[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30842-30843]
[FR Doc No: 2014-12365]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-489-000]

Northern Natural Gas Company; Notice of Application

    Take notice that on May 16, 2014, Northern Natural Gas Company

(Northern), 1111 South 103rd Street, Omaha, Nebraska 68124, filed in
Docket No. CP14-489-000, an application pursuant to section 7(b) of the
Natural Gas Act (NGA), to abandon in-place compression facilities at
its Tescott compressor station located in Ottawa County, Kansas, all as
more fully set forth in the application which is on file with the
Commission and open for public inspection.
    Any questions regarding the applications should be directed to
Michael T. Loeffler, Senior Director of Certificates and External
Affairs, Northern Natural Gas Company, 1111 South 103rd Street, Omaha,
Nebraska 68124, or call<PHONE_NUMBER>.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 7 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on June 11, 2014.

    Dated: May 21, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-12365 Filed 5-28-14; 8:45 am]
BILLING CODE 6717-01-P


1 INFORMATION COLLECTION REQUEST ( ICR)

OMB 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY STRATOSPHERIC OZONE PROTECTION A. JUSTIFICATION 1. Identification of the Information Collection a) Title: Recordkeeping and Periodic Reporting of the Production, Import, Recycling, Destruction, Transshipment and Feedstock Use of Ozone Depleting Substances. Process for Exempting Critical Uses from the Phaseout of Methyl Bromide.

EPA Number: 1432.23 b) Short Characterization:

With this Information Collection Request ( ICR), the Office of Air and Radiation ( OAR) is seeking permission to require the submission of data from regulated industries to EPA and to require recordkeeping or key documents to ensure compliance with the Montreal Protocol on Substances that Deplete the Ozone Layer ( Protocol) and the Clean Air Act. Furthermore, this information is necessary in order to grant the exemptions being proposed. Entities applied to EPA for a critical use exemption that would allow for the continued production and import of methyl bromide after the phaseout in January 2005. EPA used the data submitted by end users to create a nomination of critical uses which was submitted to the Protocol's Ozone Secretariat for review by an international panel of experts. The uses authorized internationally by the Parties to the Protocol will be made available in the U. S. on an annual basis. This ICR seeks to characterize the burden associated with the producing, importing, distributing, and using of critically exempted methyl bromide.

2. Need For, and Use Of, the Collection a) Authority for the Collection This information collection is authorized under section 604 ( d)( 6) of the Clean Air Act Amendments of 1990, added by Section 764 of the 1999 Omnibus Consolidated and Emergency Supplemental Appropriations Act ( Public Law No. 105 277; October 21, 1998).

b) Practical Utility/ Users of the Data The reported data will enable EPA to: 2 1) Ensure that critical use exemptions comply with Section 604( d)( 6) as amended in 1998; 2) Maintain compliance with the Protocol requirements for annual data submission on the production of ozone depleting substances; 3) Analyze technical use data to ensure that exemptions are used in accordance with requirements included in today's proposed rulemaking.

3. Nonduplication, Consultation, and Other Collection Criteria a) Nonduplication All the information requested from respondents under this ICR is authorized by statute ( CAA Section 114 and 604 ( d)( 6)) and is not available from other sources because it is proprietary or sensitive information.

b) Public Notice EPA will provide public notice and comment regarding this ICR when the accompanying proposed rulemaking entitled: Protection of Stratospheric Ozone: Process for Exempting Critical Uses of Methyl Bromide ( RIN # 2060 AJ63) is published in the Federal Register.

c) Consultations EPA has held several consultations, in the form of stakeholder meetings, on the options for the proposed rulemaking as well as the options for reporting and recordkeeping requirements. Copies of transcripts from two of the six sessions held during the summer of 2003 are available at EPA's website at www. epa. gov/ ozone. EPA anticipates receiving comments from stakeholders through the notice and comment process as well.

d) Effects of Less Frequent Collection The U. S. government is required to report data to the Ozone Secretariat on an annual basis. EPA is requesting quarterly reporting from entities such as producers and importers in order to monitor the likelihood of compliance throughout the year. In addition, these entities typically prepare quarterly reports and prefer to report smaller data sets to EPA and not leave the entire task to the end of the year. EPA is requesting annual reporting from some entities that have less infrastructure or are less familiar with Protocol reporting requirements.

e) General Guidelines This rule does not exceed any of the OMB guidelines f) Confidentiality 3 EPA informs respondents that they may assert claims of business confidentiality for any of the information they submit. Information claimed confidential will be treated in accordance with the procedures for handling information claimed as confidential under 40 CFR Part 2, Subpart b, and will be disclosed only if EPA determines that the information is not entitled to confidential treatment. If no claim of confidentiality is asserted when the information is received by EPA, it may be made available to the public without further notice to the respondents ( 40 CFR 2.203).

g) Sensitive Information Individual reporting data may be claimed as sensitive and will be treated as confidential information in accordance with procedures outlined in 40 CFR Part 2.

4. The Respondents and the Information Requested a) Respondents/ SIC Codes Respondents producers, importers, distributors, and custom applicators of methyl bromide as well as users of methyl bromide who are farmers of minor vegetable crops and companies that store agricultural commodities. The appropriate North American Industry Classification System ( NAICS) and Standard Industrial Classification ( SIC) codes for these entities are: 4 TABLE I: NAICS CLASSIFICATION OF REGULATED ENTITIES Category NAICS code SIC code Agricultural production Storage Uses Distributors and Applicators Producers and Importers 1112 Vegetable and Melon farming 1113 Fruit and Nut Tree Farming 1114 Greenhouse, Nursery, and Floriculture Production 115114 Postharvest Crop activities ( except Cotton Ginning) 311211 Flour Milling 311212 Rice Milling 493110 General Warehousing and Storage 493130 Farm Product Warehousing and Storage 115112 Soil Preparation, Planting and Cultivating 424910 Farm Supplies Merchant Wholesalers 325310 Pesticide and Other Agricultural Chemical Manufacturing 0171 Berry Crops 0172 Grapes 0173 Tree Nuts 0175 Deciduous Tree Fruits ( except apple orchards and farms) 0179 Fruit and Tree Nuts, NEC 0181 Ornamental Floriculture and Nursery Products 0831 Forest Nurseries and Gathering of Forest Products 2041 Flour and Other Grain Mill Products 2044 Rice Milling 4221 Farm Product Warehousing and Storage 4225 General Warehousing and Storage 0721 Crop Planting, Cultivation, and Protection 2879 Pesticides and Agricultural Chemicals, NEC 5 b) Information Requested i) Data Items EPA has proposed to require the following information to be reported to the Agency by the following entities.

· Producers and importers · Quarterly: number and type of expended and unexpended critical use allowances and critical stock allowances; · Annually: kilograms of methyl bromide held in inventory for themselves or third parties; · Annually: number of kilograms and type of methyl bromide sold.

· Distributors, fumigators and applicators · Annually: the number and type of expended critical stock allowances; · Annually: the total amount and type of methyl bromide bought( in kilograms); · Annually: the total amount and type held in inventory for themselves or on behalf of a third party ( in kilograms); · Annually: the total amount and type of methyl bromide sold ( in kilograms);

( B) Recordkeeping · Producers and importers · Self certification form for each sale that indicates the buyer will only sell/ use the methyl bromide for approved critical uses; · Order forms and invoices for methyl bromide; · Records to be kept for 3 years.

· Distributors, fumigators, and applicators · Self certification form for each sale that indicates the buyer will only sell/ use the methyl bromide for approved critical uses; · Order forms and invoices for methyl bromide; · Records to be kept for 3 years.

5. The Information Collected, Agency Activities, Collection Methodology, and Information Management a) Agency Activities · All reported data will be reviewed by EPA. 6 · EPA will ensure that compliance has been maintained with U. S. production and consumption levels of exempted material at the national and sector levels.

· EPA will report annually to the Ozone Secretariat, through the U. S. Department of State, on U. S. compliance with allowable production and consumption levels.

· EPA will adjust future amounts of exempted materials requested based on actual use data and levels of material in inventory.

· The data will then be stored.

b) Collection and Methodology and Management Data will be tracked by industry and reported to EPA. Quarterly and annual submissions to EPA will be provided to EPA via a paper submission. EPA will use our electronic tracking system to update company specific and overall U. S. compliance with production and consumption. Confidential business information will be stored in appropriately controlled areas.

c) Small Entity Flexibility The information collection is authorized by statute under section 604 of the Clean Air Act and is required in order to ensure U. S. compliance with international treaty obligations under the Montreal Protocol. Bearing in mind, U. S. obligations, EPA designed a system that would remove almost all burden from the end users of methyl bromide, some of whom are small entities, and placed it instead on chemical manufacturers, distributors and applicators, who are not small entities. This ICR is related to the collection of information for an exemption program. Participation in this system is therefore voluntary and constitutes a benefit. However, in order to minimize the administrative burden on end users of methyl bromide participating in this system, some of whom may be small entities, EPA is proposing a system that is streamlined. EPA is proposing a system that would only require end users to sign a short form ( 1 2 pages in length) certifying that they are buying the exempted material for an allowable use and will use it accordingly. The form would be kept by the supplier, not the end user.

d) Collection Schedule The information is to be submitted on an annual or quarterly basis ( see section 5 a) to EPA beginning in the first quarter of 2005 and continuing for the life of the exemption.

6) Estimating the Burden and Cost of Collection 7 a) Estimating the Burden The basis of the analysis is the identification of the steps involved in understanding and complying with the new requirements. EPA drew upon experience implementing similar regulations among the same entities in order to derive estimates of the burden associated with the reporting and recordkeeping requirements.

b) Estimating the Respondent Cost To determine respondent costs, EPA used an hourly industry wage rate of $ 80 per hour. Some activities, such as rule familiarization, are in fact one time activities therefore total respondent burden hours indicated in Table II ( below) may be overestimated.

TABLE II RESPONDENT BURDEN HOURS PER YEAR Collection Activity No. of respondents Total no. of responses Hours per response Total hours Rule Familiarization 54 54 4 216 Data Compilation ( quarterly basis) 4 16 4 64 Data Compilation ( annual basis) 50 50 8 400 Data Reporting ( quarterly basis) 4 16 .5 8 Data Reporting ( annual basis) 50 50 .5 25 Reporting on Allowance Trading Activities 4 16 .5 8 Self Certification Activities by Producers, Importers, and Distributors 54 100 .25 25 Self Certification Activities by End Users 2,000 2,500 .25 625 Total Burden Hours 2,802 18 1,370 TABLE III CAPITAL AND OPERATING COSTS 8 Activity No of Entities Affected Estimated Annual Cost per entity Total Estimated Annual Cost None c) Estimating Agency Burden and Cost The basis of this analysis is the identification of the steps involved in distributing critical use allowances, reviewing reporting data, submitting data to the Ozone Secretariat on U. S. compliance, and developing guidance for regulated entities. Each hour of extramural ( contractor) time is valued at $ 80.00 per hour including overhead and fringe. Each hour of Agency time is valued using the 2003 OPM annual base pay table divided by 2,080 to estimate the hourly wage and then multiplied by 1.6, the standard government benefits multiplier. The hourly wage rates are as flows: for EPA managerial staff the rate is $ 65.49, for technical staff ( GS 13 level) the value is $ 47.12, and for clerical staff ( GS 5 level) is $ 18.03. The data in table IV reflects total annual Agency effort.

TABLE IV AGENCY BURDEN HOURS Hours per Response No. of Responses Managerial Hours per Response Technical Hours per Response Clerical Hours per Response Extramural Hours per Response Total Agency Hours/ Year Write/ revise reporting forms n/ a 25 25 0 150 200 Process annual reports 50 .5 1.5 0 1 150 Process quarterly reports 16 .5 1.5 0 1 48 Determine historic baseline 16 .5 1 0 0 24 Distribute allowances annually 4 1 5 0 4 40 Report to the Ozone Secretariat 1 0 10 0 0 10 TOTAL 27.5 44 0 156 472 d) Estimating the Respondent Universe EPA was able to estimate the number of regulated entities drawing upon experience regulating the same entities, except for end users of methyl bromide, as we do under the phaseout program. EPA believes that there are 4 producers and importers of methyl bromide who report quarterly and up to 50 distributors/ applicators of methyl bromide who report annually. EPA was able estimate the 9 number of potential end users based on self reported data from those entities who requested an exemption. Our estimate for the total number of applicators/ end users who may participate in the system is 2,000.

e) Bottom Line Burden Hours and Cost Tables i) The burden hours portion of the respondent reporting burden and operating/ capital costs are estimated in Tables II and III respectively. The dollar estimate associated with this burden is displayed in Table V below.

TABLE V RESPONDENT BURDEN HOURS AND COSTS Response No of Responses Hours/ Response Cost/ Hour Total Cost Reporting 1,186 1.07 $ 80 $ 101,835 Recordkeeping  producers, importers, distributors 54 .25 $ 80 $ 1,080 Recordkeeping  end users 2,500 .25 $ 80 $ 50,000 Total $ 152,915 ii) Agency burden is reported in Table IV. The dollar value associated with this burden is displayed below in Table VI.

TABLE VI ANNUAL AGENCY BURDEN HOURS AND COSTS Managerial Hours Annual Total @ $ 65.49 Technical Hours Annual Total @ $ 47.12 Clerical Hours Annual Total @ $ 18.03 Extramural Hours Annual Total $ 80.00 Total Agency Hours per Year Total Agency Costs per Year Hours/ Response 70 170 0 232 472 $ 31,155 f) Reasons for Change in Burden Amending current regulations to create exemption program.

g) Burden Statement Table II presents the average annual respondent burden. For respondents affected by the methyl bromide critical use exemption, the annual reporting and recordkeeping burden is as follows: 4 producers and importers at a total of 110 hours per year for this group of entities; 50 distributors and applicators at 635 hours per year; 2,000 end users at 625 hours per year. The total industry burden hours per year are therefore 1,370 under the option proposed 10 by EPA. 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; 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. An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15. To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this rule, which includes this ICR, under Electronic Docket ID number OAR 2003 0230. Submit any comments related to the rule ICR for this proposed rule to EPA and OMB. See " Addresses' section at the beginning of this notice for where to submit comments to EPA. Send comments to OMB at the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17 th Street NW, Washington D. C. 20503 attn: Desk Officer for EPA. Include the EPA ICR number ( 1432.23) in correspondence related to this ICR.


[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Page 45876]
[FR Doc No: 2017-21088]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4323-DR; Docket ID FEMA-2017-0001]

North Dakota; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Dakota (FEMA-4323-DR), dated July 12, 2017, and
related determinations.

DATES: The change occurred on September 21, 2017.

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

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

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

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-21088 Filed 9-29-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 82, Number 234 (Thursday, December 7, 2017)]
[Notices]
[Page 57775]
[FR Doc No: 2017-26345]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4347-DR; Docket ID FEMA-2017-0001]

Kansas; Amendment No. 1 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Kansas (FEMA-4347-DR), dated November 7, 2017, and
related determinations.

DATES: The change occurred on November 20, 2017.

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

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Constance C.
Johnson-Cage, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Michael R. Scott as
Federal Coordinating Officer for this disaster.

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

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-26345 Filed 12-6-17; 8:45 am]
 BILLING CODE 9111- 23-P


Louisville, KY IN MSA Bullitt Jefferson Oldham The Louisville, KY MSA was listed in 2001 as being the 50th largest MSA within the United States. This MSA encompasses seven counties, Scott, Clark, Floyd, and Harrison Counties, Indiana and Oldham, Jefferson, and Bullitt Counties, Kentucky. 2 BULLITT COUNTY, KENTUCKY Bullitt County is part of the Louisville, Kentucky Metropolitan Statistical Area ( MSA) and is on the I 65 South interstate corridor. It is located directly south of Jefferson County, northeast of Hardin County, and northwest of Nelson County.

Geography/ Topography Bullitt County has a land mass of 299 square miles and is the southern most county in the entire MSA. The Ohio River touches the western county border. The county is geographically at the junction of the Outer Bluegrass and the Knobs Regions.

Meteorological Information Wind speed/ wind direction information shows that the majority of the time for the period 1988   1992, the wind in the Bullitt County area came from the south southwest and typically at 7 10 knots. ( See figure 1 A) The mean high temperature for July for the area from 1961 through 1990 was 87 ° F, the mean low was 67 ° F. The mean precipitation for the same period was 4.5 inches.

Planning The authority for air quality planning in the Bullitt County area resides with the Kentucky Natural Resources and Environmental Protection Cabinet. Transportation planning for Bullitt County is performed by the Kentuckiana Regional Planning and Development Agency ( KIPDA).

Air Monitoring For the 2000   2002 monitoring period, the Bullitt County ozone monitor ( 21 029 0006) showed a design value of 0.085 parts per million ( ppm), which would be classified as a county in violation of the standard. ( See table 1 A)

Population Based on projections to 2001 from the 2000 census data, there are 63,043 persons living in Bullitt County. That represents approximately 211 persons per square mile. The population of Bullitt County is approximately 35% rural with 3 65% of the people living in incorporated areas. The largest cities in Bullitt County are Mt. Washington and Shepherdsville. ( See table 1 C)

Bullitt County's population from 1990 through 2000 increased by approximately 29% ( 47,567 to 61,236). The population is further expected to increase by an additional 27% between 2000 and 2010. ( See table 1 B)

Based on 2001 population data for the entire Louisville MSA, Bullitt County represents approximately 6% of the total 2001 population in the entire MSA and 8% of the Kentucky portion of the MSA. ( See table 1 C)

Air Emissions Point source VOC emissions from Bullitt County were estimated at 7.76 tons per summer day ( tpsd) in 2001 which represents approximately 22% of the total 35.89 tpsd of the overall VOC point source emissions from the Kentucky portion of the Louisville MSA. The Kentucky portion of the MSA's point source NOx emissions were estimated to be 87.20 tpsd. Bullitt County's point source NOx contribution is approximately 0.80 tpsd or 1% of the Kentucky portion of the Louisville MSA total. ( See table 1 D)

2001 Point Source Emissions Point sources located within Bullitt County are subject to PSD requirements, CTG RACT requirements, Maximum Achievable Control Technology ( MACT) requirements for sources of Hazardous Air Pollutants, and New Source Performance Standards ( NSPS). Any controls imposed as a result of previous nonattainment designations in the partial county area are required to remain in the area. VOC Emissions tons per summer day Bullitt 22%

Jefferson 76% Oldham 2%

NOx Emissions tons per summer day Jefferson 99% Bullitt 1% Oldham 0% 4 It should be noted that reformulated gasoline, an emission control strategy relating to onroad mobile sources, and Stage I controls at gasoline stations are in place in the former 1 hour ozone nonattainment portion of Bullitt County.

Onroad mobile source VOC emissions within Bullitt County were estimated to be 3.50 tpsd emissions in 2001. This represents approximately 10% of the total 36.04 tpsd of onroad mobile VOC emissions in the Kentucky portion of the Louisville MSA. Bullitt County onroad mobile NOx emissions were estimated to be 7.77 tpsd which is approximately 9% of the total 86.35 tpsd contribution from all three Kentucky counties in the MSA. ( See table 1 D)

2001 Onroad Mobile Source Emissions Commuting traffic from other counties into Bullitt County is high, while the commuting traffic from Bullitt County into other counties is significant.

Commuting Classifications Not Significant 0 10% Minimal 11 30% High 31 50% Significant 51% or more VOC Emissions tons per summer day Bullitt 10% Oldham 6%

Jefferson 84% NOx Emissions tons per summer day Bullitt 9% Oldham 5%

Jefferson 86% 5 2001 VOC Contribution ( tons per summer day)

7.76 3.5 27.49 30.42 0.64 2.12 0 10 20 30 40 50 60 70 Bullitt Jefferson Oldham Mobile Point 0.80 7.77 86.38 74.13 0.02 4.45 0 20 40 60 80 100 120 140 160 Bullitt Jefferson Oldham Mobile Point 2001 NOx Contribution ( tons per summer day) 6 Conclusion and Recommendation The monitoring and emissions data presented indicate that Bullitt County, Kentucky, should be designated nonattainment for the 8 hour ozone standard. 7 OLDHAM COUNTY, KENTUCKY Oldham County is part of the Louisville, Kentucky Metropolitan Statistical Area ( MSA) and is on the I 71 North South interstate corridor. It is located northwest of Jefferson County, south of Trimble County, and northwest of Shelby County.

Geography/ Topography Oldham County has a land area of 189 square miles and is the eastern most county in the entire MSA. The Ohio River forms the northwest border of the county. The county geographically is in the Outer Bluegrass Region.

Meteorological Information Wind speed/ wind direction information shows that the majority of the time for the period 1988   1992, the wind in the Oldham County area came from the south southwest and typically at 7 10 knots. ( See figure 1 A) The mean high temperature for July for the area from 1961 through 1990 was 87 ° F, the mean low was 67 ° F. The mean precipitation for the same period was 4.5 inches.

Planning The authority for air quality planning in the Oldham County area resides with the Kentucky Natural Resources and Environmental Protection Cabinet. Transportation planning for Oldham County is performed by the Kentuckiana Regional Planning and Development Agency ( KIPDA).

Air Monitoring For the 2000   2002 monitoring period, the Oldham County ozone monitor ( 21 185 0004) showed a design value of 0.087 parts per million ( ppm), which would be classified as a county in violation of the standard. ( See table 1 A)

Population Based on projections to 2001 from the 2000 census data, there are 48,000 persons living in Oldham County. That represents approximately 254 persons per square mile. The population of Oldham County is approximately 35% rural 8 with 65% of the people living in incorporated areas. The largest city in Oldham County is LaGrange. ( See table 1 C)

Oldham County's population from 1990 through 2000 increased by approximately 39% ( 33,263 to 46,178). The population is further expected to increase by an additional 36% between 2000 and 2010. ( See table 1 B)

Based on 2001 population data for the entire Louisville MSA, Oldham County represents approximately 5% of the total 2001 population in the entire MSA and 6% of the Kentucky portion of the MSA. ( See table 1 C)

Air Emissions Point source VOC emissions from Oldham County were estimated at 0.64 tpsd in 2001 which represents approximately 2% of the total 35.89 tpsd of the overall VOC point source emissions from the Kentucky portion of the Louisville MSA. The Kentucky portion of the MSA's point source NOx emissions were estimated to be 87.20 tpsd. Oldham County's point source NOx contribution is approximately 0.02 tpsd or less than 1% of the Kentucky portion of the Louisville MSA total. ( See table 1 D)

2001 Point Source Emissions Point sources located within Oldham County are subject to PSD requirements, CTG RACT requirements, Maximum Achievable Control Technology ( MACT) requirements for sources of Hazardous Air Pollutants, and New Source Performance Standards ( NSPS). Any controls imposed as a result of previous nonattainment designations in the partial county area are required to remain in the area. VOC Emissions tons per summer day Bullitt 22%

Jefferson 76% Oldham 2%

NOx Emissions tons per summer day Jefferson 99% Bullitt 1% Oldham 0% 9 It should be noted that reformulated gasoline, an emission control strategy relating to onroad mobile sources, and Stage I controls at gasoline stations are in place in the former 1 hour ozone nonattainment portion of Oldham County.

Onroad mobile source VOC emissions within Oldham County were estimated to be 2.12 tpsd in 2001. This represents approximately 6% of the total 36.04 tpsd onroad mobile VOC emissions in the Kentucky portion of the Louisville MSA. Oldham County onroad mobile NOx emissions were estimated to be 4.45 tpsd which is approximately 5% of the total 86.35 tpsd contribution from all three Kentucky counties in the MSA. ( See table 1 D)

2001 Onroad Mobile Source Emissions Commuting traffic from other counties into Oldham County is high, while the commuting traffic from Oldham County into other counties is significant.

Commuting Classifications Not Significant 0 10% Minimal 11 30% High 31 50% Significant 51% or more VOC Emissions tons per summer day Bullitt 10% Oldham 6%

Jefferson 84% NOx Emissions tons per summer day Bullitt 9% Oldham 5%

Jefferson 86% 10 2001 VOC Contribution ( tons per summer day)

7.76 3.5 27.49 30.42 0.64 2.12 0 10 20 30 40 50 60 70 Bullitt Jefferson Oldham Mobile Point 0.80 7.77 86.38 74.13 0.02 4.45 0 20 40 60 80 100 120 140 160 Bullitt Jefferson Oldham Mobile Point 2001 NOx Contribution ( tons per summer day) 11 Conclusion and Recommendation The monitoring and emissions data presented indicate that Oldham County, Kentucky, should be designated nonattainment for the 8 hour ozone standard. 12 JEFFERSON COUNTY, KENTUCKY Jefferson County is part of the Louisville, Kentucky Metropolitan Statistical Area ( MSA) and is located at the intersection of the I 65 North South, I 71 North South, and I 64 East West interstate corridors in central Kentucky.

Geography/ Topography Jefferson County has a land mass of 385 square miles and is the central county in the Kentucky portion of the Louisville MSA. Oldham County lies to the northwest and Bullitt County to the south of Jefferson County. The Ohio River forms the northern border of Jefferson County.

Meteorological Information Wind speed/ wind direction information shows that the majority of the time for the period 1988   1992, the wind in the Jefferson County area came from the south southwest and typically at 7 10 knots. ( See figure 1 A) The mean high temperature for July for the area from 1961 through 1990 was 87 ° F, the mean low was 67 ° F. The mean precipitation for the same period was 4.5 inches.

Planning The authority for air quality planning in the Jefferson County resides with the Louisville Metro Air Pollution Control District and with the Kentucky Natural Resources and Environmental Protection Cabinet which provides oversight. Transportation planning for Jefferson County is performed by the Kentuckiana Regional Planning and Development Agency ( KIPDA).

Air Monitoring For the 2000   2002 monitoring period, the Jefferson County ozone monitor ( 21 111 0027 Bates) showed a design value of 0.085 parts per million ( ppm), which would be classified as a county in violation of the standard. ( See table 1 A)

Population Based on projections to 2001 from the 2000 census data, there are 692,910 persons living in Jefferson County. That represents approximately 1,800 13 persons per square mile. The population of Jefferson County is approximately 2% rural with 98% of the people living in incorporated areas. The largest city in Jefferson County is Louisville. ( See table 1 C)

Jefferson County's population from 1990 through 2000 increased by approximately 4% ( 665,123 to 693,604). The population is further expected to increase by an additional 3% between 2000 and 2010. ( See table 1 B)

Based on 2001 population data for the entire Louisville MSA, Jefferson County represents approximately 67% of the total 2001 population in the entire MSA and 86% of the Kentucky portion of the MSA. ( See table 1 C)

Air Emissions Point source VOC emissions from Jefferson County were estimated at 27.49 tpsd in 2001 which represents approximately 76% of the total 35.89 tpsd of the overall VOC point source emissions from the Kentucky portion of the Louisville MSA. The Kentucky portion of the MSA's point source NOx emissions were estimated to be 87.20 tpsd. Jefferson County's point source NOx contribution is approximately 86.38 tpsd or 99% of the Kentucky portion of the Louisville MSA total. ( See table 1 D)

2001 Point Source Emissions Point sources located within Jefferson County are subject to PSD requirements, CTG RACT requirements, Maximum Achievable Control Technology ( MACT) requirements for sources of Hazardous Air Pollutants, New Source Performance Standards ( NSPS), and any additional local emission control measures. Any VOC Emissions tons per summer day Bullitt 22%

Jefferson 76% Oldham 2%

NOx Emissions tons per summer day Jefferson 99% Bullitt 1% Oldham 0% 14 controls imposed as a result of previous nonattainment designations are required to remain in Jefferson County. It should be noted that three emission control strategies relating to onroad mobile sources are currently in place in Jefferson County: a vehicle inspection and maintenance program, Stage II Vapor Recovery, and reformulated gasoline. Stage I controls at gasoline stations are also in place in Jefferson County. Onroad mobile source VOC emissions within Jefferson County were estimated to be 30.42 tpsd in 2001. This represents approximately 84% of the total 36.04 tpsd of onroad mobile VOC emissions in the Kentucky portion of the Louisville MSA. Jefferson County onroad mobile NOx emissions were estimated to be 74.13 tpsd which is approximately 86% of the total 86.35 tpsd contribution from all three Kentucky counties in the MSA. ( See table 1 D)

2001 Onroad Mobile Source Emissions Commuting traffic from other counties into Jefferson County is minimal, while the commuting traffic from Jefferson County into other counties is not significant.

Commuting Classifications Not Significant 0 10% Minimal 11 30% High 31 50% Significant 51% or more VOC Emissions tons per summer day Bullitt 10% Oldham 6%

Jefferson 84% NOx Emissions tons per summer day Bullitt 9% Oldham 5%

Jefferson 86% 15 2001 VOC Contribution ( tons per summer day)

2001 NOx Contribution ( tons per summer day) 7.76 3.50 27.49 30.42 0.64 2.12 0 10 20 30 40 50 60 70 Bullitt Jefferson Oldham Mobile Point 0.80 7.77 86.38 74.13 0.02 4.45 0 20 40 60 80 100 120 140 160 Bullitt Jefferson Oldham Mobile Point 16 Conclusion and Recommendation The monitoring and emissions data presented indicate that Jefferson County, Kentucky, should be designated nonattainment for the 8 hour ozone standard. 17 Louisville MSA Figure 1 A Wind Rose Patterns Figure 1 B 2001 VOC and NOx Emissions Kentucky Portion of the Louisville MSA ( tons per summer day)

11.26 8.57 57.91 160.51 2.76 4.47 0 20 40 60 80 100 120 140 160 180 Bullitt Jefferson Oldham VOC NOx 18 Table 1 A Kentucky Portion of the Louisville MSA Ozone Design Values ( parts per million)

County 2000 2001 2002 Design Value Jefferson Bates .090 .081 .085 .085 WLKY .084 .077 .088 .083 Watson Lane .076 .081 .096 .084 Bullitt .082 .082 .091 .085 Oldham .085 .086 .091 .087 Table 1 B Kentucky Portion of the Louisville MSA Population Growth Data County 1990 2000 % Growth 1990   2000 2010 % Growth 2000   2010 Bullitt 47,567 61,236 28.7% 77,928 27.3%

Jefferson 665,123 693,604 4.3% 717,376 3.4%

Oldham 33,263 46,178 38.8% 62,789 36.0%

Table 1 C 2001 Estimated Louisville MSA Population Growth Data Kentucky Estimated Population Bullitt County 63,043 Jefferson County 692,910 Oldham County 48,000 Indiana Clark County 97,364 Floyd County 71,348 Harrison County 34,929 Scott County 23,247 Total Estimated Population 1,030,841 19 Table 1 D Kentucky Portion of the Louisville MSA 2001 VOC and NOx Emissions ( tons per summer day)

VOC NOx County Point Mobile Total Point Mobile Total Bullitt 7.76 3.50 11.26 0.80 7.77 8.57 Jefferson 27.49 30.42 57.91 86.38 74.13 160.51 Oldham 0.64 2.12 2.76 0.02 4.45 4.47 Total 35.89 36.04 71.93 87.20 86.35 173.55


[Federal Register: March 6, 2008 (Volume 73, Number 45)]
[Notices]
[Page 12182-12183]
[DOCID:fr06mr08-76]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Summaries of Medical and Clinical Pharmacology Reviews of
Pediatric Studies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of summaries of medical and clinical pharmacology reviews
of pediatric studies submitted in supplements for BETOPTIC (betaxolol),
LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), RISPERDAL
(risperidone), and TIMOLOL (timolol). These summaries are being made
available consistent with the Best Pharmaceuticals for Children Act
(the BPCA). For all pediatric supplements submitted under the BPCA, the
BPCA requires FDA to make available to the public a summary of the
medical and clinical pharmacology reviews of the pediatric studies
conducted for the supplement.

ADDRESSES: Submit written requests for single copies of the summaries
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Please specify by product name which summary
or summaries you are requesting. Send one self-addressed adhesive label
to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries.

FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6460, Silver Spring, MD 20993-0002, 301-
796-0700, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of summaries of medical and
clinical pharmacology reviews of pediatric studies conducted for
BETOPTIC (betaxolol), LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin),
RISPERDAL (risperidone), and TIMOLOL (timolol). The summaries are being
made available consistent with section 9 of the BPCA (Public Law 107-
109). Enacted on January 4, 2002, the BPCA reauthorizes, with certain
important changes, the pediatric exclusivity program described in
section 505A of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 355a). Section 505A of the act permits certain applications to
obtain 6 months of marketing exclusivity if, in accordance with the
requirements of the statute, the sponsor submits requested information
relating to the use of the drug in the pediatric population.
    One of the provisions the BPCA added to the pediatric exclusivity
program pertains to the dissemination of pediatric information.
Specifically, for all pediatric supplements submitted under the BPCA,
the BPCA requires FDA to make available to the public a summary of the
medical and clinical pharmacology reviews of pediatric studies
conducted for the supplement (21 U.S.C. 355a(m)(1)). The summaries are
to be made available not later than 180 days after the report on the
pediatric study is submitted to FDA (21 U.S.C. 355a(m)(1)). Consistent
with this provision of the BPCA, FDA has posted on the Internet at
http://www.fda.gov/cder/pediatric/index.htm summaries of medical and
clinical pharmacology reviews of pediatric studies submitted in
supplements for BETOPTIC (betaxolol), LAMICTAL (lamotrigine), LEVAQUIN
(levofloxacin), RISPERDAL (risperidone), and TIMOLOL (timolol). Copies
are also available by mail (see ADDRESSES).

II. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/pediatric/index.htm.

    Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4426 Filed 3-5-08; 8:45 am]

BILLING CODE 4160-01-S


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ Office of Enforcement and Compliance Assurance 2. OMB control number b. G None a. 2060  0416 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NESHAP for the Portland Cement Manufacturing Industry ( 40 CFR Part 63, Subpart LLL)

8. Agency form number( s) ( If applicable) EPA ICR Number: 1801.03 9. Keywords Portland cement, cement 10. Abstract Owners or operators of portland cement manufacturing facilities must submit notifications and reports and maintain records required by the General Provisions ( 40 CFR Part 63, Subpart A) and maintain records of specific information needed to determine if compliance has been achieved.

11. Affected public ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. X Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 107 b. Total annual responses 214 1. Percentage of these responses collected electronically 0 % c. Total hours requested 53,181 d. Current OMB inventory 77,331 e. Difference ( 24,150) f. Explanation of difference 1. Program Change 2. Adjustment ( 24,150) 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs $ 0 b. Total annual costs ( O& M) $ 685 c. Total annualized cost requested $ 685 d. Current OMB inventory $ 1,432 e. Difference ($ 747) f. Explanation of difference 1. Program change 2. Adjustment ($ 747)

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. X Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Gregory Fried Phone: ( 202) 564 7016 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C. § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of:

"( i) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95


MEMORANDUM

DATE: 11/21/14

FROM: 		Ken Mitchell/EPA Region 4

TO:CLEAN POWER PLAN FOR EXISTING POWER PLANTS; DOCKET ID: OAR - 2013-0602

SUBJECT:DISCUSSION OF THE CLEAN POWER Plan with Melonie Santiago-Mosier/Sun Edison

SUMMARY:
REGION 4 PROVIDED INFORMATION ON THE CLEAN POWER PLAN to Melonie Santiago-Mosier of Sun
Edison on September 5, 2014.  The Clean Power Plan for Existing Power Plants was proposed on
June 2, 2014.
ATTENDEES:

EPA
Ken Mitchell/EPA R4
Matt Clouse/EPA OAP
Chris Sherry/EPA OAP

External Stakeholders
Melonie Santiago-Mosier/Sun Edison


[Federal Register: October 7, 2009 (Volume 74, Number 193)]
[Notices]
[Page 51645-51647]
[DOCID:fr07oc09-115]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Notice of Funding Availability and Solicitation of Applications
for Grants Under the Railroad Rehabilitation and Repair Grant Program

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of funding availability; solicitation of applications.

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SUMMARY: Under this Notice, the FRA encourages interested State
departments of transportation to submit applications for grants to
repair and rehabilitate Class II and Class III railroad infrastructure
damaged by hurricanes, floods, and other natural disasters in areas for
which the President declared a major disaster after January 1, 2008,
under Title IV of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act of 1974.

DATES: FRA will begin accepting grant applications 10 days after
publication of this Notice of Funding Availability in

the Federal Register. Applications may be submitted until close of
business December 20, 2009.

ADDRESSES: Applications for grants under this Program must be submitted
electronically to ``Grants.gov'' at http://www.grants.gov. Grants.Gov
allows organizations to find and apply electronically for competitive
grant opportunities from all Federal grant-making agencies. Any State
wishing to submit an application pursuant to this notice should
immediately initiate the process of registering with Grants.Gov. Please
confirm all Grants.gov submissions by sending an e-mail to
<EMAIL_ADDRESS>    For application materials that an applicant is unable to submit via
Grants.Gov (such as oversized engineering drawings), applicants may
submit an original and two (2) copies to the Federal Railroad
Administration at the following address: Federal Railroad
Administration, Attention: Alice Alexander, Office of Railroad
Development, 1200 New Jersey Avenue, SE., Mail Stop 20, Washington, DC
20590, by close of business December 20, 2009.
    Due to delays caused by enhanced screening of mail delivered via
the U.S. Postal Service, applicants are encouraged to use other means
to assure timely receipt of materials.

FOR FURTHER INFORMATION CONTACT: Alice Alexander, Office of Railroad
Development, Federal Railroad Administration, 1200 New Jersey Avenue,
SE., W36-410, Washington, DC 20590; Phone:<PHONE_NUMBER>; Fax: (202)
493-6333.

SUPPLEMENTARY INFORMATION: The collection of information associated
with the Railroad Rehabilitation and Repair grant program was approved
previously by the Office of Management and Budget under OMB No. 2130-
0580. The FRA is seeking renewed approval from OMB for this collection
of information, which currently expires on October 31, 2009.
    There is approximately $5,000,000 remaining in the Railroad
Rehabilitation and Repair Grant Program (Catalog of Federal Domestic
Assistance (CFDA) Program Number 20.314) which was originally supported
with up to $20,000,000 of Federal funds provided to FRA as part of the
Consolidated Security, Disaster Assistance, and Continuing
Appropriations Act, 2009 (Pub. L. 110-329, September 30, 2008.)
Following the November 6, 2008, Notice of Funding Availability (NOFA),
applications were received and evaluated according to criteria
described in the notice. On May 27, 2009, the FRA selected 12 projects
totaling approximately $15 million under this program. FRA will start
accepting applications after publishing this NOFA in the Federal
Register for the approximately $5,000,000 remaining.
    Funds provided under this Program may constitute no more than 80
percent of the total cost of a selected project, with the remaining
cost funded from other non-Federal sources. FRA anticipates awarding
grants to multiple eligible participants. Eligible projects include
repairs and rehabilitation to Class II and Class III railroad
infrastructure damaged by hurricanes, floods, and natural disasters
that are located in counties that have been identified in a Disaster
Declaration for Public Assistance issued by the President between
January 1, 2008 and October 7, 2009. (http://www.fema.gov/news/
disasters.fema#sev1).
    Class II and Class III railroad infrastructure eligible for repair
and rehabilitation consists of railroad rights-of-way, bridges, signals
and other infrastructure which are part of the general railroad system
of transportation and primarily used by railroads to move freight
traffic. Section 24312 (Labor Standards) of Title 49, United States
Code, applies to grantees assisted under this Program. The grantees
must exhaust all other Federal and State resources prior to seeking
assistance under this Program. FRA anticipates that no further public
notification will be made with respect to soliciting grant applications
and selecting grantees under this Program.
    Purpose: Since 2008, the President has made 113 major disaster
declarations related to hurricanes, floods, and other natural
disasters. Funds provided under this Program will assist Class II and
Class III railroads rebound from these disasters declared in 2008 and
October 7, 2009.

    Authority: The Consolidated Security, Disaster Assistance, and
Continuing Appropriations Act, 2009 (Pub. L. 110-329, September 30,
2008).

    Funding: The Consolidated Security, Disaster Assistance, and
Continuing Appropriations Act, 2009 (the Act) provided $20,000,000, to
remain available until expended. The Act directs the Secretary of
Transportation to competitively award grants covering up to 80 percent
of project costs, with the remaining project costs provided in non-
Federal cash, equipment, or supplies. Further, the Act allows the
Secretary to retain up to one-half of 1 percent of the funds to fund
the oversight by FRA of the design and implementation of projects
funded by these grants. The funding provided for these grants will be
made available to the grantee(s) on a reimbursable basis. It is
anticipated that the available funding could support projects proposed
by multiple applicants. FRA may choose to award a grant or grants in
any amount within the limit of the available funds.
    Following the November 6, 2008, NOFA, applications were received
and evaluated according to criteria described in the notice. On May 27,
2009, the FRA selected 12 projects totaling approximately $15 million
under this program. FRA will start accepting applications after
publishing this NOFA in the Federal Register for the approximately $5
million remaining in this program.
    Schedule for Rehabilitation and Repair Grant Program: FRA will
begin accepting grant applications within ten days after the
publication of the NOFA in the Federal Register. All applications must
be received by the close of business December 20, 2009 deadline.
    Eligible Participants: The department of transportation of any
eligible State may apply for funding under this notice, provided that
the applicant State has an eligible project and has exhausted all other
Federal and State resources prior to seeking assistance under this
Program.
    Eligible Projects: To be eligible for funding under this Program, a
project must include the rehabilitation and repair of Class II or Class
III railroad infrastructure damaged by hurricanes, floods, and other
natural disasters in counties for which the President declared a major
disaster under Title IV of the Robert T. Stafford Disaster Relief and
Emergency Assistant Act of 1974 between January 1, 2008, and October 7,
2009. Rehabilitation or repairs must be made to rights-of-way, bridges,
signals, and other infrastructure which are part of the general
railroad system of transportation. In addition, the railroad
infrastructure replaced or rehabilitated must be primarily used to move
freight traffic.
    Funding Period: Funds will be available under this program only for
the reimbursement of costs incurred after a major disaster declaration
in calendar year 2008 and 2009 until the publication of this NOFA in
the counties covered by such a declaration.
    Selection Criteria: FRA will consider the following selection
factors in evaluating applications for grants under this Program:
    1. The inability of the Class II or Class III railroad to fund the
project without Federal grant funding.

    2. The effects on rail operations, specifically the movement of
freight, of the proposed rehabilitation or repair.
    3. The likelihood of continued railroad operations on the track
that is proposed to be repaired or rehabilitated for more than three
years after project work is complete.
    Requirements for Grant Applications: The following points describe
the minimum content which will be required in grant applications. These
requirements may be satisfied through a narrative statement submitted
by the applicant and supported by spreadsheet documents, tables,
drawings, and other materials, as appropriate. Each grant application
must:
    1. Designate a point of contact for the applicant and provide his
or her name, title, and contact information, including phone number,
mailing address and e-mail address. The point of contact must be an
employee of the applicant.
    2. Include an explanation of why the project is an eligible project
and a thorough discussion of how the project meets all of the selection
criteria, as listed below:
    a. The inability of the Class II or Class III railroad to fund the
project without Federal grant funding.
    b. The effects on rail operations, specifically the movement of
freight, of the proposed rehabilitation or repair.
    c. The likelihood of continued railroad operations on the track
that is proposed to be repaired or rehabilitated for more than three
years after project work is complete.
    3. Identify all funds (including amounts) received from other
Federal and/or State disaster relief programs that directly benefited
the project(s) for which funds are being sought under this Program, or
demonstrate that all such efforts at procuring such funding have failed
or been exhausted. This demonstration should include a recitation of
specific Federal and State disaster relief programs investigated by the
applicant. Among the Federal programs which the applicant might
investigate are those administered by the Federal Emergency Management
Administration, the Small Business Administration, the Federal Highway
Administration, and the U.S. Department of Agriculture.
    4. Include the completed forms:
    (a) Standard Form 424, ``Application for Federal Assistance,''
Standard Form 424C, ``Budget Information for Construction Programs,''
Standard Form 424D, ``Assurances--Construction Programs.''
    (b) The relevant sections of the most recent audit performed in
compliance with OMB Circular A-133, if available. Information on
Circular A-133 can be found at http://www.whitehouse.gov/omb/circulars/
a133/a133.html.
    (c) Signed copies of FRA's Additional Assurances and
certifications, available at http://www.fra.dot.gov/downloads/admin/
assurancesandcertifications.pdf.
    5. Include a detailed description of the scope of work, budget and
schedule and ensure that they are consistent. Describe the proposed
project's physical location, mile-post limits, and include any
drawings, plans, or schematics that have been prepared relating to the
proposed project.
    If funding requested under this Program is only going to support a
portion of the overall rehabilitation and repair of the applicant's
project, describe the complete project, and specify in detail which
portion will involve Federal funding. In addition, FRA strongly
encourages applicants to estimate complete project costs and explain
how the Class II and Class III railroad on whose property the project
is located will finance the complete project.
    6. The budget for the cost of the project should, to the extent
possible, be separated into the following categories: (1)
Administrative; (2) Engineering fees; (3) Demolition and removal; (4)
Construction labor, supervision, and management; (5) Equipment; (6)
Materials, by type (e.g. ties, rail, ballast, signals, and switches);
(7) Contingencies; and (8) Inspection fees. Costs may be reimbursed as
long as expenditures were incurred after the date of the natural
disaster.
    7. Describe the source and amount of non-Federal funds, broken down
by cash, equipment, or supplies.
    8. Describe proposed project implementation and include an overview
of project management arrangements.
    9. For the railroad(s) operating on the infrastructure proposed to
be rehabilitated or repaired, describe the frequency of service, axle-
load limits, and estimated railroad gross ton miles for the first full
year after completion of the project.
    10. Provide an overview of all work done to date to rehabilitate
and repair damage caused by the natural disaster.
    11. Describe the status or progress toward completing any
environmental documentation or clearance for the proposed project under
the National Environmental Policy Act, the National Historic
Preservation Act, section 4(f) of the DOT Act, or other applicable
Federal or State environmental impact assessment laws. FRA's Procedures
for Considering Environmental Impacts (64 FR 28545, May 26, 1999)
describes FRA's process for the assessment of environmental impacts and
the preparation and processing of appropriate documents. That document
is available online at http://www.fra.dot.gov/us/content/166. For
projects that may be categorically excluded from detailed environmental
review, as discussed in FRA's Procedures Section 4(c), categorical
exclusion worksheets are available at: http://www.fra.dot.gov/us/
content/1606. Applicants are encouraged to contact FRA as early as
possible to discuss the environmental review process.
    Format: Excluding spreadsheets, drawings, and tables, the narrative
statement for grant applications may not exceed ten pages in length.
With the exclusion of oversized engineering drawings (which may be
submitted in hard copy to the FRA at the address indicated above), all
application materials should be submitted as attachments through
Grants.Gov. Spreadsheets consisting of budget or financial information
should be submitted via Grants.Gov as Microsoft Excel (or compatible)
documents.

    Issued in Washington, DC, on September 30, 2009.
Mark E. Yachmetz,
Associate Administrator for Railroad Development.
[FR Doc. E9-24182 Filed 10-6-09; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 79, Number 173 (Monday, September 8, 2014)]
[Notices]
[Pages 53249-53250]
[FR Doc No: 2014-21222]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-67]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR.

The purpose of this notice is to improve the public's awareness of, and
participation in, this aspect of FAA's regulatory activities. Neither
publication of this notice nor the inclusion or omission of information
in the summary is intended to affect the legal status of the petition
or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before September 29, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2014-
0604 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC 20951.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on September 2, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition For Exemption

    Docket No.: FAA-2014-0604.
    Petitioner: Montico, Inc.
    Section of 14 CFR parts 21 Subpart H; Sec. Sec.  45.23(b), 91.7(a),
91.9(b)(2), 91.103(b), 91.109, 91.119, 91.121, 91.151(a), 91.203(a) and
(b), 91.405(a), 91.407(a)(1), 91.409(a)(2), and 91.417(a) and (b).
    Description of Relief Sought: The petitioner is seeking an
exemption to commercially operate their sUAS (55 lbs or less) for the
purpose of inspection, monitoring, mapping and photographing attached
equipment and engineering studies involving communication towers, wind
turbine tower facilities and power transmission tower operations.

[FR Doc. 2014-21222 Filed 9-5-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Rules and Regulations]
[Pages 31859-31861]
[FR Doc No: 2014-12814]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2014-N-0576]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Powered Surgical Instrument for Improvement in
the Appearance of Cellulite

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
powered surgical instrument for improvement in the appearance of
cellulite into class II (special controls). The Agency is classifying
the device into class II (special controls) in order to provide a
reasonable assurance of safety and effectiveness of the device.

DATES: This order is effective July 3, 2014. The classification was
applicable on July 12, 2013.

FOR FURTHER INFORMATION CONTACT: Jitendra Virani, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G459, Silver Spring, MD 20993-0002, 301-
796-6398.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012, 126 Stat. 1054), provides two procedures by which a
person may request FDA to classify a device under the criteria set
forth in section 513(a)(1) (a de novo request). Under the first
procedure, the person submits a premarket notification under section
510(k) of the FD&C Act for a device that has not previously been
classified and, within 30 days of receiving an order classifying the
device into class III under section 513(f)(1) of the FD&C Act, the
person requests a classification under section 513(f)(2). Under the
second procedure, rather than first submitting a premarket notification
under section 510(k) and then a request for classification under the
first procedure, the person determines that there is no legally
marketed device upon which to base a determination of substantial
equivalence and requests a classification under section 513(f)(2) of
the FD&C Act. If the person submits a request to classify the device
under this second procedure, FDA may decline to undertake the
classification request if FDA identifies a legally marketed device that
could provide a reasonable basis for review of substantial equivalence
with the device or if FDA determines that the device submitted is not
of ``low-moderate risk'' or that general controls would be inadequate
to control the risks and special controls to mitigate the risks cannot
be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device. In
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order
on March 14, 2011, classifying the Cabochon System into class III,
because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II. On October 29,
2011, Cabochon Aesthetics, Inc., submitted a request for classification
of the Cabochon System under section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the device be classified into class II
(Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable

assurance of safety and effectiveness, but there is sufficient
information to establish special controls to provide reasonable
assurance of the safety and effectiveness of the device for its
intended use. After review of the information submitted in the de novo
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on July 12, 2013, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding Sec.  878.4790.
    Following the effective date of this final classification
administrative order, any firm submitting a premarket notification
(510(k)) for a powered surgical instrument for improvement in the
appearance of cellulite will need to comply with the special controls
named in the final administrative order.
    The device is assigned the generic name powered surgical instrument
for improvement in the appearance of cellulite, and it is identified as
a prescription device that is used for the controlled release of
subcutaneous tissue for improvement in the appearance of cellulite. The
device consists of a cutting tool powered by a motor and a means for
instrument guidance to control the areas of subcutaneous tissue cutting
underneath the cellulite depressions or dimples.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks:

 Table 1--Powered Surgical Instrument for Improvement in the Appearance
               of Cellulite Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Mechanical Injury (excessive treatment   Non-clinical Testing.
 or treatment of non-intended areas).    In Vivo Evaluation.
Infection..............................  Sterility Assurance Testing.
                                         Shelf-life Testing.
Electrical Shock.......................  Electrical Safety Testing.
Electromagnetic Interference...........  Electromagnetic Compatibility
                                          (EMC) Testing.
Adverse Tissue Reaction................  Biocompatibility Testing.
Use Error..............................  In Vivo Evaluation.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to
the general controls, address these risks to health and provide
reasonable assurance of safety and effectiveness:
    (1) Non-clinical testing must be performed to demonstrate that the
device meets all design specifications and performance requirements,
and to demonstrate durability and mechanical integrity of the device.
    (2) In vivo evaluation of the device must demonstrate device
performance, including the safety of the release methodology and blood
loss at the treatment sites.
    (3) All elements of the device that may contact the patient must be
demonstrated to be biocompatible.
    (4) Electrical safety and electromagnetic compatibility of the
device must be demonstrated.
    (5) The labeling must include a summary of in vivo evaluation data
and all the device specific warnings, precautions, and/or
contraindications.
    (6) Sterility and shelf-life testing for the device must
demonstrate the sterility of patient contacting components and the
shelf life of these components.
    Powered surgical instruments for improvement in the appearance of
cellulite are prescription devices restricted to patient use only upon
the authorization of a practitioner licensed by law to administer or
use the device. (Proposed Sec.  878.4790(a) (21 CFR 878.4790(a)); see
section 520(e) of the FD&C Act (21 U.S.C. 360j(e)) and Sec.  801.109
(21 CFR 801.109) (Prescription devices.).) Prescription use
restrictions are a type of general controls as defined in section
513(a)(1)(A)(i) of the FD&C Act.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification prior to marketing the device,
which contains information about the powered surgical instrument for
improvement in the appearance of cellulite they intend to market.

II. Environmental Impact

    The Agency has 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.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously 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 (44 U.S.C. 3501-3520). The collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120, and
the collections of information in 21 CFR part 801, regarding labeling,
have been approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.

    1. K101231: De Novo Request per 513(f)(2) pursuant to the
Agency's NSE Determination, dated March 14, 2011, from Cabochon
Aesthetics, Inc., dated October 29, 2011.

List of Subjects in 21 CFR Part 878

    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
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as
follows:

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

0
2. Add Sec.  878.4790 to subpart E to read as follows:

Sec.  878.4790  Powered surgical instrument for improvement in the
appearance of cellulite.

    (a) Identification. A powered surgical instrument for improvement
in the appearance of cellulite is a prescription device that is used
for the controlled release of subcutaneous tissue for improvement in
the appearance of cellulite. The device consists of a cutting tool
powered by a motor and a means for instrument guidance to control the
areas of subcutaneous tissue cutting underneath the cellulite
depressions or dimples.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Non-clinical testing must be performed to demonstrate that the
device meets all design specifications and performance requirements,
and to demonstrate durability and mechanical integrity of the device.
    (2) In vivo evaluation of the device must demonstrate device
performance, including the safety of the release methodology and blood
loss at the treatment sites.
    (3) All elements of the device that may contact the patient must be
demonstrated to be biocompatible.
    (4) Electrical safety and electromagnetic compatibility of the
device must be demonstrated.
    (5) The labeling must include a summary of in vivo evaluation data
and all the device specific warnings, precautions, and/or
contraindications.
    (6) Sterility and shelf-life testing for the device must
demonstrate the sterility of patient contacting components and the
shelf life of these components.

    Dated: May 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12814 Filed 6-2-14; 8:45 am]
BILLING CODE 4160-01-P