[Federal Register Volume 78, Number 110 (Friday, June 7, 2013)]
[Notices]
[Pages 34393-34395]
[FR Doc No: 2013-13532]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0602]

Electronic Submission of Tobacco Product Applications and Other
Information; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA), Center for Tobacco Products
(CTP), is announcing a 1-day workshop to obtain public input on topics
related to the potential electronic submission of tobacco product
applications and other information. This workshop will focus on the
technical aspects of electronic submissions, including potential
standards for content, format, and structure. The input from the public
workshop may assist the Agency in the potential development and
implementation of an electronic submission standard for CTP. FDA is
also opening a public docket to receive comments on this topic.
    Date and Time: The public workshop will be held on July 18, 2013,
from 9

a.m. to 3 p.m. Individuals who wish to attend, participate in, or view
the free Webcast of the public workshop must register by 5 p.m. EDT on
June 21, 2013. Submit either electronic or written comments to the
docket by August 19, 2013.
    Location: The public workshop will be held at 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-287-1373.
    Contact Person: Karen M. Templeton-Somers, Office of Science,
Center for Tobacco Products, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD, 20850, 1-877-287-1373, FAX: 240-276-
3655, email<EMAIL_ADDRESS>    Registration to Attend the Workshop: If you wish to attend the
workshop, make an oral presentation at the workshop, or view the free
Webcast, you must register by submitting an electronic or written
request by 5 p.m. EDT on June 21, 2013. Submit electronic requests to
http://www.surveymonkey.com/s/HWY9KNC. A confirmation email will be
sent to your registered email address at least 2 weeks prior to the
workshop date. Those without email access may register by contacting
Karen M. Templeton-Somers (see Contact Person). Registration is free,
but early registration is recommended because seating is limited. FDA
may limit the number of participants from each organization as well as
the total number of participants based on space limitations. Onsite
registration on the day of the workshop will be based on space
availability. CTP plans to provide a free-of-charge, live Webcast of
the workshop. Please note that the Webcast link will not be live until
the meeting begins at approximately 9 a.m. EDT on July 18, 2013. If
registration reaches maximum capacity, FDA will post a notice closing
registration for the workshop at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm.
    Requests for Oral Presentations: If you wish to make an oral
presentation, please state your intention on your registration
submission and submit your name, title, company or organization (if
applicable), address, telephone number, and email address. FDA has
included specific topics for discussion in section II of this document.
You should identify by number each discussion topic(s) you wish to
address in your presentation, and the approximate desired length of
your presentation. FDA is interested in obtaining input from a range of
stakeholders and interested parties, including, but not limited to,
large and small pharmaceutical manufacturers experienced with
electronic Common Technical Document (eCTD); vendors of software used
to support electronic submissions; and large and small tobacco product
manufacturers. Individuals and organizations with common interests are
urged to coordinate their presentations or request time for a joint
presentation. All requests to make oral presentations must be received
by the close of registration at 5 p.m. EDT on June 21, 2013. Following
the close of registration, FDA will determine the amount of time
allotted to each presenter and the approximate time each oral
presentation is to begin, and will select and notify participants by
June 28, 2013. Presenters must submit any presentation materials to
Karen M. Templeton-Somers (see Contact Person) via email no later than
July 10, 2013. FDA will do its best to accommodate questions during the
workshop, although questions from the audience may be limited. In
addition, we strongly encourage submitting comments to the docket (see
Comments).
    If you need special accommodations because of disability, please
contact Karen M. Templeton-Somers (see Contact Person) at least 7 days
before the workshop.
    Comments: Regardless of attendance at the public workshop,
interested persons may submit comments on any of the topics for
discussion in section II of this document by August 19, 2013. Submit
electronic comments to http://www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is
only necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

SUPPLEMENTARY INFORMATION:

I. Background and Workshop Topics

    The purpose of this workshop is to obtain public input from
regulated industry and other stakeholders and interested parties on the
potential development and implementation of a standardized structure
for electronic submission of tobacco product applications and other
information. Stakeholders and interested parties could include, but are
not limited to, large and small pharmaceutical manufacturers with
experience in electronic submissions; vendors of software used to
support electronic submissions; and large and small tobacco product
manufacturers. The workshop will focus on technical aspects related to
electronic submissions and standards currently used in other FDA
centers. The types of submissions potentially subject to any future
electronic submission standard may include, but are not limited to,
applications for premarket review of new tobacco products (section
910(b)(1) of the Federal Food, Drug, and Cosmetic Act) (the FD&C Act)
(21 U.S.C. 387j(b)(1)), modified risk tobacco product applications
(section 911(d) of the FD&C Act (21 U.S.C. 387k(d)), and reports
submitted under section 905(j) of the FD&C Act (21 U.S.C. 387e(j)). In
particular, FDA would like to discuss how available standardized
submission structure and technologies facilitate preparation,
submission, retrieval, processing, review, and archiving of
submissions. For more information on study data standards resources,
please see http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm.
    The electronic submission workshop will include discussion on eCTD,
which is an International Conference on Harmonization (ICH)
specification developed by ICH and its member parties. The eCTD
provides an organizational structure for regulatory submissions
utilizing comprehensive table of contents headings and hierarchy. Other
FDA centers have been receiving submissions in the eCTD format since
2003. For more information on eCTD, please see http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm.
    CTP is interested in receiving input at the workshop and in the
docket on the potential standardization of electronic tobacco product
submissions. The input from the workshop may assist the Agency in
developing and implementing a harmonized electronic submission standard
at CTP.

II. Workshop Topics for Discussion

    FDA is seeking public input on the following topics:
     How have other regulated industries standardized the
structure of submissions to FDA and how has that facilitated the
submission and review process? What aspects may be applicable to
tobacco product submissions?
     What technologies do tobacco companies currently use to
prepare their submissions? Is a document management system used? Are
specific technologies used? Is electronic data capture used in clinical
trials or other

studies? What systems and standards currently are used to manage data
and documents?
     How are data collected and managed for submission to CTP?
Is a laboratory information management system used?
     Are there any technical limitations CTP should consider in
developing and implementing any harmonized electronic submission
standard?
     Would a pilot program designed to test a modified eCTD be
useful?

    Dated: June 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13532 Filed 6-6-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: September 17, 2010 (Volume 75, Number 180)]
[Notices]
[Page 57013]
[DOCID:fr17se10-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EG10-40-000, EG10-41-000, et al.]

Notice of Effectiveness of Exempt Wholesale Generator Status;
Taloga Wind, LLC, Stephentown Regulation Services LLC, et al.

September 9, 2010.

------------------------------------------------------------------------
                                                            Docket No.
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Taloga Wind, LLC.......................................      EG10-40-000
Stephentown Regulation Services LLC....................      EG10-41-000
Longview Power, LLC....................................      EG10-42-000
Alta Wind I, LLC.......................................      EG10-43-000
Alta Wind II, LLC......................................      EG10-44-000
Alta Wind III, LLC.....................................      EG10-45-000
Alta Wind IV, LLC......................................      EG10-46-000
Alta Wind V, LLC.......................................      EG10-47-000
Synergics Roth Rock Wind Energy, LLC...................      EG10-49-000
Synergics Roth Rock North Wind Energy, LLC.............      EG10-50-000
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    Take notice that during the month of August 2010, the status of the
above-captioned entities as Exempt Wholesale Generators became
effective by operation of the Commission's regulations, 18 CFR
366.7(a).

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-23213 Filed 9-16-10; 8:45 am]
BILLING CODE 6717-01-P


              Statement Supporting the Renewal of the Information
             Collection Procedure for Local Planning Requirements
                  and Facility Emergency Release Notification

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

      1(a)	Title of the Information Collection

      Emergency Planning and Release Notification Requirements under Emergency Planning and Community Right-to-Know Act Sections 302, 303, and 304 (Renewal)
      EPA No. 1395.08, OMB No. 2050-0092

      1(b)	Short Characterization

      This information collection request (ICR) was previously approved as OMB No. 2050-0092 through July 31, 2012.  The Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) establishes authorities for emergency planning and preparedness, emergency release notification reporting, community right-to-know reporting, and toxic chemical release reporting.

      Under the emergency planning provisions of EPCRA, codified in 40 CFR part 355 requires any facility where an extremely hazardous substance (EHS) is present in an amount at or in excess of the threshold planning quantity (TPQ) to notify the state emergency response commission (SERC) and local emergency planning committee (LEPC) by May 17, 1987.  This activity has been completed; the section 302 costs and burden hours for this ICR, therefore, reflect only the estimate of the cost and burden incurred by new facilities that have an EHS in excess of the TPQ during the period covered by this ICR.

      EPCRA section 303 requires LEPCs to prepare emergency plans for facilities that have EHSs in excess of the TPQs in their local planning district.  Facilities are required to provide local planners with information necessary for the preparation of emergency plans.  In addition, the facilities are required to inform LEPCs of any relevant changes in chemical use or production that may affect the emergency plans.  Section 303 requires LEPCs to complete their emergency plans by October 17, 1988.  This ICR therefore reflects the costs attributable to the requirement of annually updating the local emergency response plans required under section 303(a).

      Emergency release notification provisions under EPCRA section 304, codified in 40 CFR part 355 requires facilities to report to SERCs and LEPCs releases in excess of quantities established by EPA.  Facilities are required to report releases above the reportable quantity (RQ) of any EHS or hazardous substance defined under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) section 101.  Notice of release must be given to both the LEPC and SERC.  In addition, facilities must provide a written follow-up report providing additional information on the release, its impacts, and any actions taken in response.

      EPA estimates that 95,000 facilities (23,750 manufacturers and 71,250 non-manufacturers) are subject to reporting under EPCRA section 302 and 3,456 SERCs and LEPCs are subject to section 303.  EPA estimates that approximately 12,000 release notifications are made annually under section 304 to SERC and LEPC.  The total burden to facilities over the three year information collection period is estimated to be 481,050 hours (160,350 hours annually), at a cost of $27.3 million $(9.1 million annually), with an associated state and local burden of 320,568 hours (106,856 hours annually), at a cost of $13.2 million (4.4 million annually).

2.	NEED FOR AND USE OF THE COLLECTION

      2(a)	Need/Authority for the Collection

      The authority for these requirements is EPCRA sections 302, 303, and 304 (42 U.S.C. '11002, 11003, and 11004).

      Section 302 of EPCRA required the EHS list to be "the same list as the list published in November 1985 by the Administrator in Appendix A of the `Chemical Emergency Preparedness Program Interim Guidance'."  The section further required EPA to "publish an interim final regulation establishing a threshold planning quantity for each substance on the list..."  If EPA failed to publish the interim final rule, "the threshold planning quantity for the substance shall be 2 pounds until such time as the Administrator publishes regulations establishing a threshold for the substance."

      The interim final rule was published in the Federal Register on November 17, 1986 (51 FR 41570), followed by a final rule published on April 22, 1987 (52 FR 13378).  The EHS list consisted at that time of 406 chemicals, and the TPQs ranged from one pound to ten thousand pounds.  There are currently 355 chemicals on the EHS list.

      The EHS list along with the TPQs is used to designate facilities for initial screening for the local emergency planning process.  Section 303 of EPCRA requires facilities that have to provide the notification under section 302 to designate a facility coordinator to the LEPC and to "promptly provide information to [the LEPC] necessary for developing and implementing the emergency plan."  In this manner, the LEPC determines the potential scope of a response and, therefore, the amount of effort necessary for emergency planning.  The LEPC will review its plan annually and incorporate any changes or additions.  These emergency plans increase the local response and preparedness capability by allowing local planners to work with industry in their community, to determine the level of preparedness necessary for a response if a release should occur.

      Under section 304, respondents are required to notify the LEPC and SERC of releases of EHSs or hazardous substances (as identified under CERCLA) above the reportable quantity.  The purpose of the reporting is to allow response agencies to determine whether their assistance is needed in handling the response action.  The facility must provide a written follow-up report.

      2(b)	Practical Utility/Users of the Data

      The information provided by facilities under sections 302, 303, and 304 is provided to the SERCs and LEPCs.  Individuals can obtain the information by contacting the SERCs and LEPCs.  The information provided under sections 302 and 303 is used to increase the community's level of preparedness to respond to releases of chemicals in their community.  The information is also made available to the public to allow individuals to practice their "right-to-know" about the hazards posed by chemicals in their community.

      The information provided under section 304 is the trigger to activate the community's chemical emergency response system.  The written follow-up report is to update and clarify the information provided in the initial call.  It is also made available to the public so that the community can understand what happened during the release.

3.	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

      3(a)	Non-Duplication

      Currently, there are no federal reporting requirements comparable to sections 302, 303, and 304 of EPCRA.  Release reporting under CERCLA section 103 is an emergency notification to the National Response Center (NRC), while release reporting under section 304 is directly to local and state entities.  The follow-up report required under section 304 is also unique.

      3(b)	Consultations

	EPA contacted the following industry representatives to develop an estimate for the burden for section 304 reporting.  The representatives were asked to estimate the time it took make their notifications to the NRC, SERC, and LEPC.  In addition, if their release(s) required an EPCRCA section 304 follow-up report, an estimate of the effort required to produce that report.

Eastman Kodak Co.
Rochester, NY  14652
Stephen Zapf
(585) 722-2663

Honeywell International, Inc.
Hopewell, VA  23860
Kenneth Tomko
(804) 541-5735

Dow Chemical
Midland, MI 48674
Chris Arnold
(989) 636-4400

Citgo Refinery
Lemont, IL  60439
Leo Cleveland
(630) 257-4381

Koch Nitrogen
Enid, OK  73701
Michael Hammons
(580) 478-3473

Missouri American Water Company
Chesterfield, MO  63017
Tim Ganz,
(314) 606-2333

Chevron Products Company
Richmond, CA  94801
Juan Li
(510) 242-2112

Weyerhaeuser Co.
Longview, WA  98632
Brian Wood
(360) 636-7080

      3(c)	Public Notice

      In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.	), the Agency notified the public through a Federal Register notice on the re-submission of this ICR on 	February 16, 2012 (77 FR 9235).   EPA did not receive any comments.

      3(d)	Effects of Less Frequent Collection

      The reporting deadlines for sections 302, 303, and 304 are set by statute.  EPA has no authority to allow less frequent collection.

      3(e)	General Guidelines

      The collection activities specified in this renewal ICR adhere to the guidelines specified by OMB.

      3(f)	Confidentiality

      The respondent may claim specific chemical identities as trade secret in the notification to LEPC on information for developing and implementing the emergency response plan, under Section 303(d)(2) and (d)(3).  Such information must be submitted according to EPCRA sections 322 and 323 (40 CFR Part 350).
All trade secrecy claims submitted to EPA under EPCRA are handled and stored according to procedures set out in the Manual for Physical Handling, Security, And Protection of Files Containing Trade Secret Claims Submitted under Sections 303, 311 and  312  of the Emergency Planning and Community Right-to-Know Act (EPCRA, March 2010).  These procedures were developed expressly for EPCRA trade secrecy claims with the knowledge that these documents are sensitive.  Handling and review of documents containing EPCRA trade secret information is permitted only by persons who have obtained formal clearance to access the information based on a work-related need to engage in these activities.  When not being processed or reviewed by authorized individuals, the claim submissions containing trade secret information are stored in restricted access areas.  To ensure that appropriate handling procedures are activated and the confidentiality of EPCRA trade secret submissions is maintained, the Agency attaches a cover sheet to the top of each trade secret document and otherwise marks the document to clearly identify the document as EPCRA confidential.

      3(g)	Sensitive Questions

      The information gathering activities under this renewal ICR do not involve any sensitive questions.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

      4(a)	Respondents/NAICS Codes

      Sections 302, 303, and 304 are applicable to all facilities that either have present or release the regulated substances.  These sections apply to facilities in both the manufacturing and non-manufacturing sectors.  EPCRA, as written, does not apply to federal facilities.  However, Executive Order 12856 requires all federal agencies to comply with the law.

      Facilities in the following major group of NAICS codes may be subject to either or both implementing regulations under EPCRA section 302 and 304.  There may be other facilities covered by these regulations, but not listed.  Major groups that may be subject are:  11 (Agriculture, Forestry, Fishing and Hunting), 22 (Utilities), 31-33 (Manufacturing),  43 (Wholesale Trade), 44- 45 (Retail Trade), 48-49 (Transportation and Warehousing).

      4(b)	Information Requested

      4(b)(i)	Data Items

      Facilities newly subject to section 302 must notify their SERC and LEPC of their reporting obligation.  Under section 303, the facility must designate a coordinator and provide "information to (the LEPC) necessary for developing and implementing the (LEPC's) emergency plan."  The amount of information necessary to fulfill this requirement is determined by the facility and the LEPC.  If a facility has very low likelihood of having a release that would impact the community, the LEPC would probably require very little information for emergency planning.  However, if the facility is a large chemical plant or is in close proximity to a populated area, the LEPC most likely will develop extensive planning (especially if the facility is anticipating an offsite response).  Information requested for the plan would likely include:

   * Names, hazards, quantities, and storage information for hazardous chemicals on-site;

   * Methods and procedures to be followed by facility owners and operators to respond to a release;

   * Description of emergency equipment;

   * Methods for determining the occurrence of a release, and the area or population likely to be affected by the release; and

   * Procedures to provide reliable, effective, and timely notification.

      LEPCs were required to have their plans completed by October 17, 1988.  Therefore, only facilities newly subject to these requirements would have to provide this information.  Facilities already subject would only have to update the LEPC if the information that they have already provided changes.

      Under section 304, respondents are required to notify the LEPC and SERC of releases of EHSs or hazardous substances (as identified in CERCLA section 101) above the reportable quantity.  The notice must include the following information, to the extent that it is known:

   * The chemical name or identity of any substance involved in the release;

   * An indication of whether the substance is on the list of EHSs;

   * An estimate of the quantity of any such substance that was released into the environment;

   * The time and duration of the release;

   * The medium or media into which the release occurred;

   * Any known or anticipated acute or chronic health risks associated with the emergency and, where appropriate, advice regarding medical attention necessary for exposed individuals;

   * Proper precautions to take as a result of the release, including evacuation (unless such information is readily available to the community emergency coordinator pursuant to the emergency plan); and

   * The name and telephone number of the person or persons to be contacted for further information.

The facility must provide a written follow-up report that includes the information above and any updates.  Also, additional information must be given:

   * Actions taken to respond to and contain the release;

   * Any known or anticipated acute or chronic health risks associated with the release; and

   * Where appropriate, advice regarding medical attention necessary for exposed individuals.

      4(b)(ii)	Respondent Activities

      To determine if a facility is subject to section 302, the facility would need to review the EHS list to determine if it has any of the 355 chemicals on-site.  The facility would then need to look at the inventory of any EHSs it may have on-site and compare it to the TPQ.  If the facility has an EHS above the TPQ, the facility would need to contact (preferably in writing) their SERC and LEPC to notify them of their reporting obligation.

      To comply with section 303, the designated facility coordinator would have to work with the LEPC to ensure that the community has an adequate plan to respond to emergencies that would involve their facility.  Facility coordinators may be asked to serve as an industry representative to the LEPC.

      To comply with section 304, the facility would need to determine, when an EHS or a CERCLA hazardous substance is being released, if the quantity of the chemical released is greater than the reportable quantity; this information needs to be provided in the initial telephone notification to the SERC and LEPC. The material safety data sheet (MSDS) or other information that the facility has would provide the health risks and medical information, as well as response information.

      The written follow-up notice needs to be filed "as soon as practical after a release." This notice documents and updates the information provided in the initial notification.  Because the initial notification should be provided immediately after the discovery of the release, the written follow-up notice allows the facility more time to determine with greater precision the information provided in the initial notification.  The facility may include a copy of its own internal report of the circumstances of the accident.

5.	THE INFORMATION COLLECTED:  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

      5(a)	Agency Activities

      No information provided under sections 302, 303, and 304 is sent to EPA.  All of the information is kept at the state or local level.

      5(b)	Collection Methodology and Management

      EPA does not receive the data; therefore, EPA does not have any special data collection methodology and management.  However, to assist SERCs and LEPCs in their information management practices and emergency planning, EPA and the National Oceanic and Atmospheric Administration have created the Computer Aided Management of Emergency Operations (CAMEO) database.

      5(c)	Small Entity Flexibility

      There are no special allowances made for small businesses in the regulations for sections 302, 303, and 304.  The burden hours for small businesses are considered to be smaller than those for large facilities because of the reduced number of chemicals and processes present at smaller facilities.

      5(d)	Collection Schedule

      The frequency of collection for these sections of EPCRA is required by statute.  Facilities are required to report any relevant changes when they occur.  Under section 304, releases of EHSs and CERCLA hazardous substances in excess of the reportable quantity must be reported "immediately" after the owner/operator has knowledge that they occurred.  The written follow-up notice is required "as soon as practicable after the release."

6.	ESTIMATING THE BURDEN AND COST OF COLLECTION

      6(a)	Estimating Respondent Burden

      EPA estimated the respondent burden hours and costs associated with all recordkeeping and reporting requirements covered in EPCRA sections 302, 303, and 304.  Unit burden and costs were estimated by labor category required for each of the tasks performed by facilities under 40 CFR Part 355, and tasks performed by LEPCs under EPCRA section 303.

      EPA estimates that approximately, 95,000 facilities are subject to sections 302 and 303.  EPA estimates that approximately 25 percent of these facilities are manufacturers (23,750) and 71,250 facilities are non-manufacturers.  We do not expect any new facilities to be in compliance during this ICR period based on the data obtained from few SERCs we contacted.  Number of facilities subject to section 302 fluctuates from year-to-year.  We assume that this is due to facilities using chemicals that are less hazardous or keeping inventory down.

      The number of notifications under section 304 was based on the number of reports of CERCLA hazardous substance and EHS releases reported to the National Response Center in 2011, approximately 12,000.

      Exhibit 1 presents the estimated unit burden by labor category required for each of the tasks performed by facilities under 40 CFR Part 355, and tasks performed by LEPCs under EPCRA section 303.
      Read and Understand Regulations

	EPA assumes that only newly regulated facilities incur the cost of reading and understanding regulations at 40 CFR Part 355.  As explained above, we do not expect any new facilities to come into compliance in the period covered by this ICR based on information we received from few SERCs.  Therefore, EPA did not estimate any burden for this activity for new facilities.  All currently regulated facilities are already familiar with the regulations and the burden for this activity was estimated in previous ICRs.

      Emergency Planning by Facilities (40 CFR 355.30)

      All newly regulated facilities must first determine whether they have at least a threshold planning quantity of an EHS.  All newly regulated facilities are required to notify the SERC and designate a facility representative.  As mentioned above, we do not expect any new facilities to be in compliance in this ICR period.  Currently covered facilities already completed this activity.

	Because few facilities have significant changes that would affect emergency planning, EPA estimates that only ten percent of all subject facilities will be required to inform LEPCs of any changes at the facility.  EPA assumes that only manufacturers may have changes occurring at the facilities which require notification to the LEPCs.

	In addition, because little information is required from facilities after the initial submittal, EPA also estimates that only five percent of all subject facilities will provide additional information to LEPCs either to develop or implement emergency plans.  The burden associated with providing local governments with updated information for planning purposes is assumed to be a small percentage of the initial burden for contributing to planning efforts.  EPA estimates that it may take 13.0 hours for currently covered facilities to inform LEPC of any changes relevant to emergency planning and to provide information to the LEPC requests to develop emergency response plans.  (See Exhibit 1).

      Emergency Release Notification by Facilities (40 CFR 355.40)

The number of annual reportable quantity (RQ) releases based on the number of CERCLA hazardous substance and EHS releases reported in the National Response Center for 2011, is approximately 12,000.  EPA estimates 90 percent of RQ releases require notifying LEPCs and SERCs, and 10 percent require notifying the 911 operator.  All reportable releases require a written follow-up report.

      For this ICR, EPA contacted few industries that reported releases to the National Response Center (see Section 3(b) of this document), to determine the actual burden incurred to comply with initial notification and written follow-up requirements in Section 304 of EPCRA.  EPA's estimates in previous ICRs were slightly lower than the burden reported by these industries.  EPA has calculated an average of the numbers reported by industries to use in this ICR.  The burden per respondent for initial notification is approximately 0.50 hours, for written follow-up, it is approximately 8.0 hours.  EPA estimates that it takes approximately 0.25 hours to report a transportation-related release to the 911 operator.

      Emergency Response Plan Development by SERCs and LEPCs (40 CFR 300.215)

      Emergency Response Plans must be reviewed and updated annually.  EPA estimates that SERCs review all LEPC plans over a three-year period.  EPA contacted few LEPCs to determine the burden associated with reviewing or updating their emergency response plan.   Based on information from LEPCs, the time required to update plans varies from 18 to 40 hours.  To develop an estimate, EPA assumed that the largest 120 LEPCs would spend 40 hours a year and the smaller LEPCs would spend 20 hours a year; a weighted average of 21 hours was obtained for the recordkeeping burden to keep records of all Emergency Response Plans.

      Similarly, a weighted average was developed for recordkeeping associated with release reports. The LEPC with a large concentration of chemical plants indicated that it spent a month on release notification; the other LEPCs indicated that this activity took five hours a year at most.  A weighted average of 10 hours was developed for the annual burden for each of the LEPCs (3,400) and SERCs (56).  This burden is same as what was estimated in the previous ICR.
6(b)	Estimating Respondent Costs

Estimating costs to respondents on an annual basis is accomplished by multiplying the respondent burden estimates for each labor category by the corresponding labor rate for that category.  Unit costs for each respondent or activity are then multiplied by the number of respondents or activities performed on an annual basis to yield a total cost for each information collection activity in Section 6(d).  These costs are shown in Exhibit 1.

      EPA estimates an hourly respondent labor cost for manufacturing facility respondents of $62.94 for managerial staff, $59.64 for technical staff, and $25.52 for clerical staff, including wages and benefits. Hourly respondent labor costs for non-manufacturing facility respondents are estimated at $57.10 for managerial staff, $45.34 for technical staff, and $22.92 for clerical staff.

      EPA estimates an hourly respondent labor cost (including overhead) for LEPCs and SERCs of $49.59 for managerial staff, $48.67 for technical staff, and $28.46 for clerical staff.  EPA consulted Bureau of Labor and Statistics, December 2011 for wage and labor rates.

      Total burden hours and costs for the ICR are shown in Exhibit 2.

      Capital and O&M Costs

	Capital costs incurred by state and local agencies were estimated in the previous ICR.  Capital costs include the cost of space required to store information in filing cabinets.  Life expectancy for file cabinets is assumed to be 15 years.  Therefore, the Agency did not develop any cost for this since it was developed in the previous ICR.

	Operating and maintenance costs are limited to mailing costs.  Facilities are assumed to incur postage costs for the following activities:

   * Providing information to the LEPC as required under EPCRA section 303(d)(3).

   * Submitting written follow-up notice (assume about 4 pages per report)

	Facilities are expected to incur long distance charges when notifying SERCs.  This estimate affects notification of the SERC of any RQ release.  Long distance charges are estimated to be $3.50 per fifteen-minute call.

	LEPCs are assumed to incur postage costs for the following activities:

   * Submitting Emergency Response Plans to the SERCs for review.

   * Submitting Emergency Response Plans as requested by SERCs to federal regional response teams for review

	Postage is estimated to cost $0.45 for a first class letter and $5.15 to submit a LEPC plan (plan is up to 500 pages and weighs up to 5 pounds).

	Operation and maintenance costs are shown in Exhibit 3.

      6(c)	Estimating Agency Burden and Cost

      EPA estimates no annual Agency burden associated with this ICR.  Only state and local government entities implement the program in sections 302, 303, and 304 of EPCRA.

      6(d)	Estimating Total Annual Respondent Burden and Costs

      Exhibit 2 presents the respondent burden for each information collection activity and for the sum of all information collection activities performed by each respondent type.  The total average annual burden to facility respondents is 160,350 hours at a cost of $9.1 million (or 481,050 hours at a cost of $27.3 million for three years).  The total average annual respondent burden for state and local governments is 106,856 hours at a cost of $4.4 million (or 320,568 hours at a cost of $13.2 million for three years).  These burden estimates are summarized in Exhibit 2.

      6(e)	Bottom Line Burden Hours and Cost

	See Exhibit 4, below.

      6(f)	Reasons for Change in Burden

      The number of respondents increased by 12,000 from the previous ICR.  This is due to an increase in the number of reports of Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) hazardous substance and Extremely Hazardous Substance (EHS) releases reported to the National Response Center in 2011. There is a decrease of 28,550 hours from the previous ICR due to adjustments for current burden estimates. There is a decrease of $8,392 O&M costs which is also due to making estimates at current levels.

       Burden incurred by LEPCs remain the same as in the previous ICR.  Labor and wage rates are adjusted to the current data available on BLS, December 2011.

      6(g)	Burden Statement

      As explained in the previous sections of this document, EPA does not expect any new facilities to come into compliance during this ICR period.  This ICR only covers periodic reporting or updates of information submitted previously by existing facilities.  The average reporting burden for a limited number of existing facilities, to inform the LEPC of any changes at the facility that may affect emergency planning is 2.0 hours.  The average reporting burden for facilities to provide information to LEPC is 11.0 hours.  The average reporting burden for facilities reporting releases under 40 CFR 355.30 is estimated to average approximately 9 hours per release, including the time for determining if the release is a reportable quantity, notifying the LEPC and SERC, or the 911 operator, and developing and submitting a written follow-up notice.  There are no record-keeping requirements for facilities under EPCRA Sections 302-304.  The total burden to facilities over three years is 481,050 hours at a cost of $27.3 million.

      The average burden for emergency planning activities is 21 hours per plan for LEPCs, and 16 hours per plan for SERCs.  Each SERC and LEPC is also estimated to incur an annual record keeping burden of 10 hours.  The total burden to LEPC and SERC over three years is 320,568 hours at a cost of $13.2 million.

      The annual public reporting and recordkeeping burden for this collection of information is estimated to average 2.4 hours per response.

      Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency.  This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; 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 ICR under Docket ID Number EPA-HQ-SFUND-2005-0008, which is available for online viewing at www.regulations.gov, or in person viewing at the Superfund Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C.  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Superfund Docket is<PHONE_NUMBER>.  An electronic version of the public docket is available at www.regulations.gov.  This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  When in the system, select "search," then key in the Docket ID Number identified above.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-SFUND-2005-0008 and OMB Control Number 2050-0092 in any correspondence.

                                   Exhibit 1
      Section 302, 303, and 304 Reporting and Recordkeeping Requirements
                        Estimated Unit Burden and Cost

                              Annual Hours Burden
                                  Total Hours

Information Collection Activity

                                  Management
                                   Technical
                                   Clerical
                                    Burden
                                  Annual Cost

EMERGENCY PLANNING (40 CFR 355.10) (Facilities)

Inform LEPC of changes to facility that may affect emergency planning

                                     0.50
                                     1.00
                                     0.50
                                     2.00
                                    $103.87

Provide information to LEPC, as required

                                     2.00
                                     8.00
                                     1.00
                                     11.00
                                    $628.52

EMERGENCY RELEASE NOTIFICATION (40 CFR 355.30) (Facilities)

Determine if a release is an RQ

                                     0.10
                                     0.10
                                     0.00
                                     0.25
                                    $12.25

Notify LEPC and SERC of any RQ release

                                     0.50
                                     0.00
                                     0.00
                                     0.50
                                    $31.47

Develop and submit written follow-up notice

                                     1.50
                                     5.00
                                     1.50
                                     8.00
                                    $430.89

Notify 911 operator of transportation-related releases

                                     0.25
                                     0.00
                                     0.00
                                     0.25
                                    $15.74

EMERGENCY RESPONSE PLANS (EPCRA section 303)

Update Emergency Response Plans (LEPCs)

                                     5.00
                                     15.00
                                     1.00
                                     21.00
                                   $1,006.46

Review Emergency Response Plans (SERCs)

                                     4.00
                                     12.00
                                     0.00
                                     16.00
                                   $782.40

Keep records and make them available to the public

                                     0.00
                                     0.00
                                     10.00
                                     10.00
                                    $284.60

                                   Exhibit 2
      Section 302, 303, and 304 Reporting and Recordkeeping Requirements
                       Estimated Annual Burden and Cost

                                   Number of
                               Annual Hours Burden
                                  Total Hours

Information Collection Activity

                                  Respondents

Management
                                   Technical
                                   Clerical
                                    Burden
                                  Annual Cost
RULE FAMILIARIZATION (Facilities)

Read and understand regulations at 40 CFR Part 355
                                       0

                                       0
                                       0

                                       0
                                       0
                                         Subtotal

                                       -

                                       -
                                       -
                                       -
                                       0
                                       0
EMERGENCY PLANNING (355.30) (Facilities)

Calculate if chemicals meet/exceed TPQ
                                       0

                                       0
                                       0
                                       0
                                       0
                                       0

Notify SERC that facility is subject to emergency planning
                                       0

                                       0
                                       0
                                       0
                                       0
                                       0

Designate facility representative and notify LEPC
                                       0

                                       0
                                       0
                                       0
                                       0
                                       0

Inform LEPC of facility changes that may affect emer. Planning
                                     9,500

                                     4,750
                                     9,500
                                     4,750
                                    19,000
                                   $986,765

Provide information to LEPC, as required
                                     4,750

                                     9,500
                                    38,000
                                     4,750
                                    52,250
                                  $2,985,470
                                        Subtotal

                                    71,250
                                  $3,972,235
EMERGENCY RELEASE NOTIFICATION (355.40) (Facilities)

Determine if release is an RQ
                                    12,000

                                     1,200
                                     1,200
                                       0
                                     2,400
                                   $147,000

Notify LEPC and SERC of any RQ release
                                    10,800

                                     5,400
                                       0
                                       0
                                     5,400
                                   $339,876

Develop and submit written follow-up notice
                                    10,800

                                    16,200
                                    54,000
                                    10,800
                                    81,000
                                  $4,653,612

Notify 911 operator of transportation-related releases
                                     1,200

                                      300
                                       0
                                       0
                                      300
                                    $4,722

                                       Subtotal

                                    89,100
                                  $5,145,210

Total (Facilities)
Total (Facilities)

EMERGENCY RESPONSE PLANS (300.215) (SERCs, LEPCs, and RRTs)

Update Emergency Response Plans (LEPCs)
                                     3,400

                                    17,000
                                    51,000
                                     3,400
                                    71,400
                                  $3,421,964

Review Emergency Response Plans (SERCs)
                                      56

                                      224
                                      672
                                       0
                                      896
                                    $43,814

Keep records and make them available to the public
                                     3,456

                                       0
                                       0
                                    34,560
                                    34,560
                                   $983,577
                                       Subtotal (SERCs and  LEPCs)

                                    106,856
                                  $4,449,355

Exhibit 3

Capital/Start-up and O& M Costs (Annual) Facilities, SERCs and LEPCs

                                   Activity
                            Capital/Start-up Costs
                                O & M Costs
Provide information to LEPC, as required
                                      --
                                   $2,137.50
Notify LEPC and SERC of any RQ release
                                      --
                                    $36,330
Develop and submit written follow-up notice
                                      --
                                    $4,860
Submit Emergency Response Plans
                                      --
                                    $17,000

                                   Exhibit 4

               Summary of Total Annual Burden and Cost Estimates

                                 Burden Hours
                                     Labor
                                   O & M

Facilities
                                    160,350
                                  $9,117,445
                                    $43,327
SERCs and LEPCs
                                    106,856
                                  $4,448,335
                                    $17,000
Total
                                    267,206
                                  $13,565,780
                                    $60,327


[Federal Register: June 22, 2009 (Volume 74, Number 118)]
[Notices]
[Page 29524-29525]
[DOCID:fr22jn09-115]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Petro America Corp.; Order of Suspension of
Trading

June 18, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Petro America Corp. (``Petro America'') (trading symbol: PTRZ) because
of questions regarding the accuracy and adequacy of assertions by Petro
America concerning, among other things: The company's business
operations and assets, including regarding its purported oil trading
and storage business and holdings, its purported millions of dollars in
assets, and its securities issued and outstanding.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in securities
related to the above company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period from 9:30 a.m. EDT,
June 18, 2009 through 11:59 p.m. EDT, on July 1, 2009.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-14673 Filed 6-18-09; 11:15 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Notices]
[Page 57430]
[FR Doc No: 2015-24056]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2015-0097]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    In accordance with part 235 of Title 49 Code of Federal Regulations
and 49 U.S.C. 20502(a), this document provides the public notice that
by a document dated June 23, 2015, CSX Transportation (CSX) petitioned
the Federal Railroad Administration (FRA) seeking approval for the
discontinuance or modification of a signal system. FRA assigned the
petition Docket Number FRA-2015-0097.
    Applicant: CSX Transportation, Mr. David B. Olson, Chief Engineer,
Communications & Signals, 500 Water Street, Speed Code J-350,
Jacksonville, FL 32202.
    CSX seeks approval of the discontinuance of Control Point Watson on
the Chicago Division, Grand Rapids Terminal Subdivision, Milepost
CGE0.4. Signals #2, #4, #6, and #8 and power-operated switch #3 will be
removed. Existing power-operated switch #1 will be converted to a hand-
operated switch.
    The reason given for the proposed discontinuance is to eliminate
facilities no longer needed in present-day operation.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by November 9, 2015 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its processes. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.
See also http://www.regulations.gov/#!privacyNotice for the privacy
notice of regulations.gov.

    Issued in Washington, DC, on September 16, 2015.
Ron Hynes,
Director, Office of Technical Oversight.
[FR Doc. 2015-24056 Filed 9-22-15; 8:45 am]
 BILLING CODE 4910-06-P


A list of meeting materials from the New York Attorney General's Office during a non-government stakeholder listening session with the OMB and various EOP offices held on 06/02/2022 for the Accidental Release Prevention Requirements: Risk Management Program Under the Clean Air Act; Safer Communities by Chemical Accident Prevention. A Proposed Rule.

Attachment 1.	2021 7 30 Final RMP Comment Letter Harris County TX
Attachment 2.	GAO report on climate change risks
Attachment 3.	Written Testimony of AAG LMH with exhibits


[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Rules and Regulations]
[Page 56504]
[FR Doc No: 2020-17181]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

EPA-R09-OAR-2019-0655; FRL-10012-28-Region 9 Air Plan Approval;
California; San Joaquin Valley Unified Air Pollution Control District
and Feather River Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve revisions to the San Joaquin Valley Unified Air
Pollution Control District (SJVUAPCD or District) and the Feather River
Air Quality Management District (FRAQMD) portions of the California
State Implementation Plan (SIP) under the Clean Air Act (CAA or Act).
For the SJVUAPCD, these revisions concern a rule intended to track
information related to emissions of volatile organic compounds (VOCs)
and particulate matter (PM) from commercial charbroilers, and an
administrative rule for the registration of certain emission units
historically exempted from the SJVUAPCD's permit requirements. We are
approving into the California SIP amendments to a SJVUAPCD local rule,
which require owners and operators of commercial underfired
charbroilers to submit a one-time information report and which subject
certain underfired charbroilers to registration and weekly
recordkeeping requirements. We are also approving a SJVUAPCD rule
addressing registration requirements for these and certain other
emission units. For the FRAQMD, these revisions concern a negative
declaration for the Control Techniques Guidelines (CTG) for the Oil and
Natural Gas Industry.

DATES: This rule is effective October 14, 2020.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2019-0655. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information the
disclosure of which is restricted by statute. Certain other material,
such as copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Stanley Tong, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>Or Nicole Law, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On May 29, 2020 (85 FR 32327), the EPA proposed to approve the
following documents listed in Table 1 into the California SIP.

                                          Table 1--Submitted Documents
----------------------------------------------------------------------------------------------------------------
              Local agency                     Rule or document            Adopted/ amended          Submitted
----------------------------------------------------------------------------------------------------------------
SJVUAPCD................................  Rule 2250--Permit-Exempt    Adopted 10/19/2006........   \1\ 4/30/2020
                                           Equipment Registration.
SJVUAPCD................................  Rule 4692--Commercial       Amended 06/21/2018........  \2\ 11/21/2018
                                           Charbroiling.
FRAQMD..................................  Reasonably Available        Adopted 08/06/2018........  \3\ 12/07/2018
                                           Control Technology (RACT)
                                           State Implementation Plan
                                           (SIP) Revision for the
                                           South Sutter County
                                           Portion of the Sacramento
                                           Metropolitan
                                           Nonattainment Area for 8-
                                           Hour ozone--Negative
                                           Declaration for Control
                                           Techniques Guidelines for
                                           the Oil and Natural Gas
                                           Industry.
----------------------------------------------------------------------------------------------------------------

    We proposed to approve SJVUAPCD Rule 2250 and amended Rule 4692,
and FRAQMD's negative declaration for the Control Techniques Guidelines
for the Oil and Natural Gas Industry (EPA-453/B-16-001), because we
determined that they comply with the relevant CAA requirements. Our
proposed action contains more information on the documents and our
evaluation.
---------------------------------------------------------------------------

    \1\ This submittal was transmitted to the EPA by a letter from
CARB dated April 30, 2020.
    \2\ This submittal was transmitted to the EPA by a letter from
CARB dated November 16, 2018.
    \3\ This submittal was transmitted to the EPA by a letter from
CARB dated December 2, 2018.
---------------------------------------------------------------------------

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
The public comment period closed on June 29, 2020. During this period,
we received one anonymous comment that supported our proposed approval.

III. EPA Action

    No comments were submitted that change our assessment of the rules
and negative declaration as described in our proposed action.
Therefore, as authorized in section 110(k)(3) of the Act, the EPA is
fully approving the documents listed in Table 1 into the California
SIP.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with the requirements of 1
CFR 51.5, the EPA is finalizing the incorporation by reference of the
SJVUAPCD rules described in the amendments to 40 CFR part 52 set forth
below. The EPA has made, and will continue to make, these documents
available through www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the Clean Air Act. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 13, 2020. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate Matter, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: July 31, 2020.
John Busterud,
Regional Administrator, Region IX.

    For the reasons stated in the preamble, the EPA amends Part 52,
chapter I, title 40 of the Code of Federal Regulations as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(310)(i)(A)(2) and
(c)(379)(i)(C)(8), revising paragraph (c)(527)(i)(B) and adding
paragraph (c)(540) to read as follows:

Sec.  52.220  Identification of plan--in part.

* * * * *
    (c) * * *
    (310) * * *
    (i) * * *
    (A) * * *
    (2) Previously approved on June 3, 2003 in paragraph
(c)(310)(i)(A)(1) of this section and now deleted with replacement in
paragraph (c)(527)(i)(B)(1) of this section, Rule 4692, adopted on
March 21, 2002.
* * * * *
    (379) * * *
    (i) * * *
    (C) * * *
    (8) Previously approved on November 3, 2011 in paragraph
(c)(379)(i)(C)(5) of this section and now deleted with replacement in
paragraph (c)(527)(i)(B)(1) of this section, Rule 4692, ``Commercial
Charbroiling,'' amended on September 17, 2009.
* * * * *
    (527) * * *
    (i) * * *
    (B) San Joaquin Valley Unified Air Pollution Control District.
    (1) Rule 4692, ``Commercial Charbroiling,'' amended on June 21,
2018.
    (2) [Reserved]
* * * * *
    (540) New regulations for the following APCD were submitted on
April 30, 2020, by the Governor's designee, as an attachment to a
letter dated April 30, 2020.
    (i) Incorporation by reference.
    (A) San Joaquin Valley Unified Air Pollution Control District.
    (1) Rule 2250, ``Permit-Exempt Equipment Registration,'' adopted
October 19, 2006.
    (2) [Reserved]
    (B) [Reserved]
    (ii) [Reserved]

Sec.  52.222  [AMENDED]

0
3. Section 52.222 is amended by revising paragraph (a)(11) to read as
follows:
    (a) * * *
    (11) Feather River Air Quality Management District.
    (i) Negative declarations for Feather River Air Quality Management
District.

----------------------------------------------------------------------------------------------------------------
                                                                2006 RACT SIP    2009 RACT SIP    2014 RACT SIP
         CTG source category            Negative declaration   submitted 7/11/  submitted 10/27/ submitted 9/29/
                                       CTG reference document         07               09               14
----------------------------------------------------------------------------------------------------------------
Aerospace...........................  EPA-453/R-97-004--                    X   ...............               X
                                       Control of VOC
                                       Emissions from Coating
                                       Operations at
                                       Aerospace
                                       Manufacturing and
                                       Rework.
Automobile Coating; Metal Coil        EPA-450/2-77-008--                    X   ...............               X
 Container, & Closure; Paper &         Control of Volatile
 Fabric.                               Organic Emissions from
                                       Existing Stationary
                                       Sources--Volume II
                                       Surface Coating of
                                       Cans, Coils, Paper,
                                       Fabrics, Automobiles,
                                       and Light-Duty Trucks.
Automobile and Light-Duty Truck       EPA-453/R-08-006--       ...............               X                X
 Assembly Coatings.                    Control Techniques
                                       Guidelines for
                                       Automobile and Light-
                                       Duty Assembly Coatings.
Cutback Asphalt.....................  EPA-450/2-77-037--                    X   ...............               X
                                       Control of Volatile
                                       Organic Emissions from
                                       Use of Cutback Asphalt.
Dry Cleaning........................  EPA-450/3-82-009--                    X   ...............               X
                                       Control of Volatile
                                       Organic Compound
                                       Emissions from Large
                                       Petroleum Dry Cleaners.
Flat Wood Paneling Coatings.........  EPA-453/R-06-004--       ...............               X                X
                                       Control Techniques
                                       Guidelines for Flat
                                       Wood Paneling Coatings.
Fiberglass Boat Manufacturing         EPA-453/R-08-004--       ...............               X                X
 Materials.                            Control Techniques
                                       Guidelines for
                                       Fiberglass Boat
                                       Manufacturing
                                       Materials.
Flexible Package Printing...........  EPA-453/R06-003--        ...............               X                X
                                       Control Techniques
                                       Guidelines for
                                       Flexible Package
                                       Printing.
Gasoline Loading Terminal...........  EPA-450/2-77-026--                    X   ...............               X
                                       Control of
                                       Hydrocarbons from Tank
                                       Truck Gasoline Loading
                                       Terminals.
Gasoline Trucks.....................  EPA-450/2-78-051--                    X   ...............               X
                                       Control of Volatile
                                       Organic Compound Leaks
                                       from Gasoline Tank
                                       Trucks and Vapor
                                       Collection Systems.
Gasoline Bulk Plants................  EPA-450/2-77-035--                    X   ...............               X
                                       Control of Volatile
                                       Organic Emissions from
                                       Gasoline Bulk Plants.
Graphic Arts Rotogravure and          EPA-450/2-78-033--                    X   ...............               X
 Flexography.                          Control of Volatile
                                       Organic Emissions from
                                       Existing Stationary
                                       Sources--Volume VIII:
                                       Rotogravure and
                                       Flexography.
Industrial Cleaning Solvents........  EPA-453/R-06-001--                    X                X                X
                                       Control Techniques
                                       Guidelines for
                                       Industrial Cleaning
                                       Solvents.
Large Appliance Coating.............  EPA-450/2-77-034--                    X   ...............               X
                                       Control of Volatile
                                       Organic Emissions from
                                       Existing Stationary
                                       Sources, Volume V:
                                       Surface Coating of
                                       Large Appliances.
Large Appliance Coating.............  EPA-453/R-07-004--       ...............               X                X
                                       Control Techniques for
                                       Large Appliance
                                       Coatings.
Magnet Wire Coating.................  EPA-450/2-77-033--                    X   ...............               X
                                       Control of Volatile
                                       Organic Emissions from
                                       Existing Stationary
                                       Sources--Volume IV:
                                       Surface Coating of
                                       Insulation of Magnet
                                       Wire.
Metal Can Coating; Metal Coil         EPA-450/2-77-008--                    X   ...............               X
 Coating.                              Control of Volatile
                                       Organic Emissions from
                                       Existing Stationary
                                       Sources--Volume II:
                                       Surface Coating of
                                       Cans, Coils, Paper,
                                       Fabrics, Automobiles,
                                       and Light-Duty Trucks.
Metal Furniture.....................  EPA-450/2-77-032--                    X   ...............               X
                                       Control of Volatile
                                       Organic Emissions from
                                       Existing Stationary
                                       Sources--Volume III:
                                       Surface Coating of
                                       Metal Furniture.
Metal Furniture Coatings............  EPA-453/R-07-005--       ...............               X                X
                                       Control Techniques
                                       Guidelines for Metal
                                       Furniture Coatings.
Metal Parts and Products............  EPA-450/2-78-015--                    X   ...............               X
                                       Control of Volatile
                                       Organic Emissions from
                                       Existing Stationary
                                       Sources--Volume VI:
                                       Surface Coating of
                                       Miscellaneous Parts
                                       and Products.
Miscellaneous Industrial Adhesives..  EPA-453/R-08-005--                    X                X                X
                                       Control Techniques
                                       Guidelines for
                                       Miscellaneous
                                       Industrial Adhesives.
Miscellaneous Metal and Plastic       EPA-453/R-08-003--       ...............               X                X
 Parts Coatings.                       Control Techniques
                                       Guidelines for
                                       Miscellaneous Metal
                                       and Plastic Parts
                                       Coatings.
Natural Gas/Gasoline................  EPA-450/2-83-007--                    X   ...............               X
                                       Control of VOC
                                       Equipment Leaks from
                                       Natural Gas/Gasoline
                                       Processing Plants.
Offset Lithographic Printing and      EPA-453/R-06-002--       ...............               X                X
 Letterpress Printing.                 Control Techniques
                                       Guidelines for Offset
                                       Lithographic Printing
                                       and Letterpress
                                       Printing.
Paper and Fabric Coating............  EPA-450/2-77-008--                    X   ...............               X
                                       Control of Volatile
                                       Organic Emissions from
                                       Existing Stationary
                                       Sources--Volume II:
                                       Surface Coating of
                                       Cans, Coils, Paper,
                                       Fabrics, Automobiles,
                                       and Light-Duty Trucks.
Paper, Film, and Foil Coatings......  EPA-453/R-07-003--       ...............               X                X
                                       Control Techniques
                                       Guidelines for Paper,
                                       Film, and Foil
                                       Coatings.
Petroleum Liquid Storage Tanks......  EPA-450/2-77-036--                    X   ...............               X
                                       Control of VOC
                                       Emissions from Storage
                                       of Petroleum Liquids
                                       in Fixed Roof Tanks.
Petroleum Liquid Storage Tanks......  EPA-450/2-78-047--                    X   ...............               X
                                       Control of VOC
                                       Emissions from
                                       Petroleum Liquid
                                       Storage in External
                                       Floating Roof Tanks.
Pharmaceutical Products.............  EPA-450/2-78-029--                    X   ...............               X
                                       Control of Volatile
                                       Organic Emissions from
                                       Manufacture of
                                       Synthesized
                                       Pharmaceutical
                                       Products.
Resin Manufacturing.................  EPA-450/3-83-008--                    X   ...............               X
                                       Control of VOC
                                       Emissions from
                                       Manufacture of High-
                                       Density Polyethylene,
                                       Polypropylene, and
                                       Polystyrene Resins.
Resin Manufacturing.................  EPA-450/3-83-006--                    X   ...............               X
                                       Control of VOC
                                       Fugitive Emissions
                                       from Synthetic Organic
                                       Chemical Polymer and
                                       Resin Manufacturing
                                       Equipment.
Refineries..........................  EPA-450/2-77-025--                    X   ...............               X
                                       Control of Refinery
                                       Vacuum Producing
                                       Systems, Wastewater
                                       Separators, and
                                       Process Unit
                                       Turnarounds.
Refineries..........................  EPA-450/2-78-036--                    X   ...............               X
                                       Control of VOC Leaks
                                       from Petroleum
                                       Refinery Equipment.
Rubber Tire Manufacturing...........  EPA-450/2-78-030--                    X   ...............               X
                                       Control of Volatile
                                       Organic Emissions from
                                       Manufacture of
                                       Pneumatic Rubber Tires.
Ship Coatings.......................  61 FR 44050                           X   ...............               X
                                       Shipbuilding and Ship
                                       Repair Operations
                                       (Surface Coating).
Ship Coatings.......................  EPA-453/R-94-032--       ...............  ...............               X
                                       Alternative Control
                                       Technology Document--
                                       Surface Coating
                                       Operations at
                                       Shipbuilding and Ship
                                       Repair Operations
                                       (Surface Coating).
Solvent Cleaning Degreasers.........  EPA-450/2-77-022--                    X   ...............               X
                                       Control of Volatile
                                       Organic Emissions from
                                       Solvent Metal Cleaning.
Synthetic Organic Chemical            EPA-450/3-84-015--                    X   ...............               X
 Manufacturing.                        Control of VOC
                                       Emissions from Air
                                       Oxidation Processes in
                                       Synthetic Organic
                                       Chemical Manufacturing
                                       Industry.
Synthetic Organic Chemical            EPA-450/4-91-031--                    X   ...............               X
 Manufacturing.                        Control of VOC
                                       Emissions from Reactor
                                       Processes and
                                       Distillation
                                       Operations in
                                       Synthetic Organic
                                       Chemical Manufacturing
                                       Industry.
Wood Coating Factory Surface of Flat  EPA-450/2-78-032--                    X   ...............               X
 Wood Paneling.                        Control of Volatile
                                       Organic Emissions from
                                       Existing Stationary
                                       Sources--Volume VII:
                                       Factory Surface of
                                       Flat Wood Paneling.
Wood Furniture Coating..............  EPA-453/R-96-007--                    X   ...............               X
                                       Control of VOC
                                       Emissions from Wood
                                       Furniture
                                       Manufacturing
                                       Operations.
----------------------------------------------------------------------------------------------------------------

    (ii) A negative declaration for the Control Techniques Guidelines
for the Oil and Natural Gas Industry, EPA 453/B-16-001, was submitted
on December 7, 2018, as an attachment to a letter dated December 2,
2018, and adopted on August 6, 2018, titled: ``Reasonably Available
Control Technology (RACT) State Implementation Plan (SIP) Revision for
the South Sutter County Portion of the Sacramento Metropolitan
Nonattainment Area for 8-Hour ozone--Negative Declaration for Control
Techniques Guidelines for the Oil and Natural Gas Industry.''
* * * * *
[FR Doc. 2020-17181 Filed 9-11-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Pages 22871-22872]
[FR Doc No: 2013-09016]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 Notice of Effectiveness of Exempt Wholesale Generator or Foreign
Utility Company Status

------------------------------------------------------------------------
                                                           Docket Nos.
------------------------------------------------------------------------
Carson Cogeneration Company, LP........................      EG13-11-000
Delano Energy Center, LLC..............................      EG13-12-000
Alpaugh 50, LLC........................................      EG13-13-000
Alpaugh North, LLC.....................................      EG13-14-000
Niagara Wind Power, LLC................................      EG13-15-000
Conestogo Wind, LP.....................................       FC13-7-000
------------------------------------------------------------------------

    Take notice that during the month of March 2013, the status of the
above-captioned entities as Exempt Wholesale Generators or Foreign
Utility Companies became effective by operation of the Commission's
regulations. 18 CFR 366.7(a).

    Dated: April 11, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-09016 Filed 4-16-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 56 (Monday, March 24, 2014)]
[Notices]
[Pages 16009-16010]
[FR Doc No: 2014-06371]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0218]

Premarket Notification Submissions for Bipolar Electrosurgical
Vessel Sealers for General Surgery; Draft Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Premarket Notification
(510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for
General Surgery.'' FDA has developed this guidance document to assist
industry in preparing premarket notification (510(k)) submissions for
bipolar electrosurgical vessel sealers intended for use in general
surgery. This draft guidance is not final nor is it in effect at this
time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 23, 2014.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Premarket Notification (510(k)) Submissions for Bipolar
Electrosurgical Vessel Sealers for General Surgery'' to the Office of
the Center Director, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G404, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this guidance document to assist industry in
preparing premarket notification (510(k)) submissions for bipolar
electrosurgical vessel sealers intended for use in general surgery.
These devices are designed to seal isolated blood and lymphatic vessels
for hemostasis (as an alternative to ties) through the use of high
frequency electrical current between two electrodes in close proximity.
The scope of this document is limited to the class II, electrosurgical
devices and accessories classified under 21 CFR 878.4400,
Electrosurgical cutting and coagulation device and accessories. This
generic type of device includes bipolar vessel sealing instruments,
associated electrosurgical generators, and accessories for use in open,
endoscopic, and laparoscopic general surgical procedures. This guidance
is intended only to address bipolar electrosurgical vessel sealers that
have general indications for use in general surgery.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the content
of premarket notification (510(k)) submissions for bipolar
electrosurgical vessel sealers intended for use in general surgery. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Premarket Notification
(510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for
General Surgery'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1300048 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; and the collections of information in 21 CFR parts
801 and 809 have been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and

will be posted to the docket at http://www.regulations.gov.

    Dated: March 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06371 Filed 3-21-14; 8:45 am]
BILLING CODE 4160-01-P