[Federal Register: October 28, 2010 (Volume 75, Number 208)]
[Notices]
[Page 66391-66393]
[DOCID:fr28oc10-59]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0049]

Regulations Containing Procedures for Handling of Retaliation
Complaints; Extension of the Office of Management and Budget's (OMB)
Approval of Information Collection (Paperwork) Requirements

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

ACTION: Request for public comments.

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SUMMARY: OSHA solicits comments concerning its proposal to extend OMB
approval of the information collection requirements for handling of
retaliation complaints filed under various whistleblower protection
statutes contained in regulations at: 29 CFR part 24, Procedures for
the Handling of Retaliation Complaints under Federal Employee
Protection Statutes; 29 CFR part 1977, Discrimination Against Employees
Exercising Rights under the Williams-Steiger Occupational Safety and
Health Act; 29 CFR part 1978, Procedures for the Handling of
Retaliation Complaints under the Employee Protection Provision of the
Surface Transportation Assistance Act of 1982; 29 CFR part 1979,
Procedures for Handling Discrimination Complaints Under Section 519 of
the Wendell H. Ford Aviation Investment and Reform Act for the 21st
Century; 29 CFR part 1980, Procedures for Handling of Discrimination
Complaints Under Section 806 of the Corporate and Criminal Fraud
Accountability Act of 2002, Title VIII of the Sarbanes-Oxley Act 2002;
29 CFR part 1981, Procedures for the Handling of Discrimination
Complaints under Section 6 of the Pipeline Safety and Improvement Act
of 2002; 29 CFR part 1982, Procedures for the Handling of Retaliation
Complaints Under the National Transit Systems Security Act of 2007,
Enacted as Section 1413 of the Implementing Recommendations of the 9/11
Commission Act of 2007, and the

Federal Railroad Safety Act, as Amended by Section 1521 of the
Implementing Recommendations of the 9/11 Commission Act of 2007; and 29
CFR part 1983, Procedures for the Handling of Retaliation Complaints
Under Section 219 of the Consumer Product Safety Improvement Act of
2008. These regulations set forth procedures employees must use to file
a complaint with OSHA alleging that their employer violated a
whistleblower protection provision contained in certain statutes that
prohibit retaliatory action by employers against employees who engage
in activities protected by the statutes.

DATES: Comments must be submitted (postmarked, sent, or received) by
December 27, 2010.

ADDRESSES: Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, and messenger or courier
service: You must submit your comments and attachments to the OSHA
Docket Office, OSHA Docket No. OSHA-2010-0049, U.S. Department of
Labor, Occupational Safety and Health Administration, Room N-2625, 200
Constitution Avenue, NW., Washington, DC 20210. Deliveries (hand,
express mail, and messenger or courier service) are accepted during the
Department of Labor's and Docket Office's normal business hours, 8:15
a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA-2010-
0049). All comments, including any personal information you provide,
are placed in the public docket without change, and will be made
available online at http://www.regulations.gov. For further information
on submitting comments see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may obtain a copy of the ICR by
contacting Theda Kenney or Todd Owen, Directorate of Standards and
Guidance, OSHA, U.S. Department of Labor, Room N-3609, 200 Constitution
Avenue, NW., Washington, DC 20210; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Nilgun Tolek, Office of the
Whistleblower Protection Program, Directorate of Enforcement Programs,
OSHA, U.S. Department of Labor, Room N-3610, 200 Constitution Avenue,
NW., Washington, DC 20210; telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (e.g., an employee filing a retaliation
complaint) burden, conducts a preclearance consultation program to
provide the public with an opportunity to comment on proposed and
continuing information collection requirements in accordance with the
Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program
ensures that information is in the desired format, reporting burden
(time and costs) is minimal, collection instruments are clearly
understood, and OSHA's estimate of the information collection burden is
accurate.
    The Agency is responsible for investigating alleged violations of
``whistleblower'' provisions contained in a number of statutes. These
whistleblower provisions prohibit retaliation by employers against
employees who report alleged violations of certain laws or regulations.
Accordingly, these provisions prohibit an employer from discharging or
taking any other retaliatory action against an employee because the
employee engages in any of the protected activities specified by the
whistleblower provisions of the statutes.
    These statutes are covered under the following regulations: 29 CFR
part 24, Procedures for the Handling of Retaliation Complaints under
Federal Employee Protection Statutes (29 CFR part 24 covers: Safe Water
Drinking Act, 42 U.S.C. 300j-9(i); Federal Water Pollution Control Act,
33 U.S.C. 1367; Toxic Substances Control Act, 15 U.S.C. 2622; Solid
Waste Disposal Act, 42 U.S.C. 6971; Clean Air Act, 42 U.S.C. 7622;
Energy Reorganization Act of 1974, 42 U.S.C. 5851; and the
Comprehensive Environmental Response, Compensation and Liability Act,
42 U.S.C. 9610); 29 CFR part 1977, Discrimination Against Employees
Exercising Rights under the Williams-Steiger Occupational Safety and
Health Act (29 CFR part 1977 covers: the Occupational Safety and Health
Act, 29 U.S.C. 660; the Asbestos Hazard Emergency Response Act, 15
U.S.C. 2651; and the International Safe Container Act, 46 U.S.C.
80507); 29 CFR part 1978, Procedures for the Handling of Retaliation
Complaints under the Employee Protection Provision of the Surface
Transportation Assistance Act of 1982; 29 CFR part 1979, Procedures for
Handling Discrimination Complaints Under the Wendell H. Ford Aviation
Investment and Reform Act for the 21st Century; 29 CFR part 1980,
Procedures for Handling of Discrimination Complaints Under Section 806
of the Corporate and Criminal Fraud Accountability Act of 2002, Title
VIII of the Sarbanes-Oxley Act of 2002; 29 CFR part 1981, Procedures
for the Handling of Discrimination Complaints under Section 6 of the
Pipeline Safety and Improvement Act of 2002; 29 CFR part 1982,
Procedures for the Handling of Retaliation Complaints Under the
National Transit Systems Security Act of 2007, Enacted as Section 1413
of the Implementing Recommendations of the 9/11 Commission Act of 2007,
and the Federal Railroad Safety Act, as Amended by Section 1521 of the
Implementing Recommendations of the 9/11 Commission Act of 2007; and 29
CFR part 1983, Procedures for the Handling of Retaliation Complaints
Under Section 219 of the Consumer Product Safety Improvement Act of
2008. Information collection requirements contained in future
regulations promulgated by the Agency with respect to a whistleblower
provision of any other Federal law, except those that are assigned to
another DOL agency, will be added to this information collection.
    These regulations specify the procedures that an employee must use
to file a complaint with OSHA alleging that their employer violated a
whistleblower provision for which the Agency has investigative
responsibility. Any employee who believes that such a violation
occurred may file a complaint, or have the complaint filed on their
behalf. Four of these regulations, 29 CFR parts 24, 1979, 1980 and
1981, require that complaints must be filed in writing, and should
include a full statement of the acts and omissions, with pertinent
dates, that are believed to constitute the violation. The other
regulations, 29 CFR

parts 1977, 1978, 1982, and 1983, require no particular form of filing
for complaints.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on individuals who must
comply; for example, by using automated or other technological
information collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirements contained in the regulations containing
procedures for handling retaliation complaints at 29 CFR parts 24,
1978, 1979, 1980, 1981, 1982, and 1983.\1\ OSHA is proposing to
increase the burden hours in the currently approved information
collection request from 390 burden hours to 2,160 burden hours (a total
increase of 1,770 hours). These information collection requirements are
included in this extension. This increase is due to the Agency's
determination that all of the Agency's regulations containing
procedures for the investigation of retaliation complaints, regardless
of the form used to file a complaint, contain information collection
requirements associated with the initiation of the complaint. The
increase is also due to updated information showing an increase in the
annual number of complaints filed. The Agency will summarize the
comments submitted in response to this notice, and will include this
summary in the request to OMB.
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    \1\ Several of these regulations use the term ``discrimination''
or ``discrimination complaints'' in their titles. These terms are
synonymous with ``retaliation'' and ``retaliation complaints,''
respectively.
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    Type of Review: Extension of a currently approved collection.
    Title: Regulations Containing Procedures for Handling Retaliation
Complaints.
    OMB Number: 1218-0236.
    Affected Public: Individuals.
    Number of Respondents: 2,160.
    Frequency of Recordkeeping: Once per complaint.
    Average Time per Response: 1 hour.
    Total Annual Hours Requested: 2,160.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2010-0049). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, and messenger or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://
www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit
comments and access the docket is available at the Web site's ``User
Tips'' link. Contact the OSHA Docket Office for information about
materials not available through the Web site, and for assistance in
using the Internet to locate docket submissions.

V. Authority and Signature

    David Michaels, PhD, MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 4-2010
(75 FR 55355).

    Signed at Washington, DC, on October 25, 2010.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2010-27264 Filed 10-27-10; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 78, Number 129 (Friday, July 5, 2013)]
[Rules and Regulations]
[Pages 40382-40383]
[FR Doc No: 2013-16036]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0258; Airspace Docket No. 13-ANM-12]

Modification of Class D and E Airspace; Twin Falls, ID

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies Class E airspace at Twin Falls Joslin
Field-Magic Valley Regional Airport, Twin Falls, ID, to accommodate
aircraft using the Navigation (RNAV) Global Positioning System (GPS)
and the Instrument Landing System (ILS) or Localizer (LOC) standard
instrument approach procedures at the airport. This action also updates
the geographic coordinates of the airport and navigation aid for the
respective Class E airspace areas, as well as corrects the airport name
to Twin Falls Joslin Field-Magic Valley Regional Airport. Reference to
Class D airspace, omitted from the Title in the notice of proposed
rulemaking is included in this rule. This improves the safety and
management of Instrument Flight Rules (IFR) operations at the airport.

DATES: Effective date, 0901 UTC, October 17, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On May 1, 2013, the FAA published in the Federal Register a notice
of proposed rulemaking (NPRM) to modify controlled airspace at Twin
Falls Joslin Field-Magic Valley Regional Airport, Twin Falls, ID (78 FR
25406). Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal to the
FAA. No comments were received. Subsequent to publication, the FAA
found that the Class D airspace reference was omitted from the Title,
and is added in this rule to note the airport's name change. Except for
editorial changes, and the changes made above, this rule is the same as
published in the NPRM.
    Class D and E airspace designations are published in paragraphs
5000, 6002, 6004 and 6005, respectively, of FAA Order 7400.9W dated
August 8, 2012, and effective September 15, 2012, which is incorporated
by reference in 14 CFR 71.1. The Class D and Class E airspace
designations listed in this document will be published subsequently in
that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by modifying Class E airspace extending upward from 700 feet
above the surface and 1,200 feet above the surface at Twin Falls Joslin
Field-Magic Valley Regional Airport, Twin Falls, ID, to accommodate
aircraft using the RNAV (GPS) and the ILS or LOC standard instrument
approach procedures at the airport. Also, the geographic coordinates of
the airport and Twin Falls VHF Omni-Directional Radio Range Tactical
Air Navigation Aid (VORTAC) is updated to coincide with the FAA's
aeronautical database for the respective Class E airspace areas. This
action is necessary for the safety and management of IFR operations.
The airport formerly called Twin Falls-Sun Valley Regional Airport,
Joslin Field or Joslin Field-Magic Valley Regional is renamed Twin
Falls Joslin Field-Magic Valley Regional Airport under its respective
Class D and E airspace areas.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under 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
only affects air traffic procedures and air navigation, it is certified
this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act. The FAA's authority to issue rules
regarding aviation safety is found in Title 49 of the U.S. Code.
Subtitle 1, Section 106 discusses 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 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 modifies
controlled airspace at Twin Falls Joslin Field-Magic Valley Regional
Airport, Twin Falls, ID.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 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 14 CFR Part 71 continues to read as
follows:

    Authority: 49 U.S.C. 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 the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and

effective September 15, 2012 is amended as follows:

Paragraph 5000 Class D airspace.

* * * * *

ANM ID D Twin Falls, ID [Modified]

Twin Falls Joslin Field-Magic Valley Regional Airport, ID
    (Lat. 42[deg]28'55'' N., long. 114[deg]29'16'' W.)

    That airspace extending upward from the surface to and including
6,700 feet MSL within a 4.3-mile radius of Twin Falls Joslin Field-
Magic Valley Regional Airport. This Class D airspace area is
effective during the specific dates and times established in advance
by a Notice to Airmen. The effective date and time will thereafter
be continuously published in the Airport/Facility Directory.

Paragraph 6002 Class E airspace designated as surface areas.

* * * * *

ANM ID E2 Twin Falls, ID [Modified]

Twin Falls Joslin Field-Magic Valley Regional Airport, ID
    (Lat. 42[deg]28'55'' N., long. 114[deg]29'16'' W.)

    Within a 4.3-mile radius of Twin Falls Joslin Field-Magic Valley
Regional Airport. This Class E airspace area is effective during the
specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Airport/Facility Directory.

Paragraph 6004 Class E airspace designated as an extension to Class
D surface area.

* * * * *

ANM ID E4 Twin Falls, ID [Modified]

Twin Falls Joslin Field-Magic Valley Regional Airport, ID
    (Lat. 42[deg]28'55'' N., long. 114[deg]29'16'' W.)
Twin Falls VORTAC
    (Lat. 42[deg]28'48'' N., long. 114[deg]29'22'' W.)

    That airspace extending upward from the surface 4.2 miles south
and 4.4 miles north of the Twin Falls VORTAC 086[deg] and 281[deg]
radials extending from the 4.3-mile radius of Twin Falls Joslin
Field-Magic Valley Regional Airport to 9.2 miles east and 9.2 miles
west of the VORTAC. This Class E airspace area is effective during
the specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Airport/Facility Directory.

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ANM ID E5 Twin Falls, ID [Modified]

Twin Falls Joslin Field-Magic Valley Regional Airport, ID
    (Lat. 42[deg]28'55'' N., long. 114[deg]29'16'' W.)

    That airspace extending upward from 700 feet above the surface
within 10.5 miles north and 6 miles south of the Twin Falls Joslin
Field-Magic Valley Regional Airport 086[deg] bearing extending 26.1
miles east, and within 4.3 miles each side of the airport 156[deg]
bearing extending 8.3 miles southeast and within 10.3 miles north
and 7.3 miles south of the airport 281[deg] bearing extending 20
miles west; that airspace extending upward from 1,200 feet above the
surface bounded by a line beginning at lat. 43[deg]22'00'' N., long.
115[deg]08'00'' W.; to lat. 43[deg]09'00'' N., long. 114[deg]03'00''
W.; to lat. 42[deg]33'00'' N., long. 114[deg]03'00'' W.; to lat.
42[deg]18'00'' N., long. 114[deg]06'00'' W.; to lat. 41[deg]48'00''
N., long. 115[deg]00'00'' W.; to lat. 43[deg]01'00'' N., long.
115[deg]20'00'' W., thence to the point of beginning.

    Issued in Seattle, Washington, on June 24, 2013.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-16036 Filed 7-3-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Page 23418]
[FR Doc No: 2021-09171]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4535-DR; Docket ID FEMA-2021-0001]

Wyoming; Amendment No. 4 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 Wyoming (FEMA-4535-DR), dated April 11, 2020, and
related determinations.

DATES: This amendment was issued March 11, 2021.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Wyoming is hereby amended to include Individual
Assistance limited to COVID-19 Funeral Assistance under Other Needs
Assistance for those areas determined to have been adversely affected
by the event declared a major disaster by the President in his
declaration of April 11, 2020.

    Individual Assistance limited to COVID-19 Funeral Assistance
under Other Needs Assistance for all areas in the State of Wyoming
(already designated for Individual Assistance, limited to the Crisis
Counseling Program and emergency protective measures [Category B]
not authorized under other Federal statutes, including direct
Federal 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.)

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-09171 Filed 4-30-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 102 (Tuesday, May 28, 2019)]
[Notices]
[Pages 24526-24527]
[FR Doc No: 2019-11012]

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

Food and Drug Administration

[Docket No. FDA-2019-D-0914]

Review and Update of Device Establishment Inspection Processes
and Standards; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is extending
the comment period for the notice of availability that appeared in the
Federal Register on March 29, 2019. FDA requested comments on the draft
guidance for industry entitled ``Review and Update of Device
Establishment Inspection Processes and Standards.'' The Agency is
taking this action in response to a request for an extension to allow
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the document published
March 29, 2019 (84 FR 11983). Submit either electronic or written
comments on the draft guidance by June 27, 2019, to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-0914 for ``Review and Update of Device Establishment
Inspection Processes and Standards.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the

electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tiffany Kelley, Office of Regulatory
Affairs, Division of Operational Policy, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register on March 29, 2019, FDA published a notice
of availability with a 60-day comment period to request comments on the
draft guidance for industry entitled ``Review and Update of Device
Establishment Inspection Processes and Standards.''
    The Agency has received a request for a 30-day extension of the
comment period. The request conveyed concern that the current 60-day
comment period does not allow sufficient time to develop thoughtful and
detailed input.
    FDA has considered the request and is extending the comment period
for the notice of availability for 30 days, until June 27, 2019. The
Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments without significantly delaying
guidance on these important issues.

II. Significance of Draft Guidance

    FDA is issuing this draft guidance consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21
CFR part 803 have been approved under OMB control number 0910-0437. The
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073.

IV. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet at either
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Persons unable to download
an electronic copy of ``Review and Update of Device Establishment
Inspection Processes and Standards; Draft Guidance for Industry'' may
send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document.

    Dated: May 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11012 Filed 5-24-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 7, 2009 (Volume 74, Number 87)]
[Proposed Rules]
[Page 21287-21290]
[DOCID:fr07my09-19]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 145

[Docket No. FAA-2006-26408]
RIN 2120-AI53

Repair Stations; Withdrawal

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM); withdrawal.

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

SUMMARY: The FAA is withdrawing a previously published NPRM that
proposed to revise the system of ratings and require repair stations to
establish a quality program. The NPRM also proposed to require each
repair station to maintain a capability list, designate a chief
inspector, and have permanent housing for facilities, equipment,
materials, and personnel. The proposal would have specified additional
instances where the FAA may deny a repair station certificate, and
clarified some existing repair station regulations.

We are withdrawing the NPRM because we have determined that it does not
adequately address the current repair station environment, and because
of the significant issues commenters raised.

DATES: The proposed rule published on December 1, 2006 (71 FR 70254),
is withdrawn as of May 7, 2009.

FOR FURTHER INFORMATION CONTACT: George W. Bean, Repair Station Branch,
AFS-340, Federal Aviation Administration, 955 L'Enfant Plaza, SW.,
Washington, DC 20024; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    In 1989, the FAA held four public meetings to provide a forum for
the public to comment on possible revisions to the rules governing
repair stations.
    After considering the comments and data collected from these
meetings, the FAA published the Repair Stations notice of proposed
rulemaking (NPRM) in June 1999.\1\ Subsequently, in August 2001, the
FAA published the Repair Stations; final rule with request for comments
and direct final rule with request for comments; final rule.\2\ The FAA
requested comments on the paperwork burden and on removing appendix A
\3\ from part 145, which the FAA had not originally proposed.
---------------------------------------------------------------------------

    \1\ 64 FR 33142; June 21, 1999.
    \2\ 66 FR 41088; August 6, 2001.
    \3\ This Appendix set forth job functions and equipment
requirements for repair stations.
---------------------------------------------------------------------------

    On October 19, 2001, the FAA tasked the Aviation Rulemaking
Advisory Committee (ARAC) to address ratings and quality assurance for
repair stations.\4\ ARAC provided its recommendations in May 2002.\5\
---------------------------------------------------------------------------

    \4\ 66 FR 53281; October 19, 2001.
    \5\ http://www.faa.gov/regulations_policies/rulemaking/
committees/arac/.
---------------------------------------------------------------------------

    On December 1, 2006, the FAA published the NPRM entitled Repair
Stations \6\ that considered ARAC's recommendations. The comment period
closed on March 1, 2007. However, the FAA received a request from the
Aeronautical Repair Station Association (ARSA) to extend the comment
period. In a notice published in the Federal Register on February 27,
2007, the FAA granted a 45-day comment period extension to April 16,
2007.\7\
---------------------------------------------------------------------------

    \6\ 71 FR 70254; December 1, 2006.
    \7\ 72 FR 8641; February 27, 2007.
---------------------------------------------------------------------------

    The December 1, 2006 NPRM, applicable to repair station operators
and applicants, proposed the following changes to part 145:
     Repair stations would establish and maintain a capability
list of all articles for which they are rated. The list would identify
each article by manufacturer and the type, make, model, category or
other nomenclature designated by the article's manufacturer. Repair
stations with an Avionics or a Component rating would be required to
organize their lists by category of the article.
     The FAA would revise the ratings and classes that may be
issued to a certificated repair station. The proposed amendments
included ones that would discontinue the issuance of limited ratings,
and instead allow issuance of limitations to the rating the
certificated repair station holds.
     The FAA would require repair stations to establish a
quality system that includes an internal evaluation system that reviews
the complete repair station once a year.
     Applicants for a repair station certificate would include
a letter of compliance as part of their application.
     A certificate holder would be required to provide
permanent housing for its facilities, equipment, materials, and
personnel.
     Certificate holders would be required to designate a chief
inspector.
     The FAA would use certification from an authority
``acceptable to the FAA'' as a basis for issuing a certificate to a
person located outside the United States.
     The FAA would identify reasons it could use to deny the
issuance of a repair station certificate.

Discussion of Comments

    The FAA received more than 500 comments to the NPRM. While there
was general support for the need to revise the repair station rules,
several commenters asked us to withdraw the rule. Many other commenters
expressed concerns related to ratings (particularly avionics rating),
capability list, quality system, letter of compliance, chief inspector,
housing and facilities, the FAA's denial of a repair station
certificate, and some were out of scope.

Requests To Withdraw the NPRM

    The ARSA, Aircraft Electronics Association (AEA), AGC Incorporated,
Spirit Avionics, Ltd., Temple Electronics Company, and Lynden Air Cargo
recommended withdrawal of the rule. While ARSA commended the FAA for
attempting to clarify and simplify the rating system, it suggested the
FAA issue a supplemental notice of proposed rulemaking that considers
the comments to the NPRM. The other commenters recommended withdrawal
because there has been too much regulation of repair stations within
the past few years.

Oversight and Inconsistent Application

    Comments received from the International Brotherhood of Teamsters,
Professional Airways Systems Specialists, and Transportation Trades
Department generally support the proposal. The unions did argue,
however, that the agency did not go far enough in certain areas
involving oversight and surveillance. While the issues they raised were
outside the scope of the proposal, various legislative proposals under
consideration by the Congress may address these issues in the future.

Ratings

    Several commenters, including Southern Avionics & Communications,
Executive AutoPilots, Inc., Genesis Aviation, Aircom Avionics, American
Airlines, Turbine Weld, Inc., and others, expressed general disapproval
of the proposed rating system.
    Spirit Avionics, Ltd., believes to combine the proposed new
avionics rating with current market forces will negatively affect the
ability of avionics-only repair stations to remain viable. The
commenter said the NPRM does not recognize that avionics service
facilities are transitioning to flight line repairs and avionics
upgrades as main sources of revenue. The commenter also said the NPRM
does not recognize that avionics repair stations' ability to perform
such services are based primarily on the avionics equipment onboard the
aircraft rather than on the type, make, or model of the aircraft.
    Midcoast Aviation said while it believes including electrical
equipment as part of an avionics rating to be appropriate, it does not
see legitimacy in removing those [electrical] systems/components from
the aircraft or powerplant rating.
    Goodrich Aviation Technical Services said the proposed rule does
not adequately define the type of work required for the avionics
rating. It said a repair station with an aircraft, powerplant, or
propeller rating should not be required to obtain a separate avionics
rating to maintain articles associated with its ratings and
capabilities. Midcoast Aviation commented similarly.
    Spirit Avionics, Ltd., and Griffin Avionics, Inc., commented the
change from an airframe to an aircraft rating is ambiguous and
completely unnecessary. These commenters argued that this change is
unwarranted and would result in dramatic increases in administrative
costs, without improving aircraft maintenance safety or capability.
    ARSA said since all ratings would require a capabilities list under
the

proposal, there does not appear to be a need for class ratings. It also
said it does not agree with the limitations of some of the ratings or
the proposed requirement for capabilities listing. Other commenters
expressed a similar disagreement with the limitations and privileges of
some ratings, stating the limitations do not appear consistent.

Capability List

    Eighteen commenters, including Chromalloy Connecticut, Southern
Avionics and Communication, Avionics Shop, Inc., Turbine Weld, Inc.,
Association of Asia Pacific Airlines, National Air Transportation
Association (NATA), and others, stated strong opposition to the
proposed capability list requirement. These commenters expressed
concern that the proposed requirement would cause chaos and bankruptcy.
They said such requirements are not justified, are unnecessary, are
irrelevant, and are economically punitive, without offering further
safety benefits.
    Boeing believes the capability list would require a significant
amount of administrative resources to be kept current and would require
excessive amounts of information to be documented and tracked,
particularly for larger repair stations. Boeing sees minimal to no
safety benefits from these proposed requirements.
    Airbus believes the requirement for a capability list is implicitly
included in Sec.  145.211. While it fully understands the need for a
standardized format for such a list, the details as proposed in Sec.
145.215 seem to go beyond a practical documentation under an approved
system.
    A number of commenters, including United Airlines, Turbine Weld,
Inc., Griffin Avionics, Inc., AEA, and Temple Electronics Company
object to the proposed capability list because it could require having
several hundred types of ratings attached to a single repair station
aircraft rating.

Quality System

    ARSA commented that the majority of repair stations have not
instituted quality assurance systems and most do not use computers.
Therefore, reviewing, changing, and maintaining the proposed quality
system would be expensive. Also, ARSA said repair stations cannot be
held responsible for compliance with all part 145 regulations. But, can
be held accountable only for ensuring compliance with those
requirements under their specific responsibility and control.
    AEA and Temple Electronics Company believe the stated benefit of
the quality system requirements is based on ``false premises'' because
the FAA cited different cost-benefit estimates in prior repair station
rules. They commented that the FAA removed the quality assurance
requirements proposed in the 1999 NPRM from the subsequent 2001 final
rule because the requirements were overly burdensome and not cost
effective. The commenters further said that, despite removal of these
requirements from the 2001 final rule, the FAA introduced similar
requirements in the 2006 NPRM, without taking time to assess whether
the prior rule had proven successful.
    Spirit Avionics, Ltd., Weld Avionics, Inc., Southern Avionics &
Communications, Executive AutoPilots, Inc., Vero Beach Avionics, Inc.,
Aircraft Owners and Pilots Association, and two individual commenters
said if a repair station properly performs maintenance according to
FAA-approved processes, maintaining a Quality Assurance System would be
extremely burdensome and would have little merit.

Letter of Compliance

    ARSA, AEA, Temple Electronics Company, and Aeropro, Inc., said a
mandatory Letter of Compliance would be burdensome, unnecessary, and
redundant. AEA said the letter is a carryover from the period when the
repair station manual was simply a statement of commitment to comply
with the regulations. Aeropro, Inc., commented that because something
has been a long standing practice is not sufficient reason to include
it as a mandatory provision in the rule. It said including language
similar to that in Sec.  119.35, for certificate applications, would be
more appropriate.

Chief Inspector

    ARSA asked the FAA to withdraw the proposed requirement for a chief
inspector, unless the agency can provide a specific definition of the
position and justify the position's expenses against an increase in
safety. Similarly, Aerospace Industries Association of America
commented that its member companies cannot support the proposed
requirement to create a chief inspector post in every repair station.
The NPRM does not clearly define the functional responsibilities,
accountability, and authority of the position, nor are the benefits of
having such a position clearly defined.
    Several other commenters, including Chromalloy Gas Turbine Corp.,
Boeing, TCI Inc., Aeropro, Inc., British Airways, Vero Beach Avionics,
Inc., Marshall Aerospace, and several individual commenters expressed
support for the above sentiments.

Housing and Facilities

    The NATA, Midcoast Aviation, and Spirit Avionics, Ltd., said if the
aircraft and personnel are protected during the repair or maintenance
process, there is no need to build or lease an expensive hangar, which
may prove to be financially unsound.
    United Airlines and Islip Avionics, Inc., disagreed with the
proposed permanent housing provision. They said they disagreed because
not all repair or maintenance work requires a fully enclosed facility
as some operations can be performed at the maintenance terminal,
instead of at the hangar. Also, they said that some repair stations are
located at airports that are publicly owned.
    General Electric Company, Aviation Services, Boeing, and Aerospace
Industries commented that repair stations holding aircraft ratings with
limitations must not be subject to the undue burden of obtaining
permanent housing. These commenters said the housing requirements
should be in line with the appropriate ratings limitations.

Denial of a Repair Station Certificate

    Aviation Services, Inc., (ASI) does not agree that a person who has
had a repair station certificate revoked and met the other applicable
conditions should be permanently ineligible for issuance of a repair
station certificate, as proposed in Sec.  145.53. ASI expressed concern
that the primary basis for the FAA's proposed permanent revocation is
based on one incident that ASI believes is not representative. It said
if a permanent revocation is appropriate, it should apply only to
repair stations that perform work for persons who operate under parts
121 and 135.
    Aviation Suppliers Association (ASA), AEA, Temple Electronics
Company, and Aeropro, Inc., believe proposed Sec.  145.53(c) would
apply overly severe punishment. AEA and Temple Electronics Company
suggested that any revocation should be bound by some time frame and
should be included as part of the enforcement action that revoked the
certificate.
    An individual commenter said, while the rule punishes inappropriate
behavior, it does little to positively reinforce the safety culture
created and sustained by top management.

Reason for Withdrawal

    We are withdrawing the December 2006 Repair Station NPRM because it
does not adequately address the current

repair station operating environment. Also, we are withdrawing it
because of the many significant issues commenters to the NPRM raised,
which the FAA needs to consider in developing a better proposal.
    The current NPRM is based on recommendations developed in 2001 by
ARAC. At that time, air carriers performed the majority of their
maintenance work in-house. Since then, air carriers have increasingly
contracted their maintenance. According to an analysis by the Office of
Inspector General in 2003, the nine major air carriers were contracting
34 percent of their heavy airframe maintenance checks to repair
stations. By 2007, this figure had increased to 71 percent.\8\ The NPRM
as written does not address this changing operational dynamic.
---------------------------------------------------------------------------

    \8\ Air Carriers' Outsourcing of Aircraft Maintenance, OIG
Report Number: AV-2008-090, September 30, 2008--http://
www.oig.dot.gov/item.jsp?id=2364.
---------------------------------------------------------------------------

    In their comments to the NPRM, many small repair station operators
said the proposal takes a ``one-size-fits-all'' approach. This
approach, they argue, does not adequately address the operational
differences between large and small repair stations. As a result, the
commenters said, the NPRM would place a substantial economic and
administrative burden on their operations.
    Many commenters, as noted in the Discussion of Comments section of
this document, argued against adopting key portions of the NPRM for a
variety of reasons. Several commenters asked us to withdraw the NPRM in
its entirety. For the reasons we have discussed, we believe the best
course of action is to withdraw the NPRM. Withdrawal will give us time
to thoroughly review and properly address the substantial changes in
the repair station operating environment and the many issues raised by
commenters.

Conclusion

    Withdrawal of the December 1, 2006, Repair Stations; Proposed Rule
does not preclude the FAA from issuing another proposal on the subject.
In fact, we have initiated rulemaking to update and revise the
regulations for repair stations to more fully address the significant
changes in the repair station business model. The new proposed rule
will address concerns from the 2006 NPRM, as well as other issues
related to bringing the repair station regulations up-to-date with
industry practice. The public will be provided the opportunity for
public comment on this rulemaking through the NPRM process.

    Issued in Washington, DC, on April 30, 2009.
Chester D. Dalbey,
Deputy Director, Flight Standards Service.
[FR Doc. E9-10638 Filed 5-6-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Proposed Rules]
[Pages 56959-56961]
[FR Doc No: 2019-22917]

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

40 CFR Part 52

[EPA-R09-OAR-2019-0381; FRL-10001-25-Region 9]

Air Plan Approval; California; Placer County Air Pollution
Control District; Stationary Source Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing a
limited approval and limited disapproval of a revision to the Placer
County Air Pollution Control District (PCAPCD or ``District'') portion
of the California State Implementation Plan (SIP). This revision
concerns the District's New Source Review (NSR) permitting program for
new and modified sources of air pollution under the Clean Air Act (CAA
or ``Act''). This action updates the PCAPCD's applicable SIP with
current administrative requirements for the issuance of permits. We are
taking comments on this proposal and plan to follow with a final
action.

DATES: Any comments must arrive by November 25, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2019-0381 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be removed or edited from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region IX, Air-3-
1, 75 Hawthorne St., San Francisco, CA 94105,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rule did the State submit?
    B. Are there other versions of this rule?
    C. What is the purpose of the submitted rule?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rule?
    B. Does the rule meet the evaluation criteria?
    C. Proposed Action and Public Comment
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rule did the State submit?

    Table 1 lists the rule addressed by this proposal, including the
date it was adopted by the PCAPCD and submitted by the California Air
Resources Board (CARB).

                                             Table 1--Submitted Rule
----------------------------------------------------------------------------------------------------------------
                                                                                Adopted or
                  Rule No.                                Rule Title                  amended        Submitted
----------------------------------------------------------------------------------------------------------------
501........................................  General Permit Requirements........         8/12/10         12/7/10
----------------------------------------------------------------------------------------------------------------

    On January 13, 2011, the EPA determined that this SIP submittal met
the completeness criteria in 40 CFR part 51, appendix V, which must be
met before formal EPA review.

B. Are there other versions of this rule?

    There is no previous version of Rule 501 approved in the SIP. Rule
501 will replace the current SIP-approved rules listed in Table 2,
which are applicable to specific air basins in Placer County, as noted.

                                           Table 2--SIP-Approved Rules
----------------------------------------------------------------------------------------------------------------
                                                                                Federal Register
            Rule No.                   Rule title            Air basin      SIP approval date       Citation
----------------------------------------------------------------------------------------------------------------
2 (aka Article 2)..............  Application for         Lake Tahoe.......          5/31/1972        37 FR 10856
                                  Building Permit.
403............................  Responsibility of       Lake Tahoe.......          6/14/1978        43 FR 25684
                                  Permittee.
502............................  Permit Exemptions.....  Lake Tahoe.......          6/23/1982        47 FR 27065
503............................  Transfer..............  Lake Tahoe.......          6/23/1982        47 FR 27065
505............................  Cancellation of         Lake Tahoe.......          6/23/1982        47 FR 27065
                                  Authority to
                                  Construct.
507............................  Provision of Sampling   Lake Tahoe.......          4/23/1982        47 FR 17486
                                  and Testing
                                  Facilities.
514............................  Standards for Granting  Lake Tahoe.......          6/23/1982        47 FR 27065
                                  Applications.
2 (aka Article 2)..............  Application for         Mountain.........          5/31/1972        37 FR 10856
                                  Building Permit.
403............................  Responsibility of       Mountain.........          6/14/1978        43 FR 25684
                                  Permittee.
501............................  Permit to Operate,      Mountain.........          5/18/1981        46 FR 27115
                                  paragraph b.
502............................  Permit Exemptions.....  Mountain.........          5/18/1981        46 FR 27115
505............................  Cancellation of         Mountain.........          7/12/1990        55 FR 28622
                                  Authority to
                                  Construct.
507............................  Provision of Sampling   Mountain.........         11/15/1978        43 FR 53035
                                  and Testing
                                  Facilities.
507............................  Provision of Sampling   Mountain.........          7/12/1990        55 FR 28622
                                  and Testing
                                  Facilities, paragraph
                                  d.
2 (aka Article 2)..............  Application for         Sacramento.......          5/31/1972        37 FR 10856
                                  Building Permit.
403............................  Responsibility of       Sacramento.......          6/14/1978        43 FR 25684
                                  Permittee.

507............................  Provision of Sampling   Sacramento.......         11/15/1978        48 FR 53035
                                  and Testing
                                  Facilities.
----------------------------------------------------------------------------------------------------------------

    If the EPA finalizes the action proposed herein, these rules will
be removed from the SIP.

C. What is the purpose of the submitted rule?

    The submitted rule is intended to satisfy the ``general'' or
``minor'' NSR requirements of section 110(a)(2)(C) and related EPA
regulations. General NSR requirements are applicable to all permits
issued by the PCAPCD. Rule 501 consolidates the requirements from
several existing rules and codified these requirements into a single
administrative rule.

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rule?

    The submitted rule must meet the CAA's general requirements for
SIPs and SIP revisions in CAA sections 110(a), 110(l), and 193, as well
as contain the applicable regulatory provisions required by 40 CFR
51.160-51.164.
    Section 110(a)(2)(A) of the Act requires that regulations submitted
to the EPA for SIP approval must be legally enforceable. Section 110(l)
of the Act prohibits the EPA from approving any SIP revisions that
would interfere with any applicable requirement concerning attainment
and reasonable further progress (RFP) or any other applicable
requirement of the Act. Section 193 of the Act prohibits the
modification of a SIP-approved control requirement in effect before
November 15, 1990 in a nonattainment area, unless the modification
ensures equivalent or greater emission reductions of the relevant
pollutant(s). With respect to procedures, CAA sections 110(a) and
110(l) require that a state conduct reasonable notice and hearing
before adopting a SIP revision.
    Section 110(a)(2)(C) of the Act requires each SIP to include a
program to regulate the modification and construction of any stationary
source within the areas covered by the SIP as necessary to assure
attainment and maintenance of the National Ambient Air Quality
Standards (NAAQS). The EPA's regulations at 40 CFR 51.160-51.164
provide general programmatic requirements to implement this statutory
mandate. These requirements, commonly referred to as the ``minor NSR''
or ``general NSR'' program, apply generally to both major and non-major
stationary sources and modifications and in both attainment and
nonattainment areas, in contrast to the specific statutory and
regulatory requirements for permitting programs under parts C and D of
title I of the Act that apply to major sources in attainment and
nonattainment areas, respectively.

B. Does the rule meet the evaluation criteria?

    The EPA has reviewed the submitted rule in accordance with the rule
evaluation criteria described above. With respect to the procedural
requirements, based on our review of the public process documentation
included with the submitted rule, we find that that the PCAPCD has
provided sufficient evidence of public notice and opportunity for
comment and public hearings prior to adoption and submittal of this
rule, in accordance with the requirements of CAA sections 110(a) and
110(l).
    With respect to the substantive requirements of CAA sections 110(l)
and 193, we find that our approval of this SIP submittal would not
interfere with any applicable requirement concerning attainment and RFP
or any other applicable requirement of the Act, and that the submitted
rule is not subject to section 193 of the Act because it does not
contain any control requirements.
    With respect to the substantive statutory and regulatory
requirements for a general NSR permit program as contained in CAA
section 110(a)(2)(C) and 40 CFR 51.160-51.164, we find the submitted
rule satisfies these requirements, except as discussed below.
    Submitted Rule 501 contains the following deficiencies. The
technical support document (TSD) included in the docket for this
proposed rulemaking contains a more detailed analysis.
    1. Rule 501, Section 303.1 is deficient because it does not
specifically require the Air Pollution Control Officer (APCO) to
determine and deny a permit if a proposed project will (1) cause a
violation of the SIP or (2) interfere with attainment or maintenance of
a NAAQS. It is also deficient because it only requires the APCO to
evaluate whether an emission unit will be operated in compliance with
all applicable requirements as of the application completeness date,
rather than as of the date of permit issuance. (See TSD Section 5.2.1,
Item 1.(b).)
    2. The District's minor NSR program is deficient because it does
not contain any public notice requirements for new or modified emission
units located in the Lake Tahoe Air Basin portion of Placer County.
(See TSD Section 5.2.1, Item 2.(a).)
    3. Rule 501 is deficient because it does not contain any provisions
that address stack height procedures as required by 40 CFR 51.164. (See
TSD Section 5.2.1, Item 5.)
    4. Rule 501, Section 200--Definitions, is deficient because it
references and relies on the definitions contained in Rule 504,
``Emission Reduction Credits,'' which is not SIP-approved. (See TSD
Section 5.2.3.)
    The submitted rules are otherwise consistent with criteria for the
EPA's approval of regulations submitted for inclusion in the SIP,
including the requirement at CAA section 110(c)(2)(A) that submitted
regulations be legally enforceable.
    For the reasons stated above and explained further in our TSD, we
find that the submitted NSR rules generally satisfy the applicable CAA
and regulatory requirements for a general NSR permit program, subject
to the four deficiencies noted above.

C. Proposed Action and Public Comment

    As authorized by CAA section 110(k)(3) and 301(a), we are proposing
limited approval and limited disapproval of Rule 501 ``General Permit
Requirements'' into the PCAPCD portion of the California SIP. If
finalized, this action will incorporate the submitted rule into the
SIP, including those provisions identified as deficient. The approval
of Rule 501 is limited because EPA is simultaneously proposing a
limited disapproval of Rule 501 under section 110(k)(3).
    If we finalize this action as proposed, our action will be codified
through revisions to 40 CFR 52.220 (Identification of plan--in part).
    We will accept comments from the public on this proposal until
November 25, 2019.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the PCAPCD rule described in Table 1 of this preamble. The
EPA has made, and will continue to make, these materials available
through https://www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

IV. Statutory and Executive Order Reviews

    Under the CAA, the EPA Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the Act. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

    Administrative practice and procedure, Environmental protection,
Air pollution control, Carbon monoxide, Incorporation by reference,
Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur dioxide,
Volatile organic compounds.

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

    Dated: October 4, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2019-22917 Filed 10-23-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Notices]
[Pages 2454-2455]
[FR Doc No: 2018-00675]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1265]

Determination of Regulatory Review Period for Purposes of Patent
Extension; DAKLINZA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for DAKLINZA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by March
19, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by July 16, 2018. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of March 19, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-E-1265 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; DAKLINZA.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the

actual amount of extension that the Director of USPTO may award (for
example, half the testing phase must be subtracted as well as any time
that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product DAKLINZA
(daclatasvir dihydrochloride). DAKLINZA is indicated for use with
sofosbuvir for the treatment of chronic HCV genotype 3 infection.
Subsequent to this approval, the USPTO received a patent term
restoration application for DAKLINZA (U.S. Patent No. 8,329,159) from
Bristol-Myers Squibb Company, and the USPTO requested FDA's assistance
in determining this patent's eligibility for patent term restoration.
In a letter dated July 12, 2016, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of DAKLINZA represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
DAKLINZA is 2,808 days. Of this time, 2,327 days occurred during the
testing phase of the regulatory review period, while 481 days occurred
during the approval phase. These periods of time were derived from the
following dates:

    1. The date an exemption under section 505(i) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i))
became effective: November 17, 2007. The applicant claims November
16, 2007, as the date the investigational new drug application (IND)
became effective. However, FDA records indicate that the IND
effective date was November 17, 2007, which was 30 days after FDA
receipt of the IND.
    2. The date the application was initially submitted with respect
to the human drug product under section 505(b) of the FD&C Act:
March 31, 2014. FDA has verified the applicant's claim that the new
drug application (NDA) for DAKLINZA (NDA 206843) was initially
submitted on March 31, 2014.
    3. The date the application was approved: July 24, 2015. FDA has
verified the applicant's claim that NDA 206843 was approved on July
24, 2015.

    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 467 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00675 Filed 1-16-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 5, 2008 (Volume 73, Number 109)]
[Notices]
[Page 32071]
[DOCID:fr05jn08-109]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Notice of Informational Filing

    In accordance with Section 236.913 of Title 49 of the Code of
Federal Regulations (CFR), notice is hereby given that the Federal
Railroad Administration (FRA) has received an informational filing from
the Northeast Illinois Regional Commuter Railroad Corporation (Metra)
to permit field testing of the railroad's processor-based train control
system. The informational filing is described below, including the
requisite docket number where the informational filing and any related
information may be found. The document is also available for public
inspection; however, FRA is not accepting public comments.

Northeast Illinois Regional Commuter Railroad Corporation

[Docket Number FRA-2008-0057]

    Metra has submitted an informational filing to permit field testing
of the railroad's processor-based train control system identified as
Electronic Train Management System (ETMS). The informational filing
addresses the requirements under 49 CFR 236.913(j)(1).
    Specifically, the informational filing contains a description of
the ETMS product and an operational concepts document, pursuant to 49
CFR 236.913(j)(1). The ETMS is a locomotive-centric, non-vital system
designed to be overlaid on existing methods of operation and to provide
an improved level of railroad safety through enforcement of a train's
authority limits and both permanent and temporary speed restrictions.
An associated temporary waiver petition has also been submitted to
support field testing of Metra's ETMS pursuant to 49 CFR Sections 211.7
and 211.51, and can be found in the same docket as this informational
filing (FRA-2008-0057).
    Metra desires to commence field testing on or about July 1, 2008,
or as soon as practicable thereafter, contingent upon FRA's acceptance
and approval of their informational filing. Metra intends to test and
develop ETMS on its Rock Island District between Chicago, IL and
Joliet, IL.
    Interested parties are invited to review the informational filing
and associated documents at DOT's Docket Management facility during
regular business hours (9 a.m.-5 p.m.) at 1200 New Jersey Avenue, SE.,
Room W12-140, Washington, DC 20590. All documents in the public docket
are available for inspection and copying on the internet at http://
www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications received into any of our dockets by name of the
individual submitting the document (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC on May 30, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E8-12545 Filed 6-4-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register: November 29, 2006 (Volume 71, Number 229)]
[Notices]
[Page 69105]
[DOCID:fr29no06-33]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-68-000]

Enbridge Pipelines (KPC), Notice of Proposed Changes in FERC Gas
Tariff

(November 21, 2006)
    Take notice that on November 15, 2006, Enbridge Pipelines (KPC)
(KPC) tendered for filing as part of its FERC Gas Tariff, First Revised
Volume No. 1, the following tariff sheets, to become effective on
December 15, 2006:

Second Revised Sheet No. 117
Second Revised Sheet No. 301
Second Revised Sheet No. 312
Third Revised Sheet No. 324
Second Revised Sheet No. 337
Second Revised Sheet No. 345
Second Revised Sheet No. 357

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-20192 Filed 11-28-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 144 (Monday, July 28, 2014)]
[Proposed Rules]
[Pages 43704-43705]
[FR Doc No: 2014-17610]

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

40 CFR Parts 52 and 81

[EPA-R05-OAR-2013-0791; FRL-9914-23-Region-5]

Approval and Promulgation of Air Quality Implementation Plans;
Ohio; Redesignation of the Bellefontaine Area to Attainment of the 2008
Lead Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: On October 29, 2013, the Ohio Environmental Protection Agency
(OEPA) submitted a request for the Environmental Protection Agency
(EPA) to redesignate the Bellefontaine nonattainment area to attainment
for the 2008 national ambient air quality standards (NAAQS) for lead.
EPA is proposing to determine that the Bellefontaine area meets the
requirements for redesignation and is also proposing to approve several
additional related actions. EPA is proposing to approve, as revisions
to the Ohio state implementation plan, the state's plan for maintaining
the 2008 lead NAAQS through 2025 for the area. EPA is proposing to
approve the 2010 emissions inventory for the Bellefontaine area, which
meet the comprehensive emissions inventory requirement of the Act. EPA
is proposing to approve these actions in accordance with the Clean Air
Act and EPA's implementation regulations regarding the 2008 lead NAAQS.

DATES: Comments must be received on or before August 27, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2013-0791, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Douglas Aburano, Chief, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Douglas Aburano, Chief, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
Such deliveries are only accepted during the Regional Office normal
hours of operation, and special arrangements should be made for
deliveries of boxed information. The Regional Office official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Sarah Arra, Environmental Scientist,
Attainment Planning and Maintenance Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: July 11, 2014.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2014-17610 Filed 7-25-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 17, 2009 (Volume 74, Number 136)]
[Notices]
[Page 34795-34796]
[DOCID:fr17jy09-107]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

Maritime Advisory Committee for Occupational Safety and Health
(MACOSH)

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

ACTION: MACOSH meeting, notice of.

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SUMMARY: The Maritime Advisory Committee for Occupational Safety and
Health (MACOSH) was established under Section 7 of the Occupational
Safety and Health (OSH) Act of 1970 to advise the Assistant Secretary
of Labor for Occupational Safety and Health on issues relating to
occupational safety and health in the maritime industries. The purpose
of this Federal Register

notice is to announce the Committee and workgroup meetings scheduled
for September 1-2, 2009.

DATES: The Shipyard and Longshore workgroups will meet on Tuesday,
September 1, 2009, 8 a.m. to 4:30 p.m., and the Committee will meet on
Wednesday, September 2, 2009, from 8 a.m. to 4:30 p.m.

ADDRESSES: The Committee and workgroups will meet at the Newport News
Marriott Hotel, 740 Town Center Drive, Newport News, VA 23606 ((757)
873-9299). Mail comments, views, or statements in response to this
notice to Danielle Watson, Office of Maritime, OSHA, U.S. Department of
Labor, Room N-3609, 200 Constitution Avenue, NW., Washington, DC 20210;
phone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For general information about MACOSH
and this meeting, contact: Amy Wangdahl, Acting Director, Office of
Maritime, OSHA, U.S. Department of Labor, Room N-3609, 200 Constitution
Avenue, NW., Washington, DC 20210; phone:<PHONE_NUMBER>. Individuals
with disabilities wishing to attend the meeting should contact Danielle
Watson at<PHONE_NUMBER> no later than August 18, 2009, to obtain
appropriate accommodations.

SUPPLEMENTARY INFORMATION: All MACOSH meetings are open to the public.
All interested persons are invited to attend the MACOSH meeting at the
time and location listed above. The MACOSH agenda will include: An OSHA
activities update; a review of the minutes from the previous meeting;
and reports from each workgroup. MACOSH may also discuss the following
topics based on the workgroup reports: Surface preparation (29 CFR 1915
subpart C, Painting and Coatings); Safety and Health Injury Prevention
Sheets (SHIPS) rigging guidance document; arc flash guidance;
commercial fishing industry quick cards; injury and fatality data
initiative; activities related to shipyard employment; scaffolding and
falls (29 CFR 1915 subpart E); welding guidance; break bulk cargo
safety guidance; safety zone guidance; speed limits in marine
terminals; and defective containers.
    Public Participation: Written data, views, or comments for
consideration by MACOSH on the various agenda items listed above should
be submitted to Danielle Watson at the address listed above.
Submissions received by August 18, 2009, will be provided to Committee
members and will be included in the record of the meeting. Requests to
make oral presentations to the Committee may be granted as time
permits.

    Authority:  This notice was prepared under the direction of
Jordan Barab, Acting Assistant Secretary of Labor for Occupational
Safety and Health, U.S. Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210, pursuant to Sections 6(b)(1) and
7(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C.
655, 656), the Federal Advisory Committee Act (5 U.S.C. App. 2),
Secretary of Labor's Order 5-2007 (72 FR 31160), and 29 CFR part
1912.

    Signed at Washington, DC, this 14th day of July, 2009.
Jordan Barab,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. E9-17022 Filed 7-16-09; 8:45 am]

BILLING CODE 4510-26-P