
[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]


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

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: http://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 
http://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 http://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 http://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 http://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


