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, 36533-36534 [2014-15031]
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Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices
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 https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/CosmeticGuidances
or https://www.regulations.gov. Use the
FDA Web site listed in the previous
sentence to find the most current
version of the guidance.
Dated: June 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15032 Filed 6–26–14; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
wreier-aviles on DSK5TPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:30 Jun 26, 2014
Jkt 232001
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 https://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:
DATES:
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
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
36533
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 §§ 170.101, 170.106,
and 171.1 have been approved under
OMB control number 0910–0495; the
collections of information in §§ 70.25,
71.1, 170.35, and 171.1 have been
approved under OMB control number
0910–0016; the collections of
information in § 170.39 have been
approved under OMB control number
0910–0298; and the collections of
information in proposed § 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 https://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 https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/FoodGuidances or
at https://www.regulations.gov. Use the
FDA Web site listed in the previous
E:\FR\FM\27JNN1.SGM
27JNN1
36534
Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices
processing your requests. See the
section for
electronic access to the guidance.
Submit electronic comments on the
guidance to https://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: Ritu
Nalubola, Office of Policy, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4236, Silver Spring,
MD 20993–0002, 301–796–4830,email:
Ritu.Nalubola@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
sentence to find the most current
version of the guidance.
SUPPLEMENTARY INFORMATION
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0530]
Guidance for Industry: Considering
Whether a Food and Drug
Administration-Regulated Product
Involves the Application of
Nanotechnology; Availability
AGENCY:
I. Background
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance entitled ‘‘Guidance for
Industry: Considering Whether an FDARegulated Product Involves the
Application of Nanotechnology.’’ This
guidance explains FDA’s current
thinking on determining whether FDAregulated products involve the
application of nanotechnology. The
guidance identifies two Points to
Consider, which address both particle
dimensions and dimension-dependent
properties or phenomena. If either point
applies to a given product, industry and
FDA should consider whether
evaluations of safety, effectiveness,
public health impact, or regulatory
status of that product have identified
and adequately addressed any unique
properties or behaviors of the product.
These two Points to Consider are
intended to provide an initial screening
tool that can be broadly applied to all
FDA-regulated products, with the
understanding that these points are
subject to change in the future as new
information becomes available.
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: Considering
Whether an FDA-Regulated Product
Involves the Application of
Nanotechnology’’ to the Office of Policy,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
wreier-aviles on DSK5TPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:30 Jun 26, 2014
Jkt 232001
We are announcing the availability of
a guidance entitled ‘‘Guidance for
Industry: Considering Whether an FDARegulated Product Involves the
Application of Nanotechnology.’’
This guidance is intended for
manufacturers, suppliers, importers,
and other stakeholders. It describes
FDA’s current thinking on determining
whether FDA-regulated products
involve the application of
nanotechnology. In the Federal Register
of June 14, 2011 (76 FR 34715), we
made available a draft guidance entitled
‘‘Draft Guidance for Industry:
Considering Whether an FDA-Regulated
Product Involves the Application of
Nanotechnology’’ and gave interested
parties an opportunity to submit
comments by August 15, 2011, 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 June
2011.
This guidance provides an
overarching framework for FDA’s
approach to the regulation of
nanotechnology products. Based on our
current scientific and technical
understanding of nanomaterials and
their characteristics, FDA believes that
evaluations of safety, effectiveness,
public health impact, or regulatory
status of nanotechnology products
should consider any unique properties
and behaviors that the application of
nanotechnology may impart. This
guidance identifies two Points to
Consider that should be applied when
considering whether FDA-regulated
products involve the application of
nanotechnology. These Points address
both particle dimensions and
dimension-dependent properties or
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
phenomena. If either point applies to a
given product, industry and FDA should
consider whether the evaluations of
safety, effectiveness, public health
impact, or regulatory status of that
product have identified and adequately
addressed any unique properties or
behaviors of the product.
These two Points to Consider are
intended to provide an initial screening
tool that can be broadly applied to all
FDA-regulated products, with the
understanding that these points are
subject to change in the future as new
information becomes available. In
particular, FDA may further refine these
points, either as applicable broadly to
all FDA-regulated products or as
applicable to particular products or
classes of products, as justified by
scientific information.
We will consider future revisions to
our approach, including developing
regulatory definitions relevant to
nanotechnology, as warranted and in
keeping with evolving scientific
understanding. FDA may also provide
additional guidance, including productspecific guidance documents, to address
issues such as the regulatory status,
safety, effectiveness, performance,
quality, or public health impact of
nanotechnology products.
We urge industry to consult early
with FDA so that any questions related
to the regulatory status, safety,
effectiveness, or public health impact of
products that involve the application of
nanotechnology can be appropriately
and adequately addressed.
II. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents 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. You may use an
alternative approach if such approach
satisfies the requirements of applicable
statutes and regulations.
III. Comments
Interested persons may submit either
electronic comments regarding the
guidance to https://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 https://
www.regulations.gov.
E:\FR\FM\27JNN1.SGM
27JNN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/FoodGuidances or at https://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
