Page 1 of 13 INFORMATION COLLECTION REQUEST ( ICR)

ENVIRONMENTAL PROTECTION AGENCY STRATOSPHERIC OZONE PROTECTION SUPPORTING STATEMENT PART A 1. Identification of the Information Collection a) Title: Reporting and Recordkeeping Requirements of the HCFC Allowance System OMB Number:

EPA Number: 2014.02 b) Short Characterization:

In order to meet its obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer ( Protocol) and the Clean Air Act Amendments of 1990 ( CAAA), EPA is establishing an allowance system for class II controlled substances or hydrochlorofluorocarbons ( HCFCs). Under the Protocol, the U. S. is obligated to limit HCFC consumption ( defined by the Protocol as production plus imports, minus exports) under a specific cap. The U. S. is also a signatory to amendments to freeze HCFC production on January 1, 2004. EPA is controlling U. S. production and import of HCFCs by granting baseline allowances based on the historical activity levels of producers and importers. Since each allowance will be equal to 1 kilogram of HCFC, EPA will be able to monitor the quantity of HCFCs being produced, imported, exported, transformed, or destroyed. There are two types of allowances: consumption allowances and production allowances. Transfers of production and consumption allowances among producers and importers is allowed.

Producers, importers, and exporters are required to submit to EPA quarterly reports of the quantity of HCFCs in each of their transactions; they are also required to report the quantity of HCFCs transformed or destroyed. EPA is requiring all producers, importers, and exporters maintain records such as Customs entry forms, bills of lading, sales records, and canceled checks to support their quarterly reports. The quarterly reports may be faxed or mailed to EPA, where they will be handled as confidential business information. EPA will store the submitted information in a computerized database designed to track allowance balances and transfer activities. EPA is currently exploring the possibility of having reports filled and submitted to the Agency over a secure Web site. If and when electronic reporting would occur, EPA would change its guidance document and its ICR to indicate a change in burden hours. EPA will use the information to ensure that the U. S. maintains compliance with the Protocol caps and to report annually to United Nations Environment Programme the U. S. activity in HCFCs.

EPA will store the submitted information in a computer system designed to track allowance balances and transfer activities. The information collection will involve 52 respondents: seven producers, 14 importers, 16 exporters, as well as 15 entities petitioning for HCFC 141b exemption allowances. ( three companies both produce and import) The total industry burden and cost are estimated at 3,292 hours and $ 253,089. Page 2 of 13 2. Need For, and Use Of, the Collection a) Authority for the Collection CAA § 603( b) Production, import, and export level reports On a quarterly basis, or such other basis ( not less than annually) as determined by the Administrator, each person who produced, imported, or exported a class I or class II substance shall file a report with the Administrator setting for the amount of the substance that such person produced, imported, and exported during the preceding reporting period. Each such report shall be signed and attested by a responsible officer. No such report shall be required from a person after April of the calender year after such person permanently ceases production, importation, and exportation of the substance and so notified the Administrator in writing.

Montreal Protocol on Substances that Deplete the Ozone Layer Article 7: Reporting of data 1. Each Party shall provide to the Secretariat, within three months of becoming a Party, statistical data on its production, imports and exports of each of the controlled substances in Annex A for the year 1986, or the best possible estimates of such data where actual data are not available.

2. Each Party shall provide to the Secretariat statistical data on its production, imports and exports of each of the controlled substances  in Annex B and Groups I and II of Annex C for the year 1989;

 in Annex E, for the year 1991,

or the best possible estimates of such data where actual data are not available, not later than three months after the date when the provisions set out in the Protocol with regard to the substances in Annexes B, C and E respectively enter into force for that Party.

3. Each Party shall provide to the Secretariat statistical data on its annual production ( as defined in paragraph 5 of Article 1) of each of the controlled substances listed in Annexes A, B, C and E and, separately, for each substance,

 Amounts used for feedstocks,

 Amounts destroyed by technologies approved by the Parties, and  Imports from and exports to Parties and non Parties respectively,

for the year during which provisions concerning the substances in Annexes A, B, C and E respectively entered into force for that Party and for each year thereafter. Each Party shall provide to the Secretariat statistical data on the annual amount of the controlled substance listed in Annex E used for quarantine and pre shipment applications. Data shall be forwarded not later than nine months after the end of the year to which the data relate. Page 3 of 13 3 bis. Each Party shall provide to the Secretariat separate statistical data of its annual imports and exports of each of the controlled substances listed in Group II of Annex A and Group I of Annex C that have been recycled.

4. For Parties operating under the provisions of paragraph 8 ( a) of Article 2, the requirements in paragraphs 1, 2, 3 and 3 bis of this Article in respect of statistical data on imports and exports shall be satisfied if the regional economic integration organization concerned provides data on imports and exports between the organization and States that are not members of that organization.

b) Practical Utility/ Users of the Data The reporting and recordkeeping requirements included in the rule will enable EPA to: 1) Ensure compliance with the restrictions on production, import and export of controlled ozonedepleting substances during the phaseout of class II substances; 2) To allow exempted production and import for certain uses and the consequent tracking of that production and import; 3) Address industry and Federal concerns regarding the illegal import of mislabeled used controlled substances; 4) Satisfy U. S. obligations to report data under Article 7 under the Protocol; 5) Fulfill statutory obligations under Section 603( b) and of Title VI of the CAAA for reporting and monitoring; 6) Provide information to report to Congress on the production, use and consumption of class II controlled substances as statutorily required in Section 603( d) of Title VI of the CAAA.

Beginning January 1, 2003, the phaseout of production and consumption of HCFC 141b will become effective. To ensure an orderly phaseout of the production and consumption of HCFCs, this action establishes production and consumption allowances and the reporting requirements of the regulations.

In order to monitor each company's production, import, export, destruction, and transformation, the reporting system requires information which can be used to check industry compliance with the stratospheric ozone protection regulations. Compliance during the phaseout means companies generally produce, import, and export class II substances based on the allocated allowances, including specific and limited exemptions. Exemptions may include HCFC 141b exemption allowances for HCFC 141b.

The information reported to EPA is entered into an electronic tracking system to ensure companies do not exceed their allowances and to guarantee the U. S. does not violate it obligations under the Protocol. Thus, the information is used for compliance monitoring for individual companies and for monitoring U. S. compliance with obligations under the Protocol.

Information is collected to provide reports to the Secretariat of Protocol to meet U. S. international treaty obligations. Requirements to report data are listed in Article 7 of the Protocol.

Industry representatives and many Federal agencies, including EPA, are concerned about claims of fraudulent imports of controlled substances that are mislabeled as used, recycled or reclaimed. EPA established a petition process to provide information for controlling the import of these materials and act as a deterrent to potential fraud. Companies that wish to import used, recycled or reclaimed controlled substances must provide detailed information about the previous use of the material. This rule establishes Page 4 of 13 the information that a company must provide in a petition in order to assist EPA and other agencies in independently verifying that the material listed was, in fact, previously used.

3. Nonduplication, Consultations, and Other Collection Criteria a) Nonduplication All the information requested from respondents under this ICR is required by statute ( CAA § 603( b)) and is not available from other sources because it is proprietary information submitted by industry sources. It does not duplicate the current collection of information but replaces it with quarterly reporting by producers, importers, and exporters, and a petition process for the import of used HCFCs. Those entities granted HCFC 141b exemption allowances after its phaseout on January 1, 2003, will have to report semi annually on their usage of the chemical and annually on their search for an alternative and their continuing need for the exemption.

b) Public Notice Required Prior to ICR Submission to OMB Since this is a rule related ICR, public notice soliciting public comments on the ICR and estimates of burden were done as part of the preamble.

c) Consultations In 1998, EPA conducted two stakeholder meetings for members of the industry while considering the many aspects of an HCFC allowance system. EPA published an Advance Notice of Proposed Rulemaking on April 5, 1999, in which the options for an allowance system were discussed. The comments on the Advance Notice did not indicate any concern with the information collection that had been in place since 1996 or with any future information collection associated with the HCFC allowance system under consideration.

In addition, the following agencies were provided with a copy of the rule for review: U. S. Department of Commerce, U. S. Office of Trade Representatives, National Aeronautics and Space Administration, U. S. Air Force, U. S. Navy, U. S. Coast Guard, and the U. S. Army.

d) Effects of Less Frequent Collection Less frequent collection of data would compromise statutory requirement under section 603 of the CAAA to monitor production, import and export levels. Less frequent collection of information would hinder EPA's ability to identify a violation of the regulation. Penalties for exceeding the regulatory limits are assessed daily at $ 27,500 per kilogram per day which necessitates frequent information collection. Violations would be much more complex to pursue and enforce if the information were submitted less frequently.

Less frequent reporting would potentially put the United States in a non compliance status under the Protocol. If the U. S. were to exceed the limits established by international treaty it would jeopardize the ability of the U. S. to negotiate and secure favorable positions in the international forum. Quarterly reporting allows EPA the necessary time to take actions if production, import or export begin to exceed Protocol limits or the limits set in Section 605 of Title VI in the CAAA.

Less frequent collection of information would place an undue burden on both EPA and industry to ensure accuracy of data. Any inaccuracy would be compounded by the greater time between an actual Page 5 of 13 event and the efforts needed to correct the historical information. Inaccuracies in information would compromise EPA's ability to implement the program. Inaccuracies would also reduce the validity of both reports to Congress and reports to the Secretariat of the Protocol.

e) General Guidelines This rule does not exceed any of the OMB guidelines.

f) Confidentiality 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 Questions This section is not applicable because this ICR does not involve matters of a sensitive nature.

4. The Respondents and the Information Requested a) Respondents/ SIC Codes The following is a list of SIC and NAICS codes associated with producers, importers, exporters, transformers, and destroyers of HCFCs affected by the reporting and recordkeeping requirements covered under this ICR:

Category NAICS code SIC code Examples of regulated entities Page 6 of 13 Chlorofluorocarbon gas manufacturing Chlorofluorocarbon gas importers Chlorofluorocarbon gas exporters Urethane and Other Foam Product ( Except Polystyrene) Manufacturing 325120 326150 2869 3086 Chlorodifluoromethane manufacturers; Dichlorofluoroethane manufacturers; Chlorodifluoroethane manufacturers. Chlorodifluoromethane importers; Dichlorofluoroethane importers; Chlorodifluoroethane importers. Chlorodifluoromethane exporters; Dichlorofluoroethane exporters; Chlorodifluoroethane exporters Insulation and cushioning, foam plastics ( except polystyrene) manufacturing b) Information Requested This action establishes a system of production allowances and consumption allowances for the production and import of controlled substances that EPA will monitor through quarterly and annual reports. Producers, importers, exporters and others must maintain records and report to EPA information on expended and unexpended allowances, transformation, destruction, transfers, and exports.

i) Data Items The following data items may be needed under this system.

records containing inventories of production and consumption allowances reflecting any transfers as required by Section 82.24

records containing production, raw materials used, sales, shipments, controlled substances recovered and recycled, and import activities as required by Section 82.24

reports on feedstock consumption, shipments, total consumption allowances, production allowances, and data on recoverable and recyclable materials if importing as required by Section 82.24

reports on import activities as required by Section 82.24

end of year export reports of Class II chemicals provided by companies that did not previously submit export reports as required by Section 82.24 Page 7 of 13

transfer requests documenting allowance and inter pollutant trade negotiations as required under Section 82.18 and a signed document from the principal diplomatic representative in that nation's embassy in the U. S. stating that the appropriate authority within that nation has established or revised production limits for the nation

requests for consumption allowances as required by Section 82.20

petitions to import and produce HCFCs for HCFC 141b exemption allowances as required under section 82.18 ° reports on HCFC 141b use and search for alternatives under the HCFC 141b exemption allowances as required by Section 82.24 All producers, importers, exporters, and others identified under Section 82.13 or Section 82.24 must perform the following:

Producers ° quantities of raw materials and feedstocks; ° expended and unexpended production, consumption, export production, and Article 5 allowances; ° quantities of chemical produced, sold, transfered, exported, transformed, or destroyed; ° documentation of sales and transfers, invoices, receipts; ° production for transformation and destruction; ° documentation of any spill that exceeds 100 pounds; ° verification of destruction; ° information from exporter certifying that exports are for transformation or destruction; and ° quantity of HCFC 141b produced for HCFC 141b exemption allowance purposes and orders placed, and ° written verifications of recipient and intended use; ° quantity of HCFC 141b produced with export allowance.

Importers ° expended and unexpended consumption allowances for imports of HCFCs; ° quantities imported; ° commodity codes; ° date of entry/ port of entry/ originating country; ° transhipment information; ° importer number; ° bills of lading; ° customs entry forms; ° documentation of sale; ° verification of destruction or transformation; ° imports of used, recycled and reclaimed HCFCs, including information on previous and intended use, exporter, potential reclaimers; ° import petitions and re petitions; ° imports of containers with a heel; ° imports for transformation and destruction; and ° quantity of HCFC 141b imported for HCFC 141b exemption allowance uses. Page 8 of 13 Exporters ° expended and unexpended consumption allowances for exports of HCFCs; ° quantity exported to Article 2 and Article 5 countries; ° the exporting vessel on which HCFCs are shipped, Customs Form 7525; ° quantity exported for transformation or destruction; and ° certification that export will be transformed or destroyed, if applicable. ° quantity of HCFC 141b exported.

Transformers, Destroyers, and Other ° quantity purchased for transformation or destruction on an annual basis; ° information on destruction technique and efficiency ( initially with updated information); ° information on origination and destination of transhipments; ° information on products made with or containing HCFC 141b for HCFC 141b exemption allowance purposes; ° information on trading partners and trade, signed documentation from diplomatic representatives; regarding production limits, transfer requests, notice of trade, revised notices of production limits.

HCFC 141b exemption allowance petitioners ° total quantity of HCFC 141b received to date; ° identity of producer or importer of HCFC 141b; ° petition for HCFC 141b exemption allowances.

All records and reports must comply with the requirements specified in Section 82.24. Requirements for keeping records associated with the reports listed above are for three years. These recordkeeping requirements pertain to original documents that are held by companies in the normal course of conducting business, such as Customs entry forms, accounts of daily production runs, sales invoices, and bills of lading. Information from these recordkeeping documents are summarized in reports. Recordkeeping requirements are designed to aid EPA in compliance monitoring, site inspection and enforcement actions.

( ii) Respondent Activities All producers, importers, and exporters identified under Section 82.13 or Section 82.24 must perform the following:

Producers must keep records and submit reports on a quarterly basis as required by Section ( 82.24 ( b)).

Importers must keep records and submit reports on a quarterly basis as required by Section ( 82.24 ( c, f )).

Exporters must keep records and submit notices as required by Section ( 82.24( d)).

Transformers, Destroyers, and Other must keep records and submit reports on an annual basis as required by Section ( 82.24 ( c, e, f)). Trading parties must keep records and submit notices and reports as required under Section ( 82.17( e, f, h)) and 82.23. Page 9 of 13

Entities granted HCFC 141b exemption allowances must keep records and submit reports on a semi annual basis as required by Section ( 82.24( h)).

All records and reports must comply with the requirements specified in Section 82.24. Requirements for keeping records associated with the reports listed above are for three years. These recordkeeping requirements pertain to original documents that are held by companies in the normal course of conducting business, such as Customs entry forms, accounts of daily production runs, sales invoices, and bills of lading. Information from these recordkeeping documents are summarized in reports. Recordkeeping requirements are designed to aid EPA in compliance monitoring, site inspection and enforcement actions.

5. The Information Collected  Agency Activities, Collection Methodology, and Information Management a) Agency Activities ° notify producers/ importers/ exporters of baseline allowances;

° modify Tracking System to incorporate additions of HCFCs and other regulatory requirements;

° revise guidance document to describe reporting requirements;

° enter and store information submitted from companies in the Tracking System;

° respond to companies submitting tracked/ monitored information, such as requests for transfers;

° review petitions submitted to import used HCFCs;

° review petitions submitted requesting HCFC 141b exemption allowances;

° review information and conduct compliance monitoring activities related to restrictions on production, import, export, transformation and destruction of HCFCs for individual companies;

° inspect records maintained by producers, importers, exporters, transformers, and destroyers of HCFCs;

° review information in tracking system to ensure U. S. is not exceeding consumption and production caps agreed to as a Party to the Protocol;

° review information in tracking system to ensure exempted production and imports do not exceed limits statutorily set in Section 605 of Title VI of the CAAA;

° compile reports mandated by U. S. obligations under the Protocol and Title VI of the CAAA, including Reports to Congress.

b) Collection Methodology and Management After the final rule establishing the allowance system for HCFCs is published, the Agency will provide forms to companies in a newly revised Guidance Document. The Agency will provide forms for Page 10 of 13 the different activities and allowances associated with HCFCs. A copy of the current Guidance Document for Stratospheric Ozone Protection Program after January 1, 1996 is attached.

Although the use of the forms is voluntary, they are generally used by every participant in the regulatory program. In the past, the forms greatly facilitated and eased submission of data for respondents. The reporting requirements, first promulgated in the July 30, 1992 final rule, and then simplified and reduced through amendments published in the Federal Register on May 10, 1995 eased administrative and reporting burden.

An electronic version of the Tracking System will be available for distribution to companies to allow electronic reporting by diskette. A version of the Industry Version of the Tracking System is attached. The system is operated using a Microsoft Access 95 format. The diskette sent to companies will contain a stand alone executable file of Microsoft Access so they may operate the reporting system without needing the specific software.

In general, the regulatory program and the reporting requirements are similar to those already used by companies involved in production and consumption of chlorofluorocarbons ( CFCs). Since many of these firms also produce HCFCs, the administrative burden on these firms to establish recordkeeping and reporting systems is believed to be minimal.

c) Small Entity Flexibility Much of this information collection is required by statute. The rest of the information required is collected in response to Congressional requests for reports and U. S. reporting obligations under the Protocol. EPA believes the information collection is required to ensure allowance holders have intended access to their allowances, to produce these nationally and internationally mandated reports, and to ensure compliance with sections 605 and 606 of the CAAA. Entities will be submitting information to the Agency through petitions requesting HCFC 141b exemption allowances. Those qualifying entities will be granted a benefit in the form of HCFC 141b exemption allowances which allow limited continued production of HCFC 141b beyond the long established phaseout date. Although most respondents to the program are large companies, the burden on all affected entities, and especially the burden on small entities, has been reduced to every extent possible.

d) Collection Schedule After April 1, 2001:

° Producers, importers, and exporters will report to EPA quarterly, with reports due 15 days after the end of each quarter; ° Transformers and destroyers will report annually. ° Entities holding HCFC 141b exemption allowances will report semi annually.

In the past, companies have expressed a desire to report quarterly rather than annually in order to ease their overall burden and increase the accuracy of their submissions. Companies claimed that quarterly submissions allow more accurate self monitoring for maintaining compliance with the regulations. Companies claimed that smaller quarterly reports are easier to compile than larger semi annual or annual reports.

6) Estimating the Burden and Cost of Collection Page 11 of 13 a) Estimating Respondent Burden The basis of the analysis is the identification of the principal steps involved in complying with EPA reporting requirements and the estimated burden associated with each step. The burden has been estimated by identifying the number of times the step will be undertaken and the number of hours required to complete each step. This information is based on quarterly reporting requirements, or less, as well as EPA experience with the CFC ( chlorofluorocarbon) allowance system.

b) Estimating Respondent Cost To determine the respondent costs, the average hourly wage rate of $ 76.88 for the chemical industry was derived from 1999 hourly rate information for managerial and technical staff provided by the Bureau of Labor Statistics. Burden hours per occurrence, as described above, were multiplied by the labor rate to determine respondent costs.

c) Estimating Agency Burden and Cost The basis of this analysis is the identification of the steps involved in implementing and operating the system. The costs associated with each step have been estimated by identifying the number of times the step will be undertaken, the number of hours required to complete each step, and the total dollar cost. Costs are subdivided into Agency and contractor costs. The hourly rates for EPA technical and managerial staff of $ 36.14 and $ 50.24, respectively, were derived from the GS Salary Schedule. These hourly basic rates are from the Office of Personnel Management website. EPA then multiplied hourly rates by the standard government benefits multiplication factor of 1.6. The cost of contractor time and overhead is valued at $ 75.00 per hour and a 6 percent contract fee is included. The number of occurrences of each activity is based on quarterly reporting requirements as well as EPA experience with the CFC allowance tracking system.

d) Estimating the Respondent Universe and Total Burden and Costs EPA estimates that seven producers and fourteen importers will be subject to the allowance program. Fourteen companies also function as exporters and importers from time to time. EPA also estimates fifteen entities will petition for HCFC 141b exemption allowances. The number of firms subject to the allowance program was determined by examining historical production and consumption data for HCFCs. This totals fifty two respondents.

e) Bottom Line Burden Hours and Cost Tables EPA's development and dissemination of the Guidance Document for the Stratospheric Ozone Protection Program After January 1, 1996, was designed to inform all entities potentially subject to the reporting and recordkeeping requirements of the accelerated phaseout regulation. The Guidance Document explains the reasons the information is collected and the ways in which the information is used by the Agency. The preamble to the amended regulation and the Guidance Document both cite the authority under which respondents may claim information to be confidential. The Guidance Document and the final industry version of the electronic reporting diskette will be amended to include a clear description of the proposed reporting requirements for HCFCs and will include a clear burden statement. All forms currently cite the OMB Control Number and will be amended to include the expiration date once approved. Page 12 of 13 The industry reporting burden is estimated in Table I. The estimate includes the time needed to comply with EPA's reporting requirements, as well as that used for the completion of the reports under the amended regulations.

The allowance system rule for ozone depleting substances proposes requiring respondents to submit reports to the Agency and maintain records. Operating and maintenance ( O& M) costs include activities and systems to submit transfer requests, maintain data on production, imports, and exports, prepare and submit reports, and prepare and submit petition import requests. The O& M costs are estimated at $ 253,089 for the HCFC allowance system rule.

Agency burden is reported in Table II. The Agency, with contractor support, will revise the Tracking System to incorporate changes due to regulatory revisions. The estimated hours are 518 hours for revising the Tracking System and guidance document.

The data in the Tracking System is compiled and reviewed at the end of each year to ensure statutory compliance with CAAA and to ensure U. S. compliance with obligations under the Montreal Protocol. The Agency hours for activities related to review of information gathered under this program are estimated to be 1,834 hours.

The Agency reviews requests from producers, importers, and exporters, including petitions to import used HCFCs, as they are submitted by individuals or companies. The number of petitions the Agency reviews may vary. In future years, EPA estimates the Agency will devote approximately 390 hours reviewing requests from these firms.

Summary Bottom Line Burden Hours and Costs:

a) Respondent annual burden hours 3,292 b) Respondent annual labor costs $ 253,089 c) Respondent capital/ start up costs $ 219,108 d) Respondent O & M costs $ 253,089 e) Agency annual burden hours 3,345 f) Agency's annual labor costs $ 200,628 ( f) Reasons for Change in Burden Not applicable g) Burden Statement Table I presents the average annual respondent burden. For companies affected by the regulations for the HCFC allowance system, the reporting burden is estimated to be an average of 129.48 hours per respondent per year. This estimate includes time for preparing and submitting reports. The recordkeeping burden for companies affected by the allowance for HCFCs is estimated to average 10.14 hours per respondent per year. This estimate includes time for gathering information, and developing and maintaining records.

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 Page 13 of 13 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.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822T), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB control number in any correspondence.

APPENDIX I Collection Activity CFR Citation for Recordkeeping and Reporting Producer's Report 82.24 ( b)

Importer's Report 82.24 ( c) ( f)

Notification of Trade 82.23, 82.24 Export Report 82.24 ( d)

Transformation & Destruction 82.24 ( b) ( c) ( e)

HCFC 141b exemption allowance 82.24 ( b) ( h)

Transhipment Report 82.24 ( c) ( 5)


[Federal Register: July 19, 2010 (Volume 75, Number 137)]
[Notices]
[Page 41855]
[DOCID:fr19jy10-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-52-000]

Enogex L.L.C.; Notice of Petition for Rate Approval

July 13, 2010.
    Take notice that on July 1, 2010, Enogex L.L.C. (Enogex) filed
pursuant to section 284.123(b)(2) of the Commission's regulations,
filed a petition requesting that the Commission approve its rates
pursuant to section 311(a)(2) of the Natural Gas Policy Act of 1978.
Enogex proposes to reduce its fixed fuel percentages to a fuel factor
of 0.69% for the East Zone and a fuel factor of 0.59% for the West Zone
of its system for the period of August 1, 2010 through March 31, 2011.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern time on Monday, July 26, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-17558 Filed 7-16-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 218 (Friday, November 12, 2010)]
[Notices]
[Page 69426]
[FR Doc No: 2010-28478]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13844-000]

Qualified Hydro 31, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

November 5, 2010.
    On September 29, 2010, Qualified Hydro 31, LLC filed an
application, pursuant to Section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Salamonie Lake Dam
Hydroelectric Project No. 13844, to be located at the existing
Salamonie Lake Dam on the Salamonie River, in the City of Wabash, in
Wabash County, Indiana. The Salamonie Lake Dam is owned by the United
States government and operated by the U.S. Army Corps of Engineers.
    The proposed project would consist of: (1) The existing earth-
filled dam which is 133 feet in height with an overall length of 6,100
feet; (2) a new reinforced concrete powerhouse, 40 feet by 60 feet, to
be located downstream of the existing stilling basin; (3) a new 75-
foot-long, 8.0-foot-diameter penstock; (4) two vertical Kaplan turbine-
generator units with a combined capacity of 3.5 megawatts; (5) a new 4
MVA substation adjacent to the powerhouse; (6) a new 7,500-foot-long,
12.5 to 34.5-kilovolt transmission line; and (7) appurtenant
facilities. The project would have an estimated annual generation of
11.0 gigawatt-hours.
    Applicant Contact: Ramya Swaminathan, 33 Commercial Street,
Gloucester, MA 01930,<PHONE_NUMBER>.
    FERC Contact: Tyrone A. Williams,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, and competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance date of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
(http://www.ferc.gov/docs-filing/ferconline.asp) under the ``eFiling''
link. For a simpler method of submitting text only comments, click on
``Quick Comment.'' For assistance, please contact FERC Online Support
at FERCOnlineSupport.gov; call toll-free at<PHONE_NUMBER>; or, for
TTY, contact<PHONE_NUMBER>. Although the Commission strongly
recommends electronic filing, documents may also be paper-filed. To
paper-file, an original and eight copies should be mailed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426. For more information on how to
submit these types of filings please go to the Commission's website
located at http://www.ferc.gov/filing-comments.asp.
    More information about this project, including a copy of the
application can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13844) in the docket number field to access
the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-28478 Filed 11-10-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50075-50077]
[FR Doc No: 2017-23489]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-5870]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Aquaporin-4 Autoantibody Immunological Test
System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the Aquaporin-4 autoantibody immunological test system into class II
(special controls). The special controls that apply to the device type
are identified in this order and will be part of the codified language
for the Aquaporin-4 autoantibody immunological test system's
classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective October 30, 2017. The classification was
applicable on April 25, 2016.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the Aquaporin-4 autoantibody
immunological test system as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (the FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On July 2, 2015, KRONUS, Inc. submitted a request for De Novo
classification of the KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA
Assay. 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. We classify 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 that, in combination with the general controls,
provide reasonable assurance of the safety and effectiveness of the
device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review
of the information submitted in the request, we determined that the
device can be classified into class II with the establishment of
special controls. FDA has determined that these special controls, in
addition to general controls, will provide reasonable assurance of the
safety and effectiveness of the device.
    Therefore, on April 25, 2016, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.5665. We have named
the generic type of device Aquaporin-4 autoantibody immunological test
system, and it is identified as a device that consists of reagents used
to measure by immunochemical techniques autoantibodies in human serum
samples that react with Aquaporin-4 (AQP4Ab). The measurements aid in
the diagnosis of neuromyelitis optica and neuromyelitis optica spectrum
disorders, in conjunction with other clinical, laboratory, and
radiological (e.g., magnetic resonance imaging) findings.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures

required to mitigate these risks in table 1.

  Table 1--Aquaporin-4 Autoantibody Immunological Test System Risks and
                           Mitigation Measures
------------------------------------------------------------------------
                                            Mitigation measures/21 CFR
            Identified risks                         section
------------------------------------------------------------------------
Inaccurate test results that provide     Special controls (1), (2), and
 false positive or false negative         (3) (21 CFR 866.5665(b)(1); 21
 results can lead to improper patient     CFR 866.5665(b)(2); and 21 CFR
 management.                              866.5665(b)(3)).
Failure to correctly interpret test      Special controls (1)(iii), (2),
 results can lead to false positive or    and (3) (21 CFR
 false negative results.                  866.5665(b)(1)(iii); 21 CFR
                                          866.5665(b)(2); and 21 CFR
                                          866.5665(b)(3)).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.

III. Analysis of 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.

IV. Paperwork Reduction Act of 1995

    This final 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, the collections of
information in part 820 have been approved under OMB control number
0910-0073, and the collections of information in 21 CFR parts 801 and
809, regarding labeling have been approved under OMB control number
0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, 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
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

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

0
2. Add Sec.  866.5665 to subpart F to read as follows:

Sec.  866.5665   Aquaporin-4 autoantibody immunological test system.

    (a) Identification. An Aquaporin-4 autoantibody immunological test
system is a device that consists of reagents used to measure by
immunochemical techniques autoantibodies in human serum samples that
react with Aquaporin-4 (AQP4Ab). The measurements aid in the diagnosis
of neuromyelitis optica (NMO) and neuromyelitis optica spectrum
disorders (NMOSD) in conjunction with other clinical, laboratory, and
radiological (e.g., magnetic resonance imaging) findings.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must include the following
information:
    (i) A detailed device description including:
    (A) A detailed description of all components including all required
ancillary reagents in the test;
    (B) If applicable, a detailed description of instrumentation and
equipment, including illustrations or photographs of non-standard
equipment or manuals;
    (C) If applicable, detailed documentation of the device software,
including, but not limited to, standalone software applications and
hardware-based devices that incorporate software;
    (D) A detailed description of appropriate internal and external
quality controls that are recommended or provided. The description must
identify those control elements that are incorporated into the
specified testing procedures;
    (E) Detailed specifications for sample collection, processing, and
storage;
    (F) A detailed description of methodology and assay procedure;
    (G) A description of how the assay cutoff (the medical decision
point between positive and negative) was established and validated as
well as supporting data; and
    (H) Detailed specification of the criteria for test results
interpretation and reporting.
    (ii) Detailed information demonstrating the performance
characteristics of the device, including:
    (A) Device precision/reproducibility data generated from within-
run, between-run, between-day, between-lot, between-site, and total
precision for multiple nonconsecutive days, as applicable. A well
characterized panel of patient samples or pools from the indicated
population that covers the device measuring range must be used.
    (B) Device linearity data generated from samples covering the
device measuring range, if applicable.
    (C) Information on traceability to a reference material and
description of value assignment of calibrators and controls, if
applicable.
    (D) Device analytical sensitivity data, including limit of blank,
limit of detection, and limit of quantitation, if applicable.
    (E) Device analytical specificity data, including interference by
endogenous and exogenous substances, as well as cross-reactivity with
samples derived from patients with other autoimmune diseases or
conditions.
    (F) Device instrument carryover data, when applicable.
    (G) Device stability data, including real-time stability under
various storage times and temperatures.
    (H) Specimen stability data, including stability under various
storage times, temperatures, freeze-thaw, and transport conditions,
where appropriate.
    (I) Method comparison data generated by comparison of the results
obtained with the device to those obtained with a legally marketed
predicate device with similar indications of use. A well-characterized
panel of patient samples from the indicated population covering the
device measuring range must be used.

    (J) Specimen matrix comparison data, if more than one specimen type
or anticoagulant can be tested with the device. Samples used for
comparison must be from well-characterized patient samples covering the
device measuring range.
    (K) Clinical performance must be established by comparing data
generated by testing samples from the indicated population and the
differential diagnosis or non-target disease groups with the device to
the clinical diagnostic standard.
    (1) The diagnosis of NMO and NMOSD must be based on clinical
findings, laboratory tests (e.g., serological tests), and radiological
tests (e.g., magnetic resonance imaging).
    (2) The differential diagnosis or non-target disease group must
include the applicable diseases or conditions, including but not be
limited to the following: Multiple sclerosis, stroke, Lyme disease,
shingles, syphilis, human immunodeficiency virus, hepatitis B,
tuberculosis, Srgen's syndrome, systemic lupus erythematous, systemic
vasculitis, sarcoidosis, Graves' disease, Hashimoto's disease, Type I
diabetes, rheumatoid arthritis, Addison's disease, and myasthenia
gravis.
    (3) Diagnosis of diseases or conditions for the differential or
non-target disease groups must be based on established diagnostic
criteria and clinical evaluation.
    (4) For all samples, the diagnostic clinical criteria and the
demographic information must be collected and provided.
    (5) The clinical validation results must demonstrate clinical
sensitivity and clinical specificity for the test values based on the
presence or absence of NMO and NMOSD.
    (6) The data must be summarized in tabular format comparing the
interpretation of results to the disease status.
    (L) Expected/reference values generated by testing an adequate
number of samples from apparently healthy normal individuals.
    (iii) Identification of risk mitigation elements used by the
device, including description of all additional procedures, methods,
and practices incorporated into the directions for use that mitigate
risks associated with testing.
    (2) The device's 21 CFR 809.10(b) compliant labeling must include
warnings relevant to the device including:
    (i) A warning statement that reads ``The device is for use by
laboratory professionals in a clinical laboratory setting''; and
    (ii) A warning statement that reads ``The device is not to be used
as a stand-alone device but as an adjunct to other clinical
information. A diagnosis of Neuromyelitis Optica (NMO) and
Neuromyelitis Optica Spectrum Disorders (NMOSD) should not be made on a
single test result. The clinical symptoms, results from physical
examination, laboratory tests (e.g., serological tests), and
radiological tests (e.g. Magnetic Resonance Imaging), when appropriate,
should always be taken into account when considering the diagnosis of
NMO and NMOSD.''
    (3) The device's 21 CFR 809.10(b) compliant labeling must include a
detailed description of the protocol and performance studies performed
in accordance with paragraph (b)(1)(ii) of this section and a summary
of the results.

    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23489 Filed 10-27-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Pages 31670-31671]
[FR Doc No: 2016-11759]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77829; File No. SR-NYSE-2016-24]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Designation of a Longer Period for Commission Action on a
Proposed Rule Change, as Modified by Amendment No. 2, Relating to Pre-
Opening Indications and Opening Procedures

May 13, 2016.
    On March 17, 2016, New York Stock Exchange LLC (``Exchange'' or
``NYSE'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend its rules relating to pre-opening
indications and opening procedures. On March 30, 2016, the Exchange
filed Amendment No. 1 to the proposed rule change. On March 31, 2016,
the Exchange filed Amendment No. 2 to the proposed rule change. The
proposed rule change, as modified by Amendment No. 2, was published for
comment in the Federal Register on April 6, 2016.\3\ The Commission
received no comments on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 77491 (Mar. 31,
2016), 81 FR 20030.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is May 21, 2016. The Commission is extending this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change.
Accordingly, the Commission, pursuant to section 19(b)(2) of the
Act,\5\ designates July 5,

2016, as the date by which the Commission should either approve or
disapprove or institute proceedings to determine whether to disapprove
the proposed rule change (File Number SR-NYSE-2016-24).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2016-11759 Filed 5-18-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4477-4478]
[FR Doc No: 2018-01843]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC11-119-002.
    Applicants: Gabelli, Mario J.
    Description: Request for Reauthorization and Extension of Blanket
Authorizations Under Section 203 of the Federal Power Act and Request
for Expedited Consideration of Mario J. Gabelli, et al.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5100.
    Comments Due: 5 p.m. ET 2/15/18.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-3376-004; ER11-3377-004; ER11-3378-004.
    Applicants: North Hurlburt Wind, LLC, Horseshoe Bend Wind, LLC,
South Hurlburt Wind, LLC.
    Description: Notice of Non-Material Change in Status of North
Hurlburt Wind, LLC, et. al.
    Filed Date: 1/24/18.
    Accession Number: 20180124-5164.
    Comments Due: 5 p.m. ET 2/14/18.

    Docket Numbers: ER14-2102-002.
    Applicants: Danskammer Energy, LLC.
    Description: Notice of Non-Material Change in Status of Danskammer
Energy, LLC.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5088.
    Comments Due: 5 p.m. ET 2/15/18.

    Docket Numbers: ER15-2680-007.
    Applicants: Sandstone Solar LLC.
    Description: Compliance filing: Sandstone Solar LLC Notice of
Change in Status to be effective 1/26/2018.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5116.
    Comments Due: 5 p.m. ET 2/15/18.

    Docket Numbers: ER16-474-006.
    Applicants: Central Antelope Dry Ranch C LLC.
    Description: Compliance filing: Central Antelope Dry Ranch C LLC
Change in Status to be effective 1/26/2018.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5103.
    Comments Due: 5 p.m. ET 2/15/18.

    Docket Numbers: ER16-890-006.
    Applicants: Summer Solar LLC.
    Description: Compliance filing: Summer Solar Notice of Change in
Status to be effective 1/26/2018.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5102.
    Comments Due: 5 p.m. ET 2/15/18.

    Docket Numbers: ER16-1255-005.
    Applicants: Antelope Big Sky Ranch LLC.
    Description: Compliance filing: Antelope Big Sky Ranch Change of
Status to be effective 1/26/2018.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5114.
    Comments Due: 5 p.m. ET 2/15/18.

    Docket Numbers: ER16-1901-005.
    Applicants: Elevation Solar C LLC.
    Description: Compliance filing: Elevation Solar C LLC Notice of
Change in Status to be effective 1/26/2018.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5099.
    Comments Due: 5 p.m. ET 2/15/18.

    Docket Numbers: ER16-1973-005.
    Applicants: Western Antelope Blue Sky Ranch B LLC.
    Description: Compliance filing: Western Antelope Blue Sky Ranch B
Change in Status to be effective 1/26/2018.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5115.
    Comments Due: 5 p.m. ET 2/15/18.

    Docket Numbers: ER16-2578-005.
    Applicants: North Lancaster Ranch LLC.
    Description: Compliance filing: North Lancaster Ranch Change in
Status to be effective 1/26/2018.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5110.
    Comments Due: 5 p.m. ET 2/15/18.

    Docket Numbers: ER18-713-000.
    Applicants: CA Flats Solar 150, LLC.
    Description: Baseline eTariff Filing: CA Flats Solar 150, LLC MBR
Tariff to be effective 3/26/2018.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5026.
    Comments Due: 5 p.m. ET 2/15/18.

    Docket Numbers: ER18-714-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Luz Solar Partners LTD., V
LGIA Kramer Junction 5 Project SA No. 207, TOT694 to be effective 2/2/
2018.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5046.
    Comments Due: 5 p.m. ET 2/15/18.

    Docket Numbers: ER18-715-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA SA No. 4905;
Queue No. AC2-196 to be effective 1/18/2018.
    Filed Date: 1/25/18.
    Accession Number: 20180125-5047.
    Comments Due: 5 p.m. ET 2/15/18.

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

    Dated: January 25, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-01843 Filed 1-30-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: December 4, 2006 (Volume 71, Number 232)]
[Proposed Rules]
[Page 70338]
[DOCID:fr04de06-24]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2006-0883; FRL-8251-1]

Approval and Promulgation of Implementation Plans; State of
Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA proposes to approve the State Implementation Plan (SIP)
revision submitted by the state of Missouri for the inclusion of
revisions to the Construction Permit Exemptions rule. The Construction
Permit Exemptions rule lists specific construction or modification
projects that are not required to obtain permits to construct under the
Construction Permits Required rule. Revisions to this rule include
updating the insignificance levels used for construction permit
exemptions, adding a new exemption for manufacturing operations, which
produce insignificant emissions, clarifying the grain handling
facilities exemption, and restructuring of the record keeping portion
of the rule. Missouri developed the revisions to this rule under two
separate state rulemaking processes.

DATES: Comments on this proposed action must be received in writing by
January 3, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2006-0883 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail: Amy Algoe-Eakin, Environmental Protection Agency, Air
Planning and Development Branch, 901 North 5th Street, Kansas City,
Kansas 66101.
    4. Hand Delivery or Courier: Deliver your comments to: Amy Algoe-
Eakin, Environmental Protection Agency, Air Planning and Development
Branch, 901 North 5th Street, Kansas City, Kansas 66101. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8 to 4:30, excluding legal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Amy Algoe-Eakin at<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of the Federal
Register, EPA is approving the state's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action. A detailed rationale for the approval is set
forth in the direct final rule. If no relevant adverse comments are
received in response to this action, no further activity is
contemplated in relation to this action. If EPA receives relevant
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed action. EPA will not institute a second comment
period on this action. Any parties interested in commenting on this
action should do so at this time. Please note that if EPA receives
adverse comment on part of this rule and if that part can be severed
from the remainder of the rule, EPA may adopt as final those parts of
the rule that are not the subject of an adverse comment. For additional
information, see the direct final rule which is located in the rules
section of this Federal Register.

    Dated: November 17, 2006.
John B. Askew,
Regional Administrator, Region 7.
[FR Doc. E6-20434 Filed 12-1-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 110 (Friday, June 9, 2017)]
[Proposed Rules]
[Pages 26760-26762]
[FR Doc No: 2017-11951]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-0385]
RIN 1625-AA00

Safety Zone; Canal Fest Water Ski Show; Erie Canal System, Fish
Creek, Sylvan Beach, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary safety zone
for certain waters of the Erie Canal System, Fish Creek, Sylvan Beach,
NY. This action is necessary to provide for the safety of life on these
navigable waters during the Canal Fest Water Ski Show on August 13,
2017. This proposed rulemaking would prohibit persons and vessels from
passing through the safety zone during the water ski show unless
authorized by the Captain of the Port Buffalo or a designated
representative. We invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before July 10, 2017.

ADDRESSES: You may submit comments identified by docket number USCG-
2017-0385 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LT Michael Collet, Chief of
Waterways Management, U.S. Coast Guard Sector Buffalo; telephone 716-
843-9322, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On April 09, 2017, the Sylvan Verona Beach Resort Association
notified the Coast Guard that it will be conducting a water ski show
from 12:30 p.m. to 2:30 p.m. on August 13, 2017. The water ski show to
take place in the waters of Fish Creek on the Erie Canal System
contained within the following positions: Starting at position
43[deg]11'37.79'' N. and 075[deg]43'53.27'' W., running Northeast to
position 43[deg]11'43.15'' N. and 075[deg]43'44.88'' W., then Southeast
to 43[deg]11'42.82'' N. and 075[deg]43'43.42'' W. then Southwest to
43[deg]11'36.90'' N. and 075[deg]43'52.06'' W. then returning to the
point of origin. The Captain of the Port Buffalo (COTP) has determined
that a water ski show on a navigable waterway will pose a significant
risk to participants and the boating public.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within the demonstration area of the scheduled
event. Vessel traffic will be allowed to pass through the safety zone
between demonstrations. The Coast Guard proposes this rulemaking under
authority in 33 U.S.C. 1231.

III. Discussion of Proposed Rule

    The COTP proposes to establish a safety zone from 12:15 p.m. to
2:30 p.m.

on August 13, 2017 that would be effective and enforced intermittently.
The safety zone will encompass all waters of Fish Creek; Sylvan Beach,
NY contained within the following positions: Starting at position
43[deg]11'37.79'' N. and 075[deg]43'53.27'' W., running Northeast to
position 43[deg]11'43.15'' N. and 075[deg]43'44.88'' W., then Southeast
to 43[deg]11'42.82'' N. and 075[deg]43'43.42'' W. then Southwest to
43[deg]11'36.90'' N. and 075[deg]43'52.06'' W. then returning to the
point of origin. The duration of the zone is intended to ensure the
safety of vessels and these navigable waters before, during, and after
the scheduled 12:30 p.m. to 2:30 p.m. water skiing event. Vessels will
be permitted to pass through the safety zone intermittently during the
event as allowed by the COTP or the on-scene representative. No vessel
or person would be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative. The regulatory
text we are proposing appears at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility.
    Executive Order 13771 (``Reducing Regulation and Controlling
Regulatory Costs''), directs agencies to reduce regulation and control
regulatory costs and provides that ``for every one new regulation
issued, at least two prior regulations be identified for elimination,
and that the cost of planned regulations be prudently managed and
controlled through a budgeting process.''
    This NPRM has not been designated a ``significant regulatory
action,'' under Executive Order 12866. Accordingly, the NPRM has not
been reviewed by the Office of Management and Budget.
    As this proposed rule is not a significant regulatory action, this
rule is exempt from the requirements of Executive Order 13771. See
OMB's Memorandum titled ``Interim Guidance Implementing Section 2 of
the Executive Order of January 30, 2017 titled `Reducing Regulation and
Controlling Regulatory Costs' '' (February 2, 2017).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
would be able to safely transit through this safety zone in between
water skiing acts which would impact a small designated area of Fish
Creek for 2.5 hours. Moreover, the Coast Guard would issue a Broadcast
Notice to Mariners via VHF-FM marine channel 16 about the zone, and the
rule would allow vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule

involves the establishment of a safety zone for 2.5 hours during
intermittent periods. Normally such actions are categorically excluded
from further review under section 2.B.2, and Figure 2-1, paragraph
34(g) of the Instruction. Paragraph 34(g) pertains to the establishing,
disestablishing, or changing Regulated Navigation Areas and security or
safety zones. A preliminary Record of Environmental Consideration (REC)
supporting this determination is available in the docket where
indicated under the ADDRESSES section of this preamble. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T09-0385 to read as follows:

Sec.  165.T09-0385   Safety Zone; Canal Fest Water Ski Show, Erie Canal
System, Fish Creek, Sylvan Beach, NY.

    (a) Location. This zone will encompass all waters of Fish Creek;
Sylvan Beach, NY contained within the following positions: Starting at
position 43[deg]11'37.79'' N. and 075[deg]43'53.27'' W., running
Northeast to position 43[deg]11'43.15'' N. and 075[deg]43'44.88'' W.,
then Southeast to 43[deg]11'42.82'' N. and 075[deg]43'43.42'' W., then
Southwest to 43[deg]11'36.90'' N. and 075[deg]43'52.06'' W., then
returning to the point of origin.
    (b) Enforcement Period. This regulation will be enforced
intermittently on August 13, 2017 from 12:15 p.m. until 2:45 p.m.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Buffalo or his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Buffalo is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Buffalo to act on his
behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone must contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
Buffalo or his on-scene representative may be contacted via VHF Channel
16. Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port Buffalo, or his on-scene representative.

    Dated: June 5, 2017.
J.S. Dufresne,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2017-11951 Filed 6-8-17; 8:45 am]
BILLING CODE 9110-04-P