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, 23733-23734 [2016-09367]

Download as PDF Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 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. [FR Doc. 2016–09370 Filed 4–21–16; 8:45 am] BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES DATES: Food and Drug Administration ADDRESSES: Submit either electronic or written comments by July 5, 2016. [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. Notice; request for comments and for scientific data and information; extension of comment period. ACTION: 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 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 https://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 E:\FR\FM\22APN1.SGM 22APN1 EN22AP16.056</GPH> Dated: April 18, 2016. Leslie Kux, Associate Commissioner for Policy. 23733 mstockstill on DSK4VPTVN1PROD with NOTICES 23734 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 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 https:// 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: https://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 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: 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 VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 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. FOR FURTHER INFORMATION CONTACT: Emmeline Ochiai, email address: HP2030@hhs.gov. Correction In the Federal Register, dated March 17, 2016, on page 14455, correct the DATES section to read: Nominations for membership to the Committee must be submitted by 6:00 p.m. Eastern Time on May 2, 2016. Dated: April 13, 2016. Donald Wright, Deputy Assistant Secretary for Health, Disease Prevention and Health Promotion. [FR Doc. 2016–09132 Filed 4–21–16; 8:45 am] BILLING CODE 4150–32–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Closed Meeting AGENCY: Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. In the Federal Register notice first published on March 17, 2016, on page 14455, and corrected on April 12, 2016, on page 21581, the U.S. Department of Health and Human Services announced its intent to establish the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) and invited nominations for membership. The nomination period is scheduled to end at 6:00 p.m. on April 18, 2016. The notice is being amended to extend the solicitation period for nominations for two weeks to allow more time for interested individuals to submit nominations. Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel NTU 2016. Date: May 18–19, 2016. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, One Democracy Plaza, Room 1066, 6701 Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Barbara J. Nelson, Ph.D., Scientific Review Officer, Office of Scientific Review, National Center for Advancing Translational, Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy 1, Room 1080, Bethesda, MD 20892–4874, 301–435–0806, nelsonbj@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) [FR Doc. 2016–09367 Filed 4–21–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of Intent To Establish the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 and Solicitation of Nominations for Membership; Correction Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, U.S. Department of Health and Human Services. ACTION: Notice; correction. SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\22APN1.SGM 22APN1

Agencies

[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23733-23734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 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: 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

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