Document ID: FDA-2011-D-0490-0001
Agency: fda
Document Type: Notice
Title: Draft Guidances for Industry: Assessing Effects of Significant Manufacturing Process Changes, Including Emerging Technologies on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances
Posted Date: 2012-04-25T04:00Z

[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Pages 24722-24723]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9936]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Draft Guidance for Industry: Assessing the Effects of Significant 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; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Guidance for Industry: 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 The draft guidance, when 
finalized, will explain 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 affects the safety and 
regulatory status of the food substance, and whether a new regulatory 
submission to FDA is warranted.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either written or electronic comments on the draft 
guidance by July 24, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: Assessing the Effects of 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),

[[Page 24723]]

Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug 
Administration, 5100 Paint Branch Pkwy, College Park, MD 20740, 240-
402-1200. Send one self-addressed adhesive label to assist that office 
in processing your requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.
    Submit electronic comments on the draft 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. All comments should be identified with 
the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Annette M. McCarthy, Center for Food 
and Applied Nutrition (HFS-205), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1057, FAX 301-436-
2972, email: Annette.McCarthy@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance document 
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.'' This 
draft guidance, when finalized, will represent 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 
affects the safety and regulatory status of the food substance, and 
whether a new regulatory submission is warranted.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency'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.

II. Paperwork Reduction Act of 1995

    This draft guidance refers 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 Sec. Sec.  170.101, 170.106, 171.1 (21 
CFR 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 \1\ have been approved under OMB control number 0910-0342.
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    \1\ In April 1997, FDA proposed a voluntary procedure (proposed 
Sec.  170.36) whereby manufacturers would notify FDA about a view 
that a particular use (or uses) of a substance is not subject to the 
statutory premarket approval requirements based on a determination 
that such use is generally recognized as safe (GRAS) (62 FR 18938, 
April 17, 1997). FDA invited interested persons who determine that a 
use of a substance is GRAS to notify FDA of those determinations, 
under the framework of the 1997 proposed rule, during the interim 
between the proposed and final rules (62 FR 18938 at 18954). FDA 
received OMB approval for submissions received under the framework 
of the 1997 proposed rule.
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III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.regulations.gov or http://www.fda.gov/FoodGuidances. 
Always access an FDA guidance document by using FDA's Web site listed 
previously to find the most current version of the guidance.

    Dated: April 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9936 Filed 4-24-12; 8:45 am]
BILLING CODE 4160-01-P