
[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]


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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, 
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 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


