DSM Nutritional Products; Filing of Food Additive Petition (Animal Use), 16252 [2014-06487]
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Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Proposed Rules
Docket: For access to the docket to
read background documents or
comments received, go to https://
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, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
With regard to the proposed rule: Ryan
Newkirk, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2428.
With regard to the information
collection: Domini Bean, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400T, Rockville, MD 20850,
Domini.Bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
tkelley on DSK3SPTVN1PROD with PROPOSALS
I. Background
In the Federal Register of December
24, 2013, we published a proposed rule
entitled ‘‘Focused Mitigation Strategies
to Protect Food Against Intentional
Adulteration’’ with a 100-day comment
period on the provisions of the
proposed rule and on the information
collection provisions that are subject to
review by OMB under the PRA (44
U.S.C. 3501–3520).
FDA has received requests for an
extension of the comment period on the
proposed rule. The requests conveyed
concern that the current 100-day
comment period does not allow time to
thoroughly analyze the proposed rule
since this is unlike any other proposal
and due to the inherent complexity and
unique nature of food defense issues.
The requests also stated an extended
comment period would allow interested
persons an opportunity to fully review
and analyze the approaches FDA has
proposed for the rule and its potential
impact as well as consider the
complexity and if the proposal has the
flexibility to address the many types of
food operations that will be affected.
FDA has considered the requests and is
granting an extension of the comment
period to June 30, 2014, for the
‘‘Focused Mitigation Strategies to
Protect Food Against Intentional
Adulteration’’ proposed rule to allow
interested persons additional time to
submit comments. We also are
extending the comment period for the
information collection provisions to
June 30, 2014, to make the comment
period for the information collection
provisions the same as the comment
period for the provisions of the
VerDate Mar<15>2010
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proposed rule. To clarify, FDA is
requesting comment on all issues raised
by the proposed rule.
II. Paperwork Reduction Act of 1995
Interested persons may either submit
electronic comments regarding the
information collection to oira_
submission@omb.eop.gov or fax written
comments to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX: 202–395–7285. All
comments should be identified with the
title ‘‘Focused Mitigation Strategies to
Protect Food Against Intentional
Adulteration.’’
III. Request for Comments
Interested persons may submit either
electronic comments regarding the
proposed rule 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.
Dated: March 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–06468 Filed 3–24–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submit electronic
comments 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:
Isabel W. Pocurull, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6853.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(section 409(b)(5) (21 U.S.C. 348(b)(5)),
notice is given that a food additive
petition (FAP 2280) has been filed by
DSM Nutritional Products, 45
Waterview Blvd., Parsippany, NJ 07054.
The petition proposes to amend Title 21
of the Code of Federal Regulations (CFR)
in part 573 Food Additives Permitted in
Feed and Drinking Water of Animals (21
CFR part 573) to provide for the safe use
of 25-hydroxyvitamin D3 in feed for
swine.
The petitioner has requested a
categorical exclusion from preparing an
environmental assessment or
environmental impact statement under
21 CFR 25.32(r). Interested persons may
submit either electronic or written
comments regarding this request for
categorical exclusion to the Division of
Dockets Management (see DATES and
ADDRESSES). 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.
ADDRESSES:
Food and Drug Administration
Dated: March 19, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
21 CFR Part 573
[FR Doc. 2014–06487 Filed 3–24–14; 8:45 am]
BILLING CODE 4160–01–P
[Docket No. FDA–2014–F–0295]
DSM Nutritional Products; Filing of
Food Additive Petition (Animal Use)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of petition.
The Food and Drug
Administration (FDA) is announcing
that DSM Nutritional Products has filed
a petition proposing that the food
additive regulations be amended to
provide for the safe use of 25hydroxyvitamin D3 in feed for swine.
DATES: Submit either electronic or
written comments on the petitioner’s
request for categorical exclusion from
preparing an environmental assessment
or environmental impact statement by
April 24, 2014.
SUMMARY:
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 860
[Docket No. FDA–2013–N–1529]
Medical Device Classification
Procedures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA) is proposing to
amend its regulations governing
classification and reclassification of
medical devices to conform to the
SUMMARY:
E:\FR\FM\25MRP1.SGM
25MRP1
Agencies
[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Proposed Rules]
[Page 16252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06487]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2014-F-0295]
DSM Nutritional Products; Filing of Food Additive Petition
(Animal Use)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of petition.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that DSM
Nutritional Products has filed a petition proposing that the food
additive regulations be amended to provide for the safe use of 25-
hydroxyvitamin D3 in feed for swine.
DATES: Submit either electronic or written comments on the petitioner's
request for categorical exclusion from preparing an environmental
assessment or environmental impact statement by April 24, 2014.
ADDRESSES: Submit electronic comments 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: Isabel W. Pocurull, Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6853.
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a
food additive petition (FAP 2280) has been filed by DSM Nutritional
Products, 45 Waterview Blvd., Parsippany, NJ 07054. The petition
proposes to amend Title 21 of the Code of Federal Regulations (CFR) in
part 573 Food Additives Permitted in Feed and Drinking Water of Animals
(21 CFR part 573) to provide for the safe use of 25-hydroxyvitamin
D3 in feed for swine.
The petitioner has requested a categorical exclusion from preparing
an environmental assessment or environmental impact statement under 21
CFR 25.32(r). Interested persons may submit either electronic or
written comments regarding this request for categorical exclusion to
the Division of Dockets Management (see DATES and ADDRESSES). 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.
Dated: March 19, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-06487 Filed 3-24-14; 8:45 am]
BILLING CODE 4160-01-P