[Federal Register Volume 78, Number 180 (Tuesday, September 17, 2013)]
[Notices]
[Pages 57145-57146]
[FR Doc No: 2013-22519]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: CP13-545-000.
    Applicants: Dominion Transmission, Inc.
    Description: Joint Application (Abandonment of Ellisburg to Leidy
Capacity Lease).
    Filed Date: 9/6/13.
    Accession Number: 20130906-5138.
    Comments Due: 5 p.m. ET 9/23/13.

    Docket Numbers: RP13-1318-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Negotiated Rate Cleanup--Name Change for Contract
510694 to be effective 10/9/2013.
    Filed Date: 9/9/13.
    Accession Number: 20130909-5136.
    Comments Due: 5 p.m. ET 9/23/13.

    Docket Numbers: RP13-1319-000.
    Applicants: Destin Pipeline Company, L.L.C.
    Description: Destin Pipeline Company, L.L.C. submits tariff filing
per 154.204: Changes to Sections 6.2 & 7.4 to be effective 10/10/2013.
    Filed Date: 9/9/13.
    Accession Number: 20130909-5373.
    Comments Due: 5 p.m. ET 9/23/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For

other information, call<PHONE_NUMBER> (toll free). For TTY, call (202)
502-8659.

    Dated: September 10, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-22519 Filed 9-16-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Proposed Rules]
[Pages 3883-3885]
[FR Doc No: 2021-00325]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1119; Project Identifier 2019-SW-089-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus Helicopters Model EC 155B and EC155B1 helicopters. This
proposed AD was prompted by a report of mechanical deformation of the
protective cover of the ``SHEAR'' control pushbutton on the copilot
collective stick. This proposed AD would require replacement of the
protective cover of the ``SHEAR'' control pushbutton on the pilot and
copilot collective sticks and re-identification of the pilot and
copilot collective sticks, as specified in a European Union Aviation
Safety Agency (EASA) AD, which is proposed for incorporation by
reference. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this proposed AD by March 1,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
phone: +49 221 89990 000; email<EMAIL_ADDRESS>internet:
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood
Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
1119.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
1119; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Katherine Venegas, Aviation Safety
Engineer, Los Angeles ACO, FAA, 3960 Paramount Blvd., Lakewood, CA
90712; phone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2020-1119; Project Identifier
2019-SW-089-AD'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposal.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Katherine Venegas, Aviation Safety Engineer, Los Angeles ACO, FAA, 3960
Paramount Blvd., Lakewood, CA 90712; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Any commentary that the FAA receives that is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0246, dated October 1, 2019
(EASA AD 2019-0246) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus Helicopters Model EC 155B and EC155B1 helicopters.
    This proposed AD was prompted by a report of mechanical deformation
of the protective cover of the ``SHEAR'' control pushbutton on the
copilot collective stick of an EC 225 LP helicopter from incorrect
handling. The FAA has determined that Model EC

155B and EC155B1 helicopters are also affected due to an identical
switch guard design. The FAA is proposing this AD to address mechanical
deformation of the protective cover of the ``SHEAR'' control pushbutton
on the copilot collective stick, which could lead to un-commanded
shearing of the hoist cable and possible injury to hoisted person(s).
See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2019-0246 describes procedures for replacement of the
protective cover of the ``SHEAR'' control pushbutton on the pilot and
copilot collective sticks and re-identification of the pilot and
copilot collective sticks. This material is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the bilateral agreement with the State of Design Authority, the FAA
has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2019-0246, described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD and except as discussed under
``Differences Between this Proposed AD and the MCAI.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2019-0246
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2019-0246 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2019-0246 that is required for compliance with EASA AD 2019-
0246 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2020-1119 after the FAA
final rule is published.

Differences Between This Proposed AD and the MCAI

    Where paragraph (1) of EASA AD 2019-0246 refers to a table for the
compliance time for the modification, for this proposed AD, the
compliance time for the modification is before any hoist operations
after the effective date of this AD but no later than 3 months after
the effective date of this AD.

Costs of Compliance

    The FAA estimates that this proposed AD affects 17 helicopters of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
2 work-hours x $85 per hour = $170...........................          $2,446           $2,616          $44,472
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators. The FAA does not control warranty
coverage for affected operators. As a result, the FAA has included all
known costs in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator,

the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Airbus Helicopters: Docket No. FAA-2020-1119; Project Identifier
2019-SW-089-AD.

(a) Comments Due Date

    The FAA must receive comments by March 1, 2021.

(b) Affected Airworthiness Directives (ADs)

    None.

(c) Applicability

    This AD applies to all Airbus Helicopters Model EC 155B and
EC155B1 helicopters, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 6700, Rotorcraft
flight control.

(e) Reason

    This AD was prompted by a report of mechanical deformation of
the protective cover of the ``SHEAR'' control pushbutton on the
copilot collective stick. The FAA is issuing this AD to address
mechanical deformation of the protective cover of the ``SHEAR''
control pushbutton on the copilot collective stick, which could lead
to un-commanded shearing of the hoist cable and possible injury to
hoisted person(s).

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2019-0246, dated October 1, 2019 (EASA AD 2019-0246).

(h) Exceptions to EASA AD 2019-0246

    (1) Where EASA AD 2019-0246 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0246 does not apply
to this AD.
    (3) Where the service information referenced in EASA AD 2019-
0246 specifies to use tooling, equivalent tooling may be used.
    (4) Where paragraph (1) of EASA AD 2019-0246 refers to a table
for the compliance time for the modification, for this AD, the
compliance time for the modification is before the first hoist
operation done after the effective date of this AD but no later than
3 months after the effective date of this AD.
    (5) Although the service information referenced in EASA 2019-
0246 specifies to discard certain parts, this AD does not include
that requirement.

(i) Special Flight Permit

    Special flight permits may be issued in accordance with 14 CFR
21.197 and 21.199 to operate the helicopter to a location where the
helicopter can be modified (if the operator elects to do so),
provided the helicopter is not used for hoist operations and no
passengers are onboard.

(j) Alternative Methods of Compliance (AMOCs):

    The Manager, Rotorcraft Standards Branch, FAA, may approve AMOCs
for this AD. Send your proposal to: Manager, Rotorcraft Standards
Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; phone: 817-
222-5110; email<EMAIL_ADDRESS>
(k) Related Information

    (1) For EASA AD 2019-0246, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; phone: +49 221 89990 000; email:
<EMAIL_ADDRESS>internet: www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. This material may be found in the AD docket
on the internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2020-1119.
    (2) For more information about this AD, contact Katherine
Venegas, Aviation Safety Engineer, Los Angeles ACO, FAA, 3960
Paramount Blvd., Lakewood, CA 90712; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
    Issued on December 4, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-00325 Filed 1-14-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Pages 7238-7239]
[FR Doc No: 2022-02618]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0058; FMCSA-2018-0136; FMCSA-2018-0138; FMCSA-
2018-0139; FMCSA-2019-0109; FMCSA-2019-0110]

Qualification of Drivers; Exemption Applications; Hearing

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions for 23
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on December 26, 2021. The
exemptions expire on December 26, 2023.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2017-0058, FMCSA-2018-0136, FMCSA-2018-0138, FMCSA-2018-
0139, FMCSA-2019-0109, or FMCSA-2019-0110 in the keyword box, and click
``Search.'' Next, sort the results by ``Posted (Newer-Older),'' choose
the first notice listed, and click ``Browse Comments.'' 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 20590-0001, 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<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its regulatory process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    On December 29, 2021, FMCSA published a notice announcing its
decision to renew exemptions for 23 individuals from the hearing
standard in 49 CFR 391.41(b)(11) to operate a CMV in interstate
commerce and requested comments from the public (86 FR 74213). The
public comment period ended on January 28, 2022, and no comments were
received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(11).
    The physical qualification standard for drivers regarding hearing
found in Sec.  391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not

less than 5 feet with or without the use of a hearing aid or, if tested
by use of an audiometric device, does not have an average hearing loss
in the better ear greater than 40 decibels at 500 Hz, 1,000 Hz, and
2,000 Hz with or without a hearing aid when the audiometric device is
calibrated to American National Standard (formerly ASA Standard)
Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, 35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 3, 1971).

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based upon its evaluation of the 23 renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
hearing requirement in Sec.  391.41 (b)(11).
    As of December 26, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following 23 individuals have satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate CMV drivers (86 FR 74213):

Mario Alvarado (CA)
Kasseth Andrews (MA)
Denis Ayers (MD)
Joseph Bence (OH)
Daryl A. Broker (MN)
Justin Brooks (WA)
Christa Butner (NC)
William Darnell (AZ)
Travis Davisson (IA)
Erik De Leon (TX)
Mitchell Estill (MO)
Paul Hoover (PA)
Amy Ivins (NE)
James Johnson (MN)
Keith Kenyon (WI)
Nicholas Kulasa (IL)
John Martikainen (CT)
John Silvers (NY)
Michael Swetnam (TX)
Mark Tabangcora (CA)
Yvon Victor (NJ)
Jeremy Williams (CA)
Joseph Williams (MD)

    The drivers were included in docket number FMCSA-2017-0058, FMCSA-
2018-0136, FMCSA-2018-0138, FMCSA-2018-0139, FMCSA-2019-0109, or FMCSA-
2019-0110. Their exemptions were applicable as of December 26, 2021 and
will expire on December 26, 2023.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-02618 Filed 2-7-22; 8:45 am]
BILLING CODE 4910-EX-P


Hawkins County Technical Support Documentation Summary Hawkins County has a land area of 487 square miles and is located in the ridge and valley terrain of the East Grand Division of the state north of I 81 and just west of the Kingsport area bordering Virginia. The predominate wind direction and speed is from the south southwest at 7 to 10 knots.

Hawkins County does not have an ozone monitor. For the 2001 2003 monitoring period, the ozone monitors located in Sullivan County are showing 8 hour design values of 0.086 parts per million ( ppm) which would be classified as nonattainment.

Based on projections to 2002 from the 2000 census data, there are 54,793 persons living in Hawkins County. This indicates a population density of 112.6 persons per square mile. The population of Hawkins County is approximately 61.4% rural with the remaining 38.6% living in incorporated areas. The largest city in Hawkins County is Church Hill. The population is expected to increase by 1.8% between 2000 and 2010. Based on the 2002 population data for the entire JC K B MSA, Hawkins County represents approximately 11% of the total JCK B MSA population.

Point source NOX emissions from Hawkins County were estimated at 36.8 ton/ day in 1999 which represents approximately 39% of the 95.21 ton/ day of overall NOX point source emissions from the JC K B MSA. VOC emissions were estimated at 12.8 ton/ day in 1999 which represents approximately 9% of the 150.45 ton/ day of overall VOC point source emissions from the JC K B MSA.

For NOX and VOC control, point sources located within Hawkins County are subject to Prevention of Significant Deterioration ( PSD) requirements, Control Technology Guideline Reasonable Available Control Technology ( CTG RACT) requirements, Maximum Achievable Control Technology ( MACT) requirements for Hazardous Air Pollutants ( HAP), and New Source Performance Standards ( NSPS).

Mobile source NOX emissions from Hawkins County were estimated at 5.76 ton/ day in 1999 which represents approximately 8% of the 74.14 ton/ day of overall NOX mobile source emissions from the JC K B MSA. VOC emissions were estimated at 3.8 ton/ day in 1999 which represents approximately 10% of the 38.24 ton/ day of overall VOC mobile source emissions from the JC K B MSA. Commuting traffic from surrounding counties into Hawkins County is minimal. Commuting traffic from Hawkins County into surrounding counties is high.

The emissions data presented indicate that Hawkins County could be making a contribution to the ozone forming emissions; however, the electric generating facility in Hawkins County is subject to the NOX SIP call, and at the minimum would be required to add low NOX burner controls thereby significantly reducing the impact to the JC K B MSA area. Hawkins County also only represents 11% of the total JC K B MSA population with 61.4 % of the county being rural. Taking all of the above factors into consideration, Hawkins County should be designated attainment for the 8 hour ozone standard.


[Federal Register: September 14, 2007 (Volume 72, Number 178)]
[Notices]
[Page 52591-52593]
[DOCID:fr14se07-74]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56379; File No. SR-ISE-2007-79]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fee Changes

September 10, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 31, 2007, the International Securities Exchange, LLC (``ISE''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the ISE.
The ISE has designated this proposal as one establishing or changing a
due, fee, or other charge imposed by the ISE under section
19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The ISE proposes to amend the Schedule of Fees to clarify and amend
its Trading Application Software Fees with respect to FIX and API
sessions. The text of the proposed rule change is available on the
ISE's Web site (http://www.ise.com), at the principal office of the

ISE, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend the Schedule of Fees with respect to
Electronic Access Member (``EAM'') Trading Application Software Fees. A
member can connect via an Application Programming Interface (``API'')
session or a Financial Information eXchange (``FIX'') session. The ISE
uses an open API which members program to in order to develop
applications that send trading commands and/or queries to and receive
broadcasts and/or transactions from the trading system. The API
processes quotes, receives orders from EAMs, tracks activity in the
underlying markets, when applicable, executes trades in the matching
engine, and broadcasts trade details to the participating members. The
ISE pays a licensing fee for the use of the options API, whereas ISE
owns the proprietary rights to the equity API. Accordingly, fees are
higher for options API sessions than they are for equity API sessions.
FIX is an industry-wide messaging standard protocol. While the FIX
specification is open and free, implementing FIX requires planning,
software, and network services that ISE provides.
    On December 5, 2006, the Exchange filed to adopt fees related to
the trading of equity securities on the ISE Stock Exchange, LLC, a
facility of ISE. In ISE-2006-76, the Exchange proposed to charge a
Session/API \5\ fee of $250 per month to connect to the ISE Stock
Exchange, with a waiver until June 30, 2007 for second and subsequent
connections.\6\ The Exchange allowed this waiver to expire on June 30,
2007, at which time the fee to connect to the ISE Stock Exchange, on a
monthly basis, became $250 per session, i.e., for each connection to
the ISE Stock Exchange, regardless of whether the Equity EAM is
connected via FIX or API. Subsequent to the fee increase, the Exchange
analyzed the impact of the fee increase on Equity EAMs and determined
that the disparity between the increase in fees and the additional work
required to assist the Equity EAMs in maintaining additional lines to
the Exchange was not accurately

correlated. Accordingly, the Exchange has decided to reduce the fee for
third and subsequent connections to the ISE Stock Exchange.\7\ The
Exchange proposes to assess the following fees for Equity EAMs: $250
each for the first and second connection and $50 for each additional
connection, regardless of whether the Equity EAM is connected via FIX
or API.\8\
---------------------------------------------------------------------------

    \5\ Historically, the Schedule of Fees referred to ``FIX'' as
``Session.'' However, in this filing the Exchange is proposing to
clarify this by defining session fees as either FIX or API.
    \6\ See Securities Exchange Act Release No. 54897 (December 8,
2006), 71 FR 75593 (December 15, 2006) (SR-ISE-2007-76) (Notice of
filing and immediate effectiveness of proposed rule change relating
to ISE Stock Exchange fees).
    \7\ Telephone conference between Laura Clare, Assistant General
Counsel, ISE, and Jan Woo, Special Counsel, Division of Market
Regulation, Commission, on September 7, 2007 (``Telephone conference
on September 7, 2007'') (correcting the filing to state that the
Exchange is proposing to reduce the fee increase for the third and
subsequent connections (whether they are API or FIX) to the ISE
Stock Exchange for Equity EAMs).
    \8\ Telephone conference on September 7, 2007 (clarifying that
the $250 charge will be assessed for each of the first two
connections made by Equity EAMs that connect via the API or FIX).
---------------------------------------------------------------------------

    Historically, the Exchange charged options members the following
Session/API fee to connect to the Exchange: $250 per month for the
first five CLICK terminals and $100 per month for six or more
terminals. Further, under a pilot program previously adopted by the
Exchange, all Session/API fees associated with a second and any
subsequent CLICK terminals were waived. As a result, members were only
charged a $250 per month Session/API fee to connect to the Exchange.
Earlier this year, once all existing CLICK terminals were
decommissioned, the Exchange submitted a fee filing that, among other
things, proposed to remove all references to CLICK terminals from its
fee schedule.\9\ In doing so, and after conducting an internal analysis
of the impact of fees to members, the Exchange notes that the CLICK Fee
Filing actually raised the Session/API fees for members, contrary to
what the Exchange intended. Thus, this filing seeks to remedy the
mistake the CLICK Fee Filing has caused.
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 55960 (June 26,
2007), 72 FR 36531 (July 3, 2007) (the ``CLICK Fee Filing'').
---------------------------------------------------------------------------

    Accordingly, the Exchange proposes to reinstate the tiered session
fee for EAM Options API, as it was never the intent of the Exchange to
eliminate this fee reduction on sixth and additional sessions.\10\ For
Options EAMs that connect via the API the proposed fee is $250 for each
of the first five connections and $100 for each additional
connection.\11\ With respect to the FIX fees, the Exchange proposes to
charge EAMs one fee for FIX sessions, regardless of whether the EAM is
an Options EAM or an Equity EAM. As discussed above, the Exchange
proposes a $250 fee for the first FIX connection and an additional $250
for the second FIX connection and $50 for each additional connection
thereafter.
---------------------------------------------------------------------------

    \10\ Telephone conference between Laura Clare, Assistant General
Counsel, ISE, and Jan Woo, Special Counsel, Division of Market
Regulation, Commission, on September 10, 2007 (clarifying that the
proposed rule change is to reinstate a tiered session fee for EAM
Options API including a fee reduction for sixth and additional
sessions).
    \11\ Telephone conference on September 7, 2007 (clarifying that
the $250 charge will be assessed for each of the first five
connections made by Options EAMs that connect via the API).
---------------------------------------------------------------------------

    Further, the Exchange proposes to rearrange and add clarifying
language to this section of the Schedule of Fees to delineate
specifically which fees apply to FIX sessions and which fees apply to
API sessions, and which fees apply to Options EAMs and which fees apply
to Equity EAMs.
2. Statutory Basis
    The Exchange believes that the basis under the Act for this
proposed rule change is the requirement under section 6(b)(4) of the
Act \12\ that an exchange have an equitable allocation of reasonable
dues, fees and other charges among its members and other persons using
its facilities.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to section
19(b)(3)(A) of the Act \13\ and Rule 19b-4(f)(2) \14\ thereunder
because it changes a fee imposed by the Exchange. At any time within 60
days of the filing of such proposed rule change, the Commission may
summarily abrogate such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-ISE-2007-79 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2007-79. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2007-79 and should be
submitted on or before October 5, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-18132 Filed 9-13-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: October 14, 2010 (Volume 75, Number 198)]
[Notices]
[Page 63227-63228]
[DOCID:fr14oc10-124]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63054; File No. SR-EDGX-2010-13]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Amendments to the EDGX Exchange, Inc. Fee Schedule

October 6, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 30, 2010, the EDGX Exchange, Inc. (the ``Exchange''
or the ``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    EDGX Exchange, Inc. (``Exchange'' or ``EDGX'') proposes to amend
its fees and rebates applicable to Members \3\ of the Exchange pursuant
to EDGX Rule 15.1(a) and (c).
---------------------------------------------------------------------------

    \3\ A Member is any registered broker or dealer, or any person
associated with a registered broker or dealer, that has been
admitted to membership in the Exchange.
---------------------------------------------------------------------------

    All of the changes described herein are applicable to EDGX Members.
The text of the proposed rule change is available on the Exchange's
Internet Web site at http://www.directedge.com.

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

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

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

1. Purpose
    The Exchange proposes to make several amendments to its fee
schedule. First, it proposes to increase the fee for removing liquidity
from $0.0029 per share to $0.0030 per share. Conforming amendments have
been made to the B, V, Y, 3, and 4 Flags (``add liquidity'' flags) to
reflect this change. Secondly, it proposes to decrease the rebate for
adding liquidity from $0.0029 per share to $0.0026 per share.
Conforming amendments have been made to the N, W, and 6 flags (``remove
liquidity'' flags) to reflect this change. The Exchange believes that
these rate changes will enable it to maintain a competitive position
with regards to other away market centers.
    Secondly, the Exchange proposes to incorporate a three tier rebate
structure. The Exchange proposes to introduce the Mega Tier, which
modifies the rebate incorporated in footnote 1 of the fee schedule.
There are two alternative ways a Member can qualify for the Mega Tier
rebate. First, footnote 1 of the fee schedule currently provides that
Members can qualify for a rebate of $0.0032 per share for all liquidity
posted on EDGX if they add or route at least 5,000,000 shares of
average daily volume prior to 9:30 AM or after 4:00 PM (includes all
flags except 6) AND add a minimum of 50,000,000 shares of average daily
volume on EDGX in total. The Exchange proposes to amend the 50,000,000
share minimum to 25,000,000 shares. Secondly, footnote 1 further
provides that Members will be provided a $0.0031 rebate per share for
liquidity added on EDGX if the Member on a daily basis, measured
monthly, posts 0.75% of the Total Consolidated Volume (``TCV'') in
average daily volume. TCV is defined as volume reported by all
exchanges and trade reporting facilities to the consolidated
transaction reporting plans for Tapes A, B and C securities. The
Exchange proposes to increase this rebate to $0.0032 per share.
    Next, the Exchange proposes to introduce the Ultra Tier, in which a
Member will be provided a $0.0031 rebate per share for liquidity added
on EDGX if the Member posts 0.50% of TCV in average daily volume to
EDGX, as measured on a monthly basis.
    Finally, the Exchange propose to introduce the Super Tier, in which
a Member will be provided a $0.0030 rebate per share for liquidity
added on EDGX if the Member posts 10,000,000 shares or more of average
daily volume to EDGX, as measured on a monthly basis.
    The Exchange believes that the above pricing is appropriate since
higher rebates are directly correlated with more stringent criteria.
The Mega Tier rebate ($0.0032 per share) has the most stringent
criteria, and is $0.0001 greater than the Ultra Tier rebate ($0.0031
per share) and $0.0002 greater than the Super Tier rebate ($0.0030 per
share). For example, based on average TCV for August 2010 (7.2
billion), in order for a Member to qualify for the Mega Tier, the
Member would have to post 54 million shares on EDGX. In order to
qualify for the Ultra Tier, which has less stringent criteria than the
Mega Tier, the Member would have to post 36 million shares on EDGX.
Finally, the Super Tier has the least stringent criteria. In order for
a Member to qualify for this rebate, the Member would have to post 10
million shares on EDGX. In addition, these rebates also result, in
part, from lower administrative costs associated with higher volume.
    Finally, the Exchange proposes to make a clarifying amendment to
the price guarantee language found in footnote 1 of the schedule to
clarify that the share amounts are based upon average daily volume.
    EDGX Exchange proposes to implement these amendments to the
Exchange fee schedule on October 1, 2010.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\4\ in general, and
furthers the objectives of Section 6(b)(4),\5\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its members and other persons using its
facilities. The

Exchange notes that it operates in a highly competitive market in which
market participants can readily direct order flow to competing venues
if they deem fee levels at a particular venue to be excessive. The
proposed rule change reflects a competitive pricing structure designed
to incent market participants to direct their order flow to the
Exchange. Finally, the Exchange believes that the proposed rates are
equitable in that they apply uniformly to all Members. In addition, the
rebates provided result, in part, from lower administrative costs
associated with higher volume. The Exchange believes the fees and
credits remain competitive with those charged by other venues and
therefore continue to be reasonable and equitably allocated to those
members that opt to direct orders to the Exchange rather than competing
venues.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3) of the Act \6\ and Rule 19b-4(f)(2) \7\ thereunder. At any
time within 60 days of the filing of such proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-EDGX-2010-13 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-EDGX-2010-13. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission,\8\ all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGX-2010-13 and should be
submitted on or before November 4, 2010.
---------------------------------------------------------------------------

    \8\ The text of the proposed rule change is available on
Exchange's Web site at http://www.directedge.com, on the
Commission's Web site at http://www.sec.gov, at EDGX, and at the
Commission's Public Reference Room.

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

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-25744 Filed 10-13-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 4, 2008 (Volume 73, Number 234)]
[Notices]
[Page 73938-73939]
[DOCID:fr04de08-42]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0607]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Reclassification Petitions for Medical Devices

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reclassification petitions for
medical devices.

DATES:  Submit written or electronic comments on the collection of
information by February 2, 2009.

ADDRESSES:  Submit electronic comments on the collection of information
to  http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr.,Office Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

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

Reclassification Petitions for Medical Devices--21 CFR Section 860.123
(OMB Control Number 0910-0138)--Extension

    FDA has responsibility under sections 513(e) and (f), 514(b),
515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360c(e) and (f), 360d(b), 360e(b), and 360j(l)) and part 860 (21
CFR part 860), subpart C, to collect data and information contained in
reclassification petitions. The reclassification provisions of the act
allow any person to petition for reclassification of a device from any
one of the three classes, i.e., I, II, and III, to another class. The
reclassification content regulation (Sec.  860.123) requires the
submission of sufficient, valid scientific evidence demonstrating that
the proposed reclassification will provide a reasonable assurance of
safety and effectiveness of the device type for its indications for
use. Thus, the reclassification provisions of the act serve primarily
as a vehicle for manufacturers to seek reclassification from a higher
to a lower class, thereby reducing the regulatory requirements
applicable to a particular device type or to seek reclassification from
a lower to a higher class, thereby increasing the regulatory
requirements. The reclassification petitions requesting classification
from class III to class II or class I, if approved, provides an
alternative route to the market in lieu of premarket approval for class
III devices or from class I or II to one or the other class, which may
increase requirements.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.123                                                                 6                     1                  6                500              3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on the last 3 years, and actual reclassification petitions
received, FDA anticipates that six petitions will be submitted each
year. The time required to prepare and submit a reclassification
petition, including the time needed to assemble supporting data,
averages 500 hours per petition. This average is based upon estimates
by FDA administrative and technical staff that are familiar with the
requirements for submission of a reclassification petition, have
consulted and advised manufacturers on these requirements, and have
reviewed the documentation submitted.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: November 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28695 Filed 12-3-08; 8:45 am]

BILLING CODE 4160-01-S