81 FR 42714 - Inorganic Arsenic in Rice Cereals for Infants: Action Level; Draft Guidance for Industry; Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic in Rice and Rice Products Risk Assessment: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
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 | 42714-42715 | |
| FR Document | 2016-15478 |
[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)] [Notices] [Pages 42714-42715] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15478] ----------------------------------------------------------------------- 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Food and Drug Administration [Docket No. FDA-2016-D-1099] Inorganic Arsenic in Rice Cereals for Infants: Action Level; Draft Guidance for Industry; Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic in Rice and Rice Products Risk Assessment: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. ----------------------------------------------------------------------- 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for the notice, published in the Federal Register of April 6, 2016 (81 FR 19976), announcing the availability of a draft guidance for industry entitled ``Inorganic Arsenic in Rice Cereals for Infants: Action Level,'' a supporting document entitled ``Supporting Document for Action Level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
![42714 Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices
information marked as ‘‘confidential’’ DEPARTMENT OF HEALTH AND do not wish to be made available to the
will not be disclosed except in HUMAN SERVICES public, submit the comment as a
accordance with 21 CFR 10.20 and other written/paper submission and in the
applicable disclosure law. For more Food and Drug Administration manner detailed (see ‘‘Written/Paper
information about FDA’s posting of [Docket No. FDA–2016–D–1099] Submissions’’ and ‘‘Instructions’’).
comments to public dockets, see 80 FR Written/Paper Submissions
56469, September 18, 2015, or access Inorganic Arsenic in Rice Cereals for
Infants: Action Level; Draft Guidance Submit written/paper submissions as
the information at: http://www.fda.gov/
for Industry; Supporting Document for follows:
regulatoryinformation/dockets/ • Mail/Hand delivery/Courier (for
default.htm. Action Level for Inorganic Arsenic in
Rice Cereals for Infants; Arsenic in written/paper submissions): Division of
Docket: For access to the docket to Rice and Rice Products Risk Dockets Management (HFA–305), Food
read background documents or the Assessment: Report; Availability; and Drug Administration, 5630 Fishers
electronic and written/paper comments Extension of the Comment Period Lane, Rm. 1061, Rockville, MD 20852.
received, go to http:// • For written/paper comments
www.regulations.gov and insert the AGENCY: Food and Drug Administration, submitted to the Division of Dockets
docket number, found in brackets in the HHS. Management, FDA will post your
heading of this document, into the ACTION: Notice of availability; extension comment, as well as any attachments,
of the comment period. except for information submitted,
‘‘Search’’ box and follow the prompts
marked and identified, as confidential,
and/or go to the Division of Dockets SUMMARY: The Food and Drug if submitted as detailed in
Management, 5630 Fishers Lane, Rm. Administration (FDA or we) is ‘‘Instructions.’’
1061, Rockville, MD 20852. extending the comment period for the Instructions: All submissions received
FOR FURTHER INFORMATION CONTACT: FDA notice, published in the Federal must include the Docket No. FDA–
PRA Staff, Office of Operations, Food Register of April 6, 2016 (81 FR 19976), 2016–D–1099 for ‘‘Inorganic Arsenic in
and Drug Administration, 8455 announcing the availability of a draft Rice Cereals for Infants: Action Level;
Colesville Rd., COLE–14526, Silver guidance for industry entitled Draft Guidance for Industry; Supporting
Spring, MD 20993–0002, PRAStaff@ ‘‘Inorganic Arsenic in Rice Cereals for Document for Action Level for Inorganic
Infants: Action Level,’’ a supporting Arsenic in Rice Cereals for Infants;
fda.hhs.gov.
document entitled ‘‘Supporting Arsenic in Rice and Rice Products Risk
SUPPLEMENTARY INFORMATION: In the Document for Action Level for Inorganic Assessment: Report; Availability.’’
Federal Register of May 5, 2016 (81 FR Arsenic in Rice Cereals for Infants,’’ and Received comments will be placed in
27140), FDA published a notice giving a risk assessment report entitled the docket and, except for those
interested persons until July 5, 2016, to ‘‘Arsenic in Rice and Rice Products Risk submitted as ‘‘Confidential
comment on the information collection Assessment: Report.’’ We are taking this Submissions,’’ publicly viewable at
provisions of the Agency’s regulations action due to maintenance on the http://www.regulations.gov or at the
Federal eRulemaking portal in early July Division of Dockets Management
that require registration for domestic
2016. between 9 a.m. and 4 p.m., Monday
and foreign facilities that manufacture,
DATES: Submit either electronic or through Friday.
process, pack, or hold food for human • Confidential Submissions—To
or animal consumption in the United written comments by July 19, 2016.
ADDRESSES: You may submit comments submit a comment with confidential
States. information that you do not wish to be
as follows:
From July 1 through July 5, 2016, the made publicly available, submit your
Federal eRulemaking Portal, http:// Electronic Submissions comments only as a written/paper
www.regulations.gov, is undergoing Submit electronic comments in the submission. You should submit two
maintenance. We are, therefore, following way: copies total. One copy will include the
extending the comment period for • Federal eRulemaking Portal: http:// information you claim to be confidential
commenting on the information www.regulations.gov. Follow the with a heading or cover note that states
collection provisions of the Agency’s instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
regulations that require registration for Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The
domestic and foreign facilities that including attachments, to http:// Agency will review this copy, including
manufacture, process, pack, or hold www.regulations.gov will be posted to the claimed confidential information, in
the docket unchanged. Because your its consideration of comments. The
food for human or animal consumption
comment will be made public, you are second copy, which will have the
in the United States. The extended
solely responsible for ensuring that your claimed confidential information
comment period will close on July 12,
comment does not include any redacted/blacked out, will be available
2016. for public viewing and posted on http://
confidential information that you or a
Dated: June 24, 2016. third party may not wish to be posted, www.regulations.gov. Submit both
Leslie Kux, such as medical information, your or copies to the Division of Dockets
Associate Commissioner for Policy. anyone else’s Social Security number, or Management. If you do not wish your
[FR Doc. 2016–15475 Filed 6–29–16; 8:45 am] confidential business information, such name and contact information to be
as a manufacturing process. Please note made publicly available, you can
mstockstill on DSK3G9T082PROD with NOTICES
BILLING CODE 4164–01–P
that if you include your name, contact provide this information on the cover
information, or other information that sheet and not in the body of your
identifies you in the body of your comments and you must identify this
comments, that information will be information as ‘‘confidential.’’ Any
posted on http://www.regulations.gov. information marked as ‘‘confidential’’
• If you want to submit a comment will not be disclosed except in
with confidential information that you accordance with 21 CFR 10.20 and other
VerDate Sep<11>2014 20:01 Jun 29, 2016 Jkt 238001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1](https://thefederalregister.org/doc/81_FR_42840/page/1.svg)
![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
VerDate Sep<11>2014 20:01 Jun 29, 2016 Jkt 238001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1](https://thefederalregister.org/doc/81_FR_42840/page/2.svg)
Document Created: 2018-02-08 07:44:43
Document Modified: 2018-02-08 07:44:43
| 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 of availability; extension of the comment period. | |
| Dates | Submit either electronic or written comments by July 19, 2016. | |
| 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. | |
| FR Citation | 81 FR 42714 |
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