[Federal Register: May 27, 2008 (Volume 73, Number 102)]
[Proposed Rules]
[Page 30322-30326]
[DOCID:fr27my08-14]

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

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration

15 CFR Part 909

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 151

[USCG-2007-0164]
RIN 0648-AV68; 1625-AB24

Definition of Marine Debris for Purposes of the Marine Debris
Research, Prevention, and Pollution Act

AGENCIES: National Ocean Service (NOS), National Oceanic and
Atmospheric Administration (NOAA), Department of Commerce; Coast Guard,
Department of Homeland Security.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: NOAA and the Coast Guard propose to define marine debris for
purposes of the Marine Debris Research, Prevention, and Reduction Act.
NOAA and the Coast Guard propose a joint definition of marine debris.
Interested parties may submit comments on this proposed rule.

DATES: Comments and related material must be received by July 28, 2008.

ADDRESSES: Comments and related material received from the public, as
well as documents mentioned in this preamble as being available in the
docket, are part of docket USCG-2007-0164. When submitting comments,
please indicate whether your comments are directed to the Coast Guard,
NOAA, or both, and include in the subject line ``Comments on marine
debris definition''. To avoid duplication, please use only one of the
following methods to comment. Comments received by any of these methods
will be posted on the docket and will be available for review at http:/
/www.regulations.gov:

Coast Guard

    (1) Online: http://www.regulations.gov. Follow the instructions for
submitting comments to docket USCG-2007-0164.
    (2) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (3) Hand delivery: 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., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>.

NOAA

    (1) On-line: http://www.regulations.gov. Follow the instructions
for submitting comments to docket USCG-2007-0164.
    (2) E-mail: NOAA.MarineDebris.FRNcomments.noaa.gov.
    (3) Mail: NOAA Ocean Service, Office of Response and Restoration,
N/ORR, 1305 East-West Hwy., Silver Spring, MD 20910 c/o Dr. Holly A.
Bamford.
    (5) Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call:
    NOAA: Dr. Holly A. Bamford, NOAA Marine Debris Program at (301)
713-2989.
    Coast Guard: LTJG David Major, Environmental Standards Division at
(202) 372-1402.
    If you have questions on viewing or submitting material to the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The proposed rule would define the term
`marine debris' for purposes of the Marine Debris Research, Prevention,
and Reduction Act (the Act). The definition was developed jointly by
the National Oceanic and Atmospheric Administration (NOAA) and the
United States Coast Guard (Coast Guard), in consultation with the
Interagency Marine Debris Coordinating Committee (IMDCC).
    The proposed rule defining marine debris states: ``For the purposes
of the Marine Debris Research, Prevention, and Reduction Act (33 U.S.C.
1951-1958 (2006)) only, marine debris is defined as any persistent
solid material that is manufactured or processed and directly or
indirectly, intentionally or unintentionally, disposed of or abandoned
into the marine environment or the Great Lakes.''

I. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided. The Coast Guard has an
agreement with the Department of Transportation (DOT) to use the Docket
Management Facility. Please see DOT's ``Privacy Act'' paragraph below.

A. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2007-0164), indicate the specific section of this
document to which each comment applies, and give the reason for each
comment. The Coast Guard recommends that you include your name and a
mailing address, an e-mail address, or a phone number in the body of
your document so that the Coast Guard can contact you if they have
questions regarding your submission. You may submit your comments and
material by electronic means, mail, fax, or delivery to the Docket
Management Facility at the address under ADDRESSES; but please submit
your comments and material by only one means. If you submit them by
mail or 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 them by mail and would like to know that they reached the
Facility, please enclose a stamped, self-addressed postcard or
envelope. The Coast Guard and NOAA will consider all comments and
material received during the comment period. They may change this
proposed rule in view of them.

B. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov at
any time, click on ``Search for Dockets,'' and enter the docket number
for this rulemaking (USCG-2007-0164) in the Docket ID box, and click
enter.

C. Privacy Act

    Anyone can search the electronic form of all comments received into
the docket by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review the Department of
Transportation's Privacy Act Statement in the Federal Register
published on April 11, 2000 (65 FR 19477), or you may visit http://
DocketsInfo.dot.gov.

D. Public Meeting

    The Coast Guard and NOAA do not now plan to hold a public meeting.
But you may submit a request for one to the Docket Management Facility
at the address under ADDRESSES explaining why one would be beneficial.
If we determine that one would aid this rulemaking, we will hold one at
a time and place announced by a later notice in the Federal Register.

II. Acronyms

IMDCC Interagency Marine Debris Coordinating Committee
MARPOL 73/78 International Convention for the Prevention of
Pollution from Ships, 1973, as modified by the protocol of 1978
NEPA National Environmental Policy Act
NOAA National Oceanic and Atmospheric Administration
NOS National Ocean Service
Sec.  Section

III. Background and Purpose

    The quantity of marine debris has increased over the years in spite
of both domestic and international efforts to minimize it. As society
develops new uses for materials, in particular plastics, the variety
and quantity of items found in the marine environment has increased
dramatically. These products range from common domestic material (e.g.
bags, cups, bottles, balloons) to industrial products (e.g. strapping
bands, plastic sheeting, hard hats, resin pellets) to lost or discarded
fishing gear (e.g. nets, buoys, traps, lines, light

sticks). Modern fishing gear (e.g. nets, lines, pots, and other
recreational or commercial fishing equipment) is generally made of
synthetic materials and metal, and can persist when disposed of,
abandoned, or discarded in the marine environment.
    In 2005, Congress instructed NOAA to create a centralized program
within the agency to coordinate existing activities related to marine
debris and to develop effective strategies for research, prevention,
and reduction of marine debris. Subsequently, in 2006, Congress passed
the Marine Debris Research, Prevention, and Reduction Act (the Act) (33
U.S.C. 1951-1958 (2006)), the purposes of which include to identify,
determine the sources of, assess, reduce, and prevent marine debris and
its adverse impacts on the marine environment and navigation safety.
The Act also reactivated the Interagency Marine Debris Coordinating
Committee (IMDCC), an interagency Federal body responsible for
developing and recommending comprehensive and multi-disciplinary
approaches to reduce the sources and impacts of marine debris to the
nation's marine environment, natural resources, public safety, and
economy. The IMDCC meets quarterly to ensure coordination of research,
monitoring, education, and regulatory actions addressing the persistent
marine debris problem. The Act requires NOAA and the Coast Guard to
consult with the IMDCC on the development of this proposed definition
of marine debris. Furthermore, the Act requires NOAA to develop a
federal marine debris clearinghouse to make accessible the most recent
information on marine debris including prevention and reduction
strategies, literature on marine debris impacts, and outreach and
education material for multiple audiences.
    The Act makes permanent a Marine Debris Prevention and Removal
Program within NOAA (NOAA Program) which, among other things, is aimed
at reducing and preventing the occurrence and adverse impacts of marine
debris on the marine environment and navigational safety. The NOAA
Program includes mapping, identification, impact assessment, removal,
and prevention of marine debris with a focus on threats to living
marine resources including commercial fisheries, species protected
under the Endangered Species Act and Marine Mammal Protection Act, and
the habitat upon which they depend. The NOAA Program is also intended
to include use of non-regulatory approaches to reduce and prevent the
loss of fishing gear, including the development of local or regional
protocols for lost gear reduction and prevention. Such measures could
include new gear technology, incentives to reduce the risk of lost
gear, outreach and education, and other non-regulatory measures to
cooperatively minimize the volume of lost and discarded fishing gear
and to aid in its recovery. The Act authorizes NOAA to provide grants
to entities whose activities affect research or regulation of marine
debris and entities with expertise in a field related to marine debris.
    The Act requires the Coast Guard to enforce the International
Convention for the Prevention of Pollution from Ships, 1973, as
modified by the 1978 Protocol (MARPOL 73/78), Annex V and the Act to
Prevent Pollution from Ships, 33 U.S.C. 1901-1915 (1996). The Coast
Guard will continue to monitor and enforce the requirements of these
acts among the appropriate regulated industries and communities. The
Coast Guard also intends to maintain its voluntary reporting program,
to report damage to vessels and disruption to navigation caused by
marine debris and increase international cooperation to reduce marine
debris. The Act also requires the Coast Guard to submit to Congress a
report evaluating the Coast Guard's progress on these initiatives. In
addition, the Act requires the Coast Guard to obtain a report from the
National Research Council on the effectiveness of international and
domestic measures to prevent and reduce marine debris and its impacts.
The Coast Guard is actively working to fulfill these requirements.

IV. Discussion of Proposed Rule

    The Act requires NOAA and the Coast Guard, in consultation with the
IMDCC, to ``jointly develop and promulgate through regulations a
definition of the term `marine debris', [f]or the purposes of the
Act.'' 33 U.S.C. 1954(b)(2006). The Act expressly limits the
application of the definition of marine debris to the implementation
and requirements of the Act. The Act does not authorize NOAA or the
Coast Guard to undertake regulatory actions other than the promulgation
of this definition, and the proposed definition of marine debris does
not affect the regulatory or management activities of other federal
agencies.
    NOAA and the Coast Guard worked together to develop the proposed
definition and considered both agencies' responsibilities under the Act
when developing the proposed definition. NOAA and the Coast Guard are
committed to continuing to work together to jointly develop any future
revisions of the definition of marine debris for the purposes of the
Act.
    Generally, the term ``marine debris'' has a variety of meanings to
the many entities working in and affecting the marine environment. The
proposed definition, however, focuses on solid debris from both land-
based and ocean-based sources and its adverse impacts on the marine
environment and navigation safety. While alternative definitions were
considered, the proposed definition would allow NOAA to consider the
broadest possible range of marine debris projects for funding pursuant
to the Act while providing the Coast Guard sufficient parameters to
conduct useful and focused studies and reports required by the Act.
    As required by the Act, NOAA and the Coast Guard consulted with the
IMDCC during the development of the definition of marine debris in this
proposed rule. Among the comments received from IMDCC members was a
suggestion to include the phrase ``unauthorized'' in the definition in
order to exclude those materials explicitly permitted to be discharged
into the marine environment.
    NOAA and the Coast Guard decided not to include the term
``unauthorized'' in the proposed definition because it would
inappropriately narrow the definition. Such a limited definition would
be inconsistent with the objectives of the Act, which are to identify,
determine the sources of, assess, reduce, and prevent the full range of
marine debris and its adverse effects on the marine environment and
navigation safety. Several laws, such as the Act to Prevent Pollution
from Ships, and the Ocean Dumping Act, allow the discharge, disposal or
placement of persistent material into the ocean that could be
considered ``marine debris'' as defined in this regulation. Authorities
to dispose of or abandon material that is otherwise authorized by law,
and may be considered marine debris as defined in this regulation, are
not prohibited from disposal or otherwise affected by the programs
implemented pursuant to the Act or the promulgation of this definition.
    Some IMDCC members also commented that the definition of marine
debris should be limited to debris with adverse effects on the marine
environment. NOAA and the Coast Guard chose not to include this
limitation because it would restrict opportunities to conduct research
projects where the adverse impacts of marine debris are already known
to be harmful and limit opportunities for conducting research where
impacts are unknown or uncertain. Limiting the

range of research opportunities in this way would diminish the ability
of NOAA and the Coast Guard to fulfill the objectives of the Act.
    Promulgation of this definition will help fulfill the requirements
of the Act and define the scope of the NOAA and Coast Guard programs
pursuant to the Act. The NOAA Program will meet the objectives of the
Act through coordination with the Coast Guard, the IMDCC, other Federal
agencies, across NOAA line offices, and through partnerships with State
and local governments, non-governmental organizations, universities,
and marine related industries, particularly the fishing industry and
the Regional Fishery Management Councils. The implementation of the Act
will contribute to accomplishing NOAA's mission to promote marine
ecosystem health, commerce, and transportation.

V. Regulatory Evaluation

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

A. Executive Order 12866

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order.

B. Regulatory Flexibility Act

    The Chief Counsel for Regulation of the Department of Commerce
certified to the Chief Counsel for Advocacy of the Small Business
Administration that this proposed rule, if adopted, would not have a
significant economic impact on a substantial number of small entities.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), the Coast
Guard has considered whether this proposed rule would have a
significant economic impact on a substantial number of small entities.
The term ``small entities'' comprises small businesses, not-for-profit
organizations that are independently owned and operated and are not
dominant in their fields, and governmental jurisdictions with
populations of less than 50,000. The factual basis for this
certification is set forth below.
    Under 33 U.S.C. 1954, NOAA and the Coast Guard, in consultation
with the Interagency Marine Debris Coordinating Committee (IMDCC), are
required to promulgate jointly a definition of ``marine debris'' for
the purposes of the Act. This proposed rule is relevant only to the
scope and implementation of the NOAA and Coast Guard programs
established by the Act and does not regulate any on-going activities.
It serves only to define the scope of the grants and other cooperative
funding that may be available through NOAA to federal and non-federal
entities. The Coast Guard program provides for the Coast Guard to take
certain actions in consultation with the IMDCC, pertaining to
compliance with MARPOL Annex V and development and implementation of a
plan to improve ship-board waste management, as well as actions to
improve international cooperation to reduce marine debris and establish
a voluntary marine debris reporting program for vessel operators. The
NOAA program provides for NOAA, subject to available funding, to carry
out activities with regard to the mapping, identification, impact
assessment, removal and prevention of marine debris, as well as improve
efforts to reduce and prevent the loss of fishing gear and outreach and
education of the public. The Act further establishes a grant program
administered by NOAA and makes funding opportunities available to non-
federal entities, including private and public entities, to conduct
activities that fulfill the requirements of the Act.
    Therefore, the Coast Guard and NOAA certify under 5 U.S.C. 605(b)
that this proposed rule would not have a significant economic impact on
a substantial number of small entities. If you think that your
business, organization, or governmental jurisdiction qualifies as a
small entity and that this rule would have a significant economic
impact on it, please submit a comment through one of the mechanisms
listed in the ADDRESSES section. In your comment, explain why you think
it qualifies and how and to what degree this rule would economically
affect it.

C. Collection of Information

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

D. Federalism

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

E. Unfunded Mandates Reform Act

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

F. Taking of Private Property

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

G. Civil Justice Reform

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

H. Protection of Children

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

I. Indian Tribal Governments

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

J. Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not

likely to have a significant adverse effect on the supply,
distribution, or use of energy.

K. Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards. If you are
aware of voluntary consensus standards that might apply but are not
listed, please identify them in a comment to the Docket Management
Facility at the address under ADDRESSES and explain why they should be
used.

L. National Environmental Policy Act

    The Coast Guard has analyzed this proposed rule under Commandant
Instruction M16475.lD which guides the Coast Guard in complying with
the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-
4370f), and NOAA has analyzed the proposed rule under NOAA
Administrative Order 216-6, which sets forth NOAA's environmental
review procedures for implementing NEPA. NOAA and the Coast Guard have
made a preliminary determination this action is not likely to have a
significant effect on the human environment.
    A preliminary Coast Guard ``Environmental Analysis Check List''
supporting this preliminary determination is available in the docket
where indicated under the ``Public Participation and Request for
Comments'' section of this preamble. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule. This proposed rule has no
expected direct, indirect or cumulative impacts for the purposes of
NEPA and is not likely to have a significant effect on the human
environment. The proposed rule does not regulate any on-going
activities and serves only to define the scope of the grants and other
cooperative funding that may be available through NOAA to federal and
non-federal entities.

M. Department of Commerce Docket Number

    The clearance docket number for the Department of Commerce is:
070615197-7864-02.

    NOAA signature,
    Dated: March 14, 2008.
John H. Dunnigan,
Assistant Administrator for Ocean Services and Coastal Zone Management.
    Coast Guard signature,

    Dated: May 19, 2008.
B.M. Salerno,
RADM, Coast Guard, Assistant Commandant for Marine Safety, Security and
Stewardship.

List of Subjects

15 CFR Part 909

    Marine resources, Marine debris, Marine pollution, Ocean dumping.

33 CFR Part 151

    Administrative practice and procedure, Oil pollution, Penalties,
Reporting and recordkeeping requirements, and Water pollution control.
    For the reasons discussed in the preamble, NOAA proposes to add 15
CFR part 909 and the Coast Guard proposes to amend 33 CFR part 151 as
follows:
    1. 15 CFR part 909 is added to read as follows:

PART 909--MARINE DEBRIS

Sec.
909.1 Definition of marine debris for the purposes of the Marine
Debris Research, Prevention, and Reduction Act.

    Authority: 33 U.S.C. 1951-1958 (2006).

Sec.  909.1  Definition of marine debris for the purposes of the Marine
Debris Research, Prevention, and Reduction Act.

    (a) Marine debris. For the purposes of the Marine Debris Research,
Prevention, and Reduction Act (33 U.S.C. 1951-1958 (2006)) only, marine
debris is defined as any persistent solid material that is manufactured
or processed and directly or indirectly, intentionally or
unintentionally, disposed of or abandoned into the marine environment
or the Great Lakes.
    (b) NOAA and the Coast Guard have jointly promulgated the
definition of marine debris in this part. Coast Guard's regulation may
be found in 33 CFR 151.3000.

PART 151--VESSELS CARRYING OIL, NOXIOUS LIQUID SUBSTANCES, GARBAGE,
MUNICIPAL OR COMMERCIAL WASTE, AND BALLAST WATER

    2. Add subpart E, to part 151 to read as follows:

Subpart E--Definition of Marine Debris for the Purposes of the
Marine Debris Research, Prevention, and Reduction Act

    Authority: 33 U.S.C. 1951-1958 (2006); 33 CFR 1.05-1; Department
of Homeland Security Delegation No. 0170.1.

Sec.  151.3000  Definition of Marine Debris for the purposes of the
Marine Debris Research, Prevention, and Reduction Act.

    (a) Marine debris. For the purposes of the Marine Debris Research,
Prevention, and Reduction Act (33 U.S.C. 1951-1958 (2006)) only, marine
debris is defined as any persistent solid material that is manufactured
or processed and directly or indirectly, intentionally or
unintentionally, disposed of or abandoned into the marine environment
or the Great Lakes.
    (b) NOAA and the Coast Guard have jointly promulgated the
definition of marine debris in this part. NOAA's regulation may be
found in 15 CFR 909.

 [FR Doc. E8-11700 Filed 5-23-08; 8:45 am]

BILLING CODE 3510-JE-P


[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Rules and Regulations]
[Pages 26564-26566]
[FR Doc No: 2018-12270]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0507; Product Identifier 2018-NM-027-AD; Amendment
39-19308; AD 2018-12-04]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 777-300ER series airplanes. This AD requires
replacing the water filter assembly in certain steam ovens. This AD was
prompted by a report that water can enter the steam oven cavity and
become heated and then released when the oven door is opened. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective June 25, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 25,
2018.
    We must receive comments on this AD by July 23, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this final rule, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110 SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may
view this service information at the FAA, Transport Standards Branch,
2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2018-0507.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0507; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The street address for Docket Operations (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Stanley Chen, Aerospace Engineer,
Cabin Safety and Environmental Systems Section, FAA, Seattle ACO
Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-
231-3565; email: [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We have received a report that members of the cabincrew on a Model
787 airplane were injured when hot

water escaped during the opening of the steam oven door. The incident
occurred with Jamco steam ovens, part number (P/N) ASN2001-1 and P/N
ASN2001-12. Investigation revealed that the current water filter
configuration allows foreign objects to enter the water system, which
can prevent the solenoid valve from moving to a fully closed position
and subsequently allow water to enter the steam oven cavity. Water in
the steam oven cavity can become heated and then released when the door
is opened. A new water filter assembly has been developed, which
includes a larger screen to prevent foreign object debris from moving
downstream to block the solenoid valve from moving to a fully closed
position. This condition, if not addressed, could result in water
becoming heated as it collects in the bottom of the oven during the
cooking cycle, resulting in hot water escaping when the oven door is
opened, and subsequent injury to the cabincrew.
    The Jamco steam ovens installed on Model 777-300ER series airplanes
have the same part numbers as those installed on the affected Model 787
airplane; therefore, Model 777-300ER series airplanes are subject to
the same unsafe condition revealed on the Model 787 airplane. The
unsafe condition on Model 787 airplanes has been addressed.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Service Bulletin 777-25-0617, dated June 6,
2014. The service information describes procedures for replacing the
water filter assembly in Jamco steam ovens, P/N ASN2001-1 and P/N
ASN2001-12. This service information is reasonably available because
the interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires accomplishing the actions specified in the service
information described previously.

FAA's Justification and Determination of the Effective Date

    There are currently no domestic operators of this product.
Therefore, we find that notice and opportunity for prior public comment
are unnecessary and that good cause exists for making this amendment
effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this final rule. Send your comments to an address
listed under the ADDRESSES section. Include the docket number FAA-2018-
0507 and Product Identifier 2018-NM-027-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this final rule. We will
consider all comments received by the closing date and may amend this
final rule because of 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 final rule.

Costs of Compliance

    Currently, there are no affected U.S.-registered airplanes. If an
affected airplane is imported and placed on the U.S. Register in the
future, we provide the following cost estimates to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
             Action                      Labor cost          Parts cost               Cost per product
----------------------------------------------------------------------------------------------------------------
Replacement.....................  1 work-hour x $85 per                $0  $85 per steam oven.
                                   hour = $85 per steam
                                   oven.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all known costs in our cost
estimate.

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-12-04 The Boeing Company: Amendment 39-19308 ; Docket No. FAA-
2018-0507; Product Identifier 2018-NM-027-AD.

(a) Effective Date

    This AD is effective June 25, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-300ER series
airplanes, certificated in any category, as identified in Boeing
Service Bulletin 777-25-0617, dated June 6, 2014.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Unsafe Condition

    This AD was prompted by a report that water can enter the steam
oven cavity and become heated and then released when the oven door
is opened. This condition, if not addressed, could result in injury
to the cabincrew.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Replacement of Water Filter Assembly

    Within 375 days after the effective date of this AD: Replace the
water filter assembly for Jamco steam ovens, part number (P/N)
ASN2001-1 and P/N ASN2001-12, at the locations identified in, and in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 777-25-0617, dated June 6, 2014.

    Note 1 to paragraph (g) of this AD: Boeing Service Bulletin 777-
25-0617, dated June 6, 2014, refers to Jamco Service Bulletin
ASN2001-25-3118, Revision 1, dated June 5, 2014, as an additional
source of information for replacement of the water filter assembly.

(h) Parts Installation Prohibition

    As of the effective date of this AD, no person may install on
any airplane, a Jamco steam oven having P/N ASN2001-1 or P/N
ASN2001-12, unless the modification required by paragraph (g) of
this AD is accomplished for that steam oven.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, 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
manager of the certification office, send it to the attention of the
person identified in paragraph (j) of this AD. Information may be
emailed to: [email protected].
    (2) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO Branch, to make those findings. To be approved,
the repair method, modification deviation, or alteration deviation
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.

(j) Related Information

    For more information about this AD, contact Stanley Chen,
Aerospace Engineer, Cabin Safety and Environmental Systems Section,
FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198;
phone and fax:<PHONE_NUMBER>; email: [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Service Bulletin 777-25-0617, dated June 6, 2014.
    (ii) Reserved.
    (3) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on May 29, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-12270 Filed 6-7-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 219 (Tuesday, November 13, 2012)]
[Rules and Regulations]
[Page 67563]
[FR Doc No: 2012-27537]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2012-0925]

Special Local Regulation; Annual Marine Events on the Colorado
River, Between Davis Dam (Bullhead City, AZ) and Headgate Dam (Parker,
AZ) Within the San Diego Captain of the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce special local regulations during
the Blue Water Resort and Casino Thanksgiving Regatta, on the waters of
Lake Moovalya, Parker, Arizona, from November 23 through November 24,
2012. These special local regulations are necessary to provide for the
safety of the participants, crew, spectators, sponsor vessels of the
race, and general users of the waterway. During the enforcement period,
persons and vessels are prohibited from entering into, transiting
through, or anchoring within this safety zone unless authorized by the
Captain of the Port, or his designated representative.

DATES: The regulations in 33 CFR 100.1102 will be enforced on November
23 through November 24, 2012 from 6:30 a.m. until 6:00 p.m. each day.
If the event is delayed by inclement weather, these regulations will
also be enforced on November 25, 2012, from 6:30 a.m. to 6:00 p.m.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Petty Officer Deborah Metzger, Waterways Management, U.S.
Coast Guard Sector San Diego, CA; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulations in 33 CFR 100.1102 in support of the annual Blue
Water Resort and Casino Thanksgiving Regatta (Item 9 on Table 1 of 33
CFR 100.1102). The Coast Guard will enforce the special local
regulations in that portion of Lake Moovalya, Parker, AZ between the
northern and southern boundaries of La Paz County Park on November 23
through November 24, 2012 from 6:30 a.m. to 6:00 p.m. each day. If the
event is delayed by inclement weather, these regulations will also be
enforced on November 25, 2012, from 6:30 a.m. to 6:00 p.m. The Blue
Water Resort and Casino Thanksgiving Regatta will set up the course on
November 22 and race on November 23 through November 24, 2012. Groups
will be broken up into different classes and compete in designated
heats. There will be 40 heats per day.
    Under the provisions of 33 CFR 100.1102, persons and vessels are
prohibited from entering into, transiting through, or anchoring within
this safety zone unless authorized by the Captain of the Port, or his
designated representative. The Coast Guard may be assisted by other
Federal, State, or local law enforcement agencies in enforcing this
regulation.
    This notice is issued under authority of 33 CFR 100.1102 and 5
U.S.C. 552(a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with extensive advance
notification of this enforcement period via the Local Notice to
Mariners, state, or local agencies.

    Dated: October 18, 2012.
S.M. Mahoney,
Acting, Captain of the Port San Diego, United States Coast Guard.
[FR Doc. 2012-27537 Filed 11-9-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: January 30, 2007 (Volume 72, Number 19)]
[Notices]
[Page 4252]
[DOCID:fr30ja07-49]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-142-000]

CenterPoint Energy Gas Transmission Company; Notice of Proposed
Changes in FERC Gas Tariff

January 23, 2007.
    Take notice that on January 22, 2007, CenterPoint Energy Gas
Transmission Company (CEGT) tendered for filing as part of its FERC Gas
Tariff, Sixth Revised Volume No. 1, the tariff sheets attached to
Appendix A to the filing, to be effective March 1, 2007.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of 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>.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-1372 Filed 1-29-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Notices]
[Pages 6574-6576]
[FR Doc No: 2018-03017]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2336]

Determination of Regulatory Review Period for Purposes of Patent
Extension; JUVEDERM VOLUMA XC

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for JUVEDERM VOLUMA XC and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that medical
device.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
16, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section
for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 16, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date. Furthermore, any
interested person may petition FDA for a determination regarding
whether the applicant for extension acted with due diligence during the
regulatory review period by August 13, 2018. See ``Petitions'' in the
SUPPLEMENTARY INFORMATION section for more information.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your

comment does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-E-2336 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; JUVEDERM VOLUMA XC.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device JUVEDERM VOLUMA
XC. JUVEDERM VOLUMA XC is indicated for deep (subcutaneous and/or
supraperiosteal) injection for cheek augmentation to correct age-
related volume deficit in the midface in adults over the age of 21.
Subsequent to this approval, the USPTO received a patent term
restoration application for JUVEDERM VOLUMA XC (U.S. Patent No.
7,741,476) from Pierre Lebreton, and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated October 30, 2015, FDA advised the USPTO
that this medical device had undergone a regulatory review period and
that the approval of JUVEDERM VOLUMA XC represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
JUVEDERM VOLUMA XC is 1,896 days. Of this time, 1,110 days occurred
during the testing phase of the regulatory review period, while 786
days occurred during the approval phase. These periods of time were
derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: August 15, 2008. The applicant claims
that the investigational device exemption (IDE) required under section
520(g) of the FD&C act for human tests to begin became effective on
July 24, 2009. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
August 15, 2008, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to
the device under section 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e): August 29, 2011. FDA has verified the applicant's
claim that the premarket approval application (PMA) for JUVEDERM VOLUMA
XC (PMA P110033) was initially submitted August 29, 2011.

    3. The date the application was approved: October 22, 2013. FDA has
verified the applicant's claim that PMA P110033 was approved on October
22, 2013.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 567 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03017 Filed 2-13-18; 8:45 am]
 BILLING CODE 4164-01-P