[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Pages 50095-50096]
[FR Doc No: 2012-20332]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC12-134-000.
    Applicants: NRG Energy, Inc, GenOn Energy, Inc.
    Description: Joint Application for Authorization of Disposition of
Jurisdictional Assets and Merger Under Sections 203(a)(1) and 203(a)(2)
of the Federal Power Act of NRG Energy, Inc. and GenOn Energy, Inc.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5135.
    Comments Due: 5 p.m. ET 8/31/12.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2488-004.
    Applicants: Oasis Power Partners, LLC, Crescent Ridge LLC, Eurus
Combine Hills I LLC, Avenal Park LLC, Sand Drag LLC, Sun City Project
LLC, Eurus Combine Hills II LLC.
    Description: Notice of Non-Material Change in Status of Avenal Park
LLC, et al.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5116.
    Comments Due: 5 p.m. ET 8/31/12.

    Docket Numbers: ER10-2532-002.
    Applicants: Oasis Power Partners, LLC, Crescent Ridge LLC, Eurus
Combine Hills I LLC, Avenal Park LLC, Sand Drag LLC, Sun City Project
LLC, Eurus Combine Hills II LLC.
    Description: Notice of Non-Material Change in Status of Avenal Park
LLC, et al.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5116.
    Comments Due: 5 p.m. ET 8/31/12.

    Docket Numbers: ER10-2722-002.
    Applicants: Oasis Power Partners, LLC, Crescent Ridge LLC, Eurus
Combine Hills I LLC, Avenal Park LLC, Sand Drag LLC, Sun City Project
LLC, Eurus Combine Hills II LLC.
    Description: Notice of Non-Material Change in Status of Avenal Park
LLC, et al.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5116.
    Comments Due: 5 p.m. ET 8/31/12.

    Docket Numbers: ER10-2787-002.
    Applicants: Oasis Power Partners, LLC, Crescent Ridge LLC, Eurus
Combine Hills I LLC, Avenal Park LLC, Sand Drag LLC, Sun City Project
LLC, Eurus Combine Hills II LLC.
    Description: Notice of Non-Material Change in Status of Avenal Park
LLC, et al.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5116.
    Comments Due: 5 p.m. ET 8/31/12.

    Docket Numbers: ER11-2855-003.
    Applicants: Oasis Power Partners, LLC, Crescent Ridge LLC, Eurus
Combine Hills I LLC, Avenal Park LLC, Sand Drag LLC, Sun City Project
LLC, Eurus Combine Hills II LLC.
    Description: Notice of Non-Material Change in Status of Avenal Park
LLC, et al.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5116.
    Comments Due: 5 p.m. ET 8/31/12.

    Docket Numbers: ER11-2856-003.
    Applicants: Oasis Power Partners, LLC, Crescent Ridge LLC, Eurus
Combine Hills I LLC, Avenal Park LLC, Sand Drag LLC, Sun City Project
LLC, Eurus Combine Hills II LLC.
    Description: Notice of Non-Material Change in Status of Avenal Park
LLC, et al.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5116.
    Comments Due: 5 p.m. ET 8/31/12.

    Docket Numbers: ER11-2857-003.
    Applicants: Oasis Power Partners, LLC, Crescent Ridge LLC, Eurus
Combine Hills I LLC, Avenal Park LLC, Sand Drag LLC, Sun City Project
LLC, Eurus Combine Hills II LLC.
    Description: Notice of Non-Material Change in Status of Avenal Park
LLC, et al.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5116.
    Comments Due: 5 p.m. ET 8/31/12.

    Docket Numbers: ER12-1801-001.
    Applicants: Tucson Electric Power Company.
    Description: Tucson Electric Power Attachment C Compliance Filing
to be effective 7/16/2012.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5069.
    Comments Due: 5 p.m. ET 8/31/12.

    Docket Numbers: ER12-2435-000.
    Applicants: Entergy Mississippi, Inc.
    Description: EMI-SMEPA 2nd Rev IA RS 251 to be effective 8/18/2011.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5067.
    Comments Due: 5 p.m. ET 8/31/12.

    Docket Numbers: ER12-2436-000.
    Applicants: Arizona Public Service Company.
    Description: LGIA for the Foothills Solar Project, Service
Agreement No. 324 to be effective 8/31/2012.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5070.
    Comments Due: 5 p.m. ET 8/31/12.

    Docket Numbers: ER12-2437-000.
    Applicants: Granite State Electric Company.
    Description: 2012 Borderline Sales Tariff Rate Update to be
effective 11/1/2011.
    Filed Date: 8/10/12.
    Accession Number: 20120810-5091.
    Comments Due: 5 p.m. ET 8/31/12.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings 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<PHONE_NUMBER>.

    Dated: August 10, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-20332 Filed 8-17-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26932-26933]
[FR Doc No: 2019-12167]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0054]

Request for Information Concerning Commercial Motor Vehicle
Driver Detention Times During Loading and Unloading

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

ACTION: Request for information.

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SUMMARY: FMCSA requests information on existing or potential sources of
data to better understand driver detention times during the loading and
unloading of commercial motor vehicles (CMVs) and the potential impact
of such delays on roadway safety. A recent study by the U.S. Department
of Transportation's (DOT) Office of Inspector General found that better
data are needed to fully understand the issues associated with driver
detention.

DATES: Comments on this notice must be received on or before September
9, 2019.

ADDRESSES: You may submit comments identified by Docket Number FMCSA-
2019-0054 using any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001
between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal
holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the 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. The online FDMS is available 24 hours
each day, 365 days each year. If you want acknowledgment that we
received your comments, please include a self-addressed, stamped
envelope or postcard or print the acknowledgement page that appears
after submitting comments on-line.
    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.

FOR FURTHER INFORMATION CONTACT: For information concerning this
notice, contact Ms. Nicole Michel, Research Division, Office of
Analysis, Research and Technology, FMCSA, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001,<PHONE_NUMBER><EMAIL_ADDRESS>If
you have questions on viewing or submitting material to the docket,
contact Docket Services at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2019-0054), indicate the specific question of this
document to which each comment applies, and provide a source for your
data. 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 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,
put the docket number, FMCSA-2019-0054, in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, 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.

Confidential Business Information

    Confidential Business Information (CBI) is commercial or financial
information that is customarily not made available to the general
public by the submitter. Under the Freedom of Information Act, CBI is
eligible for protection from public disclosure. If you have CBI that is
relevant or responsive to this notice, it is important that you clearly
designate the submitted comments as CBI. Accordingly, please mark each
page of your submission as ``confidential'' or ``CBI.'' Submissions
designated as CBI and meeting the definition noted above will not be
placed in the public docket of this notice. Submissions containing CBI
should be sent to Mr. Brian Dahlin, Chief, Regulatory Evaluation
Division, Federal Motor Carrier Safety Administration, 1200 New Jersey
Avenue SE, Washington, DC 20590-0001. Any commentary that FMCSA
receives which is not specifically designated as CBI will be placed in
the public docket for this notice.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble as being available in the docket, go to http://www.regulations.gov. Insert the docket number, FMCSA-2019-0054, in the
keyword box, and click ``Search.'' Next, click the ``Open Docket
Folder'' button and choose the document to review. If you do not have
access to the internet, you may view the docket by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

II. Background

    A number of studies have examined the issue of CMV driver delays in
the loading and unloading process, and what their potential impact may
be on roadway safety and the economy. For example, in 2011 the
Government Accountability Office (GAO), in its report More Could Be
Done to Determine Impact of Excessive Loading and Unloading Wait Times
on Hours of

Service Violations (GAO-11-198),\1\ recommended that ``FMCSA examine
the extent to which detention time contributes to hours of service
violations in its future studies on driver fatigue and detention
time.'' In response to the GAO report, FMCSA sponsored a study \2\
among a sample of carriers which generated estimates of driver delay
times. Among the sampled carriers, the study found that drivers
experienced detention time during approximately 10 percent of their
stops for an average duration of 1.4 hours beyond a commonly accepted
two-hour loading and unloading period [total driver wait time =
(legitimate loading/unloading time) + (delay times)]. Most recently, in
a 2018 report titled Estimates Show Commercial Driver Detention
Increases Crash Risks and Costs, but Current Data Limit Further
Analysis,\3\ DOT's Office of Inspector General recommended that FMCSA
collaborate with industry stakeholders to develop and implement a plan
to collect and analyze reliable, accurate, and representative data on
the frequency and severity of driver detention.
---------------------------------------------------------------------------

    \1\ https://www.gao.gov/assets/320/315297.pdf.
    \2\ Driver Detention Times in Commercial Motor Vehicle
Operations (December 2014), https://rosap.ntl.bts.gov/view/dot/194/dot_194_DS1.pdf?
    \3\ https://www.oig.dot.gov/library-item/36237.
---------------------------------------------------------------------------

    Although the above referenced studies estimated overall wait times,
they were not able to separate normal loading and unloading times
(e.g., the time it would usually take to load and unload a CMV under
typical schedules) from detention time (delays in the start of the
loading and unloading process which disrupt the driver's available
driving and/or on-duty time). This is a critical data gap in our
understanding of the detention issue.
    FMCSA is interested in data sources, methodologies, and potential
technologies that could provide insight into loading and unloading
delays experienced by CMV drivers.

III. Request for Information

    Specifically, FMCSA requests information that addresses the
following questions:
    1. Are data currently available that can accurately record loading,
unloading, and delay times?
    2. Is there technology available that could record and delineate
prompt loading and unloading times versus the extended delays sometimes
experienced by drivers?
    3. How can delay times be captured and recorded in a systematic,
comparable manner?
    4. Could systematic collection and publication of loading,
unloading, and delay times be useful in driver or carrier business
decisions and help to reduce loading, unloading, and delay times?
    5. What should FMCSA use as an estimate of reasonable loading/
unloading time? Please provide a basis for your response.
    6. How do contract arrangements between carriers and shippers
address acceptable wait times? Do these arrangements include penalties
for delays attributable to a carrier or shipper?
    7. What actions by FMCSA, within its current statutory authority,
would help to reduce loading, unloading, and delay times?

    Issued under authority delegated in 49 CFR 1.87 on: June 4,
2019.
Raymond P. Martinez,
Administrator.
[FR Doc. 2019-12167 Filed 6-7-19; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Proposed Rules]
[Pages 69157-69158]
[FR Doc No: 2011-28859]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1224; Directorate Identifier 2011-NM-175-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 &
440) airplanes. This proposed AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    There have been several occurrences of the air driven generator
(ADG) failure to power essential buses during functional tests of
the ADG. It was found that the low threshold setting of the circuit
protection on the ADG generator control unit (GCU) can prevent the
supply of power from the ADG to the essential buses. In the event of
an emergency, loss of power to the essential buses can prevent
continued safe flight.
* * * * *
    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by December 23,
2011.

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
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.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: Assata Dessaline, Aerospace Engineer,
Avionics and Flight Test Branch, ANE-172, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; 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-2011-1224;
Directorate Identifier 2011-NM-175-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

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2011-26, dated July 25, 2011 (referred to after this as ``the MCAI''),
to correct an unsafe condition for the specified products. The MCAI
states:

    There have been several occurrences of the air driven generator
(ADG) failure to power essential buses during functional tests of
the ADG. It was found that the low threshold setting of the circuit
protection on the ADG generator control unit (GCU) can prevent the
supply of power from the ADG to the essential buses. In the event of
an emergency, loss of power to the essential buses can prevent
continued safe flight.
    This [TCCA] directive mandates the replacement of the ADG GCU.

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

Relevant Service Information

    Bombardier, Inc. has issued Service Bulletin 601R-24-130, dated
April 27, 2011. 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.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 589 products of U.S. registry. We also estimate that
it would take about 2 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 $0 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 $100,130, or $170
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:

Bombardier, Inc.: Docket No. FAA-2011-1224; Directorate Identifier
2011-NM-175-AD.

Comments Due Date

    (a) We must receive comments by December 23, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes, certificated in any
category, serial number 7305 through 7990 inclusive, and 8000
through 8109 inclusive.

Subject

    (d) Air Transport Association (ATA) of America Code 24:
Electrical Power.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    There have been several occurrences of the air driven generator
(ADG) failure to power essential buses during functional tests of
the ADG. It was found that the low threshold setting of the circuit
protection on the ADG generator control unit (GCU) can prevent the
supply of power from the ADG to the essential buses. In the event of
an emergency, loss of power to the essential buses can prevent
continued safe flight.
* * * * *

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 24 months after the effective date of this AD, remove
the ADG GCU, part number (P/N) 604-90800-7, and install a new or
serviceable ADG GCU, P/N 604-90800-27, in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 601R-24-
130, dated April 27, 2011.

Parts Installation

    (h) As of the effective date of this AD, no person may install
an ADG GCU, P/N 604-90800-7, on any airplane.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows:

    No differences.

Other FAA AD Provisions

    (i) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, 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 ACO, send it to Attn: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
10, Westbury, New York 11590; telephone<PHONE_NUMBER>; fax (516)
794-5531. 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

    (j) Refer to MCAI Canadian Airworthiness Directive CF-2011-26,
dated July 25, 2011; and Bombardier Service Bulletin 601R-24-130,
dated April 27, 2011; for related information.

    Issued in Renton, Washington, on October 27, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-28859 Filed 11-7-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 4, 2009 (Volume 74, Number 171)]
[Notices]
[Page 45867-45872]
[DOCID:fr04se09-76]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0233]

Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of availability.

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SUMMARY:  Under the Food and Drug Administration Modernization Act of
1997 (Modernization Act), the Food and Drug Administration (FDA) is
required to report annually in the Federal Register on the status of
postmarketing requirements and commitments required of, or agreed upon,
by holders of approved drug and biological products. This is the
agency's report on the status of the studies and clinical trials that
applicants have agreed to or are required to conduct.

FOR FURTHER INFORMATION CONTACT:
    Cathryn C. Lee, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6464,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
    Robert Yetter, Center for Biologics Evaluation and Research (HFM-
25), Food and Drug Administration, 1400 Rockville Pike, Rockville, MD
20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Modernization Act

    Section 130(a) of the Modernization Act (Public Law 105-115)
amended the Federal Food, Drug, and Cosmetic Act (the act) by adding a
new provision requiring reports of certain postmarketing studies,
including clinical trials, for human drug and biological products
(section 506B of the act (21 U.S.C. 356(b)). Section 506B of the act
provides FDA with additional authority to monitor the progress of a
postmarketing study or clinical trial that an applicant has been
required to or has agreed to conduct by requiring the applicant to
submit a report annually

providing information on the status of the postmarketing study/clinical
trial. This report must also include reasons, if any, for failure to
complete the study/clinical trial. These studies and clinical trials
are intended to further define the safety, efficacy, or optimal use of
a product and therefore play a vital role in fully characterizing the
product.
    Under the Modernization Act, commitments to conduct postmarketing
studies or clinical trials included both studies/clinical trials that
applicants agreed to conduct as well as studies/clinical trials that
applicants were required to conduct under FDA regulations.\1\
---------------------------------------------------------------------------

    \1\ FDA could require postmarketing studies and clinical trials
under the following circumstances: To verify and describe clinical
benefit for a human drug approved in accordance with the accelerated
approval provisions (21 U.S.C. 356(b)(2)(A); 21 CFR 314.510 and
601.41); for a drug approved on the basis of animal efficacy data
because human efficacy trials are not ethical or feasible (21 CFR
314.610(b)(1) and 601.91(b)(1)); and for marketed drugs that are not
adequately labeled for children (Pediatric Research Equity Act (21
U.S.C. 355B; Public Law 108-155)).
---------------------------------------------------------------------------

B. The Food and Drug Administration Amendments Act of 2007

    On September 27, 2007, the President signed Public Law 110-85, the
Food and Drug Administration Amendments Act of 2007 (FDAAA). Section
901, in Title IX of FDAAA, created a new section 505(o) of the act
authorizing FDA to require certain studies and clinical trials for
human drug and biological products approved under section 505 of the
act or section 351 of the Public Health Service Act. Under FDAAA, FDA
has been given additional authority to require applicants to conduct
and report on postmarketing studies and clinical trials to assess a
known serious risk, assess signals of serious risk, or identify an
unexpected serious risk related to the use of a product. This new
authority became effective on March 25, 2008. FDA may now take
enforcement action against applicants who fail to conduct studies and
clinical trials required under FDAAA, as well as studies and clinical
trials required under FDA regulations (see sections 505(o)(1), 502(z),
and 303(f) of the act; 21 U.S.C. 355(o)(1), 352(z), and 333(f)).
    Although regulations implementing the Modernization Act
postmarketing authorities use the term ``postmarketing commitment'' to
refer to both required studies and studies applicants agree to conduct,
in light of the new authorities enacted in FDAAA, FDA has decided it is
important to distinguish between enforceable postmarketing requirements
and unenforceable postmarketing commitments. Therefore, in this notice
and report, FDA refers to studies/clinical trials that an applicant is
required to conduct as ``postmarketing requirements'' (PMRs) and
studies/clinical trials that an applicant agrees to but is not required
to conduct as ``postmarketing commitments'' (PMCs). Both are addressed
in this notice and report.

C. FDA's Implementing Regulations

    On October 30, 2000 (65 FR 64607), FDA published a final rule
implementing section 130 of the Modernization Act. This rule modified
the annual report requirements for new drug applications (NDAs) and
abbreviated new drug applications (ANDAs) by revising Sec.
314.81(b)(2)(vii) (21 CFR 314.81(b)(2)(vii)). The rule also created a
new annual reporting requirement for biologics license applications
(BLAs) by establishing Sec.  601.70 (21 CFR 601.70). The rule described
the content and format of the annual progress report, and clarified the
scope of the reporting requirement and the timing for submission of the
annual progress reports. The rule became effective on April 30, 2001.
The regulations apply only to human drug and biological products that
are approved under NDAs, ANDAs, and BLAs. They do not apply to animal
drugs or to biological products regulated under the medical device
authorities.
    The reporting requirements under Sec. Sec.  314.81(b)(2)(vii) and
601.70 apply to PMRs and PMCs made on or before the enactment of the
Modernization Act (November 21, 1997), as well as those made after that
date. Therefore, studies and clinical trials required under FDAAA are
covered by the reporting requirements in these regulations.
    Sections 314.81(b)(2)(vii) and 601.70 require applicants of
approved drug and biological products to submit annually a report on
the status of each clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical toxicology study/clinical trial that is
required by FDA or that they have committed to conduct either at the
time of approval or after approval of their NDA, ANDA, or BLA. The
status of PMCs concerning chemistry, manufacturing, and production
controls and the status of other studies/clinical trials conducted on
an applicant's own initiative are not required to be reported under
Sec. Sec.  314.81(b)(2)(vii) and 601.70 and are not addressed in this
report. It should be noted, however, that applicants are required to
report to FDA on these commitments made for NDAs and ANDAs under Sec.
314.81(b)(2)(viii). Furthermore, section 505(o)(1)(E) of the act as
amended by FDAAA requires that applicants report periodically on the
status of each required study/clinical trial and each study/clinical
trial ``otherwise undertaken * * * to investigate a safety issue * * *
.''
    According to the regulations, once a PMR has been required or a PMC
has been agreed upon, an applicant must report on the progress of the
PMR/PMC on the anniversary of the product's approval until the PMR/PMC
is completed or terminated and FDA determines that the PMR/PMC has been
fulfilled or that the PMR/PMC is either no longer feasible or would no
longer provide useful information. The annual progress report must
include a description of the PMR/PMC, a schedule for completing the
PMR/PMC, and a characterization of the current status of the PMR/PMC.
The report must also provide an explanation of the PMR/PMC status by
describing briefly the progress of the PMR/PMC. A PMR/PMC schedule is
expected to include the actual or projected dates for the following:
(1) Submission of the final protocol to FDA, (2) completion of subject
accrual or initiation of an animal study, (3) completion of the study/
clinical trial, and (4) submission of the final report to FDA. The
status of the PMR/PMC must be described in the annual report according
to the following definitions:
     Pending: The study/clinical trial has not been initiated
(i.e., no subjects have been enrolled or animals dosed), but does not
meet the criteria for delayed (i.e., the original projected date for
initiation of subject accrual or initiation of animal dosing has not
passed);
     Ongoing: The study/clinical trial is proceeding according
to or ahead of the original schedule;
     Delayed: The study/clinical trial is behind the original
schedule;
     Terminated: The study/clinical trial was ended before
completion, but a final report has not been submitted to FDA; or
     Submitted: The study/clinical trial has been completed or
terminated, and a final report has been submitted to FDA.
    Databases containing information on PMRs/PMCs are maintained at the
Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER).

II. Summary of Information From Postmarketing Status Reports

    This report, published to fulfill the annual reporting requirement
under the Modernization Act, summarizes the status of PMRs and PMCs as
of September 30, 2008. If a requirement or commitment did not have a
schedule, or

a postmarketing progress report was not received in the previous 12
months, the PMR/PMC is categorized according to the most recent
information available to the agency.
    Information in this report covers any PMR/PMC that was made, in
writing, at the time of approval or after approval of an application or
a supplement to an application, including PMRs required under FDAAA
(section 505(o)(3) of the act), PMRs required under FDA regulations
(e.g., PMRs required to demonstrate clinical benefit of a product
following accelerated approval (see footnote 1 of this document)), and
PMCs agreed to by the applicant.
    Information summarized in this report includes the following: (1)
The number of applicants with open (uncompleted) PMRs/PMCs, (2) the
number of open PMRs/PMCs, (3) the status of open PMRs/PMCs as reported
in Sec.  314.81(b)(2)(vii) or Sec.  601.70 annual reports, (4) the
status of concluded PMRs/PMCs as determined by FDA, and (5) the number
of applications with open PMRs/PMCs for which applicants did not submit
an annual report within 60 days of the anniversary date of U.S.
approval.
    Additional information about PMRs/PMCs submitted by applicants to
CDER and CBER is provided on FDA's Web site at http://www.fda.gov/
Drugs/GuidanceComplianceRegulatoryInformation/Post-
marketingPhaseIVCommitments/default.htm. Neither the Web site nor this
notice include information about PMCs concerning chemistry,
manufacturing, and controls. It is FDA policy not to post information
on the Web site until it has been reviewed for accuracy. Numbers
published in this notice cannot be compared with the numbers resulting
from searches of the Web site because this notice incorporates totals
for all PMRs/PMCs in FDA databases, including PMRs/PMCs undergoing
review for accuracy. In addition, the report in this notice will be
updated annually while the Web site is updated quarterly (i.e.,
January, April, July, and October).
    Many applicants have more than one approved product and for many
products there is more than one PMR or PMC. Specifically, there were
158 unique applicants with 297 NDAs/ANDAs that had open PMRs/PMCs.
There were 54 unique applicants with 94 BLAs that had open PMRs/PMCs.
    Annual status reports are required to be submitted for each open
PMR/PMC within 60 days of the anniversary date of U.S. approval of the
original application. In fiscal year (FY) 2008, 27 percent (59/215) of
NDA/ANDA and 52 percent (43/83) of BLA annual status reports were
reported late or were overdue at the close of the FY, September 30,
2008. Of the annual status reports due but not submitted within 60 days
of the anniversary date of U.S. approval of the original application,
100 percent (59/59) of the NDA/ANDA and 42 percent (18/43) of the BLA
reports were submitted before September 30, 2008.
    Most PMRs are progressing on schedule (95 percent for NDAs/ANDAs;
89 percent for BLAs). Most PMCs are also progressing on schedule (96
percent for NDAs/ANDAs; 78 percent for BLAs). Most of the PMCs that are
currently listed in the database were developed before the
postmarketing requirements section of FDAAA took effect.\2\
---------------------------------------------------------------------------

    \2\ Although there are PMCs that might meet FDAAA standards for
required safety studies/clinical trials under section 505(o)(3)(B)
of the act (21 U.S.C. 355(o)(3)(B)) if they were first determined to
be necessary today, they may be converted to PMRs only if FDA
becomes aware of new safety information.
---------------------------------------------------------------------------

III. What's New About This Report

    This report now provides six separate tables instead of one summary
table. The tables distinguish between PMRs and PMCs and between on-
schedule and off-schedule PMRs and PMCs according to the original
schedule milestones. On-schedule PMRs/PMCs are categorized as pending,
ongoing, or submitted. Off-schedule PMRs/PMCs that have missed one of
the original milestone dates are categorized as delayed or terminated.
The tables include data as of September 30, 2008.
    Table 1 of this document provides an overall summary of the data on
all PMRs and PMCs. Tables 2 and 3 of this document provide detail on
PMRs. Table 2 of this document provides additional detail on the status
of on-schedule PMRs.
    Table 1 of this document shows that most PMRs (95 percent for NDAs/
ANDAs and 89 percent for BLAs) and most PMCs (96 percent for NDAs/ANDAs
and 78 percent for BLAs) are on schedule. Overall, of the PMRs that are
pending (i.e., have not been initiated), 73 percent were created within
the past 3 years.
    Table 2 of this document shows that most pending PMRs for both drug
and biological products are in response to the Pediatric Research and
Equity Act (PREA), under which FDA requires sponsors to study new
drugs, when appropriate, for pediatric populations. Under section
505B(a)(3) of the act, the initiation of these studies generally is
deferred until required safety information from other studies has first
been submitted and reviewed. PMRs for products approved under the
animal efficacy rule (21 CFR 314.600 for drugs; 21 CFR 601.90 for
biological products) can be conducted only when the product is used for
its indication as a counterterrorism measure. In the absence of a
public health emergency, these studies/clinical trials will remain
pending indefinitely. The next largest category of pending PMRs
comprises those studies/clinical trials required by FDA under FDAAA,
which became effective on March 25, 2008.
    Section 921 of FDAAA requires FDA to review the backlog of
postmarketing safety commitments and report to Congress. CDER
contracted with an external group to review the backlog of its PMRs/
PMCs as well as PMR/PMC annual status reports.\3\ The contractors's
report was recently completed and can be found on the FDA Web site at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-
marketingPhaseIVCommitments/ucm064436.htm. As Exhibit 9 of the report
shows, the external review has resulted in a decreased number of NDA
PMRs/PMCs categorized as pending because their statuses have been
updated to other categories (e.g., submitted). Some of this decrease is
reflected in the NDA statistics reported in this notice, which shows
the status of the PMRs/PMCs as of September 30, 2008, and additional
status changes will be reflected in the statistics reported in the next
annual notice showing the status of the PMRs/PMCs as of September 30,
2009.
---------------------------------------------------------------------------

    \3\ The external backlog review covered PMRs/PMCs for NDAs and
CDER-regulated BLAs. CBER conducted a separate backlog review of the
CBER-regulated BLAs.

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

    Table 3 of this document provides additional detail on the status
of off-schedule PMRs. The majority of off-schedule PMRs (which account
for only 5 percent of the total for NDAs/ANDAs and 11 percent for BLAs)
are delayed according to the original schedule milestones (93 percent
(13/14) for NDAs/ANDAs; 71 percent (5/7) for BLAs). However, after
discussion between FDA and applicants, the original schedules may have
been adjusted for unanticipated delays in the progress of the study/
clinical trial (e.g., difficulties with subject enrollment in a trial
for a marketed drug or need for additional time to analyze results). In
this report, study status reflects the status in relation to the
original study schedule regardless of whether adjustments to the
schedule have been made.
    Tables 4 and 5 of this document provide additional detail on the
status of PMCs. Table 4 provides additional detail on the status of on-
schedule PMCs. Pending PMCs comprise 56 percent (544/965) of the on-
schedule NDA and ANDA PMCs and 40 percent (112/279) of the on-schedule
BLA PMCs.
    Table 5 of this document provides additional details on the status
of off-schedule PMCs. The majority of off-schedule PMCs (which account
for only 4 percent for NDAs/ANDAs and 22 percent for BLAs) are delayed
according to the original schedule milestones (91 percent (39/43) for
NDAs/ANDAs; 97 percent (76/78) for BLAs). However, after discussion
between FDA and applicants, the original schedules may have been
adjusted for unanticipated delays in the progress of the study/clinical
trial (e.g., difficulties with subject enrollment in a trial for a
marketed drug or need for additional time to analyze results).
    Table 6 of this document provides details about PMRs and PMCs that
were concluded in the previous year. Most concluded PMRs and PMCs were
fulfilled (80 percent of NDA/ANDA PMRs and 70 percent of BLA PMRs; 86
percent of NDA/ANDA PMCs and 97 percent of BLA PMCs).

Table 1.--Summary of Postmarketing Requirements and Commitments (Numbers
                        as of September 30, 2008)
------------------------------------------------------------------------
               NDA/ANDA (% of Total PMR or   BLA (% of Total PMR or % of
                     % of Total PMC)                Total PMC)\1\
------------------------------------------------------------------------
Number of                              306                            65
 open PMRs
------------------------------------------------------------------------
  On-                            292 (95%)                      58 (89%)
   schedule
   open PMRs
   (see
   table 2
   of this
   document)
------------------------------------------------------------------------
  Off-                             14 (5%)                       7 (11%)
   schedule
   open PMRs
   (see
   table 3
   of this
   document)
------------------------------------------------------------------------
Number of                            1,008                           357
 open PMCs
------------------------------------------------------------------------
  On-                            965 (96%)                     279 (78%)
   schedule
   open PMCs
   (see
   table 4
   of this
   document)
------------------------------------------------------------------------
  Off-                             43 (4%)                      78 (22%)
   schedule
   open PMCs
   (see
   table 5
   of this
   document)
------------------------------------------------------------------------
\1\ On October 1, 2003, FDA completed a consolidation of certain
  therapeutic products formerly regulated by CBER into CDER.
  Consequently, CDER now reviews many BLAs. Fiscal year statistics for
  postmarketing requirements and commitments for BLAs reviewed by CDER
  are included in BLA totals in this table.

 Table 2.--Summary of On-Schedule Postmarketing Requirements (Numbers as
                         of September 30, 2008)
------------------------------------------------------------------------
 On-Schedule
  Open PMRs     NDA/ANDA (% of Total PMR)      BLA (% of Total PMR)\1\
------------------------------------------------------------------------
Pending by type
------------------------------------------------------------------------
  Accelerate                            15                             3
   d
   approval
------------------------------------------------------------------------
  PREA\2\                              194                            24
------------------------------------------------------------------------
  Animal                                 2                             0
   efficacy\
   3\
------------------------------------------------------------------------
  FDAAA                                 30                            12
   safety
   (since
   March 25,
   2008)
------------------------------------------------------------------------
  Total                          241 (79%)                      39 (60%)
------------------------------------------------------------------------
Ongoing
------------------------------------------------------------------------
  Accelerate                            17                             3
   d
   approval
------------------------------------------------------------------------
  PREA\2\                               13                             6
------------------------------------------------------------------------
  Animal                                 0                             0
   efficacy\
   3\
------------------------------------------------------------------------
  FDAAA                                  0                             4
   safety
   (since
   March 25,
   2008)
------------------------------------------------------------------------
  Total                           30 (10%)                      13 (20%)
------------------------------------------------------------------------
Submitted
------------------------------------------------------------------------
  Accelerate                            12                             2
   d
   approval
------------------------------------------------------------------------
  PREA\2\                                9                             4
------------------------------------------------------------------------

  Animal                                 0                             0
   efficacy\
   3\
------------------------------------------------------------------------
  FDAAA                                  0                             0
   safety
   (since
   March 25,
   2008)
------------------------------------------------------------------------
  Total                           21 (12%)                        6 (9%)
------------------------------------------------------------------------
Combined                         292 (95%)                      58 (89%)
 Total
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.
\2\ Many PREA studies have a pending status. PREA studies are usually
  deferred because the product is ready for approval in adults.
  Initiation of these studies also may be deferred until additional
  safety information from other studies has first been submitted and
  reviewed.
\3\ PMRs for products approved under the animal efficacy rule (21 CFR
  314.600 for drugs; 21 CFR 601.90 for biological products) can be
  conducted only when the product is used for its indication as a
  counterterrorism measure. In the absence of a public health emergency,
  these studies/clinical trials will remain pending indefinitely.

Table 3.--Summary of Off-Schedule Postmarketing Requirements (Numbers as
                         of September 30, 2008)
------------------------------------------------------------------------
Off-Schedule
  Open PMRs     NDA/ANDA (% of Total PMR)      BLA (% of Total PMR)\1\
------------------------------------------------------------------------
Delayed
------------------------------------------------------------------------
  Accelerate                             4                             2
   d
   approval
------------------------------------------------------------------------
  PREA                                   9                             3
------------------------------------------------------------------------
  Animal                                 0                             0
   efficacy
------------------------------------------------------------------------
  FDAAA                                  0                             0
   safety
   (since
   March 25,
   2008)
------------------------------------------------------------------------
  Total                            13 (4%)                        5 (8%)
------------------------------------------------------------------------
Terminated                        1 (0.3%)                        2 (3%)
------------------------------------------------------------------------
Combined                           14 (5%)                       7 (11%)
 total
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

 Table 4.--Summary of On-Schedule Postmarketing Commitments (Numbers as
                         of September 30, 2008)
------------------------------------------------------------------------
 On-Schedule
  Open PMCs     NDA/ANDA (% of Total PMC)      BLA (% of Total PMC)\1\
------------------------------------------------------------------------
Pending                          544 (54%)                     112 (31%)
------------------------------------------------------------------------
Ongoing                          166 (17%)                      93 (26%)
------------------------------------------------------------------------
Submitted                        255 (25%)                      74 (21%)
------------------------------------------------------------------------
Combined                         965 (96%)                     279 (78%)
 total
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

 Table 5.--Summary of Off-Schedule Postmarketing Commitments (Numbers as
                         of September 30, 2008)
------------------------------------------------------------------------
Off-Schedule
  Open PMCs     NDA/ANDA (% of Total PMC)      BLA (% of Total PMC)\1\
------------------------------------------------------------------------
Delayed                            39 (4%)                      76 (21%)
------------------------------------------------------------------------
Terminated                        4 (0.4%)                        2 (1%)
------------------------------------------------------------------------
Combined                           43 (4%)                      78 (22%)
 total
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

      Table 6.--Summary of Concluded Postmarketing Requirements and
            Commitments (October 1, 2007 to October 1, 2008)
------------------------------------------------------------------------
                  NDA/ANDA (% of Total)          BLA (% of Total)\1\
------------------------------------------------------------------------
Concluded PMRs
------------------------------------------------------------------------
  Requiremen                      12 (80%)                       7 (70%)
   t met
   (fulfille
   d)
------------------------------------------------------------------------

  Requiremen                        1 (7%)                             0
   t not met
   (released
   and new
   revised
   requireme
   nt
   issued)
------------------------------------------------------------------------
  Requiremen                       2 (13%)                       3 (30%)
   t no
   longer
   feasible
   or
   product
   withdrawn
   (released
   )
------------------------------------------------------------------------
  Total                                 15                            10
------------------------------------------------------------------------
Concluded PMCs
------------------------------------------------------------------------
  Commitment                      94 (86%)                      30 (97%)
   met
   (fulfille
   d)
------------------------------------------------------------------------
  Commitment                        3 (3%)                             0
   not met
   (released
   and new
   revised
   requireme
   nt/
   commitmen
   t issued)
------------------------------------------------------------------------
  Commitment                      12 (11%)                        1 (3%)
   no longer
   feasible
   or
   product
   withdrawn
   (released
   )
------------------------------------------------------------------------
  Total                                109                            31
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

    Dated: August 31, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21302 Filed 9-3-09; 8:45 am]

BILLING CODE 4160-01-S


                                MEMO TO RECORD

DATE:		August 15, 2011
TO:		Record
FROM:		Paul Shriner, EPA
SUBJECT:    Section 316(b) Existing Facility Proposed Rule Record

In developing the Section 316(b) Existing Facility proposal, EPA relied on materials contained in the dockets for the Phase I, Phase II, and Phase III rules.  The Existing Facility rule docket (Docket ID EPA-HQ-OW-2008-0667) incorporates and includes all materials from:

1) the Phase I hard copy docket "National Pollutant Discharge Elimination System: Regulations Addressing Cooling Water Intake Structures for New Facilities; Final Rule" (paper docket W-00-32)
2) the Phase I docket "National Pollutant Discharge Elimination System - Amendment of Final
Regulations Addressing Cooling Water Intake Structures for New Facilities" (Docket ID EPA-HQ-OW-2002-0052)
3) the Phase II docket "National Pollutant Discharge Elimination System - Regulations To
Establish Requirements for Cooling Water Intake Structures at Phase II Existing Facilities"
(Docket ID EPA-HQ-OW-2002-0049)
4) the Phase III docket "National Pollutant Discharge Elimination System - Regulations To Establish Requirements for Cooling Water Intake Structures at Phase III Facilities" (Docket ID EPA-HQ-OW-2004-0002)

EPA has assigned each Section 316(b) record item a document control number (DCN).  In the
Section 316(b) record, the DCN number is a five digit number, where the first digit is used to identify the rulemaking phase in which the item was first identified, created, or submitted to
EPA's Section 316(b) record; see Exhibit 1.

Exhibit 1: Using the DCN to identify Phases of the Section 316(b) Record
DCN number
Corresponding Section 316(b) Record
1-xxxx
Phase I proposal materials
2-xxxx
Phase I Notice of Data Availability (NODA) materials
3-xxxx
Phase I final rule materials, public comments on the Phase I proposed rule, and public comments on the Phase I NODA
4-xxxx
Phase II proposal materials
5-xxxx
Phase II Notice of Data Availability materials
6-xxxx
Phase II final rule materials, public comments on the Phase II proposed rule, and public comments on the Phase II NODA
7-xxxx
Phase III proposal materials
8-xxxx
Phase III Notice of Data Availability materials
9-xxxx
Phase III final rule materials, public comments on Phase III proposed rule, and public comments on the Phase III NODA
10-xxxx
Reserved for Existing Facility proposal materials
11-xxxx
Reserved for Existing Facility Notice of Data Availability materials
12-xxxx
Reserved for Existing Facility final rule materials, public comments on the Existing Facility proposed rule, and public comments on the Existing Facility NODA

Inclusion of Phase I, Phase II, and Phase III record materials in this Existing Facility Rule docket does not in any way re-open the Phase I, Phase II or Phase III final rules.  The Existing Facility proposal is an entirely separate rulemaking proceeding.  EPA will not consider comments submitted in connection with the Phase I, Phase II or Phase III proceedings to be comments on the Existing Facility proposal.  Members of the public interested in commenting on the Existing Facility proposal must follow the procedures set forth in the Federal Register notice for submission of those comments.


[Federal Register Volume 75, Number 223 (Friday, November 19, 2010)]
[Notices]
[Pages 70963-70965]
[FR Doc No: 2010-29168]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2010-0151; Notice 1]

General Motors Corporation, Receipt of Petition for Decision of
Inconsequential Noncompliance

    General Motors Corporation (GM),\1\ has determined that
approximately 1,113 Model Year (MY) 2011 Buick Regal passenger cars do
not fully comply with paragraph S4.3(d) of 49 CFR 571.110, Federal
Motor Vehicle Safety Standard (FMVSS) No. 110, Tire Selection and Rims
for Motor Vehicles With a GVWR of 4,536 Kilograms (10,000 pounds) or
Less. GM filed an appropriate report pursuant to 49 CFR part 573,
Defect and Noncompliance Responsibility and Reports dated July 26,
2010.
---------------------------------------------------------------------------

    \1\ General Motors LLC (GM) is vehicle manufacturer incorporated
under the laws of the state of Michigan.
---------------------------------------------------------------------------

    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), GM has petitioned for an exemption from the
notification and remedy requirements of 49 U.S.C. Chapter 301 on the
basis that this noncompliance is inconsequential to motor vehicle
safety.
    This notice of receipt of GM's, petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    Affected are approximately 1,113 model year 2011 Buick Regal
passenger cars manufactured between January 20, 2010, and May 18, 2010
at GM's R[uuml]sselsheim assembly plant.

    The National Highway Traffic Safety Administration (NHTSA) notes
that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that
permit manufacturers to file petitions for a determination of
inconsequentiality allow NHTSA to exempt manufacturers only from the
duties found in sections 30118 and 30120, respectively, to notify
owners, purchasers, and dealers of a defect or noncompliance and to
remedy the defect or noncompliance. Therefore, these provisions only
apply to the 1,113 \2\ vehicles that have already passed from the
manufacturer to an owner, purchaser, or dealer.
---------------------------------------------------------------------------

    \2\ GM's petition, which was filed under 49 CFR part 556,
requests an agency decision to exempt GM as a manufacturer from the
notification and recall responsibilities of 49 CFR part 573 for
1,113 of the affected vehicles. However, the agency cannot relieve
GM distributors of the prohibitions on the sale, offer for sale, or
introduction or delivery for introduction into interstate commerce
of the noncompliant vehicles under their control after GM recognized
that the subject noncompliance existed.
---------------------------------------------------------------------------

    Paragraph S4.3 of FMVSS No. 110 requires in pertinent part:

    S4.3 Placard. Each vehicle, except for a trailer or incomplete
vehicle, shall show the information specified in S4.3 (a) through
(g), and may show, at the manufacturer's option, the information
specified in S4.3 (h) and (i), on a placard permanently affixed to
the driver's side B-pillar. In each vehicle without a driver's side
B-pillar and with two doors on the driver's side of the vehicle
opening in opposite directions, the placard shall be affixed on the
forward edge of the rear side door. If the above locations do not
permit the affixing of a placard that is legible, visible and
prominent, the placard shall be permanently affixed to the rear edge
of the driver's side door. If this location does not permit the
affixing of a placard that is legible, visible and prominent, the
placard shall be affixed to the inward facing surface of the vehicle
next to the driver's seating position. This information shall be in
the English language and conform in color and format, not including
the border surrounding the entire placard, as shown in the example
set forth in Figure 1 in this standard. At the manufacturer's
option, the information specified in S4.3 (c), (d), and, as
appropriate, (h) and (i) may be shown, alternatively to being shown
on the placard, on a tire inflation pressure label which must
conform in color and format, not including the border surrounding
the entire label, as shown in the example set forth in Figure 2 in
this standard. The label shall be permanently affixed and proximate
to the placard required by this paragraph. The information specified
in S4.3 (e) shall be shown on both the vehicle placard and on the
tire inflation pressure label (if such a label is affixed to provide
the information specified in S4.3 (c), (d), and, as appropriate, (h)
and (i)) may be shown in the format and color scheme set forth in
Figures 1 and 2. * * *
    (d) Tire size designation, indicated by the headings ``size'' or
``original tire size'' or ``original size,'' and ``spare tire'' or
``spare,'' for the tires installed at the time of the first purchase
for purposes other than resale. For full size spare tires, the
statement ``see above'' may, at the manufacturer's option replace
the tire size designation. If no spare tire is provided, the word
``none'' must replace the tire size designation; * * *

    GM explains that the noncompliance with FMVSS No. 110 is the
omission of the letter ``T'' in the spare tire size printed on the tire
and loading information labels that it affixed to the vehicles.
Currently the tire size designation shows the spare tire size as ``125/
80R16'' instead of ``T125/80R16.''
    GM reported that the noncompliance was brought to their attention
in May of 2010 by the Global Subsystem Leadership Team during an
internal audit in the R[uuml]sselsheim Assembly Plant.
    GM additionally stated that it believes that this noncompliance is
inconsequential to motor vehicle safety for the following reasons:
    (1) All information for maintaining and/or replacing the front and
rear tires, as well as the seating capacity and vehicle capacity weight
are correct on tire and loading information labels on the subject
vehicles.
    (2) The vehicles are equipped with spare tires that have the
complete tire size (T125/80R16) molded their sidewalls.
    (3) When a customer needs to replace the spare tire, he/she will
take the vehicle to a tire store. The tire store will know what compact
spare tire is needed based on the information in their catalog or by
looking at the spare tire provided with the vehicle. In the case, they
were to refer to the tire and loading information label, it will show
the spare tire size 125/80R16 without the letter T. The only tire
available with the size designation of 125/80R16 is the compact spare
tire T125/80R16, and should not cause any confusion or error.
    (4) Risk to the public is negligible because the vehicles are
equipped with the correct spare tire, and the tire and loading
information label does have the correct inflation pressure for the
compact spare tire.
    (5) GM is not aware of any incidents or injuries related to the
subject condition.
    GM has additionally informed NHTSA that it has corrected the
noncompliance so that all future production vehicles will have
compliant labels.
    In summation, GM believes that the described noncompliance of its
vehicles to meet the requirements of FMVSS No. 110 is inconsequential
to motor vehicle safety, and that its petition, to exempt from
providing recall notification of noncompliance as required by 49 U.S.C.
30118 and remedying the recall noncompliance as required by 49 U.S.C.
30120, and should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance.
    Interested persons are invited to submit written data, views, and
arguments on this petition. Comments must refer to the docket and
notice number cited at the beginning of this notice and be submitted by
any of the following methods:
    a. By mail addressed to: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
    b. By hand delivery to U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590. The Docket Section is open on
weekdays from 10 a.m. to 5 p.m. except Federal Holidays.
    c. Electronically: By logging onto the Federal Docket Management
System (FDMS) Web site at http:[sol][sol]www.regulations.gov/. Follow
the online instructions for submitting comments. Comments may also be
faxed to 1-202-493-2251.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to
http:[sol][sol]www.regulations.gov, including any personal information
provided.
    Anyone is able to search the electronic form of all 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.). DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

    You may view documents submitted to a docket at the address and
times given above. You may also view the documents on the Internet at
http:[sol][sol]www.regulations.gov by following the online instructions
for accessing the dockets available at that Web site.
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.
    Comment closing date: December 20, 2010

    Authority:  49 U.S.C. 30118, 30120: Delegations of authority at
CFR 1.50 and 501.8.

    Issued on: November 15, 2010.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2010-29168 Filed 11-18-10; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 87, Number 249 (Thursday, December 29, 2022)]
[Notices]
[Pages 80183-80184]
[FR Doc No: 2022-28310]

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ENVIRONMENTAL PROTECTION AGENCY

[CERCLA 01-2022-0056 and 01-2022-0057; FRL-10526-01-R1]

Proposed CERCLA Administrative Settlement Agreement for Removal
Action by Prospective Purchaser and Proposed CERCLA Administrative Cost
Recovery Settlement: Wells G&H Superfund Site, Woburn, Massachusetts

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed settlement; request for public comments.

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SUMMARY: Notice is hereby given by EPA Region 1 of a proposed
settlement comprised of two administrative agreements, an
administrative Settlement Agreement under Section 122(h)(1) of the
Comprehensive Environmental Response, Compensation and Liability Act
(``CERCLA'') (``122(h) Agreement''), In the Matter of: Wells G&H
Superfund Site, Woburn, MA: Olympia Nominee Trust et al., EPA Region 1,
CERCLA Docket No. 01-2022-0057, and an Administrative Settlement
Agreement for Removal Action by Prospective Purchaser (``PPA''), In the
Matter of: Wells G&H Superfund Site, Woburn, MA: IV5 60 Oympia Ave LLC
et al., EPA Region 1, CERCLA Docket No. 01-2022-0056.

DATES: Comments must be submitted by January 30, 2023.

ADDRESSES: Comments should be addressed to RuthAnn Sherman, Senior
Enforcement Counsel, Office of Regional Counsel, U.S. Environmental
Protection Agency, 5 Post Office Square, Suite 100 (04-2), Boston, MA
02109-3912,<PHONE_NUMBER>, [email protected], and should
reference the Wells G&H Superfund Site, U.S. EPA Docket Nos: CERCLA 01-
2022-0056 and CERCLA 01-2022-0057.

FOR FURTHER INFORMATION CONTACT: A copy of the proposed settlement may
be obtained from RuthAnn Sherman, Senior Enforcement Counsel, Office of
Regional Counsel, U.S. Environmental Protection Agency, Region I, 5
Post Office Square, Suite 100 (04-2), Boston, MA 02109-3912, telephone
number:<PHONE_NUMBER>, email address: [email protected].

SUPPLEMENTARY INFORMATION: The EPA and the respective nonfederal
parties have signed these agreements and the settlement has been
approved by the Environmental and Natural Resources Division of the
United States Department of Justice. The settlement is for recovery of
response costs and performance of a response action related to two
parcels totaling 21.3 acres (the ``Property''), located within the 330-
acre Wells G&H Superfund Site, in Woburn, Massachusetts (the ``Site'').
Under the 122(h) Agreement, three current and former owners and
operators of the Property (collectively, ``Olympia'') will pay $1.2
million in reimbursement of past response costs paid by the United
States in connection with an ongoing removal action at the Property,
started by Olympia approximately 18 years ago. Under the PPA, two non-
liable prospective purchasers will enhance and accelerate the removal
action, including the cleanup of trichloroethylene in soils and
volatile organic compounds in groundwater, pay 80% of EPA's future
oversight costs, and pay 100% of the United States' other future
response costs. The prospective purchasers in the PPA are: IV5 60
OLYMPIA AVE LLC and IV5 60 OLYMPIA AVE LAND LLC; and the Settling
Parties in the 122(h) Agreement are: Olympia Nominee Trust, Olympia
Aberjona, LLC, and Juniper Development Group LLC. The settlement has
been approved by the Environmental and Natural Resources Division of
the United States Department of Justice. For 30 days following the date
of publication of this notice, the United States will receive

written comments relating to the settlement. The United States will
consider all comments received and may modify or withdraw its consent
to this settlement if comments received disclose facts or
considerations which indicate that the settlement is inappropriate,
improper, or inadequate. The United States' response to any comments
received will be available for public inspection at the Environmental
Protection Agency--Region 1, 5 Post Office Square, Suite 100, Boston,
MA 02109-3912.
    This proposed settlement comprised of two administrative agreements
concerning the Wells G&H Superfund Site, located in Woburn, Middlesex
County, Massachusetts, is made in accordance with the authority of the
Attorney General to compromise and settle claims of the United States,
consistent with the Comprehensive Environmental Response, Compensation,
and Liability Act (CERCLA).
    For 30 days following the date of publication of this notice, the
United States will receive written comments relating to the settlement.
The Effective Date of the PPA is the date upon which both of the
following events have occurred: (a) EPA issues written notice to
Purchaser that the public comment period has closed and the United
States, after review of and response to any public comments received,
has determined not to withhold its consent or seek to modify the
Agreement; and (b) Purchaser has executed the Prospective Purchaser
Agreement; and (3) Purchaser has closed on the purchase of the property
at the Site. Upon the Effective Date of the PPA, the Settling Parties
under the 122(h) Agreement shall pay the $1.2 million in past response
costs.

    Dated: December 22, 2022.
Bryan Olson,
Director, Superfund and Emergency Management Division.
[FR Doc. 2022-28310 Filed 12-28-22; 8:45 am]
BILLING CODE 6560-50-P