Literature Review Approach “Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid”; Request for Information and Comments, 20672-20673 [2013-07901]
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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
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Dated: April 1, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–07907 Filed 4–4–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Literature Review Approach
‘‘Identifying Research Needs for
Assessing Safe Use of High Intakes of
Folic Acid’’; Request for Information
and Comments
The National Toxicology
Program (NTP) at the National Institute
of Environmental Health Sciences
(NIEHS) in conjunction with the NIH
Office of Dietary Supplements (ODS) is
planning a workshop to identify
research needs based on consideration
of the state of the science related to the
safe use of high intakes of folic acid.
The NTP and the ODS invite comments
on an approach document, ‘‘Identifying
Research Needs for Assessing Safe Use
of High Intakes of Folic Acid,’’ for
review of the pertinent literature. The
document is available on the NTP Folic
Acid Request for Information (RFI) Web
site (https://ntp.niehs.nih.gov/go/38143).
Information gathered through this
request will be used in prioritizing
topics for the state of the science
workshop.
DATES: The deadline for receipt of
information and comments is May 28,
2013.
ADDRESSES: Comments should be
submitted at https://ntp.niehs.nih.gov/
go/38143.
FOR FURTHER INFORMATION CONTACT:
Abee L. Boyles, Ph.D., Health Scientist,
Office of Health Assessment and
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:14 Apr 04, 2013
Jkt 229001
Translation, Division of the NTP,
NIEHS, PO Box 12233, MD: K2–04,
Research Triangle Park, NC 27709;
telephone: (919) 541–7886; fax: (301)
480–3230; email: abee.boyles@nih.gov.
Courier address: NIEHS, Room 2158,
530 Davis Drive, Morrisville, NC 27560
or Regan Bailey, Ph.D., R.D., Nutritional
Epidemiologist, ODS, NIH, 6100
Executive Blvd., Room 3B01, Bethesda,
MD 20892–7517; telephone: (301) 496–
0187; fax: (301) 480–1845; email:
regan.bailey@nih.gov.
SUPPLEMENTARY INFORMATION:
Background: The NTP in conjunction
with the NIH ODS is planning a
workshop to identify research needs
based on consideration of the state of
the science related to the safe use of
high intakes of folic acid. The benefit of
supplemental folic acid for pregnant
women to prevent neural tube defects in
their children is well established; at the
same time, there is interest in
understanding potential adverse health
impacts from high intakes of folic acid.
This project aims to identify research
needs and inform the development of a
research agenda for evaluating the safe
use of high intakes of folic acid.
Due to the vastness of the research on
folate and folic acid, screening of the
literature was undertaken to identify the
potential adverse health effects for
which further research might be
warranted. An approach document,
‘‘Identifying Research Needs for
Assessing Safe Use of High Intakes of
Folic Acid,’’ is available on the RFI Web
site (https://ntp.niehs.nih.gov/go/38143)
and should be referenced in responding
to the RFI. This document (1) outlines
the approach used to screen the
literature, (2) describes the results of the
screening effort, and (3) proposes a list
of health outcomes for discussion at the
workshop. As background for the
workshop, a literature review document
on these health outcomes will be
prepared using systematic review
methodology.
Humans require folate, a watersoluble B-complex vitamin, for the
synthesis of nucleic acids and to
provide methyl groups for biochemical
reactions within cells. These functions
are needed for everyday growth and cell
division, including during 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. 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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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 (1000mg) was established
with the paucity of data available to the
committee at the time; i.e., limited but
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.
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, the form of
folate commonly added to foods and
dietary supplements.
Information gathered through this RFI
will be used in prioritizing topics for the
state of the science workshop. The date
and location of the workshop have not
yet been determined, but when set, will
be announced in the Federal Register,
the NIH Guide, and on the OHAT
project Web site (https://
ntp.niehs.nih.gov/go/38144). The
overarching goals of this workshop are
to identify research needs and inform
the development of a research agenda
for evaluating the safe use of high
intakes of folic acid. The workshop will
bring together experts from multiple
disciplines including, but not limited to,
epidemiology, nutrition, medicine, and
toxicology.
Request for Comments: The NTP and
the ODS invite comments on an
approach document, ‘‘Identifying
Research Needs for Assessing Safe Use
of High Intakes of Folic Acid,’’ for
review of the pertinent literature, which
is available at https://ntp.niehs.nih.gov/
go/38143. They also request information
on issues related to evaluating potential
adverse health effects of high intakes of
folic acid. The RFI Web site contains
specific questions for the following
topics:
E:\FR\FM\05APN1.SGM
05APN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
• Health effects of most concern for
high folate intake
• Assessments of folic acid intake and
folate levels that are relevant and
validated for high exposure
• Critical co-factors for the evaluation
of potential health impacts of folic acid
• Experts in the field who should be
considered for inclusion in the
workshop
Responses are invited from all
interested parties, such as the nutrition
research community, health
professionals, educators, policy makers,
industry, and the public. Responses to
this RFI are voluntary. The comments
collected will be analyzed and
considered in planning and
development of future initiatives. We do
not intend to publish a summary of
responses received or any other
information provided, except very broad
characterizations, such as the number of
responses received. Despite this,
proprietary, classified, or confidential
information should not be included in
your response. This RFI 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 comment submitted
or for its use of that comment.
Background Information on NTP and
ODS: The NTP is an interagency
program, established in 1978 (43 FR
53060) and headquartered at the NIEHS,
whose mission 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 within the
Division of the NTP. 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 https://
ntp.niehs.nih.gov/).
The mission of the ODS 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 U.S. population. 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
VerDate Mar<15>2010
17:14 Apr 04, 2013
Jkt 229001
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 https://
ods.od.nih.gov/). The Dietary
Supplement Health and Education Act
of 1994 (Public Law 103–417, DSHEA),
authorized the establishment of the ODS
at the NIH in 1995.
Dated: April 1, 2013.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2013–07901 Filed 4–4–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2013–0026]
Privacy Act of 1974; Department of
Homeland Security/U.S. Citizenship
and Immigration Services-015
Electronic Immigration System-2
Account and Case Management
System of Records
Privacy Office, Department of
Homeland Security.
ACTION: Notice of Privacy Act System of
Records.
AGENCY:
In accordance with the
Privacy Act of 1974, the Department of
Homeland Security proposes to update
and reissue a current Department of
Homeland Security system of records
titled, ‘‘Department of Homeland
Security/U.S. Citizenship and
Immigration Services-015 Electronic
Immigration System-2 Account and
Case Management System of Records.’’
This system of records allows the
Department of Homeland Security/U.S.
Citizenship and Immigration Services
to: collect and maintain records on an
individual after that individual submits
a benefit request and/or creates or
updates a U.S. Citizenship and
SUMMARY:
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Fmt 4703
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20673
Immigration Services Electronic
Immigration System account; gather any
missing information; manage workflow;
assist U.S. Citizenship and Immigration
Services in making a benefit
determination; and provide a repository
of data to assist with the efficient
processing of future benefit requests.
U.S. Citizenship and Immigration
Services Electronic Immigration System2 Account and Case Management will
also be used to process and track all
actions related to a particular case,
including scheduling of biometrics
appointments and interviews, requests
for evidence or additional information,
and issuing decision notices and/or
proofs of benefit. This notice updates
this system of records to (1) include
additions to the categories of
individuals and categories of records,
(2) clarify routine uses ‘‘A,’’ ‘‘H,’’ ‘‘L,’’
and ‘‘M,’’ (3) delete routine use ‘‘S,’’ and
(4) reflect a reduced retention period for
attorney and accredited representative
accounts. Additionally, this notice
includes non-substantive changes to
simplify the formatting and text of the
previously published notices. The
exemptions for the existing system of
records notice will continue to be
applicable for this system of records
notice. Additionally, this system will
continue to be included in the
Department of Homeland Security’s
inventory of record systems.
DATES AND COMMENTS: Submit comments
on or before May 6, 2013. In particular,
DHS requests comments concerning the
application of the exemptions to the
newly added categories of individuals
and category of records. This updated
system will be effective May 6, 2013.
ADDRESSES: You may submit comments,
identified by docket number DHS–
2013–0026 by one of the following
methods:
• Federal e-Rulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 202–343–4010.
• Mail: Jonathan R. Cantor, Acting
Chief Privacy Officer, Privacy Office,
Department of Homeland Security,
Washington, DC 20528.
Instructions: All submissions received
must include the agency name and
docket number for this rulemaking. All
comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read background documents or
comments received, please visit https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For
general questions, please contact:
E:\FR\FM\05APN1.SGM
05APN1
]]>Agencies
[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20672-20673]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07901]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Literature Review Approach ``Identifying Research Needs for
Assessing Safe Use of High Intakes of Folic Acid''; Request for
Information and Comments
SUMMARY: The National Toxicology Program (NTP) at the National
Institute of Environmental Health Sciences (NIEHS) in conjunction with
the NIH Office of Dietary Supplements (ODS) is planning a workshop to
identify research needs based on consideration of the state of the
science related to the safe use of high intakes of folic acid. The NTP
and the ODS invite comments on an approach document, ``Identifying
Research Needs for Assessing Safe Use of High Intakes of Folic Acid,''
for review of the pertinent literature. The document is available on
the NTP Folic Acid Request for Information (RFI) Web site (https://ntp.niehs.nih.gov/go/38143). Information gathered through this request
will be used in prioritizing topics for the state of the science
workshop.
DATES: The deadline for receipt of information and comments is May 28,
2013.
ADDRESSES: Comments should be submitted at https://ntp.niehs.nih.gov/go/38143.
FOR FURTHER INFORMATION CONTACT: Abee L. Boyles, Ph.D., Health
Scientist, Office of Health Assessment and Translation, Division of the
NTP, NIEHS, PO Box 12233, MD: K2-04, Research Triangle Park, NC 27709;
telephone: (919) 541-7886; fax: (301) 480-3230; email:
abee.boyles@nih.gov. Courier address: NIEHS, Room 2158, 530 Davis
Drive, Morrisville, NC 27560 or Regan Bailey, Ph.D., R.D., Nutritional
Epidemiologist, ODS, NIH, 6100 Executive Blvd., Room 3B01, Bethesda, MD
20892-7517; telephone: (301) 496-0187; fax: (301) 480-1845; email:
regan.bailey@nih.gov.
SUPPLEMENTARY INFORMATION: Background: The NTP in conjunction with the
NIH ODS is planning a workshop to identify research needs based on
consideration of the state of the science related to the safe use of
high intakes of folic acid. The benefit of supplemental folic acid for
pregnant women to prevent neural tube defects in their children is well
established; at the same time, there is interest in understanding
potential adverse health impacts from high intakes of folic acid. This
project aims to identify research needs and inform the development of a
research agenda for evaluating the safe use of high intakes of folic
acid.
Due to the vastness of the research on folate and folic acid,
screening of the literature was undertaken to identify the potential
adverse health effects for which further research might be warranted.
An approach document, ``Identifying Research Needs for Assessing Safe
Use of High Intakes of Folic Acid,'' is available on the RFI Web site
(https://ntp.niehs.nih.gov/go/38143) and should be referenced in
responding to the RFI. This document (1) outlines the approach used to
screen the literature, (2) describes the results of the screening
effort, and (3) proposes a list of health outcomes for discussion at
the workshop. As background for the workshop, a literature review
document on these health outcomes will be prepared using systematic
review methodology.
Humans require folate, a water-soluble B-complex vitamin, for the
synthesis of nucleic acids and to provide methyl groups for biochemical
reactions within cells. These functions are needed for everyday growth
and cell division, including during 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. 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
but 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.
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, the form of folate commonly added
to foods and dietary supplements.
Information gathered through this RFI will be used in prioritizing
topics for the state of the science workshop. The date and location of
the workshop have not yet been determined, but when set, will be
announced in the Federal Register, the NIH Guide, and on the OHAT
project Web site (https://ntp.niehs.nih.gov/go/38144). The overarching
goals of this workshop are to identify research needs and inform the
development of a research agenda for evaluating the safe use of high
intakes of folic acid. The workshop will bring together experts from
multiple disciplines including, but not limited to, epidemiology,
nutrition, medicine, and toxicology.
Request for Comments: The NTP and the ODS invite comments on an
approach document, ``Identifying Research Needs for Assessing Safe Use
of High Intakes of Folic Acid,'' for review of the pertinent
literature, which is available at https://ntp.niehs.nih.gov/go/38143.
They also request information on issues related to evaluating potential
adverse health effects of high intakes of folic acid. The RFI Web site
contains specific questions for the following topics:
[[Page 20673]]
Health effects of most concern for high folate intake
Assessments of folic acid intake and folate levels that
are relevant and validated for high exposure
Critical co-factors for the evaluation of potential health
impacts of folic acid
Experts in the field who should be considered for
inclusion in the workshop
Responses are invited from all interested parties, such as the
nutrition research community, health professionals, educators, policy
makers, industry, and the public. Responses to this RFI are voluntary.
The comments collected will be analyzed and considered in planning and
development of future initiatives. We do not intend to publish a
summary of responses received or any other information provided, except
very broad characterizations, such as the number of responses received.
Despite this, proprietary, classified, or confidential information
should not be included in your response. This RFI 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 comment submitted or
for its use of that comment.
Background Information on NTP and ODS: The NTP is an interagency
program, established in 1978 (43 FR 53060) and headquartered at the
NIEHS, whose mission 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 within the Division of the NTP. 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 https://ntp.niehs.nih.gov/).
The mission of the ODS 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 U.S. population. 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 https://ods.od.nih.gov/). The Dietary Supplement Health and
Education Act of 1994 (Public Law 103-417, DSHEA), authorized the
establishment of the ODS at the NIH in 1995.
Dated: April 1, 2013.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2013-07901 Filed 4-4-13; 8:45 am]
BILLING CODE 4140-01-P
