Workshop on Addressing Challenges in the Assessment of Botanical Dietary Supplement Safety; Notice of Public Meeting; Registration Information, 79053-79054 [2015-31833]

Download as PDF Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES be accessed from the NIH Videocasting and Podcasting Web site (https:// videocast.nih.gov/). The meeting 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: National Advisory General Medical Sciences Council. Date: January 28–29, 2016. Closed: January 28, 2016, 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, Conference Rooms E1 & E2, 45 Center Drive, Bethesda, MD 20892. Open: January 29, 2016, 8:30 a.m. to Adjournment. Agenda: For the discussion of program policies and issues, opening remarks, report of the Director, NIGMS, and other business of the Council. Place: National Institutes of Health, Natcher Building, Conference Rooms E1 & E2, 45 Center Drive, Bethesda, MD 20892. Contact Person: Ann A. Hagan, Ph.D., Associate Director for Extramural Activities, NIGMS, NIH, DHHS, 45 Center Drive, Room 2AN24B, MSC 6200, Bethesda, MD 20892, (301) 594–4499, hagana@nigms.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxis, hotel, and airport shuttles, will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s home page (https:// www.nigms.nih.gov/About/Council/) where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: December 11, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–31772 Filed 12–17–15; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 19:20 Dec 17, 2015 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting 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: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Investigator Initiated Program Project Application (P01). Date: January 12, 2016. Time: 12:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3G61, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Dharmendar Rathore, Ph.D., Senior Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3G30, National Institues of Health/NIAID, 5601 Fishers Lane, Drive, MSC 9823, Bethesda, MD 20892–9823, 240–669–5058, rathored@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: December 14, 2015. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–31770 Filed 12–17–15; 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 Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 79053 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; Member Conflict: Radiation Biology. Date: January 5, 2016. Time: 2:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Syed M. Quadri, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6210, MSC 7804, Bethesda, MD 20892, 301–435– 1211, quadris@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: December 14, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–31767 Filed 12–17–15; 8:45 am] BILLING CODE 4140–01–P 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 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 (https://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). SUMMARY: E:\FR\FM\18DEN1.SGM 18DEN1 79054 Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices 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 (https:// 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: mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 19:20 Dec 17, 2015 Jkt 238001 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 (https://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 (https:// 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/visitorinformation/campus-access-security. PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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 https:// ntp.niehs.nih.gov and https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 E:\FR\FM\18DEN1.SGM 18DEN1

Agencies

[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]


-----------------------------------------------------------------------

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 (https://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 
(https://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 (https://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 (https://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 
https://ntp.niehs.nih.gov and https://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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.