Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; Reopening of Comment Period, 52370-52371 [2016-18720]
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52370
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Proposed Rules
Availability and Summary of
Documents Proposed for Incorporation
by Reference
This document proposes to amend
FAA Order 7400.9Z, Airspace
Designations and Reporting Points,
dated August 6, 2015, and effective
September 15, 2015. FAA Order
7400.9Z is publicly available as listed in
the ADDRESSES section of this document.
FAA Order 7400.9Z lists Class A, B, C,
D, and E airspace areas, air traffic
service routes, and reporting points.
The Proposal
The FAA is proposing an amendment
to Title 14 Code of Federal Regulations
(14 CFR) Part 71 by modifying Class E
En route domestic airspace extending
upward from 1,200 feet above the
surface in the vicinity of the Blue Mesa
VOR/DME, Blue Mesa, CO. One small
airspace area northwest, near Montrose,
CO, and one small airspace area
southeast, near Trinidad, CO, both
excluded from the current boundary,
would be added for the safety and
management of IFR operations,
specifically point-to-point, en route
operations outside of the established
airway structure, and Air Traffic Control
vectoring services.
Class E airspace designations are
published in paragraph 6006 of FAA
Order 7400.9Z, dated August 6, 2015,
and effective September 15, 2015, which
is incorporated by reference in 14 CFR
71.1. The Class E airspace designations
listed in this document will be
published subsequently in the Order.
ehiers on DSK5VPTVN1PROD with PROPOSALS
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current, is non-controversial and
unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified that this rule, when
promulgated, would not have a
significant economic impact on a
substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
13:56 Aug 05, 2016
Jkt 238001
This proposal will be subject to an
environmental analysis in accordance
with FAA Order 1050.1F,
‘‘Environmental Impacts: Policies and
Procedures’’ prior to any FAA final
regulatory action.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
The Proposed Amendment
Accordingly, pursuant to the
authority delegated to me, the Federal
Aviation Administration proposes to
amend 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g), 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9Z,
Airspace Designations and Reporting
Points, dated August 6, 2015, and
effective September 15, 2015, is
amended as follows:
■
Paragraph 6006
Airspace Areas.
En Route Domestic
*
*
*
*
ANM CO E6
Regulatory Notices and Analyses
VerDate Sep<11>2014
Environmental Review
*
Blue Mesa, CO [Amended]
Blue Mesa VOR/DME, CO
(Lat. 38°27′08″ N., long. 107°02′23″ W.)
That airspace extending upward from
1,200 feet above the surface within an area
bounded by Lat. 35°39′30″ N., long.
107°25′27″ W.; to Lat. 36°14′38″ N., long.
107°40′25″ W.; to Lat. 37°16′00″ N., long.
108°22′00″ W.; to Lat. 37°58′51″ N., long.
108°22′29″ W.; to Lat. 39°01′00″ N., long.
107°47′00″ W.; to Lat. 39°07′40″ N., long.
107°13′47″ W.; to Lat. 39°11′48″ N., long.
106°29′16″ W.; to Lat. 39°40′23″ N., long.
103°29′02″ W.; to Lat. 36°59′57″ N., long.
104°18′04″ W.; to Lat. 36°17′00″ N., long.
104°14′00″ W.; to Lat. 36°12′53″ N., long.
104°56′21″ W.; to Lat. 36°13′34″ N., long.
105°54′42″ W.; thence to the point of
beginning.
Issued in Seattle, Washington, on July 29,
2016.
Tracey Johnson,
Manager, Operations Support Group, Western
Service Center.
[FR Doc. 2016–18676 Filed 8–5–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 175, 176, 177, and 178
[Docket No. FDA–2016–F–1253]
Breast Cancer Fund, Center for
Environmental Health, Center for Food
Safety, Center for Science in the Public
Interest, Clean Water Action,
Consumer Federation of America,
Earthjustice, Environmental Defense
Fund, Improving Kids’ Environment,
Learning Disabilities Association of
America, and Natural Resources
Defense Council; Filing of Food
Additive Petition; Reopening of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of petition; reopening of
comment period.
ACTION:
The Food and Drug
Administration (FDA or we) is
reopening the comment period for the
notice of filing that appeared in the
Federal Register of May 20, 2016 (81 FR
31877). In the notice, we requested
comments on a filed food additive
petition (FAP 6B4815), submitted by the
Breast Cancer Fund, Center for
Environmental Health, Center for Food
Safety, Center for Science In The Public
Interest, Clean Water Action, Consumer
Federation of America, Earthjustice,
Environmental Defense Fund,
Improving Kids’ Environment, Learning
Disabilities Association of America, and
Natural Resources Defense Council,
proposing that we amend and/or revoke
specified regulations to no longer
provide for the food contact use of
specified ortho-phthalates. We are
taking this action in response to a
request for an extension to allow
interested persons additional time to
submit comments.
DATES: FDA is reopening the comment
period on the notice of filing of a food
additive petition published on May 20,
2016 (81 FR 31877). Submit either
electronic or written comments by
September 19, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
E:\FR\FM\08AUP1.SGM
08AUP1
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Proposed Rules
ehiers on DSK5VPTVN1PROD with PROPOSALS
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–F–1253 for ‘‘Breast Cancer Fund,
Center for Environmental Health, Center
for Food Safety, Center for Science in
the Public Interest, Clean Water Action,
Consumer Federation of America,
Earthjustice, Environmental Defense
Fund, Improving Kids’ Environment,
Learning Disabilities Association of
America, and Natural Resources Defense
Council; Filing of Food Additive
Petition.’’ 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
VerDate Sep<11>2014
13:56 Aug 05, 2016
Jkt 238001
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
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:
Kelly Randolph, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740–3835, 240–
402–1188.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 20, 2016 (81 FR
31877), FDA published a notice of filing
of a food additive petition (FAP 6B4815)
submitted by the Breast Cancer Fund,
Center for Environmental Health, Center
for Food Safety, Center for Science in
the Public Interest, Clean Water Action,
Consumer Federation of America,
Earthjustice, Environmental Defense
Fund, Improving Kids’ Environment,
Learning Disabilities Association of
America, and Natural Resources Defense
Council, c/o Mr. Thomas Neltner, 1875
Connecticut Ave. NW., Suite 600,
Washington, DC 20009. The notice
invited comments on the petition. The
petition proposes that we amend and/or
revoke specified regulations to no longer
provide for the food contact use of
specified ortho-phthalates. Specifically,
the petitioners request that we consider
that ortho-phthalates are a class of
chemically and pharmacologically
PO 00000
Frm 00003
Fmt 4702
Sfmt 4702
52371
related substances, and state that there
is no longer a reasonable certainty of no
harm for the food contact uses of the
specified ortho-phthalates. If we
determine that new data are available
that justify amending the specified food
additive regulations in 21 CFR parts
175, 176, 177, and 178 so that they will
no longer provide for the use of the
ortho-phthalates, we will publish such
an amendment of these regulations in
the Federal Register, as set forth in
§ 171.130 and § 171.100 (21 CFR
171.100).
We have received a request for a 60day extension of the comment period for
the petition. The request conveyed
concern that the 60-day comment period
does not allow sufficient time to collect
and provide data and information and
develop a meaningful and thoughtful
response to the assertions set forth in
the petition.
FDA has considered the request;
however, because the request was
submitted too late to allow us to extend
the comment period, we are, instead,
reopening the comment period until
September 19, 2016. We believe that reopening the comment period until that
date allows adequate time for interested
persons to submit comments without
significantly delaying our review.
Dated: August 2, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. 2016–18720 Filed 8–5–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1105
[Docket No. FDA–2016–N–1555]
Refuse To Accept Procedures for
Premarket Tobacco Product
Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA) is issuing a
proposed rule describing when FDA
would refuse to accept a tobacco
product submission (or application)
because the application has not met a
minimum threshold for acceptability for
FDA review. Under the proposed rule,
FDA would refuse to accept a tobacco
product submission, for example, that is
not in English, does not pertain to a
tobacco product, or does not identify the
SUMMARY:
E:\FR\FM\08AUP1.SGM
08AUP1
Agencies
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Proposed Rules]
[Pages 52370-52371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18720]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 175, 176, 177, and 178
[Docket No. FDA-2016-F-1253]
Breast Cancer Fund, Center for Environmental Health, Center for
Food Safety, Center for Science in the Public Interest, Clean Water
Action, Consumer Federation of America, Earthjustice, Environmental
Defense Fund, Improving Kids' Environment, Learning Disabilities
Association of America, and Natural Resources Defense Council; Filing
of Food Additive Petition; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of petition; reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is reopening the
comment period for the notice of filing that appeared in the Federal
Register of May 20, 2016 (81 FR 31877). In the notice, we requested
comments on a filed food additive petition (FAP 6B4815), submitted by
the Breast Cancer Fund, Center for Environmental Health, Center for
Food Safety, Center for Science In The Public Interest, Clean Water
Action, Consumer Federation of America, Earthjustice, Environmental
Defense Fund, Improving Kids' Environment, Learning Disabilities
Association of America, and Natural Resources Defense Council,
proposing that we amend and/or revoke specified regulations to no
longer provide for the food contact use of specified ortho-phthalates.
We are taking this action in response to a request for an extension to
allow interested persons additional time to submit comments.
DATES: FDA is reopening the comment period on the notice of filing of a
food additive petition published on May 20, 2016 (81 FR 31877). Submit
either electronic or written comments by September 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
[[Page 52371]]
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-F-1253 for ``Breast Cancer Fund, Center for Environmental
Health, Center for Food Safety, Center for Science in the Public
Interest, Clean Water Action, Consumer Federation of America,
Earthjustice, Environmental Defense Fund, Improving Kids' Environment,
Learning Disabilities Association of America, and Natural Resources
Defense Council; Filing of Food Additive Petition.'' 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 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: Kelly Randolph, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740-3835, 240-402-1188.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 20, 2016 (81
FR 31877), FDA published a notice of filing of a food additive petition
(FAP 6B4815) submitted by the Breast Cancer Fund, Center for
Environmental Health, Center for Food Safety, Center for Science in the
Public Interest, Clean Water Action, Consumer Federation of America,
Earthjustice, Environmental Defense Fund, Improving Kids' Environment,
Learning Disabilities Association of America, and Natural Resources
Defense Council, c/o Mr. Thomas Neltner, 1875 Connecticut Ave. NW.,
Suite 600, Washington, DC 20009. The notice invited comments on the
petition. The petition proposes that we amend and/or revoke specified
regulations to no longer provide for the food contact use of specified
ortho-phthalates. Specifically, the petitioners request that we
consider that ortho-phthalates are a class of chemically and
pharmacologically related substances, and state that there is no longer
a reasonable certainty of no harm for the food contact uses of the
specified ortho-phthalates. If we determine that new data are available
that justify amending the specified food additive regulations in 21 CFR
parts 175, 176, 177, and 178 so that they will no longer provide for
the use of the ortho-phthalates, we will publish such an amendment of
these regulations in the Federal Register, as set forth in Sec.
171.130 and Sec. 171.100 (21 CFR 171.100).
We have received a request for a 60-day extension of the comment
period for the petition. The request conveyed concern that the 60-day
comment period does not allow sufficient time to collect and provide
data and information and develop a meaningful and thoughtful response
to the assertions set forth in the petition.
FDA has considered the request; however, because the request was
submitted too late to allow us to extend the comment period, we are,
instead, reopening the comment period until September 19, 2016. We
believe that re-opening the comment period until that date allows
adequate time for interested persons to submit comments without
significantly delaying our review.
Dated: August 2, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2016-18720 Filed 8-5-16; 8:45 am]
BILLING CODE 4164-01-P