[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57041-57043]
[FR Doc No: 2015-23596]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0383]

Qualification of Drivers; Application for Exemptions; Hearing

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to grant requests from 30
individuals for exemptions from the Agency's physical qualifications
standard concerning hearing for interstate drivers. The current
regulation prohibits hearing impaired individuals from operating CMVs
in interstate commerce. After notice and opportunity for public
comment, the Agency concluded that granting exemptions for these
drivers to operate property-carrying CMVs will provide a level of
safety that is equivalent to or greater than the level of safety
maintained without the exemptions. The exemptions are valid for a 2-
year period and may be renewed, and the exemptions preempt State laws
and regulations.

DATES: The exemptions are effective September 21, 2015. The exemptions
expire on September 21, 2017.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Office of Carrier, Driver and Vehicle Safety,<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., e.t., Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

A. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov and/or Room W12-140 on the ground
level of the West Building, 1200 New Jersey Avenue SE., Washington, DC,
between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal
holidays.
    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.dot.gov/privacy.

B. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the safety regulations for a 2-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 2-year period. The current provisions of the FMCSRs
concerning hearing state that a person is physically qualified to drive
a CMV if that person:

    First perceives a forced whispered voice in the better ear at
not less than 5 feet with or without the use of a hearing aid or, if
tested by use of an audiometric device, does not have an average
hearing loss in the better ear greater than 40 decibels at 500 Hz,
1,000 Hz, and 2,000 Hz with or without a hearing aid when the
audiometric device is calibrated to American National Standard
(formerly ASA Standard) Z24.5--1951.

49 CFR 391.41(b)(11). This standard was adopted in 1970, with a
revision in 1971 to allow drivers to be qualified under this standard
while wearing a hearing aid, 35 FR 6458, 6463 (April 22, 1970) and 36
FR 12857 (July 3, 1971).
    FMCSA grants 30 individuals an exemption from Sec.  391.41(b)(11)
concerning hearing to enable them to operate property-carrying CMVs in
interstate commerce for a 2-year period. The Agency's decision on these
exemption applications is based on the current medical literature and
information and the ``Executive Summary on Hearing, Vestibular Function
and Commercial Motor Driving Safety'' (the 2008 Evidence Report)
presented to FMCSA on August 26, 2008. The evidence report reached two
conclusions regarding the matter of hearing loss and CMV driver safety:
(1) No studies that examined the relationship between hearing loss and
crash risk exclusively among CMV drivers were identified; and (2)
evidence from studies of the private driver license holder population
does not support the contention that individuals with hearing
impairment are at an increased risk for a crash. In addition, the
Agency reviewed each applicant's driving record found in the CDLIS,\1\
for CDL holders, and inspections recorded in MCMIS.\2\ For non-CDL
holders, the Agency reviewed the driving records from the State
licensing agency. Each applicant's record demonstrated a safe driving
history. The Agency believes the drivers covered by the exemptions do
not pose a risk to public safety.
---------------------------------------------------------------------------

    \1\ Commercial Driver License Information System (CDLIS) is an
information system that allows the exchange of commercial driver
licensing information among all the States. CDLIS includes the
databases of 51 licensing jurisdictions and the CDLIS Central Site,
all connected by a telecommunications network.
    \2\ Motor Carrier Management Information System (MCMIS) is an
information system that captures data from field offices through
SAFETYNET, CAPRI, and other sources. It is a source for FMCSA
inspection, crash, compliance review, safety audit, and registration
data.
---------------------------------------------------------------------------

C. Comments

    On April 7, 2015, FMCSA published a notice of receipt of exemption

applications and requested public comment on 30 individuals (FR 80
18697; Docket number FMCSA-2015-07909. The comment period ended on May
7, 2015. In response to this notice, nine comments were received
expressing safety concerns for the far reaching ramifications to the
commercial driving industry of allowing deaf drivers to test, train
and/or drive commercially. Some of these comments were addressed in a
previous notice. Additionally they expressed concern for the process by
which exemptions are granted from parts of 49 CFR 391.41, the increased
volume of exemptions, and the need to rely on scientific support as a
basis for granting the exemptions. FMCSA acknowledges the stakeholder's
concerns and may consider the initial steps to revising the physical
qualification standards through a formal rulemaking process.

D. Exemptions Granted

    Following individualized assessments of the exemption applications,
FMCSA grants exemptions from 49 CFR 391.41(b)(11) to 30 individuals.
Under current FMCSA regulations, all of the 30 drivers receiving
exemptions from 49 CFR 391.41(b)(11) would have been considered
physically qualified to drive a CMV in interstate commerce except that
they do not meet the hearing requirement. FMCSA has determined that the
following 30 applicants should be granted an exemption:

Neal Everett Boatman, Jr.

    Mr. Boatman, 37, holds an operator's license in Arizona.

Herbert Dean Crowe

    Mr. Crowe, 50, holds an operator's license in Missouri.

David Keith Cannon

    Mr. Cannon, 47, holds an operator's license in Missouri.

Bryant Cater

    Mr. Cater, 54, holds a Class A commercial driver's license (CDL) in
Tennessee.

Frankye D. Crews

    Ms. Crews, 44, holds an operator's license in Florida.

Justin Craig Cribb

    Mr. Cribb, 36, holds an operator's license in South Carolina.

William Reeder Darnell

    Mr. Darnell, 40, holds a Class A commercial driver's license (CDL)
in Arizona.

Mark Dickson

    Mr. Dickson, 55, holds an operator's license in Texas.

Kelly Gene Eller

    Mr. Eller, 50, holds an operator's license in North Carolina.

Elliot David Fellows

    Mr. Fellows, 22, holds an operator's license in New York.

David H. Grady

    Mr. Grady, 46, holds a Class B commercial driver's license (CDL) in
Colorado.

Alissa Haselhorst

    Ms. Haselhorst, 27, holds an operator's license in Nebraska.

Nathan John Hill

    Mr. Hill, 31, holds an operator's license in Georgia.

Jason R. Gensler

    Mr. Gensler, 36, holds an operator's license in Ohio.

Thomas P. Lipyanic, Jr.

    Mr. Lipyanic, 49, holds a Class A commercial driver's license (CDL)
in Pennsylvania.

Brian L. Lloyd

    Mr. Lloyd, 41, holds an operator's license in Ohio.

Kelsey Rae Maginity

    Ms. Maginity, 23, holds an operator's license in Iowa.

Donald B. Malley

    Mr. Malley, 60, holds a Class A commercial driver's license (CDL)
in Missouri.

Courtney Maloney

    Ms. Maloney, 26, holds an operator's license in New York.

Amy Elizabeth Marcus

    Ms. Marcus, 42, holds an operator's license in Michigan.

Jonython A. Mason

    Mr. Mason, 33, holds an operator's license in California.

Scott Matchett

    Mr. Matchett, 32, holds an operator's license in New York.

Kathy Ann Meadows

    Ms. Meadows, 57, holds a Class A commercial driver's license (CDL)
in Georgia.

Devin Jamal Moffett

    Mr. Moffett, 23, holds an operator's license in Georgia.

Anthony Joseph Saive

    Mr. Saive, 29, holds a Class B commercial driver's license (CDL) in
Ohio.

David W. Shores

    Mr. Shores, 47, holds a Class A commercial driver's license (CDL)
in North Carolina.

Jonathan P. Veach

    Mr. Veach, 32, holds an operator's license in Illinois.

Michael Whitman

    Mr. Whitman, 39, holds an operator's license in New Jersey.

Richard E. Whittaker

    Mr. Whittaker, 44, holds a Chauffeur's license in Indiana.

Brian David Whittington

    Mr. Whittington, 48, holds a Class A commercial driver's license
(CDL) in Michigan.

Basis for Exemption

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the hearing standard in 49 CFR 391.41(b)(11) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. With the exemption, applicants can
drive in interstate commerce. Thus, the Agency's analysis focuses on
whether an equal or greater level of safety is likely to be achieved by
permitting each of these drivers to drive in interstate commerce as
opposed to restricting him or her to driving in intrastate commerce.
The driver must comply with the terms and conditions of the exemption.
This includes reporting any crashes or accidents as defined in 49 CFR
390.5 and reporting all citations and convictions for disqualifying
offenses under 49 CFR part 383 and 49 CFR 391.

Conclusion

    The Agency is granting exemptions from the hearing standard, 49 CFR
391.41(b)(11), to 30 individuals based on an evaluation of each
driver's safety experience. Safety analysis of information relating to
these 30 applicants meets the burden of showing that granting the
exemptions would achieve a level of safety that is equivalent to or
greater than the level that would be achieved without the exemption. In
accordance with 49 U.S.C. 31315, each exemption will be valid for 2
years from the effective date with annual recertification required
unless revoked earlier by FMCSA. The exemption will be revoked if the

following occurs: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained prior to being granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136 and 31315.
    FMCSA exempts the following 30 drivers for a period of 2 years from
the physical qualification standard concerning hearing: Neal Everett
Boatman, Jr. (AZ); Herbert Dean Crowe (MO); David Keith Cannon (MO);
Bryant Cater (TN); Frankye D. Crews (FL); Justin Craig Cribb (SC);
William Reeder Darnell (AZ); Mark Dickson (TX); Kelly Gene Eller (NC);
Elliot David Fellows (NY); David H. Grady (CO); Alissa Haselhorst (NE);
Nathan John Hill (GA); Jason R. Gensler (OH); Thomas P. Lipyanic, Jr.
(PA); Brian L. Lloyd (OH); Kelsey Rae Maginity (IA); Donald B. Malley
(MO); Courtney Maloney (NY); Amy Elizabeth Marcus (MI); Jonython A.
Mason (CA); Scott Matchett (NY); Kathy Ann Meadows (GA); Devin Jamal
Moffett (GA); Anthony Joseph Saive (OH); David W. Shores (NC); Jonathan
P. Veach (IL); Michael Whitman (NJ); Richard E. Whittaker (IN); amd
Brian David Whittington (MI).

    Issued on: September 8, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-23596 Filed 9-18-15; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 60973-60975]
[FR Doc No: 2012-24599]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP11-2619-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Annual Cash-Out Report Period Ending July 31, 2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5255.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1105-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Vanguard Permian 597 & 598 to Tenaska 600 & 599 Cap
Rel Neg Rate Agmts to be effective 10/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5036.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1106-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: HK 37367 to Sequent 39757 Cap Rel Neg Rate Agmt filing
to be effective 10/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5040.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1107-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: QEP Amendments 36601-11 and 37657-22 to Neg Rate Agmts
to be effective 10/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5041.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1108-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Cap Rel Neg Rate Agmt--Encana 37663 to Texla 40128 to
be effective 10/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5042.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1109-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: ONEOK 34951 to BG Energy 40123 cap rel neg rate agmt
filing to be effective 10/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5043.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1110-000.
    Applicants: Northern Natural Gas Company.
    Description: 20120928 Negotiated Rate to be effective 10/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5044.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1111-000.
    Applicants: Total Peaking Services, L.L.C.
    Description: Total Peaking Services, L.L.C.--Order No. 587-V
Compliance Filing to be effective 12/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5063.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1112-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: MNUS FRQ 2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5070.

    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1113-000.
    Applicants: Ryckman Creek Resources, LLC.
    Description: NAESB Compliance Filing to be effective 12/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5071.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1114-000.
    Applicants: Kern River Gas Transmission Company.
    Description: 2012 NAESB 2.0 to be effective 12/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5084.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1115-000.
    Applicants: Eastern Shore Natural Gas Company.
    Description: NAESB Compliance Order No. 587-V to be effective 12/1/
2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5097.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1116-000.
    Applicants: Transwestern Pipeline Company, LLC.
    Description: 2012 TW NAESB 2.0 Filing to be effective 12/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5109.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1117-000.
    Applicants: ETC Tiger Pipeline, LLC.
    Description: ETC Tiger 2012 NAESB Version 2.0 Filing to be
effective 12/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5113.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1118-000.
    Applicants: Fayetteville Express Pipeline LLC.
    Description: FEP 2012 NAESB Version 2.0 Compliance Filing to be
effective 12/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5118.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1119-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: HK 37731 to Texla 40150 Cap Rel Neg Rate Agmt filing
to be effective 10/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5133.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1120-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: HK 37731 to Sequent 40151 Cap Rel Neg Rate Agmt filing
to be effective 10/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5134.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1121-000.
    Applicants: Portland General Electric Company.
    Description: Order 587-B Filing to be effective 12/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5147.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1122-000.
    Applicants: ANR Pipeline Company.
    Description: Marshfield Reduction Project to be effective 11/1/
2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5157.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1123-000.
    Applicants: Viking Gas Transmission Company.
    Description: Semi Annual FLRP--Fall 2012 to be effective 11/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5159.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1124-000.
    Applicants: Guardian Pipeline, L.L.C.
    Description: Transporter's Use Gas Annual Adjustment 2012 to be
effective 11/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5178.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1125-000.
    Applicants: Gulf States Transmission LLC.
    Description: Gulf States Transmission 2012 NAESB V2.0 Filing to be
effective 12/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5201.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1126-000.
    Applicants: Northwest Pipeline GP.
    Description: Non-Conforming Filing--WPX (137679) & Idaho Power
(139664) to be effective 11/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5211.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1127-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: LNG Fuel Tracker Filing 2012 to be effective 11/1/
2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5218.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1128-000.
    Applicants: TWP Pipeline LLC.
    Description: NAESB Compliance Filing to be effective 12/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5224.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1129-000.
    Applicants: Rager Mountain Storage Company LLC.
    Description: NAESB Compliance Filing to be effective 12/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5233.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1130-000.
    Applicants: Equitrans, L.P.
    Description: Negotiated Rate Service Agreement Filing--EQT Energy,
LLC to be effective 10/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5234.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1131-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Interim Fuel Filing 9-28-2012 to be effective 11/1/
2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5235.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1132-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Tariff Merger Filing to be effective 10/29/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5252.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1133-000.
    Applicants: ANR Storage Company.
    Description: Market-Based Rates to be effective 11/1/2012.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5256.
    Comments Due: 5 p.m. ET 10/10/12.

    Docket Numbers: RP12-1134-000.
    Applicants: Fayetteville Express Pipeline LLC.
    Description: FEP 2012 HUB Service Filing to be effective 1/1/2013.
    Filed Date: 9/28/12.
    Accession Number: 20120928-5258.
    Comments Due: 5 p.m. ET 10/10/12.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP10-1403-002
    Applicants: Sabine Pipe Line LLC
    Description: Sabine--Compliance with NAESB WGQ v2.0 to be effective
12/1/2012
    Filed Date: 9/28/12
    Accession Number: 20120928-5259
    Comments Due: 5 p.m. ET 10/10/12

    Docket Numbers: RP11-2399-001
    Applicants: Chandeleur Pipe Line Company

    Description: Chandeleur--Compliance with NAESB WGQ Version 2.0 to
be effective 12/1/2012
    Filed Date: 9/28/12
    Accession Number: 20120928-5231
    Comments Due: 5 p.m. ET 10/10/12

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR Sec.  385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: October 1, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-24599 Filed 10-4-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Notices]
[Pages 91181-91183]
[FR Doc No: 2016-30243]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3995]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Pediatric Uses of Devices;
Requirement for Submission of Information on Pediatric Subpopulations
That Suffer From a Disease or Condition That a Device Is Intended To
Treat, Diagnose, or Cure

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

that suffer from a disease or condition that a device is intended to
treat, diagnose, or cure.

DATES: Submit either electronic or written comments on the collection
of information by February 14, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-3995 for ``Medical Devices; Pediatric Uses of Devices;
Requirement for Submission of Information on Pediatric Subpopulations
That Suffer From a Disease or Condition That a Device Is Intended to
Treat, Diagnose, or Cure.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Devices; Pediatric Uses of Devices; Requirement for Submission
of Information on Pediatric Subpopulations That Suffer From a Disease
or Condition That a Device Is Intended To Treat, Diagnose, or Cure--21
CFR Part 814--OMB Control Number 0910-0748--Extension

    Section 515A(a) of the FD&C Act requires applicants who submit
certain medical device applications to include readily available
information providing a description of any pediatric subpopulations
that suffer from the disease or condition that the device is intended
to treat, diagnose, or cure, and the number of affected pediatric
patients. The information submitted will allow FDA to track the number
of approved devices for which there is a pediatric subpopulation that
suffers from the disease or condition that the device is intended to
treat, diagnose, or cure and the review time for each such device
application.
    These requirements apply to applicants who submit humanitarian
device exemption requests (HDEs), premarket approval applications
(PMAs) or PMA supplements, or a product development protocol (PDP).
    FDA expects to receive approximately 45 original PMA/PDP/HDE
applications

each year, 5 of which FDA expects to be HDEs. This estimate is based on
the average of FDA's receipt of new PMA applications. The Agency
estimates that 10 of the estimated 40 original PMA submissions will
fail to provide the required pediatric use information and their
sponsors will therefore be required to submit PMA amendments. The
Agency also expects to receive approximately 700 supplements that will
include the pediatric use information required by section 515A(a) of
the FD&C Act and part 814 (21 CFR part 814).
    All that is required is to gather, organize, and submit information
that is readily available, using any approach that meets the
requirements of section 515A(a) of the FD&C Act and part 814. We
believe that because the applicant is required to organize and submit
only readily available information, no more than 8 hours will be
required to comply. Furthermore, because supplements may include
readily available information on pediatric populations by referencing a
previous submission, FDA estimates the average time to obtain and
submit the required information in a supplement to be 2 hours. FDA
estimates that the total estimated burden is 1,760 hours.
    FDA estimates the burden of this collection of information as
follows:

                                   Table 1--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
                                                            Number of                     Average
         Activity/21 CFR section             Number of    responses per  Total annual   burden per   Total hours
                                            respondents    respondent      responses     response
----------------------------------------------------------------------------------------------------------------
Pediatric information in an original PMA             30               1            30             8          240
 or PDP--814.20(b)(13)...................
Pediatric information in a PMA amendment--           10               1            10             8           80
 814.37(b)(2)............................
Pediatric information in a PMA                      700               1           700             2        1,400
 supplement--814.39(c)(2)................
Pediatric information in an HDE--                     5               1             5             8           40
 814.104(b)(6)...........................
                                          ----------------------------------------------------------------------
    Total................................  ............  ..............  ............  ............        1,760
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: December 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30243 Filed 12-15-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19376-19378]
[FR Doc No: 2011-8313]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0013]

Statement of Organizations, Functions, and Delegations of
Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has reorganized the
Center for Drug Evaluation and Research (CDER), Office of Surveillance
and Epidemiology (OSE). This reorganization includes the organizations
and their substructure components as listed in this document. This
reorganization includes the establishment of six Staffs: Executive
Operations and Strategic Planning Staff, Regulatory Science Staff,
Regulatory Affairs Staff, Program Management and Analysis Staff,
Project Management Staff, and Technical Information Staff. It will also
include Office of Medication Error Prevention and Risk Management
(OMEPRM) and Office of Pharmacovigilance and Epidemiology (OPE) under
OSE. OMEPRM will consist of the Division of Risk Management and the
Division of Medication Error Prevention and Analysis. OPE will consist
of the Division of Epidemiology I and Division of Epidemiology II and
the Division of Pharmacovigilance I and Division of Pharmacovigilance
II. Also included are the abolishment of Business Process Improvement
Staff, Regulatory Policy Staff, and Review Management Staff within OSE
Immediate Office.

FOR FURTHER INFORMATION CONTACT: Karen Koenick, Center for Drug
Evaluation and Research (HFD-063), Food and Drug Administration, 11919
Rockville Pike, rm. 324, Rockville, MD 20852,<PHONE_NUMBER>.

I. Summary

    The Statement of Organization, Functions, and Delegations of
Authority for the Department of Health and Human Services (35 FR 3685,
February 25, 1970; 60 FR 56605, November 9, 1995; 64 FR 36361, July 6,
1999; and 72 FR 50112, August 30, 2007) is amended to reflect the
restructuring of CDER, FDA as follows.

II. Organization

    CDER is headed by the Director, and includes the following
organizational unit:

Office of Surveillance and Epidemiology

    1. Provides leadership, direction, planning, budgeting, management,
and supervision of Divisions and Staffs; and premarketing and
postmarketing risk assessment program operations.
    2. Develops and maintains international and national contact with
regulators.
    3. Develops, coordinates, and implements postmarket risk assessment
policy, guidance, and interpretations.
    4. Initiates regulation development and enhancement.
    5. Coordinates and implements policies and initiatives, including
information management initiatives across the Agency.

Regulatory Science Staff

    1. Provides leadership, direction, and coordination for OSE
regulatory research activities.
    2. Develops and manages relationships with outside scientific
groups that interface with OSE scientists on a variety of projects that
relate to OSE's drug safety mission. These outside groups include
academic organizations, private organizations, and other Federal
Agencies.
    3. Coordinates the access to large databases for
pharmacoepidemiologic and pharmacovigilance studies, as well as to the
outside scientists with drug safety expertise to collaborate with CDER.
    4. Develops regulatory research programs that will support OSE as a
whole, including risk management, pharmacovigilance, and medication
error detection and prevention; in addition to epidemiology.

Regulatory Affairs Staff

    1. Responsible for the coordination and implementation of
regulatory policies by staff within OSE by coordinating the development
and upkeep of guidances, MAPPs, and standard operating procedures,
answering regulatory questions, managing the process for waivers of

postmarketing safety reporting requirements and citizen petition
responses, and being involved in the development of safety regulations.
    2. Provides leadership on initiatives related to the Medical
Dictionary for Regulatory Activities (MedDRA).

Executive Operations & Strategic Planning Staff

    1. Creates and maintains professional and skills training programs
for OSE personnel.
    2. Plans and tracks goals and objectives of all OSE Offices and
Divisions.
    3. Evaluates OSE work products and communications using quality
control technology.
    4. Interacts with Executive Secretariat, Press Office, and etc.

Technical Information Staff

    1. Provides coordination, development and assessment of policies,
procedures, and best practices related to OSE data and information
system management within OSE.
    2. Provides representation for OSE on Center and Agency best
practices boards associated with staff responsibilities.
    3. Represents OSE in Center and Agency boards or workgroups that
address business process improvements and information technology
related to postmarket drug safety.
    4. Ensures that OSE's informatics systems (e.g., Adverse Event
Reporting System, Phonetic Orthographic Computer Analysis, and Phonetic
Orthographic Computer Analysis) serve OSE's needs.

Program Management and Analysis Staff

    1. Provides leadership, direction, planning, budgeting, management,
and supervision of programs related to the OSE office administration
and contracts management.
    2. Provides guidance and support services to the OSE on all aspects
of administrative, budget, and facilities management and provides
service and support on human resource, personnel operations services,
and recruitment activities.
    3. Provides management, tracking and facilitation of projects
related to office administration and contracts management within OSE.
    4. Provides coordination, development, and assessment of policies,
procedures, and best practices related to OSE office administration and
contract management within OSE.
    5. Provides representation for OSE on center and Agency best
practices boards associated with staff responsibilities.

Project Management Staff

    1. Provides leadership, direction, planning, management, and
supervision of programs related to drug safety reviews and staff.
    2. Provides management, tracking, and facilitation of projects
related to drug safety reviews within OSE.
    3. Provides coordination, development, and assessment of policies
and procedures related to drug safety reviews, review templates, and
other best practices related to drug safety reviews within OSE.
    4. Provides representation for OSE on Center best practices
associated with staff responsibilities.

Office of Medication Error Prevention and Risk Management

    1. Directs and supports the Divisions of Medication Error
Prevention and Analysis and Risk Management.
    2. Leads OSE review of proposed and implemented Risk Minimization
Action Plans (RiskMAPs)/Risk Evaluation and Mitigation Strategies
(REMS).
    3. Coordinates risk communication components of drug safety risk
management programs.
    4. Coordinates reviews of proposed proprietary trade names for
their potential to result in sound-alike or look-alike medication
errors.
    5. Performs root-cause analyses of postmarketing medication error
reports.

Division of Medication Error Prevention and Analysis

    1. Plans, directs, and provides information technology support to
the OSE.
    2. Develops and maintains necessary software, processes,
procedures, training, and security or databases available to OSE.
    3. Acts as focal point for all hardware, software, and other
information systems issues.
    4. In conjunction with the OSE programs, evaluates extant
information resources for utility and value to the OSE missions.
Arranges for necessary accesses, training, and other needs related to
effective use of those resources.
    5. Develops and maintains the OSE Center for Drug Evaluation and
Research Network (CDERNET) Web pages and works with other Agency
programs to develop and maintain Internet pages related to office
programs.
    6. Serves as the primary OSE contact for World Health Organization
(WHO) searches, Freedom of Information (FOI) and National Technical
Information Services (NTIS) issues, and for database searches.
    7. Reviews proposed proprietary trade names for their potential to
result in sound-alike or look-alike medication errors.
    8. Analyzes and performs root-cause analyses of postmarketing
medication error reports.
    9. Develops and implements internal MAPPs and guidance on
medication error and patient safety initiatives.

Division of Risk Management

    1. Plans and directs all risk management activities in the OSE.
    2. Provides risk management expertise to OSE and the center.
    3. Reviews all proposed Risk Minimization Action Plans (RiskMAPs)
or Risk Management Plans (RMPs) for conformance with FDA's standards.
    4. Conducts postmarketing monitoring of all products with approved
RiskMAPs.
    5. Conducts evaluations of the performance of RiskMAPs.
    6. In conjunction with Office of New Drugs (OND), conducts
premarketing risk assessments for some products.
    7. Helps develop and maintain the Agency's OSE CDERNET RiskMAP Web
pages and works with other Agency programs to develop and maintain
RiskMAP Internet pages.
    8. Develops and implements internal MAPPs and guidance on risk
management initiatives.

Office of Pharmacovigilance and Epidemiology

    1. Directs and supports the Divisions of Pharmacovigilance and
Epidemiology.
    2. Evaluates the safety of marketed drugs.
    3. Reviews adverse event reports with OND.
    4. Collaborates with other offices to recommend appropriate
actions.
    5. Provides recommendations on risk management programs and REMS.
    6. Coordinates the review and analysis of epidemiologic study
protocols and results of epidemiologic studies submitted by industry,
from the literature or other sources that are related to the
postmarketing safety of drugs.

Division of Epidemiology I

    1. Provides leadership, direction, planning, budgeting, management,
and supervision of Division programs and staff.
    2. Reviews and provides analyses of epidemiologic study protocols
and results of epidemiologic studies submitted by industry, from the
literature or other sources that are related to the postmarketing
safety of drugs.

    3. Provides development and assessment of methodologies and best
practices for active and passive surveillance systems and for
incorporating such data, when appropriate, into the review of the
postmarketing safety of drugs.
    4. Reviews and analyzes drug utilization information.
    5. Performs epidemiologic research on drug safety issues.
    6. Provides epidemiologic and drug utilization expertise to support
medical review divisions in areas of responsibility, as well as, for
Advisory Committee presentations and related documents.
    7. Provides input on epidemiologic and drug utilization aspects of
information for the public related to significant postmarketing safety
information regarding drugs, biologics, devices, and foods.
    8. Develops and implements internal MAPPs and guidance on
epidemiologic and drug utilization initiatives.

Division of Epidemiology II

    1. Provides leadership, direction, planning, budgeting, management,
and supervision of Division programs and staff.
    2. Reviews and analyzes epidemiologic study protocols and results
of epidemiologic studies submitted by industry from the literature or
other sources that are related to the postmarketing safety of drugs.
    3. Provides for the development and assessment of methodologies and
best practices for scientifically-sound observational studies related
to postmarketing safety of drugs.
    4. Reviews and analyzes drug utilization information.
    5. Performs epidemiologic research on drug safety issues.
    6. Provides epidemiologic and drug utilization expertise to support
medical review divisions in areas of responsibility, as well as, for
Advisory Committee presentations and related documents.
    7. Provides input on epidemiologic and drug utilization aspects of
information for the public related to significant postmarketing safety
information regarding drugs, biologics, devices, and foods.
    8. Develops and implements internal MAPPs and guidance on
epidemiologic and drug utilization initiatives.

Division of Pharmacovigilance I

    1. Provides leadership, direction, planning, budgeting, management,
and supervision of Division programs and staff.
    2. Reviews and provides analysis of adverse event reports from
industry submissions and from reports submitted directly to FDA related
to marketed drugs in order to detect safety signals and evaluate risk;
and performs followup when such signals are detected.
    3. Provides development and assessments of methodologies and best
practices for scientifically-sound safety signal detection and drug
risk evaluation related to the postmarketing safety of drugs.
    4. Provides safety signal detection and drug risk evaluation
support to medical review divisions in areas of responsibility, as well
as, for Advisory Committee presentations.
    5. Provides recommendations on safety signal detection and drug
risk evaluation aspects of proposed and implemented RiskMAPs or RMPs.
    6. Provides input on signal detection and drug risk evaluation
included in information for the public related to significant safety
information regarding drugs, biologics, devices, and foods.
    7. Develops and implements internal MAPPs and guidance on safety
signal detection and drug risk evaluation initiatives.

Division of Pharmacovigilance II

    1. Provides leadership, direction, planning, budgeting, management,
and supervision of Division programs and staff.
    2. Reviews and provides analyses of adverse event reports from
industry submissions and from reports submitted directly to FDA related
to marketed drugs in order to detect safety signals and evaluate risk;
performs followup when such signals are detected.
    3. Provides development and assessment of methodologies and best
practices for scientifically-sound safety signal detection and drug
risk evaluation related to the postmarketing safety of drugs.
    4. Provides safety signal detection and drug risk evaluation
support to medical review divisions in areas of responsibility, as well
as, for Advisory Committee presentations.
    5. Provides recommendations on safety signal detection and drug
risk evaluation aspects of proposed and implemented RiskMAPs or RMPs.
    6. Provides input on signal detection and drug risk evaluation
included in information for the public related to significant safety
information regarding drugs, biologics, devices, and foods.
    7. Develops and implements internal MAPPs and guidance on safety
signal detection and drug risk evaluation initiatives.

III. Delegation of Authority

    Pending further delegation, directives or orders by the
Commissioner of the Food and Drugs or the Center Director, CDER, all
delegations and redelegations of authority made to officials and
employees of affected organizational components will continue in them
or their successors pending further redelegations, provided they are
consistent with this reorganization.

    Dated: April 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8313 Filed 4-6-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 156 (Monday, August 13, 2012)]
[Rules and Regulations]
[Pages 48058-48060]
[FR Doc No: 2012-19444]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 27

[Docket No. FAA-2012-0820; Special Conditions No. 27-028-SC]

Special Conditions: Eurocopter France, EC130T2; Use of 30-Minute
Power Rating

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Eurocopter France
Model EC130T2 helicopter. This model helicopter will have the novel or
unusual design feature of a 30-minute power rating, generally intended
to be used for hovering at increased power for search and rescue
missions. The applicable airworthiness regulations do not contain
adequate or appropriate safety standards for this design feature. These
special conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: The effective date of these special conditions is July 30, 2012.
We must receive your comments by September 27, 2012.

ADDRESSES: Send comments identified by docket number FAA-2012-0820
using any of the following methods:
    Federal eRegulations Portal: Go to http://www.regulations.gov and
follow the online instructions for sending your comments
electronically.
    Mail: Send comments to Docket Operations, M-30, U.S. Department of
Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West
Building Ground Floor, Washington, DC, 20590-0001.
    Hand Delivery of Courier: Take comments to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE., Washington, DC, between 8 a.m., and 5 p.m., Monday through
Friday, except Federal holidays.
    Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://regulations.gov, including any personal information
the commenter provides. Using the search function of the docket web
site, anyone can find and read the electronic form of all comments
received into any FAA docket, including the name of the individual
sending the comment (or signing the comment for an association,
business, labor union, etc.). DOT's complete Privacy Act Statement can
be found in the Federal Register published on April 11, 2000 (65 FR
19477-19478), as well as at http://DocketsInfo.dot.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room @12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m., and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Eric Haight, Rotorcraft Standards
Staff, ASW-111, Rotorcraft Directorate, Aircraft Certification Service,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Reason for No Prior Notice and Comment Before Adoption

    The FAA has determined that notice and opportunity for public
comment are impractical because we do not expect substantive comments,
and because this special condition only affects this one manufacturer.
We also considered that these procedures would significantly delay the
issuance of the design approval, and thus, the delivery of the affected
aircraft. As certification for the Eurocopter France model EC130T2 is
imminent, the FAA finds that good cause exists for making these special
conditions effective upon issuance.

Comments Invited

    While we did not precede this with a notice of proposed special
conditions, we invite interested people to take part in this rulemaking
by sending written

comments, data, or views. The most helpful comments reference a
specific portion of the special conditions, explain the reason for any
recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We will consider comments filed late if it is possible to do
so without incurring expense or delay. We may change these special
conditions based on the comments we receive.

Background and Discussion

    On October 7, 2008, Eurocopter France applied to amend Type
Certificate No. H9EU to include the new EC130T2 model. The EC130T2
model is a derivative of the EC130B4, which is currently approved under
Type Certificate No. H9EU. The EC130T2 is a 14 CFR part 27 normal
category, single-engine rotorcraft, which will be certificated for
single-pilot operation and a maximum of seven passengers. This model
includes increased performance from the Turbomeca Arriel 2D engine, an
upgraded main transmission, new vehicle engine management display
(VEMD) avionics, and an active vibration control system.
    Eurocopter France proposes that the EC130T2 model use a novel and
unusual design feature, which is a 30-minute power rating, identified
in the Arriel 2D engine type certification data sheet (TCDS) [FAA
Turbomeca TCDS No. E00054EN]. 14 CFR 1.1 defines ``rated takeoff
power'' as limited in use to no more than 5 minutes for takeoff
operation. Thus, the use of takeoff power for 30 minutes will require
special airworthiness standards, known as special conditions, to
address the use of this 30-minute power rating and its effects on the
rotorcraft. These special conditions will add requirements to the
existing airworthiness standards in 14 CFR 27.923 (Rotor drive system
and control mechanism tests), Sec.  27.1305 (Powerplant instruments),
and Sec.  27.1521 (Powerplant limitations).
    For the EC130T2, the European Aviation Safety Agency (EASA) has
issued CRI E-02, which documents the special conditions.
    The following is a summary of the final special conditions:
    In addition to the requirements of Section 27.923, Rotor Drive
System and Control Mechanism Tests, the aircraft drive-system effects
due to use of the 30-minute power rating versus the Takeoff (5-minute)
rating must be accounted for in the rotor drive-system testing.
    In addition to the requirements of Section 27.1305, Powerplant
Instruments, since this new 30-minute power rating has a time limit
associated with its use, the pilot must have the means to identify:
     When the rated engine power level is achieved,
     When the event begins, and
     When the time interval expires.
    In addition to the requirements of Section 27.1521, Powerplant
Limitations, a new 30-minute rating must be defined for the use of
takeoff power for greater than 5 minutes and must be limited to no more
than 30 minutes per use.
    Furthermore, the Model EC130T2 rotorcraft flight manual must
include limitations on use of the 30-minute power rating to state:
     Continuous use above MCP is limited to 30 minutes, and
     Cumulative use above MCP is limited to 1 hour per flight.

Type Certification Basis

    Under 14 CFR 21.101, Eurocopter France must show that the EC130T2
model helicopter meets the applicable provisions of the regulations
incorporated by reference in Type Certificate No. H9EU, or the
applicable regulations in effect on the date of application for the
amendment to the type certificate. The regulations incorporated by
reference in the type certificate are commonly referred to as the
``original type certification basis.'' The regulations incorporated by
reference in H9EU are as follows:
    (a) 14 CFR 21.29, and part 27 Amendments 27-1 through 27-32, except
14 CFR 27.952 is not adopted.
    (b) 14 CFR Part 36 Appendix H through Amendment 20
    (c) Special Condition 27-009-SC for HIRF
    (d) Equivalent Level of Safety Findings issued against:
    (1) 14 CFR 27.1549(b) Powerplant Instrument Markings.
    (2) 14 CFR 27.1027(b)(2) Main Gearbox Oil Filter Bypass
    The Administrator has determined that the applicable airworthiness
regulations (that is, 14 CFR part 27) do not contain adequate or
appropriate safety standards for the EC130T2 model helicopter because
of a novel or unusual design feature. Therefore, special conditions are
prescribed under the provisions of 14 CFR 21.16.
    The FAA issues special conditions, as defined by 14 CFR 11.19, in
accordance with 14 CFR 11.38, and they become part of the type
certification basis under Sec.  21.101.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, or should any other model already included on
the same type certificate be modified to incorporate the same novel or
unusual design feature, the special conditions would also apply to the
other model.

Novel or Unusual Design Features

    The EC130T2 model helicopter will incorporate a novel or unusual
design feature, which is:
     A 30-minute power rating.

Applicability

    These special conditions are applicable to the Eurocopter France
Model EC130T2 helicopter. These special conditions would apply if
Eurocopter France seeks to amend Type Certificate No. H9EU to add
another model that has the same unusual design feature.

Conclusion

    This action affects only certain novel or unusual design features
on the Eurocopter France Model EC130T2 helicopter. It is not a rule of
general applicability, and it affects only the applicant who applied to
the FAA for approval of this feature.

List of Subjects in 14 CFR Part 27

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

0
The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701-44702, 44704.

The Special Conditions

0
Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Eurocopter France model EC130T2
helicopter. Unless stated otherwise, all requirements in Sec. Sec.
27.923, 27.1305 and 27.1521 remain unchanged.
    (a) Section 27.923 Rotor drive system and control mechanism tests,
at Amendment 27-29. In addition to the requirements of this section,
the test prescribed in Sec.  27.923(e) must be conducted in intervals
of not less than 30 minutes.
    (b) Section 27.1305 Powerplant instruments, at Amendment 27-37. In
addition to the requirements of this section, a means must be provided
to indicate to the pilot when the engine is at the 30-minute power
level, when the event begins, and when the time interval expires.
    (c) Section 27.1521 Powerplant limitations, at Amendment 27-29. In

addition to the requirements of this section, use of the 30-minute
power must be limited to no more than 30 minutes per use, and no more
than one hour per flight. The use of the 30-minute power must also be
limited by:
    (1) The maximum rotational speed, which may not be greater than--
    (i) The maximum value determined by the rotor design; or
    (ii) The maximum value demonstrated during the type tests;
    (2) The maximum allowable gas temperature; and
    (3) The maximum allowable torque.

Kimberly K. Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2012-19444 Filed 8-10-12; 8:45 am]
BILLING CODE 4910-13-P


	UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Served: May 12, 2003

In the matter of the citizenship of

DHL AIRWAYS, INC.

Under 49 U.S.C. § 40102(a)(15)

Docket OST-2002-13089

NOTICE ON REQUEST FOR EXTENSION OF TIME FOR

SUBMISSION OF RECOMMENDED DECISION

By Order 2003-4-14, issued April 17, 2003 (“Instituting Order”), the
Department instituted a de novo review of the current citizenship of DHL
Airways, Inc. (“DHL Airways”) before an Administrative Law Judge.
We directed the Law Judge to submit a Recommended Decision (“RD”) to
the Department by September 2, 2003.  In so doing, we also stated that,
if the Law Judge determined that additional time was needed to complete
this proceeding, he could request an extension of time from the DOT
Decisionmaker.

On April 29, 2003, Chief Administrative Law Judge Ronnie A. Yoder held a
prehearing conference in this proceeding, and on May 2, issued his
prehearing conference report (“Report”), which included a request to
the Decisionmaker for an extension of time.

In his request, Judge Yoder indicated that DHL Airways proposed October
31 as the due date for the RD and that the other parties indicated a
willingness to accept November 24, but later changed that to December 23
without further explanation.  The Chief Judge requested November 24 as
the date for submission of his RD.  In support of his request, the Chief
Judge notes that the issues in this proceeding have been before the
Department for 2½ years.  See Report at 3.

It is precisely because these issues have been before the Department for
this length of time that we believe that there should be an expeditious
resolution of this matter.  To make it possible to complete this
proceeding by our September 2 deadline, the Department directed that all
parties designate, in a filing in this docket within seven days of the
issuance of the Instituting Order, the documents that should be included
in the record in the proceedings before the Law Judge.  Not one of the
parties complied with this order in a timely manner.  See Report at 3.
We believed that this seven-day deadline was reasonable at the time we
imposed it, and we continue to believe that it was a reasonable time
frame, despite the fact that the parties disregarded it, and instead of
complying with our direction, now seek additional time to expand this
proceeding.

The Chief Judge further states that additional time is necessary because
there has been no previous opportunity for discovery.  See Report at 5
n.6.  While we have directed the Chief Judge to conduct a de novo review
of this matter, the issue involved in this proceeding has been the
subject of multiple pleadings before the Department over the past 2½
years, by each of these parties.  We recognize and acknowledge that some
limited discovery may be justified.  Under these circumstances, however,
the process of discovery should take considerably less time than it
might have if this issue were new to the parties.  That is particularly
true because discovery should be limited only to facts relevant to the
issue of the current citizenship of DHL Airways.

Lastly, the Chief Judge states that the “need for additional time is
especially acute as the Instituting Order provides that Public Counsel
will not participate in these proceedings.”  See Report at 5.  We see
no reason why the participation of Public Counsel would have helped the
parties to meet the deadlines set by the Instituting Order.  Both sides
of the questions at issue here are adequately, indeed amply, represented
by competent counsel.  We therefore see no reason to believe that the
parties would require the intervention of Public Counsel to develop a
full record on the issues in a timely way.  It is an obligation of the
parties who requested this proceeding to devote the resources necessary
to proceed expeditiously and meet all deadlines with the same zeal that
they have demonstrated in addressing the issue of whether we should
institute an oral evidentiary hearing in the first place.

We believe that the original September 2 deadline afforded the Chief
Judge and all parties an adequate amount of time to fully consider the
important issues raised in this proceeding. We note that Federal Express
Corp., United Parcel Service Co., and Lynden Air Cargo, LLC have
expressed concerns in this docket about the impact of alleged
“foreign” competition and that DHL Airways has stated its concern
about the impact on its business of the extensive time that this
proceeding has been pending.  Nevertheless, we have decided to grant the
request for an extension in part and believe that a deadline of October
31 would adequately serve the public interest.  For the reasons stated
above, we regard an extension of almost two months, to October 31, as
more than sufficient.  A further extension would unreasonably extend a
proceeding that, in the public interest, should be brought to closure
without undue delay.  Moreover, we see no reasons why this case cannot
be completed on time if the Instituting Order is complied with by all
parties and rigorously enforced by the Chief Judge.

ACCORDINGLY, We extend the deadline to submit a Recommended Decision to
the Department to October 31, 2003.  No further extensions will be
granted unless warranted by extraordinary circumstances.

We will serve a copy of this notice on each of the parties in this
proceeding as set forth in the attached Service List.

Dated at Washington, DC, May 12, 2003:

   READ C. VAN DE WATER

Assistant Secretary for Aviation

     and International Affairs

Attachment

SERVICE LIST

DHL AIRWAYS, INC.

Docket OST-2002-13089

The Honorable Ronnie A. Yoder

Chief Administrative Law Judge

Office of Hearing, M-20, Room 5411

U.S. Department of Transportation

Washington, DC 20590

   FAX:<PHONE_NUMBER>

	Robert Jeffrey Kelsey

Federal Express Corporation

3620 Hacks Cross Road

Bldg. B, 2nd Floor

Memphis, TN  38125

   FAX:<PHONE_NUMBER>

Sanford M. Litvack

Joanna R. Swomley

Quinn, Emanueal, Urquhart, Oliver

  & Hedges, LLP

Counsel for DHL Airways, Inc.

805 Third Avenue

New York, NY  10022

   FAX:<PHONE_NUMBER>

	Pierre Murphy

Law Office of Pierre Murphy

Counsel for Lynden Air Cargo, LLC

1200 New Hampshire Avenue, NW

Suite 800

Washington, DC 20036

   FAX:<PHONE_NUMBER>

David L. Vaughan

Kelley Drye & Warren LLP

Counsel for United Parcel Service Co.

1200 19th Street, NW, Suite 500

Washington, DC  20036

   FAX:<PHONE_NUMBER>

	Patricia L. Thomas

Chief, Air Carrier Fitness Division, X-56

U.S. Department of Transportation

Room 6401

400 7th Street, SW

Washington, DC 20590

  FAX:<PHONE_NUMBER>

 See, e.g., UPS Reply of September 17, 2002, Docket OST-2002-13089, at
12-13 (alleging Deutsche Post engages in “anti-competitive behavior”
causing “unfair competition”); FedEx Reply of September 24, 2002,
Docket OST-2002-13089, at 3 (“The Department is required to ensure
that U.S. air carriers compete on an equal footing with foreign air
carriers.  This responsibility has become even more important since last
year’s tragic events.”  (footnote omitted)); Lynden Air Cargo Motion
of November 8, 2002, Docket OST-2002-13089, at 4 (stating loss of Air
Mobility Command contract to DHL Airways  “will have serious financial
consequences for our company”).

 See Report at 4.

 PAGE   1

 PAGE   2


[Federal Register Volume 76, Number 113 (Monday, June 13, 2011)]
[Notices]
[Page 34228]
[FR Doc No: 2011-14546]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-3723-000]

TrueLight Energy, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
TrueLight Energy, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is June 27, 2011.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 7, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-14546 Filed 6-10-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78277-78278]
[FR Doc No: 2010-31445]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63483; File No. SR-FINRA-2010-065]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change To Extend the Pilot Period of Amendments to FINRA
Rule 11892 Governing Clearly Erroneous Transactions

December 9, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 8, 2010, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by FINRA. FINRA has designated
the proposed rule change as constituting a ``non-controversial'' rule
change under paragraph (f)(6) of Rule 19b-4 under the Act,\3\ which
renders the proposal effective upon receipt of this filing by the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rule 11892 (Clearly Erroneous
Transactions in Exchange-Listed Securities) to extend the effective
date of the pilot, which is currently scheduled to expire on December
10, 2010, until April 11, 2011.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA, at the
Commission's Web site at http://www.sec.gov, and at the Commission's
Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    FINRA proposes to amend FINRA Rule 11892.02 to extend the effective
date of the amendments set forth in File No. SR-FINRA-2010-032 (the
``pilot''), which are currently scheduled to expire on December 10,
2010, until April 11, 2011.
    The pilot was drafted in consultation with other self-regulatory
organizations (``SROs'') and Commission staff to provide for uniform
treatment: (1) Of clearly erroneous execution reviews in Multi-Stock
Events involving twenty or more securities; and (2) in the event
transactions occur that result in the issuance of an individual stock
trading pause by the primary listing market and subsequent transactions
that occur before the trading pause is in effect for transactions
otherwise than on an exchange. FINRA also implemented additional
changes to the Rule as part of the pilot that reduce the ability of
FINRA to deviate from the objective standards set forth in the Rule.\4\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 62885 (September 10,
2010), 75 FR 56641 (September 16, 2010) (Order Approving File No.
SR-FINRA-2010-032).
---------------------------------------------------------------------------

    The extension proposed herein would allow the pilot to continue to
operate without interruption while FINRA and the other SROs further
assess whether the pilot should be adopted permanently and whether
other initiatives should be adopted in lieu of the current pilot.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\5\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change is
consistent with the clearly erroneous rules of other SROs and will
promote the goal of transparency and uniformity across markets
concerning reviews of potentially clearly erroneous executions in
various contexts. Further, FINRA believes that the proposed changes
enhance the objectivity of decisions made by FINRA with respect to
clearly erroneous executions.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \6\ and Rule 19b-
4(f)(6)(iii) thereunder.\7\ FINRA has asked

the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because such waiver
will allow the pilot program to continue uninterrupted and help ensure
uniformity among the national securities exchanges and FINRA with
respect to the treatment of clearly erroneous transactions.\8\
Accordingly, the Commission waives the 30-day operative delay
requirement and designates the proposed rule change as operative upon
filing with the Commission.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Commission notes that FINRA has satisfied this
requirement.
    \8\ For purposes only of waiving the 30-day operative delay, the
Commission has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form http://www.sec.gov/rules/sro.shtml; or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2010-065 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number SR-FINRA-2010-065. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site http://www.sec.gov/rules/sro.shtml. Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of FINRA.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make publicly
available. All submissions should refer to File Number SR-FINRA-2010-
065 and should be submitted on or before January 5, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-31445 Filed 12-14-10; 8:45 am]
BILLING CODE 8011-01-P