81 FR 42715 - 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 126 (June 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 126 (June 30, 2016)
| Page Range | 42715-42716 | |
| FR Document | 2016-15480 |
[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)] [Notices] [Pages 42715-42716] From the Federal Register Online [www.thefederalregister.org] [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: 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
![Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices 42715
applicable disclosure law. For more DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
information about FDA’s posting of HUMAN SERVICES confidential business information, such
comments to public dockets, see 80 FR as a manufacturing process. Please note
56469, September 18, 2015, or access Food and Drug Administration that if you include your name, contact
the information at: http://www.fda.gov/ [Docket No. FDA–2016–N–0321] information, or other information that
regulatoryinformation/dockets/ identifies you in the body of your
default.htm. Risk Assessment of Foodborne Illness comments, that information will be
Associated With Pathogens From posted on http://www.regulations.gov.
Docket: For access to the docket to • If you want to submit a comment
Produce Grown in Fields Amended
read background documents or the with confidential information that you
With Untreated Biological Soil
electronic and written/paper comments Amendments of Animal Origin; do not wish to be made available to the
received, go to http:// Request for Scientific Data, public, submit the comment as a
www.regulations.gov and insert the Information, and Comments; Extension written/paper submission and in the
docket number, found in brackets in the of Comment Period manner detailed (see ‘‘Written/Paper
heading of this document, into the Submissions’’ and ‘‘Instructions’’).
‘‘Search’’ box and follow the prompts AGENCY: Food and Drug Administration,
HHS. Written/Paper Submissions
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm. ACTION: Notice; extension of comment Submit written/paper submissions as
1061, Rockville, MD 20852. period. follows:
• Mail/Hand delivery/Courier (for
FOR FURTHER INFORMATION CONTACT: SUMMARY: The Food and Drug written/paper submissions): Division of
Philip L. Chao, Center for Food Safety Administration (FDA or we) is Dockets Management (HFA–305), Food
and Applied Nutrition (HFS–24), Food extending the comment period for the and Drug Administration, 5630 Fishers
and Drug Administration, 5100 Paint notice entitled ‘‘Risk Assessment of Lane, Rm. 1061, Rockville, MD 20852.
Branch Pkwy., College Park, MD 20740, Foodborne Illness Associated With • For written/paper comments
240–402–2378. Pathogens From Produce Grown in submitted to the Division of Dockets
Fields Amended With Untreated Management, FDA will post your
SUPPLEMENTARY INFORMATION: In the Biological Soil Amendments of Animal comment, as well as any attachments,
Federal Register of April 6, 2016 (81 FR Origin; Request for Scientific Data, except for information submitted,
19976), FDA published a notice Information, and Comments’’ that marked and identified, as confidential,
announcing the availability of a draft appeared in the Federal Register of if submitted as detailed in
guidance for industry entitled March 4, 2016. The notice requested ‘‘Instructions.’’
‘‘Inorganic Arsenic in Rice Cereals for scientific data, information, and Instructions: All submissions received
Infants: Action Level,’’ a supporting comments that would assist in the must include the Docket No. FDA–
document entitled ‘‘Supporting development of a risk assessment for 2016–N–0321 for ‘‘Risk Assessment of
Document for Action Level for Inorganic produce grown in fields or other Foodborne Illness Associated With
Arsenic in Rice Cereals for Infants,’’ and growing areas amended with untreated Pathogens From Produce Grown in
a risk assessment report entitled biological soil amendments of animal Fields Amended With Untreated
‘‘Arsenic in Rice and Rice Products Risk origin (including raw manure). In the Biological Soil Amendments of Animal
Assessment: Report.’’ Although you can Federal Register notice of April 22, Origin; Request for Scientific Data,
2016, the comment period for this Information, and Comments.’’ Received
comment on any guidance at any time,
request was initially extended to July 5, comments will be placed in the docket
to ensure that we consider comments on
2016. We are taking this action due to and, except for those submitted as
this draft guidance before we begin maintenance on the Federal ‘‘Confidential Submissions,’’ publicly
work on the final version, interested eRulemaking portal in early July 2016. viewable at http://www.regulations.gov
persons were originally given until July or at the Division of Dockets
DATES: FDA is extending the comment
5, 2016, to comment on the draft period on the notice published March 4, Management between 9 a.m. and 4 p.m.,
guidance, the supporting document, or 2016 (81 FR 11572). Submit either Monday through Friday.
the risk assessment report. In early July electronic or written comments by July • Confidential Submissions—To
2016, the Federal eRulemaking Portal, 19, 2016. submit a comment with confidential
http://www.regulations.gov, is ADDRESSES: You may submit comments information that you do not wish to be
undergoing maintenance. We are, as follows: made publicly available, submit your
therefore, extending the comment comments only as a written/paper
period for the draft guidance, the Electronic Submissions submission. You should submit two
supporting document, and the risk Submit electronic comments in the copies total. One copy will include the
assessment report. The extended following way: information you claim to be confidential
comment period will close on July 19, • Federal eRulemaking Portal: http:// with a heading or cover note that states
2016. www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Dated: June 24, 2016.
Comments submitted electronically, Agency will review this copy, including
Leslie Kux, including attachments, to http:// the claimed confidential information, in
Associate Commissioner for Policy. www.regulations.gov will be posted to its consideration of comments. The
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2016–15478 Filed 6–29–16; 8:45 am] the docket unchanged. Because your second copy, which will have the
BILLING CODE 4164–01–P comment will be made public, you are claimed confidential information
solely responsible for ensuring that your redacted/blacked out, will be available
comment does not include any for public viewing and posted on http://
confidential information that you or a www.regulations.gov. Submit both
third party may not wish to be posted, copies to the Division of Dockets
such as medical information, your or Management. If you do not wish your
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![42716 Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices
name and contact information to be DEPARTMENT OF HEALTH AND regulations and the existing delegation
made publicly available, you can HUMAN SERVICES of authority to approve and issue
provide this information on the cover regulations.
sheet and not in the body of your Office of the Secretary These delegations shall be exercised
comments and you must identify this under financial and administrative
information as ‘‘confidential.’’ Any Administration for Children and requirements applicable to the
information marked as ‘‘confidential’’ Families Administration for Children and
will not be disclosed except in Families authorities.
Delegation of Authority I hereby affirm and ratify any actions
accordance with 21 CFR 10.20 and other
AGENCY: Office of the Secretary, taken by the Assistant Secretary for
applicable disclosure law. For more
Administration for Children and Children and Families, or your
information about FDA’s posting of subordinates, which involved the
comments to public dockets, see 80 FR Families, HHS.
exercise of these authorities delegated
56469, September 18, 2015, or access ACTION: Delegation of authority.
herein prior to the effective date of this
the information at: http://www.fda.gov/ delegation.
regulatoryinformation/dockets/ SUMMARY: Notice is hereby given that I
delegate to the Assistant Secretary for This delegation supersedes all
default.htm. existing delegations of these authorities.
the Administration for Children and
Docket: For access to the docket to Families (ACF) the following authorities DATES: This delegation is effective upon
read background documents or the vested in the Secretary of Health and signature.
electronic and written/paper comments Human Services under the Trafficking Dated: June 21, 2016.
received, go to http:// Victims Protection Act of 2000 (TVPA), Sylvia M. Burwell,
www.regulations.gov and insert the Public Law 106–386, as amended. Secretary.
docket number, found in brackets in the Authority under section [FR Doc. 2016–15470 Filed 6–29–16; 8:45 am]
heading of this document, into the 107(b)(1)(B)(i) of the TVPA (22 U.S.C. BILLING CODE 4184–34–P
‘‘Search’’ box and follow the prompts 7105(b)(1)(B)(i)) to expand benefits and
and/or go to the Division of Dockets services to victims of severe forms of
Management, 5630 Fishers Lane, Rm. trafficking in persons in the United DEPARTMENT OF HEALTH AND
1061, Rockville, MD 20852. States, without regard to immigration HUMAN SERVICES
status. In the case of non-entitlement
FOR FURTHER INFORMATION CONTACT: Jane programs funded by the Secretary of Mandatory Guidelines for Federal
Van Doren, Center for Food Safety and Health and Human Services, such Workplace Drug Testing Programs
Applied Nutrition (HFS–005), Food and benefits and services may include
Drug Administration, 5100 Campus Dr., services to assist potential victims of AGENCY: Substance Abuse and Mental
College Park, MD 20740, 240–402–2927. trafficking in achieving certification and Health Services Administration
to assist minor dependent children of (SAMHSA), Department of Health and
SUPPLEMENTARY INFORMATION: In the Human Services (HHS).
Federal Register of April 22, 2016 (81 victims of severe forms of trafficking in
persons or potential victims of ACTION: HHS approval of entities that
FR 23733), FDA published a notice certify Medical Review Officers (MRO).
giving interested persons until July 5, trafficking.
Authority under section SUMMARY: The current version of the
2016, to comment on our request for
107(b)(1)(B)(ii) of the TVPA (22 U.S.C. Department of Health and Human
scientific data, information, and
7105(b)(1)(B)(ii)) to make grants for a Services (HHS) Mandatory Guidelines
comments that would assist us in our national communication system to assist
plan to develop a risk assessment for for Federal Workplace Drug Testing
victims of severe forms of trafficking in Programs (Mandatory Guidelines),
produce grown in fields or other persons in communicating with service
growing areas amended with untreated effective on October 1, 2010, addresses
providers. the role and qualifications of Medical
biological soil amendments of animal Authority under section 107(f) of the
origin (including raw manure). Review Officers (MROs) and HHS
TVPA (22 U.S.C. 7105(f)) to establish a approval of entities that certify MROs.
In early July 2016, the Federal program to assist United States citizens
DATES: HHS approval is effective June
eRulemaking Portal, http:// and aliens lawfully admitted for
30, 2016.
www.regulations.gov, is undergoing permanent residence who are victims of
severe forms of trafficking. In addition FOR FURTHER INFORMATION CONTACT:
maintenance. We are, therefore,
to the authority to provide such victims Jennifer Fan, Pharm.D., J.D., Division of
extending the comment period for our Workplace Programs (DWP), Center for
request for scientific data, information, with specialized services, the program
also has the authority to identify current Substance Abuse Prevention (CSAP),
and comments. The extended comment Substance Abuse and Mental Health
period will close on July 19, 2016. providers and provide a means to make
referrals to programs for which such Services Administration (SAMHSA),
Dated: June 24, 2016. victims are already eligible. In the 5600 Fishers Lane, Room 16N02B,
Leslie Kux, course of exercising the authority to Rockville, MD 20857; Telephone: (240)
Associate Commissioner for Policy. conduct activities, personnel in the 276–1759; Email: jennifer.fan@
Administration for Children and samhsa.hhs.gov.
[FR Doc. 2016–15480 Filed 6–29–16; 8:45 am]
Families will consult with the Attorney SUPPLEMENTARY INFORMATION: Subpart
mstockstill on DSK3G9T082PROD with NOTICES
BILLING CODE 4164–01–P
General, the Secretary of Labor, and M-Medical Review Officer (MRO),
non-governmental organizations that section 13.1(b) of the Mandatory
provide services to victims of severe Guidelines, ‘‘Who may serve as an
forms of trafficking in the United States. MRO?’’ states as follows: ‘‘Nationally
These authorities may be redelegated. recognized entities that certify MROs or
These authorities shall be exercised subspecialty boards for physicians
under the Department’s policy on performing a review of Federal
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Document Created: 2018-02-08 07:44:37
Document Modified: 2018-02-08 07:44:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; extension of comment period. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 42715 |
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