Responsible Innovation in Dietary Supplements; Public Meeting; Request for Comments, 14660-14662 [2019-07168]
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Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2019–N–1388]
Centers for Disease Control and
Prevention
Responsible Innovation in Dietary
Supplements; Public Meeting; Request
for Comments
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
AGENCY:
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AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
SUMMARY:
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we) is announcing the following public
meeting entitled ‘‘Responsible
Innovation in Dietary Supplements.’’
The purpose of the public meeting is to
give interested parties an opportunity to
present ideas for facilitating responsible
innovation in the dietary supplement
industry while preserving and
strengthening FDA’s ability to
efficiently and effectively protect the
public from unsafe and unlawful
products.
The public meeting will be held
on May 16, 2019, from 8:30 a.m. to 4
p.m. Eastern Time. Submit either
electronic or written comments on this
public meeting by July 15, 2019. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at Food and Drug Administration,
Center for Food Safety and Applied
Nutrition, Wiley Auditorium, 5001
Campus Dr., College Park, MD 20740.
FDA is establishing a docket for
public comment on this meeting. You
may submit comments as follows.
Please note that late, untimely filed
comments may not be considered.
Electronic comments must be submitted
on or before July 15, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
July 15, 2019. 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.
DATES:
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
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Federal Register / Vol. 84, No. 70 / Thursday, April 11, 2019 / Notices
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
amozie on DSK9F9SC42PROD 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–
2019–N–1388 for ‘‘Responsible
Innovation in Dietary Supplements;
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.
• 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
our 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/
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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:
Juanita Yates, Food and Drug
Administration, Center for Food Safety
and Applied Nutrition (HFS–009), 5001
Campus Dr., College Park, MD 20740,
240–402–1731, email: Juanita.yates@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On February 11, 2019, FDA
announced new efforts to strengthen the
regulation of dietary supplements by
modernizing and reforming FDA’s
oversight (see Statement from FDA
Commissioner Scott Gottlieb, M.D., on
the Agency’s new efforts to strengthen
regulation of dietary supplements by
modernizing and reforming FDA’s
oversight, available at https://
www.fda.gov/NewsEvents/Newsroom/
PressAnnouncements/ucm631065.htm).
FDA’s announcement acknowledged the
need to ensure that our regulatory
framework is flexible enough to
adequately evaluate product safety
without unnecessarily restricting
innovation. We invite public input
about whether and how we should
adjust our current dietary supplement
regulatory approach to better allow for
innovation and growth in the dietary
supplement marketplace while
maintaining and strengthening our
ability to efficiently and effectively
evaluate product safety and protect the
public health.
The Dietary Supplement Health and
Education Act of 1994 (DSHEA) (Pub. L.
103–417) amended the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and
defined ‘‘dietary supplement,’’ in part,
as a product (other than tobacco)
intended to supplement the diet that
bears or contains one or more of the
following dietary ingredients:
(A) A vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man
to supplement the diet by increasing the
total dietary intake; or
(F) a concentrate, metabolite,
constituent, extract, or combination of
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14661
any ingredient described in clause (A),
(B), (C), (D), or (E).
Section 201(ff)(1) of the FD&C Act (21
U.S.C. 321(ff)(1)).
DSHEA clarified that dietary
supplements are generally subject to
regulation as foods under the FD&C Act
but also included dietary supplementspecific adulteration and misbranding
provisions. Among other things, DSHEA
provided authority for FDA to establish
current good manufacturing practice
requirements for dietary supplements
and clarified the statements of
nutritional support that can be made in
product labeling. Dietary supplement
manufacturers and distributors are
responsible for selling products that
comply with these requirements. FDA is
responsible for regulating dietary
supplements and has authority to take
enforcement action when dietary
supplements are adulterated or
misbranded.
DSHEA also added section 413 of the
FD&C Act (21 U.S.C. 350b), which
defines the term ‘‘new dietary
ingredient’’ (NDI) and describes
requirements for NDIs. Among other
things, section 413 of the FD&C Act
requires the manufacturer or distributor
of an NDI, or of a dietary supplement
containing an NDI, to submit a
premarket notification to FDA at least
75 days before introducing the NDI or
dietary supplement into interstate
commerce, unless the NDI and any other
dietary ingredients in the dietary
supplement have been present in the
food supply as an article used for food
in a form in which the food has not been
chemically altered (21 U.S.C.
350b(a)(1)).
DSHEA contemplated a dynamic
dietary supplement market with a role
for innovation. In the 25 years since
DSHEA was enacted, the dietary
supplement market has grown
significantly. What was once a $4
billion industry comprising about 4,000
products is now an industry worth more
than $40 billion with more than
50,000—and possibly as many as 80,000
or even more—products available to
consumers. Innovative new products
involving novel technologies related to
ingredients, manufacturing processes,
and delivery systems represent a
substantial portion of this growth.
A robust NDI notification process is
an integral part of the DSHEA
framework and represents FDA’s only
opportunity to evaluate the safety of
NDIs in dietary supplements before they
become available to consumers. Despite
the expanded marketplace, however, we
have only received about 1,200 NDI
notifications since DSHEA’s enactment.
FDA recognizes that not every new
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Federal Register / Vol. 84, No. 70 / Thursday, April 11, 2019 / Notices
dietary supplement product is subject to
the notification requirement, so we
continue to provide clarifications on
when premarket notifications are
required.1 A transparent, common
understanding of the requirements
surrounding dietary ingredient status
and notification, with predictable
expectations regarding compliance and
consequences for non-compliance, will
help our regulatory processes operate
effectively. Public discussion of these
issues will further our efforts to
strengthen regulation of dietary
supplements through modernization
and reform and help us better protect
the public health.
II. Topics for Discussion at the Public
Meeting
FDA will host a one-day public
meeting to provide interested parties an
opportunity to discuss various issues
related to responsible innovation in
dietary supplements, including the
following topics:
(1) The scope of the phrase ‘‘dietary
substance for use by man to supplement
the diet by increasing the total dietary
intake,’’ as used in DSHEA (section
201(ff)(1)(E) of the FD&C Act);
(2) Understanding exceptions to the
requirement for premarket notification,
and evaluating whether and how growth
in the marketplace since 1994 has
altered the impact of those provisions;
(3) Potential commercial or marketing
advantages to incentivize responsible
innovation; and
(4) Promoting overall compliance
with the premarket notification
requirement through enforcement.
The issues discussed at the public
meeting, including the above topics, and
any comments submitted to the docket
by July 15, 2019, will help us evaluate
how to proceed with our efforts to
modernize and reform FDA’s oversight
of dietary supplements.
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III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit the following
website: https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetings
Conferences/ucm632939.htm. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability. Persons interested in
1 See, e.g., Draft Guidance for Industry: Dietary
Supplements: New Dietary Ingredient Notifications
and Related Issues (August 2016), available at
https://www.fda.gov/food/guidanceregulation/
guidancedocumentsregulatoryinformation/dietary
supplements/ucm257563.htm. This draft guidance,
when finalized, will represent FDA’s current
thinking on this topic.
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attending this public meeting should
register by May 6, 2019, 11:59 p.m.
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning at 8 a.m. We will let
registrants know if registration closes
before the day of the public meeting.
Please visit the website at https://
www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/
ucm632939.htm for this information as
well as the final meeting agenda.
If you need special accommodations
due to a disability, please contact
Juanita Yates (see FOR FURTHER
INFORMATION CONTACT) no later than May
1, 2019.
Requests for Oral Comments: During
online registration you may indicate if
you wish to present during a public
comment session and which topic(s)
you wish to address. We are seeking a
broad representation of ideas and issues
presented at the meeting. We will do
our best to accommodate requests to
make public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
remarks and to request time for a joint
comment. After registration closes, we
will determine the amount of time
allotted to each participant and the
approximate time each oral comment is
to begin and will select and notify
participants by May 10, 2019. All
requests to make oral comments must be
received by the close of registration on
May 1, 2019. No commercial or
promotional material will be permitted
to be presented or distributed at the
public meeting.
Those without internet or email
access can register and/or request to
participate by contacting Juanita Yates
by the above dates (see FOR FURTHER
INFORMATION CONTACT).
Streaming Webcast of the public
meeting: This public meeting will also
be webcast. Please visit the following
website to register: https://www.fda.gov/
Food/NewsEvents/WorkshopsMeetings
Conferences/ucm632939.htm.
FDA has verified the website
addresses in this document, as of the
date this document publishes in the
Federal Register, but websites are
subject to change over time.
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 also
may be viewed at the Dockets
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Management Staff (see ADDRESSES). A
link to the transcript will also be
available on the internet at https://
www.fda.gov/Food/NewsEvents/
WorkshopsMeetingsConferences/
ucm632939.htm.
Dated: April 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07168 Filed 4–10–19; 8:45 am]
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National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Council of Research Advocates,
April 11, 2019, 9:30 a.m. to 4:00 p.m.,
National Institutes of Health, Building
31, Room 10A28, 31 Center Drive,
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This meeting notice is amended to
change the meeting date, start time, and
location. The meeting will now be held
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National Institutes of Health, Building
40, Room 1201/1203, 40 Convent Drive,
Bethesda, MD 20892. This meeting is
open to the public.
Dated: April 8, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
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]]>Agencies
[Federal Register Volume 84, Number 70 (Thursday, April 11, 2019)]
[Notices]
[Pages 14660-14662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07168]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1388]
Responsible Innovation in Dietary Supplements; Public Meeting;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Responsible
Innovation in Dietary Supplements.'' The purpose of the public meeting
is to give interested parties an opportunity to present ideas for
facilitating responsible innovation in the dietary supplement industry
while preserving and strengthening FDA's ability to efficiently and
effectively protect the public from unsafe and unlawful products.
DATES: The public meeting will be held on May 16, 2019, from 8:30 a.m.
to 4 p.m. Eastern Time. Submit either electronic or written comments on
this public meeting by July 15, 2019. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public meeting will be held at Food and Drug
Administration, Center for Food Safety and Applied Nutrition, Wiley
Auditorium, 5001 Campus Dr., College Park, MD 20740.
FDA is establishing a docket for public comment on this meeting.
You may submit comments as follows. Please note that late, untimely
filed comments may not be considered. Electronic comments must be
submitted on or before July 15, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of July 15, 2019. 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
[[Page 14661]]
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-2019-N-1388 for ``Responsible Innovation in Dietary Supplements;
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.
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
our 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: Juanita Yates, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-009),
5001 Campus Dr., College Park, MD 20740, 240-402-1731, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On February 11, 2019, FDA announced new efforts to strengthen the
regulation of dietary supplements by modernizing and reforming FDA's
oversight (see Statement from FDA Commissioner Scott Gottlieb, M.D., on
the Agency's new efforts to strengthen regulation of dietary
supplements by modernizing and reforming FDA's oversight, available at
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631065.htm). FDA's announcement acknowledged the need to ensure that
our regulatory framework is flexible enough to adequately evaluate
product safety without unnecessarily restricting innovation. We invite
public input about whether and how we should adjust our current dietary
supplement regulatory approach to better allow for innovation and
growth in the dietary supplement marketplace while maintaining and
strengthening our ability to efficiently and effectively evaluate
product safety and protect the public health.
The Dietary Supplement Health and Education Act of 1994 (DSHEA)
(Pub. L. 103-417) amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and defined ``dietary supplement,'' in part, as a product
(other than tobacco) intended to supplement the diet that bears or
contains one or more of the following dietary ingredients:
(A) A vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by
increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination
of any ingredient described in clause (A), (B), (C), (D), or (E).
Section 201(ff)(1) of the FD&C Act (21 U.S.C. 321(ff)(1)).
DSHEA clarified that dietary supplements are generally subject to
regulation as foods under the FD&C Act but also included dietary
supplement-specific adulteration and misbranding provisions. Among
other things, DSHEA provided authority for FDA to establish current
good manufacturing practice requirements for dietary supplements and
clarified the statements of nutritional support that can be made in
product labeling. Dietary supplement manufacturers and distributors are
responsible for selling products that comply with these requirements.
FDA is responsible for regulating dietary supplements and has authority
to take enforcement action when dietary supplements are adulterated or
misbranded.
DSHEA also added section 413 of the FD&C Act (21 U.S.C. 350b),
which defines the term ``new dietary ingredient'' (NDI) and describes
requirements for NDIs. Among other things, section 413 of the FD&C Act
requires the manufacturer or distributor of an NDI, or of a dietary
supplement containing an NDI, to submit a premarket notification to FDA
at least 75 days before introducing the NDI or dietary supplement into
interstate commerce, unless the NDI and any other dietary ingredients
in the dietary supplement have been present in the food supply as an
article used for food in a form in which the food has not been
chemically altered (21 U.S.C. 350b(a)(1)).
DSHEA contemplated a dynamic dietary supplement market with a role
for innovation. In the 25 years since DSHEA was enacted, the dietary
supplement market has grown significantly. What was once a $4 billion
industry comprising about 4,000 products is now an industry worth more
than $40 billion with more than 50,000--and possibly as many as 80,000
or even more--products available to consumers. Innovative new products
involving novel technologies related to ingredients, manufacturing
processes, and delivery systems represent a substantial portion of this
growth.
A robust NDI notification process is an integral part of the DSHEA
framework and represents FDA's only opportunity to evaluate the safety
of NDIs in dietary supplements before they become available to
consumers. Despite the expanded marketplace, however, we have only
received about 1,200 NDI notifications since DSHEA's enactment. FDA
recognizes that not every new
[[Page 14662]]
dietary supplement product is subject to the notification requirement,
so we continue to provide clarifications on when premarket
notifications are required.\1\ A transparent, common understanding of
the requirements surrounding dietary ingredient status and
notification, with predictable expectations regarding compliance and
consequences for non-compliance, will help our regulatory processes
operate effectively. Public discussion of these issues will further our
efforts to strengthen regulation of dietary supplements through
modernization and reform and help us better protect the public health.
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\1\ See, e.g., Draft Guidance for Industry: Dietary Supplements:
New Dietary Ingredient Notifications and Related Issues (August
2016), available at https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm257563.htm. This draft guidance, when finalized, will represent
FDA's current thinking on this topic.
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II. Topics for Discussion at the Public Meeting
FDA will host a one-day public meeting to provide interested
parties an opportunity to discuss various issues related to responsible
innovation in dietary supplements, including the following topics:
(1) The scope of the phrase ``dietary substance for use by man to
supplement the diet by increasing the total dietary intake,'' as used
in DSHEA (section 201(ff)(1)(E) of the FD&C Act);
(2) Understanding exceptions to the requirement for premarket
notification, and evaluating whether and how growth in the marketplace
since 1994 has altered the impact of those provisions;
(3) Potential commercial or marketing advantages to incentivize
responsible innovation; and
(4) Promoting overall compliance with the premarket notification
requirement through enforcement.
The issues discussed at the public meeting, including the above
topics, and any comments submitted to the docket by July 15, 2019, will
help us evaluate how to proceed with our efforts to modernize and
reform FDA's oversight of dietary supplements.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
Registration is free and based on space availability. Persons
interested in attending this public meeting should register by May 6,
2019, 11:59 p.m. Eastern Time. Early registration is recommended
because seating is limited; therefore, FDA may limit the number of
participants from each organization. Registrants will receive
confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public meeting will be provided
beginning at 8 a.m. We will let registrants know if registration closes
before the day of the public meeting. Please visit the website at
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm for this information as well as the final meeting agenda.
If you need special accommodations due to a disability, please
contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later
than May 1, 2019.
Requests for Oral Comments: During online registration you may
indicate if you wish to present during a public comment session and
which topic(s) you wish to address. We are seeking a broad
representation of ideas and issues presented at the meeting. We will do
our best to accommodate requests to make public comments. Individuals
and organizations with common interests are urged to consolidate or
coordinate their remarks and to request time for a joint comment. After
registration closes, we will determine the amount of time allotted to
each participant and the approximate time each oral comment is to begin
and will select and notify participants by May 10, 2019. All requests
to make oral comments must be received by the close of registration on
May 1, 2019. No commercial or promotional material will be permitted to
be presented or distributed at the public meeting.
Those without internet or email access can register and/or request
to participate by contacting Juanita Yates by the above dates (see FOR
FURTHER INFORMATION CONTACT).
Streaming Webcast of the public meeting: This public meeting will
also be webcast. Please visit the following website to register:
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm.
FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
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 also 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/Food/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm.
Dated: April 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07168 Filed 4-10-19; 8:45 am]
BILLING CODE 4164-01-P
