[Federal Register Volume 79, Number 235 (Monday, December 8, 2014)]
[Notices]
[Pages 72692-72694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28681]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Expert Panel Meeting on Identifying Research Needs for Assessing 
Safe Use of High Intakes of Folic Acid; Notice of Public Meeting and 
Registration Information

SUMMARY: The National Toxicology Program (NTP) and the Office of 
Dietary Supplements (ODS) announce a public expert panel meeting on May 
11-12,

[[Page 72693]]

2015, to identify research needs based on the state of the science 
related to the safe use of high intakes of folic acid. The expert panel 
meeting is open to the public. Registration is requested for public 
attendance, in-person or via the webcast, and for oral comment. 
Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/730864.

DATES: 
    Meeting: May 11-12, 2015, 8:30 a.m. Eastern Daylight Time to 
approximately 5 p.m. on May 11 and approximately 12:00 p.m. on May 12.
    Document Availability: The literature review document should be 
available by April 6, 2015, and will be posted to http://ntp.niehs.nih.gov/go/730864 when available.
    Written Public Comment Submission and Registration for Oral 
Comments: Deadline is May 4, 2015.
    Registration for Accommodation: Deadline is May 4, 2015, for 
individuals with disabilities who need accommodation to participate.

ADDRESSES:
    Meeting Location: Natcher Conference Center (Building 45), National 
Institutes of Health, Bethesda, MD 20892.
    Meeting Web page: The preliminary agenda, registration, roster, 
literature review document, and other meeting materials will be posted 
to http://ntp.niehs.nih.gov/go/730864 when available.
    Webcast: The URL for viewing the webcast will be provided to those 
who register.

FOR FURTHER INFORMATION CONTACT: Dr. Yun Xie, NTP Designated Federal 
Official, Office of Liaison, Policy and Review, DNTP, NIEHS, P.O. Box 
12233, MD K2-03, Research Triangle Park, NC 27709. Phone: (919) 541-
3436, Fax: (301) 451-5455, Email: <a href="/cdn-cgi/l/email-protection#d0a9a5befea8b9b590beb9b8feb7bfa6"><span class="__cf_email__" data-cfemail="82fbf7ecacfaebe7c2ecebeaace5edf4">[email protected]</span></a>. Hand Delivery/
Courier: 530 Davis Drive, Room 2161, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:
    Meeting and Registration: The meeting is open to the public with 
time set aside for oral public comment; attendance at NIH is limited 
only by the space available. Registration is recommended for in-person 
attendance to ensure space and to view the webcast; the URL for the 
webcast will be provided in the email confirming registration. 
Individuals who plan to provide oral comments (see below) are 
encouraged to register online by May 4, 2015, at http://ntp.niehs.nih.gov/go/730864. Individuals interested in this meeting are 
encouraged to access the Web site to stay abreast of the most current 
information regarding the meeting. Visitor and security information for 
those attending in-person is available at http://www.nih.gov/about/visitor/. Individuals with disabilities who need accommodation to 
participate in this event should contact Dr. Yun Xie at phone: (919) 
541-3436 or email: <a href="/cdn-cgi/l/email-protection#9be2eef5b5e3f2fedbf5f2f3b5fcf4ed"><span class="__cf_email__" data-cfemail="760f0318580e1f1336181f1e58111900">[email protected]</span></a>. 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 Folic Acid and Reason for the Evaluation: 
Humans require folate, a water-soluble B-complex vitamin, for everyday 
growth and cell division and for critical periods of rapid growth and 
cell division such as embryonic development. Thus, folate is necessary 
for all individuals, but is especially important for women who may 
become pregnant. At the same time, there is interest in understanding 
potential adverse health impacts from high intakes of folic acid, the 
form of folate commonly added to foods and dietary supplements.
    Folate is present in the diet through its natural occurrence in 
food, as a food additive, and as an ingredient in dietary supplements. 
Naturally occurring folate is unlikely to be associated with potential 
adverse effects because it has lower bioavailability than folic acid 
and its consumption is also limited by the bulk and caloric content of 
foods. Therefore, the primary substance of interest for considering the 
safety of high intake is folic acid.
    Evaluating the potential for adverse health effects associated with 
high folic acid intakes has been challenging because of the lack of 
systematic studies and other sources of evidence on this topic. In 
1998, the Food and Nutrition Board of the Institute of Medicine set 
Dietary Reference Intakes that included the Recommended Dietary 
Allowances (RDAs) and tolerable upper intake levels (ULs)--the highest 
level of daily intake likely to pose no risk of adverse health effects 
to almost all of the population--for folic acid and other B vitamins. 
The folic acid UL (1000 [mu]g) was established with the paucity of data 
available to the committee at the time; i.e., limited, suggestive 
evidence that excessive folate intake may precipitate or exacerbate 
neuropathy in vitamin B12-deficient individuals. Since this 1998 
publication that set the UL for folic acid, many publications have 
reported on health effects over a range of folic acid intakes. Some 
studies have raised concerns that high intake of folic acid may be 
associated with potential adverse health effects.
    Expert Panel Meeting: The NTP and ODS are convening an expert panel 
to identify research needs related to the safe use of high intakes of 
folic acid based on consideration of the state of the science. The 
expert panel meeting will bring together experts from multiple 
disciplines including, but not limited to, epidemiology, nutrition, 
medicine, and toxicology. In preparation for this evaluation, screening 
of the literature was undertaken to identify potential adverse health 
effects for which further research might be warranted. A literature 
review document is being prepared on four health outcome areas using 
systematic review methodology: (1) Cancer, (2) cognition in conjunction 
with vitamin B12, (3) hypersensitivity-related outcomes, and (4) 
endocrine and metabolic outcomes. The literature review document should 
be available by April 6, 2015, and will be posted to http://ntp.niehs.nih.gov/go/730864. A document describing the approach for 
conducting the literature evaluation has also been prepared and is 
posted on the NTP Web site (http://ntp.niehs.nih.gov/ntp/ohat/folicacid/ntpfolicacid_approach_508.pdf). This document describing the 
approach includes information on the dose levels of folic acid being 
considered for the evaluation.
    Request for Comments: The deadline for submission of written 
comments is May 4, 2015, to enable review by the expert panel and NTP 
and ODS staff prior to the meeting. Registration to provide oral 
comments is by May 4, 2015, at http://ntp.niehs.nih.gov/go/730864. 
Public comments and any other correspondence should be sent to the FOR 
FURTHER INFORMATION CONTACT. Persons submitting written comments should 
include their name, affiliation, mailing address, phone, email, and 
sponsoring organization (if any) with the document. Written comments 
received in response to this notice will be posted on the NTP Web site, 
and the submitter will be identified by name, affiliation, and/or 
sponsoring organization.
    Public comment at this meeting is welcome, with time set aside for 
the presentation of oral comments on the agenda topics. In addition to 
in-person oral comments at the NIH, public comments can be presented by 
teleconference line. There will be 50 lines for this call; availability 
is on a first-come, first-served basis. Oral comments will be received 
only during the formal public comment periods indicated on the 
preliminary agenda. The access number for the teleconference line will 
be provided to registrants by email prior to the meeting. Each 
affiliation or sponsoring

[[Page 72694]]

organization is allowed one time slot. At least 7 minutes will be 
allotted to each time slot, and if time permits, may be extended to 10 
minutes at the discretion of the chair.
    Persons wishing to make an oral presentation are asked to register 
online at http://ntp.niehs.nih.gov/go/730864 by May 4, 2015, and 
indicate whether they will present comments in-person or via the 
teleconference line. If possible, oral public commenters should send a 
copy of their slides and/or statement or talking points at that time. 
Written statements can supplement and may expand the oral presentation. 
Registration for in-person oral comments will also be available at the 
meeting, although time allowed for presentation by on-site registrants 
may be less than that for registered speakers and will be determined by 
the number of speakers who register on-site.
    Background Information on NTP and ODS: The NTP is an interagency 
program, established in 1978 (43 FR 53060) and headquartered at the 
National Institute of Environmental Health Sciences (NIEHS) of the 
National Institutes of Health (NIH). The mission of NTP is to evaluate 
agents of public health concern by developing and applying tools of 
modern toxicology and molecular biology. The NTP carries out literature 
analysis activities in the Office of Health Assessment and Translation 
and the Office of the Reports on Carcinogens. The NTP also designs and 
conducts laboratory studies and testing programs and analyzes its 
findings to assess potential hazards to human health from exposure to 
environmental substances, including dietary supplements (see http://ntp.niehs.nih.gov/).
    The mission of the ODS of the NIH is to strengthen knowledge and 
understanding of dietary supplements by evaluating scientific 
information, stimulating and supporting research, disseminating 
research results, and educating the public to foster an enhanced 
quality of life and health for the population of the United States. The 
purpose and responsibilities of the ODS are to explore more fully the 
potential role of dietary supplements as a significant part of the 
efforts of the United States to improve health care; to promote 
scientific study of the benefits of dietary supplements in maintaining 
health and preventing chronic disease and other health-related 
conditions; to conduct and coordinate scientific research within NIH 
relating to dietary supplements; to collect and compile the results of 
scientific research relating to dietary supplements, including 
scientific data from foreign sources; and to serve as the principal 
advisor to the Secretary of the Department of Health and Human Services 
and the Assistant Secretary for Health and to provide advice on issues 
relating to dietary supplements to the Director of NIH, the Director of 
the Centers for Disease Control and Prevention, and the Commissioner of 
the Food and Drug Administration (see http://ods.od.nih.gov/). The 
Dietary Supplement Health and Education Act of 1994 (Pub. L. 103-417, 
DSHEA) authorized the establishment of the ODS at the NIH in 1995.
    Background Information on NTP Expert Panels: NTP panels are 
technical, scientific advisory bodies established on an ``as needed'' 
basis to provide independent scientific peer review and advise the NTP 
on agents of public health concern, new/revised toxicological test 
methods, or other issues. These panels help ensure transparent, 
unbiased, and scientifically rigorous input to the program for its use 
in making credible decisions about human hazard, setting research and 
testing priorities, and providing information to regulatory agencies 
about alternative methods for toxicity screening. The NTP welcomes 
nominations of scientific experts for upcoming panels. Scientists 
interested in serving on an NTP panel should provide current curriculum 
vitae to the FOR FURTHER INFORMATION CONTACT. The authority for NTP 
panels is provided by 42 U.S.C. 217a; section 222 of the Public Health 
Service (PHS) Act, as amended. The panel is governed by the Federal 
Advisory Committee Act, as amended (5 U.S.C. Appendix 2), which sets 
forth standards for the formation and use of advisory committees.

    Dated: December 2, 2014.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2014-28681 Filed 12-5-14; 8:45 am]
BILLING CODE 4140-01-P


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