[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: [email protected]. 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: [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 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