[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Notices]
[Pages 11046-11049]
[FR Doc No: 2021-03700]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0003]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of applications for exemption; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 11 individuals
for an exemption from the vision requirement in the Federal Motor
Carrier Safety Regulations (FMCSRs) to operate a commercial motor
vehicle (CMV) in interstate commerce. If granted, the exemptions will
enable these individuals to operate CMVs in interstate commerce without
meeting the vision requirement in one eye.

DATES: Comments must be received on or before March 25, 2021.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2021-0003 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/docket?D= FMCSA-2021-0003. Follow the online
instructions for submitting comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., ET,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2021-0003), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov/docket?D=FMCSA-2021-0003. Click on the ``Comment Now!'' button and type
your comment into the text box on the following screen. Choose whether
you are submitting your comment as an individual or on behalf of a
third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2021-0003 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting Dockets Operations in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-
0001, between 9 a.m. and 5 p.m., ET, Monday through Friday, except
Federal holidays. To be sure someone is there to help you, please call
(202) 366-9317 or<PHONE_NUMBER> before visiting Dockets Operations.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The 11 individuals listed in this notice have requested an
exemption from the vision requirement in 49 CFR 391.41(b)(10).
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.
    The physical qualification standard for drivers regarding vision
found in Sec.  391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of at least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal Meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing standard
red, green, and amber.
    On July 16, 1992, the Agency first published the criteria for the
Vision Waiver Program, which listed the conditions and reporting
standards that CMV drivers approved for participation would need to
meet (57 FR 31458). The current Vision Exemption Program was
established in 1998, following the enactment of amendments to the
statutes governing exemptions made by Sec.  4007 of the Transportation
Equity Act for the 21st Century, Public Law 105-178, 112 Stat. 107, 401
(June 9, 1998). Vision exemptions are considered under the procedures
established in 49 CFR part 381 subpart C, on a case-by-case basis upon
application by CMV drivers who do not meet the vision standards of
Sec.  391.41(b)(10).
    To qualify for an exemption from the vision requirement, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely in intrastate commerce with the vision
deficiency for the past 3 years. Recent driving performance is
especially important in evaluating future safety, according to several
research studies designed to correlate past and future driving
performance. Results of these studies support the principle that the
best predictor of future performance by a driver is his/her past record
of crashes and traffic violations. Copies of the studies may be found
at https://www.regulations.gov/docket?D=FMCSA-1998-3637.
    FMCSA believes it can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrated the driving
performance of experienced monocular drivers in the program is better
than that of all CMV drivers collectively.\1\ The fact that experienced
monocular drivers demonstrated safe driving records in the waiver
program supports a conclusion that other monocular drivers, meeting the
same qualifying conditions as those required by the waiver program, are
also likely to have adapted to their vision deficiency and will
continue to operate safely.
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    \1\ A thorough discussion of this issue may be found in a FHWA
final rule published in the Federal Register on March 26, 1996 and
available on the internet at https://www.govinfo.gov/content/pkg/FR-1996-03-26/pdf/96-7226.pdf.
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    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971). A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and nonconcurrent events is
the number of single convictions. This study used 3 consecutive years
of data, comparing the experiences of drivers in the first 2 years with
their experiences in the final year.

III. Qualifications of Applicants

Antonio R. Barros

    Mr. Barros, 53, has had amblyopia in his left eye since childhood.
The visual acuity in his right eye is 20/20 and in his left eye, 20/
200. Following an examination in 2020, his ophthalmologist stated, ``In
my medical opinion, Mr. Barros has sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Barros
reported that he has driven straight trucks for 12 years, accumulating
120,000 miles, and tractor-trailer combinations for 12 years,
accumulating 96,000 miles. He holds a Class A CDL from NY. His driving
record for the last three years shows no crashes and no convictions for
moving violations in a CMV.

Robert D. Boudreau

    Mr. Boudreau, 54, has had amblyopia in his left eye since
childhood. The visual acuity in his right eye is 20/20 and in his left
eye, 20/350. Following an examination in 2020, his ophthalmologist
stated, ``In my medical opinion, Mr. Boudreau has sufficient vision to
perform the driving tasks to operate a commercial vehicle.'' Mr.
Boudreau reported that he has driven tractor-trailer combinations for
22 years, accumulating 2.2 million miles. He holds an operator's
license from Arizona. His driving record for the last three years shows
no crashes and no convictions for moving violations in a CMV.

Doris J. Goldsmith

    Ms. Goldsmith, 48, has complete loss of vision in her left eye due
to a traumatic incident in childhood. The visual acuity in her right
eye is 20/20, and in her left eye, hand motion only. Following an
examination in 2020, her optometrist stated, ``Her left eye is entirely
stable. In my opinion Doris is completely capable of operating a
commercial vehicle with no restriction.'' Ms. Goldsmith reported that
she has driven straight trucks for 2 years, accumulating 31,200 miles,
and tractor-trailer combinations for 20 years, accumulating 2.2 million
miles. She holds a Class DA CDL from Kentucky. Her driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Todd C. Kraese

    Mr. Kraese, 51, has had a retinal detachment in his left eye since
birth. The visual acuity in his right eye is 20/20, and in his left
eye, light perception. Following an examination in 2020, his
optometrist stated, ``In my opinion, the patient has sufficient vision
to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Kraese reported that he has driven tractor-trailer
combinations for 6 years, accumulating 36,000 miles. He holds an
operator's license from Indiana. His driving record for the last three
years shows no crashes and no convictions for moving violations in a
CMV.

Kathy A. Mason

    Ms. Mason, 55, has a prosthetic right eye due to melanoma in 2012.
The visual acuity in her right eye is no light perception, and in her
left eye, 20/20. Following an examination in 2020, her optometrist
stated, ``Her prosthetic in the left eye will not hinder her driving in
any way. She is capable of operating a commercial vehicle or any
vehicle thererof.'' Ms. Mason reported that she has driven straight
trucks for 20 years, accumulating 200,000 miles, tractor-trailer
combinations for 17 years, accumulating 85,000 miles, and buses for 13
years, accumulating 1.56 million miles. She holds a Class A CDL from
Texas. Her driving record for the last three years shows no crashes and
no convictions for moving violations in a CMV.

Luke A. Perry

    Mr. Perry, 58, has a corneal scar in his left eye due to a
traumatic incident in childhood. The visual acuity in his right eye is
20/20, and in his left eye, 20/300. Following an examination in 2020,
his ophthalmologist stated, ``It is my opinion that Mr. Perry has
sufficient vision to operate a commercial vehicle.'' Mr. Perry reported
that he has driven straight trucks for 6 years, accumulating 60,000
miles, and tractor-trailer combinations for 3 years, accumulating
330,000 miles. He holds a Class A CDL from Vermont. His driving record
for the last three years shows no crashes and no convictions for moving
violations in a CMV.

Percy C. Robinson

    Mr. Robinson, 48, has a retinal detachment in his left eye due to
spontaneous degeneration in 2008. The visual acuity in his right eye is
20/20, and in his left eye, light perception. Following an examination
in 2020, his optometrist stated, ``In my opinion, Mr. Robinson has
vision sufficient to perform the driving tasks to operate a commercial
vehicle.'' Mr. Robinson reported that he has driven straight trucks for
25 years, accumulating 120,000 miles, and tractor-trailer combinations
for 25 years, accumulating 25,000 miles. He holds a Class AM CDL from
Alabama. His driving record for the last three years shows no crashes
and no convictions for moving violations in a CMV.

Harvinder S. Sahota

    Mr. Sahota, 38, has had amblyopia in his right eye since childhood.
The visual acuity in his right eye is 20/400, and in his left eye, 20/
20. Following an examination in 2020, his ophthalmologist stated, ``In
my medical opinion Harvinder has sufficient vision, color vision and
visual fields to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Sahota reported that he has driven tractor-
trailer combinations for 3 years, accumulating 360,000 miles. He holds
a Class A CDL from California. His driving record for the last three
years shows no crashes and no convictions for moving violations in a
CMV.

Michael J. Wells

    Mr. Wells, 64, has had amblyopia in his right eye since childhood.
The visual acuity in his right eye is hand motion only, and in his left
eye, 20/25. Following an examination in 2020 his optometrist stated,
``Mr. Wells has been able to safely operate a commercial vehicle for
years and should be able to continue doing so, without his vision
impacting that ability.'' Mr. Wells reported that he has driven
straight trucks for 25 years, accumulating 1.25 million miles, and
tractor-trailer combinations for 25 years, accumulating 5 million
miles. He holds a Class A CDL from North Carolina. His driving record
for the last three years shows no crashes and no convictions for moving
violations in a CMV.

Dennis C. Welpe

    Mr. Welpe, 55, has a retinal detachment in his in his left eye due
to a traumatic incident in 1983. The visual acuity in his right eye is
20/20, and in his left eye, 20/400. Following an examination in 2020,
his ophthalmologist stated, ``It is in my opinion Mr. Welpe has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Welpe reported that he has driven buses for
37 years, accumulating 74,000 miles. He holds a Class B CDL from Texas.
His driving record for the last three years shows no crashes and no
convictions for moving violations in a CMV.

Kevin D. White

    Mr. White, 48, has a complete loss of vision in his left eye due to
a traumatic incident in childhood. The visual acuity in his right eye
is 20/20, and in his left eye, complete loss of vision. Following an
examination in 2021, his

ophthalmologist stated, ``In my medical opinion, I believe Mr. White
has sufficient vision to perform the driving tasks required to operate
a commercial vehicle.'' Mr. White reported that he has driven straight
trucks for 4 years, accumulating 160,000 miles, and tractor-trailer
combinations for 15 years, accumulating 780,000 miles. He holds a Class
A CDL from Texas. His driving record for the last three years shows no
crashes and no convictions for moving violations in a CMV.

IV. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315(b), FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments and material
received before the close of business on the closing date indicated
under the DATES section of the notice.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2021-03700 Filed 2-22-21; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Rules and Regulations]
[Pages 48689-48690]
[FR Doc No: 2015-20118]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0765]

Drawbridge Operation Regulation; Townsend Gut, Boothbay and
Southport, Maine

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Southport (SR 27) Bridge, across
Townsend Gut, mile 0.7, at Boothbay and Southport, Maine. This
deviation is necessary to facilitate replacement of the bridge wedge
motor. This deviation allows the bridge to remain in the closed
position for 24 hours.

DATES: This deviation is effective from 7 a.m. on October 5, 2015
through 7 a.m. on October 6, 2015.

ADDRESSES: The docket for this deviation, [USCG-2015-0765] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit 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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, contact Mr. Joe M. Arca, Project Officer, First
Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket, call
Ms. Cheryl Collins, Program Manager, Docket Operations, telephone (202)
366-9826.

SUPPLEMENTARY INFORMATION: The Southport (SR 27) Bridge, mile 0.7,
across the Townsend Gut has a vertical clearance in the closed position
of 10

feet at mean high water and 19 feet at mean low water. The existing
bridge operating regulations are found at 33 CFR 117.537.
    Maine Department of Transportation requested this temporary
deviation from the normal operating schedule to facilitate essential
bridge repairs.
    Under this temporary deviation, the Southport Bridge (SR 27) may
remain in the closed position from 7 a.m. on October 5, 2015 through 7
a.m. on October 6, 2015.
    The bridge will be able to open in the event of an emergency. There
is no alternate route for vessel traffic; however, vessels that can
pass under the closed draws during this closure may do so at any time.
    The Coast Guard will inform the users of the waterway through our
Local Notice to Mariners of the change in operating schedule for the
bridge so that vessels can arrange their transits to minimize any
impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: August 5, 2015.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2015-20118 Filed 8-13-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Rules and Regulations]
[Pages 66098-66100]
[FR Doc No: 2018-27568]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31227; Amdt. No. 3830]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective December 26, 2018. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of December 26, 2018.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA).
    For information on the availability of this material at NARA, call
202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg. 29 Room 104, Oklahoma
City, OK 73125. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained on FAA form documents is
unnecessary.
    This amendment provides the affected CFR sections, and specifies
the SIAPs and Takeoff Minimums and ODPs with their applicable effective
dates. This amendment also identifies the airport and its location, the
procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff
Minimums and ODPs as identified in the amendatory language for part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Procedures (TERPS). In developing these changes to SIAPs and Takeoff
Minimums and ODPs, the TERPS criteria were applied only to specific
conditions existing at the affected airports. All SIAP amendments in
this rule have been previously issued by the FAA in a FDC NOTAM as an
emergency action of immediate flight safety relating directly to
published aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference,
Navigation (air).

    Issued in Washington, DC, on November 30, 2018.
Rick Domingo,
Executive Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, (14 CFR part 97), is amended by
amending Standard Instrument Approach Procedures and Takeoff Minimums
and ODPs, effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
        AIRAC date            State             City               Airport          FDC No.      FDC date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
3-Jan-19.................  MO           Fulton.............  Elton Hensley             8/2539      11/7/18  This NOTAM, published in TL 19-01, is hereby
                                                              Memorial.                                      rescinded in its entirety.
3-Jan-19.................  MN           Hallock............  Hallock Muni.......       8/8364      11/7/18  This NOTAM, published in TL 19-01, is hereby
                                                                                rescinded in its entirety.
3-Jan-19.................  MO           Kirksville.........  Kirksville Rgnl....       8/0394     11/20/18  VOR-A, Amdt 15.
3-Jan-19.................  MO           Kirksville.........  Kirksville Rgnl....       8/0441     11/15/18  ILS OR LOC/DME RWY 36, Amdt 1.
3-Jan-19.................  MO           Kirksville.........  Kirksville Rgnl....       8/0479     11/15/18  RNAV (GPS) RWY 36, Amdt 2.
3-Jan-19.................  MO           Kirksville.........  Kirksville Rgnl....       8/0482     11/20/18  RNAV (GPS) RWY 18, Amdt 2.
3-Jan-19.................  KS           Chanute............  Chanute Martin            8/0534     11/15/18  VOR-A, Amdt 10.
                                                              Johnson.
3-Jan-19.................  NC           Rockingham.........  Richmond County....       8/1535     11/26/18  RNAV (GPS) RWY 32, Orig-B.
3-Jan-19.................  MO           Fulton.............  Elton Hensley             8/1555     11/27/18  RNAV (GPS) RWY 24, Amdt 1A.
                                                              Memorial.
3-Jan-19.................  AK           Noatak.............  Noatak.............       8/2273     11/15/18  RNAV (GPS) RWY 1, Orig.
3-Jan-19.................  AK           Noatak.............  Noatak.............       8/2274     11/15/18  RNAV (GPS) RWY 19, Orig.
3-Jan-19.................  CO           Grand Junction.....  Grand Junction            8/3575     11/16/18  RNAV (GPS) Y RWY 11, Amdt 1C.
                                                              Regional.
3-Jan-19.................  CO           Grand Junction.....  Grand Junction            8/3577     11/16/18  RNAV (GPS) RWY 29, Amdt 1B.
                                                              Regional.
3-Jan-19.................  CO           Grand Junction.....  Grand Junction            8/3579     11/16/18  LDA/DME RWY 29, Orig-C.
                                                              Regional.
3-Jan-19.................  CO           Grand Junction.....  Grand Junction            8/3581     11/16/18  ILS OR LOC RWY 11, Amdt 16C.
                                                              Regional.
3-Jan-19.................  GA           Vidalia............  Vidalia Rgnl.......       8/3626     11/15/18  ILS OR LOC RWY 25, Amdt 2.
3-Jan-19.................  CA           Colusa.............  Colusa County......       8/5707     11/15/18  RNAV (GPS) RWY 31, Amdt 1.
3-Jan-19.................  CA           Colusa.............  Colusa County......       8/5714     11/15/18  RNAV (GPS)-B, Orig.
3-Jan-19.................  CA           Colusa.............  Colusa County......       8/5722     11/15/18  VOR-A, Amdt 5.
3-Jan-19.................  KY           Greenville.........  Muhlenberg County..       8/7653     11/20/18  RNAV (GPS) RWY 6, Orig-A.
3-Jan-19.................  KY           Greenville.........  Muhlenberg County..       8/7654     11/20/18  RNAV (GPS) RWY 24, Amdt 1C.
3-Jan-19.................  KY           Greenville.........  Muhlenberg County..       8/7656     11/20/18  VOR/DME-A, Amdt 5B.
3-Jan-19.................  AR           Osceola............  Osceola Muni.......       8/7726     11/15/18  RNAV (GPS) RWY 19, Orig.
3-Jan-19.................  IN           Elkhart............  Elkhart Muni.......       8/7752     11/15/18  RNAV (GPS) RWY 27, Orig-A.
3-Jan-19.................  IN           Elkhart............  Elkhart Muni.......       8/7753     11/15/18  RNAV (GPS) RWY 18, Orig-A.
3-Jan-19.................  IN           Elkhart............  Elkhart Muni.......       8/7754     11/15/18  RNAV (GPS) RWY 9, Orig.
3-Jan-19.................  IN           Elkhart............  Elkhart Muni.......       8/7757     11/15/18  RNAV (GPS) RWY 36, Orig-A.
3-Jan-19.................  IN           Elkhart............  Elkhart Muni.......       8/7775     11/15/18  ILS OR LOC RWY 27, Amdt 2B.
3-Jan-19.................  MN           Grand Rapids.......  Grand Rapids/Itasca       8/8447     11/20/18  RNAV (GPS) RWY 16, Orig.
                                                              Co-Gordon Newstrom
                                                              Fld.
3-Jan-19.................  MN           Grand Rapids.......  Grand Rapids/Itasca       8/8449     11/20/18  VOR RWY 34, Amdt 11.
                                                              Co-Gordon Newstrom
                                                              Fld.
3-Jan-19.................  NJ           Pedricktown........  Spitfire Aerodrome.       8/8450     11/20/18  RNAV (GPS) RWY 25, Amdt 1.
3-Jan-19.................  CA           San Francisco......  San Francisco Intl.       8/8877     11/21/18  ILS OR LOC RWY 28R, ILS RWY 28R (SA CAT I),
                                                                                ILS RWY 28R (CAT II and III), Amdt 15.
3-Jan-19.................  CA           San Francisco......  San Francisco Intl.       8/8880     11/21/18  ILS OR LOC RWY 28L, ILS RWY 28L (SA CAT II),
                                                                                Amdt 27.
3-Jan-19.................  CO           Denver.............  Denver Intl........       8/9094     11/21/18  RNAV (GPS) Y RWY 16R, Amdt 1C.
3-Jan-19.................  CO           Denver.............  Denver Intl........       8/9096     11/21/18  RNAV (GPS) Y RWY 7, Amdt 1B.
3-Jan-19.................  CO           Denver.............  Denver Intl........       8/9100     11/21/18  RNAV (GPS) Y RWY 26, Amdt 1B.
3-Jan-19.................  IN           Elkhart............  Elkhart Muni.......       8/9467     11/23/18  VOR RWY 9, Amdt 6.
3-Jan-19.................  MN           Hallock............  Hallock Muni.......       8/9927     11/26/18  VOR/DME RWY 31, Amdt 7.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2018-27568 Filed 12-21-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3160-3161]
[FR Doc No: 2019-01878]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0331; FRL-9988-76-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for New Residential Wood Heaters
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NSPS for New Residential Wood
Heaters (EPA ICR No. 1176.13, OMB Control No. 2060-0161), to the Office
of Management and Budget (OMB) for review and approval in accordance
with the Paperwork Reduction Act. This is a proposed extension of the
ICR, which is currently approved through March 31, 2019. Public
comments were previously requested, via the Federal Register, on June
29, 2017 during a 60-day comment period. This notice allows for an
additional 30 days for public comments. A fuller description of the ICR
is given below, including its estimated burden and cost to the public.
An agency may neither conduct nor sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.

DATES: Additional comments may be submitted on or before March 13,
2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2013-0331, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change, including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov, or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The New Source Performance Standards (NSPS) for New
Residential Wood Heaters (40 CFR 60, Subpart AAA) apply to existing
facilities and new facilities that contain wood heaters. A wood heater
is defined as an enclosed, wood burning appliance capable of and
intended for residential or space heating and domestic water heating.
Unless otherwise specified, these devices include, but are not limited
to, adjustable burn rate wood heaters, single burn rate wood heaters
and pellet stoves. New facilities include those that commenced
construction, modification or reconstruction after the date of
proposal.
    One feature of the NSPS requires emphasis at the outset, which is
that the requirements of subpart AAA establish a certification program
instead of the usual NSPS requirements, where each affected facility is
required to demonstrate compliance through performance testing. Under
the subpart AAA-required certification program, a single wood heater is
tested to demonstrate compliance with particulate matter (PM) emission
limits for an entire model line, which could consist of thousands of
stoves. The use of a certification approach significantly reduces the
compliance burden, including information collection, for the
manufacturers of wood heating appliances. In order to minimize risks to
the environment from intentional or accidental misuse of the
certification approach, subpart AAA includes several safeguards, some
of which entail reporting and recordkeeping.
    Form Numbers: None.
    Respondents/affected entities: Owners and operators of facilities
that contain new residential wood heaters.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart AAA).
    Estimated number of respondents: 45 (total).
    Frequency of response: Initially, occasionally, and annually.
    Total estimated burden: 4,320 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $1,210,000 (per year), which includes
$740,000 in annualized capital/startup and/or operation & maintenance
costs.
    Changes in the estimates: There is an increase in the total
estimated respondent annual burden as currently identified in the OMB
Inventory of Approved Burdens due to an increase in the number of test
laboratories and third-party certifiers subject to these standards. The
number of sources has been adjusted in this ICR to reflect more current
information obtained regarding the number of manufacturers certifying
model lines in advance of Subpart AAA's Step 2 p.m. standards, which go
into effect in 2020, as well as data that indicates a decline in the
number of manufacturers based on ongoing industry consolidation and
decreasing market size, and to reflect additional entities obtaining
EPA approval as test laboratories or third-party certifiers.
    There is a decrease in capital/startup costs as compared to the
previous ICR. This change is due to a decrease in the number of
manufacturers, and because initial compliance requirements for test
laboratories and third-party certifiers within the standard occurred
during the

period of the previous ICR. The overall result is a decrease in costs
to the industry.
    The supporting statement for this information collection was
revised to clarify and consolidate the information items requested
(including notification, reporting, and recordkeeping requirements) and
respondent activities in section 4(b), as well as for agency activities
in section 5(a). These requirements were previously listed in Appendix
A of the prior ICR and have been relocated in sections 4(b) and 5(a) to
help more easily identify the relevant data items and activities that
contribute to burden. There are no changes to these requirements from
the prior ICR.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-01878 Filed 2-8-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: October 25, 2011 (Volume 76, Number 206)]
[Notices]
[Page 66061-66063]
[DOCID:fr25oc11-65]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2011-0699; FRL-8889-4]

Agency Information Collection Activities; Proposed Collection;
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR,
entitled: ``Recordkeeping and Reporting Requirements for Allegations of
Significant Adverse Reactions to Human Health or the Environment (TSCA
Section 8(c))'' and identified by EPA ICR No. 1031.10 and OMB Control
No. 2070-0017, is scheduled to expire on August 31, 2012. Before
submitting the ICR to OMB for review and approval, EPA is soliciting
comments on specific aspects of the proposed information collection.

DATES: Comments must be received on or before December 27, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0699 by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention:
Docket ID Number EPA-HQ-OPPT-2011-0699. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is<PHONE_NUMBER>. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0699. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure 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
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington,

DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number of the EPA/DC Public Reading Room is<PHONE_NUMBER>,
and the telephone number for the OPPT Docket is<PHONE_NUMBER>. Docket
visitors are required to show photographic identification, pass through
a metal detector, and sign the EPA visitor log. All visitor bags are
processed through an X-ray machine and subject to search. Visitors will
be provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Mike Mattheisen, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-3077; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits
comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What information collection activity or ICR does this action apply
to?

    Affected entities: Entities potentially affected by this ICR are
manufacturers, processors or importers of chemical substances.
    Title: ``Recordkeeping and Reporting Requirements for Allegations
of Significant Adverse Reactions to Human Health or the Environment
(TSCA Section 8(c))''.
    ICR numbers: EPA ICR No. 1031.10, OMB Control No. 2070-0017.
    ICR status: This ICR is currently scheduled to expire on August 31,
2012. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: TSCA section 8(c) requires manufacturers, processors, and
distributors of chemicals to maintain records of significant adverse
reactions to health or the environment alleged to have been caused by
such chemicals. Since section 8(c) includes no automatic reporting
provisions, EPA can obtain and use the information contained in company
files only by inspecting those files or requiring reporting of records
that relate to specific substances of concern. Therefore, under certain
conditions, and using the provisions found in 40 CFR part 717, EPA may
require companies to report such allegations to the Agency. EPA uses
such information on a case-specific basis to corroborate suspected
adverse health or environmental effects of chemicals already under
review by EPA. The information is also useful to identify trends of
adverse effects across the industry that may not be apparent to any one
chemical company. This information collection addresses the reporting
and recordkeeping provisions described above. Responses to the
collection of information are mandatory (see 40 CFR part 717).
Respondents may claim all or part of a notice confidential. EPA will
disclose information that is covered by a claim of confidentiality only
to the extent permitted by, and in accordance with, the procedures in
TSCA section 14 and 40 CFR part 2.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to range between
approximately 1 minute and 8 hours per response. Burden means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements which have subsequently
changed; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized here:
    Estimated total number of potential respondents: 13,951.
    Frequency of response: Annual.
    Estimated total average number of responses for each respondent:
1.1.
    Estimated total annual burden hours: 23,650 hours.
    Estimated total annual costs: $1,562,535. This includes an
estimated burden cost of $ 0 and an estimated cost

of $ 0 for capital investment or maintenance and operational costs.

IV. Are there changes in the estimates from the last approval?

    There is an increase of 114 hours in the total estimated respondent
burden compared with that identified in the ICR currently approved by
OMB. This increase reflects EPA's estimate of a greater number of
potential respondents affected by the reporting requirement. This
change is an adjustment.

V. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: October 5, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2011-27612 Filed 10-24-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Proposed Rules]
[Pages 81889-81890]
[FR Doc No: 2011-33275]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1410; Directorate Identifier 2011-NM-033-AD]
RIN 2120-AA64

Airworthiness Directives; Saab AB, Saab Aerosystems Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Saab AB, Saab Aerosystems Model SAAB 2000 airplanes. This proposed AD
was prompted by reports of hydraulic accumulator failure. This proposed
AD would require replacing certain hydraulic accumulators with
stainless steel hydraulic accumulators, and structural modifications in
the nose landing gear bay. We are proposing this AD to prevent failure
of hydraulic accumulators, which may result in damage to the airplane
and injury to occupants.

DATES: We must receive comments on this proposed AD by February 13,
2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed 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.
You may review copies of the referenced 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>.

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 this proposed AD, 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.

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:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2011-1410;
Directorate Identifier 2011-NM-033-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2011-0004, dated January 17, 2011 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Three cases of failure have been reported, affecting the same
type of hydraulic accumulator as installed on SAAB 2000 aeroplanes,
although all occurred on other aeroplane types. The reported cause
of these failures has been traced to corrosion. Any of the end parts
on the accumulator may depart from the pressure vessel if they are
affected by corrosion.
    This condition, if not detected and corrected, may lead to
fatigue failure of a hydraulic accumulator, possibly resulting in
damage to the aeroplane and injury to occupants. In addition, a
quality issue during the replacement of the base material in the end
parts of the accumulator may have affected the service life of the
accumulator.
    To address this unsafe condition, SAAB has introduced a new type
of hydraulic accumulator, which is made of stainless steel.
    For the reasons described above, this [EASA] AD requires the
replacement of all Part Number (P/N) 08 8423 030 1 hydraulic
accumulators with stainless steel P/N 40800-2050 hydraulic
accumulators and associated structural modifications in the nose
landing gear bay.

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

Relevant Service Information

    Saab has issued Service Bulletin 2000-29-024, Revision 01, dated
November 5, 2010. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 8 products of U.S. registry. We also estimate that
it would take about 12 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $9,995 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
the proposed AD on U.S. operators to be $88,120, or $11,015 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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 proposed
regulation:
    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 proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Saab AB, Saab Aerosystems: Docket No. FAA-2011-1410; Directorate
Identifier 2011-NM-033-AD.

Comments Due Date

    (a) We must receive comments by February 13, 2012.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Saab AB, Saab Aerosystems Model SAAB 2000
airplanes, all serial numbers; certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 29:
Hydraulic Power.

Reason

    (e) This AD was prompted by reports of hydraulic accumulator
failure. We are issuing this AD to prevent failure of hydraulic
accumulators, which may result in damage to the airplane and injury
to occupants.

Compliance

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

Actions

    (g) Within 12 months after the effective date of this AD,
replace all hydraulic accumulators having part number (P/N) 08 8423
030 1, with stainless steel hydraulic accumulators having P/N 40800-
2050, and do the structural modifications in the nose landing gear
bay, in accordance with the Accomplishment Instructions of Saab
Service Bulletin 2000-29-024, Revision 01, dated November 5, 2010.

Parts Installation

    (h) After replacement of hydraulic accumulators having P/N 08
8423 030 1 with hydraulic accumulators having P/N 40800-2050, and
doing the structural modifications in the nose landing gear bay, as
required by paragraph (g) of this AD, no person may install any
hydraulic accumulator having P/N 08 8423 030 1 on any airplane.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (i) Replacing the hydraulic accumulators and doing the
structural modifications in the nose landing gear bay, in accordance
with the Accomplishment Instructions of Saab Service Bulletin 2000-
29-024, dated November 18, 2009, before the effective date of this
AD, is acceptable for compliance with the corresponding replacement
and structural modifications required by paragraph (g) of this AD.

Other FAA AD Provisions

    (j) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, ANM-
116, International Branch, 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.

Related Information

    (k) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2011-0004, dated January 17, 2011; and Saab Service
Bulletin 2000-29-024, Revision 01, dated November 5, 2010; for
related information.

    Issued in Renton, Washington, on December 19, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-33275 Filed 12-28-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 85 (Tuesday, May 3, 2011)]
[Proposed Rules]
[Pages 24843-24846]
[FR Doc No: 2011-10664]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0148]
RIN 1625-AA00

Safety Zone; Rudey/Braga Wedding Fireworks Display, Cos Cob
Harbor, Greenwich, CT

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a temporary safety zone
around a fireworks display in Cos Cob Harbor, Greenwich, CT, located
within the Captain of the Port (COTP) Sector Long Island Sound zone.
This action is necessary to provide for the safety of life on navigable
waters during the event. Entering into, transiting through, mooring or
anchoring within this zone is prohibited unless authorized by the COTP
Sector Long Island Sound.

DATES: Comments and related material must be received by the Coast
Guard on or before June 2, 2011.
    Requests for public meetings must be received by the Coast Guard on
or before May 18, 2011.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0148 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.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or e-mail Chief Petty Officer Hugh Hamilton, Prevention
Department, Coast Guard Sector Long Island Sound,<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2011-0148), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2011-0148'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8[frac12] by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and may change the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2011-0148'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit 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.

Privacy Act

    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).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before May 18, 2011 using one of the four methods
specified under ADDRESSES. Please explain why you believe a public
meeting would be beneficial. If we determine that one would aid this
rulemaking, we will hold one at a time and place announced by a later
notice in the Federal Register.

Basis and Purpose

    The legal basis for the proposed rule is 33 U.S.C. 1226, 1231, 46
U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; Public Law 107-295,
116 Stat. 2064; and Department of Homeland Security Delegation No.
0170.1, which collectively authorize the Coast Guard to define safety
zones.
    This rule is necessary to ensure the safety of vessels and
spectators from hazards associated with fireworks events. The COTP Long
Island Sound has determined that fireworks events in close proximity to
the navigational channel and Special Anchorage Area pose a significant
risk to public safety and property. 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. Establishing a safety zone around the
location of this fireworks event will help ensure the safety of persons
and property and help minimize the associated risks.

Discussion of Rule

    This safety zone is necessary to ensure the safety of participants,
spectators, and vessels during the Rudey and Braga Fireworks event in
the COTP Long Island Sound zone as this event may pose a hazard to the
public.
    The Rudey and Braga families will be hosting a fireworks display as
part of a wedding celebration in Greenwich, CT, directly off a private
estate in Cos Cob Harbor.
    This rule proposes to create a 600 foot safety zone on the
navigable waters around the launch site located at approximately
41[deg]00'59'' N, 073[deg]36'05'' W. The safety zone will be in place
30 minutes prior to the event until 30 minutes after the event
concludes.
    The particular size of the proposed safety zone established for
this event was evaluated in accordance with Navigational and Vessel
Inspection Circular (NVIC) 07-02; Marine Safety at Firework Displays;
the National Fire Protection Association Standard 1123, Code for
Fireworks Displays (30-yard distance per inch of diameter of the
fireworks mortars), and other pertinent regulations and publications.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed 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.
    The Coast Guard determined that this rule is not a significant
regulatory action for the following reasons: The regulated area will be
of limited duration, there is very little impingement onto the
navigable waterway, and the event is designed to avoid, to the extent
possible, deep draft, fishing, and recreational boating traffic routes.
Persons and/or vessels may enter a safety zone if they obtain
permission from the Coast Guard COTP, Long Island Sound.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed 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 proposed
rule would not have a significant economic impact on a substantial
number of small entities. Persons and/or vessels may enter this safety
zone if they obtain permission from the Coast Guard COTP, Long Island
Sound.
    This proposed rule may affect the following entities, some of which
might be small entities: The owners or operators of vessels intending
to transit or anchor in a portion of the Cos Cob Harbor from 9 p.m. to
10:15 p.m. on June 25th, 2011.
    This proposed safety zone would not have a significant economic
impact on a substantial number of small entities for the following
reasons. This temporary safety zone would be activated and enforced for
only 1 hour and 15 minutes in an area where vessel traffic is expected
to be minimal. Vessel traffic could pass safely around the safety zone
through the navigational channel. Persons and/or vessels may enter a
safety zone if granted permission from the Coast Guard COTP, Long
Island Sound.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact Chief Petty Officer Hugh
Hamilton, Prevention Department, Coast Guard Sector Long Island Sound,
(203) 468-4459 or e-mail<EMAIL_ADDRESS>The Coast Guard will
not retaliate against small entities that question or complain about
this proposed rule or any policy or action of the Coast Guard.

Collection of Information

    This proposed rule would call 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 proposed 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 (adjusted for inflation) or more in any one
year. Though this proposed rule would not result in such expenditure,
we do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This proposed rule would not cause a 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 proposed 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 proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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.

Energy Effects

    We have analyzed this proposed 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 proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment. This rule is categorically
excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This
proposed rule involves the establishment of a safety zone. A
preliminary environmental analysis checklist supporting this
determination is available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREA AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapters 701, 3306,
3703; 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.

    2. Add Sec.  165.T01-0148 to read as follows:

Sec.  165.T01-0148  Safety Zone; Rudey/Braga Wedding Fireworks Display,
Cos Cob Harbor, Greenwich, CT.

    (a) Location. The following is a Safety Zone: All waters of Long
Island Sound in Cos Cob Harbor within a 600-foot radius of the
fireworks barge located in approximate position 41[deg]00'59'' N,
073[deg]36'05'' W.
    (b) Notification. Coast Guard Sector Long Island Sound will cause
notice of the enforcement of this temporary safety zone to be made by
all appropriate means to affect the widest publicity among the effected
segments of the public, including publication in the Local Notice to
Mariners and Broadcast Notice to Mariners.
    (c) Enforcement Period. This section will be enforced on 25 June,
2011, from 9 p.m. until 10:15 p.m.
    (d) Regulations. (1) The general regulations contained in 33 CFR
165.23 apply. During the enforcement period, entering into, transiting
through, mooring or anchoring within this safety zone is prohibited
unless authorized by the Captain of the Port or the designated on-scene
representatives.
    (2) This temporary safety zones is closed to all vessel traffic,
except as may be permitted by the Captain of the Port or the designated
on-scene representative. The COTP or the designated on scene
representative may be contacted via VHF Channel 16 or by telephone at
(203) 468-4404.
    (3) The ``on-scene representative'' of the COTP Long Island Sound
is any Coast Guard commissioned, warrant, or petty officer who has been
designated by the COTP to act on his behalf. The on-scene
representative of the COTP Long Island Sound may be aboard either a
Coast Guard or Coast Guard Auxiliary vessel.
    (4) Vessel operators given permission to enter or operate in the
safety zone must comply with all directions given to them by the
Captain of the Port or the designated on-scene representative.
    (5) The Captain of the Port or the designated on-scene
representative may direct the delay, cancellation, or relocation of the
specific area to be regulated within the generally described locations
listed to ensure safety and compliance with environmental laws. Such
changes in implementation of the safety zone may be required as a
result of factors that could affect their associated marine events such
as weather, vessel traffic density, spectator

activities, participant behavior or potential environmental impacts.

    Dated: April 12, 2011.
J.M. Vojvodich,
Captain, U.S. Coast Guard, Captain of the Port Long Island Sound.
[FR Doc. 2011-10664 Filed 5-2-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 75, Number 237 (Friday, December 10, 2010)]
[Notices]
[Pages 76990-76991]
[FR Doc No: 2010-31074]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0510]

Determination of Regulatory Review Period for Purposes of Patent
Extension; COARTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for COARTEM and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product COARTEM
(artemether/lumefantrine). COARTEM is indicated for treatment of acute,
uncomplicated malaria infections due to Plasmodium falciparum in
patients of 5 kilograms bodyweight and above. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for COARTEM (U.S. Patent No. 5,677,331) from
Novartis AG, and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated February 17, 2010, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of COARTEM represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
COARTEM is 285 days. Of this time, zero days occurred during the
testing phase of the regulatory review period, while 285 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C act) (21 U.S.C. 355(i)) became
effective: not applicable. FDA has verified the

applicant's claim that there was no investigational new drug
application for COARTEM.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C act: June 27,
2008. FDA has verified the applicant's claim that the new drug
application (NDA) 22-268 was submitted on June 27, 2008.
    3. The date the application was approved: April 7, 2009. FDA has
verified the applicant's claim that NDA 22-268 was approved on April 7,
2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 284 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by February 8, 2011. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by June 8, 2011. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
    Comments and petitions that have not been made publicly available
on regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31074 Filed 12-9-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 132 (Thursday, July 9, 2020)]
[Notices]
[Page 41271]
[FR Doc No: 2020-14792]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration Aviation Rulemaking Advisory
Committee; Meeting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Aviation Rulemaking Advisory Committee (ARAC)
meeting.

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SUMMARY: This notice announces a meeting of the ARAC.

DATES: The meeting will be held on Thursday, September 10, 2020, from
1:00 p.m. to 4:00 p.m. Eastern Daylight Time.
    Requests to attend the meeting must be received by Monday, August
24, 2020.
    Requests for accommodations to a disability must be received by
Monday, August 24, 2020.
    Requests to submit written materials to be reviewed during the
meeting must be received no later than Monday, August 24, 2020.

ADDRESSES: The meeting will be held virtually. Members of the public
who wish to observe the meeting must RSVP by emailing<EMAIL_ADDRESS>General committee information including copies of the
meeting minutes will be available on the FAA Committee website at
https://www.faa.gov/regulations_policies/rulemaking/committees/documents/.

FOR FURTHER INFORMATION CONTACT: Lakisha Pearson, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591,
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Any committee-related request should be sent to the person listed in
this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The ARAC was created under the Federal Advisory Committee Act
(FACA), in accordance with Title 5 of the United States Code (5 U.S.C.
App. 2) to provide advice and recommendations to the FAA concerning
rulemaking activities, such as aircraft operations, airman and air
agency certification, airworthiness standards and certification,
airports, maintenance, noise, and training.

II. Agenda

    At the meeting, the agenda will cover the following topics:

 Status Report from the FAA
 Status Updates:
    [cir] Active Working Groups
    [cir] Transport Airplane and Engine (TAE) Subcommittee
 Recommendation Reports
 Any Other Business

    Detailed agenda information will be posted on the FAA Committee
website address listed in the ADDRESSES section at least one week in
advance of the meeting.

III. Public Participation

    The meeting will be open to the public on a first-come, first-
served basis, as space is limited. Please confirm your attendance with
the person listed in the FOR FURTHER INFORMATION CONTACT section.
Please provide the following information: Full legal name, country of
citizenship, and name of your industry association, or applicable
affiliation. If you are attending as a public citizen, please indicate
so.
    For persons participating by telephone, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section by email or phone
for the teleconference call-in number and passcode. Callers are
responsible for paying long-distance charges.
    The U.S. Department of Transportation is committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, such as sign
language, interpretation, or other ancillary aids, please contact the
person listed in the FOR FURTHER INFORMATION CONTACT section.
    The FAA is not accepting oral presentations at this meeting due to
time constraints. Any member of the public may present a written
statement to the committee at any time. The public may present written
statements to the Aviation Rulemaking Advisory Committee by providing a
copy to the Designated Federal Officer via the email listed in the FOR
FURTHER INFORMATION CONTACT section.

    Issued in Washington, DC, on July 2, 2020.
Brandon Roberts,
Executive Director, Office of Rulemaking.
[FR Doc. 2020-14792 Filed 7-8-20; 8:45 am]
BILLING CODE 4910-13-P