Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period, 60921-60922 [2017-27789]
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Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Proposed Rules
methionine as a nutritional source of
chromium in cattle feed.
Interested persons were originally
given until October 23, 2017, to
comment on the petitioner’s
environmental assessment. The
environmental assessment was not
placed on public display until October
13, 2017. On our own initiative, we are
reopening the comment period to allow
potential respondents to thoroughly
evaluate and address pertinent
environmental issues. The Agency
believes that a 30-day extension allows
adequate time for interested persons to
submit comments without significantly
delaying rulemaking on this important
issue.
Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27785 Filed 12–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA–2017–F–4375]
Akzo Nobel Surface Chemistry AB;
Filing of Food Additive Petition
(Animal Use); Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notification; petition for
rulemaking; reopening of the comment
period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for the
notice of petition, published in the
Federal Register of September 21, 2017,
revising food additive regulations to
provide for the safe use of glyceryl
polyethylene glycol (200) ricinoleate as
an emulsifier in animal food that does
not include food for cats, dogs, vitamin
premixes, or aquaculture. FDA is
reopening the comment period to allow
additional time for comments on
environmental impacts.
DATES: FDA is reopening the comment
period on the notice of petition
published September 21, 2017 (82 FR
44129). Submit either electronic or
written comments by January 25, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 25,
ethrower on DSK3G9T082PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
16:59 Dec 22, 2017
Jkt 244001
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 25, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2017–F–4375 for ‘‘Food Additives
Permitted in Feed and Drinking Water
of Animals; glyceryl polyethylene glycol
(200) ricinoleate.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
PO 00000
Frm 00002
Fmt 4702
Sfmt 4702
60921
or at the Dockets Management Staff
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 Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Chelsea Trull, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6729,
Chelsea.trull@fda.hhs.gov.
In the
Federal Register of September 21, 2017,
FDA gave notice that Akzo Nobel
Surface Chemistry AB had filed a
petition to amend Title 21 of the Code
of Federal Regulations in part 573 Food
Additives Permitted in Feed and
Drinking Water of Animals (21 CFR part
573) to provide for the safe use of
glyceryl polyethylene glycol (200)
ricinoleate as an emulsifier in animal
SUPPLEMENTARY INFORMATION:
E:\FR\FM\26DEP1.SGM
26DEP1
60922
Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Proposed Rules
food that does not include food for cats,
dogs, vitamin premixes, or aquaculture.
Interested persons were originally
given until October 23, 2017, to
comment on the petitioner’s
environmental assessment. The
environmental assessment was not
placed on public display until October
13, 2017. On our own initiative, we are
reopening the comment period to allow
potential respondents to thoroughly
evaluate and address pertinent
environmental issues.
Dated: December 20, 2017
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27789 Filed 12–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
[Docket No. FDA–2017–N–6730]
Center for Devices and Radiological
Health; Medical Devices and
Combination Products; Voluntary
Malfunction Summary Reporting
Program for Manufacturers
AGENCY:
Food and Drug Administration,
HHS.
Notification; request for
comments.
ACTION:
The Food and Drug
Administration’s (FDA, Agency, or we)
Center for Devices and Radiological
Health and Center for Biologics
Evaluation and Research, is announcing
a proposed program for manufacturer
reporting of certain device malfunction
medical device reports (MDRs) in
summary form—the Voluntary
Malfunction Summary Reporting
Program. This proposed voluntary
program reflects goals for streamlining
malfunction reporting outlined in the
commitment letter agreed to by FDA
and industry and submitted to Congress,
as referenced in the Medical Device
User Fee Amendments Act of 2017
(MDUFA IV Commitment Letter). These
goals include permitting manufacturers
of devices in certain product codes to
report malfunctions on a quarterly basis
and in a summary format. In addition,
this proposed program reflects FDA’s
findings from a pilot program the
Agency conducted to study summary
reporting formats for malfunction
MDRs.
DATES: Submit either electronic or
written comments on this notification
ethrower on DSK3G9T082PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
16:59 Dec 22, 2017
Jkt 244001
by February 26, 2018. Submit comments
on information collection issues under
the Paperwork Reduction Act of 1995 by
February 26, 2018. See section IV of this
document, the ‘‘Paperwork Reduction
Act of 1995.’’
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of February 26, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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.’’
PO 00000
Frm 00003
Fmt 4702
Sfmt 4702
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–6730 for ‘‘Voluntary
Malfunction Summary Reporting
Program for Manufacturers.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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 Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
• 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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Isaac Chang, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3114, Silver Spring,
MD 20993, 301–796–6670, MDRPolicy@
fda.hhs.gov; or Stephen Ripley, Center
E:\FR\FM\26DEP1.SGM
26DEP1
]]>Agencies
[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Proposed Rules]
[Pages 60921-60922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27789]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2017-F-4375]
Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition
(Animal Use); Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; petition for rulemaking; reopening of the comment
period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the notice of petition, published in
the Federal Register of September 21, 2017, revising food additive
regulations to provide for the safe use of glyceryl polyethylene glycol
(200) ricinoleate as an emulsifier in animal food that does not include
food for cats, dogs, vitamin premixes, or aquaculture. FDA is reopening
the comment period to allow additional time for comments on
environmental impacts.
DATES: FDA is reopening the comment period on the notice of petition
published September 21, 2017 (82 FR 44129). Submit either electronic or
written comments by January 25, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 25, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 25, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2017-F-4375 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; glyceryl polyethylene glycol (200) ricinoleate.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855, 240-402-6729, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of September 21,
2017, FDA gave notice that Akzo Nobel Surface Chemistry AB had filed a
petition to amend Title 21 of the Code of Federal Regulations in part
573 Food Additives Permitted in Feed and Drinking Water of Animals (21
CFR part 573) to provide for the safe use of glyceryl polyethylene
glycol (200) ricinoleate as an emulsifier in animal
[[Page 60922]]
food that does not include food for cats, dogs, vitamin premixes, or
aquaculture.
Interested persons were originally given until October 23, 2017, to
comment on the petitioner's environmental assessment. The environmental
assessment was not placed on public display until October 13, 2017. On
our own initiative, we are reopening the comment period to allow
potential respondents to thoroughly evaluate and address pertinent
environmental issues.
Dated: December 20, 2017
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27789 Filed 12-22-17; 8:45 am]
BILLING CODE 4164-01-P
