80 FR 79053 - Workshop on Addressing Challenges in the Assessment of Botanical Dietary Supplement Safety; Notice of Public Meeting; Registration Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 243 (December 18, 2015)

Page Range		79053-79054
FR Document		2015-31833

The National Toxicology Program (NTP) announces the public workshop, ``Addressing Challenges in the Assessment of Botanical Dietary Supplement Safety.'' Presenters from academia, government, and industry will introduce the challenges in assessing botanical dietary supplement safety and present various approaches that could facilitate progress in three focus areas. The workshop will consist of plenary presentations and panel discussions. Information about the meeting and registration is available at (http://ntp.niehs.nih.gov/go/ workshop_botanicals).

Federal Register, Volume 80 Issue 243 (Friday, December 18, 2015)

[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Notices]
[Pages 79053-79054]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-31833]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Workshop on Addressing Challenges in the Assessment of Botanical
Dietary Supplement Safety; Notice of Public Meeting; Registration
Information

SUMMARY: The National Toxicology Program (NTP) announces the public
workshop, ``Addressing Challenges in the Assessment of Botanical
Dietary Supplement Safety.'' Presenters from academia, government, and
industry will introduce the challenges in assessing botanical dietary
supplement safety and present various approaches that could facilitate
progress in three focus areas. The workshop will consist of plenary
presentations and panel discussions. Information about the meeting and
registration is available at (http://ntp.niehs.nih.gov/go/workshop_botanicals).

DATES: Meeting: April 26-27, 2016, from 9 a.m. to approximately 5 p.m.
Eastern Daylight Time (EDT).

[[Page 79054]]

Meeting Registration: Registration is open through April 12, 2016;
registration will close earlier if space capacity is reached.
Registration to view the workshop via webcast is required.

ADDRESSES: Meeting Location: Lister Hill Auditorium, National Library
of Medicine, 8600 Rockville Pike, NIH Building 38A, Bethesda, MD 20894
Meeting Web page: The preliminary agenda and registration are at
(http://ntp.niehs.nih.gov/go/workshop_botanicals).
Webcast: The meeting will be webcast; the URL will be provided to
those who register to view.

FOR FURTHER INFORMATION CONTACT: Dr. Cynthia Rider, NTP Toxicologist,
NIEHS, P.O. Box 12233, MD K2-12, Research Triangle Park, NC 27709.
Telephone: (919) 541-7638, email: cynthia.rider@nih.gov.

SUPPLEMENTARY INFORMATION:

Background

The safety of botanical dietary supplements, hereafter referred to
as botanicals, is an important public health issue. According to the
2012 National Health Interview Survey, 17.7 percent of Americans
reported having used nonvitamin, nonmineral dietary supplements
(including botanicals) in the past 12 months (Clarke et al., 2015).
Botanicals pose several unique challenges to efficacy and safety
evaluation because of their inherent complexity and potential for wide
variability in nominally related products. The interrelated challenges
associated with the evaluation of botanicals include: (1) Developing
methods and criteria for assessing phytoequivalence (i.e., similarity
in chemical composition and biological activity) of botanicals, (2)
identifying the active constituent(s) or patterns of biological
response of botanicals, and (3) assessing absorption, distribution,
metabolism, and elimination (ADME) of botanicals. This workshop will
engage experts from multiple disciplines to focus on practical
approaches for addressing these challenges.
Multiple factors contribute to the variability in botanicals
including complex and inconsistent source material, manufacturing
processes, formulation, and storage. Botanicals in commerce often
display a wide range in the concentration of known constituents. Robust
procedures for comparing constituent profiles across multiple
botanicals are needed to determine how broadly safety or efficacy
evaluations with a specific product can be applied to related products.
Topics for discussion at the workshop include definition of important
chemical and biological activity features, statistical methods for
comparing across complex mixtures, and how to define ``similarity''
across botanicals (i.e., how similar do botanicals have to be in order
to apply safety data from a reference botanical to nominally-related
botanicals).
Botanicals are often perceived to have significant health benefits
with low risk of harm. Since botanicals are complex natural products,
the particular constituent(s) responsible for biological activity, as
related to efficacy or toxicity, is often unknown. Participants at the
workshop will discuss the relative merits of dedicating scientific
attention to identifying the active constituent(s) in botanicals and
identifying biological signatures that are predictive of adverse events
(biomarkers of effect). Furthermore, presentations will address
promising approaches (e.g., high throughput screening, computational
tools) and accompanying challenges for using these approaches to
advance our understanding of the risks associated with botanical use.
Understanding the ADME of botanicals is critical to evaluating
their safety. However, evaluating ADME in humans and animal models is
complicated in the case of botanicals by the large number of
constituents, the wide range of concentrations, potential interactions
(botanical-botanical and botanical-drug interactions), as well as
interindividual and animal-to-human differences in pharmacokinetics.
The workshop will include discussion of knowledge gaps and available
options for assessing ADME of botanicals to inform future safety
evaluations.

Meeting and Registration

This meeting is open to the public, free of charge, with attendance
limited only by the space available. Individuals who plan to attend in
person should register at (http://ntp.niehs.nih.gov/go/workshop_botanicals) by April 12, 2016, to facilitate meeting planning.
Registration will close earlier if space capacity is reached.
Registration is required to view the Webcast; the URL for the Webcast
will be provided in the email confirming registration. A preliminary
agenda and additional information are available at (http://ntp.niehs.nih.gov/go/workshop_botanicals). Interested individuals are
encouraged to access the Web site to stay abreast of the most current
information regarding the workshop.
Visitor and security information for those attending in person is
available at https://www.nih.gov/about-nih/visitor-information/campus-access-security. Individuals with disabilities who need accommodation
to participate in this event should contact Dr. Rider at telephone:
(919) 541-7638 or email: cynthia.rider@nih.gov. TTY users should
contact the Federal TTY Relay Service at 800-877-8339. Requests should
be made at least five business days in advance of the event.

Background Information on the NTP

NTP is an interagency program established in 1978 (43 FR 53060) to
strengthen the Department of Health and Human Services' activities in
toxicology research and testing, and develop and validate new and
better testing methods. Other activities of the program focus on
strengthening the science base in toxicology and providing information
about potentially toxic chemicals to health regulatory and research
agencies, scientific and medical communities, and the public. NTP is
located administratively at the National Institute of Environmental
Health Sciences (NIEHS). Information about NTP and NIEHS is found at
http://ntp.niehs.nih.gov and http://www.niehs.nih.gov, respectively.

Reference

Clarke, T.C. et al. Trends in the use of complementary health
approaches among adults: United States, 2002-2012, in National
health statistics reports. 2015. National Center for Health
Statistics: Hyattsville, MD.

Dated: December 15, 2015.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2015-31833 Filed 12-17-15; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices 79053

be accessed from the NIH Videocasting DEPARTMENT OF HEALTH AND provisions set forth in sections
and Podcasting Web site (http:// HUMAN SERVICES 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
videocast.nih.gov/). as amended. The grant applications and
The meeting will be closed to the National Institutes of Health the discussions could disclose
public in accordance with the confidential trade secrets or commercial
National Institute of Allergy and property such as patentable material,
provisions set forth in sections Infectious Diseases; Notice of Closed
552b(c)(4) and 552b(c)(6), title 5 U.S.C., and personal information concerning
Meeting individuals associated with the grant
as amended. The grant applications and
the discussions could disclose Pursuant to section 10(d) of the applications, the disclosure of which
confidential trade secrets or commercial Federal Advisory Committee Act, as would constitute a clearly unwarranted
property, such as patentable material, amended (5 U.S.C. App.), notice is invasion of personal privacy.
and personal information concerning hereby given of the following meeting. Name of Committee: Center for Scientific
individuals associated with the grant The meeting will be closed to the Review Special Emphasis Panel; Member
applications, the disclosure of which public in accordance with the Conflict: Radiation Biology.
would constitute a clearly unwarranted provisions set forth in sections Date: January 5, 2016.
Time: 2:00 p.m. to 3:00 p.m.
invasion of personal privacy. 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Agenda: To review and evaluate grant
Name of Committee: National Advisory as amended. The grant applications and applications.
General Medical Sciences Council. the discussions could disclose Place: National Institutes of Health, 6701
Date: January 28–29, 2016. confidential trade secrets or commercial Rockledge Drive, Bethesda, MD 20892
Closed: January 28, 2016, 8:30 a.m. to 5:00 property such as patentable material, (Telephone Conference Call).
p.m. and personal information concerning Contact Person: Syed M. Quadri, Ph.D.,
Agenda: To review and evaluate grant individuals associated with the grant Scientific Review Officer, Center for
applications. applications, the disclosure of which Scientific Review, National Institutes of
Place: National Institutes of Health, would constitute a clearly unwarranted Health, 6701 Rockledge Drive, Room 6210,
Natcher Building, Conference Rooms E1 & MSC 7804, Bethesda, MD 20892, 301–435–
invasion of personal privacy. 1211, quadris@csr.nih.gov.
E2, 45 Center Drive, Bethesda, MD 20892.
Open: January 29, 2016, 8:30 a.m. to Name of Committee: National Institute of (Catalogue of Federal Domestic Assistance
Adjournment. Allergy and Infectious Diseases Special Program Nos. 93.306, Comparative Medicine;
Agenda: For the discussion of program Emphasis Panel; NIAID Investigator Initiated 93.333, Clinical Research, 93.306, 93.333,
policies and issues, opening remarks, report Program Project Application (P01). 93.337, 93.393–93.396, 93.837–93.844,
of the Director, NIGMS, and other business Date: January 12, 2016. 93.846–93.878, 93.892, 93.893, National
of the Council. Time: 12:00 p.m. to 3:00 p.m. Institutes of Health, HHS)
Place: National Institutes of Health, Agenda: To review and evaluate grant
applications. Dated: December 14, 2015.
Natcher Building, Conference Rooms E1 &
E2, 45 Center Drive, Bethesda, MD 20892. Place: National Institutes of Health, Room Melanie J. Gray,
Contact Person: Ann A. Hagan, Ph.D., 3G61, 5601 Fishers Lane, Rockville, MD Program Analyst, Office of Federal Advisory
Associate Director for Extramural Activities, 20892 (Telephone Conference Call). Committee Policy.
NIGMS, NIH, DHHS, 45 Center Drive, Room Contact Person: Dharmendar Rathore, [FR Doc. 2015–31767 Filed 12–17–15; 8:45 am]
2AN24B, MSC 6200, Bethesda, MD 20892, Ph.D., Senior Scientific Review Officer,
BILLING CODE 4140–01–P
(301) 594–4499, hagana@nigms.nih.gov. Scientific Review Program, Division of
Extramural Activities, Room 3G30, National
Any interested person may file written
Institues of Health/NIAID, 5601 Fishers Lane,
comments with the committee by forwarding DEPARTMENT OF HEALTH AND
Drive, MSC 9823, Bethesda, MD 20892–9823,
the statement to the Contact Person listed on HUMAN SERVICES
240–669–5058, rathored@mail.nih.gov.
this notice. The statement should include the
name, address, telephone number and, when (Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology, National Institutes of Health
applicable, the business or professional
affiliation of the interested person. and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Workshop on Addressing Challenges
In the interest of security, NIH has in the Assessment of Botanical Dietary
instituted stringent procedures for entrance Research, National Institutes of Health, HHS)
Supplement Safety; Notice of Public
onto the NIH campus. All visitor vehicles, Dated: December 14, 2015.
including taxis, hotel, and airport shuttles, Meeting; Registration Information
Natasha M. Copeland,
will be inspected before being allowed on SUMMARY: The National Toxicology
Program Analyst, Office of Federal Advisory
campus. Visitors will be asked to show one Program (NTP) announces the public
Committee Policy.
form of identification (for example, a workshop, ‘‘Addressing Challenges in
government-issued photo ID, driver’s license, [FR Doc. 2015–31770 Filed 12–17–15; 8:45 am]
or passport) and to state the purpose of their BILLING CODE 4140–01–P
the Assessment of Botanical Dietary
visit. Information is also available on the Supplement Safety.’’ Presenters from
Institute’s home page (http:// academia, government, and industry
www.nigms.nih.gov/About/Council/) where DEPARTMENT OF HEALTH AND will introduce the challenges in
an agenda and any additional information for HUMAN SERVICES assessing botanical dietary supplement
the meeting will be posted when available. safety and present various approaches
(Catalogue of Federal Domestic Assistance National Institutes of Health that could facilitate progress in three
Program Nos. 93.859, Biomedical Research focus areas. The workshop will consist
and Research Training, National Institutes of Center for Scientific Review; Notice of of plenary presentations and panel
mstockstill on DSK4VPTVN1PROD with NOTICES

Health, HHS) Closed Meeting discussions. Information about the
Dated: December 11, 2015. Pursuant to section 10(d) of the meeting and registration is available at
Melanie J. Gray, Federal Advisory Committee Act, as (http://ntp.niehs.nih.gov/go/workshop_
Program Analyst, Office of Federal Advisory amended (5 U.S.C. App.), notice is botanicals).
Committee Policy. hereby given of the following meeting. DATES: Meeting: April 26–27, 2016, from
[FR Doc. 2015–31772 Filed 12–17–15; 8:45 am] The meeting will be closed to the 9 a.m. to approximately 5 p.m. Eastern
BILLING CODE 4140–01–P public in accordance with the Daylight Time (EDT).

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Document Created: 2015-12-18 01:39:08
Document Modified: 2015-12-18 01:39:08

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		Meeting: April 26-27, 2016, from 9 a.m. to approximately 5 p.m. Eastern Daylight Time (EDT).
Contact		Dr. Cynthia Rider, NTP Toxicologist, NIEHS, P.O. Box 12233, MD K2-12, Research Triangle Park, NC 27709. Telephone: (919) 541-7638, email: [email protected]
FR Citation		80 FR 79053

80 FR 79053 - Workshop on Addressing Challenges in the Assessment of Botanical Dietary Supplement Safety; Notice of Public Meeting; Registration Information

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 243 (December 18, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health