Food Additives; Bisphenol A; Availability, 17145-17147 [2010-7511]
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jlentini on DSKJ8SOYB1PROD with NOTICES
Transcutaneous Electrical Nerve
Stimulator with Limited Output for Pain
Relief; Draft Guidance for Industry and
FDA Staff’’ (1574); (6) ‘‘Class II Special
Controls Guidance Document:
Transcutaneous Electrical Stimulator for
Aesthetic Purposes; Draft Guidance for
Industry and FDA Staff’’ (1575); (7)
‘‘Class II Special Controls Guidance
Document: Transcutaneous Electrical
Stimulator with Limited Output for
Aesthetic Purposes; Draft Guidance for
Industry and FDA Staff’’ (1576); (8)
‘‘Class II Special Controls Guidance
Document: Powered Muscle Stimulator
for Rehabilitation; Draft Guidance for
Industry and FDA Staff’’ (1577); (9)
‘‘Class II Special Controls Guidance
Document: Powered Muscle Stimulator
with Limited Output for Rehabilitation;
Draft Guidance for Industry and FDA
Staff’’ (1578); (10) ‘‘Class II Special
Controls Guidance Document: Powered
Muscle Stimulator for Muscle
Conditioning; Draft Guidance for
Industry and FDA Staff’’ (1579); and/or
(11) ‘‘Class II Special Controls Guidance
Document: Powered Muscle Stimulator
with Limited Output for Muscle
Conditioning; Draft Guidance for
Industry and FDA Staff’’ (1580).
Persons interested in obtaining a copy
of any or all of the draft guidance
documents may also do so by using the
Internet. CDRH maintains an entry on
the Internet for easy access to
information including text, graphics,
and files that may be downloaded to a
personal computer with Internet access.
Updated on a regular basis, the CDRH
home page includes device safety alerts,
Federal Register reprints, information
on premarket submissions (including
lists of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/MedicalDevices/
default.htm. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
These 11 draft guidance documents
refer to previously approved collections
of information found in FDA
regulations. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in part 807
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(21 CFR part 807), subpart E pertain to
premarket submission requirements for
any person who intends to market
certain medical devices, and have been
approved under OMB control number
0910–0120.
Elsewhere in this issue of the Federal
Register, FDA is publishing a proposed
rule that would designate special
controls for each of these devices and
would exempt six of them from the
premarket notification requirements of
the act. The proposed rule contains an
analysis of the paperwork burden for the
proposed rule, including the anticipated
reduction in burden for manufacturers
who follow the special controls and for
manufacturers of the six proposed
exempt device types. Consistent with
the Paperwork Reduction Act of 1995,
we solicit comment on our revised
burden estimates.
V. Comments
The agency is specifically interested
in comments on the types of claims
appropriate for devices included within
these 11 classifications and, for the
devices that remain subject to premarket
review, the data sponsors should submit
to support those claims. For example,
under the proposed rule, certain
transcutaneous electrical stimulators for
aesthetic purposes would remain
subject to 510(k). The agency is
interested in comments on the type of
data sponsors should submit to show a
transcutaneous electrical nerve
stimulator device achieves ‘‘aesthetic
effects through physical change to the
structure of the body’’ as well as the
predicate device does.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two copies of any mailed
comments, except that individuals may
submit one copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets between
9 a.m. and 4 p.m., Monday through
Friday.
Dated: March 24, 2010.
Jeffrey Shuren,
Director, Center for Devices and Radiological
Health.
[FR Doc. 2010–7634 Filed 4–2–10; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0100]
Food Additives; Bisphenol A;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comment.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of five documents related to
FDA’s continuing assessment of
Bisphenol A (BPA) and soliciting public
comments on the four documents
prepared by FDA’s Center for Food
Safety and Applied Nutrition (CFSAN).
These documents do not represent an
agency opinion or position on BPA, on
which an interim update was recently
provided. (See https://www.fda.gov/
NewsEvents/PublicHealthFocus/
ucm064437.htm). Rather, these
documents provide perspectives and
opinions that are being considered by
FDA as it continues its safety
assessment of BPA. This action will
enable FDA to consider comments from
the public in its assessment of BPA for
food contact applications.
DATES: Submit written or electronic
information and comments by June 4,
2010.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Francis Lin, Center for Food Safety and
Applied Nutrition (HFS–275), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
301–436–1215.
SUPPLEMENTARY INFORMATION:
I. Background
BPA is a chemical used in certain
food contact materials. Uses of BPA
were approved by FDA under its food
additive regulations in the early 1960s.
In recent years, questions have been
raised about BPA’s safety. On August
14, 2008, FDA delivered its Draft
Assessment of BPA for Use in Food
Contact Applications (the Draft
Assessment) (Ref. 1) to a Subcommittee
of FDA’s Science Board for external
review.
On September 16, 2008, the
Subcommittee held a public meeting on
BPA as part of its external review
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Federal Register / Vol. 75, No. 64 / Monday, April 5, 2010 / Notices
process, after which the Subcommittee
wrote and transmitted its report to the
FDA Science Board. On October 31,
2008, the Science Board accepted the
Subcommittee’s report and transmitted
it to FDA with suggestions for revising
the Draft Assessment and instructions to
conduct a more in-depth review of
certain relatively recent low-dose
studies identified in a draft report,
released in April 2008, by the National
Toxicology Program (NTP) Center for
the Evaluation of Risks to Human
Reproduction (CERHR) (Ref. 2) and
included in the final assessment
completed by the NTP (Ref. 3).
FDA’s Center for Food Safety and
Applied Nutrition (CFSAN) has
provided a review, as suggested by the
Science Board, of the low-dose studies
mentioned in the NTP report and issued
a memorandum describing that review
(Doc. 1).1 In this review (Doc. 1),
CFSAN also describes its review of
other relevant studies that were either
made available since the publication of
the NTP report or suggested by the
Science Board for consideration. Five
expert, non-FDA, government scientists
were requested by FDA to conduct a
scientific review of CFSAN’s assessment
of the low-dose studies. Their reviews
are combined and made available in
Doc. 2 and, as such, provide
perspectives on Doc. 1 that may be
helpful as additional context, including
for those who may want to comment on
the CFSAN documents.
Based on its initial review of these
materials, FDA recently provided an
interim update where it expressed
‘‘some concern’’ about the potential
effects of BPA on the brain, behavior,
and prostate gland of fetuses, infants,
and children, consistent with the final
NTP report (Ref. 3), and indicated steps
it is taking and interim
recommendations, to address these
concerns (see https://www.fda.gov/
NewsEvents/PublicHealthFocus/
ucm064437.htm). FDA also recognized
(id.), as did the NTP review, substantial
uncertainties with respect to the overall
interpretation of these studies and their
potential implications for human health
effects of BPA exposure. These
uncertainties relate to issues such as the
routes of exposure employed, the lack of
consistency among some of the
measured endpoints or results between
studies, the relevance of some animal
models to human health, differences in
the metabolism (and detoxification) of
and responses to BPA both at different
ages and in different species, and
limited or absent dose response
information for some studies.
In a third document (Doc. 3), CFSAN
reviews and summarizes a number of
studies of BPA and health that were
made available after its assessment of
low-dose studies (Doc. 1). Among the
additional studies summarized in Doc. 3
is an as yet unpublished study focused
on the potential developmental
neurotoxicity of dietary BPA in rats
(Ref. 4), which was commissioned by
the American Chemistry Council and
submitted to FDA.
FDA also is making available
CFSAN’s updated dietary exposure
estimate for the food contact uses of
BPA in packaging for infant formula,
baby and adult foods, and polycarbonate
nursing bottles (Doc. 4). Finally, FDA is
making available CFSAN’s review of
available biomonitoring data on BPA
(Doc. 5).
At this time, as FDA continues its
safety assessment of BPA, we are
seeking public comment on the four
CFSAN documents (Docs. 1, 3, 4, and 5)
that are relevant to this safety
assessment. While pre-decisional
documents such as these are not
required to be made available for public
comment, we believe it is appropriate in
this case due to the complexity of the
scientific issues and the degree of public
interest in FDA’s scientific assessment
of BPA. As we update our assessment,
which may include additional peer
review, we will consider any public
comments received, as well as new
scientific findings as they become
available. The five documents, which
are available in the docket established
for this notice, are listed in table 1 of
this document.
TABLE 1.
Document No.
Date
Title
August 31, 2009
Memorandum from Toxicology Group 1, Division of Food Contact Notifications, Office of Food Additive
Safety, Center for Food Safety and Applied Nutrition; HFS–275: ‘‘Bisphenol A (CAS RN. 80–05–7):
Review of Low-Dose Studies’’
2
November 2009
External Governmental Reviewer Comments on Draft Report: ‘‘Bisphenol A (CAS RN. 80–05–7): Review
of Low-Dose Studies’’
3
November 24, 2009
Memorandum from Toxicology Group 1, Division of Food Contact Notifications, Office of Food Additive
Safety, Center for Food Safety and Applied Nutrition; HFS–275: ‘‘Bisphenol A (CAS RN. 80–05–7):
studies added to ‘Review of Low Dose Studies’ assessment’’
4
October 22, 2009
Memorandum from: Chemistry Review Group 1, Division of Food Contact Notifications and Chemistry
Team, HFS–275 and Chemistry Review Team, Division of Biotechnology and GRAS Notice Review,
Office of Food Additive Safety, Center for Food Safety and Applied Nutrition; HFS–255: ‘‘Exposure to
Bisphenol A (BPA) for infants, toddlers and adults from the consumption of infant formula, toddler food
and adult (canned) food’’
5
jlentini on DSKJ8SOYB1PROD with NOTICES
1
November 16, 2009
Memorandum from: Regulatory Group 2, Division of Food Contact Notifications, Office of Food Additive
Safety, Center for Food Safety and Applied Nutrition, HFS–275: ‘‘Summary of Bisphenol A Biomonitoring Studies’’
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
1 See table 1 of this document for a description
of Document (Doc.) numbers 1 through 5.
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Federal Register / Vol. 75, No. 64 / Monday, April 5, 2010 / Notices
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.regulations.gov.
IV. References
We have placed the following
references on display in the Division of
Dockets Management (see ADDRESSES).
You may see them between 9 a.m. and
4 p.m., Monday through Friday. FDA
has verified the Web site addresses, but
FDA is not responsible for any
subsequent changes to non-FDA Web
sites after this document publishes in
the Federal Register.
1. Draft Assessment of Bisphenol A for Use
in Food Contact Applications (August 14,
2008). Accessible at: https://www.fda.gov/
food/foodingredientspackaging/
ucm166145.htm.
2. Draft NTP Brief on Bisphenol A, April
14, 2008. Accessible at: https://
cerhr.niehs.nih.gov/chemicals/bisphenol/
BPADraftBriefVF_04_14_08.pdf.
3. National Toxicology Program, Center for
the Evaluation of Risks to Human
Reproduction. NTP–CERHR Monograph on
the Potential Human Reproductive and
Developmental Effects of Bisphenol A. NIH
Publication No. 08–5994. September 2008.
Accessible at: https://cerhr.niehs.nih.gov/
chemicals/bisphenol/bisphenol.pdf.
4. WIL Research Laboratories, LLC. A
Dietary Developmental Neurotoxicity Study
of Bisphenol A in Rats (WIL–186056),
September 30, 2009.
Dated: March 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–7511 Filed 4–2–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0343]
jlentini on DSKJ8SOYB1PROD with NOTICES
International Conference on
Harmonisation; Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex 9 on
Tablet Friability General Chapter;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled ‘‘Q4B
Evaluation and Recommendation of
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16:35 Apr 02, 2010
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Pharmacopoeial Texts for Use in the
ICH Regions; Annex 9: Tablet Friability
General Chapter.’’ The guidance was
prepared under the auspices of the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The guidance provides the results of the
ICH Q4B evaluation of the Tablet
Friability General Chapter harmonized
text from each of the three
pharmacopoeias (United States,
European, and Japanese) represented by
the Pharmacopoeial Discussion Group
(PDG). The guidance conveys
recognition of the three pharmacopoeial
methods by the three ICH regulatory
regions and provides specific
information regarding the recognition.
The guidance is intended to recognize
the interchangeability between the local
regional pharmacopoeias, thus avoiding
redundant testing in favor of a common
testing strategy in each regulatory
region. This guidance is in the form of
an annex to the core guidance on the
Q4B process entitled ‘‘Q4B Evaluation
and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions’’ (core ICH Q4B guidance).
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. The
guidance may also be obtained by mail
by calling CBER at 1–800–835–4709 or
301–827–1800. Send two self-addressed
adhesive labels to assist the office in
processing your requests. Requests and
comments should be identified with the
docket number found in brackets in the
heading of this document. Submit
written comments on the guidance to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H. King,
Sr., Center for Drug Evaluation and
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17147
Research (HFD–003), Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 4150, Silver Spring,
MD 20993–0002, 301–796–1242; or
Christopher Joneckis, Center for
Biologics Evaluation and Research
(HFM–25), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–0373.
Regarding the ICH: Michelle Limoli,
Office of International Programs (HFG–
1), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In the Federal Register of August 14,
2009 (74 FR 41144), FDA published a
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]]>Agencies
[Federal Register Volume 75, Number 64 (Monday, April 5, 2010)]
[Notices]
[Pages 17145-17147]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7511]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0100]
Food Additives; Bisphenol A; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of five documents related to FDA's continuing assessment
of Bisphenol A (BPA) and soliciting public comments on the four
documents prepared by FDA's Center for Food Safety and Applied
Nutrition (CFSAN). These documents do not represent an agency opinion
or position on BPA, on which an interim update was recently provided.
(See https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm).
Rather, these documents provide perspectives and opinions that are
being considered by FDA as it continues its safety assessment of BPA.
This action will enable FDA to consider comments from the public in its
assessment of BPA for food contact applications.
DATES: Submit written or electronic information and comments by June 4,
2010.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Francis Lin, Center for Food Safety
and Applied Nutrition (HFS-275), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1215.
SUPPLEMENTARY INFORMATION:
I. Background
BPA is a chemical used in certain food contact materials. Uses of
BPA were approved by FDA under its food additive regulations in the
early 1960s. In recent years, questions have been raised about BPA's
safety. On August 14, 2008, FDA delivered its Draft Assessment of BPA
for Use in Food Contact Applications (the Draft Assessment) (Ref. 1) to
a Subcommittee of FDA's Science Board for external review.
On September 16, 2008, the Subcommittee held a public meeting on
BPA as part of its external review
[[Page 17146]]
process, after which the Subcommittee wrote and transmitted its report
to the FDA Science Board. On October 31, 2008, the Science Board
accepted the Subcommittee's report and transmitted it to FDA with
suggestions for revising the Draft Assessment and instructions to
conduct a more in-depth review of certain relatively recent low-dose
studies identified in a draft report, released in April 2008, by the
National Toxicology Program (NTP) Center for the Evaluation of Risks to
Human Reproduction (CERHR) (Ref. 2) and included in the final
assessment completed by the NTP (Ref. 3).
FDA's Center for Food Safety and Applied Nutrition (CFSAN) has
provided a review, as suggested by the Science Board, of the low-dose
studies mentioned in the NTP report and issued a memorandum describing
that review (Doc. 1).\1\ In this review (Doc. 1), CFSAN also describes
its review of other relevant studies that were either made available
since the publication of the NTP report or suggested by the Science
Board for consideration. Five expert, non-FDA, government scientists
were requested by FDA to conduct a scientific review of CFSAN's
assessment of the low-dose studies. Their reviews are combined and made
available in Doc. 2 and, as such, provide perspectives on Doc. 1 that
may be helpful as additional context, including for those who may want
to comment on the CFSAN documents.
---------------------------------------------------------------------------
\1\ See table 1 of this document for a description of Document
(Doc.) numbers 1 through 5.
---------------------------------------------------------------------------
Based on its initial review of these materials, FDA recently
provided an interim update where it expressed ``some concern'' about
the potential effects of BPA on the brain, behavior, and prostate gland
of fetuses, infants, and children, consistent with the final NTP report
(Ref. 3), and indicated steps it is taking and interim recommendations,
to address these concerns (see https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm). FDA also recognized (id.), as did the
NTP review, substantial uncertainties with respect to the overall
interpretation of these studies and their potential implications for
human health effects of BPA exposure. These uncertainties relate to
issues such as the routes of exposure employed, the lack of consistency
among some of the measured endpoints or results between studies, the
relevance of some animal models to human health, differences in the
metabolism (and detoxification) of and responses to BPA both at
different ages and in different species, and limited or absent dose
response information for some studies.
In a third document (Doc. 3), CFSAN reviews and summarizes a number
of studies of BPA and health that were made available after its
assessment of low-dose studies (Doc. 1). Among the additional studies
summarized in Doc. 3 is an as yet unpublished study focused on the
potential developmental neurotoxicity of dietary BPA in rats (Ref. 4),
which was commissioned by the American Chemistry Council and submitted
to FDA.
FDA also is making available CFSAN's updated dietary exposure
estimate for the food contact uses of BPA in packaging for infant
formula, baby and adult foods, and polycarbonate nursing bottles (Doc.
4). Finally, FDA is making available CFSAN's review of available
biomonitoring data on BPA (Doc. 5).
At this time, as FDA continues its safety assessment of BPA, we are
seeking public comment on the four CFSAN documents (Docs. 1, 3, 4, and
5) that are relevant to this safety assessment. While pre-decisional
documents such as these are not required to be made available for
public comment, we believe it is appropriate in this case due to the
complexity of the scientific issues and the degree of public interest
in FDA's scientific assessment of BPA. As we update our assessment,
which may include additional peer review, we will consider any public
comments received, as well as new scientific findings as they become
available. The five documents, which are available in the docket
established for this notice, are listed in table 1 of this document.
Table 1.
------------------------------------------------------------------------
Document
No. Date Title
------------------------------------------------------------------------
1 August 31, Memorandum from Toxicology Group 1, Division of
2009 Food Contact Notifications, Office of Food
Additive Safety, Center for Food Safety and
Applied Nutrition; HFS-275: ``Bisphenol A (CAS
RN. 80-05-7): Review of Low-Dose Studies''
------------------------------------------------------------------------
2 November External Governmental Reviewer Comments on Draft
2009 Report: ``Bisphenol A (CAS RN. 80-05-7): Review
of Low-Dose Studies''
------------------------------------------------------------------------
3 November Memorandum from Toxicology Group 1, Division of
24, 2009 Food Contact Notifications, Office of Food
Additive Safety, Center for Food Safety and
Applied Nutrition; HFS-275: ``Bisphenol A (CAS
RN. 80-05-7): studies added to `Review of Low
Dose Studies' assessment''
------------------------------------------------------------------------
4 October Memorandum from: Chemistry Review Group 1,
22, 2009 Division of Food Contact Notifications and
Chemistry Team, HFS-275 and Chemistry Review
Team, Division of Biotechnology and GRAS Notice
Review, Office of Food Additive Safety, Center
for Food Safety and Applied Nutrition; HFS-255:
``Exposure to Bisphenol A (BPA) for infants,
toddlers and adults from the consumption of
infant formula, toddler food and adult (canned)
food''
------------------------------------------------------------------------
5 November Memorandum from: Regulatory Group 2, Division of
16, 2009 Food Contact Notifications, Office of Food
Additive Safety, Center for Food Safety and
Applied Nutrition, HFS-275: ``Summary of
Bisphenol A Biomonitoring Studies''
------------------------------------------------------------------------
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received
[[Page 17147]]
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.regulations.gov.
IV. References
We have placed the following references on display in the Division
of Dockets Management (see ADDRESSES). You may see them between 9 a.m.
and 4 p.m., Monday through Friday. FDA has verified the Web site
addresses, but FDA is not responsible for any subsequent changes to
non-FDA Web sites after this document publishes in the Federal
Register.
1. Draft Assessment of Bisphenol A for Use in Food Contact
Applications (August 14, 2008). Accessible at: https://www.fda.gov/food/foodingredientspackaging/ucm166145.htm.
2. Draft NTP Brief on Bisphenol A, April 14, 2008. Accessible
at: https://cerhr.niehs.nih.gov/chemicals/bisphenol/BPADraftBriefVF_04_14_08.pdf.
3. National Toxicology Program, Center for the Evaluation of
Risks to Human Reproduction. NTP-CERHR Monograph on the Potential
Human Reproductive and Developmental Effects of Bisphenol A. NIH
Publication No. 08-5994. September 2008. Accessible at: https://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.pdf.
4. WIL Research Laboratories, LLC. A Dietary Developmental
Neurotoxicity Study of Bisphenol A in Rats (WIL-186056), September
30, 2009.
Dated: March 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7511 Filed 4-2-10; 8:45 am]
BILLING CODE 4160-01-S
