81_FR_23811 81 FR 23733 - 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

81 FR 23733 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 78 (April 22, 2016)

Page Range23733-23734
FR Document2016-09367

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). We are taking this action for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 81 Issue 78 (Friday, April 22, 2016) 
[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23733-23734]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09367]


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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; request for comments and for scientific data and 
information; 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). We are taking this action for an extension to 
allow interested persons additional time to submit comments.

DATES: Submit either electronic or written comments by July 5, 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

[[Page 23734]]

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 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 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2927.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 4, 2016 (81 
FR 11572), we published a 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.'' The 
notice requested 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 (BSAAO) (including raw manure). The risk 
assessment will evaluate and, if feasible, quantify the risk of human 
illness associated with consumption of produce grown in fields or other 
growing areas amended with untreated biological soil amendments of 
animal origin that are potentially contaminated with enteric pathogens, 
such as Escherichia coli O157:H7 or Salmonella. The risk assessment 
also will evaluate the impact of certain interventions, such as use of 
a time interval between application of the soil amendment and crop 
harvest, on the predicted risk. The risk assessment is intended to 
inform policy decisions with regard to produce safety.
    We received multiple requests for an extension of the comment 
period. The requests conveyed concern that the original 60-day comment 
period does not allow sufficient time to provide the scientific data, 
information, and comments described in the notice. We have considered 
the requests and are extending the comment period for the notice until 
July 5, 2016. We believe that a 60-day extension allows adequate time 
for interested persons to submit comments without significantly 
delaying rulemaking on these important issues.

    Dated: April 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09367 Filed 4-21-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 23733 Dated: April 18, 2016. produce grown in fields or other manner detailed (see ‘‘Written/Paper Leslie Kux, growing areas amended with untreated Submissions’’ and ‘‘Instructions’’). Associate Commissioner for Policy. biological soil amendments of animal Written/Paper Submissions [FR Doc. 2016–09370 Filed 4–21–16; 8:45 am] origin (including raw manure). We are BILLING CODE 4164–01–C taking this action for an extension to Submit written/paper submissions as allow interested persons additional time follows: to submit comments. • Mail/Hand delivery/Courier (for DEPARTMENT OF HEALTH AND DATES: Submit either electronic or written/paper submissions): Division of HUMAN SERVICES written comments by July 5, 2016. Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Food and Drug Administration ADDRESSES: You may submit comments Lane, Rm. 1061, Rockville, MD 20852. as follows: • For written/paper comments [Docket No. FDA–2016–N–0321] Electronic Submissions submitted to the Division of Dockets Risk Assessment of Foodborne Illness Management, FDA will post your Associated With Pathogens From Submit electronic comments in the comment, as well as any attachments, Produce Grown in Fields Amended following way: except for information submitted, With Untreated Biological Soil • Federal eRulemaking Portal: http:// marked and identified, as confidential, Amendments of Animal Origin; www.regulations.gov. Follow the if submitted as detailed in Request for Scientific Data, instructions for submitting comments. ‘‘Instructions.’’ Information, and Comments; Extension Comments submitted electronically, Instructions: All submissions received of Comment Period including attachments, to http:// must include the Docket No. FDA– www.regulations.gov will be posted to 2016–N–0321 for ‘‘Risk Assessment of AGENCY: Food and Drug Administration, the docket unchanged. Because your HHS. Foodborne Illness Associated With comment will be made public, you are Pathogens From Produce Grown in ACTION: Notice; request for comments solely responsible for ensuring that your Fields Amended With Untreated and for scientific data and information; comment does not include any Biological Soil Amendments of Animal extension of comment period. confidential information that you or a Origin; Request for Scientific Data, SUMMARY: The Food and Drug third party may not wish to be posted, Information, and Comments.’’ Received Administration (FDA or we) is such as medical information, your or comments will be placed in the docket extending the comment period for the anyone else’s Social Security number, or and, except for those submitted as notice entitled ‘‘Risk Assessment of confidential business information, such ‘‘Confidential Submissions,’’ publicly Foodborne Illness Associated With as a manufacturing process. Please note viewable at http://www.regulations.gov Pathogens From Produce Grown in that if you include your name, contact or at the Division of Dockets Fields Amended With Untreated information, or other information that Management between 9 a.m. and 4 p.m., identifies you in the body of your mstockstill on DSK4VPTVN1PROD with NOTICES Biological Soil Amendments of Animal Monday through Friday. Origin; Request for Scientific Data, comments, that information will be • Confidential Submissions—To Information, and Comments’’ that posted on http://www.regulations.gov. submit a comment with confidential appeared in the Federal Register of • If you want to submit a comment information that you do not wish to be March 4, 2016. The notice requested with confidential information that you made publicly available, submit your scientific data, information, and do not wish to be made available to the comments only as a written/paper comments that would assist in the public, submit the comment as a submission. You should submit two EN22AP16.056</GPH> development of a risk assessment for written/paper submission and in the copies total. One copy will include the VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\22APN1.SGM 22APN1

23734 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices information you claim to be confidential untreated biological soil amendments of FOR FURTHER INFORMATION CONTACT: with a heading or cover note that states animal origin that are potentially Emmeline Ochiai, email address: ‘‘THIS DOCUMENT CONTAINS contaminated with enteric pathogens, HP2030@hhs.gov. CONFIDENTIAL INFORMATION.’’ The such as Escherichia coli O157:H7 or Correction Agency will review this copy, including Salmonella. The risk assessment also the claimed confidential information, in will evaluate the impact of certain In the Federal Register, dated March its consideration of comments. The interventions, such as use of a time 17, 2016, on page 14455, correct the second copy, which will have the interval between application of the soil DATES section to read: claimed confidential information amendment and crop harvest, on the Nominations for membership to the redacted/blacked out, will be available predicted risk. The risk assessment is Committee must be submitted by 6:00 for public viewing and posted on http:// intended to inform policy decisions p.m. Eastern Time on May 2, 2016. www.regulations.gov. Submit both with regard to produce safety. Dated: April 13, 2016. copies to the Division of Dockets We received multiple requests for an Donald Wright, Management. If you do not wish your extension of the comment period. The Deputy Assistant Secretary for Health, name and contact information to be requests conveyed concern that the Disease Prevention and Health Promotion. made publicly available, you can original 60-day comment period does [FR Doc. 2016–09132 Filed 4–21–16; 8:45 am] provide this information on the cover not allow sufficient time to provide the BILLING CODE 4150–32–P sheet and not in the body of your scientific data, information, and comments and you must identify this comments described in the notice. We information as ‘‘confidential.’’ Any have considered the requests and are DEPARTMENT OF HEALTH AND information marked as ‘‘confidential’’ extending the comment period for the HUMAN SERVICES will not be disclosed except in notice until July 5, 2016. We believe accordance with 21 CFR 10.20 and other that a 60-day extension allows adequate National Institutes of Health applicable disclosure law. For more time for interested persons to submit information about FDA’s posting of comments without significantly National Center for Advancing comments to public dockets, see 80 FR delaying rulemaking on these important Translational Sciences; Notice of 56469, September 18, 2015, or access issues. Closed Meeting the information at: http://www.fda.gov/ Dated: April 18, 2016. Pursuant to section 10(d) of the regulatoryinformation/dockets/ Leslie Kux, Federal Advisory Committee Act, as default.htm. Associate Commissioner for Policy. amended (5 U.S.C. App.), notice is Docket: For access to the docket to [FR Doc. 2016–09367 Filed 4–21–16; 8:45 am] hereby given of the following meeting. read background documents or the BILLING CODE 4164–01–P The meeting will be closed to the electronic and written/paper comments public in accordance with the received, go to http:// provisions set forth in sections www.regulations.gov and insert the DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., docket number, found in brackets in the HUMAN SERVICES as amended. The grant applications and heading of this document, into the the discussions could disclose ‘‘Search’’ box and follow the prompts Announcement of Intent To Establish confidential trade secrets or commercial and/or go to the Division of Dockets the Secretary’s Advisory Committee on property such as patentable material, Management, 5630 Fishers Lane, Rm. National Health Promotion and Disease and personal information concerning 1061, Rockville, MD 20852. Prevention Objectives for 2030 and individuals associated with the grant FOR FURTHER INFORMATION CONTACT: Jane Solicitation of Nominations for applications, the disclosure of which Van Doren, Center for Food Safety and Membership; Correction would constitute a clearly unwarranted Applied Nutrition (HFS–005), Food and AGENCY: Office of Disease Prevention invasion of personal privacy. Drug Administration, 5100 Paint Branch and Health Promotion, Office of the Name of Committee: National Center for Pkwy., College Park, MD 20740, 240– Assistant Secretary for Health, Office of Advancing Translational Sciences Special 402–2927. the Secretary, U.S. Department of Health Emphasis Panel NTU 2016. SUPPLEMENTARY INFORMATION: In the and Human Services. Date: May 18–19, 2016. Federal Register of March 4, 2016 (81 ACTION: Notice; correction. Time: 8 a.m. to 5 p.m. FR 11572), we published a notice Agenda: To review and evaluate grant entitled ‘‘Risk Assessment of Foodborne SUMMARY: In the Federal Register notice applications. Illness Associated with Pathogens from first published on March 17, 2016, on Place: National Institutes of Health, One Democracy Plaza, Room 1066, 6701 Produce Grown in Fields Amended with page 14455, and corrected on April 12, Democracy Boulevard, Bethesda, MD 20892, Untreated Biological Soil Amendments 2016, on page 21581, the U.S. (Virtual Meeting). of Animal Origin; Request for Scientific Department of Health and Human Contact Person: Barbara J. Nelson, Ph.D., Data, Information, and Comments.’’ The Services announced its intent to Scientific Review Officer, Office of Scientific notice requested scientific data, establish the Secretary’s Advisory Review, National Center for Advancing information, and comments that would Committee on National Health Translational, Sciences (NCATS), National assist us in our plan to develop a risk Promotion and Disease Prevention Institutes of Health, 6701 Democracy Blvd., assessment for produce grown in fields Objectives for 2030 (Committee) and Democracy 1, Room 1080, Bethesda, MD 20892–4874, 301–435–0806, nelsonbj@ mstockstill on DSK4VPTVN1PROD with NOTICES or other growing areas amended with invited nominations for membership. mail.nih.gov. untreated biological soil amendments of The nomination period is scheduled to (Catalogue of Federal Domestic Assistance animal origin (BSAAO) (including raw end at 6:00 p.m. on April 18, 2016. The Program Nos. 93.859, Pharmacology, manure). The risk assessment will notice is being amended to extend the Physiology, and Biological Chemistry evaluate and, if feasible, quantify the solicitation period for nominations for Research; 93.350, B—Cooperative risk of human illness associated with two weeks to allow more time for Agreements; 93.859, Biomedical Research consumption of produce grown in fields interested individuals to submit and Research Training, National Institutes of or other growing areas amended with nominations. Health, HHS) VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\22APN1.SGM 22APN1


Document Created: 2017-08-22 23:37:03
Document Modified: 2017-08-22 23:37:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for comments and for scientific data and information; extension of comment period.
DatesSubmit either electronic or written comments by July 5, 2016.
ContactJane Van Doren, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2927.
FR Citation81 FR 23733 
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