			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

    Issued by the Department of Transportation on  December 3, 2003

NOTICE OF ACTION TAKEN – DOCKET OST-2003-15758

________________________________________________________________________
________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Joint Application of UNITED AIR LINES, INC., AND BRITISH MIDLANDS
AIRWAYS LIMITED d/b/a bmi (“bmi”), filed  July 23, 2003, for:

XX  Exemption for two years for United under 49 U.S.C. §40109 to
provide the following service:

Scheduled foreign air transportation of persons, property, and mail
between (1) any point or points in the United States and a point or
points in the United Kingdom, directly and via intermediate points; (2)
any point or points within the United Kingdom; and (3) any point or
points in the United Kingdom and any point or points in third countries,
by code-sharing on flights operated by bmi; and to integrate this
authority with authority at other points United is authorized to serve
by certificate or exemption.

XX  Exemption for two years for bmi under 49 U.S.C. §40109 to provide
the following service:

Scheduled foreign air transportation of persons, property, and mail
between (1) any point or points in the United States and any point or
points in the United Kingdom, directly or via intermediate points;
(2) any point or points within the United States; and (3) any point or
points in the United States and any point or points in third countries,
by code-sharing on flights operated by United.

XX Statement of Authorization for United under 14 CFR Part 212 to:

Display bmi’s “BD*” designator code on flights operated by United
between (1) points in the United States; (2) points in the United States
and points in the United Kingdom, directly or via intermediate points;
and (3) points in the United States and points in third countries.

XX Statement of Authorization for bmi under 14 CFR Part 212 to:

Display United’s “UA*” designator code on flights operated by bmi
between (1) points within the United Kingdom; (2) points in the United
States and regional airports in the United Kingdom, directly and via
intermediate points; and (3) points in the United Kingdom and points in
third countries.

The applicants initially propose to conduct code-share operations under
this authority over various routes (see Appendix D to this Notice).

Applicant reps:  Jeffrey Manley (United)<PHONE_NUMBER> and Marshall
Sinick (bmi)<PHONE_NUMBER>

DOT Analyst:    Linda Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, in part (subject to limitations and conditions, see below)

XX  Balance Denied (see below)

The above action was effective when taken: December 3, 2003, through
Decemberv3, 2005.

Responsive Pleadings:  Continental Airlines, Inc. (Continental), Delta
Air Lines, Inc. (Delta), and Northwest Airlines, Inc. (Northwest) filed
answers to the request.  United/bmi filed a consolidated reply to the
answers.

Continental, Delta, and Northwest oppose the United/bmi application,
stating that the proposed code-share arrangement would grant
extrabilateral U.S.-Heathrow access to bmi while doing nothing to
improve the plight of U.S.

- see next page -

													2

carriers that remain locked out of Heathrow by the restrictive policies
of the U.K. Government.  The carriers argue that, contrary to the
applicants’ arguments, the Department’s prior approvals of the
Delta/Virgin Atlantic and Continental/Virgin Atlantic code-share
arrangements do not support the UA/bmi request here.  The carriers
explain that the Department’s extrabilateral approvals of the
Delta/Virgin and Continental/Virgin arrangements secured new Heathrow
access for U.S.-flag non-incumbent carriers where grant of the UA/bmi
request would promote new U.S.-Heathrow access for a U.K. carrier (and,
in this particular case, a U.K. carrier that is a member of one of the
two dominant alliances at London Heathrow).

In its joint reply, United/bmi maintain that the “lion’s share of
the economic benefits of expanded codesharing between United and bmi,
including most particularly transatlantic codesharing, will inure to
United”and will provide needed financial resources to United at a
difficult juncture in its history.  The applicants state that this
benefit and the improvement of service options for travelers, provide
compelling reasons for approval of the request.  United/bmi argue that
the bilateral environment that existed two and one-half years ago when
the Department denied a similar UA/bmi request has completely changed.
United/bmi assert that, at that time, the Department hoped the denial
would bring pressure on the United Kingdom to move toward aviation
liberalization; however, this previous bilateral framework has been
replaced by the multilateral United States-European Union negotiation
– a process that will “consume several years under the most
optimistic estimates.”  United/bmi state that, during the interim, the
United States and the United Kingdom should approve balanced exchanges
of “procompetitive opportunities such as the United/bmi codeshare.”
United/bmi assert that grant of the application will have an immediate
and substantial beneficial impact on consumers and on United, and will
not adversely affect the current multilateral negotiating process.

Decision:  We have decided to grant the applicants’ request to expand
their existing code-share arrangement to the extent that it is
consistent with the terms of the aviation agreement between the United
States and the United Kingdom.  We have decided to deny the
applicants’ request for extrabilateral authority to provide code-share
services at London Heathrow (see Appendix D for a summary of the
applicants’ initially proposed code-share routes, and the
Department’s corresponding action) and for unlimited U.S.-London
exemption authority.

Our action here grants the applicants the following authority, subject
to the conditions described herein:

	United:

I.  Exemption authority to conduct scheduled foreign air transportation
of persons, property, and mail between any point or points in the United
States and regional airports in the United Kingdom, directly and via
intermediate points, and beyond the United Kingdom to any point or
points in third countries, limited to operations under its code-sharing
agreement with bmi, whereby United will place its code on flights
operated by bmi; and to combine this authority with authority at other
points United is authorized to serve by certificate or exemption.

II.  A statement of authorization to display bmi’s “BD” designator
code on flights operated by United

between (1) points in the United States; (2) points in the United States
and regional airports in the United Kingdom, either nonstop or via
third-country intermediates; and (3) points in the United States and
points in third countries, either nonstop or via third-country
intermediates.

bmi:

I.  Exemption authority to conduct scheduled foreign air transportation
of persons, property, and mail between regional airports in the United
Kingdom and any point or points in the United States, via bmi’s
authorized U.S. gateways, and beyond the United States to any point or
points in third countries, limited to operations under its code-sharing
agreement with United, whereby bmi will place its code on flights
operated by United.

II.  A statement of authorization to display United’s “UA”
designator code on flights operated by bmi

between (1) points in the United Kingdom; (2) points in the United
States and regional airports in the United Kingdom, either nonstop or
via third-country intermediates; and (3) points in the United Kingdom
and points in third countries, either nonstop or via third-country
intermediates.

- see next page -

													3

Our basis for grant of this authority, as limited and conditioned by
this Notice, is the 1995 Memorandum of Consultations between the United
States and the United Kingdom (MOC).  We also find that the services we
are authorizing will enhance competition in the markets involved, to the
benefit of the traveling and shipping public.  Moreover, the authority
granted is comparable to authority we have granted to America/British
Airways and Continental/Virgin Atlantic.  See Order 2003-5-33 (in Docket
OST-2002-13861), and Notice of Action Taken dated August 22, 2003 (in
Docket OST-1997-2880).

As stated above, we have decided not to grant the applicants the broad
authority sought between any point in the United States and London.
While United has argued that it would benefit financially from the
Heathrow code-share services proposed at a difficult time in the
carrier’s history, the grant of such extrabilateral authority to bmi
is beyond what we are prepared to grant to a carrier of the United
Kingdom at this time.  Accordingly, given the current state of our
aviation relationship with the United Kingdom, we continue to believe
that the best course of action here is to deny, without prejudice, that
portion of the application involving the extrabilateral authority at
London.

Action taken by:   Paul L. Gretch, Director

                               Office of International Aviation

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

	XX   United’s certificates of public convenience and necessity

	XX   Standard Exemption Conditions (attached as Appendices A and B)

------------------------------------------------------------------------
------------------------------------------------------------------------
------------Conditions:  The exemption authority granted to United and
bmi is limited to services provided on a code-share basis only.  The
code-share operations conducted under this authorization are subject to
the conditions contained in Appendices A, B, and C below.  United and
bmi may initially conduct the authorized code-share operations over the
approved routes set forth in Appendix D to this Notice; and may conduct
code-share operations in additional markets subject to the terms,
conditions, and limitations of this Notice, and in particular conditions
(b) and (e) of Appendix C.

The route integration authority granted to United is subject to the
condition that any service provided under this exemption shall be
consistent with all applicable agreements between the United States and
the foreign countries involved.  Furthermore, (a) nothing in the award
of the route integration authority granted should be construed as
conferring upon United rights (including fifth-freedom intermediate
and/or beyond rights) to serve markets where U.S. carrier entry is
limited unless United notifies the Department of its intent to serve
such a market and unless and until the Department has completed any
necessary carrier selection procedures to determine which carrier(s)
should be authorized to exercise such rights; and (b) should there be a
request by any such carrier to use the limited-entry route rights that
are included in United’s authority by virtue of the route integration
authority granted here, but that are not then being used by United, the
holding of such authority by route integration will not be considered as
providing any preference for United in a competitive carrier selection
proceeding to determine which carrier(s) should be entitled to use the
authority at issue.

________________________________________________________________________
_________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicants qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
 To the extent not granted or dismissed, we denied all requests in the
referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov/reports_aviation.aspAPPENDIX A

U.S. CARRIER EXEMPTION CONDITIONS

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security.  To assure compliance with all applicable U.S.
Government requirements concerning security, the holder shall, before
commencing any new service (including charter flights) to or from a
foreign airport, contact its Principal Security Inspector (PSI) to
advise the PSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

												8/2003

APPENDIX B

FOREIGN CARRIER EXEMPTION CONDITIONS

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its Principal Security Inspector (PSI) to advise the PSI of its
plans and to find out whether the Transportation Security Administration
has determined that security is adequate to allow such airport(s) to be
served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

											8/2003CODE-SHARE CONDITIONS			APPENDIX C

The code-share operations authorized here are subject to the following
conditions:

(a)  The statements of authorization will remain in effect only as long
as (i) United and bmi continue to hold the necessary underlying
authority to operate the code-share services at issue, and (ii) the
code-share agreement providing for the code-share operations remains in
effect;

(b)  United and/or bmi must notify the Department no later than 30 days
before they begin any new code-share service under the code-share
services authorized here.  Such notice shall identify the market(s) to
be served, which carrier will be operating the aircraft in the
code-share market added, and the date on which the service will begin.
Such notices should be filed in Docket OST-2003-15758;

(c)  United and/or bmi must notify the Department immediately if the
code-share agreement under which these code-share services are operated
is no longer in effect or if the carriers decide to cease operating all
or a portion of the approved code-share services.  We expect this
notification to be received within 10 days of such non-effectiveness or
of such decision.  Such notices should be filed in Docket
OST-2003-15758;

(d)  The code-sharing operations conducted under this authority must
comply with 14 CFR 257 and with any amendments to the Department’s
regulations concerning code-share arrangements that may be adopted.
Notwithstanding any provisions in the contract between the carriers, our
approval here is expressly conditioned upon the requirements that the
subject foreign air transportation be sold in the name of the carrier
holding out such service in computer reservation systems and elsewhere;
that the carrier selling such transportation (i.e., the carrier shown on
the ticket) accept responsibility for the entirety of the code-share
journey for all obligations established in its contract of carriage with
the passenger; that the passenger liability of the operating carrier be
unaffected; and that the operating carrier shall not permit the code of
its U.S. code-sharing partner to be carried on any flight that enters,
departs, or transits the airspace of any area for whose airspace the
Federal Aviation Administration has issued a flight prohibition;

(e)  The authority to operate to third countries is subject to the
condition that any service provided under the statement of authorization
shall be consistent with all applicable agreements between the United
States and the foreign countries involved.  Furthermore, (i) nothing in
the award of this blanket statement of authorization should be construed
as conferring upon United and bmi rights (including code-share, fifth
freedom intermediate and/or beyond rights) to serve markets where U.S.
carrier rights are limited unless United and bmi notify us of their
intent to serve such a market and unless and until the Department has
completed any necessary carrier selection procedures to determine which
carrier(s) should be authorized to exercise such rights;1 and (ii)
should there be a request by any carrier to use the limited-entry route
rights that are included in United and bmi’s authority by virtue of
the blanket statement of authorization granted here, but that are not
being used by United and bmi, the holding of such authority will not be
considered as providing any preference for United and bmi in a
competitive carrier selection proceeding to determine which carrier(s)
should be entitled to use the authority at issue; and

(f)  The authority granted here is specifically conditioned so that
neither United nor bmi shall give any force or effect to any contractual
provisions between themselves that are contrary to these conditions.

________________________

1 The notice in paragraph (b) above can be used for this notification.

APPENDIX D

											Page 1 of 5

Initially-Proposed Code-Share Operations and Department Action

GATEWAY CITY	BEYOND CITY	DISPOSITION

	(intra U.S. – BD* on UA)

	Chicago	Anchorage	Approved

	Atlanta	Approved

	Austin	Approved

	Baltimore	Approved

	Boise	Approved

	Boston	Approved

	Cedar Rapids	Approved

	Charlotte	Approved

	Cincinnati	Approved

	Cleveland	Approved

	Colorado Springs	Approved

	Columbus	Approved

	Dallas/Ft. Worth	Approved

	Dayton	Approved

	Denver	Approved

	Des Moines	Approved

	Detroit	Approved

	Ft. Lauderdale	Approved

	Ft. Myers	Approved

	Grand Rapids	Approved

	Hartford	Approved

	Houston	Approved

	Indianapolis	Approved

	Kansas City	Approved

	Las Vegas	Approved

	Los Angeles	Approved

	Miami	Approved

	Minneapolis/St. Paul	Approved

	New Orleans	Approved

	New York	Approved

	Oakland	Approved

	Omaha	Approved

	Orange County	Approved

	Orlando	Approved

	Philadelphia	Approved

	Phoenix	Approved

APPENDIX D

											Page 2 of 5

Initially-Proposed Code-Share Operations and Department Action

GATEWAY CITY	BEYOND CITY	DISPOSITION

	(intra U.S. – BD* on UA)

	Chicago (cont’d)	Pittsburgh	Approved

	Portland (PDX)	Approved

	Rochester	Approved

	Sacramento	Approved

	St. Louis	Approved

	St. Thomas	Approved

	Salt Lake City	Approved

	San Antonio	Approved

	San Diego	Approved

	San Francisco	Approved

	San Jose	Approved

	San Juan	Approved

	Seattle	Approved

	Spokane	Approved

	Tampa	Approved

	Tucson	Approved

	Wichita	Approved

Washington, D.C.	Atlanta	Approved

	Austin	Approved

	Boston	Approved

	Chicago	Approved

	Cincinnati	Approved

	Dallas/Ft. Worth	Approved

	Denver	Approved

	Detroit	Approved

	Hartford	Approved

	Houston	Approved

	Indianapolis	Approved

	Kansas City	Approved

	Las Vegas	Approved

	Los Angeles	Approved

	Miami	Approved

	Minneapolis/St. Paul	Approved

	New Orleans	Approved

	New York	Approved

	Oakland	Approved

APPENDIX D

											Page 3 of 5

Initially-Proposed Code-Share Operations and Department Action

GATEWAY CITY	BEYOND CITY	DISPOSITION

	(intra U.S. – BD* on UA)

	Washington, D.C. (cont’d) 	Orange County	Approved

	Orlando	Approved

	Philadelphia	Approved

	Phoenix	Approved

	Portland (PDX)	Approved

	St. Thomas	Approved

	Salt Lake City	Approved

	San Diego	Approved

	San Francisco	Approved

	San Jose	Approved

	San Juan	Approved

	Seattle	Approved

	Tampa	Approved

	Tucson	Approved

	(beyond U.S. – BD* on UA)

	Chicago	Mexico City	Approved

Washington, D.C.	Mexico City	Approved

	(intra U.K. – UA* on BD)

	London (LHR)	Belfast	Approved

	Edinburgh	Approved

	Glasgow	Approved

	Leeds/Bradford	Approved

	Manchester	Approved

	Teeside	Approved

Manchester	Aberdeen	Approved

	Edinburgh	Approved

	Glasgow	Approved

	(beyond U.K. – UA* on BD)

	Birmingham	Brussels	Approved

East Midlands	Amsterdam	Approved

	Brussels	Approved

	Frankfurt	Approved

	Paris	Approved

APPENDIX D

											Page 4 of 5

Initially-Proposed Code-Share Operations and Department Action

GATEWAY CITY	BEYOND CITY	DISPOSITION

	(beyond U.K. – UA* on BD)

	London (LHR) 	Amsterdam	Approved

	Barcelona	Approved

	Berlin	Approved

	Brussels	Approved

	Budapest	Approved

	Cologne/Bonn	Approved

	Copenhagen	Approved

	Dresden	Approved

	Dublin	Approved

	Faro	Approved

	Frankfurt	Approved

	Geneva	Approved

	Hanover	Approved

	Helsinki	Approved

	Lisbon	Approved

	Madrid	Approved

	Malaga	Approved

	Milan	Approved

	Nice	Approved

	Paris	Approved

	Prague	Approved

	Rome	Approved

	Stockholm	Approved

	Stuttgart	Approved

	Warsaw	Approved

Manchester	Dusseldorf	Approved

	Frankfurt	Approved

	(U.S.-U.K. – UA* on BD)

	Manchester	Chicago	Approved

	Washington, D.C.	Approved

APPENDIX D

											Page 5 of 5

Initially-Proposed Code-Share Operations and Department Action

GATEWAY CITY	BEYOND CITY	DISPOSITION

	(U.S.-U.K. – BD* on UA)

	London (LHR)	Chicago	Denied

	Los Angeles	Denied

	New York/Newark	Denied

	San Francisco	Denied

	Washington, D.C.	Denied

 “Regional airports” in the United Kingdom include all U.K.
airports, except Heathrow and Gatwick.


[Federal Register: September 17, 2009 (Volume 74, Number 179)]
[Notices]
[Page 47790-47791]
[DOCID:fr17se09-34]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2009-0379; FRL-8958-3]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NSPS for Beverage Can Surface
Coating (Renewal); EPA ICR Number 0663.09, OMB Control Number 2060-0001

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
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approved collection. The ICR which is abstracted below describes the
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DATES: Additional comments may be submitted on or before October 19,
2009.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2009-0379, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
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FOR FURTHER INFORMATION CONTACT: Leonard Lazarus, Office of Enforcement
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<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On July 8, 2009 (74 FR 32580) EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
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    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2009-0379, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
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    Use EPA's electronic docket and comment system at http://
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    Title: NSPS for Beverage Can Surface Coating (Renewal).
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approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: Respondents are owners or operators of beverage can
surface coating facilities. These standards apply to each beverage can
surface coating operation in which organic coatings are applied
(exterior base coat operations, over varnish coating operations, and
inside spray coating operations) that commenced construction,
modification or reconstruction after November 26, 1980. Owners or
operators of the affected facilities described must make initial
reports when a source becomes subject to the standards, conduct and
report on a performance test, demonstrate and report on continuous
monitor performance, and maintain records of the occurrence and
duration of any startup, shutdown, or malfunction in the operation of
an affected facility. Semiannual reports of excess emissions are
required. These notifications, reports, and records are essential in
determining compliance; and are required, in general, of all sources
subject to New Source Performance Standards (NSPS).
    Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintenance
reports, and records. All reports are sent to the delegated State or
local authority. In the event that there is no such delegated
authority, the reports are sent directly to the EPA regional office.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 43
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Owners or operators of beverage can
surface coating facilities.
    Estimated Number of Respondents: 48.
    Frequency of Response: Semiannually, On Occasion, Initially.
    Estimated Total Annual Hour Burden: 5,134.
    Estimated Total Annual Cost: $515,230--which includes $414,430 in
labor costs, $100,800 in annual Operation and Maintenance (O&M) costs,
and no capital/startup costs.
    Changes in the Estimates: There is no change in the burden hours or
cost to the respondents in this ICR compared to the previous ICR. This
is due to two considerations:
    (1) The regulations have not changed over the past three years and
are not anticipated to change over the next three years; and (2) the
growth rate for the respondents is very low, negative or nonexistent.
Therefore, the labor hours and cost figures in the previous ICR reflect
the current burden to the respondents and are reiterated in this ICR.
It should be noted that there is a minor correction of $200 to the O&M
costs due to rounding errors in the previous ICR.

    Dated: September 11, 2009.
John Moses,
Director, Collection Strategies Division.
[FR Doc. E9-22427 Filed 9-16-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: November 21, 2008 (Volume 73, Number 226)]
[Notices]
[Page 70630-70631]
[DOCID:fr21no08-46]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-17-000, PF08-14-000]

Florida Gas Transmission Company, LLC; Notice of Application

November 17, 2008.
    Take notice that on October 31, 2008, Florida Gas Transmission
Company, LLC (FGT), 5444 Westheimer Road, Houston, Texas 77056-5306,
filed in the above referenced docket an application pursuant to section
7(c) of the Natural Gas Act (NGA) and parts 157 and 284 of the
Commission's regulations, for an order granting a certificate of public
convenience and necessity authorizing the construction and operation of
natural gas pipeline and compression facilities and to acquire pipeline
facilities, all as more fully set forth in the application which is on
file with the Commission and open to public inspection. The filing is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site 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, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    Specifically, FGT proposes in its Phase VIII Expansion Project to:
(i) Construct and operate 483.2 miles of pipeline loop, mainline, and
laterals; (ii) install 213,600 horsepower of compression at existing
and new compressor stations; (iii) acquire from Florida Power & Light
Company (FPL) a 22.7 mile pipeline; and (iv) construct and operate
various metering and regulating facilities. All of the facilities
comprising the Phase VIII Expansion Project will be located in the
states of Alabama and Florida. FGT estimates that the proposed
facilities will cost approximately $2.455 billion. The facilities will
be able to provide an annual average of 820,000 MMBtu/day of firm
transportation. FGT proposes a new firm rate schedule, Rate Schedule
FTS-3 for service on the expansion.
    Any questions concerning this application may be directed to
Stephen T. Veatch, Sr. Director, Certificates and Tariffs, Florida Gas
Transmission Company, LLC, 5444 Westheimer Road, Houston, Texas 77056-
5306 or at<PHONE_NUMBER> or<EMAIL_ADDRESS>    On March 18, 2008, the Commission staff granted FGT's request to
utilize the FERC Pre-Filing Process and assigned Docket No. PF08-14-000
to staff activities involved the Phase VIII Expansion Project. Now as
of the filing of FGT's application on October 31, 2008, the Pre-Filing
Process for this project has ended. From this time forward, this
proceeding will be conducted in Docket No. CP09-17-000, as noted in the
caption of this Notice.
    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 the 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 in the proceeding with the Commission
and must mail a copy to the applicant and to every other party. 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: December 8, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-27688 Filed 11-20-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Rules and Regulations]
[Pages 12088-12093]
[FR Doc No: 2019-06024]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2015-N-3785]
RIN 0910-AI00

Medical Devices; Orthopedic Devices; Classification of Posterior
Cervical Screw Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to classify posterior cervical screw systems into
class II (special controls) and to continue to require a premarket
notification (510(k)) to provide a reasonable assurance of safety and
effectiveness of the device. A posterior cervical screw system is a
device used to provide immobilization and stabilization in the cervical
spine as an adjunct to spinal fusion surgery. The term ``posterior
cervical screw systems'' is used to distinguish these devices from
currently classified thoracolumbosacral pedicle screw systems for use
in other spinal regions.

DATES: This rule is effective May 1, 2019.

ADDRESSES: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule 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: Genevieve McRae, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1457, Silver Spring, MD 20993-0002, 301-
796-6423, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of General Comments and FDA Response
    C. Specific Comments and FDA Response
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Consultation and Coordination With Indian Tribal Governments
X. Reference

I. Executive Summary

A. Purpose of the Final Rule

    Through this final rule, FDA is classifying posterior cervical
screw systems (product code NKG) into class II (special controls). This
decision was based upon the recommendation of the Orthopaedic and
Rehabilitation Devices Panel (the Panel) and our consideration and
analysis of the public comments received following the publication of
the proposed rule. FDA believes that the special controls established
and imposed by this final rule, together with

the general controls, will provide a reasonable assurance of safety and
effectiveness of the device.

B. Summary of the Major Provisions of the Final Rule

    This final rule revises the identification language for posterior
cervical screw systems, classifies posterior cervical screw systems
into class II (special controls), and establishes the following special
controls for posterior cervical screw systems with which manufacturers
must comply: (1) The design characteristics of the device ensure that
the geometry and material composition are consistent with the intended
use of the device; (2) nonclinical performance testing must demonstrate
mechanical function and durability of the implant; (3) device
components must be demonstrated to be biocompatible; (4) validation
testing must demonstrate the cleanliness and sterility of, or the
ability to clean and sterilize, the device components and device-
specific instruments; and (5) device labeling must include a clear
description of the technological features of the device, the intended
use and indications for use, and certain specified device-specific
warnings, precautions, and contraindications.

C. Legal Authority

    FDA is issuing this rule under the authority of the provisions of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to
medical devices (21 U.S.C. 301 et seq.), including section 513(a)
regarding device classes (21 U.S.C. 360c(a)), section 513(b) and (c)
regarding device classification panels, and section 513(d) regarding
device classification.

D. Costs and Benefits

    We estimate that the final rule will affect 32 manufacturers of 38
products. Manufacturers of these affected products will incur one-time
costs of $78.69 each to read and understand the rule, and will incur
one-time labeling costs of $13,189 for each product. The present value
of the total costs is estimated at $503,700. The annualized cost of
this rule over 10 years is estimated to be $62,777 at a 7 percent
discount rate and $52,853 at a 3 percent discount rate. We did not
estimate quantifiable benefits of the final rule.

II. Background

A. History of This Rulemaking

    In the Federal Register of March 10, 2016 (81 FR 12607), FDA issued
a proposed rule to classify posterior cervical screw systems as class
II with special controls, and proposed special controls for these
devices, and invited interested persons to comment on the proposed
regulation by June 8, 2016. These recommendations were based upon
feedback received from the Panel on September 21, 2012.

B. Summary of Comments to the Proposed Rule

    FDA received four sets of comments on the proposed rule from trade
organizations, professional societies, and an individual. The comments
within the scope of FDA's proposal to classify posterior cervical screw
systems into class II (special controls) were supportive and included a
few suggested clarifications and/or changes to the language of the
proposed rule. We considered all comments in the development of this
final rule and accepted several suggested changes, as discussed in
section IV below.

III. Legal Authority

    The FD&C Act (21 U.S.C. 301 et seq.), as amended, established a
comprehensive system for the regulation of medical devices intended for
human use. The FD&C Act establishes three categories (classes) of
devices, reflecting the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness (section 513(a)
of the FD&C Act). The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Class I devices are those devices for which the general controls of
the FD&C Act (controls authorized by or under the general controls
sections of the FD&C Act (sections 501, 502, 510, 516, 518, 519, or
520) (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j), or any
combination of such sections) are sufficient to provide a reasonable
assurance of the safety and effectiveness of the device; or those
devices for which insufficient information exists to determine that
general controls are sufficient to provide reasonable assurance of the
safety and effectiveness of the device or to establish special controls
to provide such assurance, but because the devices are not purported or
represented to be for a use in supporting or sustaining human life or
for a use which is of substantial importance in preventing impairment
of human health, and do not present a potential unreasonable risk of
illness or injury, are to be regulated by general controls (section
513(a)(1)(A) of the FD&C Act).
    Class II devices are those devices for which general controls by
themselves are insufficient to provide reasonable assurance of the
safety and effectiveness, and for which there is sufficient information
to establish special controls to provide such assurance, including the
promulgation of performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines,
recommendations, and other appropriate actions as the Agency deems
necessary to provide such assurance (section 513(a)(1)(B) of the FD&C
Act).
    Class III devices are those devices for which insufficient
information exists to determine that general controls and special
controls would provide a reasonable assurance of safety and
effectiveness, and are purported or represented for a use in supporting
or sustaining human life or for a use which is of substantial
importance in preventing impairment of human health, or present a
potential unreasonable risk of illness or injury (section 513(a)(1)(C)
of the FD&C Act).
    FDA refers to devices that were in commercial distribution before
May 28, 1976 (the date of enactment of the Medical Device Amendments of
1976), as ``preamendments devices.'' Pursuant to section 513(d)(1) of
the FD&C Act, FDA classifies these devices after FDA: (1) Receives a
recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device (section 513(d)(1) of the FD&C
Act). FDA has classified most preamendments devices under these
procedures and has followed these procedures to classify posterior
cervical screw systems.

IV. Comments on the Proposed Rule and FDA Response

A. Introduction

    FDA received four sets of comments on the proposed rule by the
close of the comment period. One of the comments received was regarding
a different device type that is not associated with posterior cervical
screw systems and is thus outside the scope of the rule. We describe
and respond to the applicable comments in section IV.B and C. We have
grouped certain comments under the same number because the subject
matter of the comments is similar; conversely, in some cases, we have
separated different issues discussed in the same comment and designated
them as distinct comments, with separate numbers. The number assigned
to each comment or comment topic is purely for organizational purposes
and does not signify the comment's value or

importance or the order in which it was received.

B. Description of General Comments and FDA Response

    All comments within the scope of the rulemaking support FDA's
proposed classification of posterior cervical screw systems into class
II (special controls). One commenter notes that it supports the
proposed classification of the device because ``the use of posterior
cervical screw systems has been the standard of care for surgical
management of cervical spine disorders arising from tumor, trauma,
degerative [sic] disease and deformity for approximately 20 years.''
FDA agrees that the device type is well understood, which enables the
establishment of special controls that provide a reasonable assurance
of safety and effectiveness for these devices.

C. Specific Comments and FDA Response

    (Comment 1) A commenter suggests removing the phrase ``utilizing
pedicle and lateral mass screws'' when identifying and referring to
posterior cervical screw systems as there are additional screw types
that fall within these systems.
    (Response 1) FDA agrees with this comment and has revised each
relevant instance of this language within the regulation accordingly
(i.e., the recommended Precaution statement in Sec.
888.3075(b)(5)(iii)(A) (21 CFR 888.3075(b)(5)(iii)(A)).
    (Comment 2) A commenter recommends revising the proposed
identification of ``posterior cervical screw systems'' to remove the
specification of spinal levels for specific screw types listed in the
identification and replacing it with a range of spinal levels
applicable to all screw types utilized in the device.
    (Response 2) FDA disagrees with the proposed edits to the
identification language. Evidence in the scientific literature is not
adequate to support the use of pars screws, translaminar screws, and
transarticular screws outside of the specified level (C2) based upon
anatomic differences between C2 and other levels. Therefore, this
change is not accepted.
    (Comment 3) A commenter notes that, while the preamble to the
proposed rule specified that posterior cervical screw systems do not
include dynamic features, the examples of dynamic features listed in
the proposed identification language included ``non-uniform'' elements,
which could be interpreted to include dual-diameter rods that may be a
component of current posterior cervical screw systems. A dual-diameter
rod is a rigid rod that transitions between two different diameters
along its length.
    (Response 3) FDA agrees that dual-diameter rods are often part of
rigid posterior cervical screw systems and that the proposed
identification language should be revised to clarify that dual diameter
rods or plate/rod combinations are examples of ``longitudinal
members,'' which may be included in posterior cervical screw systems.
We have also revised the identification to specify that posterior
cervical screw systems are rigidly fixed devices that do not contain
dynamic features, including but not limited to, non-uniform
longitudinal elements or features that allow more motion or flexibility
compared to rigid systems.
    (Comment 4) A commenter notes inconsistencies or errors in the
indications for use in the proposed rule.
    (Response 4) FDA agrees with this comment and has revised the
indications for use within Sec.  888.3075 to correct the noted errors.
FDA has also clarified the language specifying the indications for use
by replacing ``degenerative disease'' with ``degeneration'' to more
appropriately reference the state to be treated and replacing
``radiographic studies'' with ``imaging studies (radiographs, computed
tomography, magnetic resonance imaging)'' to account for the various
imaging modalities that may be used in preoperative planning prior to
implantation of a posterior cervical screw system.
    (Comment 5) A commenter suggests that ``wear'' be removed from the
list of potential means by which a device could fail.
    (Response 5) FDA disagrees with this comment. Posterior cervical
screw systems are comprised of multiple interconnecting components that
have the potential to generate wear during spinal motion. Therefore,
the definition of device failure has not been modified.
    (Comment 6) A commenter recommends removing ``design
characteristics'' as a special control because this item should be a
requirement of all premarket notifications.
    (Response 6) FDA disagrees with this comment. FDA considers the
``design characteristics'' special control necessary to help
differentiate technological features for rigid posterior cervical screw
systems, included within the scope of this regulation, from features
considered to be dynamic.
    (Comment 7) A commenter recommends revising the biocompatibility
special control to be ``compliance with biocompatibility standards''
rather than ``[d]evice components must be demonstrated to be
biocompatible'' because the majority of posterior cervical screw
systems are made of materials that have a long history of safe use and,
as such, are compatible with standards. Testing for compliance with
biocompatibility standards would be relevant only for alternative or
new materials.
    (Response 7) FDA disagrees with this comment. The FD&C Act and
FDA's regulations allow for flexibility in the methods for addressing
certain regulatory requirements. Specifically, the substantial
equivalence section of the FD&C Act (section 513(i)(1)(D)) states
whenever the Secretary of Health and Human Services (the Secretary)
requests information to demonstrate that devices with differing
technological characteristics are substantially equivalent, the
Secretary shall only request information that is necessary to making
substantial equivalence determinations. In making such a request, the
Secretary shall consider the least burdensome means of demonstrating
substantial equivalence and request information accordingly. Hence,
there may be alternatives to FDA-recognized consensus standards to
satisfy the special control related to the biocompatibility of devices
within this device type.
    (Comment 8) A commenter suggests modifying the first precaution
within the labeling special control (Sec.  888.3075(b)(5)(iii)(a)) to
include ``nerve roots'' as an anatomical structure to consider during
preoperative planning.
    (Response 8) FDA agrees with this comment. This precaution has been
revised to include a reference to ``neurologic structures.''
    (Comment 9) A commenter suggests that, within the Economic Analysis
section of the proposed rule, it is unclear whether or not the required
addition of precautions to the device labeling would require
manufacturers to submit a new 510(k) for devices already on the market
and recommends that we explicitly state that such a submission would
not be required to revise the labeling for devices already on the
market to add the precautions.
    (Response 9) FDA disagrees with this comment. As in the proposed
rule, the language in the Economic Analysis of the final rule (see Ref.
1) states, ``It is not expected that manufacturers of devices already
on the market would need to submit new 510(k) notifications, 510(k)
amendments, or add-to-files to demonstrate conformance with the special
controls,'' which includes the

addition of the specified precaution statement.
    (Comment 10) A commenter recommends minor editorial revisions to
the risks and descriptive text associated with risks as outlined in the
proposed rule.
    (Response 10) FDA disagrees with this comment. The recommended
edits were minor and would not substantively change the meaning of the
risks and associated mitigations for the device; therefore, we do not
accept these suggested edits in this final rule.

V. Effective Date

    This final rule will become effective 30 days after its publication
in the Federal Register.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. We have identified 16 manufacturers that could be considered
small entities. Two of these manufacturers each produce two devices
covered by this rule. Because our final regulatory impact analysis
finds that more small entities will incur relatively low costs to
comply with the final rule than estimated in our preliminary regulatory
impact analysis, we have decided not to certify the final rule and find
that the final rule will not have a significant economic impact on a
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $150
million, using the most current (2017) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    This final rule classifies posterior cervical screw systems as
class II devices with special controls. Although these devices are
currently unclassified, manufacturers are subject to premarket
requirements similar to class II devices, with manufacturers receiving
clearance to market via a 510(k) submission without a PMA requirement.
We have concluded that special controls in addition to general controls
are sufficient to reasonably ensure the safety and effectiveness of
these devices and that these devices may be classified as class II
(special controls).
    Table 1 provides the Regulatory Information Service Center and
Office of Information and Regulatory Affairs Combined Information
System accounting information for this analysis.

                                      Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                     Primary                                    ------------------------------------------------
            Category                estimate      Low estimate    High estimate                   Discount rate  Period covered           Notes
                                                                                Year dollars         (%)           (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized         ..............  ..............  ..............            2016               7              10  .......................
     $millions/year.                                                                       2016               3              10
    Annualized Quantified......  ..............  ..............  ..............            2016               7              10  .......................
                                                                                2016               3              10
    Qualitative
Costs:
    Annualized Monetized                  0.063  ..............  ..............            2016               7              10  .......................
     $millions/year.                      0.053                                            2016               3              10
    Annualized Quantified......  ..............  ..............  ..............            2016               7              10  .......................
                                                                                2016               3              10
    Qualitative
Transfers:
    Federal Annualized           ..............  ..............  ..............            2016               7              10  .......................
     Monetized $millions/year.                                                             2016               3              10
                                ------------------------------------------------------------------------------------------------------------------------
                                 From:
                                 To:                                             ..............
                                ------------------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized   ..............  ..............  ..............            2016               7              10  .......................
     $millions/year.                                                                       2016               3              10
                                ------------------------------------------------------------------------------------------------------------------------
                                 From:
                                 To:                                             ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business:.....................................................................................................................................
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in table 2, we estimate present
and annualized values of costs and cost savings over an infinite time
horizon. Based on these costs, we consider this final rule a regulatory
action under Executive Order 13771.

                                                            Table 2--E.O. 13771 Summary Table
                                               [In $ millions 2016 dollars, over an infinite time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................             0.5  ..............  ..............             0.5  ..............  ..............
Present Value of Cost Savings...........................  ..............  ..............  ..............  ..............  ..............  ..............
Present Value of Net Costs..............................             0.5  ..............  ..............             0.5  ..............  ..............
Annualized Costs........................................           0.033  ..............  ..............           0.015  ..............  ..............
Annualized Cost Savings.................................  ..............  ..............  ..............  ..............  ..............  ..............
Annualized Net Costs....................................           0.033  ..............  ..............           0.015  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 1) and at
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This final rule establishes special controls that refer to
currently approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information
in 21 CFR part 807, subpart E, have been approved under OMB control
number 0910-0120; the collections of information in 21 CFR part 801
have been approved under OMB control number 0910-0485; and the
collections of information in 21 CFR part 807 have been approved under
OMB control number 0910-0625. The precaution labeling provisions in
Sec.  888.3075(b)(5) are not subject to review by OMB because they do
not constitute a ``collection of information'' under the PRA. Rather,
the following labeling in Sec.  888.3075(b)(5)(iii)(A) and
(b)(5)(iii)(B) is a public disclosure of information originally
supplied by the Federal Government to the recipient for the purpose of
disclosure to the public (5 CFR 1320.3(c)(2)).

IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects 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. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.

X. Reference

    The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

    1. The full analysis of economic impacts is available in Docket
No. FDA-2015-N-3785 for this final rule at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 888

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for part 888 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  888.3075 to subpart D to read as follows:

Sec.  888.3075  Posterior cervical screw system.

    (a) Identification. Posterior cervical screw systems are comprised
of multiple, interconnecting components, made from a variety of
materials that allow an implant system to be built from the occiput to
the upper thoracic spine to fit the patient's anatomical and
physiological requirements, as determined by preoperative cross-
sectional imaging. Such a spinal assembly consists of a combination of
bone anchors via screws (i.e., occipital screws, cervical lateral mass
screws, cervical pedicle screws, C2 pars screws, C2 translaminar
screws, C2 transarticular screws), longitudinal members (e.g., plates,
rods, including dual diameter rods, plate/rod combinations), transverse
or cross connectors, interconnection mechanisms (e.g., rod-to-rod
connectors, offset connectors), and closure mechanisms (e.g., set
screws, nuts). Posterior cervical screw systems are rigidly fixed
devices that do not contain dynamic features, including but not limited
to: non-uniform longitudinal elements or features that allow more
motion or flexibility compared to rigid systems.
    Posterior cervical screw systems are intended to provide
immobilization and stabilization of spinal segments in patients as an
adjunct to fusion for acute and chronic instabilities of the cervical
spine and/or craniocervical junction and/or cervicothoracic junction
such as: (1) Traumatic spinal fractures and/or traumatic dislocations;
(2) deformities; (3) instabilities; (4) failed previous fusions (e.g.,
pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal
degeneration, including neck and/or arm pain of discogenic origin as
confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration
of the facets with instability; and (9) reconstruction following
decompression to treat radiculopathy and/or myelopathy. These systems
are also intended to restore the integrity of the spinal column even in
the absence of fusion for a limited time period in patients with
advanced stage tumors involving the cervical spine in whom life
expectancy is of insufficient duration to permit achievement of fusion.

    (b) Classification. Class II (special controls). The special
controls for posterior cervical screw systems are:
    (1) The design characteristics of the device, including engineering
schematics, must ensure that the geometry and material composition are
consistent with the intended use.
    (2) Nonclinical performance testing must demonstrate the mechanical
function and durability of the implant.
    (3) Device components must be demonstrated to be biocompatible.
    (4) Validation testing must demonstrate the cleanliness and
sterility of, or the ability to clean and sterilize, the device
components and device-specific instruments.
    (5) Labeling must include the following:
    (i) A clear description of the technological features of the device
including identification of device materials and the principles of
device operation;
    (ii) Intended use and indications for use including levels of
fixation;
    (iii) Device specific warnings, precautions, and contraindications
that include the following statements:
    (A) ``Precaution: Preoperative planning prior to implantation of
posterior cervical screw systems should include review of cross-
sectional imaging studies (e.g., CT and/or MRI) to evaluate the
patient's cervical anatomy including the transverse foramen, neurologic
structures, and the course of the vertebral arteries. If any findings
would compromise the placement of these screws, other surgical methods
should be considered. In addition, use of intraoperative imaging should
be considered to guide and/or verify device placement, as necessary.''
    (B) ``Precaution: Use of posterior cervical pedicle screw fixation
at the C3 through C6 spinal levels requires careful consideration and
planning beyond that required for lateral mass screws placed at these
spinal levels, given the proximity of the vertebral arteries and
neurologic structures in relation to the cervical pedicles at these
levels.''
    (iv) Identification of magnetic resonance (MR) compatibility
status;
    (v) Cleaning and sterilization instructions for devices and
instruments that are provided non-sterile to the end user, and;
    (vi) Detailed instructions of each surgical step, including device
removal.

    Dated: March 22, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-06024 Filed 3-29-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 174 (Monday, September 11, 2023)]
[Notices]
[Pages 62424-62426]
[FR Doc No: 2023-19531]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0352]

Commercial Driver's License Standards: Recreation Vehicle
Industry Association Application for Exemption

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

ACTION: Notice of final exemption; renewal of exemption.

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SUMMARY: FMCSA announces its final decision to renew the Recreation
Vehicle Industry Association's (RVIA) exemption from the Federal
commercial driver's license (CDL) requirements for drivers who deliver
certain newly manufactured motorhomes and recreational vehicles (RVs)
to dealers or trade shows before retail sale (driveaway operations),
subject to revised terms and conditions. FMCSA announced its decision
to provisionally renew RVIA's exemption on May 19, 2022, pending a
review of any comments received in response to that notice. Four
comments were submitted to the docket and are discussed later in this
notice. The Agency believes that drivers who qualify for the exemption
will maintain a level of safety that is equivalent to, or greater than,
the level of safety that would be obtained by complying with the CDL
requirements.

DATES: This renewed exemption was effective April 6, 2022, and expires
on April 6, 2027.

FOR FURTHER INFORMATION CONTACT: Ms. Pearlie Robinson, Driver and
Carrier

Operations Division; Office of Carrier, Driver and Vehicle Safety
Standards, FMCSA, at<PHONE_NUMBER> or by email at
[email protected]. If you have questions on viewing or
submitting material to the docket, contact Dockets Operations, (202)
366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation

Viewing Comments and Documents

    To view comments, go to www.regulations.gov, insert the docket
number ``FMCSA-2014-0352'' in the keyword box, and click ``Search.''
Next, sort the results by ``Posted (Newer-Older),'' choose the first
notice listed, and click ``Browse Comments.''
    To view documents mentioned in this notice as being available in
the docket, go to www.regulations.gov, insert the docket number
``FMCSA-2014-0352'' in the keyword box, click ``Search,'' and choose
the document to review.
    If you do not have access to the internet, you may view the docket
online by visiting Dockets Operations in Room W12-140 on the ground
floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington,
DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except
Federal holidays. To be sure someone is there to help you, please call
(202) 366-9317 or<PHONE_NUMBER> before visiting Dockets Operations.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b)(2) and 49
CFR 381.300(b) to renew an exemption from the Federal Motor Carrier
Safety Regulations for a five-year period if it finds ``such exemption
would likely achieve a level of safety that is equivalent to, or
greater than, the level that would be achieved absent such exemption.''
(49 U.S.C. 31315(b)(1). FMCSA evaluated RVIA's application and
provisionally renewed the exemption from 49 CFR 383.91(a)(1)-(2) for a
five-year period as previously announced in the Federal Register on May
19, 2022 (87 FR 30553).

III. Background

Current Regulation(s) Requirements

    The CDL regulations require drivers to hold a CDL when operating
vehicles in Groups A and B (49 CFR 383.91(a)(1) and 383.91(a)(2)).
Group A vehicles are any combination of vehicles with a gross
combination weight rating (GCWR) of 26,001 pounds or more, provided the
gross vehicle weight rating (GVWR) of the towed unit is over 10,000
pounds. Group B vehicles are any single vehicle with a GVWR of 26,001
pounds or more, or any such vehicle towing a vehicle not over 10,000
pounds. The GVWR is the value specified by the manufacturer as the
loaded weight of the vehicle.

III. Application for Renewal of Exemption

    The RVIA requested a second renewal of an exemption from the CDL
requirement in 49 CFR 383.91(a)(1)-(2). The exemption allows drivers of
RVs with GCWRs and GVWRs of 26,001 pounds or more to operate without a
CDL provided the RV has an actual vehicle weight of less than 26,001
pounds. A combination of RV trailer and tow vehicle must have a gross
combined weight of less than 26,001 pounds and the actual weight of the
towed unit must not exceed 10,000 pounds.

IV. Public Comments

    On May 19, 2022, FMCSA published its decision to provisionally
grant a five-year renewal (until 2027) of RVIA's original exemption and
asked for public comment (87 FR 30553). Four comments were submitted to
the docket. Two commenters opposed the exemption, one commenter did not
oppose or support the exemption, and one commenter supported the
exemption.
    AWM Associates, LLC (AWM) and James Underwood opposed the
exemption. James Underwood said, ``All drivers using a vehicle for
commercial purpose should have a commercial license. Hence the name of
the license.''
    AWM asserted that FMCSA's grant of an exemption from the CDL
requirements ``tramples a state's rights.'' AWM reported a list of
states that require RV owners of large RVs to obtain a CDL. AWM
contends that ``it is not FMCSA's obligation to facilitate economic
issues,'' but rather to require safe operation of commercial motor
vehicles (CMVs).
    The American Truck Dealers Division of the National Automobile
Dealers Association (ATD) supported the exemption, and it urged FMCSA
to amend its regulations to make the exemption permanent and to expand
its application to ``all new and empty CMVs with actual unloaded (curb)
weights or actual combination weights of less than 26,000 lbs.''

V. Response to Public Comments and Agency Decision

    FMCSA has evaluated the public comments and affirms its decision to
renew the exemption. The RVs covered by the exemption all have gross
vehicle weight ratings above the 26,001-pound threshold for a CDL, but
their actual weights, i.e., their gross vehicle weights, will remain
below that level during the driveaway or towaway operation of the
vehicles. In response to the comments that opposed the exemption,
private owners and drivers of larger RVs, like the RVs addressed in
this exemption, have operated without CDLs, often at GVWs well above
the 26,001-pound threshold, for decades without generating concern
among law enforcement professionals that they pose a risk to highway
safety. Furthermore, drivers employed specifically to deliver such
vehicles to a dealer or customer have more experience behind the wheel
of the RV than most private RV owners operating the vehicle for
recreational purposes. RVIA demonstrated that the manufacturers and
dealers who now employ CDL holders in driveaway/towaway operations have
a recordable accident rate far below the level that would result in an
unsatisfactory crash rating under FMCSA's safety fitness rating
methodology.\1\ That result is likely related to the fact that drivers
covered by this exemption are required to comply with all other
applicable FMCSA safety regulations, including medical standards and
hours-of-service limits.
---------------------------------------------------------------------------

    \1\ 49 CFR part 385, Appendix B.
---------------------------------------------------------------------------

    With regard to ATD's suggestion to amend the regulation to make
this exemption permanent, such an action is outside the scope of this
proceeding, but FMCSA notes that parties may petition the Agency for
rulemaking under 49 CFR part 389.
    The Agency continues to believe that drivers covered by this
exemption will not experience any deterioration of their safety record.
FMCSA modifies the terms and conditions specified in the May 19, 2022,
notice to clarify that the exemption does not apply to the
transportation of RVs as cargo in another CMV. The exemption applies
only to the operation of the empty RV itself (driveaway deliveries).
Unless exempt motor carriers fail to maintain the terms and conditions
specified in the May 19, 2022, decision, the exemption will remain in
effect through April 6, 2027.

VI. Exemption Decision

A. Grant of Exemption

    FMCSA renews the exemption for a period of five years subject to
the terms and conditions of this decision. The exemption from the
requirements of 49 CFR 383.91(a)(1)-(2) is effective April 6, 2022,
through April 6, 2027, 11:59 p.m. local time, unless renewed or
rescinded.

B. Applicability of Exemption

    The exemption is restricted to employees of driveaway-towaway
companies, RV manufacturers, and RV dealers transporting empty RVs as a
driveaway delivery, with the RV's wheels on the surface of the roadway,
between the manufacturing site and dealer location and for movements
prior to first retail sale. Drivers covered by the exemption will not
be required to hold a CDL when transporting RVs with a gross vehicle
weight not exceeding 26,000 pounds, or a combination of RV trailer/tow
vehicle with the gross weight of the towed unit not exceeding 10,000
pounds and the gross combined weight not exceeding 26,000 pounds. The
exemption does not apply to the transportation of an RV as cargo in
another CMV.

C. Terms and Conditions

    When operating under this exemption, motor carriers and drivers are
subject to the following terms and conditions:
    (1) The drivers and motor carriers must comply with all other
applicable Federal Motor Carrier Safety Regulations (49 CFR parts 350-
399);
    (2) The drivers must be able to provide this exemption document to
enforcement officials; and
    (3) The drivers must be in possession of a valid State driver's
license.

D. Preemption

    In accordance with 49 U.S.C. 31315(d), as implemented by 49 CFR
381.600, during the period this exemption is in effect, no State shall
enforce any law or regulation that conflicts with or is inconsistent
with this exemption with respect to a firm or person operating under
the exemption.

E. Notification to FMCSA

    Motor carriers using exempt drivers must notify FMCSA within 5
business days of any accident (as defined in 49 CFR 390.5) involving
any of its CMVs operating under the terms of this exemption. The
notification must include the following information:
    (a) Name of the exemption: ``RVIA'';
    (b) Name of the operating motor carrier;
    (c) Date of the accident;
    (d) City or town, and State, in which the accident occurred, or
closest to the accident scene;
    (e) Driver's name and license number;
    (f) Vehicle number and State license number;
    (g) Number of individuals suffering physical injury;
    (h) Number of fatalities;
    (i) The police-reported cause of the accident;
    (j) Whether the driver was cited for violation of any traffic laws,
motor carrier safety regulations; and
    (k) The driver's total driving time and total on-duty time period
prior to the accident.
    Reports filed under this provision shall be emailed to
[email protected].

F. Termination

    Based on the safety record of drivers operating under the exemption
up to this point, FMCSA has no basis to believe the drivers covered by
this renewed exemption will experience any deterioration of their
safety record. The exemption will be rescinded, however, if: (1) motor
carriers and drivers operating under the exemption fail to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315.

Robin Hutcheson,
Administrator.
[FR Doc. 2023-19531 Filed 9-8-23; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: March 14, 2008 (Volume 73, Number 51)]
[Notices]
[Page 13882-13883]
[DOCID:fr14mr08-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13110-000]

Duquesne Light Company; Notice of Application Accepted for Filing
and Soliciting Motions To Intervene, Protests, and Comments

March 7, 2008.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 13110-000.
    c. Date filed: February 11, 2008.
    d. Applicant: Duquesne Light Company.
    e. Name of Project: Allegheny Lock & Dam No. 7 Hydroelectric
Project.
    f. Location: Allegheny River in Armstrong County, Pennsylvania. It
would use the U.S. Army Corps of Engineers' Allegheny Lock & Dam No. 7.
    g. Filed Pursuant to: Federal Power Act, 16 USC 791(a)-825(r).
    h. Applicant Contact: Mr. Chris P. McClain, Paul C. Rizzo
Associates Inc., 105 Mall Boulevard, Suite 270-E, Monroeville, PA
15146,<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing motions to intervene, protests and comments:
60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-13110-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list

for the project. Further, if an intervenor files comments or documents
with the Commission relating to the merits of an issue that may affect
the responsibilities of a particular resource agency, they must also
serve a copy of the document on that resource agency.
    k. Competing Application: Project No. 12901-000, Date Filed: July
30, 2007, Date Issued: November 16, 2007, Competing Applications
Deadline: closed.
    l. Description of Project: The proposed project, using the U.S.
Army Corps of Engineers' Allegheny Lock & Dam No. 7 and operated in a
run-of-river mode, would consist of: (1) A new intake structure; (2) a
new powerhouse containing two generating units with a total installed
capacity of 17 megawatts; (3) a new 12,000-foot long, 34 kilovolt
transmission line; and (4) appurtenant facilities. The proposed
Allegheny Lock & Dam No. 2 Project would have an average annual
generation of 90 gigawatt-hours, which would be used to service its
customers.
    m. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street, NE., Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>. This filing may
also be viewed on the Commission's Web site 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, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item h
above.
    n. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    o. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    p. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    q. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. Any of the above-
named documents must be filed by providing the original and the number
of copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Any additional copy must be sent to Director,
Division of Hydropower Administration and Compliance, Federal Energy
Regulatory Commission, at the above-mentioned address. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link. The Commission strongly encourages electronic filings.
    r. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-5112 Filed 3-13-08; 8:45 am]

BILLING CODE 6717-01-P