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, 42715-42716 [2016-15480]

Download as PDF Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: SUMMARY: Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS–24), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–2378. In the Federal Register of April 6, 2016 (81 FR 19976), FDA published a notice announcing the availability of a draft guidance for industry entitled ‘‘Inorganic Arsenic in Rice Cereals for Infants: Action Level,’’ a supporting document entitled ‘‘Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants,’’ and a risk assessment report entitled ‘‘Arsenic in Rice and Rice Products Risk Assessment: Report.’’ Although you can comment on any guidance at any time, to ensure that we consider comments on this draft guidance before we begin work on the final version, interested persons were originally given until July 5, 2016, to comment on the draft guidance, the supporting document, or the risk assessment report. In early July 2016, the Federal eRulemaking Portal, https://www.regulations.gov, is undergoing maintenance. We are, therefore, extending the comment period for the draft guidance, the supporting document, and the risk assessment report. The extended comment period will close on July 19, 2016. mstockstill on DSK3G9T082PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: June 24, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–15478 Filed 6–29–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 20:01 Jun 29, 2016 Jkt 238001 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. 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: 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 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 42715 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 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 E:\FR\FM\30JNN1.SGM 30JNN1 42716 Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices 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. 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. FOR FURTHER INFORMATION CONTACT: 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, https:// 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. SUPPLEMENTARY INFORMATION: Dated: June 24, 2016. Leslie Kux, Associate Commissioner for Policy. mstockstill on DSK3G9T082PROD with NOTICES [FR Doc. 2016–15480 Filed 6–29–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 20:01 Jun 29, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Administration for Children and Families Delegation of Authority Office of the Secretary, Administration for Children and Families, HHS. ACTION: Delegation of authority. AGENCY: Notice is hereby given that I delegate to the Assistant Secretary for the Administration for Children and Families (ACF) the following authorities vested in the Secretary of Health and Human Services under the Trafficking Victims Protection Act of 2000 (TVPA), Public Law 106–386, as amended. Authority under section 107(b)(1)(B)(i) of the TVPA (22 U.S.C. 7105(b)(1)(B)(i)) to expand benefits and services to victims of severe forms of trafficking in persons in the United States, without regard to immigration status. In the case of non-entitlement programs funded by the Secretary of Health and Human Services, such benefits and services may include services to assist potential victims of trafficking in achieving certification and to assist minor dependent children of victims of severe forms of trafficking in persons or potential victims of trafficking. Authority under section 107(b)(1)(B)(ii) of the TVPA (22 U.S.C. 7105(b)(1)(B)(ii)) to make grants for a national communication system to assist victims of severe forms of trafficking in persons in communicating with service providers. Authority under section 107(f) of the TVPA (22 U.S.C. 7105(f)) to establish a program to assist United States citizens and aliens lawfully admitted for permanent residence who are victims of severe forms of trafficking. In addition to the authority to provide such victims with specialized services, the program also has the authority to identify current providers and provide a means to make referrals to programs for which such victims are already eligible. In the course of exercising the authority to conduct activities, personnel in the Administration for Children and Families will consult with the Attorney General, the Secretary of Labor, and non-governmental organizations that provide services to victims of severe forms of trafficking in the United States. These authorities may be redelegated. These authorities shall be exercised under the Department’s policy on SUMMARY: PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 regulations and the existing delegation of authority to approve and issue regulations. These delegations shall be exercised under financial and administrative requirements applicable to the Administration for Children and Families authorities. I hereby affirm and ratify any actions taken by the Assistant Secretary for Children and Families, or your subordinates, which involved the exercise of these authorities delegated herein prior to the effective date of this delegation. This delegation supersedes all existing delegations of these authorities. DATES: This delegation is effective upon signature. Dated: June 21, 2016. Sylvia M. Burwell, Secretary. [FR Doc. 2016–15470 Filed 6–29–16; 8:45 am] BILLING CODE 4184–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Mandatory Guidelines for Federal Workplace Drug Testing Programs Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services (HHS). ACTION: HHS approval of entities that certify Medical Review Officers (MRO). AGENCY: The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs. DATES: HHS approval is effective June 30, 2016. FOR FURTHER INFORMATION CONTACT: Jennifer Fan, Pharm.D., J.D., Division of Workplace Programs (DWP), Center for Substance Abuse Prevention (CSAP), Substance Abuse and Mental Health Services Administration (SAMHSA), 5600 Fishers Lane, Room 16N02B, Rockville, MD 20857; Telephone: (240) 276–1759; Email: jennifer.fan@ samhsa.hhs.gov. SUPPLEMENTARY INFORMATION: Subpart M-Medical Review Officer (MRO), section 13.1(b) of the Mandatory Guidelines, ‘‘Who may serve as an MRO?’’ states as follows: ‘‘Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal SUMMARY: E:\FR\FM\30JNN1.SGM 30JNN1

Agencies

[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]


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

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.

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

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: 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 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

[[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: 
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 
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, https://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
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