[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Notices]
[Page 5559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01858]
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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.
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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: http://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 http://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 http://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,
[email protected].
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 http://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 http://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