Document ID: FDA-2013-N-0590-0003
Agency: fda
Document Type: Proposed Rule
Title: Implementation of the Food and Drug Administration Food Safety
Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act; Reopening of Comment Period
Posted Date: 2014-06-18T04:00Z

[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Proposed Rules]
[Page 34668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14213]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2013-N-0590]
RIN 0910-AG97

Implementation of the Food and Drug Administration Food Safety 
Modernization Act Amendments to the Reportable Food Registry Provisions 
of the Federal Food, Drug, and Cosmetic Act; Reopening of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; reopening of comment 
period.

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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the advance notice of proposed rulemaking that 
appeared in the Federal Register of March 26, 2014. In the advance 
notice of proposed rulemaking, FDA solicited comments, data, and 
information to assist the Agency in implementing the FDA Food Safety 
Modernization Act (FSMA), which added new provisions to the Reportable 
Food Registry (RFR) requirements of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act). We are taking this action in response to a 
request for an extension to allow interested persons additional time to 
submit comments.

DATES: Submit either electronic or written comments by August 18, 2014.

ADDRESSES: You may submit comments, identified by Agency name, Docket 
No. FDA-2013-N-0590 and/or Regulatory Information Number (RIN) 0910-
AG97, by any of the following methods:

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 way:
     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-0590, and RIN 0910-AG97 for this advance 
notice of proposed 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.
    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 (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ted Elkin, Center for Food Safety and 
Applied Nutrition (HFS-008), Food and Drug Administration, 5100 Paint 
Branch Pkwy, College Park, MD 20740, 240-402-2428; or April Hodges, 
Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 
7519 Standish Pl., Rockville, MD 20855, 240-276-9237.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 26, 2014 (79 FR 16698), we 
published an advance notice of proposed rulemaking with a 75-day 
comment period to request comments to assist us in implementing FSMA, 
which added new provisions to the RFR requirements of the FD&C Act. 
Interested persons were originally given until June 9, 2014, to comment 
on the advance notice of proposed rulemaking.
    We have received a request for a 60-day extension of the comment 
period for the advance notice of proposed rulemaking. The request 
conveyed concern that the 75-day comment period did not allow 
sufficient time to develop a meaningful or thoughtful response to the 
advance notice of proposed rulemaking particularly in light of other 
FSMA-related rulemakings for which the Agency is also requesting 
comments.
    We have considered the request and are reopening the comment period 
for the advance notice of proposed rulemaking for 60 days, until August 
18, 2014. We believe that reopening the comment period an additional 60 
days allows adequate time for interested persons to submit comments 
without significantly delaying rulemaking on these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document 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. 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: June 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14213 Filed 6-17-14; 8:45 am]
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