DSM Nutritional Products; Filing of Food Additive Petition (Animal Use), 16252 [2014-06487]

Download as PDF 16252 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 16:23 Mar 24, 2014 Jkt 232001 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 Frm 00017 Fmt 4702 Sfmt 4702 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.

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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
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