
on behalf of a child or loved one.
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
(1) Of all of the symptoms that you
experience because of your condition,
which one of these symptoms has the
most significant impact on your life?
Examples may include nausea,
vomiting, abdominal pain, swelling of
extremities, facial swelling, tongue
swelling, hoarseness or loss of voice,
shortness of breath, and difficulty
urinating.
(2) Are there specific activities that
are important to you that you cannot do
at all or as well as you would like
because of your condition? Please
describe, using specific examples.
Examples may include: Participating in
physical activities; and attending work
or school and family or social activities,
during or between attacks.
(3) How have your condition and its
symptoms changed over time?
(4) What worries you most about your
condition?
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Topic 2: Patients’ Perspectives on
Current Approaches to Treatment
(1) What are you currently doing to
treat your condition and its symptoms?
• What, if anything, are you doing to
prevent acute HAE attacks? Examples
may include treatments with
prescription medicines; over-thecounter products; and other therapies,
including non-drug therapies.
• What, if anything, do you selfadminister for acute HAE attacks?
• If you give yourself medication for
acute HAE attacks, which types of
attacks, with respect to body location(s),
are you comfortable treating yourself?
• What treatment has your health
professional used for your acute HAE
attacks? Examples may include
prescription medicines; over-thecounter products; and other therapies,
including non-drug therapies.
(2) How well do these treatments
work for you?
(3) What are the most significant
disadvantages or complications of your
current treatments, and how do they
affect your daily life?
(4) How has your treatment regimen
changed over time and why?
(5) What aspects of your condition are
not improved by your current treatment
regimen?
(6) What treatment has had the most
positive impact on your quality of life?
(7) Short of a complete cure for your
condition, what specific things would
VerDate Sep<11>2014
18:50 Jul 19, 2017
Jkt 241001
you look for in an ideal treatment for
your condition?
(8) If you had the opportunity to
consider participating in a clinical trial
studying experimental treatments, what
things would you consider when
deciding whether or not to participate?
III. Meeting Attendance and
Participation
Registration: If you wish to attend this
meeting, visit https://
www.eventbrite.com/e/patient-focuseddrug-development-for-hereditaryangioedema-public-meeting-tickets32300298061. Persons interested in
attending this public meeting must
register by August 10, 2017. If you are
unable to attend the meeting in person,
you can register to view a live Webcast
of the meeting. You will be asked to
indicate in your registration if you plan
to attend in person or via the Webcast.
Registration is free and based on space
availability, with priority given to early
registrants. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation once they have been
accepted. Onsite registration on the day
of the meeting will be based on space
availability. If you need special
accommodations due to a disability,
please contact Barbara Kass or Loni
Warren Henderson (see FOR FURTHER
INFORMATION CONTACT) no later than
September 18, 2017.
Requests for Oral Presentations:
Patients and patient representatives who
are interested in presenting comments
as part of the initial panel discussions
will be asked to indicate in their
registration which topic(s) they wish to
address. These patients and patient
representatives also must send to
PatientFocused_CBER@fda.hhs.gov a
brief summary of responses to the topic
questions by August 3, 2017. Panelists
will be notified of their selection
approximately 7 days before the public
meeting. We will try to accommodate all
patients and patient representatives who
wish to speak, either through the panel
discussion or audience participation;
however, the duration of comments may
be limited by time constraints.
Transcripts: Please be advised that, as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
Internet at https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
ucm542320.htm.
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
33505
Dated: July 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15202 Filed 7–19–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3857]
Enhanced Drug Distribution Security
Under the Drug Supply Chain Security
Act; Public Meetings; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meetings;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing three public meetings
entitled ‘‘Enhanced Drug Distribution
Security Under the Drug Supply Chain
Security Act (DSCSA).’’ These public
meetings are intended 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.
DATES: The public meetings will be held
on: August 23, 2017, from 9 a.m. to 4
p.m.; December 5 and 6, 2017, from 9
a.m. to 4 p.m.; and February 28, 2018,
from 9 a.m. to 4 p.m.
ADDRESSES: The public meetings will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503A, Silver Spring, MD 20993.
Entrance for the public meeting
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.
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 the deadlines for
submitting either electronic or written
comments are 30 days after the meeting
to which the comments relate.
Comments received by mail/hand
delivery/courier (for written/paper
SUMMARY:
E:\FR\FM\20JYN1.SGM
20JYN1
33506
Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices
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
midnight Eastern Time at the end of the
specified date. See the SUPPLEMENTARY
INFORMATION section for registration
dates and for the deadlines for
submitting electronic or written
comments related to these public
meetings (table 1).
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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–
2017–N–3857 for ‘‘Enhanced Drug
Distribution Security Under the Drug
Supply Chain Security Act; Public
Meetings; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
VerDate Sep<11>2014
18:50 Jul 19, 2017
Jkt 241001
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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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, 301–
796–3130, CDERODSIRPublicMeetings@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On November 27, 2013, the Drug
Supply Chain Security Act (DSCSA)
(Title II, Pub. L. 113–54) was signed into
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360eee–1(i)),
which was added by the DSCSA, directs
FDA to hold public meetings to enhance
the safety and security of the
pharmaceutical distribution supply
chain and provide opportunities for
comment from stakeholders.
II. Purpose of the Public Meetings
FDA will hold public meetings on
August 23, 2017, December 5 and 6,
2017, and February 28, 2018, on
enhanced drug distribution security.
The purpose of these public meetings 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. These public meetings will
focus on the following topics for
discussion:
• What supply chain security should
look like in 2023
• What is needed for enhanced drug
distribution security
• What is needed for electronic
interoperability
• Standards for product tracing
• Data architecture options for an
electronic interoperable system
• The management and maintenance of
product tracing data
• The use of aggregation and inference
for enhanced product tracing and
verification
• Building capacity for a unit-level
system for product tracing and
verification
FDA may include additional
discussion topics. Materials for each
public meeting will be provided on
FDA’s Web site at https://www.fda.gov/
Drugs/NewsEvents/UCM559090.htm 10
days before each public meeting.
III. Registration for the Public Meetings
To request registration for the public
meetings, provide your information
including name, company or
organization, address, telephone
number, and email address to FDA at
E:\FR\FM\20JYN1.SGM
20JYN1
Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices
https://www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. Registration requests
for each meeting should be received
during the time periods specified in
table 1. FDA is limiting attendance due
to restricted space. In addition, 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 public meeting to
represent his/her organization. This will
help ensure that the meeting will have
broad and varied representation,
including across the pharmaceutical
distribution supply chain. Registrants
will receive confirmation of
participation for their chosen meeting
from FDA within 14 days of the date of
each meeting. There is no registration
fee for the public meetings. There will
be no onsite registration. If registration
33507
reaches maximum capacity, FDA will
post a notice closing registration for the
meeting on FDA’s Web site at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.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
meeting.
TABLE 1—PUBLIC MEETING INFORMATION
Public meeting
Topics
# 1 ..........................
• Supply chain security in 2023 ...........
• Enhanced drug distribution security
needs.
Advance registration .............................
# 2 ..........................
# 3 ..........................
Comment period closes ........................
Request special accommodations due
to a disability.
• Electronic interoperability ..................
• Standards for data exchange ...........
• Data architecture ...............................
• Aggregation and inference.
Advance registration .............................
Comment period closes ........................
Request special accommodations due
to a disability.
• Further refinement of enhanced drug
distribution security needs.
• Building capacity for a unit-level system.
Advance registration .............................
Comment period closes ........................
Request special accommodations due
to a disability.
IV. Webcasting of the Public Meeting
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Portions of each public meeting will
be recorded and webcast on the day of
the meeting. Information for how to
access the webcast will be available at
https://www.fda.gov/Drugs/NewsEvents/
UCM559090.htm within 7 days prior to
each public meeting. The webcast will
be conducted in listening mode only.
Dated: July 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15204 Filed 7–19–17; 8:45 am]
August 23, 2017, 9 a.m. to 4 p.m.
by July 31, 2017 ...................................
September 22, 2017 .............................
by August 16, 2017 ..............................
October 2–27, 2017 ..............................
January 5, 2018 ....................................
by November 28, 2017 .........................
January 2–26, 2018 ..............................
March 30, 2018 .....................................
by February 21, 2018 ...........................
Food and Drug Administration
[Docket No. FDA–2010–N–0597]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
SUMMARY:
18:50 Jul 19, 2017
Jkt 241001
PO 00000
Frm 00032
Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registration.
See ‘‘Comments’’.
See FOR FURTHER INFORMATION
CONTACT.
February 28, 2018, 9 a.m. to 4 p.m.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registration.
See ‘‘Comments’’.
See FOR FURTHER INFORMATION
CONTACT.
December 5–6, 2017, 9 a.m. to 4 p.m.
BILLING CODE 4164–01–P
VerDate Sep<11>2014
Relevant section of this document or
electronic address
Date/Time
Fmt 4703
Sfmt 4703
Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registration.
See ‘‘Comments’’.
See FOR FURTHER INFORMATION
CONTACT.
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by August 21,
2017.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0620. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
E:\FR\FM\20JYN1.SGM
20JYN1
Agencies
[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33505-33507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15204]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-3857]
Enhanced Drug Distribution Security Under the Drug Supply Chain
Security Act; Public Meetings; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meetings; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing three public meetings entitled ``Enhanced Drug Distribution
Security Under the Drug Supply Chain Security Act (DSCSA).'' These
public meetings are intended 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.
DATES: The public meetings will be held on: August 23, 2017, from 9
a.m. to 4 p.m.; December 5 and 6, 2017, from 9 a.m. to 4 p.m.; and
February 28, 2018, from 9 a.m. to 4 p.m.
ADDRESSES: The public meetings will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503A, Silver Spring, MD 20993.
Entrance for the public meeting 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.
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 the deadlines for submitting either
electronic or written comments are 30 days after the meeting to which
the comments relate. Comments received by mail/hand delivery/courier
(for written/paper
[[Page 33506]]
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 midnight Eastern Time at the end of the specified date.
See the SUPPLEMENTARY INFORMATION section for registration dates and
for the deadlines for submitting electronic or written comments related
to these public meetings (table 1).
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-2017-N-3857 for ``Enhanced Drug Distribution Security Under the
Drug Supply Chain Security Act; Public Meetings; 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.
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.gpo.gov/fdsys/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.
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, 301-
796-3130, CDERODSIRPublicMeetings@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On November 27, 2013, the Drug Supply Chain Security Act (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(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360eee-1(i)), which was added by the DSCSA,
directs FDA to hold public meetings to enhance the safety and security
of the pharmaceutical distribution supply chain and provide
opportunities for comment from stakeholders.
II. Purpose of the Public Meetings
FDA will hold public meetings on August 23, 2017, December 5 and 6,
2017, and February 28, 2018, on enhanced drug distribution security.
The purpose of these public meetings 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. These public meetings will focus on
the following topics for discussion:
What supply chain security should look like in 2023
What is needed for enhanced drug distribution security
What is needed for electronic interoperability
Standards for product tracing
Data architecture options for an electronic interoperable
system
The management and maintenance of product tracing data
The use of aggregation and inference for enhanced product
tracing and verification
Building capacity for a unit-level system for product tracing
and verification
FDA may include additional discussion topics. Materials for each
public meeting will be provided on FDA's Web site at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm 10 days before each public
meeting.
III. Registration for the Public Meetings
To request registration for the public meetings, provide your
information including name, company or organization, address, telephone
number, and email address to FDA at
[[Page 33507]]
https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. Registration
requests for each meeting should be received during the time periods
specified in table 1. FDA is limiting attendance due to restricted
space. In addition, 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 public meeting to
represent his/her organization. This will help ensure that the meeting
will have broad and varied representation, including across the
pharmaceutical distribution supply chain. Registrants will receive
confirmation of participation for their chosen meeting from FDA within
14 days of the date of each meeting. There is no registration fee for
the public meetings. There will be no onsite registration. If
registration reaches maximum capacity, FDA will post a notice closing
registration for the meeting on FDA's Web site at https://www.fda.gov/Drugs/NewsEvents/UCM559090.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 meeting.
Table 1--Public Meeting Information
----------------------------------------------------------------------------------------------------------------
Relevant section of
Public meeting Topics Date/Time this document or
electronic address
----------------------------------------------------------------------------------------------------------------
# 1.................................. Supply chain August 23, 2017, 9 a.m.
security in 2023. to 4 p.m.
Enhanced drug
distribution security
needs.
Advance registration... by July 31, 2017....... Online registration
only at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. No
onsite registration.
Comment period closes.. September 22, 2017..... See ``Comments''.
Request special by August 16, 2017..... See FOR FURTHER
accommodations due to INFORMATION CONTACT.
a disability.
# 2.................................. Electronic December 5-6, 2017, 9
interoperability. a.m. to 4 p.m.
Standards for
data exchange.
Data
architecture.
Aggregation
and inference.
Advance registration... October 2-27, 2017..... Online registration
only at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. No
onsite registration.
Comment period closes.. January 5, 2018........ See ``Comments''.
Request special by November 28, 2017... See FOR FURTHER
accommodations due to INFORMATION CONTACT.
a disability.
# 3.................................. Further February 28, 2018, 9
refinement of enhanced a.m. to 4 p.m.
drug distribution
security needs.
Building
capacity for a unit-
level system.
Advance registration... January 2-26, 2018..... Online registration
only at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. No
onsite registration.
Comment period closes.. March 30, 2018......... See ``Comments''.
Request special by February 21, 2018... See FOR FURTHER
accommodations due to INFORMATION CONTACT.
a disability.
----------------------------------------------------------------------------------------------------------------
IV. Webcasting of the Public Meeting
Portions of each public meeting will be recorded and webcast on the
day of the meeting. Information for how to access the webcast will be
available at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm within
7 days prior to each public meeting. The webcast will be conducted in
listening mode only.
Dated: July 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15204 Filed 7-19-17; 8:45 am]
BILLING CODE 4164-01-P