Document ID: FDA-2016-D-1099-0003
Agency: fda
Document Type: Notice
Title: Inorganic Arsenic in Rice Cereals for Infants: Action Level; Draft Guidance
for Industry; Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic in Rice and Rice Products Risk  Assessment: Report; Availability; Extension of the Comment Period
Posted Date: 2016-06-30T04:00Z

[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42714-42715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15478]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1099]

Inorganic Arsenic in Rice Cereals for Infants: Action Level; 
Draft Guidance for Industry; Supporting Document for Action Level for 
Inorganic Arsenic in Rice Cereals for Infants; Arsenic in Rice and Rice 
Products Risk Assessment: Report; Availability; Extension of the 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice, published in the Federal Register of 
April 6, 2016 (81 FR 19976), announcing the availability of a draft 
guidance for industry entitled ``Inorganic Arsenic in Rice Cereals for 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.'' We are taking this action due 
to maintenance on the Federal eRulemaking portal in early July 2016.

DATES: 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-D-1099 for ``Inorganic Arsenic in Rice Cereals for Infants: 
Action Level; Draft Guidance for Industry; Supporting Document for 
Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic 
in Rice and Rice Products Risk Assessment: Report; Availability.'' 
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 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

[[Page 42715]]

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: 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.

SUPPLEMENTARY INFORMATION: 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, 
http://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.

    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