[Federal Register Volume 88, Number 72 (Friday, April 14, 2023)]
[Notices]
[Pages 23024-23025]
[FR Doc No: 2023-07936]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-1542-000]

Desert Peak Energy Storage I, 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
Desert Peak Energy Storage I, 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 May 1, 2023.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be

delivered to Health and Human Services, 12225 Wilkins Avenue,
Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: April 10, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-07936 Filed 4-13-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 17 (Wednesday, January 26, 2011)]
[Rules and Regulations]
[Pages 4529-4532]
[FR Doc No: 2011-1660]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-1126]
RIN 1625-AA00

Safety Zone; Underwater Hazard, Gravesend Bay, Brooklyn, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone on the
waters of Gravesend Bay, Brooklyn, New York. This rule is necessary to
provide for the safety of life and property on the navigable waters.
This rule is intended to restrict unauthorized persons and vessels from
traveling through or conducting underwater activities within a portion
of Gravesend Bay until recently discovered military munitions are
rendered safe and removed from the area.

DATES: This rule is effective from January 26, 2011 until 11:59 p.m. on
June 30, 2011. This rule has been enforced with actual notice since
December 18, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-1126 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-1126 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590,

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Lieutenant William George, Waterways
Management Division, Coast Guard Sector New York; telephone 718-354-
4114, e-mail<EMAIL_ADDRESS>If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b) (B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because immediate action is necessary to
ensure the safety of the public in the vicinity of munitions recently
discovered in Gravesend Bay by civilian divers. U.S. Navy underwater
surveys confirmed the location of unexploded ordnance in Gravesend Bay.
In the interest of public safety the U.S. Navy has requested that the
Coast Guard restrict access to the area in which the munitions are
located until the munitions can be rendered safe and removed. Immediate
action is required to ensure that no unauthorized persons and vessels
travel through or conduct underwater activities that may disturb the
current location of the unexploded ordnance, such as dive operations or
anchoring within close proximity to the unexploded munitions.
Publishing a NPRM and waiting 30 days for comment would be contrary to
the public interest because any delay in the effective date of this
rule would expose mariners, the boating public, and divers to the
potential hazards associated with unexploded ordnance. Furthermore, a
separate notice of proposed rulemaking will be pursued, where the
public will have the opportunity to provide comment.
    For these reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds
that good cause exists for making this rule effective less than 30 days
after publication in the Federal Register.

Basis and Purpose

    In response to media reports of military munitions found in
Gravesend Bay by civilian divers, U.S. Navy Explosive Ordnance Disposal
divers from Naval Weapons Station Earle conducted underwater surveys
and confirmed the location of munitions on the bottom of Gravesend Bay.
The munitions consist of approximately 1,500 rounds of 20mm ammunition,
one 3-inch diameter projectile and two cartridge casings.
    In the interest of public safety, the U.S. Navy has requested that
the Coast Guard limit access to the location in Gravesend Bay where the
munitions are located until the ordnance could be rendered safe and
removed.
    This temporary safety zone is necessary to ensure the safety of
mariners, vessels, and civilian divers from the potential hazards
associated with unexploded military munitions. This temporary final
rule is an interim measure while a long-term rulemaking process is
pursued separately under docket number USCG-2010-1091.

Discussion of Rule

    The Captain of the Port New York is establishing a temporary safety
zone around the location of the unexploded ordnance site to ensure the
safety of mariners and vessels transiting in the vicinity of unexploded
ordnance as well as divers intending to dive in the area.
    The safety zone will encompass all waters of Gravesend Bay within
110-yard radius of a point at the approximate position 40[deg]36'30''
N, 074[deg]02'14'' W (NAD 83), approximately 70 yards southeast of the
Verrazano Bridge Brooklyn tower.
    All persons and vessels shall comply with the instructions of the
Coast Guard Captain of the Port or the designated on-scene
representative. Entry into, transiting, anchoring, or diving within the
safety zone is prohibited unless authorized by the Captain of the Port
New York, or the on-scene representative. The Captain of the Port or
the on-scene representative may be contacted via VHF Channel 16.

Regulatory Analyses

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

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    This rule temporarily restricts access to a small portion of
Gravesend Bay until unexploded military ordnance are rendered safe and
removed. The safety zone is located in an area where the Coast Guard
expects insignificant adverse impact to mariners from the zone's
activation. This rule is intended to protect the public from the
hazards associated with unexploded ordnance. Furthermore, vessels will
be able to safely transit around the area.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners and operators of vessels intending to
transit or anchor in a portion of Gravesend Bay, in the vicinity of the
Verrazano Bridge, Brooklyn, NY.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: Vessel
traffic can safely transit around the zone. The rule limits access to a
relatively small portion of the waterway where there is a known hazard
until the hazard is rendered safe. Before the effective period, we will
issue maritime advisories widely available to users of the waterway.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman

and the Regional Small Business Regulatory Fairness Boards. The
Ombudsman evaluates these actions annually and rates each agency's
responsiveness to small business. If you wish to comment on actions by
employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The
Coast Guard will not retaliate against small entities that question or
complain about this rule or any policy or action of the Coast Guard.

Collection of Information

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

Federalism

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

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

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

Technical Standards

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

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of a temporary
safety zone on the waters of Gravesend Bay until recently discovered
military munitions are rendered safe and removed from the area. An
environmental analysis checklist and a categorical exclusion
determination will be available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. A new temporary Sec.  165.T01-1126 is added as follows:

Sec.  165.T01-1126  Safety Zone; Underwater Hazard, Gravesend Bay,
Brooklyn, NY.

    (a) Regulated area. The following area is a temporary safety zone:
All waters of Gravesend Bay within 110-yard radius of a point at the
approximate position 40[deg]36'30'' N, 074[deg]02'14'' W (NAD 83),
approximately 70-yards southeast of the Verrazano Bridge Brooklyn
tower.
    (b) Effective period. This regulation is effective from 12:01 a.m.
on December 18, 2010 until 11:59 p.m. June 30, 2011.
    (c) Regulations. (1) The general regulation contained in 33 CFR
165.23 apply.
    (2) Entry into or movement within this zone is prohibited unless
authorized by the Captain of the Port New York.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port New York or the designated on-
scene-patrol personnel. These designated on-scene-patrol personnel
comprise commissioned, warrant, and petty officers of the Coast Guard.
Upon being hailed by a U.S. Coast Guard vessel by siren, radio,
flashing light or other means, the operator of a vessel shall proceed
as directed.

    Dated: December 17, 2010.
L.L. Fagan,
Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2011-1660 Filed 1-25-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 25 (Thursday, February 6, 2020)]
[Notices]
[Page 6966]
[FR Doc No: 2020-02301]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4468-DR; Docket ID FEMA-2020-0001]

Florida; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for State of Florida (FEMA-4468-DR), dated October 21, 2019, and
related determinations.

DATES: This change occurred on January 7, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Gary R.
Stanley, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Thomas J. McCool as
Federal Coordinating Officer for this disaster.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-02301 Filed 2-5-20; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50010-50013]
[FR Doc No: 2015-20309]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2918]

Pilot Program for Medical Device Reporting on Malfunctions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is soliciting
nominations for participation in a pilot program for the submission of
medical device reports for malfunctions of class I devices and certain
class II devices in summary format on a quarterly basis. Under the
Medical Device Reporting on Malfunctions pilot program, FDA intends to
work with manufacturers to identify candidates for the pilot program
and intends to continue to accept nominations until candidates for the
pilot program have been selected.

DATES: FDA will begin accepting nominations for participation in the
voluntary pilot program on September 1, 2015, and intends to continue
to accept nominations until candidates for the pilot program have been
selected. See section II for instructions on how to participate in the
voluntary pilot program.

FOR FURTHER INFORMATION CONTACT: William C. Maloney, Center for Devices
and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3236,
Silver Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration Amendments Act of 2007 (FDAAA)
(Pub. L. 110-85), amended section 519(a) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(a)), relating to the
reporting of device malfunctions to FDA under part 803 (21 CFR part
803). Specifically, FDAAA amended the FD&C Act to require that medical
device reports of malfunctions for class I devices and those class II
devices that are not permanently implantable, life supporting, or life
sustaining--with the exception of any type of class I or II device
which FDA has, by notice, published in the Federal Register or by
letter to the person who is the manufacturer or importer of the device,
indicated should be subject to part 803 in order to protect the public
health--be submitted in accordance with the criteria established by FDA
(section 519(a)(1)(B)(ii) of the FD&C Act).\1\ The criteria must
require the reports to be in summary form and made on a quarterly basis
(section 519(a)(1)(B)(ii) of the FD&C Act).
---------------------------------------------------------------------------

    \1\ In light of section 1003(d) of the FD&C Act (21 U.S.C.
393(d)) and the Secretary of Health and Human Services' (the
Secretary's) delegation to the Commissioner of Food and Drugs,
statutory references to ``the Secretary'' have been changed to
``FDA'' or the ``Agency'' in this document.
---------------------------------------------------------------------------

    FDA is considering the development of malfunction reporting
criteria for devices subject to section 519(a)(1)(B)(ii) of the FD&C
Act. In the interim, FDA clarified that all manufacturers of class I
devices and those class II devices that are not permanently
implantable, life supporting, or life sustaining, must continue to
report in full compliance with part 803 (76 FR 12743 at 12744, March 8,
2011).
    The malfunction reporting requirements for class III devices and
those class II devices that are permanently implantable, life
supporting, or life sustaining were not altered by FDAAA. Under the
amended section 519(a) of the FD&C Act, device manufacturers are to
continue to submit malfunction reports in accordance with part 803 for
all class III devices and for those class II devices that are
permanently implantable, life supporting, or life sustaining, unless
FDA grants an exemption or variance from, or an alternative to, a
requirement under such regulations under Sec.  803.19 (section
519(a)(1)(B)(i) of the FD&C Act).
    In addition, under section 519(a) of the FD&C Act, as amended by
FDAAA, there is no change to the obligation for an importer to submit
malfunction reports to the manufacturer in accordance with part 803 for
devices that it imports into the United States (section
519(a)(1)(B)(iii) of the FD&C Act).
    FDA intends to use the information learned and experiences gained
from the pilot program to develop the malfunction reporting criteria
for devices subject to section 519(a)(1)(B)(ii) of the FD&C Act.

II. Pilot Program for Medical Device Reporting (MDR) on Malfunctions

    FDA has developed this pilot program for manufacturers interested
in submitting malfunction reports for certain devices in a summary
format on a quarterly basis. This notice provides:

(1) The guiding principles underlying the pilot program, (2) the
conditions for participation in the pilot program, (3) a description of
the pilot program, (4) the eligibility criteria for the pilot program,
(5) the procedures that FDA intends to follow in the pilot program, (6)
the manufacturer notification process, (7) FDA's review process for the
summary reports, (8) the duration of the pilot program, and (9) FDA's
evaluation process for the pilot program.

A. Guiding Principles

    The following basic principles underlie the Medical Device
Reporting on Malfunctions pilot program described in this notice. FDA
intends for these principles to create a common understanding between
the manufacturer and FDA about the goals and parameters of this pilot
program.
    1. FDA is exploring a possible approach to summary reporting of
device malfunctions on a quarterly basis under the pilot program (as
illustrated in the case examples in this notice in section II.C.
Description of the Program) that would allow FDA to collect sufficient
detail to effectively monitor the devices subject to section
519(a)(1)(B)(ii) of the FD&C Act and protect the public health.
    2. The data received in this pilot should contain details
sufficient to understand the device-related malfunctions. A narrative
text should be provided to include a summary of the malfunction events,
the results of the manufacturer's investigation of the reported
malfunctions, including the type of any remedial action taken or an
explanation of why remedial action was not taken, and any additional
information that would be helpful to understand how the manufacturer
addressed the malfunctions summarized in the report.
    3. As the summary information collected under this pilot represents
a subset of the detailed information collected under Sec.  803.52, FDA
intends to use the existing electronic Medical Device Reporting (eMDR)
infrastructure for the summary reports.
    4. All summary MDR reports \2\ will appear in the Manufacturer and
User Facility Device Experience (MAUDE) database, which is publically
available.
---------------------------------------------------------------------------

    \2\ Any information in the report that is protected from public
disclosure under the Freedom of Information Act (FOIA) will be
redacted prior to the release of the report.
---------------------------------------------------------------------------

B. Conditions

    1. Under Sec.  803.19, manufacturers who are accepted into the
program will be granted an exemption or variance from, or alternative
to, the reporting requirements under Sec. Sec.  803.50(a) and 803.52
for those malfunction events associated with the devices selected for
the pilot. Other reportable events involving the devices selected for
the pilot must be reported to FDA within the mandatory 30-calendar day
timeframe on Form FDA 3500A, as required by Sec. Sec.  803.50(a) and
803.52, or within the 5-work day timeframe as required by Sec.  803.53.
Additional information and instructions will be provided to
manufacturers accepted into the pilot.
    2. A candidate is not precluded from withdrawing from the pilot
program at any time and returning to the individual reporting
requirements of Sec. Sec.  803.50(a) and 803.52.
    3. Due to FDA resource issues, FDA intends to limit the pilot
program to no more than nine (9) candidates.
    4. At its discretion, FDA may withdraw a manufacturer from the
pilot program, for reasons including, but not limited to, any
violations of the FD&C Act, failure to follow the instructions of the
pilot program, or if FDA obtains information after the manufacturer is
accepted to the pilot program that the manufacturer is not an
appropriate candidate for the program as described in this notice in
section II.D. Appropriate Candidates. Withdrawal from the pilot program
will result in a return to the individual reporting requirements of
Sec. Sec.  803.50(a) and 803.52.
    5. At its discretion, FDA may modify specific details regarding the
pilot if needed. Any such changes will be communicated directly to the
candidates of the pilot program.

C. Description of the Program

    Candidates of the pilot program will submit Form FDA 3500A reports
in electronic reporting format on a quarterly basis. For purposes of
the pilot, ``quarterly basis'' is defined as a three (3) month period.
Each submission should represent a summary of malfunction events
received for a unique device problem code or set of codes within the
quarterly timeframe, and for a particular device model number and/or
catalog number. Device malfunctions that are summarized in one report
should not be duplicated in any other submissions within the same
quarterly timeframe.
    Summary reports should include the following information collected
on Form FDA 3500A in electronic format:
    SECTION B.5: Describe Event or Problem--The device event narrative
should include a description of the nature of the events (being as
specific as possible); and if available, a range of patient age and
weight, and a breakdown of patient gender. The first sentence of the
device event narrative should include the following sentence:
    ``This report summarizes  XXX  malfunction events''
where XXX is replaced by the number of malfunction events being
summarized.
    SECTION D.2 and D.2.b: Common Device Name and Procode--Enter the
common name of the device and the product code.
    SECTION D.3: Manufacturer Name, City and State--Enter the
manufacturer name, city and state where the manufacturer is located.
    SECTION D.4: Device Identification--Enter the model or catalog
number for the device being summarized in the MDR report.
    SECTION G.1: Contact Office (and Manufacturing Site for Devices)--
Enter the name and address of the manufacturer reporting site [contact
office], including contact name for the report submitted. Enter the
name and address of the manufacturing site for the device, if different
from the contact office.
    SECTION G.2: Phone Number--Enter the phone number for the contact
office.
    SECTION H.1: Type of Reportable Event--Check ``Malfunction'' in
this box.
    SECTION H.6: Event Problem and Evaluation Codes--Enter the device
problem code(s), including any codes received from a user facility or
importer report provided in Section F.10 of Form FDA 3500A. Enter
``9999'' as the first device problem code to identify the report as a
summary malfunction report. Enter the evaluation code(s) for the
categories of method, results, and conclusions. Enter a conclusion
code(s) even if the device was not evaluated.
    SECTION H.10: Additional Manufacturer Narrative--Provide a summary
of the results of your investigation of the reported malfunctions,
including the type of any remedial action taken or an explanation of
why remedial action was not taken, and any additional information that
would be helpful to understand how you addressed the malfunction events
summarized in the report. Also enter a breakdown of the malfunction
events summarized in the report, including the number of devices that
were returned to you; the number of devices that were labeled for
single use (if any); and the number of devices that were reprocessed
and re-used (if any).

    Note: All reportable adverse events which result in a serious
injury or death; and/or necessitate remedial action to prevent an
unreasonable risk of substantial harm to the public health, are
excluded from this pilot program. In addition, for reference here is
the

link to the on-line version of the Form FDA 3500A: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048334.pdf.

    Case Examples: The following examples are meant to illustrate the
format for how malfunction reports submitted under this pilot will be
captured. All of these examples are for class I devices and those class
II devices that are not permanently implantable, life supporting, or
life sustaining. These examples do not address interpretation of these
reportable events.
    Case Scenario #1: Multiple malfunction reports for the same device
problem. A manufacturer receives 50 similar reports within the
quarterly timeframe indicating that model XYZ pump experienced an air
detected set alarm, which interrupted delivery. The alarms may have
been a false alarm. These events were received from various sources. Of
the 50 adverse events, 46 did not involve patients, and 4 involved
patients with no reported injuries or deaths. None of these events
necessitate remedial action to prevent an unreasonable risk of
substantial harm to the public health. The XYZ pumps were recently
retrofitted with a new user interface software model V.2.04.12.
    Report for Case #1: A single summary MDR report is to be submitted
to FDA through eMDR:
     B.5: This report summarizes  50  malfunction
events. A review of the events indicated that model XYZ pump
experienced an air detected set alarm, which interrupted delivery. The
alarms may have been a false alarm. These reports were received from
various sources. Of the 50 events, 46 did not involve patients, and 4
involved patients with no patient consequences. The four patients
ranged from 25-32 years of age and 130-250 lbs. Of the reported
patients, one was male and three were female. The XYZ pumps were
recently retrofitted with a new user interface software model
V.2.04.12.
     D.2: Infusion Pump
     D.2.b: FRN
     D.3: ABC Company, 123 Baker Street, Anywhere, MD, USA
     D.4: Model XYZ
     G.1: Mr. X, ABC company, 123 Baker Street, Anywhere, MD,
USA
     G.2:<PHONE_NUMBER>
     H.1: Malfunction
     H.6: Device Codes: 9999 (Summary Malfunction); 1008 (Air
Leak)
     H.6: Manufacturer Method Codes: 10 (Actual Device
Evaluated); 38 (Visual Inspection)
     H.6: Manufacturer Results Code: 549 (Air pump assembly)
     H.6: Manufacturer Evaluation Conclusion Codes: 52 (Device
was out of calibration)
     H.10: For 40 of the 50 reported events, the devices were
returned to ABC, and their operating condition was confirmed by
service. The cause of the malfunction was determined to be a faulty
pump head module. To correct the condition, the pump head modules were
replaced.
    Case Scenario #2: Multiple malfunction reports that have two device
problems: A manufacturer receives 100 malfunction reports within the
quarterly timeframe that include two types of device malfunctions that
are related to a specific model (XYZ, Version 2) of a powered AC bed:
(1) 75 events involve a broken weld near where the motor attaches; and
(2) 55 events involve a screw that attaches the bed rail to the
mounting bracket on the bed, which snapped. Some of the events involve
both types of device malfunctions. None of the events involve patients.
None of the events necessitate remedial action to prevent an
unreasonable risk of substantial harm to the public health.
    Reports for Case #2: Under this pilot, a unique device problem code
or set of codes for a particular device model number and/or catalog
number that are summarized in one report should not be duplicated in
any other submissions within the same quarterly timeframe. As a result,
there are three categories of reports for this scenario--(1) 45 events
that involve broken welds only; (2) 25 events that involve broken
screws only; and (3) 30 events that involve both broken welds and
broken screws. Therefore, three summary reports will need to be
submitted to FDA through eMDR.
    Report #1:
     B.5: This report summarizes  45  malfunction
events. A review of the events indicated that model XYZ experienced
broken welds near where the motor attaches to the powered AC beds. No
patients were involved.
     D.2: AC Powered Beds
     D.2.b: FNL
     D.3: ABC company, 123 Baker Street, Anywhere, MD, USA
     D.4: Model XYZ
     G.1: Mr. X, ABC Company, 123 Baker Street, Anywhere, MD,
USA
     G.2:<PHONE_NUMBER>
     H.1: Malfunction
     H.6: Device Codes: 9999 (Summary Malfunction); 1069
(Break); 3195 (Weld)
     H.6: Manufacturer Method Codes: 10 (Actual Device
Evaluated); 38 (Visual Inspection)
     H.6: Manufacturer Results Code: 170 (Manufacturing process
problem)
     H.6: Manufacturer Evaluation Conclusion Codes: 12 (Design
deficiency)
     H.10: To correct the condition, the beds were taken out of
service.
    Report #2:
     B.5: This report summarizes  25  malfunction
events. A review of the events indicated that a screw that attaches the
bed rail to the mounting bracket on the bed is snapping on model XYZ.
No patients were involved.
     D.2: AC Powered Beds
     D.2.b: FNL
     D.3: ABC company, 123 Baker Street, Anywhere, MD, USA
     D.4: Model XYZ
     G.1: Mr. X, ABC Company, 123 Baker Street, Anywhere, MD,
USA
     G.2:<PHONE_NUMBER>
     H.1: Malfunction
     H.6: Device Codes: 9999 (Summary Malfunction); 1069
(Break); 568 (Screw)
     H.6: Manufacturer Method Codes: 10 (Actual Device
Evaluated); 38 (Visual Inspection)
     H.6: Manufacturer Results Code: 170 (Manufacturing process
problem)
     H.6: Manufacturer Evaluation Conclusion Codes: 12 (Design
deficiency)
     H.10: To correct the condition, the beds were taken out of
service temporarily. A technician was dispatched to replace the screw.
Load testing was applied to verify bed rail performance.
    Report #3:
     B.5: This report summarizes  30  malfunction
events. A review of the events indicated that a screw that attaches the
bed rail to the mounting bracket on the AC powered bed failed causing
the bed rail to detach and collide with the beam near where the motor
attaches. The force of impact caused a broken weld to form near the
motor attachment on the AC powered bed. No patients were involved.
     D.2: AC Powered Beds
     D.2.b: FNL
     D.3: ABC Company, 123 Baker Street, Anywhere, MD, USA
     D.4: Model XYZ
     G.1: Mr. X., ABC Company, 123 Baker Street, Anywhere, MD,
USA
     G.2:<PHONE_NUMBER>
     H.1: Malfunction
     H.6: Device Codes: 9999 (Summary Malfunction); 1069
(Break); 3195 (Screw); 568 (Weld)
     H.6: Manufacturer Method Codes: 10 (Actual Device
Evaluated); 38 (Visual Inspection)
     H.6: Manufacturer Results Code: 170 (Manufacturing process
problem)

     H.6: Manufacturer Evaluation Conclusion Codes: 12 (Design
deficiency)
     H.10: To correct the condition, the beds were taken out of
service. Technicians have examined the beds and have opened up a
Corrective and Preventive Action (CAPA) to address the design issue.

D. Appropriate Candidates

    Appropriate candidates for the pilot program are manufacturers who:
    1. Are currently submitting reports to FDA using the paper Form FDA
3500A or the electronic MDR (eMDR) format.
    2. Manufacture class I devices and/or those class II devices that
are not permanently implantable, life supporting, or life sustaining.
    3. Currently use or are willing to use eMDR to submit summary
malfunction reports to the FDA during the pilot period.
    4. Are in compliance with the Medical Device Reporting regulation
in 21 CFR part 803.

E. Procedures

1. Nomination
    A manufacturer of class I devices and those class II devices that
are not permanently implantable, life supporting, or life sustaining
may nominate themselves for participation in the pilot program by
submitting a nomination to<EMAIL_ADDRESS>FDA intends to
acknowledge receipt of nominations via return email. The following
information will assist FDA in processing and responding to
nominations:
     Name of manufacturer
     Registration number
     Contact name, address, phone number, and email address
     Model or catalog number for the device(s) that you are
requesting to include in the pilot, and
     Product classification code for the device(s) that you are
requesting to include in the pilot. You may access the Product
Classification Code database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
2. FDA Consideration
    Acceptance of nominations will start 2 weeks following the
publication date of this Federal Register notice. Because only a
limited number of candidates are needed, FDA will use its discretion in
choosing candidates based on the eligibility criteria in this Federal
Register notice in section II.D. Appropriate Candidates, the needs of
the pilot to include a diversity of manufacturers with regard to device
type (including in vitro diagnostic devices), and expected number of
malfunction events. FDA may contact the manufacturer to request
supplemental information if this information is needed in order to
complete our review of the request. The manufacturer must provide the
supplemental information within 15 days of FDA's request; otherwise,
the Agency will consider the nomination withdrawn.

F. Manufacturer Notification

    FDA intends to notify manufacturers who are selected for this pilot
program within 45 days from receiving their nomination or any
supplemental information requested by FDA. Once FDA has selected the
candidates for this pilot, FDA will notify subsequent applicants by
email that the nomination period has closed.

G. FDA Review

    All reports received under the pilot program will be reviewed and
processed in the same manner as individual medical device reports that
are submitted under part 803. A version of the report releasable under
FOIA will be accessible through the public MAUDE database.

H. Duration of the Pilot

    FDA intends for the pilot program to run for 2 calendar quarters
for each candidate and will continue until the 2 calendar quarters have
been completed for all candidates. At its discretion, FDA may terminate
the pilot program before the close of this period, or FDA may extend
the pilot program beyond the 2 calendar quarters. The decision to
terminate or extend the pilot will be announced in the Federal
Register.

I. Evaluation

    FDA intends to evaluate all information and feedback received from
the candidates and to use the information and experiences gained from
the pilot program to develop criteria for summary reporting on a
quarterly basis for devices subject to section 519(a)(1)(B)(ii) of the
FD&C Act.

III. Paper Reduction Act of 1995

    This notice refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 803 have been
approved under OMB control number 0910-0437; the collections of
information in Form FDA 3500A have been approved under OMB control
number 0910-0291.

    Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20309 Filed 8-17-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33547-33549]
[FR Doc No: 2017-15255]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0109; Notice 2]

Mercedes-Benz USA, LLC, Grant of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition.

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

SUMMARY: Mercedes-Benz USA, LLC (MBUSA), has determined that certain
model year (MY) 2015-2016 Mercedes-Benz CLS-Class motor vehicles do not
fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No.
110, Tire Selection and Rims and Motor Home/Recreation Vehicle Trailer
Load Carrying Capacity Information for Motor Vehicles with a GVWR of
4,536 kilograms (10,000 pounds) or Less. MBUSA filed a Safety Recall
Report dated September 12, 2016. MBUSA also petitioned NHTSA on October
4, 2016, for a decision that the subject noncompliance is
inconsequential as it relates to motor vehicle safety.

ADDRESSES: For further information on this decision contact Kerrin
Bressant, Office of Vehicle Safety Compliance, the National Highway
Traffic Safety Administration (NHTSA), telephone<PHONE_NUMBER>,
facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Overview

    Mercedes-Benz USA, LLC (MBUSA), has determined that certain model
year (MY) 2015-2016 Mercedes-Benz CLS-Class motor vehicles do not fully
comply with paragraph S4.3(a) of Federal Motor Vehicle Safety Standard
(FMVSS) No. 110, Tire Selection and Rims and Motor Home/Recreation
Vehicle Trailer Load Carrying Capacity Information for Motor Vehicles
with a GVWR of 4,536 kilograms (10,000 pounds) or Less. MBUSA filed a
report dated September 12, 2016, pursuant to 49 CFR part 573, Defect
and Noncompliance Responsibility and Reports. MBUSA also petitioned
NHTSA on October 4, 2016, pursuant to 49 U.S.C. 30118(d) and 30120(h)
and 49 CFR part 556, for an exemption from the notification and remedy
requirements of 49 U.S.C. Chapter 301 on the basis that this
noncompliance is inconsequential as it relates to motor vehicle safety.
    Notice of receipt of the petition was published, with a 30-day
public comment period on December 20, 2016,

in the Federal Register (81 FR 92964). No comments were received. To
view the petition and all supporting documents log onto the Federal
Docket Management System (FDMS) Web page at: http://www.regulations.gov/. Then follow the online search instruction to
locate docket number ``NHTSA-2016-0109.''

II. Vehicles Involved

    Approximately 6,773 MY 2015-2016 Mercedes-Benz CLS 400 and
Mercedes-Benz CLS 400 4MATIC motor vehicles manufactured between May
23, 2014 and April 21, 2016, are potentially involved.

III. Noncompliance

    MBUSA explains that the noncompliance is that the subject vehicles
have tire and loading information placards affixed to their B-pillars
that incorrectly identify the maximum combined weight of occupants and
cargo. Specifically, the Mercedes CLS 400 was manufactured with a tire
and loading information placard that identifies a maximum combined
weight of 420 kilograms (926 pounds) and the Mercedes CLS 400 4MATIC
was manufactured with a tire and loading information placard that
identifies a maximum combined weight of 355 kilograms (783 pounds).
However, the maximum combined weight of occupants and cargo should be
315 kilograms (694 pounds) for the Mercedes CLS 400 and 325 kg (717
pounds) for the CLS 400 4MATIC. Therefore, the vehicles do not comply
with paragraph S4.3 of FMVSS No. 110.

IV. Rule Text

    Paragraph S4.3 of FMVSS No. 110 states:

    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. . . .
    (a) Vehicle capacity weight expressed as ``The combined weight
of occupants and cargo should never exceed XXX kilograms or XXX
pounds

V. Summary of MBUSA's Petition

    MBUSA described the subject noncompliance and stated its belief
that the noncompliance is inconsequential as it relates to motor
vehicle safety.
    In support of its petition, MBUSA submitted the following
reasoning:
    (a) The tires originally equipped on the subject vehicles are able
to carry the additional weight indicated on the tire and loading
information placard. Further, the tire pressure detailed on the placard
is sufficient to carry those weights. The maximum tire and vehicle load
information detailed in the table below demonstrates that the tire is
designed to carry a higher load than that which was incorrectly set out
on the tire label:

----------------------------------------------------------------------------------------------------------------
                                                                                Maximum vehicle load (per
                                                                                tire)
                         Tire dimension                            Maximum tire  -------------------------------
                                                                    load (lbs)                    CLS 400 4MATIC
                                                                                CLS 400 (lbs)       (lbs)
----------------------------------------------------------------------------------------------------------------
18'' front......................................................            1708            1243            1289
18'' rear.......................................................            1609            1256            1278
19'' front......................................................            1565            1243            1289
19'' rear.......................................................            1653            1256            1278
----------------------------------------------------------------------------------------------------------------

    (b) Should the driver follow the maximum combined weight of
occupants and cargo displayed on the tire and information placard,
motor vehicle safety is not negatively impacted. The vehicle platform
(including chassis and axles) serves other CLS vehicle lines and is
designed for vehicles with a higher gross vehicle weight rating
(``GVWR''). The platform therefore can handle the potential additional
weight.
    (c) Subject vehicles are equipped with the B-pillar certification
information label in accordance with 49 CFR part 567 indicating a GVWR
of 2260 kilograms (4982 pounds) for vehicle type 218.365, the CLS 400,
and a GVWR of 2330 kg (5137 pounds) for vehicle type 218.367, the CLS
400 4MATIC. The GVWR information detailed on the B-pillar certification
information label is correct. Therefore, the driver can refer to this
alternative source of information in order to determine the correct
maximum load weight of the vehicle.
    (d) After identifying the potentially incorrect values in the tire
label, Daimler AG (DAG) analyzed potential technical implications,
specifically with respect to the requirements of FMVSS No. 110,
including potential effects on axles, suspension, brakes, driving
dynamic, and crashworthiness. Based on this analysis, an impact on
steering, braking or other vehicle dynamics as a result of the tire
label weight discrepancy can be excluded.
    (e) Moreover, MBUSA is not aware of any customer complaints,
accidents or injuries alleged to have occurred as a result of this non-
compliance. Hence, field data supports the assertion that the issue
described above will have an inconsequential impact on safety.
    MBUSA concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.

NHTSA'S Decision

    NHTSA's Analysis: FMVSS No. 110 specifies requirements for tire
selection to prevent tire overload. The intent of the standard is to
ensure that vehicles are equipped with tires appropriate to handle the
vehicle manufacturer's designed maximum vehicle weight.
    The maximum weight of a vehicle is determined by adding to the
vehicle the manufacturer specified maximum weight of occupants and
cargo. FMVSS No. 110, paragraph 4.3(a) requires that vehicles be
labeled with a ``Vehicle Capacity Weight (VCW)'' value which is the
specified maximum occupant and cargo weight that can be loaded into a
vehicle. This value is equal to 68 kgs times the vehicle's designated
seating capacity plus the rated cargo/payload of the vehicle. FMVSS No.
110, (S<IP_ADDRESS> and S4.3.4(b)), requires that the vehicle maximum load
on the tire shall not be greater than the applicable maximum load
rating as marked on the sidewall of the tire or greater than the load
rating of the tire at the manufacturer specified cold inflation
pressure listed on the tire and loading information placard.
    For the subject vehicles, MBUSA noted that the VCW values on the
placards are incorrect. The tire and information placard on the CLS 400
model vehicle specifies a 420 kg VCW which should have been 315 kg, an

increase of 105 kg. The label on the CLS 400 4MATIC model vehicle
specifies a 355 kg VCW which should have been 325 kg, an increase of 30
kg. These errors could cause a consumer to load the subject vehicles
beyond their original design specifications.
    In its' petition, MBUSA provided an analysis indicating the mounted
tires on the subject vehicles are sufficient for carrying the maximum
vehicle loads derived from the higher, incorrect, VCW values. For the
CLS 400 vehicles the analysis indicates the tire load carrying
capabilities exceed the maximum tire load by at least 147 kg (710 kg
tire load rating minus 563 kg maximum tire load). For the CLS 400
4MATIC vehicles the analysis indicates the tire load carrying
capabilities exceed the maximum tire load by at least 125 kg (709 kg
tire load rating minus 584 kg maximum tire load). NHTSA verified the
tire load ratings specified by MBUSA in accordance with the European
Tyre and Rim Technical Organisation (ETRTO) manual. As shown by MBUSA,
the tire capacities are more than adequate to handle the additional
weight of the higher VCW values. MBUSA's analysis shows that the tires
mounted on the subject vehicles exceed the load requirements of FMVSS
No. 110.
    MBUSA also mentioned that the certification labels affixed to the
subject vehicles provide the vehicle's gross axle weight ratings
(GAWRs) and the gross vehicle weight rating (GVWR)in accordance with 49
CFR 567, Certification. MBUSA stated that the GAWRs and GVWR values
provided on the subject vehicles are correct as labeled. These ratings
are established by the vehicle manufacturer and provided as an
alternative source of information consumers can use to ensure a vehicle
and its' axles are not overloaded. Vehicle manufacturers specify that
these ratings should not be exceeded when loading any vehicle. The
agency reviewed the maximum loads on the axles and vehicles, using the
higher labeled VCW values, against the certified GAWRs and GVWR of the
subject vehicles. For the CLS 400 4MATIC vehicles, maximum loads were
well below the GAWR and GVWR values. For the CLS 400 vehicles, the
maximum loads are essentially at the certified GAWRs and GVWR values.
MBUSA also stated in its petition that the platform (chassis and axles)
utilized on the subject vehicles is used with other CLS vehicle lines
and is designed for vehicles with higher GVWRs. It appears from this
analysis the subject vehicles can safely accommodate the higher VCW
loads without overload concerns.
    No comments were received during the receipt notice comment period.
    NHTSA Decision: In consideration of the foregoing, NHTSA finds that
MBUSA has met its burden of persuasion that the FMVSS No. 110
noncompliance is inconsequential as it relates to motor vehicle safety.
Accordingly, MBUSA's petition is hereby granted and MBUSA is exempted
from the obligation to provide notification of, and a remedy for, that
noncompliance under 49 U.S.C. 30118 and 30120.
    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, this decision
only applies to the subject vehicles that MBUSA no longer controlled at
the time it determined that the noncompliance existed. However, the
granting of this petition does not relieve vehicle distributors and
dealers 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 MBUSA notified them
that the subject noncompliance existed.

    Authority:  49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2017-15255 Filed 7-19-17; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register: August 22, 2008 (Volume 73, Number 164)]
[Notices]
[Page 49666-49667]
[DOCID:fr22au08-50]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-454-000]

Liberty Gas Storage, LLC; Notice of Application

August 14, 2008.
    Take notice that on July 31, 2008, Liberty Gas Storage, LLC
(Liberty Gas), 101 Ash Street, San Diego, CA 92101, filed in the above
referenced docket an application pursuant to section 7(c) of the
Natural Gas Act (NGA), for an order granting a certificate of public
convenience to construct new natural gas storage, comprised of three
existing salt dome caverns and the development of a new salt dome
cavern, pipeline and appurtenant facilities. The new facilities will be
located in Cameron and Calcasieu Parishes, Louisiana, all as more fully
set forth in the application which is on file with the Commission and
open to public inspection. The filing may also be viewed on the Web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to
William Rapp, Liberty Gas Storage, 101 Ash Street, San Diego, CA 92101
or by phone at<PHONE_NUMBER>.
    Liberty Gas' new storage project has been designed to provide
approximately 18.9 billion cubic feet (Bcf) of working gas capacity
with a maximum injection rate of up to 600 million cubic feet (Mcf) per
day and a maximum withdrawal rate of up to 1.2 Bcf per day.
Additionally, Liberty Gas intends to construct 5.1 miles of 36-inch
diameter pipeline to deliver the natural gas to Cameron Interstate
Pipeline, LLC, as well as one 18,940 horsepower compressor station, a
4.0 mile brine disposal pipeline and water supply facilities necessary
to develop the proposed new cavern.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's

environmental review process. Environmental commentors will not be
required to serve copies of filed documents on all other parties.
However, the non-party commentors will not receive copies of all
documents filed by other parties or issued by the Commission (except
for the mailing of environmental documents issued by the Commission)
and will not have the right to seek court review of the Commission's
final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: September 4, 2008.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-19473 Filed 8-21-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: January 8, 2007 (Volume 72, Number 4)]
[Rules and Regulations]
[Page 656-659]
[DOCID:fr08ja07-7]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2006-0843; FRL-8261-3]

Revisions to the California State Implementation Plan, South
Coast Air Quality Management District and Ventura County Air Pollution
Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is taking direct final action to approve revisions to the
South Coast Air Quality Management District (SCAQMD) and the Ventura
County Air Pollution Control District (VCAPCD) portions of the
California State Implementation Plan (SIP). This action revises various
definitions of terms used by the SCAQMD and rescinds duplicative
requirements for landfills from the VCAPCD. We are approving and
rescinding these local rules under the Clean Air Act as amended in 1990
(CAA or the Act).

DATES: This rule is effective on March 9, 2007 without further notice,
unless EPA receives adverse comments by February 7, 2007. If we receive
such comments, we will publish a timely withdrawal in the Federal
Register to notify the public that this direct final rule will not take
effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2006-0843, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow

the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov
, including any personal information provided,

unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through
http://www.regulations.gov or e-mail. www.regulations.gov is an ``anonymous

access'' system, and EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send e-mail directly to EPA, your e-mail address will be automatically
captured and included as part of the public comment. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA

Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available in either location
(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed in the
FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Cynthia G. Allen, EPA Region IX, (415)
947-4120<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rule revisions?
II. EPA's Evaluation and Action.
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules we are approving and rescinding with the
date that they were adopted by the local air

agency and submitted by the California Air Resources Board (CARB).

----------------------------------------------------------------------------------------------------------------
                                            Rule < greek-
               Local agency                      i>                Rule title             Adopted     Submitted
----------------------------------------------------------------------------------------------------------------
SCAQMD....................................          102  Definition of Terms..........     12/03/04     06/16/06
VCAPCD....................................        74.17  Solid Waste Disposal Sites        03/10/98     07/15/05
                                                          (Rule Rescission).
----------------------------------------------------------------------------------------------------------------

    On July 21, 2006 (SCAQMD) and August 18, 2005 (VCAPCD), these rule
submittals were found to meet the completeness criteria in 40 CFR Part
51 Appendix V, which must be met before formal EPA review.

B. Are there other versions of these rules?

    We approved versions of these rules into the SIP on the dates
listed: SCAQMD Rule 102 on February 3, 2000 and VCAPCD Rule 74.17 on
October 4, 1994. SCAQMD adopted a revision to the SIP approved version
of Rule 102 on October 19, 2001 which was not submitted to us by CARB.

C. What is the purpose of the submitted rule revisions?

    Section 110(a) of the CAA requires states to submit regulations
that control volatile organic compounds, oxides of nitrogen,
particulate matter, and other air pollutants which harm human health
and the environment. These rules were developed as part of the local
agency's program to control these pollutants.
    South Coast Rule 102 has been revised to add the following
definitions: Agricultural Permit Unit, Agricultural Source, Clean Air
Solvent Certificate, Confined Animal Facility (CAF), Hazardous Air
Pollutant, Orchard Heater, and Orchard Wind Machine.
    Ventura Rule 74.17 is being rescinded in its entirety because
sources previously subject to this rule are now subject to Rule
74.17.1, which has been approved as part of the California State Plan
for landfills and is federally enforceable.
    EPA's technical support documents (TSD) have more information about
these rules.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rule?

    SCAQMD Rule 102 provides definitions that support emission controls
found in other local agency requirements. VCAPCD Rule 74.17 is being
rescinded because the requirements for controlling VOC emissions from
landfills are federally enforceable through another mechanism. In
combination with the other requirements, rule revisions must be
enforceable (see section 110(a) of the Act) and must not relax existing
requirements (see sections 110(l) and 193). EPA policy that we used to
help evaluate enforceability requirements consistently includes the
Bluebook (``Issues Relating to VOC Regulation Cutpoints, Deficiencies,
and Deviations,'' EPA, May 25, 1988) and the Little Bluebook
(``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001).

B. Do the rules meet the evaluation criteria?

    We believe these revisions are consistent with the relevant policy
and guidance regarding enforceability and SIP relaxations. The TSD has
more information on our evaluation.

C. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, EPA is fully
approving the submitted rule revisions because we believe they fulfill
all relevant requirements. We do not think anyone will object to this
approval, so we are finalizing it without proposing it in advance.
However, in the Proposed Rules section of this Federal Register, we are
simultaneously proposing approval of the same submitted rule revisions.
If we receive adverse comments by February 7, 2007, we will publish a
timely withdrawal in the Federal Register to notify the public that the
direct final approval will not take effect and we will address the
comments in a subsequent final action based on the proposal. If we do
not receive timely adverse comments, the direct final approval will be
effective without further notice on March 9, 2007. This will
incorporate this rule into the federally enforceable SIP.

III. Statutory and Executive Order Reviews

A. Executive Order 12866, Regulatory Planning and Review

    The Office of Management and Budget (OMB) has exempted this
regulatory action from Executive Order 12866, entitled ``Regulatory
Planning and Review.''

B. Paperwork Reduction Act

    These rules do not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.)

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and small governmental
jurisdictions.
    These rules will not have a significant impact on a substantial
number of small entities because SIP approvals under section 110 and
subchapter I, part D of the Clean Air Act do not create any new
requirements but simply approve requirements that the State is already
imposing. Therefore, because the Federal SIP approval does not create
any new requirements, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
    Moreover, due to the nature of the Federal-State relationship under
the Clean Air Act, preparation of flexibility analysis would constitute
Federal inquiry into the economic reasonableness of state action. The
Clean Air Act forbids EPA to base its actions concerning SIPs on such
grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976);
42 U.S.C. 7410(a)(2).

D. Unfunded Mandates Reform Act

    Under sections 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small

governments that may be significantly or uniquely impacted by the rule.
    EPA has determined that the approval action promulgated does not
include a Federal mandate that may result in estimated costs of $100
million or more to either State, local, or tribal governments in the
aggregate, or to the private sector. This Federal action approves pre-
existing requirements under State or local law, and imposes no new
requirements. Accordingly, no additional costs to State, local, or
tribal governments, or to the private sector, result from this action.

E. Executive Order 13132, Federalism

    Federalism (64 FR 43255, August 10, 1999) revokes and replaces
Executive Orders 12612 (Federalism) and 12875 (Enhancing the
Intergovernmental Partnership). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects 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.'' Under Executive Order 13132, EPA may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or EPA
consults with State and local officials early in the process of
developing the proposed regulation. EPA also may not issue a regulation
that has federalism implications and that preempts State law unless the
Agency consults with State and local officials early in the process of
developing the proposed regulation.
    These rules will not have substantial direct effects 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, as specified in Executive Order 13132, because it
merely approves a state rule implementing a federal standard, and does
not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. Thus, the
requirements of section 6 of the Executive Order do not apply to this
rule.

F. Executive Order 13175, Coordination with Indian Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This final rule does not have
tribal implications, as specified in Executive Order 13175. It will not
have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes. Thus, Executive Order 13175 does not
apply to this rule.

G. Executive Order 13045, Protection of Children From Environmental
Health Risks and Safety Risks

    Protection of Children from Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is
determined to be ``economically significant'' as defined under
Executive Order 12866, and (2) concerns an environmental health or
safety risk that EPA has reason to believe may have a disproportionate
effect on children. If the regulatory action meets both criteria, the
Agency must evaluate the environmental health or safety effects of the
planned rule on children, and explain why the planned regulation is
preferable to other potentially effective and reasonably feasible
alternatives considered by the Agency.
    These rules are not subject to Executive Order 13045 because they
do not involve decisions intended to mitigate environmental health or
safety risks.

H. Executive Order 13211, Actions that Significantly Affect Energy
Supply, Distribution, or Use

    These rules are not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12 of the National Technology Transfer and Advancement Act
(NTTAA) of 1995 requires Federal agencies to evaluate existing
technical standards when developing a new regulation. To comply with
NTTAA, EPA must consider and use ``voluntary consensus standards''
(VCS) if available and applicable when developing programs and policies
unless doing so would be inconsistent with applicable law or otherwise
impractical.
    The EPA believes that VCS are inapplicable to this action. Today's
action does not require the public to perform activities conducive to
the use of VCS.

J. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective February 7, 2007.

K. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by March 9, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: December 11, 2006.
Laura Yoshii,
Acting Regional Administrator, Region IX.

0
Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

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

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

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(187)(i)(B)(5) and
(c)(345) to read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (187) * * *
    (i) * * *
    (B) * * *
    (5) Previously approved on October 4, 1994 in paragraph
(c)(187)(i)(B)(1) of this section and now deleted without replacement,
Rule 74.17.
* * * * *
    (345) New and amended regulations for the following APCDs were
submitted on June 16, 2006, by the Governor's designee.
    (i) Incorporation by reference.
    (A) South Coast Air Quality Management District.
    (1) Rule 102, adopted on December 3, 2004.
* * * * *
 [FR Doc. E7-22 Filed 1-5-07; 8:45 am]

BILLING CODE 6560-50-P