[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42715-42716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15480]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0321]


Risk Assessment of Foodborne Illness Associated With Pathogens 
From Produce Grown in Fields Amended With Untreated Biological Soil 
Amendments of Animal Origin; Request for Scientific Data, Information, 
and Comments; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice entitled ``Risk Assessment of Foodborne 
Illness Associated With Pathogens From Produce Grown in Fields Amended 
With Untreated Biological Soil Amendments of Animal Origin; Request for 
Scientific Data, Information, and Comments'' that appeared in the 
Federal Register of March 4, 2016. The notice requested scientific 
data, information, and comments that would assist in the development of 
a risk assessment for produce grown in fields or other growing areas 
amended with untreated biological soil amendments of animal origin 
(including raw manure). In the Federal Register notice of April 22, 
2016, the comment period for this request was initially extended to 
July 5, 2016. We are taking this action due to maintenance on the 
Federal eRulemaking portal in early July 2016.

DATES: FDA is extending the comment period on the notice published 
March 4, 2016 (81 FR 11572). Submit either electronic or written 
comments by July 19, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0321 for ``Risk Assessment of Foodborne Illness Associated 
With Pathogens From Produce Grown in Fields Amended With Untreated 
Biological Soil Amendments of Animal Origin; Request for Scientific 
Data, Information, and Comments.'' Received comments will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your

[[Page 42716]]

name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper 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: Jane Van Doren, Center for Food Safety 
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 
Campus Dr., College Park, MD 20740, 240-402-2927.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 22, 2016 
(81 FR 23733), FDA published a notice giving interested persons until 
July 5, 2016, to comment on our request for scientific data, 
information, and comments that would assist us in our plan to develop a 
risk assessment for produce grown in fields or other growing areas 
amended with untreated biological soil amendments of animal origin 
(including raw manure).
    In early July 2016, the Federal eRulemaking Portal, http://www.regulations.gov, is undergoing maintenance. We are, therefore, 
extending the comment period for our request for scientific data, 
information, and comments. The extended comment period will close on 
July 19, 2016.

    Dated: June 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15480 Filed 6-29-16; 8:45 am]
 BILLING CODE 4164-01-P