Focused Mitigation Strategies To Protect Food Against Intentional Adulteration; Extension of Comment Period, 16251-16252 [2014-06468]

Download as PDF Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16 and 121 [Docket No. FDA–2013–N–1563] Appendix 4 To Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notification; extension of comment period. ACTION: The Food and Drug Administration (FDA or we) is extending the comment period for a document that appeared in the Federal Register of December 24, 2013 (78 FR 78064), entitled ‘‘Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm’’ (draft RA Appendix) to June 30, 2014. We are taking this action to keep the comment period for the draft RA Appendix consistent with the comment period for the proposed rule. DATES: FDA is extending the comment period on the draft RA Appendix. Submit either electronic or written comments on the proposed rule and the information collection by June 30, 2014. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written comments to Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ryan Newkirk, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240– 402–2428. SUPPLEMENTARY INFORMATION: SUMMARY: tkelley on DSK3SPTVN1PROD with PROPOSALS I. Background 16:23 Mar 24, 2014 II. 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. Jkt 232001 extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of December 24, 2013 (78 FR 78014), entitled ‘‘Focused Mitigation Strategies to Protect Food Against Intentional Adulteration’’ and its information collection provisions. We are taking this action in response to requests for an extension to 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 to consider the complexity and if the proposal has the flexibility to address the many types of food operations that will be affected. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule. DATES: FDA is extending the comment period on the proposed rule and its information collection provisions. Submit either electronic or written comments on the proposed rule and the information collection by June 30, 2014. ADDRESSES: You may submit comments, identified by Docket No. FDA–2013–N– 1425 and/or Regulatory Information Number (RIN) 0910–AG63, by any of the following methods, except that comments on information collection issues under the PRA must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). Electronic Submissions BILLING CODE 4160–01–P Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. DEPARTMENT OF HEALTH AND HUMAN SERVICES Written Submissions [FR Doc. 2014–06469 Filed 3–24–14; 8:45 am] Food and Drug Administration 21 CFR Parts 16 and 121 [Docket No. FDA–2013–N–1425] RIN 0910–AG63 In the Federal Register of December 24, 2013, we published a document entitled ‘‘Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm’’ (the draft RA Appendix) with a 100-day comment period on the provisions of the proposed rule. FDA has received requests for an extension of the comment period on the VerDate Mar<15>2010 proposed rule entitled ‘‘Focused Mitigation Strategies to Protect Food Against Intentional Adulteration’’ (78 FR 78014). This document directly relates to the proposal. The requests conveyed concern that the current 100day comment period does not allow time to thoroughly analyze the proposal, due to the inherent complexity and unique nature of food defense issues. FDA has considered the requests and is granting an extension of the comment period to June 30, 2014, for the draft RA Appendix to allow interested persons additional time to submit comments. Elsewhere in this issue of the Federal Register, we are also extending the comment period for the proposed rule ‘‘Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.’’ To clarify, FDA is requesting comment on all issues raised by the document. 16251 Focused Mitigation Strategies To Protect Food Against Intentional Adulteration; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Proposed rule; extension of comment period. ACTION: The Food and Drug Administration (FDA or we) is SUMMARY: PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name, Docket No. FDA–2013–N–1425, and RIN 0910– AG63 for this rulemaking. All comments received may be posted without change to https://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Request for Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. E:\FR\FM\25MRP1.SGM 25MRP1 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]
[Pages 16251-16252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06468]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 121

[Docket No. FDA-2013-N-1425]
RIN 0910-AG63


Focused Mitigation Strategies To Protect Food Against Intentional 
Adulteration; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice of proposed rulemaking that appeared in 
the Federal Register of December 24, 2013 (78 FR 78014), entitled 
``Focused Mitigation Strategies to Protect Food Against Intentional 
Adulteration'' and its information collection provisions. We are taking 
this action in response to requests for an extension to 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 to consider the complexity and if the proposal has the 
flexibility to address the many types of food operations that will be 
affected.
    We also are taking this action to keep the comment period for the 
information collection provisions associated with the rule consistent 
with the comment period for the proposed rule.

DATES: FDA is extending the comment period on the proposed rule and its 
information collection provisions. Submit either electronic or written 
comments on the proposed rule and the information collection by June 
30, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-1425 and/or Regulatory Information Number (RIN) 0910-AG63, by any of 
the following methods, except that comments on information collection 
issues under the PRA must be submitted to the Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB) (see the 
``Paperwork Reduction Act of 1995'' section of this document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency 
name, Docket No. FDA-2013-N-1425, and RIN 0910-AG63 for this 
rulemaking. All comments received may be posted without change to 
https://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Request for Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.

[[Page 16252]]

    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: 

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 
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

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