[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Notices]
[Pages 20992-20993]
[FR Doc No: 2011-8945]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0189]

Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Low Level Laser System for
Aesthetic Use; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Class II Special Controls
Guidance Document: Low Level Laser System for Aesthetic Use.'' This
guidance document describes a means by which low level laser systems
for aesthetic use may comply with the requirement of special controls
for class II devices. Elsewhere in this issue of the Federal Register,
FDA is publishing a final rule to classify low level laser systems for
aesthetic use into class II (special controls). This guidance document
is being immediately implemented as the special control for low level
laser systems for aesthetic use, but it remains subject to comment in
accordance with the Agency's good guidance practices.

DATES: Submit either electronic or written comments on the guidance at
any time. General comments on Agency guidances are welcome at any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document: Low
Level Laser System for Aesthetic Use'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Office of
Communication, Education and Radiation Programs, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Richard Felten, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1436,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying low level laser systems for aesthetic use into
class II (special controls) under section 513(f)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(2)).
This guidance document will serve as the special control for low level
laser systems for aesthetic use. Section 513(f)(2) of the FD&C Act
provides that any person who submits a premarket notification under
section 510(k) of the FD&C Act (21 U.S.C. 360(k)) for a device that has
not previously been classified may, within 30 days after receiving an
order classifying the device in class III under section 513(f)(1) of
the FD&C Act, request FDA to classify the device under the criteria set
forth in section 513(a)(1) of the FD&C Act. FDA shall, within 60 days
of receiving such a request, classify the device by written order. This
classification shall be the initial classification of the device.
Within 30 days after the issuance of an order classifying the device,
FDA must publish a notice in the Federal Register announcing such
classification. Because of the timeframes established by section
513(f)(2) of the FD&C Act, FDA has determined, under Sec.  10.115(g)(2)
(21 CFR 10.115(g)(2)), that it is not feasible to allow for public
participation before issuing this guidance as a final guidance
document. Thus, FDA is issuing this guidance document as a level 1
guidance document that is immediately in effect. FDA will consider any

comments that are received in response to this notice to determine
whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on low level laser systems for aesthetic use.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Class II Special Controls Guidance Document: Low Level Laser System
for Aesthetic Use,'' you may either send an e-mail request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 1735 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in 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 (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 820 have been approved under OMB control
number 0910-0073; and the collections of information in 21 CFR 801 have
been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8945 Filed 4-13-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6861-6863]
[DOCID:fr11fe09-27]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[IC09-725-000]

Commission Information Collection Activities (FERC-725); Proposed
Collection; Comment Request; Extension

February 4, 2009.
AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice.

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SUMMARY: In compliance with the requirements of section 3507 of the
Paperwork Reduction Act of 1995, 44 U.S.C. 3507, the Federal Energy
Regulatory Commission (Commission) is

soliciting public comment on the specific aspects of the information
collection described below.

DATES: Comments on the information collection are due by April 14,
2009.

ADDRESSES: An example of this collection of information may be obtained
from the Commission's Web site (at http://www.ferc.gov/docs-filing/
elibrary.asp). Comments may be filed either electronically or in paper
format, and should refer to Docket No. IC09-725-000. Documents must be
prepared in an acceptable filing format and in compliance with the
Federal Energy Regulatory Commission submission guidelines at http://
www.ferc.gov/help/submission-guide.asp.
    Comments may be filed electronically via the eFiling link on the
Commission's Web site at http://www.ferc.gov. First time users will
have to establish a user name and password (http://www.ferc.gov/docs-
filing/eregistration.asp) before eFiling. The Commission will send an
automatic acknowledgement to the sender's e-mail address upon receipt
of comments through eFiling.
    Commenters filing electronically should not make a paper filing.
Commenters that are not able to file electronically must send an
original and 14 copies of their comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street, NE.,
Washington, DC 20426.
    Users interested in receiving automatic notification of activity in
this docket may do so through eSubscription (at http://www.ferc.gov/
docs-filing/esubscription.asp). In addition, all comments and FERC
issuances may be viewed, printed, or downloaded remotely through FERC's
Web site using the ``eLibrary'' link and searching on Docket Number
IC09-725. For user assistance, contact FERC Online Support (e-mail at
<EMAIL_ADDRESS>or call toll-free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>).

FOR FURTHER INFORMATION CONTACT: Michael Miller, Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426. He may
be reached by telephone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>,
and by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The information collected under the
requirements of FERC-725 (``Certification of Electric Reliability
Organization; Procedures for Electric Reliability Standards'' (OMB
Control No. 1902-0225)) is used by the Commission to implement the
statutory provisions of Title XII, subtitle A of the Energy Policy Act
of 2005 (EPAct 2005).\1\
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    \1\ Energy Policy Act of 2005, Pub. L. No. 109-58, 119 Stat. 594
(2005) (codified at 42 U.S.C. 16451, et seq.)
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    The Electricity Modernization Act of 2005 was enacted into law as
part of the Energy Policy Act of 2005 on August 8, 2005. Subtitle A of
the Electricity Modernization Act amended the Federal Power Act (FPA)
by adding a new section 215, titled ``Electric Reliability.'' Section
215 of the FPA buttresses the Commission's efforts to strengthen the
reliability of the interstate grid through the granting of new
authority to provide for a system of mandatory Reliability Standards
developed by the Electric Reliability Organization (ERO) \2\ and
reviewed and approved by FERC.
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    \2\ ``Electric Reliability Organization'' or ``ERO'' means the
organization certified by the Commission the purpose of which is to
establish and enforce Reliability Standards for the Bulk-Power
System, subject to Commission review.
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    On February 3, 2006, the Commission issued Order No.672 \3\
certifying a single Electric Reliability Organization, the ERO, to
oversee the reliability of the United States' portion of the
interconnected North American Bulk-Power System, subject to Commission
oversight. The ERO is responsible for developing and enforcing the
mandatory Reliability Standards. The Reliability Standards apply to all
users, owners and operators of the Bulk-Power System. The Commission
has the authority to approve all ERO actions, to order the ERO to carry
out its responsibilities under these statutory provisions, and to also
as appropriate independently enforce Reliability Standards.
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    \3\ Rules Concerning Certification of the Electric Reliability
Organization; and Procedures for the Establishment, Approval, and
Enforcement of Electric Reliability Standards ] 31,204 71 FR 8662
(2006) Order on reh'g, 71 FR 19,814 (2006), FERC Statutes and
Regulations ] 31,212 (2006).
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    Once certified, the ERO must submit each proposed Reliability
Standard to the Commission for approval. Only a Reliability Standard
approved by the Commission is enforceable under section 215 of the FPA.
    The ERO may delegate its enforcement responsibilities to a Regional
Entity. Delegation is effective only after the Commission approves the
delegation agreement. A Regional Entity may also propose a Reliability
Standard to the ERO for submission to the Commission for approval. This
Reliability Standard may be either for application to the entire
interconnected Bulk-Power System or for application only within its own
region.
    The ERO or a Regional Entity must monitor compliance with the
Reliability Standards. It will direct a user, owner or operator of the
Bulk-Power System that violates a Reliability Standard to comply with
the Reliability Standard. The ERO or Regional Entity may impose a
penalty on a user, owner or operator for violating a Reliability
Standard, subject to review by, and appeal to, the Commission.
    Subtitle A of the Electricity Modernization Act of 2005 also
includes two reliability-related provisions that are not part of the
section 215 of the FPA. First section 1211(b) of the Act provides that
the ERO certified by the Commission as well as Regional Entities are
not departments, agencies or instrumentalities of the United States
Government. Section 1211 (c) provides that federal agencies responsible
for approving access to electric transmission or distribution
facilities located on lands within the United States will, in
accordance with applicable law, expedite any federal agency approvals
that are necessary to allow the owners or operators of these facilities
to comply with a FERC-approved Reliability Standard that pertains to
vegetation management, electric service restoration, or resolution of
situations that imminently endanger the reliability or safety of the
facilities.
    Order No. 672 set forth the criteria that an ERO applicant must
satisfy to qualify as the ERO, including the ability to develop and
enforce Reliability Standards.\4\ The ERO submission must include an
evaluation of the effectiveness of each Regional Entity. The Commission
will, as part of its assessment of the ERO's performance, assess the
performance of each Regional Entity and issue an order addressing
Regional Entity compliance. If a Regional Entity fails to comply
adequately with the Commission order, the Commission may institute a
proceeding to enforce its order, including, if necessary and
appropriate, a proceeding to consider rescission of the Commission's
approval of the Regional Entity's delegation agreement.
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    \4\ The criteria stated in the Final Rule track the statutory
criteria for ERO certification provided in section 215(c) of the
FPA.
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    The Electricity Modernization Act of 2005 buttresses the
Commission's efforts to strengthen the interstate transmission grid
through the granting of authority pursuant to section 215 of the FPA
which provides for a system of mandatory reliability rules developed by
the ERO, established by the Commission, and enforced by the Commission,
subject to Commission review.
    A submission of the information is necessary for the Commission to
carry

out its responsibilities under EPAct 2005.\5\ The Commission implements
its responsibilities through the Code of Federal Regulations, 18 CFR
Part 39. These filing requirements are mandatory.
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    \5\ 42 U.S.C. 16451 et seq.
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    Action: The Commission is requesting a three-year extension of the
current expiration date without any changes to the reporting
requirements.
    Burden Statement: The annual public reporting burden and cost for
this collection are estimated as follows:
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    \6\ The burden and cost estimates do not include the cost of
applying to become the ERO because that application process and the
resulting FERC selection have been completed.
    \7\ Per Order 672, the ERO will undergo a performance assessment
three years after certification (July 2009) and every five years
thereafter. Therefore, the total figures for FTE (10), burden hrs.
(9,800), and cost ($1,050,000) associated with doing the self-
assessment have been divided by 3 to provide average annual figures
for this notice.
    The methodology for estimating the totals for the 3-year self
assessment follows. Staff estimates that the self assessment will
take 6 months to complete. In order for NERC to complete the work in
half the time, we assume that NERC must hire double the workforce,
so 10 contractors are used in the present calculation. The
$1,050,000 was taken directly from NERC's 2009 Business Plan and
Budget.
    \8\ NERC Employee Cost Estimate: NERC Employee Compensation
Average is $140,442 (from 2009 Budget salary average). For 1.5
Employees, the Annualized Salary Expense is $210,663.
    \9\ Regional Entity (RE) Employee Cost Estimate: RE Employee
Compensation Average of $115,520 (from 2009 Budget salary average).
For 4.5 Employees, the Annualized Salary Expense is $519,840.

----------------------------------------------------------------------------------------------------------------
                                                                                Est. annual
          FERC-725 \6\                                                         FTE         burden    Est. annual
                                                                                (hrs.)      cost ($)
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Annual NERC Costs...............  3 Year Self          Contractor........     3.33 \7\     3,266.67  350,000 \7\
                                   Assessment (Due 7/                                           \7\
                                   09) \7\.
                                  Reliability          Internal..........          1.5        2,940      210,663
                                   Reporting Estimate
                                   \8\.
                                  Estimate...........  Software..........            0            0       75,000
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    Total Annual NERC Costs..............................................         4.83     6,206.67      635,663
----------------------------------------------------------------------------------------------------------------
Annual RE Costs \9\.............  Reliability          Internal..........          4.5        8,820      519,840
                                   Reporting Estimate.
                                  Estimate...........  Software..........            0            0      225,000
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    Total Annual RE Costs................................................          4.5        8,820      744,840
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    Total Annual Burden & Cost Estimate..................................         9.33    15,026.67   $1,380,503
----------------------------------------------------------------------------------------------------------------

    The estimated annual total cost to respondents is $1,380,503
\7,8,9\ (including direct labor, overhead costs to prepare the
application, and consultation to obtain specialized advice in
responding to and implementing the certification application).
    The reporting burden includes the total time, effort, or financial
resources expended to generate, maintain, retain, disclose, or provide
the information including: (1) Reviewing instructions; (2) developing,
acquiring, installing, and utilizing technology and systems for the
purposes of collecting, validating, verifying, processing, maintaining,
disclosing and providing information; (3) training personnel to respond
to an information collection; (4) searching data sources; (5) preparing
and reviewing the information collection; and (6) transmitting or
otherwise disclosing the information.
    The estimate of cost for respondents is based upon salaries for
professional and clerical support, as well as direct and indirect or
overhead costs. Direct costs include all costs directly attributable to
providing this information, such as administrative costs and the cost
for information technology. Indirect or overhead costs are costs
incurred by an organization in support of its mission. These costs
apply to activities which benefit the whole organization rather than
any one particular function or activity.
    Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency'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 those who are
to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-2868 Filed 2-10-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: May 25, 2011 (Volume 76, Number 101)]
[Notices]
[Page 30331-30332]
[DOCID:fr25my11-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 1

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

    Docket Numbers: RP11-2102-000.
    Applicants: Big Sandy Pipeline, LLC.
    Description: Big Sandy Pipeline, LLC submits tariff filing per
154.204: Big Sandy Negotiated Rate Agreement Filing to be effective 6/
1/2011.
    Filed Date: 05/11/2011.
    Accession Number: 20110511-5167.
    Comment Date: 5 p.m. Eastern Time on Monday, May 23, 2011.

    Docket Numbers: RP11-2103-000.
    Applicants: Questar Southern Trails Pipeline Company.
    Description: Questar Southern Trails Pipeline Company's Annual Fuel
Gas Reimbursement Report.
    Filed Date: 05/11/2011.
    Accession Number: 20110511-5198.
    Comment Date: 5 p.m. Eastern Time on Monday, May 23, 2011.

    Docket Numbers: RP11-2104-000.
    Applicants: White River Hub, LLC.
    Description: White River Hub, LLC's Annual Fuel Gas Reimbursement
Report.
    Filed Date: 05/11/2011.
    Accession Number: 20110511-5200.
    Comment Date: 5 p.m. Eastern Time on Monday, May 23, 2011.

    Docket Numbers: RP11-2105-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America LLC submits
tariff filing per 154.204: Filing to Remove Expired Agreements to be
effective 6/12/2011.
    Filed Date: 05/12/2011.
    Accession Number: 20110512-5077.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011.

    Docket Numbers: RP11-2106-000.
    Applicants: Transwestern Pipeline Company, LLC.
    Description: Transwestern Pipeline Company, LLC submits tariff
filing per 154.204: TW Discount-Type Adjustment Tariff Filing to be
effective 6/11/2011.
    Filed Date: 05/12/2011.
    Accession Number: 20110512-5092.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011.

    Docket Numbers: RP11-2107-000.
    Applicants: Colorado Interstate Gas Company.
    Description: Colorado Interstate Gas Company submits tariff filing
per 154.203: Pre-Filing Rate Case Settlement associated with Docket No.
RP06-397 to be effective 12/31/9998.
    Filed Date: 05/12/2011.
    Accession Number: 20110512-5094.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011.

    Docket Numbers: RP11-2108-000.
    Applicants: Equitrans, L.P.
    Description: Equitrans, L.P. submits tariff filing per 154.203:
Compliance Filing for Order No. 587-U to be effective 6/1/2011.
    Filed Date: 05/12/2011.
    Accession Number: 20110512-5116.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 24, 2011.

    Docket Numbers: RP11-2109-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: Revise Section 6.10 ROFR to be effective 6/13/2011.
    Filed Date: 05/13/2011.
    Accession Number: 20110513-5033.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 25, 2011.

    Docket Numbers: RP11-2110-000.
    Applicants: Trunkline Gas Company, LLC.
    Description: Trunkline Gas Company, LLC submits tariff filing per
154.203: Compliance with CP11-19-000 to be effective 7/16/2011.
    Filed Date: 05/13/2011.
    Accession Number: 20110513-5051.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 25, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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>.

    Dated: May 16, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-12882 Filed 5-24-11; 8:45 am]
BILLING CODE 6717-01-P