[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Proposed Rules]
[Pages 16309-16310]
[FR Doc No: 2020-05957]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2020-0055 FRL-10006-83-Region 5]

Air Plan Approval; Ohio; Technical Amendment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
remove the air pollution nuisance rule from the Ohio State
Implementation Plan (SIP) using the Clean Air Act (CAA) error
correction provision. EPA has determined that this rule was not relied
upon by Ohio to demonstrate attainment or maintenance of any National
Ambient Air Quality Standards (NAAQS). If EPA takes final action
consistent with this proposal, the nuisance provision will no longer be
part of the Ohio SIP.

DATES: Comments must be received on or before April 22, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2020-0055 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Rachel Rineheart, Environmental
Engineer, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. Why is EPA proposing to remove Ohio's nuisance rule from the SIP?

    The CAA was first enacted in 1970. Section 110(a)(1) required each
state to submit to EPA SIPs that provided for the implementation,
maintenance and enforcement of the NAAQS. In the 1970s and early 1980s,
thousands of state and local agency regulations were submitted to EPA
for incorporation into the SIP to fulfill the new Federal requirements.
In many cases, states submitted entire regulatory air pollution
programs, including many elements not required by the CAA. Due to time
and resource constraints, EPA's review of these submittals focused
primarily on the rules addressing the new substantive requirements of
the CAA, and we approved many other elements into the SIP with minimal
review. We now recognize that some of these elements are appropriate
for state and local agencies to adopt and implement, but not as
federally enforceable SIP requirements. These include rules that
prohibit air pollution nuisances. Such rules generally have no
connection to the purposes for which SIPs are developed and approved,
namely the implementation, maintenance, and enforcement of the NAAQS.

II. What is EPA's authority to correct errors in SIP rulemakings?

    Section 110(k)(6) of the CAA provides EPA with authority to make
corrections to prior SIP actions that are subsequently found to be in
error in the same manner as the prior action, and to do so without
requiring any further submission from the state. This determination and
the basis must be provided to the state and the public.

III. Which rule is EPA proposing to remove?

    Ohio rule AP-2-07, ``Air pollution nuisances prohibited,'' was
approved by EPA into the Ohio SIP on April 15, 1974. See 39 FR 13542.
Subsequently, Ohio amended and renumbered the rule as OAC 3745-15-07
and submitted it as a revision to the SIP. EPA approved the amended
provision on August 13, 1984. See 49 FR 32182. OAC 3745-15-07 prohibits
the ``emission or escape into the open air from any source or sources
whatsoever, of smoke, ashes, dust, dirt, grime, acids, fumes, gases,
vapors, odors, or any other substances or combinations of substances,
in such manner or in such amounts as to endanger the health, safety or
welfare of the public, or cause unreasonable injury or damage to
property.''
    EPA has reviewed the docket files regarding Ohio's nuisance rule
and found no information indicating that the state has relied on, or
ever intended to rely on, this rule for attainment or

maintenance of any NAAQS.\1\ Additionally, the Ohio Environmental
Protection Agency has confirmed that they have not relied on, and did
not intend to rely on, this rule for attainment or maintenance of any
NAAQS.
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    \1\ EPA has taken similar actions in a number of other states.
See, e.g., Approval and Promulgation of Implementation Plans;
Michigan: Correction, 64 FR 7790 (February 17, 1999).
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IV. What action is EPA taking?

    EPA is proposing to remove Ohio's nuisance provision from the Ohio
SIP because it does not have a reasonable connection to the attainment
and maintenance of the NAAQS. Consequently, EPA finds that its prior
approval of OAC 3745-15-07 into the Ohio SIP was in error. To correct
this error, EPA is proposing to remove OAC 3745-15-07 from the approved
Ohio SIP pursuant to section 110(k)(6) of the CAA and to codify this
removal by revising the appropriate paragraph under 40 CFR part 52,
subpart KK, Sec.  52.1870 (Identification of Plan).

V. Incorporation by Reference

    In this document, EPA is proposing to amend regulatory text that
includes incorporation by reference. EPA is proposing to remove 3745-
15-07 ``Air Pollution Nuisances Prohibited'' of the EPA-Approved Ohio
Regulations from the Ohio State Implementation Plan, which is
incorporated by reference in accordance with the requirements of 1 CFR
part 51. EPA has made, and will continue to make the State
Implementation Plan generally available through www.epa.gov/air-quality-implementation-plans/approved-air-quality-implementation-plans-region-5 and at the EPA Region 5 Office (please contact the person
identified in the For Further Information Contact section of this
preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by Reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Sulfur oxides, Volatile organic
compounds.

    Dated: March 9, 2020.
Kurt A. Thiede,
Regional Administrator, Region 5.
[FR Doc. 2020-05957 Filed 3-20-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Rules and Regulations]
[Pages 41337-41339]
[FR Doc No: 2020-14863]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0361; Airspace Docket No. 20-AEA-9]
RIN 2120-AA66

Amendment of the Class D and Class E Airspace and Revocation of
Class E Airspace; Erie and Corry, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the Class D airspace, Class E surface area
airspace, and Class E airspace extending upward from 700 feet above the
surface at Erie International Airport/Tom Ridge Field, Erie, PA;
revokes the Class E airspace area designated as an extension to Class D
and Class E surface area at Erie International Airport/Tom Ridge Field;
and amends the Class E airspace extending upward from 700 feet above
the surface at Corry-Lawrence Airport, Corry, PA. This action is the
result of airspace reviews due to the decommissioning of the Tidioute
VHF omnidirectional range (VOR) navigation aid as part of the VOR
Minimum Operational Network (MON) Program.

DATES: Effective 0901 UTC, September 10, 2020. The Director of the
Federal Register approves this incorporation by

reference action under Title 1 Code of Federal Regulations part 51,
subject to the annual revision of FAA Order 7400.11 and publication of
conforming amendments.

ADDRESSES: FAA Order 7400.11D, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class D airspace, Class E surface area airspace, and
Class E airspace extending upward from 700 feet above the surface at
Erie International Airport/Tom Ridge Field, Erie, PA; revokes the Class
E airspace area designated as an extension to Class D and Class E
surface area at Erie International Airport/Tom Ridge Field; and amends
the Class E airspace extending upward from 700 feet above the surface
at Corry-Lawrence Airport, Corry, PA, to support instrument flight rule
operations at these airports.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (85 FR 27174; May 7, 2020) for Docket No. FAA-2020-0361 to
amend the Class D airspace, Class E surface area airspace, and Class E
airspace extending upward from 700 feet above the surface at Erie
International Airport/Tom Ridge Field, Erie, PA; revoke the Class E
airspace area designated as an extension to Class D and Class E surface
area at Erie International Airport/Tom Ridge Field; and amend the Class
E airspace extending upward from 700 feet above the surface at Corry-
Lawrence Airport, Corry, PA. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received.
    Class D and E airspace designations are published in paragraph
5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11D, dated
August 8, 2019, and effective September 15, 2019, which is incorporated
by reference in 14 CFR 71.1. The Class D and E airspace designations
listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71: Amends the Class D airspace to within a 4.3-mile (increased
from a 4.2-mile) radius of Erie International Airport/Tom Ridge Field,
Erie, PA;
    Amends the Class E surface area airspace to within a 4.3-mile
(increased from a 4.2-mile) radius of Erie International Airport/Tom
Ridge Field;
    Removes the Class E airspace area designated as an extension to
Class D and Class E surface areas at Erie International Airport/Tom
Ridge Field, as it is no longer required;
    Amends the Class E airspace extending upward from 700 feet above
the surface to within a 6.4-mile (decreased from a 7.4-mile) radius of
the Corry-Lawrence Airport, Corry, PA; and removes the extension
southeast of the airport, as it is no longer required;
    And amends the Class E airspace extending upward from 700 feet
above the surface to within a 6.8-mile (increased from a 6.7-mile)
radius of Erie International Airport/Tom Ridge Field; amends the
extension to within 3.6 miles (decreased from 4.4 miles) each side of
the 054[deg] bearing from the Erie International Airport/Tom Ridge
Field: RWY 24-LOC (previously the airport) extending from the 6.8-mile
(increased from 6.7-mile) radius of the airport to 11.6 miles
(decreased from 14 miles) northeast of the airport.
    This action is the result of airspace reviews caused by the
decommissioning of the Tidioute VOR, which provided navigation
information for the instrument procedures at these airports, as part of
the VOR MON Program.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    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 only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 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

0
1. The authority citation for 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.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AEA PA D Erie, PA [Amended]

Erie International Airport/Tom Ridge Field, PA
    (Lat. 42[deg]04'59'' N, long. 80[deg]10'26'' W)

    That airspace extending upward from the surface to and including
3,200 feet MSL within a 4.3-mile radius of Erie International
Airport/Tom Ridge Field. This Class D airspace area is effective
during the specific days and times established in advance by a
Notice to Airmen. The effective days and times will thereafter be
continuously published in the Chart Supplement.

Paragraph 6002 Class E Airspace Areas Designated as Surface Areas.

* * * * *

AEA PA E2 Erie, PA [Amended]

Erie International Airport/Tom Ridge Field, PA
    (Lat. 42[deg]04'59'' N, long. 80[deg]10'26'' W)

    That airspace extending upward from the surface within a 4.3-
mile radius of Erie International Airport/Tom Ridge Field. This
Class E airspace area is effective during the specific days and
times established in advance by a Notice to Airmen. The effective
days and times will thereafter be continuously published in the
Chart Supplement.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area.

* * * * *

AEA PA E4 Erie, PA [Removed]

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA PA E5 Corry, PA [Amended]

Corry-Lawrence Airport, PA
    (Lat. 41[deg]54'27'' N, long. 79[deg]38'28'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Corry-Lawrence Airport.
* * * * *

AEA PA E5 Erie, PA [Amended]

Erie International Airport/Tom Ridge Field, PA
    (Lat. 42[deg]04'59'' N, long. 80[deg]10'26'' W)
Erie International Airport/Tom Ridge Field: RWY 24-LOC
    (Lat. 42[deg]04'32'' N, long. 80[deg]11'12'' W)
St. Vincent Health Center Heliport, PA
    (Lat. 42[deg]06'43'' N, long. 80[deg]04'51'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of Erie International Airport/Tom Ridge
Field, and within 3.6 miles each side of the 054[deg] bearing from
the Erie International Airport/Tom Ridge Field: RWY 24-LOC extending
from the 6.8-mile radius to 11.6 miles northeast of the airport, and
within a 6-mile radius of St. Vincent Health Center Heliport.

    Issued in Fort Worth, Texas, on July 6, 2020.
Steven T. Phillips,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-14863 Filed 7-9-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 118 (Wednesday, June 19, 2019)]
[Notices]
[Pages 28554-28555]
[FR Doc No: 2019-13004]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0557]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarket Surveillance of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection requirements for
postmarket surveillance of medical devices.

DATES: Submit either electronic or written comments on the collection
of information by August 19, 2019.

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 August 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 19, 2019. 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-2013-N-0557 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Postmarket Surveillance of
Medical Devices.'' 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an

existing collection of information, before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Postmarket Surveillance of Medical Devices--21 CFR Part 822

OMB Control Number 0910-0449--Extension

    Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360l) authorizes FDA to require a manufacturer to conduct postmarket
surveillance (PS) of any device that meets the criteria set forth in
the statute. The PS regulation establishes procedures that FDA uses to
approve and disapprove PS plans. The regulation provides instructions
to manufacturers, so they know what information is required in a PS
plan submission. FDA reviews PS plan submissions in accordance with 21
CFR 822.15 through 822.19 of the regulation, which describe the grounds
for approving or disapproving a PS plan. In addition, the PS regulation
provides instructions to manufacturers to submit interim and final
reports in accordance with Sec.  822.38 (21 CFR 822.38). Respondents to
this collection of information are those manufacturers that require PS
of their products.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     Activity/21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
PS submission (822.9 and 822.10)              25               1              25             120           3,000
Changes to PS plan after                       9               1               9              40             360
 approval (822.21)..............
Changes to PS plan for a device                6               1               6               8              48
 that is no longer marketed
 (822.28).......................
Waiver (822.29).................               1               1               1              40              40
Exemption request (822.30)......              16               1              16              40             640
Periodic reports (822.38).......              25               3              75              40           3,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          7,088
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Explanation of Reporting Burden Estimate: The burden captured in
table 1 is based on the data from FDA's internal tracking system.
Sections 822.26, 822.27, and 822.34 do not constitute information
collection subject to review under the PRA because it entails no burden
other than that necessary to identify the respondent, the date, the
respondent's address, and the nature of the instrument (See 5 CFR
1320.3(h)(1)).

                                Table 2--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     Activity/21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Manufacturer records (822.31)...              25               1              25              20             500
Investigator records (822.32)...              75               1              75               5             375
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             875
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Explanation of Recordkeeping Burden Estimate: FDA expects that at
least some of the manufacturers will be able to satisfy the PS
requirement using information or data they already have. For purposes
of calculating burden, however, FDA has assumed that each PS order can
only be satisfied by a 3-year clinically based surveillance plan, using
three investigators. These estimates are based on FDA's knowledge and
experience with PS.
    Our estimated burden for the information collection reflects a
decrease of 29,982 hours. We attribute this adjustment to a decrease in
the number of submissions we received over the last few years.

    Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13004 Filed 6-18-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 13 (Friday, January 18, 2013)]
[Notices]
[Pages 4144-4145]
[FR Doc No: 2013-01074]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9772-1]

Tentative Approval and Solicitation of Request for a Public
Hearing for Public Water System Supervision Program Revision for New
York

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the State of New York is revising
its approved Public Water System Supervision Program to adopt EPA's
National Primary Drinking Water Regulations for one major rule and one
correction. The EPA has determined that these revisions are no less
stringent than the corresponding Federal regulations. Therefore, the
EPA intends to approve these program revisions. All interested parties
may request a public hearing.

DATES: A request for a public hearing must be submitted to the Regional
Administrator at the address shown below February 19, 2013. If no
timely and appropriate request for a hearing is received and the
Regional Administrator does not elect to hold a hearing on her own
motion, this determination shall become final and effective February
19, 2013. More information on requesting a public hearing can be found
in the SUPPLEMENTARY INFORMATION section of this document.

ADDRESSES: Requests for Public Hearing shall be addressed to: Regional
Administrator, U.S. Environmental Protection Agency--Region 2, 290
Broadway, New York, New York 10007-1866.
    All documents relating to this determination are available for
inspection between the hours of 9:00 a.m. and 4:30 p.m., Monday through
Friday, at the following offices: New York State Department of Health,
Corning Tower, Empire State Plaza, Albany, New York 12237. U.S.
Environmental Protection Agency--Region 2, 24th Floor Drinking Water
Ground Water Protection Section, 290 Broadway, New York, New York
10007-1866.

FOR FURTHER INFORMATION CONTACT: Michael J. Lowy, Drinking Water Ground
Water Protection Section, U.S. Environmental Protection Agency--Region
2,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the United
States Environmental Protection Agency (EPA) has determined to approve
an application by the State of New York Department of Health to revise
its Public Water Supply Supervision Primacy Program to incorporate
regulations no less stringent than the EPA's National Primary Drinking
Water Regulations (NPDWR) for National Primary Drinking Water
Regulation: Ground Water Rule, Final Rule, promulgated by EPA November
8, 2006 (71 FR 65574), and the Correction promulgated by EPA November
21, 2006 (71 FR 67427).
    The application demonstrates that New York has adopted drinking
water regulations which satisfy the NPDWRs for the above. The USEPA has
determined that New York's regulations are no less stringent than the
corresponding Federal Regulations and that New York continues to meet
all requirements for primary enforcement responsibility as specified in
40 CFR 142.10.

    Authority: Section 1413 of the Safe Drinking Water Act, as
amended, 40 U.S.C. 300g-2, and 40 CFR 142.10, 142.12(d) and 142.13.

    This determination to approve New York's primacy program revision
application is made pursuant to 40 CFR 142.12(d)(3). It shall become
final and effective unless (1) a timely and appropriate request for a
public hearing is received or (2) the Regional Administrator elects to
hold a public hearing on her own motion. Any interested person, other
than Federal Agencies, may request a public hearing.
    If a substantial request for a public hearing is made within the
requested thirty day time frame, a public hearing will be held and a
notice will be given in the Federal Register and a newspaper of general
circulation. Frivolous or insubstantial requests for a hearing may be
denied by the Regional Administrator.
    Any request for a public hearing shall include the following
information: (1) Name, address and telephone number of the individual,
organization or other entity requesting a hearing; (2) a brief
statement of the requesting person's interest in the Regional
Administrator's determination and a brief statement on information that
the requesting person intends to submit at such hearing; (3) the
signature of the individual making the requests or, if the request is
made on behalf of an organization or other entity, the signature of a
responsible official of the organization or other entity.

    Dated: January 2, 2013.
Judith A. Enck,
Regional Administrator, Region 2.
[FR Doc. 2013-01074 Filed 1-17-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Page 79071]
[FR Doc No: 2010-31716]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending October 23, 2010

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et seq.). The due date for Answers,
Conforming Applications, or Motions To Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.

    Docket Number: DOT-OST-2010-0262.
    Date Filed: October 20, 2010.
    Due Date for Answers, Conforming Applications, or Motion To Modify
Scope: November 10, 2010.
    Description: Application of Dynamic Airways, LLC d/b/a Dynamic
Aviation requesting a certificate of public convenience and necessity
authorizing Dynamic to engage in foreign charter air transportation of
persons, property, and mail between any place in the United States and
any place outside thereof.

    Docket Number: DOT-OST-2010-0263.
    Date Filed: October 20, 2010.
    Due Date for Answers, Conforming Applications, or Motion To Modify
Scope: November 10, 2010.
    Description: Application of City Wings, Inc. requesting authority
to operate scheduled passenger service as a commuter air carrier.

    Docket Number: DOT-OST-2010-0264.
    Date Filed: October 22, 2010.
    Due Date for Answers, Conforming Applications, or Motion To Modify
Scope: November 15, 2010.
    Description: Application of Whitejet Transportes Aereos Ltda
requesting a foreign air carrier permit and exemption authority to
engage in charter foreign air transportation of persons, property and
mail between any point or points in the United States and any point or
points in Brazil to the full extent authorized by Air Transport
Agreement between the Government of the United States of America and
the Government of the Federative Republic of Brazil.

Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2010-31716 Filed 12-16-10; 8:45 am]
BILLING CODE 4910-9X-P


Comment Info: =================

General Comment:There is no question that some individuals have been helped to quit using e-cigarettes. But there is little question
that for every individual who has been helped, there is more than one individual who has been enabled to
continue smoking. On top of that, new users are becoming addicted, almost all as youth, and there
is no question that some of them will go on to smoking cigarettes.

This is established beyond any serious debate by the science of the last two years. The question is not whether
we need more research, or more time. The question is whether FDA will act. The question is whether FDA will
do something effective about a new gateway to smoking, a new impediment to progress in tobacco control,
and a new profit center for the industry that spreads smoking.

I urge FDA to accept NO FURTHER DELAY.

I urge FDA to DENY the tobacco industry's request to extend the 75 day comment period for another 75 days.

I stand with the American Cancer Society, American Lung Association, American Heart Association: "The idea that the industry, with all its resources, is somehow unable to formulate its position on these issues within the time period established in the proposed regulation is ludicrous."

Every day of delay is more kids getting addicted to nicotine. The industry has petitioned to extend the comment period by up to an additional 105 days, bringing the total comment period to 180 days.  Scientific analysis allows us to estimate that during the requested 105 day extension 26,000 MORE YOUTH will start experimenting with e-cigarettes and 8,000 MORE YOUTH will become established e-cigarette users.

I urge FDA to act NOW. 75 days of comment period is MORE THAN ENOUGH.

I urge FDA to do the following at a minimum:

    Apply the same restrictions on e-cigaarette advertising and promotion as apply to conventional cigarettes
    Ban the use of characterizing flavors in e-cigarettes
    Prohibit claims that e-cigarettes are effective smoking cessation aids until such time as there is convincing scientific evidence that such claims are true for e-cigarettes as they are actually used in the general population.
    Regulate e-cigarettes to set standards for product performance in order to minimize risks to users and bystanders
    Require childproofing of e-cigarette devices and refill solutions to prevent accidental pediatric poisoning.
    Regulations regarding e-cigarettes need to take into account the fact that, unlike conventional cigarettes and other tobacco products and medicinal nicotine replacement therapies, e-cigarettes can be altered by users to change the nicotine delivery and be used to deliver other drugs.

I thank you for your time.


[Federal Register Volume 76, Number 40 (Tuesday, March 1, 2011)]
[Notices]
[Pages 11239-11240]
[FR Doc No: 2011-4417]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL11-23-000]

EnerNOC, Inc.; Notice of Petition for Declaratory Order

    Take notice that on February 22, 2011, pursuant to Rule 207(a)(2)
of the Rules of Practice and Procedure of the Federal Energy Regulatory
Commission (Commission), 18 CFR 385.207(a)(2) (2010), EnerNOC, Inc.
(EnerNOC) filed a petition for declaratory order seeking clarification
that EnerNOC may continue to manage its portfolio of PJM
Interconnection, LLC (PJM) demand response resources as it has in the
past and continue to receive settlement in accordance with the PJM
tariff on file with the Commission without enforcement action being
threatened or taken on account thereof. EnerNOC also requests that the
clarification is without prejudice to the right of PJM or any other
party to seek amendment to the PJM tariff prospectively pursuant to
section 205 or 206 of the Federal Power Act.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically

should submit an original and 14 copies of the protest or intervention
to the Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 1, 2011.

    Dated: February 22, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-4417 Filed 2-28-11; 8:45 am]
BILLING CODE 6717-01-P