[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Notices]
[Pages 79053-79054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: [email protected].

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: [email protected]. 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