[Federal Register Volume 79, Number 11 (Thursday, January 16, 2014)]
[Notices]
[Pages 2904-2906]
[FR Doc No: 2014-00677]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2014-0001]

National Advisory Committee on Occupational Safety and Health
(NACOSH)

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Announcement of a meeting of NACOSH.

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SUMMARY: NACOSH will meet February 12, 2014, in Washington, DC. In
conjunction with the committee meeting, a NACOSH Work Group will meet
February 11, 2014.

DATES: NACOSH meeting: NACOSH will meet from 9 a.m. to 5 p.m.,
Wednesday, February 12, 2014.
    NACOSH Work Group meeting: A NACOSH Work Group will meet from 1-4
p.m., Tuesday, February 11, 2014.
    Comments, requests to speak, speaker presentations, and requests
for special accommodation: You must submit (postmark, send, transmit)
comments, requests to address NACOSH, speaker presentations (written or
electronic), and requests for special accommodation for the NACOSH and
NACOSH Work Group meetings by February 4, 2014.

ADDRESSES: NACOSH and NACOSH Work Group meetings: NACOSH and the NACOSH
Work Group will meet in Room C-5320-6, U.S. Department of Labor, 200
Constitution Avenue NW., Washington, DC 20210.
    Submission of comments, requests to speak, and speaker
presentations: You may submit comments, requests to address NACOSH, and
speaker presentations using one of the following methods:
    Electronically: You may submit materials, including attachments,
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions on that Web page for making
submissions;
    Facsimile: If your submission, including attachments, does not
exceed 10 pages, you may fax it to the OSHA Docket Office at (202) 693-
1648; or
    Regular mail, express mail, hand delivery, or messenger/courier
service (hard copy): You may submit your materials to the OSHA Docket
Office, Docket No. OSHA-2014-0001, Room N-2625, U.S. Department of
Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone
(202) 693-2350 (OSHA TTY<PHONE_NUMBER>). OSHA's Docket Office accepts
deliveries (hand deliveries, express mail, and messenger service)
during normal business hours, 8:15 a.m. to 4:45 p.m., e.t., weekdays.
    Requests for special accommodations: Please submit requests for
special accommodations to attend the NACOSH and NACOSH Work Group
meetings by

email, telephone, or hard copy to Ms. Frances Owens, OSHA Office of
Communications, Room N-3647, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER> (OSHA TTY
(887) 889-5627); email<EMAIL_ADDRESS>    Instructions: Your submissions must include the Agency name and
docket number for this Federal Register notice (Docket No. OSHA-2014-
0001). Due to security-related procedures, submissions by regular mail
may experience significant delays. Please contact the OSHA Docket
Office for information about security procedures for making
submissions. For additional information on submitting comments,
requests to speak and speaker presentations, see the SUPPLEMENTARY
INFORMATION section of this notice.
    OSHA will post in the public docket, without change, any comments,
requests to speak, and speaker presentations, including any personal
information that you provide. Therefore, OSHA cautions you about
submitting personal information such as Social Security numbers and
birthdates.

FOR FURTHER INFORMATION CONTACT: For press inquiries: Mr. Frank
Meilinger, Director, OSHA Office of Communications, U.S. Department of
Labor, Room N-3647, 200 Constitution Avenue NW., Washington, DC 20210;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    For general information about NACOSH and NACOSH meetings: Ms.
Elizabeth Grossman, Director, OSHA Office of Evaluation and Audit
Analysis, Directorate of Evaluation and Analysis, U.S. Department of
Labor, Room N-3641, 200 Constitution Avenue NW., Washington, DC 20210;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

NACOSH Meeting

    NACOSH will meet February 12, 2014, in Washington, DC. Some NACOSH
members may attend the meeting electronically. The NACOSH meeting is
open to the public.
    Section 7(a) of the Occupational Safety and Health Act of 1970 (OSH
Act) (29 U.S.C. 651, 656) authorizes NACOSH to advise the Secretary of
Labor and the Secretary of Health and Human Services on matters
relating to the administration of the OSH Act. NACOSH is a continuing
advisory body and operates in compliance with the OSH Act, the Federal
Advisory Committee Act (5 U.S.C. App. 2), and regulations issued
pursuant to those statutes (29 CFR part 1912a, 41 CFR part 102-3).
    The tentative agenda for the NACOSH meeting includes:
    [ssquf] Remarks from the Assistant Secretary of Labor for
Occupational Safety and Health (OSHA);
    [ssquf] Remarks from the Director of the National Institute of
Occupational Safety and Health (NIOSH);
    [ssquf] NACOSH Work Group report and consideration of work group
recommendations; and
    [ssquf] Public comments.
    OSHA transcribes NACOSH meetings and prepares detailed minutes of
NACOSH meetings. OSHA posts in the public docket NACOSH meeting
transcripts, minutes, written comments, speaker presentations, and
other materials submitted to NACOSH or presented at NACOSH and NACOSH
Work Group meetings.

NACOSH Work Group

    A NACOSH Work Group will meet February 11, 2014. The meeting is
open to the public. The purpose of the NACOSH Work Group is to discuss
issues affecting the occupational safety and health of temporary
workers and to provide recommendations to NACOSH on best practices for
ensuring the workplace safety and health of temporary workers. The
NACOSH Work Group will present a report and recommendations to NACOSH
at the February 12, 2014, meeting for the Committee's consideration and
deliberation.

Public Participation, Submissions, and Access to Public Record

    NACOSH and NACOSH Work Group meetings: All NACOSH and NACOSH Work
Group meetings are open to the public. Individuals attending NACOSH
meetings at the U.S. Department of Labor must enter the building at the
Visitors' Entrance at 3rd and C Streets, NW., and pass through building
security. Attendees must have valid government-issued photo
identification (e.g., driver's license) to enter the building. For
additional information about building security measures for attending
NACOSH and NACOSH Work Group meetings, please contact Ms. Owens (see
ADDRESSES section).
    Individuals requesting special accommodation to attend the NACOSH
and NACOSH Work Group meeting should contact Ms. Owens.
    Submission of comments: You may submit comments using one of the
methods listed in the ADDRESSES section. Your submission must include
the Agency name and Docket number for this NACOSH meeting (Docket No.
OSHA-2014-0001). OSHA will provide copies of your submissions to NACOSH
members.
    Because of security-related procedures, submissions by regular mail
may experience significant delays. For information about security
procedures for submitting materials by hand delivery, express mail, and
messenger or courier service, please contact the OSHA Docket Office
(see ADDRESSES section).
    Requests to speak and speaker presentations: If you want to address
NACOSH at the meeting you must submit your request to speak, as well as
any written or electronic presentation, by February 4, 2014, using one
of the methods listed in the ADDRESSES section. Your request must
state:
     The amount of time requested to speak;
     The interest you represent (e.g., business, organization,
affiliation), if any; and
     A brief outline of the presentation.
    PowerPoint presentations and other electronic materials must be
compatible with PowerPoint 2010 and other Microsoft Office 2010
formats. The NACOSH Chair may grant requests to address NACOSH as time
and circumstances permit.
    Public docket of NACOSH meetings: OSHA places comments, requests to
speak, and speaker presentations, including any personal information
you provide, in the public docket, without change. Those documents also
may be available online at http://www.regulations.gov. Therefore, OSHA
cautions you about submitting certain personal information such as
Social Security numbers and birthdates.
    OSHA also places in the public docket meeting transcripts, meeting
minutes, documents presented at the NACOSH meeting, and other documents
pertaining to NACOSH and NACOSH Work Group meetings. These documents
may be available online at http://www.regulations.gov.
    Access to the public record of NACOSH meetings: To read or download
documents in the public docket, go to Docket No. OSHA-2014-0001 at
http://www.regulations.gov. The index of that Web page lists all of the
documents in the public record for this meeting; however, some
documents (e.g., copyrighted materials) are not publicly available
through that Web page. All documents in the public record, including
materials not available through http://www.regulations.gov, are
available for inspection and copying in the OSHA Docket Office (see
ADDRESSES section). Please contact the OSHA Docket Office for
assistance in making

submissions to, or obtaining materials from, the public docket.
    Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This notice, as well as news releases and
other relevant information, are also available on OSHA's Web page at
http://www.osha.gov.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice under the authority granted by 29 U.S.C. 656; 5 U.S.C. App. 2;
29 CFR part 1912a; 41 CFR part 102-3; and Secretary of Labor's Order
No. 1-2012 (77 FR 3912 (1/25/2012)).

    Signed at Washington, DC, on January 10, 2014.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2014-00677 Filed 1-15-14; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)]
[Notices]
[Pages 1457-1458]
[FR Doc No: 2016-00336]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76841; File No. SR-BATS-2015-101]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change, as Modified by Amendment No. 1 Thereto, To Adopt Rule 8.17 To
Provide a Process for an Expedited Client Suspension Proceeding and
Rule 12.15 To Prohibit Disruptive Quoting and Trading Activity

January 6, 2016.
    On November 6, 2015, BATS Exchange, Inc. (``Exchange'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to adopt new BATS
Rule (``Rule'') 12.15, which would prohibit certain disruptive quoting
and trading activity on the Exchange, and new Rule 8.17, which would
permit BATS to conduct a new Expedited Client Suspension Proceeding
when it believes

proposed Rule 12.15 has been violated.\3\ On November 17, 2015, the
Exchange filed Amendment No. 1 to the proposal.\4\ The proposed rule
change, as modified by Amendment No. 1, was published for comment in
the Federal Register on November 24, 2015.\5\ The Commission received
four comments on the proposal.\6\
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ This proposed rule change is a revised version of a prior
filing, BATS-2015-57, which the Exchange withdrew and revised in
order to address certain issues raised by comments submitted with
respect to BATS-2015-57. See Securities Exchange Act Release No.
76393 (November 9, 2015), 80 FR 70851 (November 16, 2015) (BATS-
2015-57) (noticing the withdrawal of BATS-2015-57).
    \4\ Amendment No. 1 amended and replaced the original proposal
in its entirety.
    \5\ See Securities Exchange Act Release No. 76470 (November 18,
2015), 80 FR 73247 (``Notice'').
    \6\ See letters from: R.T. Leuchtkafer to Brent J. Fields,
Secretary, Commission, dated December, 14, 2015; Rick A. Fleming,
Investor Advocate, Commission, to U.S. Securities and Exchange
Commission, dated December 15, 2015; Samuel F. Lek, Chief Executive
Officer, Lek Securities Corporation, dated December 28, 2015; G.T.
Spaulding to Brent J. Fields, Secretary, Commission, dated December,
28, 2015.
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    Section 19(b)(2) of the Act \7\ provides that, within 45 days of
the publication of the notice of the filing of a proposed rule change,
or within such longer period up to 90 days as the Commission may
designate if it finds such longer period to be appropriate and
publishes its reasons for so finding, or as to which the self-
regulatory organization consents, the Commission shall either approve
the proposed rule change, disapprove the proposed rule change, or
institute proceedings to determine whether the proposed rule change
should be disapproved. The 45th day for this filing is January 8, 2016.
The Commission is extending this 45-day time period.
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    \7\ 15 U.S.C. 78s(b)(2).
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    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change and the
comments received. Accordingly, the Commission, pursuant to section
19(b)(2) of the Act,\8\ designates February 22, 2016 as the date by
which the Commission should either approve or disapprove or institute
proceedings to determine whether to disapprove the proposed rule change
(File Number SR-BATS-2015-101).
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    \8\ Id.
    \9\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-00336 Filed 1-11-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 122 (Wednesday, June 24, 2020)]
[Notices]
[Page 37941]
[FR Doc No: 2020-13624]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-2049-000]

Cedar Springs Wind III, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced Cedar Springs
Wind III, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 8, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
eLibrary link. Enter the docket number excluding the last three digits
in the docket number field to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact the Federal Energy Regulatory
Commission at<EMAIL_ADDRESS>or call toll-free, (886) 208-
3676 or TYY,<PHONE_NUMBER>.

    Dated: June 18, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-13624 Filed 6-23-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Page 57213]
[FR Doc No: 2020-20239]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC20-98-000.
    Applicants: Cypress Creek Renewables Holdings, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act, et al. of Cypress Creek Renewables Holdings, LLC.
    Filed Date: 9/3/20.
    Accession Number: 20200903-5125.
    Comments Due: 5 p.m. ET 9/24/20.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG20-241-000.
    Applicants: Mohave County Wind Farm LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Mohave County Wind Farm LLC.
    Filed Date: 9/2/20.
    Accession Number: 20200902-5271.
    Comments Due: 5 p.m. ET 9/23/20.

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

    Docket Numbers: ER19-467-007.
    Applicants: New York Independent System Operator, Inc.
    Description: Compliance filing: NYISO filing of errata to 8/12/20
ESR compliance filing set effective date to be effective 8/26/2020.
    Filed Date: 9/3/20.
    Accession Number: 20200903-5120.
    Comments Due: 5 p.m. ET 9/24/20.

    Docket Numbers: ER20-2399-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Errata to WMPA SA No. 5696, Queue
No. AF1-140 in Docket No. ER20-2399 to be effective 6/11/2020.
    Filed Date: 9/3/20.
    Accession Number: 20200903-5178.
    Comments Due: 5 p.m. ET 9/24/20.

    Docket Numbers: ER20-2804-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Sec.  205(d) Rate Filing: Amendment to Tri-State Rate
Schedule No. 52 to be effective 9/3/2020.
    Filed Date: 9/2/20.
    Accession Number: 20200902-5258.
    Comments Due: 5 p.m. ET 9/23/20.

    Docket Numbers: ER20-2805-000.
    Applicants: Cimarron Bend Assets, LLC.
    Description: Sec.  205(d) Rate Filing: Amended and Restated Shared
Facilities Agreement to be effective 9/3/2020.
    Filed Date: 9/2/20.
    Accession Number: 20200902-5269.
    Comments Due: 5 p.m. ET 9/23/20.

    Docket Numbers: ER20-2807-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Sec.  205(d) Rate Filing: Amendment to Service
Agreement No. 808 to be effective 2/25/2020.
    Filed Date: 9/3/20.
    Accession Number: 20200903-5049.
    Comments Due: 5 p.m. ET 9/24/20.

    Docket Numbers: ER20-2809-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: Tariff Revisions to
Facilitate Entry into the Western Energy Imbalance Market to be
effective 11/4/2020.
    Filed Date: 9/3/20.
    Accession Number: 20200903-5157.
    Comments Due: 5 p.m. ET 9/24/20.

    Docket Numbers: ER20-2810-000.
    Applicants: Millican Solar Energy LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 11/3/2020.
    Filed Date: 9/3/20.
    Accession Number: 20200903-5172.
    Comments Due: 5 p.m. ET 9/24/20.

    Docket Numbers: ER20-2811-000.
    Applicants: Prineville Solar Energy LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 11/3/2020.
    Filed Date: 9/3/20.
    Accession Number: 20200903-5174.
    Comments Due: 5 p.m. ET 9/24/20.

    Docket Numbers: ER20-2812-000.
    Applicants: Terminus Hydroelectric, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 11/3/2020.
    Filed Date: 9/3/20.
    Accession Number: 20200903-5177.
    Comments Due: 5 p.m. ET 9/24/20.

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

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-20239 Filed 9-14-20; 8:45 am]
BILLING CODE 6717-01-P


Regulatory Basis for Regulatory Basis for Protocol Review Protocol Review John M. Carley Office of Pesticide Programs 2 § 26.1125 Prior submission of proposed 26.1125 Prior submission of proposed human research for EPA review human research for EPA review Any person or institution who intends to conduct or sponsor human research covered by § 26.1101( a)

shall, after receiving approval from all appropriate IRBs, submit to EPA prior to initiating such research  all information relevant to the proposed research specified by § 26.1115( a), and  the following additional information, to the extent not already included: 3 IRB Records specified by IRB Records specified by § 26.1115( a)

26.1115( a)

§ 1115( a)( 1): Copies of  all research proposals reviewed,

 scientific evaluations, if any, that accompany the proposals,

 approved sample consent documents,

 progress reports submitted by investigators,

and reports of injuries to subjects. 4 IRB Records specified by IRB Records specified by § 26.1115( a)

26.1115( a)

§ 1115( a)( 2): Minutes of IRB meetings which shall be in sufficient detail to show  attendance at the meetings;

 actions taken by the IRB;

 the vote on these actions including the number of  members voting for, against, and abstaining;

 the basis for requiring changes in or disapproving research;

 a written summary of the discussion of controverted issues and their resolution. 5 IRB Records specified by IRB Records specified by § 26.1115( a)

26.1115( a)

§ 1115( a)( 4): Copies of all correspondence between the IRB and the investigators.

§ 1115( a)( 5):

 A list of IRB members identified by name; earned degrees;

representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member s chief anticipated contributions to IRB deliberations;

 any employment or other relationship between each member and the institution, for example, full time employee, a member of governing panel or board, stockholder, paid or unpaid consultant. 6 IRB Records specified by IRB Records specified by § 26.1115( a)

26.1115( a)

§ 1115( a)( 6): Written procedures for the IRB in the same detail as described in § 26.1108( a) and § 26.1108( b). 7 Additional Information Required by Additional Information Required by § 26.1125 26.1125 ( a) A discussion of:

( 1) The potential risks to human subjects ( 2) The measures proposed to minimize risks to the human subjects ( 3) The nature and magnitude of all expected benefits of such research, and to whom they would accrue ( 4) Alternative means of obtaining information comparable to what would be collected through the proposed research ( 5) The balance of risks and benefits of the proposed research 8 Additional Information Required by Additional Information Required by § 26.1125 26.1125 ( b) All information for subjects and written informed consent agreements as originally provided to the IRB,

and as approved by the IRB ( c) Information about how subjects will be recruited,

including any advertisements proposed to be used ( d) A description of the circumstances and methods proposed for presenting information to potential human subjects for the purpose of obtaining their informed consent 9 Additional Information Required by Additional Information Required by § 26.1125 26.1125 ( e) All correspondence between the IRB and the investigators or sponsors ( f) Official notification to the sponsor or investigator, in accordance with the requirements of this subpart, that research involving human subjects has been reviewed and approved by an IRB 10 § 26.1601 EPA review of proposed 26.1601 EPA review of proposed human research human research ( a) EPA shall review all protocols submitted under § 26.1125 in a timely manner. With respect to any research or any class of research, the Administrator may recommend additional conditions which, in the judgment of the Administrator, are necessary for the protection of human subjects. 11 § 26.1601 EPA review of proposed 26.1601 EPA review of proposed human research human research ( b) In reviewing proposals covered by this subpart, the Administrator may take into account [ the past record of the investigator with respect to protection of human subjects.] 12 § 26.1601 EPA review of proposed 26.1601 EPA review of proposed human research human research ( c) When research covered by subpart K takes place in foreign countries, . . . if the Administrator determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in subpart K, the Administrator may approve the substitution of the foreign procedures . . . . 13 § 26.1601 EPA review of proposed 26.1601 EPA review of proposed human research human research ( d) Following initial evaluation of the protocol by Agency staff, EPA shall submit the protocol and all supporting materials, together with the staff evaluation, to the Human Studies Review Board.

( e) EPA shall notify the submitter of the proposal of the results of the EPA and Human Studies Review Board reviews 14 EPA Completeness Check:

EPA Completeness Check:

Carroll Carroll Loye Loye Protocols Protocols 15 EPA Completeness Check:

EPA Completeness Check:

Carroll Carroll Loye Loye Protocols Protocols

EPA reviewed initial submission against requirements of § 1125

EPA notified Dr. Carroll of deficiencies

Dr. Carroll resubmitted protocols with more extensive supporting materials

IIRB refused to provide to Dr. Carroll records of IRB membership, procedures, or meeting minutes 16 EPA Completeness Check:

EPA Completeness Check:

Carroll Carroll Loye Loye Protocols Protocols

EPA contacted IIRB directly

IIRB submitted additional materials

EPA Assessment:

 A good faith effort has been made to address all requirements of § 1125.

 These protocols are completely enough described to support review by EPA and HSRB


SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY NSPS for Metal Coil Surface Coating ( Subpart TT)

1. Identification of the Information Collection 1( a) Title of the Information Collection NSPS for Metal Coil Surface Coating ( Subpart TT)

1( b) Short Characterization/ Abstract The New Source Performance Standards ( NSPS) for the regulations published at 40 CFR Part 60, Subpart TT were proposed on January 5, 1981 and promulgated on November 1, 1982. These regulations apply to the following surface coating lines in the metal coil surface coating industry: each prime coat operation, each finish coat operation, and each prime and finish coat operation cured simultaneously where the finish coat is applied wet on wet over the prime coat. These regulations apply to metal coil coating facilities commencing construction, modification or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR Part 60, Subpart TT.

In general, all NSPS standards require initial notifications, performance tests, and periodic reports. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to NSPS.

Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least two years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated State or local authority. In the event that there is no such delegated authority, the reports are sent directly to the United States Environmental Protection Agency ( EPA) Regional Office.

Approximately 161 sources are currently subject to the regulation, and it is estimated that an additional four ( 4) sources per year will become subject to the regulation in the next three years. These numbers are based on previous experience with the industry and a recent search of the Agency's AIRS ( Aerometric Information Retrieval System) Facility Subsystem ( AFS) data base. 2 The " Terms of Clearance" for the previously approved Information Collection Request ( ICR) stated:

This ICR is approved for three years. Before resubmission of this ICR for extension, the agency should revisit the estimate of the number of respondents and demonstrate to OMB that the estimates are consistent with agency experience. In addition, the agency should revise wage estimates to reflect guidance provided by EPA and/ or OMB, especially with respect to appropriate calculation of wage overhead.

The AFS data search was used to determine the number of facilities covered by the rule and the industry and Agency wage rates were updated to use the most recently available rates and overheads.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 111 of the Clean Air Act ( CAA), as amended, to establish standards of performance for new stationary sources that reflect:

. . . application of the best technological system of continuous emissions reduction which ( taking into consideration the cost of achieving such emissions reduction, or any non air quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated. Section 111( a)( l).

The Agency refers to this charge as selecting the best demonstrated technology ( BDT). Section 111 also requires that the Administrator review and, if appropriate, revise such standards every four years. In addition, Section 114( a) states that the Administrator may require any owner or operator subject to any requirement of this Act to:

( A) Establish and maintain such records; ( B) make such reports; ( C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; ( D) sample such emissions ( in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; ( F) submit compliance certifications in accordance with Section 114( a)( 3); and ( G) provide such other information as the Administrator may reasonably require. 3 In the Administrator's judgment, Volatile Organic Compounds ( VOC) emissions from surface coating of metal coils cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, NSPS were promulgated for this source category at 40 CFR Part 60, Subpart TT.

2( b) Practical Utility/ Users of the Data The control of emissions of VOC from surface coating of metal coils requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of VOC from surface coating of metal coils are the result of operation of the affected facilities. The subject standards are achieved by the capture and/ or reduction of VOC emissions using pollution control devices. The notifications required in the applicable regulations are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated and the regulations are being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standards, and serve as a record of the operating conditions under which compliance was achieved.

The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. EPA reduced the reporting frequency for this information from quarterly to semiannually in a December 1990 Federal Register Notice. The reduction in reporting frequency was in response to the Office of Management and Budget's ( OMB) previous questions regarding the need for quarterly versus semiannual reporting. The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the NSPS continue to operate the control equipment and achieve compliance with the regulation. Adequate monitoring, recordkeeping, and reporting are necessary to ensure compliance with the applicable regulations, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The recordkeeping and reporting requested are required under 40 CFR Part 60, Subpart TT.

3( a) Nonduplication If the subject standards have not been delegated, the information is sent directly to the appropriate EPA Regional Office. Otherwise, the information is sent directly to the delegated State or local agency. If a State or local agency have adopted their own similar standards to implement the Federal standards, a copy of the report submitted to the State or local agency can be sent to the Administrator in lieu of the report required by the Federal standards. Therefore, no duplication exists. 4 3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on June 20, 2002.

3( c) Consultations No comments were received on the burden published in the Federal Register.

3( d) Effects of Less Frequent Collection Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR 1320.6.

3( f) Confidentiality The required information consists of emissions data and other information that have been determined not to be private. However, any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents to the recordkeeping and reporting requirements are facilities which conduct surface coating of metal coils. The SIC code for the respondents affected by the standards is SIC ( U. S. Standard Industrial Classification) 3479 which corresponds to the NAICS ( The North American Industry Classification System) 332812 for Metal Coating, Engraving ( Except Jewelry and Silverware), and Allied Services to Manufacturing. 5 4( b) Information Requested ( i) Data Items All data in this ICR that is recorded and/ or reported is required by 40 CFR Part 60, Subpart TT.

A source must make the following reports:

Reports for 40 CFR Part 60, Subpart TT Construction/ reconstruction 60.7( a)( 1)

Anticipated startup 60.7( a)( 2)

Actual startup 60.7( a)( 3)

Initial performance test results 60.8( a), 60.465( b)

Initial performance test 60.8( d), 60.465( b)

Demonstration of continuous monitoring system 60.7( a)( 5)

Physical or operational change 60.7( a)( 4)

A source must maintain the following records:

Recordkeeping for 40 CFR Part 60, Subpart TT Startups, shutdowns, malfunctions, periods where the continuous monitoring system is inoperative 60.7( b)

Excess emissions report 60.7( c), 60.465( c), 60.465( d)

Monthly performance test of volume weighted average emissions of VOCs kg/ l of coating solids applied 60.463( b), 60.463( c)

Record average VOC content of coatings applied monthly 60.464( a), 60.464( b)

For thermal incineration: install, calibrate, maintain, and operate temperature monitoring device 60.464( c)

Records are required to be retained for 2 years. The first two years of records must be retained at the facility. 60.7( f), 60.465( e)

For catalytic incineration: maintain daily records of upstream and downstream gas temperature 60.465( e)

Maintain daily records of incinerator combustion temperature, or amounts of solvent recovered 60.464( c), 60.465( e) 6 ( ii) Respondent Activities Respondent Activities Read instructions.

Install, calibrate, maintain, and operate a device that continuously records the combustion temperature of any effluent gases incinerated to achieve compliance.

Perform initial performance test, Reference Method 24 , Reference Method 25, or data provided by the formulator of the coating, and repeat performance tests if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of 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.

Transmit, or otherwise disclose the information.

5. The Information Collected: Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the AIRS ( Aerometric Information Retrieval System) Facility Subsystem ( AFS) database. 7 5( b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to determine whether the pollution control devices are properly installed and operated. Performance test reports are used by the Agency to discern a source's initial capability to comply with the emission standard, and note the operating conditions under which compliance was achieved. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into AFS which is operated and maintained by EPA's Office of Air Quality Planning and Standards. AFS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for more than 100,000 industrial and government owned facilities. EPA uses AFS for tracking air pollution compliance and enforcement by local and State regulatory agencies, EPA Regional Offices and EPA Headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or operator for two years.

5( c) Small Entity Flexibility A majority of the affected facilities are large entities ( e. g., large businesses). However, the impact on small entities ( i. e., small businesses) was taken into consideration during the development of the regulation. Due to technical considerations involving the process operations and the types of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities. The Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small entities. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 2: Industry Burden.

6. Estimating the Burden and Cost of the Collection Table 2 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the Subpart included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory. 8 The 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.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 14,530.5 ( Total Labor Hours from Table 2). These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NSPS program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses a Technical Labor Rate of $ 57.12 per hour. This rate is from the United States Department of Labor, Bureau of Labor Statistics, March 2001, " Table 10. Private industry, by occupational and industry group." The rates are from column 1, " Total compensation." The wage rate has been increased by 110% to account for the benefit packages available to those employed by private industry. The recordkeeping and reporting requirements in NSPS Subpart TT were designed to be performed by technical staff.

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs The types of industry costs associated with the information collection activity in the regulations are labor and Continuous Emission Monitors ( CEMs). The capital/ startup costs are one time costs when a facility becomes subject to the regulation. The annual operation and maintenance costs are the ongoing costs to maintain the monitor and other costs such as photocopying and postage.

( iii) Capital/ Startup vs. Operation and Maintenance ( O& M) Costs Capital/ Startup vs. Operation and Maintenance ( O& M) Costs ( A) Continuous Monitoring Device ( B) Startup Cost ($) for One Affected Facility ( C) Number of New Affected Facilities to Startup ( D) Total Startup ( B X C) ( E) Annual O& M Costs ($) for One Affected Facility ( F) Number of Affected Facilities with O& M ( G) Total O& M ( E X F)

Temperature 7,000 4 28,000 1,800 161 289,800 The total capital/ startup costs for this ICR are $ 28,000. This is the total of column D in the above table. These costs are shown in block 14( a), Total annualized capital/ startup costs, on the OMB 83 I form. It should be noted that the numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars. 9 The total operation and maintenance ( O& M) costs for this ICR are $ 289,800. This is the total of column G. These costs are shown in block 14( b), Total annual costs ( O& M), on the OMB 83 I form.

The total respondent non labor costs in block 14 have been calculated as the addition of the capital/ startup costs, and the annual operation and maintenance costs. The average annual cost for capital/ startup and operation and maintenance costs to industry over the next three years of the ICR is estimated to be $ 317,800. This cost is shown on the OMB 83 I form in block 14 ( c), Total annualized cost requested. The numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars.

6( c) Estimating Agency Burden and Cost The only costs to the Agency are those costs associated with analysis of the reported information. Publication and distribution of the information are part of the AFS program. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

The average annual Agency cost during the 3 years of the ICR is estimated to be $ 38,116 [ see Table 1 in Section 6( e)]. This cost is based on the average hourly labor rate at a GS 12, Step 1, times a 1.6 benefits multiplication factor to account for government overhead expenses for a total of $ 38.35. This rate is from the Office of Planning and Management's ( OPM) " 2002 General Schedule" which excludes locality rates of pay. Details upon which this estimate is based appear in Table 1, below.

6( d) Estimating the Respondent Universe and Total Burden and Costs Respondent Universe and Number of Responses/ Year Regulation Citation ( A) Number of New Sources/ Year ( B) Number of Reports for New Sources ( C) Number of Existing Sources ( D) Number of Reports for Existing Sources ( F) Number of Recordkeepers that do not submit reports ( E) Total Annual Responses = ( AxB)+( CxD)+ F New and no exceedence 4 4 161 2 338 Excess emission 132 0.5 66 The number of total respondents is 165. This number is the sum of Column A and Column C of the Respondent Universe table. This represents the number of existing sources plus the number of new sources averaged over the three year period. It is shown in block 13( a), Number of respondents, on the OMB 83 I form. 10 The number of Total Annual Responses is 404. This is the number in column E of the Respondent Universe table. It is shown in block 13( b), Total annual responses, on the OMB 83 I form. The total annual labor costs are $ 829,982. This number is not shown on the OMB 83 I form in block 13( c), Total hours requested. Only the burden hours are reflected in block 13( c). Details upon which this estimate is based appear in Table 2. Annual Respondent Burden and Cost.

The total annual capital and O& M costs to the regulated entity are $ 317,800. This number is shown on the OMB 83 I form in block 14( c), Total annualized cost requested. These costs are detailed in Section 6( b)( iii), Capital/ Startup vs. Operating and Maintenance ( O& M) Costs.

6( e) Bottom Line Burden Hours Burden Hours and Cost Tables The bottom line burden hours and cost tables for both the Agency and the respondents are attached.

6( f) Reasons for Change in Burden The decrease in burden from the most recently approved ICR is due to an adjustment. The adjustment decrease in burden from the most recently approved ICR is due to a decrease in the number of new sources each year. The change in burden for new and existing facilities is also due to a reduced cost for monitoring equipment. The primary reason for the burden decrease is due to an error in Tables 1 and 2 which over estimated the number of responses per year from existing sources. Instead of 2 responses for emission reports per year, the previous ICR used 2.5 reports per year. In addition, the number of responses due to excess emission reports was calculated as twice per year rather than the correct one half times per year.

6( g) Burden Statement 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 standards are listed in 40 CFR Part 9 and 48 CFR Chapter 15. 11 Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to Ms. Susan Auby, Collection Strategies Division ( Mail Code 2822T), Office of Environmental Information, United States Environmental Protection Agency, 1200 Pennsylvania Avenue, N. W., Washington, D. C. 20460 0001; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N. W., Washington, D. C. 20503, Attention: Desk Officer for EPA. Include the EPA ICR Number and OMB Control Number in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information. 12 TABLE 1: ANNUAL AGENCY BURDEN AND COST: NEW SOURCE PERFORMANCE STANDARD ( NSPS)  METAL COIL SURFACE COATING FACILITIES, 40 CFR PART 60, SUBPART TT REPORTING/ RECORDKEEPING REQUIREMENT EPA Hours/ Occurrence ( A) Occurrence / Plant/ Year ( B) EPA Hours/ Year ( C= A* B) ( C) Plants/ Year ( D) EPA Hours/ Year ( E= C* D) ( E)

INITIAL PERFORMANCE TESTS New Plant 24 1 24 4 96 REPEAT PERFORMANCE TEST New Plant 24 0.2 4.8 4 19.2 REPORT REVIEW New Plant Notification of Construction 2 1 2 4 8 Notification of Initial Startup 0.5 1 0.5 4 2 Notification of Actual Startup 0.5 1 0.5 4 2 Notification of Initial Test 0.5 1.2 0.6 4 2.4 Review Test Results 8 1.2 9.6 4 38.4 Existing Plant VOC Emissions Reports 2 2 4 165 660 Temperature Reports 2 0.5 1 132 132 TOTAL ANNUAL HOURS 960 ANNUAL TRAVEL EXPENSES ( 1 person x 2 plants/ year x 3 d/ plant x $ 100 per diem) + ($ 350 round trip/ plant x 2 plant/ yr) = $ 1,300.00 SALARY BURDEN ( per year)

1 person x 960 h/ yr x $ 38.35/ h = $ 36,816.00 TOTAL ANNUAL BURDEN $ 38,116.00 TABLE 1: ANNUAL AGENCY BURDEN AND COST: NEW SOURCE PERFORMANCE STANDARD ( NSPS)  METAL COIL SURFACE COATING FACILITIES, 40 CFR PART 60, SUBPART TT 13 Assumptions Number of new plants ( per year) 4 Rate of failed performance tests 20%

No net growth in number of facilities. New sources will replace existing sources.

Percentage of sources that use incineration. 80%

Time required to participate with performance test ( hours per plant) 24 Time require to review construction notification ( hours) 2 Time required to review startup and initial test notifications ( hours) 0.5 Time required to review performance test results ( hours) 8 EPA labor rate ( GS 12 Step 1 x 1.6 overhead) $ 38.35 Percentage of new plant visits 10%

Round trip airfare to visit plant $ 350 14 TABLE 2: ANNUAL RESPONDENT BURDEN AND COST: NEW SOURCE PERFORMANCE STANDARD ( NSPS)  METAL COIL SURFACE COATING FACILITIES, 40 CFR PART 60, SUBPART TT REPORTING/ RECORD KEEPING REQUIREMENT Hours/ Occurrenc e ( A) Occurrence/ Year ( B) Respondents/ Year ( C) Hours/ Year ( D= A* B* C) ( D) Costs/ Year ( E)

1. APPLICATIONS N/ A N/ A N/ A N/ A N/ A 2. SURVEY AND STUDIES N/ A N/ A N/ A N/ A N/ A 3. REPORTING REQUIREMENTS a. Read Instructions 1 1 4 4 $ 228.48 b. Required Activities Initial Performance Tests 60 1 4 240 $ 13,708.80 Repeat of Performance Tests 60 0.2 4 48 $ 2,741.76 c. Gather Existing Information  Included in 3b

d. Write Report Notification of Construction/ R econstruction 2 1 4 8 $ 456.96 Notification of Anticipated Startup 2 1 4 8 $ 456.96 Notification of Initial Performance Test 2 1 4 8 $ 456.96 Notification of Actual Startup 2 1 4 8 $ 456.96 Report of Performance Test  Included in 3b

Emissions Report 5 2 165 1650 $ 94,248.00 Temperature Variance Report 4 0.5 132 264 $ 15,079.68 TABLE 2: ANNUAL RESPONDENT BURDEN AND COST: NEW SOURCE PERFORMANCE STANDARD ( NSPS)  METAL COIL SURFACE COATING FACILITIES, 40 CFR PART 60, SUBPART TT 15 REPORTING/ RECORD KEEPING REQUIREMENT Hours/ Occurrenc e ( A) Occurrence/ Year ( B) Respondents/ Year ( C) Hours/ Year ( D= A* B* C) ( D) Costs/ Year ( E)

4. RECORDKEEPING REQUIREMENTS a. Read Instructions  Included in 3a

b. Plan Activities  Included in 3b

c. Implement Activities ( Monthly Perf. Test) 1 12 165 1980 $ 113,097.60 d. Develop Record System N/ A N/ A N/ A N/ A N/ A e. Time to Enter Information Records of Operating Parameter 0.25 250 165 10312.5 $ 589,050.00 TOTAL ANNUAL BURDEN 14530.5 $ 829,982.16 TABLE 2: ANNUAL RESPONDENT BURDEN AND COST: NEW SOURCE PERFORMANCE STANDARD ( NSPS)  METAL COIL SURFACE COATING FACILITIES, 40 CFR PART 60, SUBPART TT 16 Assumptions Number of facilities reporting ( per year). With 4 new facilities over three years, the average number of facilities reporting will be 165 = 161 + ( 3* 4)/ 3) 165 Rate of failed performance tests 20%

Percentage of facilities that use incineration. 80%

Number of new facilities ( per year) 4 Each plant will file an excess emission report every other year and a no exceedence report twice a year.

Assume operation 250 days per year as specified in the NSPS review document.

Technical labor rate ( Bureau of Labor Statistics) $ 57.12


[Federal Register: August 20, 2009 (Volume 74, Number 160)]
[Notices]
[Page 42080-42081]
[DOCID:fr20au09-43]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0374]

Educating the Public About Removal of Essential-Use Designation
for Epinephrine; Public Workshop; Request for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop; request for comments.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Educating the Public About Removal of Essential-Use
Designation for Epinephrine.'' The currently approved over-the-counter
(OTC) epinephrine metered-dose inhalers (MDIs) contain
chlorofluorocarbons (CFCs) and cannot be marketed after December 31,
2011. This 1-day public workshop is intended to seek input from key
stakeholders in the asthma community, the pharmaceutical industry,
experts in health care communication, and the public on strategies to
educate consumers about the decision to remove epinephrine MDIs from
the market and transition consumers to therapeutic alternatives that do
not contain CFCs or other ozone-depleting substances (ODSs). The agency
encourages individuals, patient advocates, industry, consumer groups,
health care professionals, researchers, and other interested persons to
attend this public workshop.

DATES:  The public workshop will be held on September 25, 2009, from
8:30 a.m. to 3 p.m. However, depending on public participation, the
meeting may be extended or may end early. See section III of this
document for information on how to register for the workshop. Written
or electronic comments must be submitted by November 24, 2009.

ADDRESSES:  The public workshop will be held at FDA's, Center for Drug
Evaluation and Research Advisory Committee Conference Room, 5630
Fishers Lane, rm. 1066, Rockville, MD 20852.
    Submit written or electronic requests to make a presentation to
Faith Dugan (see FOR FURTHER INFORMATION CONTACT). Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. All comments
should be identified with the docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT:  Faith Dugan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6182, Silver Spring, MD 20993-0002, 301-
796-3446, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Under the Montreal Protocol on Substances that Deplete the Ozone
Layer (Montreal Protocol) and the Clean Air Act,\1\ FDA, in
consultation with the Environmental Protection Agency, is required to
determine whether an FDA-regulated product that releases an ODS is an
essential use of the ODS. Products containing an ODS, such as CFCs,
that are not designated as essential uses cannot be sold or distributed
in the United States. In the Federal Register of November 19, 2008 (73
FR 69532) (the final rule), we amended our regulation on the use of
ODSs in self-pressurized containers to remove the essential-use
designation for MDIs containing epinephrine. Epinephrine MDIs
containing an ODS cannot be marketed after December 31, 2011. You may
find copies of the final rule on the Internet at http://
www.regulations.gov.
---------------------------------------------------------------------------

    \1\ Montreal Protocol on Substances that Deplete the Ozone
Layer, September 16, 1987, 26 I.L.M. 1541 (1987); 1990 Amendments to
the Clean Air Act, Public Law No. 101-549 (November 15, 1990).
---------------------------------------------------------------------------

    Epinephrine is a short-acting adrenergic bronchodilator used in the
treatment of asthma. A new drug application (NDA) for OTC epinephrine
MDIs was approved in 1956. Epinephrine was designated as an essential
use in 1978 (43 FR 11301, March 17, 1978). Epinephrine MDIs are
marketed OTC as PRIMATENE MIST and as generic brands for certain retail
pharmacies. Epinephrine MDIs are the only MDIs for treatment of asthma
(or any other disease) that are approved for OTC use. Consumers do not
need a prescription from a health care provider to purchase OTC
epinephrine MDIs.
    In removing the essential-use designation for epinephrine, we
applied the criteria for removing an essential-use designation in Sec.
2.125(g)(2) (21 CFR 2.125(g)(2)). Under Sec.  2.125(g)(2), an
essential-use designation can be removed even though the active moiety
is not available in a non-CFC product if it no longer meets the
criteria specified in Sec.  2.125(f) for adding a new essential use.
The criteria in Sec.  2.125(f)(1) are: ``(i) Substantial technical
barriers exist to formulating the product without ODSs;

(ii) The product will provide an unavailable important public health
benefit; and (iii) Use of the product does not release cumulatively
significant amounts of ODSs into the atmosphere or the release is
warranted in view of the unavailable important public health benefit.''
    In a proposed rule published on September 20, 2007 (72 FR 53711),
we proposed an effective date for removal of the essential-use
designation for OTC epinephrine MDIs of December 31, 2010, and we
solicited comments on this proposed effective date. We received a
number of comments on the effective date and on the related issue of
ensuring adequate time to transition consumers who use OTC epinephrine
MDIs to non-CFC alternatives. After considering the comments, we were
persuaded that December 31, 2011, rather than December 31, 2010, as
proposed, is a more appropriate effective date for this rule. The
December 31, 2011, date provides additional time to disseminate
information about the transition to OTC epinephrine MDI users and
allows consumers more time to transition to appropriate non-CFC
alternatives. Although at least one manufacturer has stated its intent
to develop an OTC epinephrine MDI without CFCs,\2\ there is no
assurance that the product will be available by December 31, 2011.
Thus, we assume that OTC epinephrine MDI users will need to transition
to therapeutic alternatives that contain a different active moiety,
such as prescription albuterol MDIs.
---------------------------------------------------------------------------

    \2\ See Comment from Mr. Robert Sussman on behalf of Armstrong
Pharmaceuticals, Inc., submitted in response to the Proposed Rule on
Use of Ozone-Depleting Substances; Removal of Essential-Use
Designation (Epinephrine) at 1-2 (dated November 21, 2007) (Document
ID FDA-2007-N-0314-0032, available on the Internet at http://
www.regulations.gov).
---------------------------------------------------------------------------

II. Scope of Public Workshop

    FDA is holding this public workshop to obtain information about
usage of OTC epinephrine MDIs and to discuss the best methods for
disseminating information to consumers who use these MDIs about the
need to transition to alternative treatments for asthma. At the public
workshop, FDA will provide relevant background information, including a
brief summary of the Montreal Protocol, the Clean Air Act, and the
epinephrine final rule. FDA also will present an update on the current
transition from CFC MDIs to non-CFC alternatives and FDA's related
outreach efforts. Presentations by patient outreach experts and other
stakeholders will provide a framework for discussion about OTC use of
epinephrine and how best to educate epinephrine users about the phase-
out and therapeutic alternatives. The input from the public workshop
will help FDA in developing further outreach and education campaigns to
assist consumers in the transition away from OTC epinephrine MDIs.

A. Objectives of the Workshop

    The workshop objectives are as follows:
    1. Provide an overview of the regulatory framework for the
transition and FDA's current outreach activities.
    2. Discuss what is known about current OTC epinephrine MDI usage
and the demand for OTC epinephrine MDIs.
    3. Discuss the therapeutic alternatives to OTC epinephrine MDIs.
    4. Discuss how best to educate consumers who use OTC epinephrine
MDIs about the phase-out and therapeutic alternatives.

B. Issues for Comment

    FDA is interested in obtaining public comment on the following
issues relating to the transition from OTC epinephrine MDIs to
therapeutic alternatives that do not contain ozone-depleting
substances:
    1. What is known about current OTC epinephrine MDI usage? Who uses
them and under what circumstances?
    2. What sales data are available and what do they indicate about
use of OTC epinephrine MDIs?
    3. What treatment alternatives are available for consumers who must
switch from OTC epinephrine MDIs?
    4. What are effective outreach strategies for informing consumers
who use OTC epinephrine MDIs about the transition?
    5. What other education efforts should FDA undertake to effect an
orderly transition?

III. Registration

    Interested parties are encouraged to register early because space
is limited and seating will be on a first-come, first-served basis.
There is no fee to attend the public workshop. If you would like to
make an oral presentation during the open public session of the
workshop, you must register and provide an abstract of your
presentation by close of business on September 11, 2009. To register to
attend or speak at the public workshop, submit your name, title,
business affiliation (if applicable), address, telephone and fax
numbers, and e-mail address to Faith Dugan (see FOR FURTHER INFORMATION
CONTACT). FDA has included questions for comment in section II of this
document. You may identify by number each question you wish to address
in your presentation and the approximate time requested for your
presentation. FDA will do its best to accommodate requests to speak.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations and to request time for a
joint presentation. FDA will determine the amount of time allotted to
each presenter and the approximate time that each oral presentation is
scheduled to begin. Persons registered to make an oral presentation
should check in at the registration table at 8 a.m.
    If you need special accommodations due to a disability, please
contact Faith Dugan (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance.

IV. Comments

    Regardless of attendance at the public workshop, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments should be identified 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.

V. Transcripts

    Transcripts of the public workshop may be requested in writing from
the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 45 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at http://www.regulations.gov.

    Dated: August 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19985 Filed 8-19-09; 8:45 am]

BILLING CODE 4160-01-S


Appendix V to 40 CFR Part 51 -- Criteria for Determining the Completeness of Plan Submissions
                          Technical Support Document
                                   Criterion
                                    Status
(a) Identification of all regulated pollutants affected by the plan.
All Pollutants
(b) Identification of the locations of affected sources including the EPA attainment/nonattainment designation of the locations and the status of the attainment plan for the affected areas(s).
Affected sources are located in Knox County.  Knox County is currently designated as "nonattainment" for the 1997 and 2006 PM2.5 standard and either "attainment" or "unclassifiable/attainment" for all other National Ambient Air Quality Standards.
(c) Quantification of the changes in plan allowable emissions from the affected sources; estimates of changes in current actual emissions from affected sources or, where appropriate, quantification of changes in actual emissions from affected sources through calculations of the differences between certain baseline levels and allowable emissions anticipated as a result of the revision.
N/A
(d) The State's demonstration that the national ambient air quality standards, prevention of significant deterioration increments, reasonable further progress demonstration, and visibility, as applicable, are protected if the plan is approved and implemented. For all requests to redesignate an area to attainment for a national primary ambient air quality standard, under section 107 of the Act, a revision must be submitted to provide for the maintenance of the national primary ambient air quality standards for at least 10 years as required by section 175A of the Act.
N/A
(e) Modeling information required to support the proposed revision, including input data, output data, models used, justification of model selections, ambient monitoring data used, meteorological data used, justification for use of offsite data (where used), modes of models used, assumptions, and other information relevant to the determination of adequacy of the modeling analysis.
N/A
(f) Evidence, where necessary, that emission limitations are based on continuous emission reduction technology.
N/A
(g) Evidence that the plan contains emission limitations, work practice standards and recordkeeping/reporting requirements, where necessary, to ensure emission levels.
N/A
(h) Compliance/enforcement strategies, including how compliance will be determined in practice.
N/A
(i) Special economic and technological justifications required by any applicable EPA policies, or an explanation of why such justifications are not necessary.
N/A


[Federal Register: August 23, 2010 (Volume 75, Number 162)]
[Notices]
[Page 51837]
[DOCID:fr23au10-105]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1930-DR; Docket ID FEMA-2010-0002]

Iowa; Amendment No. 2 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Iowa (FEMA-1930-DR), dated July 29, 2010, and related
determinations.

DATES: Effective Date: August 14, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Iowa is hereby amended to include the Individual
Assistance program for the following areas among those areas determined
to have been adversely affected by the event declared a major disaster
by the President in his declaration of July 29, 2010.

Hamilton, Ida, Kossuth, and Taylor Counties for Individual
Assistance.

Black Hawk, Cherokee, Clayton, Decatur, Delaware, Dubuque, Fayette,
Franklin, Howard, Humboldt, Jackson, Jones, Lee, Lucas, Lyon,
Marion, O'Brien, Osceola, Ringgold, Sioux, Story, Union, Warren,
Webster, and Wright Counties for Individual Assistance (already
designated for Public Assistance).

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-20773 Filed 8-20-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 137 (Wednesday, July 17, 2019)]
[Proposed Rules]
[Pages 34073-34075]
[FR Doc No: 2019-15105]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0538; Airspace Docket No. 19-AEA-4]
RIN 2120-AA66

Proposed Amendment of VOR Federal Airway V-37 Due to the Planned
Decommissioning of Aylmer, Canada, VHF Omnidirectional Range (VOR)
Navigation Aid

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend VHF Omnidirectional Range (VOR)
Federal airway V-37 in the northeast United States to reflect changes
being made in Canadian airspace. The modification is necessary due to
the planned decommissioning of the Aylmer, Canada, VOR navigation aid
(NAVAID), which provides navigation guidance for portions of V-37. The
Aylmer VOR is being decommissioned as part of NAV CANADA's NAVAID
Modernization Program.

DATES: Comments must be received on or before September 3, 2019.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2019-0538; Airspace Docket No. 19-AEA-4 at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov.
    FAA Order 7400.11C, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11C at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that

section, the FAA is charged with prescribing regulations to assign the
use of the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify the National Airspace System as necessary
to preserve the safe and efficient flow of air traffic.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2019-0538; Airspace Docket No. 19-AEA-4) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2019-0538; Airspace Docket No. 19-AEA-4.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Operations Support Group, Central
Service Center, Federal Aviation Administration, 10101 Hillwood Blvd.,
Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace
Designations and Reporting Points, dated August 13, 2018, and effective
September 15, 2018. FAA Order 7400.11C is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11C lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

Background

    NAV CANADA, which operates Canada's civil air navigation service,
is continuing to implement various changes to Canada's instrument
flight rules (IFR) navigation infrastructure as part of their NAVAID
Modernization Program to enhance the efficiency of operations by taking
advantage of performance based navigation and modern avionic
capabilities. The changes being implemented by NAV CANADA occasionally
affect parts of U.S. VOR Federal airways that extend into Canadian
airspace. As a result, changes are required to the V-37 description to
mirror changes that have been made previously and that are planned to
be made on the Canadian side of the border.
    In 2014, NAV CANADA published their Aeronautical Information
Regulation And Control (AIRAC) Canada update, AIRAC Issue 34, effective
November 13, 2014, which revoked the V-37 airway segment from the JARVS
fix to the Toronto, ON, Canada, VOR/DME within Canadian airspace. Then,
in 2015, NAV CANADA published the Canada Aeronautical Charts
Supplement, Volume 19/Number 5, effective August 20, 2015, which
reflected the FOWEL and JARVS fixes on V-37 being composed using
radials from the Aylmer VOR. Unfortunately, the FAA overlooked
accomplishing Part 71 rulemaking actions to incorporate these two
amendment activities at the time.
    Today, NAV CANADA is planning the decommissioning of the Aylmer,
Canada, VOR in March 2020 as one of the VORs identified in their NAVAID
Modernization Program. With the planned decommissioning of the Aylmer
VOR, the ground-based NAVAID coverage in the area is insufficient to
continue to define the JARVS and FOWEL fixes along V-37 within Canada
using intersecting VOR radials. Cleveland Air Route Traffic Control
Center, Buffalo Terminal Radar Approach Control, and NAV CANADA have
agreed that usage of the V-37 airway segment north of the Erie, PA,
VOR/Tactical Air Navigation (VORTAC) NAVAID for cross border air
traffic is minimal and that there is adequate radar coverage over the
area to provide air traffic control (ATC) services. As such, the
proposed modification to V-37 would result in the airway terminating at
the Erie VORTAC and not crossing into Canada. To overcome the loss of
the airway segments extending beyond the Erie VORTAC into Canada, NAV
CANADA plans to convert the JARVS and FOWEL fixes to waypoints. IFR
traffic could file point to point through the affected area using the
waypoints that will be established, or receive ATC radar vectors
through the area. Visual flight rules pilots who elect to navigate via
the airways through the affected area could also take advantage of the
waypoints or ATC services listed previously.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to modify VOR Federal airway V-37. The
planned decommissioning of the Aylmer, Canada, VOR has made this action
necessary. The proposed change is outlined below.
    V-37: V-37 currently extends between the Craig, FL, VORTAC and the
Toronto, ON, Canada, VOR/DME, excluding the airspace within Canada. The
FAA proposes to remove the airway segments between the Erie, PA, VORTAC
and the Toronto, ON, Canada, VOR/DME, and the language excluding the
airspace within Canada. The unaffected portions of the existing airway
would remain as charted.
    All radials in the route description below are unchanged and stated
in True degrees.
    VOR Federal airways are published in paragraph 6010(a) of FAA Order
7400.11C dated August 13, 2018, and effective September 15, 2018, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal airways
listed in this document would be subsequently published in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C,
Airspace Designations and Reporting Points, dated August 13, 2018, and
effective September 15, 2018, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-37 [Amended]

    From Craig, FL; Brunswick, GA; INT Brunswick 014[deg] and
Savannah, GA, 177[deg] radials; Savannah; Allendale, SC; Columbia,
SC; Charlotte, NC; Pulaski, VA; Elkins, WV; Clarksburg, WV; INT
Clarksburg 359[deg] and Ellwood City, PA, 185[deg] radials; Ellwood
City; to Erie, PA.
* * * * *

    Issued in Washington, DC, on July 8, 2019.
Rodger A. Dean Jr.,
Manager, Airspace Policy Group.
[FR Doc. 2019-15105 Filed 7-16-19; 8:45 am]
BILLING CODE 4910-13-P


Similar to unaffected facilities, foreign producers are not directly affected by the regulation but will be included in the model as a single representative supplier. Supply of clay products from foreign producers ( qI) may be expressed by the following general formula for each product:

where p is the market price for the product,   I is the import supply elasticity ( assumed to be 1.5), and AI is a multiplicative supply parameter that calibrates the supply equation for each product given data on price and the foreign supply elasticity to replicate the observed 1999 level of imports.

B. 2 Demand for Brick and Structural Clay Products Market demand for each structural clay product ( Qd) may be expressed as the sum of domestic and foreign demand:

Qd = qd + qx ( B. 7)

where qd is the domestic demand and qx is the foreign demand, or exports, as described below.

B. 2.1 Domestic Demand Domestic demand for each clay product may be expressed by the following general formula for each product: B 14 q d

Bd p   d ( B. 8)

q x

Bx p   x ( B. 9)

where p is the market price for the product,   d is the domestic demand elasticity ( assumed to be  1.5), and Bd is a multiplicative demand parameter that calibrates the demand equation for each product given data on price and the domestic demand elasticity to replicate the observed 1999 level of domestic consumption.

B. 2.2 Foreign Demand ( Exports)

Foreign demand, or exports, for each structural clay product may be expressed by the following general formula for each product:

where p is the market price for the product,   x is the export demand elasticity ( assumed to be equal to  1.5), and Bx is a multiplicative demand parameter that calibrates the foreign demand equation for each product given data on price and the foreign demand elasticity to replicate the observed 1999 level of exports.

B. 3 Post Regulatory Market Equilibrium Determination Facility responses and market adjustments can be conceptualized as an interactive feedback process. Facilities face increased production costs due to compliance, which causes facility specific production responses ( i. e., output reduction). The cumulative effect of these responses leads to an increase in the market price that all producers ( affected and unaffected) and consumers face, which leads to further responses by producers ( affected and unaffected) as well as consumers and thus new market prices, and so on. The new equilibrium after imposing the regulation is the result of a series of iterations between B 15 producer and consumer responses and market adjustments until a stable market price arises where total market supply equals total market demand ( Qs = Qd).

This process for determining equilibrium price ( and output) with the increased production cost is modeled as a Walrasian auctioneer. The auctioneer calls out a market price for each product and evaluates the reactions by all participants ( producers and consumers), comparing total quantities supplied and demanded to determine the next price that will guide the market closer to equilibrium ( i. e., where market supply equals market demand). Decision rules are established to ensure that the process will converge to an equilibrium, in addition to specifying the conditions for equilibrium. The result of this approach is a vector of prices with the proposed regulation that equilibrates supply and demand for each product.

The algorithm for deriving the post compliance equilibria in all markets can be generalized to five recursive steps:

1) Impose the control costs on each affected facility, thereby affecting their supply decisions.

2) Recalculate the market supply of each structural clay product.

3) Determine the new prices via the price revision rule for both markets.

4) Recalculate the supply functions of all facilities with the new prices, resulting in a new market supply of each product. Evaluate market demand at the new prices.

5) Go to Step # 3, resulting in new prices for each product. Repeat until equilibrium conditions are satisfied in all markets ( i. e., the ratio of supply to demand is arbitrarily small for each product). C 16 APPENDIX C ESTIMATING CHANGES IN ECONOMIC WELFARE The economic welfare implications of the market price and output changes with the regulation can be examined using two slightly different tactics, each giving a somewhat different insight but the same implications: ( 1) changes in the net benefits of consumers and producers based on the price changes and ( 2) changes in the total benefits and costs of these products based on the quantity changes. This analysis focuses on the first measure   the changes in the net benefits of consumers and producers.

Figure C 1 depicts the change in economic welfare in a competitive market by first measuring the change in consumer surplus and then the change in producer surplus. In essence, the demand and supply curves previously used as predictive devices are now being used as a valuation tool.

This method of estimating the change in economic welfare with the regulation divides society into consumers and producers. In a market environment, consumers and producers of the good or service derive welfare from a market transaction.

The difference between the maximum price consumers are willing to pay for a good and the price they actually pay is referred to as " consumer surplus." Consumer surplus is measured as the area under the demand curve and above the price of the product.

Similarly, the difference between the minimum price producers are willing to accept for a good and the price they actually receive is referred to as " producer surplus" or profits. Producer surplus is measured as the area above the supply curve and below the C 17 price of the product. These areas can be thought of as consumers' net benefits of consumption and producers' net benefits of production, respectively.

In Figure C 1, baseline equilibrium in the competitive market occurs at the intersection of the demand curve, D, and supply curve, S. Price is P l with quantity Q l. The increased cost of production with the regulation will cause the market supply curve to shift upward to S

. The new equilibrium price of the product is P 2. With a higher price for the product, there is less consumer welfare, all else being unchanged as real incomes are reduced. In Figure C 1( a), area A represents the dollar value of the annual net loss in consumers' benefits with the increased price. C 18 P 1 P 2 Q 1 Q 2 S S'

D Q/ t $/ Q ( a) Change in Consumer Surplus with Regulation P 1 P 2 Q 1 Q 2 S S'

D Q/ t $/ Q ( b) Change in Producer Surplus with Regulation P 1 P 2 Q 1 Q 2 S S'

D Q/ t $/ Q ( c) Net Change in Economic Welfare with Regulation A B C D Figure C 1. Economic Welfare Changes with Regulation Under Perfect Competition C 19 The rectangular portion represents the loss in consumer surplus on the quantity still consumed, Q 2, while the triangular area represents the foregone surplus resulting from the reduced quantity consumed, Q l   Q 2.

In addition to the changes in consumer welfare, producer welfare also changes with the regulation. With the increase in market price, producers receive higher revenues on the quantity still purchased, Q 2. In Figure C 1( b), area B represents the increase in revenues due to this increase in price. The difference in the area under the supply curve up to the original market price, area C, measures the loss in producer surplus, which includes the loss associated with the quantity no longer produced. The net change in producer welfare is represented by area B   C.

The change in economic welfare attributable to the compliance costs of the regulation is the sum of consumer and producer surplus changes, that is,   ( A) + ( B   C). Figure C 1( c) shows the net ( negative) change in economic welfare associated with the regulation as area D. However, this analysis does not include the benefits that occur outside the market ( i. e., the value of the reduced levels of air pollution with the regulation). Including this benefit will reduce the net cost of the regulation, and may result in overall net positive benefits to society.


[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Rules and Regulations]
[Page 42010]
[FR Doc No: 2013-16811]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0469]

Drawbridge Operation Regulation; Isle of Wight (Sinepuxent) Bay,
Ocean City, MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from regulation.

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SUMMARY: The Commander Fifth Coast Guard District has issued a
temporary deviation from the regulations governing the operation of the
US 50 Bridge, over Isle of Wight (Sinepuxent) Bay, mile 0.5, at Ocean
City, MD. The deviation is necessary to accommodate the 10th annual
``Island 2 Island'' Half Marathon. This deviation allows the drawbridge
to remain in the closed position to vessels during the race.

DATES: This deviation is effective from 8 a.m. until 10:30 a.m. April
26, 2014.

ADDRESSES: The docket for this deviation [USCG-2013-0469] is available
at http://www.regulations.gov. Type the docket number in the ``Search''
box and click ``Search.'' Click on the Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140, on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Kashanda Booker, Bridge Management
Specialist, Fifth Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Barbara Hairston, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: OC Tri Running Sports, on behalf of Maryland
Transportation Authority, has requested a temporary deviation from the
current operating regulations of the US 50 Bridge across Isle Wight
(Sinepuxent) Bay mile 0.5, at Ocean City, MD.
    The closure has been requested to ensure the safety of the
increased volume of runners and spectators that will be participating
in the 10th annual ``Island 2 Island'' Half Marathon on April 26, 2014.
The event is expected to bring in over 4,000 runners and 6,000
spectators. The OC Tri Sports is extending the course to 13.1 miles to
accommodate the request of the community. Under this temporary
deviation, the Route 50 Bridge will remain in the closed position to
vessels, from 8 a.m. through 10:30 a.m. Information provided by our
Coast Guard Station Ocean City reveals that, in the past, vessel
traffic for that time of year is very limited with most vessels being
small enough to pass without a bridge lift. The US 50 Bridge, over Isle
of Wight (Sinepuxent) Bay, mile 0.5, at Ocean City, MD has a vertical
clearance in the closed position to vessels of 13 feet above mean high
water. Vessels that can pass under the bridge without a bridge opening
may do so at any time and are advised to proceed with caution. The
Atlantic Ocean is the alternate route for vessels with mast heights
greater than 13 feet transiting this section of Isle of Wight
(Sinepuxent) Bay. At all other times during the effected period, the
bridge will operate as outlined at 33 CFR 117.559.
    The Coast Guard will inform waterway users through our Local and
Broadcast Notices to Mariners of the closure periods for the bridge so
that vessels can arrange their transits to minimize any impacts caused
by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: July 3, 2013.
Waverly W. Gregory, Jr.,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2013-16811 Filed 7-12-13; 8:45 am]
BILLING CODE 9110-04-P