[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Pages 24722-24723]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry: Assessing the Effects of Significant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availability of a draft guidance entitled ``Guidance for Industry: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 The draft guidance, when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draft guidance before it begins work on the final version of the
guidance, submit either written or electronic comments on the draft
guidance by July 24, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry: Assessing the Effects of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: [email protected].
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