National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting, 14662-14663 [2019-07183]
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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1 See, e.g., Draft Guidance for Industry: Dietary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]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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,
Bethesda, MD 20892 which was
published in the Federal Register on
February 15, 2019, 84 FR 4487.
This meeting notice is amended to
change the meeting date, start time, and
location. The meeting will now be held
on May 20, 2019 at 9:00 a.m. at the
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.
[FR Doc. 2019–07181 Filed 4–10–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
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Federal Register / Vol. 84, No. 70 / Thursday, April 11, 2019 / Notices
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National
Institute of Biomedical Imaging and
Bioengineering Special Emphasis Panel;
Brain Initiative RFAs (EB–17–003; EB–
17–004) Review SEP.
Date: May 3, 2019.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: The William F. Bolger Center,
9600 Newbridge Drive, Potomac, MD
20854.
Contact Person: Ruixia Zhou, Ph.D.,
Scientific Review Officer, National
Institute of Biomedical Imaging and
Bioengineering, National Institutes of
Health, Two Democracy Boulevard,
Suite 957, 6707 Democracy Blvd.,
Bethesda, MD 20892, 301–496–4773,
zhour@mail@nih.gov.
Dated: April 5, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–07183 Filed 4–10–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AREA
Applications in Oncological Sciences.
Date: May 22, 2019.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Svetlana Kotliarova, Ph.D.,
Scientific Review Officer, Center for
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Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
Bethesda, MD 20892, 301–594–7945,
kotliars@mail.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Host Interactions with Bacterial Pathogens
Study Section.
Date: June 5, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Fouad A El-Zaatari, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3186,
MSC 7808, Bethesda, MD 20892, (301) 435–
1149, elzaataf@csr.nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Oral, Dental and Craniofacial Sciences Study
Section.
Date: June 6–7, 2019.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel at Pentagon City,
1250 South Hayes Street, Arlington, VA
22202.
Contact Person: Yi-Hsin Liu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892, 301–435–
1781, liuyh@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: April 5, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–07180 Filed 4–10–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
14663
Name of Committee: National Advisory
Board on Medical Rehabilitation Research.
Date: May 6–7, 2019.
Time: May 6, 2019, 9:00 a.m. to 5:00 p.m.
Agenda: NICHD Director’s report; Strategy
to update the NIH Rehabilitation Research
Plan; Initial Planning for the Rehabilitation
Research Conference; Complementary and
Integrative Health Update; Centers for
Medicare and Medicaid Services Research
Policies and Efforts.
Place: NICHD Offices, 6710B Rockledge
Drive, Rooms 1425/1427, Bethesda, MD
20892.
Time: May 7, 2019, 9:00 a.m. to 12:00 p.m.
Agenda: Concept Clearance; Use of
Secondary Data for Rehabilitation Science;
Scientific Presentation on Extending the
Reach of Rehabilitation Using Technology.
Place: NICHD Offices, 6710B Rockledge
Drive, Rooms 1425/1427, Bethesda, MD
20892.
Contact Person: Ralph M. Nitkin, Ph.D.,
Deputy Director, National Center for Medical
Rehabilitation Research (NCMRR), Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, NIH,
DHHS, 6710B Rockledge Drive, Room 2116,
Bethesda, MD 20892–7002, (301) 402–4206,
RN21e@nih.gov.
Individuals will also be able to view the
meeting via NIH Videocast. Select the
following link for Videocast the day of the
meeting: https://videocast.nih.gov/
default.asp.
Information is also available on the
Institute’s/Center’s home page: https://
www.nichd.nih.gov/about/advisory/nabmrr/
Pages/index.aspx where the current roster
and minutes from past meetings are posted.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: April 8, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–07182 Filed 4–10–19; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human;
Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory Board
on Medical Rehabilitation Research.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2018–1057]
RIN 1625–AA00
Extension of Comment Period for the
Safety Zone; Gastineau Channel,
Juneau, AK
Coast Guard, DHS.
Extension of comment period.
AGENCY:
ACTION:
The United States Coast
Guard is extending the comment period
for the notice of proposed rulemaking
SUMMARY:
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[Federal Register Volume 84, Number 70 (Thursday, April 11, 2019)]
[Notices]
[Pages 14662-14663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07183]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering;
Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the National Institute
of Biomedical Imaging and Bioengineering Special Emphasis Panel.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material,
[[Page 14663]]
and personal information concerning individuals associated with the
grant applications, the disclosure of which would constitute a clearly
unwarranted invasion of personal privacy.
Name of Committee: National Institute of Biomedical Imaging and
Bioengineering Special Emphasis Panel; Brain Initiative RFAs (EB-17-
003; EB-17-004) Review SEP.
Date: May 3, 2019.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant applications.
Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac,
MD 20854.
Contact Person: Ruixia Zhou, Ph.D., Scientific Review Officer,
National Institute of Biomedical Imaging and Bioengineering, National
Institutes of Health, Two Democracy Boulevard, Suite 957, 6707
Democracy Blvd., Bethesda, MD 20892, 301-496-4773, [email protected][email protected].
Dated: April 5, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-07183 Filed 4-10-19; 8:45 am]
BILLING CODE 4140-01-P
