Toxicological Principles for the Safety Assessment of Food Ingredients; Public Meeting on Updates and Safety and Risk Assessment Considerations; Extension of Comment Period, 5559 [2015-01858]
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Dated: January 27, 2015.
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Aging.
[FR Doc. 2015–01857 Filed 1–30–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1497]
Toxicological Principles for the Safety
Assessment of Food Ingredients;
Public Meeting on Updates and Safety
and Risk Assessment Considerations;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notification of public meeting;
request for comments; extension of
comment period.
ACTION:
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
notification of public meeting and
request for comments that appeared in
the Federal Register of October 30,
2014. The notification requested
comments on certain topics related to
our guidance titled ‘‘Toxicological
Principles for the Safety Assessment of
Food Ingredients,’’ known less formally
as the ‘‘Redbook’’. We are taking this
action in response to requests for an
extension to allow interested persons
additional time to submit comments.
DATES: FDA is extending the comment
period on the notification of public
meeting and request for comments
published October 30, 2014 (79 FR
64603). Submit either electronic or
written comments by May 11, 2015.
ADDRESSES: You may submit comments
by any of the following methods:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
VerDate Sep<11>2014
19:24 Jan 30, 2015
Jkt 235001
• Mail/Hand delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Docket No. (FDA–
2014–N–1497) for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jeremiah Fasano, Center for Food Safety
and Applied Nutrition (HFS–255), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1173, jeremiah.fasano@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 30,
2014 (79 FR 64603), we published a
notification of public meeting and
requested comments on certain topics
related to the Redbook. The Redbook
provides guidance to industry and other
stakeholders (e.g., academia and other
regulatory groups) regarding the
information used by FDA’s Center for
Food Safety and Applied Nutrition to
evaluate the safety of food additives and
color additives. The Redbook is
intended to help interested parties
understand FDA’s expectations
regarding:
• Determining the human exposure
that will occur from the use of the
ingredient in foods;
• Determining which toxicity studies
are appropriate;
• Designing, conducting, and
reporting the results of toxicity studies;
and
• Submitting the information to FDA
as part of a safety assessment.
Comments on the Redbook will
inform our future efforts on what should
be included, changed, or even excluded
from the updated Redbook. We are
interested in expanding the scope of the
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
5559
Redbook to emphasize the principles of
safety and risk assessment that are
shared across different regulatory
contexts for foods and cosmetics, while
still providing specific guidance for
applying these principles in particular
contexts such as the requirements for
premarket safety submissions or for risk
assessments conducted on foods and
cosmetics already on the market.
We have received a request for a 90day extension of the comment period for
the notification of public meeting and
request for comments. The request
conveyed-concern that the current 90day comment period (which would
otherwise expire on February 9, 2015)
does not allow sufficient time to
develop meaningful or thoughtful
responses to the notification of public
meeting and request for comments.
We have considered the request and
are extending the comment period for
90 days, until May 10, 2015. We believe
that a 90-day extension allows adequate
time for interested persons to submit
comments without significantly
delaying further action on these
important issues.
II. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: January 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01858 Filed 1–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2031]
For Nominations on the Food Advisory
Committee; Extension of Closing Date
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of closing
date.
The Food and Drug
Administration (FDA) is extending the
closing date for the notice that appeared
SUMMARY:
E:\FR\FM\02FEN1.SGM
02FEN1
Agencies
[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Notices]
[Page 5559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01858]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1497]
Toxicological Principles for the Safety Assessment of Food
Ingredients; Public Meeting on Updates and Safety and Risk Assessment
Considerations; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public meeting; request for comments; extension
of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the notification of public meeting and request for
comments that appeared in the Federal Register of October 30, 2014. The
notification requested comments on certain topics related to our
guidance titled ``Toxicological Principles for the Safety Assessment of
Food Ingredients,'' known less formally as the ``Redbook''. We are
taking this action in response to requests for an extension to allow
interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the notification of
public meeting and request for comments published October 30, 2014 (79
FR 64603). Submit either electronic or written comments by May 11,
2015.
ADDRESSES: You may submit comments by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Docket No.
(FDA-2014-N-1497) for this rulemaking. All comments received may be
posted without change to https://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jeremiah Fasano, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1173,
jeremiah.fasano@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 30, 2014 (79 FR 64603), we
published a notification of public meeting and requested comments on
certain topics related to the Redbook. The Redbook provides guidance to
industry and other stakeholders (e.g., academia and other regulatory
groups) regarding the information used by FDA's Center for Food Safety
and Applied Nutrition to evaluate the safety of food additives and
color additives. The Redbook is intended to help interested parties
understand FDA's expectations regarding:
Determining the human exposure that will occur from the
use of the ingredient in foods;
Determining which toxicity studies are appropriate;
Designing, conducting, and reporting the results of
toxicity studies; and
Submitting the information to FDA as part of a safety
assessment.
Comments on the Redbook will inform our future efforts on what
should be included, changed, or even excluded from the updated Redbook.
We are interested in expanding the scope of the Redbook to emphasize
the principles of safety and risk assessment that are shared across
different regulatory contexts for foods and cosmetics, while still
providing specific guidance for applying these principles in particular
contexts such as the requirements for premarket safety submissions or
for risk assessments conducted on foods and cosmetics already on the
market.
We have received a request for a 90-day extension of the comment
period for the notification of public meeting and request for comments.
The request conveyed-concern that the current 90-day comment period
(which would otherwise expire on February 9, 2015) does not allow
sufficient time to develop meaningful or thoughtful responses to the
notification of public meeting and request for comments.
We have considered the request and are extending the comment period
for 90 days, until May 10, 2015. We believe that a 90-day extension
allows adequate time for interested persons to submit comments without
significantly delaying further action on these important issues.
II. Request for Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
Dated: January 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01858 Filed 1-30-15; 8:45 am]
BILLING CODE 4164-01-P