Document ID: FDA-2011-D-0490-0018
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Assessing the Effects of Significant Manufacturing
Process Changes, Including Emerging Technologies, on the Safety and
Regulatory Status of Food Ingredients and Food Contact Substances,
Including Food Ingredients That Are Color Additives; Availability
Posted Date: 2014-06-27T04:00Z

[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36533-36534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15031]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0490]

Guidance for Industry: Assessing the Effects of Significant 
Manufacturing Process Changes, Including Emerging Technologies, on the 
Safety and Regulatory Status of Food Ingredients and Food Contact 
Substances, Including Food Ingredients That Are Color Additives; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance entitled ``Guidance for Industry: Assessing 
the Effects of Significant Manufacturing Process Changes, Including 
Emerging Technologies, on the Safety and Regulatory Status of Food 
Ingredients and Food Contact Substances, Including Food Ingredients 
that are Color Additives.'' The guidance explains FDA's current 
thinking on the factors to be considered when determining whether 
changes in manufacturing process, including the intentional reduction 
in particle size to the nanoscale, for a food substance already in the 
market affect the identity of the food substance, impact the safety of 
the use of the food substance, change the regulatory status of the use 
of the food substance, or warrant a new regulatory submission to FDA.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Guidance for Industry: Assessing the Effects of Significant 
Manufacturing Process Changes, Including Emerging Technologies, on the 
Safety and Regulatory Status of Food Ingredients and Food Contact 
Substances, Including Food Ingredients that are Color Additives'' to 
the Office of Food Additive Safety (HFS-200), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy, College Park, MD 20740. Send two self-addressed adhesive labels 
to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance.
    Submit electronic comments on the guidance to http://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: Teresa Croce, Center for Food and 
Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 240-402-1281.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance entitled 
``Guidance for Industry: Assessing the Effects of Significant 
Manufacturing Process Changes, Including Emerging Technologies, on the 
Safety and Regulatory Status of Food Ingredients and Food Contact 
Substances, Including Food Ingredients that are Color Additives.'' The 
guidance is being issued consistent with our good guidance practices 
regulation (21 CFR 10.115). The guidance represents FDA's current 
thinking on this topic. It does not create or confer any rights for or 
on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of applicable statutes and regulations. This guidance 
represents FDA's current thinking on the factors to be considered when 
determining whether changes in manufacturing process, including the 
intentional reduction in particle size to the nanoscale, for a food 
substance already in the market affect identity of the food substance, 
impact the safety of the use of the food substance, change the 
regulatory status of the use of the food substance, or warrant a new 
regulatory submission to FDA.
    In the Federal Register of April 25, 2012 (77 FR 24722), we made 
available a draft guidance entitled ``Draft Guidance for Industry: 
Assessing the Effects of Significant Manufacturing Process Changes, 
Including Emerging Technologies, on the Safety and Regulatory Status of 
Food Ingredients and Food Contact Substances, Including Food 
Ingredients that are Color Additives'' and gave interested parties an 
opportunity to submit comments by July 24, 2012, for us to consider 
before beginning work on the final version of the guidance. We received 
several comments on the draft guidance and have modified the final 
guidance where appropriate. The guidance announced in this notice 
finalizes the draft guidance dated April 2012.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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 
Sec. Sec.  170.101, 170.106, and 171.1 have been approved under OMB 
control number 0910-0495; the collections of information in Sec. Sec.  
70.25, 71.1, 170.35, and 171.1 have been approved under OMB control 
number 0910-0016; the collections of information in Sec.  170.39 have 
been approved under OMB control number 0910-0298; and the collections 
of information in proposed Sec.  170.36 (62 FR 18938, April 17, 1997) 
has been approved under OMB control number 0910-0342.

III. Comments

    Interested persons may submit either written comments regarding the 
guidance to the Division of Dockets Management (see ADDRESSES) or 
electronic comments regarding the guidance to http://www.regulations.gov. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/FoodGuidances or at http://www.regulations.gov. Use the FDA Web site listed in the previous

[[Page 36534]]

sentence to find the most current version of the guidance.

    Dated: June 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15031 Filed 6-26-14; 8:45 am]
BILLING CODE 4164-01-P