Request for Information: The National Toxicology Program Requests Information on Use, Human Exposure, and Toxicity of Vinpocetine, 58548 [2013-23212]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Notices]
[Page 58548]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23212]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information: The National Toxicology Program Requests 
Information on Use, Human Exposure, and Toxicity of Vinpocetine

SUMMARY: To facilitate the design of toxicological studies for 
vinpocetine (CAS RN: 42971-09-5), the National Toxicology Program (NTP) 
at the National Institute of Environmental Health Sciences (NIEHS) 
requests the submission of available information regarding (1) 
exposure, pharmacokinetics, toxicity, safety, or efficacy in humans; 
(2) production, use, and consumption patterns in the United States; (3) 
genotoxicity, repeated dose toxicity, prenatal developmental toxicity, 
reproductive toxicity, chronic toxicity, and carcinogenicity studies in 
experimental animals; and (4) any other information relative to the 
safety or toxicity of vinpocetine not listed above.

DATES: The deadline for receipt of information is November 4, 2013.

ADDRESSES: Submission of information via email to surhi@niehs.nih.gov 
is preferred.

FOR FURTHER INFORMATION CONTACT: Dr. Inok Surh, Research Fellow, 
Toxicology Branch, Division of the NTP, NIH/NIEHS, P.O. Box 12233, MD 
K2-12, Research Triangle Park, NC 27709. Phone: (919) 541-3862, Fax: 
(919) 541-4255, Email: surhi@niehs.nih.gov. Hand Delivery/Courier: 530 
Davis Drive, Room 2067, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION: 
    Background: The National Cancer Institute nominated the dietary 
supplement vincamine to the NTP for genotoxicity, subchronic toxicity, 
and mechanistic studies due to a lack of information on its potential 
toxicity following long-term administration (https://ntp.niehs.nih.gov/go/1123). Currently, vincamine appears to be infrequently marketed in 
the United States, while vinpocetine, a semi-synthetic derivative of 
vincamine, is widely available as a dietary supplement. In a review of 
the available literature, the NTP found that published data on 
genotoxicity, carcinogenicity, and reproductive and developmental 
toxicity for vinpocetine are very limited (https://ntp.niehs.nih.gov/ntp/htdocs/Chem_Background/ExSumPdf/Vinpocetine091613_508.pdf). To 
address the lack of data and potential widespread exposure, the NTP is 
developing a research program for toxicological characterization of 
vinpocetine.
    Request for Information: The NTP seeks to identify relevant 
information on the use, human exposure, and toxicity of vinpocetine in 
humans and experimental animal models. In particular, information is 
sought from unpublished or ongoing research studies or other sources 
not readily available. Any information provided by respondents will be 
used to supplement information the NTP has already gathered, and will 
be considered during the design of one or more types of experimental 
toxicology studies of vinpocetine. Specifically, the NTP requests the 
submission of information regarding:
    (1) Exposure, pharmacokinetics, toxicity, safety, or efficacy of 
vinpocetine in humans. (2) Production, use, and consumption patterns of 
vinpocetine in the United States. (3) Genotoxicity, repeated dose 
toxicity, prenatal developmental toxicity, reproductive toxicity, 
chronic toxicity, and carcinogenicity studies of vinpocetine in 
experimental animals. (4) Any other information relative to the safety 
or toxicity of vinpocetine not listed above.
    Responses are requested from all interested parties, such as the 
research community, health professionals, educators, policy makers, 
industry, and the public. Responses to this request for information are 
voluntary. The NTP does not intend to publish a summary of responses 
received or any other information provided. Despite this, no 
proprietary, classified, confidential, or sensitive information should 
be included in your response. This request for information is for 
planning purposes only and is not a solicitation for applications or an 
obligation on the part of the U.S. Government to provide support for 
any ideas identified in response to it. Please note that the U.S. 
Government will not pay for the preparation of any information 
submitted or for its use of that information. Persons submitting 
information should include their name, affiliation, mailing address, 
phone, fax, email address, and sponsoring organization (if any) with 
the submission. The deadline for receipt of the requested information 
is November 4, 2013.
    Background Information on the NTP: The NTP is an interagency 
program established in 1978 (43 FR 53060) to strengthen the 
Department's 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. The NTP is located administratively at the NIEHS. 
Information about the NTP and NIEHS is found at https://www.niehs.nih.gov and https://ntp.niehs.nih.gov, respectively.

    Dated: September 18, 2013.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2013-23212 Filed 9-23-13; 8:45 am]
BILLING CODE 4140-01-P