[Federal Register: April 15, 2009 (Volume 74, Number 71)]
[Proposed Rules]
[Page 17444-17445]
[DOCID:fr15ap09-28]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 101, 104, 105, and 106

[Docket No. USCG-2007-28915]
RIN 1625-AB21

Transportation Worker Identification Credential (TWIC)--Reader
Requirements

AGENCY: Coast Guard, DHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Coast Guard announces the location for a public meeting to
receive comments on an advanced notice of proposed rulemaking (ANPRM)
entitled Transportation Worker Identification Credential (TWIC)--Reader
Requirements that was published in the Federal Register on March 27,
2009. As stated in that document, the ANPRM discusses the Coast Guard's
preliminary thoughts on potential requirements for owners and operators
of certain vessels and facilities regulated by the Coast Guard under 33
CFR chapter I, subchapter H, for use of electronic readers designed to
work with TWICs as an access control measure.

DATES: A public meeting will be held on Wednesday, May 6, 2009. We
expect the meeting will run from 9 a.m. to 5 p.m. to provide an
opportunity for oral comments. The meeting may end early if all
comments are received prior to 5 p.m. Written comments and related
material may also be submitted to Coast Guard personnel specified at
that meeting. The comment period for the proposed rule closes May 26,
2009. All comments and related material submitted after the meeting
must either be submitted to our online docket via http://
www.regulations.gov on or before May 26, 2009 or reach the Docket
Management Facility by that date.

ADDRESSES: The public meeting will be held at The Sheraton Crystal City
Hotel, 1800 Jefferson Davis Highway, Arlington, Virginia 22202.
    You may submit written comments identified by docket number USCG-
2007-28915 before or after the meeting using any one of the following
methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand Delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
Our online docket for this rulemaking is available on the Internet at
http://www.regulations.gov under docket number USCG-2007-28915.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning the
meeting or the ANPRM, please call or e-mail LCDR Jonathan Maiorine,
Coast Guard; telephone 1-877-687-2243, e-mail
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Ms. Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    We published an ANPRM in the Federal Register on March 27, 2009 (74
FR 13360), entitled ``Transportation Worker Identification Credential

(TWIC)--Reader Requirements.'' In it we stated our intention to hold a
public meeting, and to publish a notice announcing the location and
date. 74 FR 13360. On April 9, 2009, we published a notice announcing
the date for that meeting, and that it would be held in the Washington
DC area. 74 FR 16161. This document is the notice of the exact location
for that meeting.
    In the ANPRM, we discuss the United States Coast Guard's
preliminary thoughts on potential requirements for owners and operators
of certain vessels and facilities regulated by the Coast Guard under 33
CFR chapter I, subchapter H, for use of electronic readers designed to
work with TWICs as an access control measure. It discusses additional
potential requirements associated with TWIC readers, such as
recordkeeping requirements for those owners or operators required to
use an electronic reader, and amendments to security plans previously
approved by the Coast Guard to incorporate TWIC requirements.
    This rulemaking action, once final, would enhance the security of
ports and vessels by ensuring that only persons who hold valid TWICs
are granted unescorted access to secure areas on vessels and port
facilities. It would also complete the implementation of the Maritime
Transportation Security Act of 2002 transportation security card
requirement, as well as the requirements of the Security and
Accountability for Every Port Act of 2006, for regulations on
electronic readers for use with Transportation Worker Identification
Credentials.
    You may view the ANPRM in our online docket, and comments submitted
thus far by going to http://www.regulations.gov. Once there, select the
Advanced Docket Search option on the right side of the screen, insert
USCG-2007-28915 in the Docket ID box, press Enter, and then click on
the item in the Docket ID column. If you do not have access to the
Internet, you may view the docket in person by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue,
SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. We have an agreement with the
Department of Transportation to use the Docket Management Facility.
    We encourage you to participate in this rulemaking by submitting
comments either orally at the meeting or in writing. If you bring
written comments to the meeting, you may submit them to Coast Guard
personnel specified at the meeting to receive written comments. These
comments will be submitted to our online public docket. All comments
received will be posted without change to http://www.regulations.gov
and will include any personal information you have provided.
    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008 issue of the
Federal Register (73 FR 3316).

Information on Service for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the public meeting,
contact LCDR Maiorine at the telephone number or e-mail address
indicated under the FOR FURTHER INFORMATION CONTACT section of this
notice.

Public Meeting

    The Coast Guard will hold a public meeting regarding its
Transportation Worker Identification Credential (TWIC)--Reader
Requirements ANPRM on Wednesday, May 6, 2009 from 9 a.m. until 5 p.m.
at The Sheraton Crystal City Hotel, 1800 Jefferson Davis Highway,
Arlington, Virginia 22202. The meeting may end early if all comments
are received prior to 5 p.m. We plan to have a transcript of the
meeting available on our online docket soon after the public meeting.
    For details on the hotel and surrounding area, including
directions, you may visit The Sheraton Crystal City Hotel Web site,
http://www.sheraton.com/crystalcity. The hotel is metro accessible and
provides shuttle service from Reagan National Airport. Additionally,
self and valet parking is available in the hotel's parking garage at a
daily rate. There is also metered parking along the street outside of
the hotel.

    Dated: April 10, 2009.
Mark E. Hammond,
Commander, U.S. Coast Guard, Acting Chief, Ports and Facilities
Activities.
 [FR Doc. E9-8606 Filed 4-14-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 77, Number 1 (Tuesday, January 3, 2012)]
[Rules and Regulations]
[Pages 1-3]
[FR Doc No: 2011-33565]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 77, No. 1 / Tuesday, January 3, 2012 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1062; Directorate Identifier 2011-NM-038-AD;
Amendment 39-16907; AD 2011-27-05]
RIN 2120-AA64

Airworthiness Directives; Saab AB, Saab Aerosystems Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are superseding an existing airworthiness directive (AD)
for all Saab AB, Saab Aerosystems Model 340A (SAAB/SF340A) and SAAB
340B airplanes. That AD currently requires an inspection of the main
landing gear (MLG) separation bolt harness for broken wires and
corroded connectors, and corrective actions if necessary; and for
certain airplanes, a modification of the MLG separation bolt's
electrical harness. This new AD requires replacement of the separation
bolt harness. This AD was prompted by reports of broken wires and
corroded connectors in the SAAB 340 MLG emergency release system. We
are issuing this AD to prevent improper release of the MLG during an
emergency situation, possibly resulting in damage to the airplane
during landing and injury to the occupants.

DATES: This AD becomes effective February 7, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 7,
2012.
    The Director of the Federal Register approved the incorporation by
reference of certain other publications listed in this AD as of July
29, 2004 (69 FR 35235, June 24, 2004).

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on October 11, 2011 (76
FR 62656), and proposed to supersede AD 2004-12-03, Amendment 39-13662
(69 FR 35235, June 24, 2004). That NPRM proposed to correct an unsafe
condition for the specified products. The MCAI states:

    In 2003, a number of reports had been received concerning broken
wires and corroded connectors in the SAAB 340 main landing gear
(MLG) emergency release system. The investigation results showed
that these were due to improper repairs and installations, not
conforming to the approved type design.
    This condition, if not corrected, could inhibit the functioning
of the separation bolt, preventing proper release of the MLG during
an emergency situation, possibly resulting in damage to aeroplane
during landing and injury to the occupants.
    To address that unsafe condition, Swedish AD (SAD) 1-186 was
issued to require an inspection and, depending on findings,
corrective action, in accordance with SAAB Service Bulletin (SB)
340-32-127.
    Subsequently, Saab introduced a modification to ensure correct
functioning of the MLG emergency release system. Accomplishment of
that modification (SAAB SB 340-32-128) was made mandatory by SAD 1-
189 [which corresponds to FAA AD 2004-12-03 Amendment 39-13662 (69
FR 35235, June 24, 2004)].
    Since that [SAD] AD was issued, service experience has shown
that this modification does not fully meet the expected results.
    Prompted by these findings, SAAB has developed an improved
separation bolt harness with a new routing.
    For the reasons described above, this [EASA] AD requires
replacement of the current separation bolt harness Part Number (P/N)
7292520-678 with the improved unit, P/N 7292520-691.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (76 FR 62656, October 11,
2011) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (76 FR 62656, October 11, 2011) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (76 FR 62656, October 11, 2011).

Differences Between This AD and the Mandatory Continuing Airworthiness
Information (MCAI) or Service Information

    This AD differs from the MCAI and/or service information as
follows: Although the MCAI states not to install a separation bolt
having P/N 7292520-678 on any airplane after modification of the
airplane, this AD states not to install a separation bolt having P/N
7292520-678 on any airplane as of the effective date of this AD.

Costs of Compliance

    We estimate that this AD will affect about 111 products of U.S.
registry.
    The actions that are required by AD 2004-12-03, Amendment 39-13662
(69 FR 35235, June 24, 2004), and retained in this AD take about 6
work-hours per product, at an average labor rate of $85 per work-hour.
Required parts cost about $1,475 per product. Based on these figures,
the estimated cost of the currently required actions is 1,985 per
product.
    We estimate that it will take about 10 work-hours per product to
comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $1,790 per
product. Where the service information lists required parts costs

that are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $96,140, or $2,640 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ''significant regulatory action'' under Executive Order
12866;
    2. Is not a ''significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (76 FR 62656, October 11,
2011), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Amendment 39-13662 (69 FR
35235, June 24, 2004) and adding the following new AD:

2011-27-05 Saab AB, Saab Aerosystems: Amendment 39-16907. Docket No.
FAA-2011-1062; Directorate Identifier 2011-NM-038-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective February 7,
2012.

(b) Affected ADs

    This AD supersedes AD 2004-12-03, Amendment 39-13662 (69 FR
35235, June 24, 2004).

(c) Applicability

    This AD applies to Saab AB, Saab Aerosystems Model 340A (SAAB/
SF340A) and SAAB 340B airplanes, all serial numbers, certificated in
any category.

(d) Subject

    Air Transport Association (ATA) of America Code 32: Landing
gear.

(e) Reason

    This AD was prompted by reports of broken wires and corroded
connectors in the SAAB 340 MLG emergency release system. We are
issuing this AD to prevent improper release of the MLG during an
emergency situation, possibly resulting in damage to the airplane
during landing and injury to the occupants.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

Restatement of Requirements of AD 2004-12-03, Amendment 39-13662 (69 FR
35235, JUNE 24, 2004), With Changes

(g) Inspection

    Within 3 months after July 29, 2004 (the effective date of AD
2004-12-03, Amendment 39-13662 (69 FR 35235, June 24, 2004)),
perform an inspection of the MLG's separation bolt harness for
broken wires and corroded connectors, and any applicable corrective
actions by doing all of the actions, in accordance with the
Accomplishment Instructions of Saab Service Bulletin 340-32-127,
dated December 18, 2002; or Revision 01, dated January 23, 2003.
Perform the inspection/corrective actions in accordance with Saab
Service Bulletin 340-32-127, dated December 18, 2002; or Revision
01, dated January 23, 2003. Perform any applicable corrective
actions before further flight.

(h) Concurrent Service Bulletins

    For Model SAAB SF340A series airplanes: Within 12 months after
July 29, 2004, do the actions specified in table 1 of this AD, as
applicable.

                    Table 1--Prior/Concurrent Actions
------------------------------------------------------------------------
                                 Accomplish all       According to the
  For airplanes with serial    actions associated      accomplishment
          numbers--                  with--           instructions of--
------------------------------------------------------------------------
004 through 108 inclusive...  Modifying the MLG     Saab Service
                               separation bolt's     Bulletin
                               electrical harness.   340[dash]32[dash]04
                                                     1, Revision 01,
                                                     dated October 9,
                                                     1987.
004 through 078 inclusive...  Modifying the MLG     Saab Service
                               separation bolt's     Bulletin
                               electrical harness.   340[dash]32[dash]02
                                                     8, Revision 01,
                                                     dated November 25,
                                                     1986.
------------------------------------------------------------------------

(i) New Requirements of This AD

    Within 12 months after the effective date of this AD: Replace
the separation bolt harnesses having part number (P/N) 7292520-678
with separation bolt harnesses having P/N 7292520-691, in accordance
with the Accomplishment Instructions of Saab Service Bulletin 340-
32-139, Revision 01, dated November 1, 2010.

(j) Parts Installation

    As of the effective date of this AD, no person may install a
separation bolt harness having P/N 7292520-678, on any airplane.

(k) Credit for Actions Accomplished in Accordance With Previous Service
Information

    Actions done before the effective date of this AD in accordance
with Saab Service Bulletin 340-32-139, dated January 12, 2010, are
acceptable for compliance with the requirements of paragraph (i) of
this AD.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Shahram
Daneshmandi, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(m) Related Information

    Refer to MCAI EASA Airworthiness Directive 2011-0003, dated
January 17, 2011, and the service information specified in
paragraphs (m)(1) through (m)(5) of this AD, as applicable, for
related information.
    (1) Saab Service Bulletin 340-32-139, Revision 01, dated
November 1, 2010.
    (2) Saab Service Bulletin 340-32-127, dated December 18, 2002.
    (3) Saab Service Bulletin 340-32-127, Revision 01, dated January
23, 2003.
    (4) Saab Service Bulletin 340-32-041, Revision 01, dated October
9, 1987.
    (5) Saab Service Bulletin 340-32-028, Revision 01, dated
November 25, 1986.

(n) Material Incorporated by Reference

    (1) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise. The
Director of the Federal Register approved the incorporation by
reference (IBR) of the following service information under 5 U.S.C.
552(a) and 1 CFR part 51 on the date specified:
    (i) Saab Service Bulletin 340-32-028, Revision 01, dated
November 25, 1986, approved for IBR July 29, 2004 (69 FR 35235, June
24, 2004).
    (ii) Saab Service Bulletin 340-32-041, Revision 01, dated
October 9, 1987, approved for IBR July 29, 2004 (69 FR 35235, June
24, 2004).
    (iii) Saab Service Bulletin 340-32-127, dated December 18, 2002,
approved for IBR July 29, 2004 (69 FR 35235, June 24, 2004).
    (iv) Saab Service Bulletin 340-32-127, Revision 01, dated
January 23, 2003, approved for IBR July 29, 2004 (69 FR 35235, June
24, 2004).
    (v) Saab Service Bulletin 340-32-139, Revision 01, dated
November 1, 2010, approved for IBR February 7, 2012.
    (2) For service information identified in this AD, contact Saab
AB, Saab Aerosystems, SE-581 88, Link[ouml]ping, Sweden; telephone
+46 13 18 5591; fax +46 13 18 4874; email
<EMAIL_ADDRESS>Internet http://www.saabgroup.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on December 23, 2011.
John P. Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-33565 Filed 12-30-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Rules and Regulations]
[Pages 15607-15608]
[FR Doc No: 2012-6424]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2010-0380; A-1-FRL-9648-5 ]

Approval and Promulgation of Air Quality Implementation Plans;
Connecticut; Determination of Attainment of the One-Hour Ozone Standard
for the Greater Connecticut Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA is determining that the Greater Connecticut serious
one-hour ozone nonattainment area did not meet the applicable deadline
of November 15, 2007, for attaining the one-hour National Ambient Air
Quality Standard (NAAQS) for ozone. This determination is based upon
complete, quality-assured, certified ambient air monitoring data that
show the area had an expected ozone exceedance rate above the level of
the now revoked one-hour ozone NAAQS for the 2005-2007 monitoring
period. Separate from and independent of this determination, EPA is
also determining that the Greater Connecticut serious one-hour ozone
nonattainment area currently attains the now revoked one-hour NAAQS for
ozone, based upon complete, quality-assured, certified ambient air
monitoring data for 2008-2010. The area first attained the one-hour
NAAQS during the 2006-2008 monitoring period, and continued in
attainment during the 2007-2009, and 2008-2010 monitoring periods.
Quality assured and quality controlled, but not yet certified ozone
data available for 2011 indicate that the area continues to attain the
one-hour NAAQS. These determinations are made under the Clean Air Act.

DATES: Effective Date: This rule is effective on April 16, 2012.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2011-0711. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically through
www.regulations.gov or in hard copy at the Office of Ecosystem
Protection, U.S. Environmental Protection Agency, EPA New England
Regional Office, Office of Ecosystem Protection, Air Quality Planning
Unit, 5 Post Office Square--Suite 100, Boston, MA 02109-3912. EPA
requests that if at all possible, you contact the contact listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Richard P. Burkhart, Air Quality
Planning Unit, U.S. Environmental Protection Agency, EPA New England
Regional Office, 5 Post Office Square, Suite 100, Boston, MA 02109-
3912, telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    The following outline is provided to aid in locating information in
this preamble.

I. What actions is EPA taking?
II. What is the effect of these actions?
III. Final Action
IV. Statutory and Executive Order Reviews

I. What actions is EPA taking?

    EPA is taking two separate and independent actions for the Greater
Connecticut one-hour ozone serious nonattainment area (hereafter, ``the
Greater Connecticut area'').

A. Determination of Failure To Attain by Applicable Attainment Date

    EPA is determining that the Greater Connecticut area did not attain
the one-hour ozone National Ambient Air Quality Standard (NAAQS) by the
applicable attainment date, November 15, 2007. This determination is
based upon complete, quality-assured and certified air quality
monitoring data for the 2005 through 2007 ozone seasons.

B. Determination of Current Attainment

    In addition, EPA is determining that the Greater Connecticut area
is currently attaining the one-hour ozone NAAQS based upon complete,
quality-assured and certified ambient air monitoring data showing the
area currently monitored attainment of the one-hour ozone NAAQS, and
that it has done so continuously since the 2006-2008 monitoring period.
    Other specific details related to these determinations and the
rationale for EPA's action are explained in the Notice of Proposed
Rulemaking (NPR) published on November 23, 2011 (76 FR 72377) and will
not be restated here. No comments were received on the NPR.

II. What is the effect of these actions?

    After revocation of the one-hour ozone standard, EPA must continue
to provide a mechanism to give effect to the one-hour anti-backsliding
requirements. See SCAQMD v. EPA, 47 F.3d 882, at 903. In keeping with
this responsibility, EPA has determined that Greater Connecticut failed
to attain the one-hour ozone standard by its applicable attainment
date. Consistent with 40 CFR 51.905(e)(2), and the South Coast
decision, upon revocation of the one-hour ozone NAAQS for an area, EPA
is no longer obligated to determine whether an area has attained the
one-hour NAAQS, except insofar as it relates to effectuating the anti-
backsliding requirements that are specifically retained. EPA's
determination here is linked solely to required, one-hour anti-
backsliding, contingency measures. A final determination of failure to
attain will not result in reclassification of the area under the
revoked one-hour standard, nor is EPA identifying or determining any
new one-hour reclassification for the area. EPA is no longer required
to reclassify an area to a higher classification for the one-hour ozone
NAAQS based upon a determination that the area failed to attain that
NAAQS by its attainment date. See 40 CFR 51.905(e)(2)(i)(B). Moreover,
EPA has previously approved the one-hour ozone attainment demonstration
and Reasonable Further Progress (ROP) plans for this area, and in doing
so noted that although there were no state implementation plan
contingency measure reductions applicable to the Greater Connecticut
area for failure to attain, there were federal measures the state had
not accounted for in its attainment demonstration that provided more
reductions than necessary to serve the purpose of contingency measures
for this area. See 66 FR 634, January 3, 2001. In addition, EPA has
also determined that the Greater Connecticut area attained the one-hour
ozone standard in 2008, and continues to

attain this standard. In this context, EPA has also determined that
there are not any additional obligations, including those relating to
one-hour ozone contingency measures, for the Greater Connecticut area
under the one-hour ozone standard.

III. Final Action

    EPA is determining that the Greater Connecticut one-hour ozone
nonattainment area did not meet its applicable one-hour ozone
attainment date of November 15, 2007, based on 2005-2007 quality-
assured ozone monitoring data. Separate from and independent of this
determination, EPA is also determining that the Greater Connecticut
one-hour ozone nonattainment area is currently attaining the one-hour
ozone standard, based on the most recent three years (2008-2010) of
complete, quality-assured ozone monitoring data at all monitoring sites
in the area. EPA's review of the data shows that the area began
attaining the one-hour ozone standard in the 2006-2008 period, and has
continued to attain this standard through the 2007-2009 and 2008-2010
monitoring periods. Quality assured and quality controlled, but not yet
certified, ozone data available for 2011 indicate that the area
continues to attain the one-hour NAAQS.

IV. Statutory and Executive Order Reviews

    These actions make determinations of attainment based on air
quality, result in the suspension of certain Federal requirements, and
would not impose additional requirements beyond those imposed by state
law. For that reason, these actions:
     Are not ``significant regulatory actions'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are 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.);
     Do 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);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are 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 Clean Air Act; and
     Do 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, these actions do not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing these actions and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule is effective on April 16, 2012.
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 15, 2012. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: March 8, 2012.
H. Curtis Spalding,
Regional Administrator, EPA New England.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

     Authority: 42 U.S.C. 7401 et seq.

Subpart H--Connecticut

0
2. Section 52.377 is amended by adding paragraph (i) to read as
follows:

Sec.  52.377  Control strategy: Ozone.

* * * * *
    (i) Determination of Attainment for the One-Hour Ozone Standard.
Effective April 16, 2012, EPA is determining that the Greater
Connecticut one-hour ozone nonattainment area did not meet its
applicable one-hour ozone attainment date of November 15, 2007, based
on 2005-2007 complete, quality-assured ozone monitoring data. Separate
from and independent of this determination, EPA is determining that the
Greater Connecticut one-hour ozone nonattainment area met the one-hour
ozone standard, based on 2008-2010 complete, quality-assured ozone
monitoring data at all monitoring sites in the area. EPA's review of
the ozone data shows that the area began attaining the one-hour ozone
standard during the 2006-2008 monitoring period, and has continued
attaining the one-hour standard through the 2007-2009 and 2008-2010
monitoring periods.

[FR Doc. 2012-6424 Filed 3-15-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Rules and Regulations]
[Pages 81836-81838]
[FR Doc No: 2011-33280]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2011-0032; FRL-9613-3]

Approval and Promulgation of Air Quality Implementation Plans;
New Mexico; Albuquerque/Bernalillo County; Prevention of Significant
Deterioration; Greenhouse Gas Tailoring Rule Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The EPA is approving a revision to the Albuquerque/Bernalillo
County, New Mexico State Implementation Plan (SIP) that was submitted
by the Governor of New Mexico to EPA on December 15, 2010. This SIP
revision modifies Albuquerque/Bernalillo County's Prevention of
Significant Deterioration (PSD) program to establish appropriate
emission thresholds for determining which new stationary sources and
modification projects become subject to Albuquerque/Bernalillo County's
PSD permitting requirements for their greenhouse gas (GHG) emissions.
EPA is fully approving the Albuquerque/Bernalillo County, New Mexico
December 15, 2010 PSD SIP revision because the Agency has determined
that this PSD SIP revision is in accordance with section 110 and part C
of the Federal Clean Air Act and EPA regulations regarding PSD
permitting for GHGs.

DATES: This final rule will be effective January 30, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R06-OAR-2011-0032. All documents in the docket are listed in
the http://www.regulations.gov index. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information the disclosure of which is restricted by statute. Certain
other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly available docket materials are
available either electronically in http://www.regulations.gov or in
hard copy at the Air Planning Section (6PD-L), Environmental Protection
Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. The file
will be made available by appointment for public inspection in the
Region 6 FOIA Review Room between the hours of 8:30 a.m. and 4:30 p.m.
weekdays except for legal holidays. Contact the person listed in the
FOR FURTHER INFORMATION CONTACT paragraph below or Mr. Bill Deese at
(214) 665-7253 to make an appointment. If possible, please make the
appointment at least two working days in advance of your visit. A 15
cent per page fee will be charged for making photocopies of documents.
On the day of the visit, please check in at the EPA Region 6 reception
area on the seventh floor at 1445 Ross Avenue, Suite 700, Dallas, Texas
75202-2733.
    The State submittal related to this SIP revision, and which is part
of the EPA docket, is also available for public inspection at the Local
Air Agency listed below during official business hours by appointment:
    Albuquerque Environmental Health Department, Suite 3023, 3rd floor,
One Civic Plaza, 400 Marquette Avenue NW., Albuquerque, New Mexico
87102.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning
today's final rule, please contact Mr. Mike Miller (6PD-R), Air Permits
Section, Environmental Protection Agency, Region 6, 1445 Ross Avenue,
Suite 1200, Dallas, TX 75202-2733. The telephone number is (214) 665-
7550. Mr. Miller can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean the EPA. This supplementary
information section is arranged as follows:

I. What is the background for this action?
II. What final action is EPA taking?
III. Statutory and Executive Order Reviews

I. What is the background for this action?

    The background for EPA's national actions pertaining to GHG's as
well as today's action is discussed in detail in our September 26, 2011
proposal (76 FR 59334). The comment period was open for thirty days and
no comments were received.

II. What final action is EPA taking?

    We are fully approving Albuquerque/Bernalillo County's December 15,
2010, SIP submittal, relating to PSD requirements for GHG-emitting
sources in Albuquerque/Bernalillo County. Specifically, the SIP
revision establishes appropriate emissions thresholds for determining
PSD applicability to new and modified GHG-emitting sources in
accordance with EPA's Tailoring Rule. We are approving this SIP
revision because it is in accordance with the Clean Air Act (CAA) and
EPA regulations regarding PSD permitting for GHGs.
    As explained in our proposed approval of the Albuquerque/Bernalillo
County December 15, 2010, SIP revision, 76 FR 59334 (September 26,
2011), since we are approving Albuquerque/Bernalillo County's changes
to its air quality regulations to incorporate the appropriate
thresholds for GHG permitting applicability into its SIP, then
paragraph (e) in Section 52.1634 of 40 CFR part 52, as included in
EPA's SIP Narrowing Rule--which codifies EPA's limiting its approval of
Albuquerque/Bernalillo County's PSD SIP to not cover the applicability
of PSD to GHG-emitting sources below the Tailoring Rule thresholds--is
no longer necessary. In today's action, we are also amending Section
52.1634 of 40 CFR part 52 to remove this unnecessary regulatory
language.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Clean Air Act
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 Clean Air Act.
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 Order
12866 (58 FR 51735, October 4, 1993);
     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 Clean Air Act; 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, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by February 27, 2012. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purpose of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, and Reporting and recordkeeping
requirements.

    Dated: December 14, 2011.
Al Armendariz,
Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart GG--New Mexico

0
2. The second table in Sec.  52.1620(c) entitled ``EPA Approved
Albuquerque/Bernalillo County, NM Regulations'' is amended by revising
the entry for ``Part 61 (20.11.61), Prevention of Significant
Deterioration,'' to read as follows:

Sec.  52.1620  Identification of plan.

* * * * *
    (c) * * *
* * * * *

                           EPA Approved Albuquerque/Bernalillo County, NM Regulations
----------------------------------------------------------------------------------------------------------------
                                                     State approval/
         State citation             Title/subject    effective date   EPA approval date        Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
   New Mexico Administrative Code (NMAC) Title 20--Environment Protection, Chapter 11--Albuquerque/Bernalillo
                                        County Air Quality Control Board
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Part 61 (20.11.61).............  Prevention of            1/10/2011  12/29/11 [Insert    Only sections
                                  Significant                         FR page number      <IP_ADDRESS>,
                                  Deterioration.                      where document      <IP_ADDRESS>,
                                                                      begins].            <IP_ADDRESS>,
                                                                                <IP_ADDRESS>,
                                                                                <IP_ADDRESS>, and
                                                                                <IP_ADDRESS> of Part 61
                                                                                are approved as of 12/
                                                                                29/11. The remainder
                                                                                of Part 61 remains
                                                                                unchanged from EPA's
                                                                                approval of April 26,
                                                                                2007 (72 FR 20728).
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

Sec.  52.1634  [Amended]

0
3. Section 52.1634 is amended by removing paragraphs (d) and (e).

[FR Doc. 2011-33280 Filed 12-28-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72080-72082]
[FR Doc No: 2023-23110]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4356]

Enforcement Policy for Non-Invasive Remote Monitoring Devices
Used To Support Patient Monitoring; Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Enforcement Policy for
Non-Invasive Remote Monitoring Devices Used to Support Patient
Monitoring.'' The enforcement policy described in this guidance applies
to modified devices where the original device was a legally marketed,
non-invasive remote monitoring device listed in the guidance that
measures or detects common physiological parameters and that is used to
support patient monitoring. The guidance is intended to describe the
enforcement policy for limited modifications to the indications,
functionality, or hardware

or software of device types in the scope of the guidance without prior
submission of a 510(k) where such submission would be required.

DATES: The announcement of the guidance is published in the Federal
Register on October 19, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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 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-2023-D-4356 for ``Enforcement Policy for Non-Invasive Remote
Monitoring Devices Used to Support Patient Monitoring.'' 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 Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to
Support Patient Monitoring'' to the Office of Policy, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Jessica Paulsen, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2108, Silver Spring, MD 20993-0002, 301-
796-6883.

SUPPLEMENTARY INFORMATION:

I. Background

    The enforcement policy described in this guidance applies to
modified devices where the original device was a legally marketed,
noninvasive remote monitoring device listed in the guidance that
measures or detects common physiological parameters and that is used to
support patient monitoring. The guidance is intended to describe the
enforcement policy for limited modifications to the indications,
functionality, or hardware or software of device types in the scope of
the guidance without prior submission of a premarket notification under
section 510(k) of the FD&C Act (21 U.S.C. 360(k)) (see 21 CFR 807.81)
where such submission would be required. This guidance supersedes
``Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to
Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-
19) Public Health Emergency'' issued in March 2020 and updated in June
2020, October 2020, and March 2023.
    In the Federal Register of March 13, 2023 (88 FR 15417), FDA
announced that that guidance was being revised to continue in effect
for 180 days after the expiration of the COVID-19 public health
emergency (PHE) declaration issued under section 319 of the Public
Health Service Act, during which time, FDA intended to further revise
the guidance. Consistent with what we said in the Federal Register of
March 13, 2023, FDA is therefore issuing this revised final guidance.
    Leveraging the perspective gained during the COVID-19 pandemic, FDA
is updating the policy reflected in the ``Enforcement Policy for Non-
Invasive Remote Monitoring Devices Used to Support Patient Monitoring
During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency'' guidance to exercise certain enforcement policies for
certain devices beyond the expiration of the COVID-19 PHE (which
expired on May 11, 2023) and the 180-day period announced in the March
13, 2023 Federal Register notice, including by removing clinical
thermometers and pulse oximeters from the scope of the guidance,
revising the policy with

respect to certain device types subject to special controls, and
removing use of the term ``claims.''
    This guidance is being implemented without prior public comment
because FDA has determined that prior public participation for this
guidance is not feasible or appropriate (see section 701(h)(1)(C) of
the FD&C Act (21 U.S.C. 371(h)(1)(C)) and Sec.  10.115(g)(2) (21 CFR
10.115(g)(2)). FDA has determined that this guidance document presents
a less burdensome policy that is consistent with public health.
Although this policy is being implemented immediately without prior
comment, it remains subject to comment in accordance with FDA's good
guidance practices regulation (Sec.  10.115(g)(3)(i)(D)). FDA will
consider all comments received and revise the guidance document as
appropriate.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec.  10.115). The guidance represents the
current thinking of FDA on ``Enforcement Policy for Non-Invasive Remote
Monitoring Devices Used to Support Patient Monitoring.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Enforcement Policy for Non-Invasive
Remote Monitoring Devices Used to Support Patient Monitoring'' may send
an email request to [email protected] to receive an electronic
copy of the document. Please use the document number GUI00007017 and
complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
the following FDA regulations, guidance, and forms have been approved
by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
            21 CFR Part                     Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     Notification.
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
------------------------------------------------------------------------

    Dated: October 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23110 Filed 10-18-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Page 26714]
[FR Doc No: 2018-12540]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: Notice is hereby given, pursuant to the provisions of
the Government in Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a public meeting on Wednesday, June
13, 2018 at 2:00 p.m. (ET).

PLACE: The public meeting will be held in the Knowles Conference Center
at Georgia State University College of Law, 85 Park Place Northeast,
Atlanta, GA 30303.

STATUS: This meeting will begin at 2:00 p.m. (ET) and will be open to
the public. Doors will open at 1:30 p.m. Visitors will be subject to
security checks. The public meeting will be webcast from 2:00 p.m. to
3:00 p.m. on the Commission's website at www.sec.gov. The public is
encouraged to RSVP for the meeting at https://www.sec.gov/investing-america.

MATTERS TO BE CONSIDERED: This Sunshine Act notice is being issued
because a quorum of the Commission may attend the meeting. The purpose
of the meeting is to provide retail investors with an opportunity to
engage with SEC officials, including the Commissioners.

CONTACT PERSON FOR MORE INFORMATION: For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact Brent J. Fields from the Office of the Secretary at
(202) 551-5400.

    Dated: June 6, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018-12540 Filed 6-6-18; 4:15 pm]
 BILLING CODE 8011-01-P


[Federal Register: May 19, 2008 (Volume 73, Number 97)]
[Rules and Regulations]
[Page 28704-28707]
[DOCID:fr19my08-2]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0219]
RIN 1625-AA00

Firework Events; Great Lake Annual Firework Events

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is establishing safety zones for various
fireworks events in the Captain of the Port Buffalo zone. This rule
consolidates current regulations establishing safety zones for annual
fireworks events in the former Captain of the Port Cleveland Zone and
the former Captain of the Port Buffalo Zone. In addition, it adds
events not previously published in Coast Guard regulations. These
safety zones are necessary to protect spectators, participants, and
vessels from the hazards associated with fireworks displays or other
events.

DATES: This rule is effective June 18, 2008.

ADDRESSES: Comments and material received from the public as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-0219 and are available online at http://
www.regulations.gov. This material is also available for inspection or
copying at two locations: The Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590 between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays and Coast Guard
Sector Buffalo, 1 Fuhrmann Boulevard, Buffalo, NY 14203 between 8 a.m.
and 4 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call CDR Joseph Boudrow, Prevention Department, Coast Guard Sector
Buffalo, Buffalo, NY at<PHONE_NUMBER>. If you have questions on
viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On April 3, 2008, we published a notice of rulemaking (NPRM)
entitled Annual Events Requiring Safety Zones in the Captain of the
Port Buffalo zone in the Federal Register (73 FR 18225). We received no
letters commenting on the rule. No public meeting was requested, and
none was held.

Background and Purpose

    On July 22, 2005, the Coast Guard consolidated the Captain of the
Port Cleveland zone and the Captain of the Port Buffalo zone into one
zone re-defining the Captain of the Port Buffalo zone. This rule will
consolidate the regulations found in 33 CFR 165.202, Safety Zones;
Annual Fireworks Events in the Captain of the Port Cleveland Zone, the
regulations found in 33 CFR 165.914, Safety Zones; Annual Fireworks
Events in the Captain of the Port Buffalo Zone so that all the annual
fireworks events in the current Captain of the Port Buffalo Zone are
found in one CFR section. In addition this rule adds events not
previously published in the CFR.
    These safety zones are necessary to protect vessels and people from
the hazards associated with fireworks displays or other events. Such
hazards include obstructions to the waterway that may cause marine
casualties and the explosive danger of fireworks and debris falling
into the water that may cause death or serious bodily harm.

Discussion of Comments and Changes

    No comments were received regarding this rule.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this rule to be so minimal that a
full Regulatory Evaluation is unnecessary.
    The Coast Guard's use of these safety zones will be periodic, of
short duration, and designed to minimize the impact on navigable
waters. These safety zones will only be enforced immediately before,
during, and after the time the events occur. Furthermore, these safety
zones have been designed to allow vessels to transit unrestricted to
portions of the waterways not affected by the safety zones. The Coast
Guard expects insignificant adverse impact to mariners from the
activation of these safety zones.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
would not have a significant economic impact on a substantial number of
small entities.
    This rule will affect the following entities, some of which might
be small entities: The owners of operators of vessels intending to
transit or anchor in the areas designated as safety zones in
subparagraphs (1) through (26) during the dates and times the safety
zones are being enforced.
    These safety zones will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
rule will be in effect for short periods of time, and only once per
year, per zone. The safety zones have been designed to allow traffic to
pass safely around the zone whenever possible and vessels will be
allowed to pass through the zones with the permission of the Captain of
the Port.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement

Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process. Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such expenditure, we
nevertheless discuss its effects elsewhere in this preamble.

Taking of Private Property

    This rule will not effect the taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or safety that may disproportionately
affect children.

Indian Tribal Governments

    The Coast Guard recognizes the treaty rights of Native American
Tribes. Moreover, the Coast Guard is committed to working with Tribal
Governments to implement local policies and to mitigate tribal
concerns. We have determined that these regulations and fishing rights
protection need not be incompatible. We have also determined that this
rule does not have tribal implications under Executive Order 13175,
Consultation and Coordination with Indian Tribal Governments, because
it does not have a substantial direct effect on one or more Indian
tribes, on the relationship between the Federal Government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes. Nevertheless, Indian Tribes
that have questions concerning the provisions of this rule or options
for compliance are encourage to contact the point of contact listed
under FOR FURTHER INFORMATION CONTACT.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD
which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have concluded that there are no factors in this case that would limit
the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph 34(g) of the Instruction, from further
environmental documentation.
    A final ``Environmental Analysis Check List'' and a final
``Categorical Exclusion Determination'' are available in the docket
where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.939 to read as follows:

Sec.  165.939  Safety Zones; Annual Fireworks Events in the Captain of
the Port Buffalo Zone.

    (a) Safety Zones. The following areas are designated Safety zones
and are listed geographically from New York to Ohio.
    (1) Boldt Castle 4th of July Fireworks, Heart Island, NY.
    (i) Location. All waters of the St. Lawrence River within a 500-
foot radius of the land position: 44[deg]20[min]39[sec] N,
075[deg]55[min]16[sec] W; at Heart Island, NY. (DATUM: NAD 83).

    (ii) Enforcement date. This section is effective from 9 p.m. to 10
p.m. on July 4 of each year.
    (2) Clayton Chamber of Commerce Fireworks, Calumet Island, NY.
    (i) Location. All waters of the St. Lawrence River within a 500-
foot radius of land position: 44[deg]15[min]05[sec] N,
076[deg]05[min]35[sec] W; in Calumet Island Harbor, NY. (DATUM: NAD
83).
    (ii) Enforcement date. This section is effective from 9 p.m. to 10
p.m. on July 1 of each year.
    (3) French Festival Fireworks, Cape Vincent, NY.
    (i) Location. All waters of the St. Lawrence River within a 500-
foot radius of land position: 44[deg]07'53'' N, 076[deg]20'02'' W.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:30 p.m. to
10:30 p.m. on the first or second weekend of July each year.
    (4) Brewerton Fireworks, Brewerton, NY.
    (i) Location. All waters of Lake Oneida within a 500-foot radius of
barge position: 43[deg]14'15'' N, 076[deg]08'03'' W; in Brewerton, NY.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:30 p.m. to
10:30 p.m. on the first weekend of July each year.
    (5) Celebrate Baldwinsville Fireworks, Baldwinsville, NY.
    (i) Location. All waters of the Seneca River within a 500-foot
radius of land position: 43[deg]09'21'' N, 076[deg]20'01'' W. (DATUM:
NAD 83).
    (ii) Enforcement date. This section is effective from 9:30 p.m. to
10 p.m. on the third weekend of September each year.
    (6) Island Festival Fireworks Display, Baldwinsville, NY.
    (i) Location. All waters of the Seneca River within a 500-foot
radius of land position: 43[deg]09'25'' N, 076[deg]20'21'' W; in
Baldwinsville, NY. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 10 p.m. to
10:30 p.m. on the first weekend of July each year.
    (7) Seneca River Days, Baldwinsville, NY.
    (i) Location. All waters of the Seneca River within a 500-foot
radius of land position: 43[deg]09'25'' N, 076[deg]20'21'' W; in
Baldwinsville, NY. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:30 p.m. to
10:30 p.m. on the first weekend of July each year.
    (8) Oswego Harborfest, Oswego, NY.
    (i) Location. All waters of Lake Ontario within a 1,000-foot radius
of barge position 43[deg]28'10'' N, 076[deg]31'04'' W; in Oswego, NY.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9 p.m.to 10
p.m. on the last Saturday in July each year.
    (9) Village Fireworks, Sodus Point, NY.
    (i) Location. All waters of Sodus Bay within a 500-foot radius of
land position: 43[deg]16'27'' N, 076[deg]58'27'' W; in Sodus Point, NY.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 10 p.m. to
10:30 p.m. on the first Saturday in July each year.
    (10) City of Syracuse Fireworks Celebration, Syracuse, NY.
    (i) Location. All waters of Onondaga Lake within a 350-foot radius
of land position 43[deg]03'37'' N, 076[deg]09'59'' W; in Syracuse, NY.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:30 p.m. to
10:30 p.m. on the last weekend in June each year.
    (11) Tom Graves Memorial Fireworks, Port Bay, NY.
    (i) Location. All waters of Port Bay within a 500-foot radius of
barge position: 43[deg]17'46'' N, 076[deg]50'02'' W; in Port Bay, NY.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 10 p.m. to
10:30 p.m. on the first weekend in July each year.
    (12) Rochester Harbor and Carousel Festival, Rochester, NY.
    (i) Location. All waters of Lake Ontario within a 500-foot radius
of land position: 43[deg]15'21'' N, 077[deg]36'19'' W in Rochester, NY.
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 8 p.m. to 10
p.m. on June 24th of each year.
    (13) North Tonawanda Fireworks Display, Tonawanda, NY.
    (i) Location. All waters of the East Niagara River within a 500-
foot radius of a barge located at position: 43[deg]01'12'' N,
078[deg]53'36'' W; in North Tonawanda, NY. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
10:15 p.m. on July 4th of each year.
    (14) Tonawanda's Canal Fest Fireworks, Tonawanda, NY.
    (i) Location. All waters of the East Niagara River within a 500-
foot radius of barge position: 43[deg]01'12'' N, 078[deg]53'36'' W; in
Tonawanda, NY. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:30 p.m. to
10:30 p.m. on the fourth Sunday in July each year.
    (15) Celebrate Erie Fireworks, Erie, PA.
    (i) Location. All waters of Presque Isle Bay within an 800-foot
radius of land position: 42[deg]08'19'' N, 080[deg]05'29'' W; at the
end of Dobbins Landing Pier, Erie, PA. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
10:30 p.m. on the third weekend in August each year.
    (16) Ashtabula Area Fireworks, Walnut Beach, Ashtabula, OH.
    (i) Location. All waters of Lake Erie and Ashtabula Harbor within a
300-yard radius of land position: 41[deg]54.167' N, 080[deg]48.416' W;
in Ashtabula, OH. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the second weekend in July each year.
    (17) Fairport Harbor Mardi Gras, Fairport Harbor, OH.
    (i) Location. All waters of Fairport Harbor and Lake Erie within a
300-yard radius of land position: 41[deg]45.500' N, 081[deg]16.300' W;
east of the harbor entrance at Fairport Harbor Beach, OH. (DATUM: NAD
83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first Saturday of July each year.
    (18) Lake County Perchfest Fireworks, Fairport, OH.
    (i) Location. All waters of Fairport Harbor and Lake Erie within a
300-yard radius of land position: 41[deg]45.500' N, 081[deg]16.300' W;
in Fairport, OH. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the second weekend in September each year.
    (19) Mentor Harbor Yacht Club Fireworks, Mentor Harbor, OH.
    (i) Location. All waters of Lake Erie and Mentor Harbor within a
200-yard radius of 41[deg]43.200' N, 081[deg]21.400' W (west of the
harbor entrance); in Mentor Harbor, OH. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first weekend in July each year.
    (20) Browns Football Halftime Fireworks, Cleveland, OH.
    (i) Location. All navigable waters of Cleveland Harbor and Lake
Erie beginning in approximate land position: 41[deg]30.823' N,
081[deg]41.620' W (the northwest corner of Burke Lakefront Airport);
continuing northwest to 41[deg]31.176' N, 081[deg]41.884' W; then
southwest to 41[deg]30.810' N, 081[deg]42.515' W; then southeast to
41[deg]30.450' N, 081[deg]42.222' W (the northwest corner of dock 28 at
the Cleveland Port Authority) then northeast back to the starting point
at 41[deg]30.823' N, 081[deg]41.620' W. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective on a Sunday during
the second or third Cleveland Brown's home game each year.
    (21) City of Cleveland 4th of July Fireworks, Cleveland, OH.
    (i) Location. All navigable waters of Cleveland Harbor and Lake
Erie within a 400-yard radius of Main Entrance Light 5 (LLNR 4180) at
position: 41[deg]30.23' N, 081[deg]42.7' W; in Cleveland, OH (DATUM:
NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first weekend in July each year.
    (22) Dollar Bank Jamboree Fireworks Display, Cleveland, OH.

    (i) Location. All navigable waters of Cleveland Harbor and Lake
Erie beginning at land position: 41[deg]30.823' N, 081[deg]41.620' W
(the northwest corner of Burke Lakefront Airport); continuing northwest
to 41[deg]31.176' N, 081[deg]41.884' W; then southwest to
41[deg]30.810' N, 081[deg]42.515' W; then southeast to 41[deg]30.450'
N, 081[deg]42.222' W (the northwest corner of dock 28 at the Cleveland
Port Authority) then northeast back to the starting point at
41[deg]30.823' N, 081[deg]41.620' W. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first weekend in July each year.
    (23) Lakewood City Fireworks Display, Lakewood, OH.
    (i) Location. All waters of Lake Erie within a 200-yard radius of
land position: 41[deg]29.755' N, 081[deg]47.780' W (off of Lakewood
Park); in Lakewood, OH. (DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first weekend in July each year.
    (24) Cleveland Yachting Club Fireworks Display, Rocky River, OH.
    (i) Location. All waters of the Rocky River and Lake Erie within a
200-yard radius of land position 41[deg]29.428' N, 081[deg]50.309' W
(DATUM: NAD 83) at Sunset Point on the western side of the mouth of the
Rocky River in Cleveland, OH.
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the third weekend in July each year.
    (25) Lorain 4th of July Celebration Fireworks Display, Lorain, OH.
    (i) Location. All waters of Lorain Harbor within a 300-yard radius
of land position 41[deg]28.591' N, 082[deg]10.855' W (DATUM: NAD 83),
east of the harbor entrance on the end of the break wall near Spitzer's
Marina.
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the first weekend in July each year.
    (26) Lorain Port Fest Fireworks Display, Lorain, OH.
    (i) Location. All waters of Lorain Harbor within a 250-yard radius
of land position: 41[deg]28.040' N, 082[deg]10.365' W; in Lorain, OH
(DATUM: NAD 83).
    (ii) Enforcement date. This section is effective from 9:45 p.m. to
11 p.m. on the third weekend in July each year.
    (b) Definitions. The following definitions apply to this section:
    (1) Designated Representative means any Coast Guard commissioned,
warrant, or petty officer designated by the Captain of the Port Buffalo
to monitor a safety zone, permit entry into the zone, give legally
enforceable orders to persons or vessels within the zones, and take
other actions authorized by the Captain of the Port.
    (2) Public vessel means vessels owned, chartered, or operated by
the United States, or by a State or political subdivision thereof.
    (c) Regulations. (1) In accordance with the general regulations in
section 165.23 of this part, entry into, transiting, or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port Buffalo, or his designated representative.
    (2)(i) These safety zones are closed to all vessel traffic, except
as may be permitted by the Captain of the Port Buffalo or his
designated representative.
    (ii) All persons and vessels must comply with the instructions of
the Coast Guard Captain of the Port or his designated representative.
    (iii) Upon being hailed by the U.S. Coast Guard by siren, radio,
flashing light or other means, the operator of a vessel shall proceed
as directed.
    (3)(i)All vessels must obtain permission from the Captain of the
Port or his designated representative to enter, move within, or exit
the safety zone established in this section when this safety zone is
enforced.
    (ii) Vessels and persons granted permission to enter the safety
zone must obey all lawful orders or directions of the Captain of the
Port or a designated representative.
    (iii) While within a safety zone, all vessels must operate at the
minimum speed necessary to maintain a safe course.
    (d) Exemption. Public vessels, as defined in paragraph (b) of this
section, are exempt from the requirements in this section.
    (e) Waiver. For any vessel, the Captain of the Port Buffalo or his
designated representative may waive any of the requirements of this
section, upon finding that operational conditions or other
circumstances are such that application of this section is unnecessary
or impractical for the purposes of public or environmental safety.
    (f) Notification. The Captain of the Port Buffalo will notify the
public that that the zones in this proposal are or will be enforced by
all appropriate means to the affected segments of the public including
publication in the Federal Register as practicable, in accordance with
33 CFR 165.7(a). Such means of notification may also include, but are
not limited to Broadcast Notice to Mariners or Local Notice to
Mariners. The Captain of the Port will issue a Broadcast Notice to
Mariners notifying the public when enforcement of the safety zone
established by this section is cancelled.

Sec.  165.202  [Removed]

0
3. Remove and reserve Sec.  165.202.

Sec.  165.914  [Removed]

0
4. Remove and reserve Sec.  165.914.

    Dated: May 9, 2008.
S.J. Ferguson,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
 [FR Doc. E8-11139 Filed 5-16-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: December 3, 2008 (Volume 73, Number 233)]
[Notices]
[Page 73689]
[DOCID:fr03de08-48]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Release Certain Properties From all Terms,
Conditions, Reservations and Restrictions of a Quitclaim Deed Agreement
Between the City of Palatka and the Federal Aviation Administration for
the Kay Larkin Field, Palatka Municipal Airport, Palatka, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for Public Comment.

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SUMMARY: The FAA hereby provides notice of intent to release certain
airport properties (14.26 acres) at the Kay Larkin Field, Palatka
Municipal Airport, Palatka, FL from the conditions, reservations, and
restrictions as contained in an Agreement between the FAA and the City
of Palatka, dated February 28, 1947. The release of property will allow
the City of Palatka to dispose of the property for other than
aeronautical purposes. The property is located in the Section 3,
Township 10 South, Range 26 East, of Putnam County. The parcel is
currently designated as non-aeronautical use. The property will be
disposed of for the purpose of allowing for the construction of a
floating dock manufacturing facility. The fair market value of the
property has been determined by appraisal to be $25,000 per acre
($356,500). The airport will receive fair market value for the
property, which will be subsequently reinvested in another eligible
airport improvement project.
    Documents reflecting the Sponsor's request are available, by
appointment only, for inspection at the City of Palatka and the FAA
Airports District Office.

DATES: January 2, 2009.

SUPPLEMENTARY INFORMATION: Section 125 of The Wendell H. Ford Aviation
Investment and Reform Act for the 21st Century (AIR-21) requires the
FAA to provide an opportunity for public notice and comment prior to
the ``waiver'' or ``modification'' of a sponsor's Federal obligation to
use certain airport land for non-aeronautical purposes.

ADDRESSES: Documents are available for review at the City of Palatka,
201 North 2nd Street, Palataka, FL 32117, and the FAA Airports District
Office, 5950 Hazeltine National Drive, Suite 400, Orlando, FL 32822.
Written comments on the Sponsor's request must be delivered or mailed
to: Richard Owen, Program Manager, Orlando Airports District Office,
5950 Hazeltine National Drive, Suite 400, Orlando, FL 32822-5024.

FOR FURTHER INFORMATION CONTACT: Richard Owen, Program Manager, Orlando
Airports District Office, 5950 Hazeltine National Drive, Suite 400,
Orlando, FL 32822-5024.

W. Dean Stringer,
Manager, Orlando Airports District Office, Southern Region.
[FR Doc. E8-28504 Filed 12-2-08; 8:45 am]

BILLING CODE 4910-13-M