[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Rules and Regulations]
[Pages 28245-28246]
[FR Doc No: 2012-11549]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-1126; Airspace Docket No. 11-ACE-22]

Amendment of Class E Airspace; Omaha, NE

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace at Omaha, NE. Additional
controlled airspace is necessary to accommodate new Area Navigation
(RNAV) Standard Instrument Approach Procedures at Eppley Airfield. The
FAA is taking this action to enhance the safety and management of
Instrument Flight Rule (IFR) operations at the airport.

DATES: Effective date: 0901 UTC, July 26, 2012. 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: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On December 13, 2011, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend Class E airspace for the
Omaha, NE, area, creating additional controlled airspace at Eppley
Airfield (76 FR 77448) Docket No. FAA-2011-1126. Interested parties
were invited to participate in this rulemaking effort by submitting
written comments on the proposal to the FAA. No comments were received.
Class E airspace designations are published in paragraph 6005 of FAA
Order 7400.9V dated August 9, 2011, and effective September 15, 2011,
which is incorporated by reference in 14 CFR 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace extending upward from 700 feet
above the surface to accommodate new standard instrument approach
procedures at Eppley Airfield, Omaha, NE. This action is necessary for
the safety and management of IFR operations at the airport.
    The FAA has determined that 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 will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
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 amends controlled airspace at Eppley Airfield, Omaha, NE.

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 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011, is amended as follows:

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

* * * * *

ACE NE E5 Omaha, NE [Amended]

Omaha, Eppley Airfield, NE
    (Lat. 41[deg]18'11'' N., long. 95[deg]53'39'' W.)
Omaha, Offutt AFB, NE
    (Lat. 41[deg]07'10'' N., long. 95[deg]54'31'' W.)
Council Bluffs, Council Bluffs Municipal Airport, IA
    (Lat. 41[deg]15'36'' N., long. 95[deg]45'31'' W.)
Blair, Blair Municipal Airport, NE
    (Lat. 41[deg]24'53'' N., long. 96[deg]06'32'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.9-mile radius of Eppley Airfield, and within 1 mile each
side of the 000[deg] bearing from Eppley Airfield extending from the
6.9-mile radius to 8.5 miles north of the airport, and within 3
miles each side of the Eppley Airfield Runway 14R ILS Localizer
course extending from the 6.9-mile radius to 12 miles northwest of
the airport, and within a 7-mile radius of Offutt AFB, and within
4.3 miles each side of the Offutt AFB ILS Runway 30 localizer course
extending from the 7-mile radius to 7.4 miles southeast of Offutt
AFB,

and within a 6.4-mile radius of the Council Bluffs Municipal
Airport, and within a 6.4-mile radius of Blair Municipal Airport,
and within 2 miles each side of the 317[deg] bearing from the Blair
Municipal Airport extending from the 6.4-mile radius to 11.6 miles,
and within 2 miles each side of the 137[deg] bearing from the Blair
Municipal Airport extending from the 6.4-mile radius to 12.2 miles.

    Issued in Fort Worth, Texas, on April 5, 2012.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2012-11549 Filed 5-11-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 13, 2007 (Volume 72, Number 113)]
[Proposed Rules]
[Page 32569-32570]
[DOCID:fr13jn07-19]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2005-AL-0002-200623e; FRL-8326-8]

Approval and Promulgation of Implementation Plans Alabama:
Approval of Revisions to the State Implementation Plan; Re-Opening of
Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; re-opening of public comment period.

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SUMMARY: EPA is re-opening the comment period for a proposed rule
published April 12, 2007 (72 FR 18428). On April 12, 2007, EPA proposed
to approve a revision to the State Implementation Plan for the State of
Alabama regarding the State's visible emissions rule, Alabama Rule 335-
3-4-.01 ``Visible Emissions.'' At the request of a commentor, EPA is
re-opening the comment period through July 11, 2007.

DATES: Written comments must be received on or before July 11, 2007.

ADDRESSES: Comments should be submitted to: Ms. Stacy Harder,
Regulatory Development Section, Air Planning Branch, Air, Pesticides
and Toxics Management Division, U.S. Environmental Protection Agency,

Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Phone:
(404) 562-9042. E-mail<EMAIL_ADDRESS>Additional instructions
to comment can be found in the notice of proposed rulemaking published
April 12, 2007 (72 FR 18428).

FOR FURTHER INFORMATION CONTACT: Ms. Stacy Harder, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number
is<PHONE_NUMBER>. Ms. Harder can also be reached via electronic mail
at<EMAIL_ADDRESS>
    Dated: June 5, 2007.
J.I. Palmer, Jr.,
Regional Administrator, Region 4.
 [FR Doc. E7-11412 Filed 6-12-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 151 (Wednesday, August 5, 2020)]
[Notices]
[Pages 47372-47373]
[FR Doc No: 2020-17065]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2015-0341; FRL-10012-94-OAR]

Notice of Availability of One Updated Chapter in the
Environmental Protection Agency's Air Pollution Control Cost Manual

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability and public comment period.

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SUMMARY: The Environmental Protection Agency (EPA) is providing notice
that one chapter of the current EPA Air Pollution Control Cost Manual
(Control Cost Manual) has been updated. The EPA is requesting comment
on: Chapter 1, Section 5, ``Wet Scrubbers for Acid Gas.'' This Control
Cost Manual chapter covers control measures for sulfur dioxide
(SO2) and acid gas emissions.

DATES: Comments must be received on or before November 3, 2020.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OAR-2015-0341, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov
(our preferred method). Follow the online instructions for submitting
comments.
     Email<EMAIL_ADDRESS>Include the Docket ID No.
EPA-HQ-OAR-2015-0341 in the subject line of the message.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Air and Radiation Docket, Mail Code 28221T, 1200 Pennsylvania
Avenue NW, Washington, DC 20460.
     Hand Delivery or Courier (by scheduled appointment only):
EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution
Avenue NW, Washington, DC 20004. The Docket Center's hours of
operations are 8:30 a.m. to 4:30 p.m., Monday through Friday (except
Federal Holidays).
    Instructions: All submissions received must include the Docket ID
No. for this document. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the ``Public Participation''
heading of the SUPPLEMENTARY INFORMATION section of this document. Out
of an abundance of caution for members of the public and our staff, the
EPA Docket Center and Reading Room are closed to the public, with
limited exceptions, to reduce the risk of transmitting COVID-19. Our
Docket Center staff will continue to provide remote customer service
via email, phone, and webform. We encourage the public to submit
comments via https://www.regulations.gov/ or email, as there may be a
delay in processing mail and faxes. Hand deliveries and couriers may be
received by scheduled appointment only. For further information on EPA
Docket Center services and the current status, please visit us online
at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Larry Sorrels, Health and
Environmental Impacts Division, Office of Air Quality Planning and
Standards, Environmental Protection Agency, C439-02, 109 T.W. Alexander
Drive, Research Triangle Park, NC 27709; telephone number: (919) 541-
5041; fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The EPA is requesting comment on the
specific Control Cost Manual chapter included in this document.

I. General Information

A. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2015-
0341, at https://www.regulations.gov (our preferred method), or the
other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. 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. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD-ROM that you mail
to the EPA docket office, mark the outside of the disk or CD-ROM as CBI
and then identify electronically within the disk or CD-ROM the specific
information that is claimed as CBI. In addition to one complete version
of the comment that includes information claimed as CBI, a copy of the
comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 Code of Federal Regulation (CFR) part 2. 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, the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    The EPA is temporarily suspending its Docket Center and Reading
Room for public visitors, with limited exceptions, to reduce the risk
of transmitting COVID-19. Our Docket Center staff will continue to
provide remote customer service via email, phone, and webform. We
encourage the public to submit comments via https://www.regulations.gov/ as there may be a delay in processing mail and
faxes. Hand deliveries or couriers will be received by scheduled
appointment only. For further information and updates on EPA Docket
Center services, please visit us online at https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID-19.

B. Tips for Preparing Your Comments

    When submitting comments, remember to: Identify the notification by
docket number and other identifying information (subject heading,
Federal Register date and page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a CFR part or
section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language/data for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns and
suggest alternatives.

     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Information Available for Public Comment

    The EPA is requesting comment on one updated chapter of the EPA Air
Pollution Control Cost Manual. The Control Cost Manual contains
individual chapters on control measures, including data and equations
to aid users in estimating capital costs for installation and annual
costs for operation and maintenance of these measures. The Control Cost
Manual is used by the EPA for estimating the impacts of rulemakings,
and serves as a basis for sources to estimate costs of controls that
are Best Available Control Technology under the New Source Review
Program, and Best Available Retrofit Technology under the Regional Haze
Program and for other programs.
    The one updated Control Cost Manual chapter is: Chapter 1, Section
5, ``Wet Scrubbers for Acid Gas'' (to be renamed ``Wet and Dry
Scrubbers for Acid Gas''). This chapter in the Control Cost Manual
will, for the first time, include cost and performance data for dry
scrubbers as well as wet scrubbers. This revised Control Cost Manual
chapter can be found in the docket for the Control Cost Manual update
(Docket ID No. EPA-HQ-OAR-2015-0341). The current Control Cost Manual
version (sixth edition) including the current chapter is available at
http://epa.gov/ttn/catc/products.html#cccinfo, and last updated in
2003. The Consolidated Appropriations Act of 2014 requested that the
EPA begin development of a seventh edition of the Control Cost Manual.
The EPA has met with state, local, and tribal officials to discuss
plans for the Control Cost Manual update as called for under the
Consolidated Appropriations Act of 2014. The EPA has met with other
groups as well at their request. The EPA has updated the selective non-
catalytic reduction (SNCR) and selective catalytic reduction (SCR)
chapters, the first two chapters (Chapter 1, Section 4; Chapter 2,
Section 4, respectively) completed for the seventh edition of the
Control Cost Manual, and made them available to the public in May 2016
(81 FR 38702, June 14, 2016) and also updated these chapters again in
May 2019. In addition, the EPA has updated the Refrigerated Condensers
(Chapter 1, Section 3 and Section 3.1) and Incinerators (Chapter 2,
Section 3, Section 3.2, now Incinerators/Oxidizers) chapters in
November 2017, the Cost Estimation: Concepts and Methodology chapter
(Chapter 2, Section 1) as of November 2017, and also the Carbon
Adsorbers (Chapter 1, Section 3, Section 3.1) and Flares (Chapter 1,
Section 3, Section 3.2) chapters in October 2018.
    To help focus review of the Wet Scrubbers for Acid Gas (or Wet and
Dry Scrubbers) chapter, we offer the following list of questions that
the EPA is particularly interested in addressing in the updated
chapter. Commenters are welcome to address any aspects of this chapter.
Please provide supporting data for responses to these questions and for
other comments on the chapter.

For the Wet and Dry Scrubbers for Acid Gas Chapter

    (1) What is a reasonable and up-to-date estimate of equipment life
(defined as design or operational life) for wet scrubbers (FGD)? Dry
scrubbers? Please provide data, if possible, on accurate estimates of
equipment life.
    (2) Are the descriptions of wet FGD scrubbers complete, up-to-date,
and accurate with regard to control of SO2 and acid gases?
Dry scrubbers? Please provide information, if possible, on descriptions
of wet and dry scrubbers' control of SO2 and acid gases if
you do not believe that the descriptions in the draft chapter are
complete, up-to-date, and accurate.
    (3) Is the applicability of wet FGD scrubbers to various types of
emissions sources complete, up-to-date, and accurate? Dry scrubbers?
    (4) Are the cost correlations, factors, and equations for wet FGD
scrubbers accurate and up-to-date? For dry scrubbers? If not, how
should they be revised? Please provide data, if possible, to address
inaccuracies.
    (5) Are the estimates of SO2 removal or control
efficiency for wet FGD scrubbers accurate and up-to-date? For dry
scrubbers? If not, what are more accurate estimates? Please provide
data, if possible, to address inaccuracies.

    Dated: July 30, 2020.
Erika N. Sasser,
Director, Health and Environmental Impacts Division.
[FR Doc. 2020-17065 Filed 8-4-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6944-6945]
[DOCID:fr11fe09-110]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Availability of a Draft Final Environmental Assessment
for the Proposed Airport Development at the Sawyer County Airport in
Hayward, WI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Availability of a Draft Final Environmental
Assessment for the Proposed Airport Development at the Sawyer County
Airport in Hayward, Wisconsin.

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SUMMARY: The Federal Aviation Administration (FAA), in conjunction with
the Wisconsin Department of Transportation Bureau of Aviation (WisDOT
BOA), have prepared a joint Federal and State Draft Final Environmental
Assessment (DFEA) for the Proposed Airport Development at the Sawyer
County Airport in Hayward, Wisconsin. The FAA and WisDOT BOA are making
available the DFEA for the following proposed airport improvement
projects: installation of an instrument landing system (ILS) for Runway
20 with medium approach lighting system with runway alignment indicator
lights; construction of a parallel taxiway/ramp expansion for Runway 2/
20; land acquisition; removal of airspace obstructions, including
removal/relocation of a town road; and relocation of precision approach
path indicator, localizer, and distance measuring equipment at Runway
20.
    The proposed airport improvement projects include both state block
program actions and FAA actions. Actions for the proposed airport
improvement project would be divided between FAA and WisDOT BOA. Agency
approvals are required to proceed. Proposed FAA actions include:
provide Federal environmental approval to establish eligibility to
participate in Federal funding for eligible projects not included in
the state block grant program which are assessed in the EA; issue an
environmental finding for FAA actions; provide ILS equipment, assist in
the design of the proposed ILS; perform the flight check,
certification, and operation of the proposed ILS; and provide long-term
maintenance of the proposed ILS.
    Proposed WisDOT BOA actions for the airport improvement projects
include: issue an environmental finding for WisDOT BOA's actions;
determine eligibility of Airport Improvement Program funds for the
proposed ILS project; approve the necessary funding for the proposed
ILS project; assist in design of the proposed ILS; purchase land for
the proposed ILS; install the proposed ILS; construct necessary airport
facilities to support proposed ILS and airport operations; develop,
implement, and monitor required mitigation for unavoidable impacts due
to the proposed ILS project.
    The DFEA has been prepared in accordance with the National
Environmental Policy Act (NEPA) of 1969, as amended, FAA Order 1050.1E,
``Policies and Procedures for Considering Environmental Impacts,''

and FAA Order 5050.4B, ``NEPA Implementing Instructions for Airport
Actions.'' The proposed action is consistent with the National Airspace
System Plan prepared by the U.S. Department of Transportation, FAA.
    The DFEA will be available for public review for 30 days at the
following locations:

Sherman and Ruth Weise Community Library, 10788 Hwy 27/77, Hayward, WI;
Sawyer County Airport Manager's Office, 10930 N. Airport Road, Hayward,
WI;
Sawyer County Clerk's Office, 10610 Main Street, Hayward, WI;
WisDOT, 4802 Sheboygan Avenue, Room 701, Madison, WI.

ADDRESSES: Written comments are encouraged from persons or interested
parties. Written comments concerning the DFEA will be accepted until 5
p.m. CST, Monday, March 16, 2009. Written comments may be sent to: Ms.
Virginia Marcks, Manager, Infrastructure Engineering Center, Federal
Aviation Administration, 2300 East Devon Avenue, Des Plaines, IL 60018.

FOR FURTHER INFORMATION CONTACT: Ms. Virginia Marcks, Manager,
Infrastructure Engineering Center, Federal Aviation Administration,
2300 East Devon Avenue, Des Plaines, Illinois 60018. Telephone number:
847-294-7494. E-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The Sawyer County Airport currently has non-precision instrument
approach capabilities. During inclement weather with low visibility and
low ceilings, aircraft pilots may not be able to land because they are
unable to see the landing runway as they approach to land. Instrument
flight rules (IFR) regulate aircraft operations during inclement
weather under low visibility and cloud ceilings. Under IFR conditions,
aircraft must use an instrument approach to initiate the landing
process. The proposed ILS would provide instrumentation that would
allow landings under IFR conditions.
    Medical transport pilots from several companies use the Sawyer
County Airport on a regular basis. Medical flights are not scheduled
events; they occur whenever a medical emergency arises, good weather or
bad. When medical transports cannot land, it is more than an
inconvenience; it's typically a life-threatening situation. An ILS at
the Sawyer County Airport would serve the purpose of increasing the
probability that those medical transports could land whenever they were
needed.

    Issued in Des Plaines, Illinois, February 6, 2009.
Joe Dillon,
Acting Manager, Infrastructure Engineering Center, Chicago, AJW-C14D,
Central Service Area.
 [FR Doc. E9-3005 Filed 2-10-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: May 25, 2010 (Volume 75, Number 100)]
[Notices]
[Page 29352]
[DOCID:fr25my10-67]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0241]

Draft Guidance for Industry on Data Elements for Submission of
Veterinary Adverse Event Reports to the Center for Veterinary Medicine;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry 188 entitled
``Data Elements for Submission of Veterinary Adverse Event Reports to
the Center for Veterinary Medicine.'' The purpose of this draft
guidance is to assist sponsors or non-applicants with filling out form
FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness,
Product Defect Report,'' as required by FDA regulations.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by August 9, 2010.

ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.
    Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lynn Post, Center for Veterinary
Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
188 entitled ``Data Elements for Submission of Veterinary
Adverse Event Reports to the Center for Veterinary Medicine.'' The
purpose of this draft guidance is to assist sponsors or non-applicants
with filling out Form FDA 1932, in both paper and electronic format.
Section 512(l) of the Federal Food, Drug and Cosmetic Act (the act) (21
U.S.C. 360b(l)) and Sec.  514.80(b) (21 CFR 514.80(b)) require
applicants of approved new animal drug applications (NADAs) and
approved abbreviated new animal drug applications (ANADAs) to report
adverse drug experiences and product/manufacturing defects.
    This continuous monitoring of approved NADAs and ANADAs affords the
primary means by which FDA obtains information regarding potential
problems with the safety and efficacy of marketed approved new animal
drugs as well as potential product/manufacturing problems. Post-
approval marketing surveillance is important because data previously
submitted to FDA may no longer be adequate, as animal drug effects can
change over time and less apparent effects may take years to manifest.
An applicant must report adverse drug experiences and product/
manufacturing defects on Form FDA 1932, ``Veterinary Adverse Drug
Reaction, Lack of Effectiveness, Product Defect Report.''

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the agency's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in section 512(l) of the act and Sec.
514.80 have been approved under OMB Control No. 0910-0645.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/default.htm or http://
www.regulations.gov.

    Dated: May 19, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-12454 Filed 5-24-10; 8:45 am]
BILLING CODE 4160-01-S


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on December 6, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-2005-23074

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  CHINA EASTERN AIRLINES CORPORATION LIMITED             Date
Filed:  November 15, 2005

Relief requested:  Exemption from 49 USC § 41301 to permit the
applicant to engage in scheduled foreign air transportation of persons,
property, and mail between a point or points in the People’s Republic
of China, and Los Angeles, California, with all flights operating via
Shanghai and/or Beijing, People’s Republic of China.

If renewal, date and citation of last action:  New authority.

Applicant representative:  Evelyn D. Sahr,<PHONE_NUMBER>            DOT
analyst:  Robert J. Finamore,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.			       			                        Action date:
December 6, 2005

Effective dates of authority granted:  December 6, 2005, through
December 6, 2006.

Basis for approval:  United States-China Air Transport Services
Agreement.

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations of our standard exemption conditions
(attached), and to the otherwise-applicable terms, conditions, and
limitations of China Eastern’s foreign air carrier permit (Order
92-11-7).

Special conditions/Remarks:  To assure that all flights conducted by
China Eastern under this authority operate via airports that have been
assessed under the Transportation Security Administration’s Foreign
Airports Assessment Program, we will require, as China Eastern has
proposed, that all such flights operate via Shanghai and/or Beijing.

Action taken by:   Paul L. Gretch, Director Office of International
Aviation

________________________________________________________________________
_______________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                              ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

05/2004

 China Eastern’s foreign air carrier permit (Order 92-11-7) authorizes
it, among other things, to conduct scheduled combination services
between Shanghai/Beijing and Los Angeles.


[Federal Register Volume 79, Number 96 (Monday, May 19, 2014)]
[Notices]
[Pages 28732-28733]
[FR Doc No: 2014-11513]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0432]

Additive Manufacturing of Medical Devices: An Interactive
Discussion on the Technical Considerations of 3-D Printing; Public
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

    The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Additive Manufacturing of Medical Devices:
An Interactive Discussion on the Technical Considerations of 3-D
Printing.'' The purpose of this workshop is to provide a forum for FDA,
medical device manufactures, additive manufacturing companies, and
academia to discuss technical challenges and solutions of 3-D printing.
The Agency would like input regarding technical assessments that should
be considered for additively manufactured devices to provide a
transparent evaluation process for future submissions.
    Dates and Times: The public workshop will be held on October 8 and
9, 2014, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Matthew Di Prima, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 2214, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by September 30, 2014, 4 p.m. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the public workshop will be provided beginning at 7 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>no later than September 23, 2014.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events-Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select the appropriate public workshop from the events list). Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Those without
Internet access should contact Susan Monahan to register (see
Registration). Registrants will receive confirmation after they have
been accepted and will be notified if they are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by September 30, 2014, 4 p.m. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information after October 1, 2014. If you have never attended a
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
    Comments: FDA is holding this public workshop to obtain information
on the technical challenges of additively manufacturing medical
devices. In order to permit the widest possible opportunity to obtain
public comment, FDA is soliciting either electronic or written comments
on all aspects of the public workshop topics. The deadline for
submitting comments related to this public workshop is November 10,
2014.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments to http://www.regulations.gov or
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. In addition, when responding to specific questions as
outlined in section II of this document, please identify the question
you are addressing. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

SUPPLEMENTARY INFORMATION:

I. Background

    Additive manufacturing, also known as 3-D printing, is a fast-
growing manufacturing technique that builds devices from computerized
blueprints or models, by layering material only where it is needed as
if building with interlocking bricks. Traditional methods of
manufacturing remove material from larger pieces by cutting, drilling,
and carving to create a final part. Through additive manufacturing
designers can alter products quickly for rapid prototype iteration or
produce small batches of multiple product designs in each batch. The 3-
D computer models used to build each part can be created using
traditional computer aided design techniques or they can be made
directly from 3-D image sources, such as computed tomography scans or
magnetic resonance imaging. Designers can also use a combination of
techniques. Consequently, 3-D printers can create truly anatomically
matched

devices or surgical guides by utilizing a patient's own medical
imaging.
    Additive manufacturing is just beginning to enter mainstream use in
medical devices. This technology unlocks new avenues for creativity and
innovation for medical device designers. For example, it can facilitate
the production of devices with intricate structures that were
previously impractical or impossible. Current industry applications
include using it as an alternative device production method for
traditional components or as a primary method to create patient-matched
devices. As the technology matures, additional capabilities may be
incorporated into medical devices. FDA has begun to receive submissions
using additive manufacturing for both traditional and patient-matched
devices, and we see many more on the horizon. Industry forecasts
project significant growth of additive manufacturing in both
traditional and innovative environments by 2025.
    Additive manufacturing may or may not present new questions
depending on its use. However, there are technical challenges
associated with the process from design to final product that need to
be properly addressed in all cases to ensure patient safety and to
promote innovation in a fast-moving field. Process verification and
validation are especially important when devices are produced
individually or in very small batches. By discussing and addressing
these technical challenges through an open forum, FDA would like to
foster innovation with a transparent process and shared expectations
for stakeholders. Participants in the workshop will include
researchers, scientists, and engineers involved with the research and
development of products using additive manufacturing as one or more
steps of the manufacturing process. The intent is to address scientific
and technical challenges posed by additive manufacturing process but
not address specific printing technologies or medical device types. The
latter will still be covered by their respective standards and guidance
documents. Ideas generated during this workshop may facilitate
development of new draft guidances and/or standards for additive
manufacturing of medical devices.

II. Topics for Discussion at the Public Workshop

    At this public workshop, participants will engage in open dialogue
and discuss the following factors that contribute to additively
manufactured medical devices.
     Preprinting considerations, including but not limited to:
    [cir] material chemistry;
    [cir] physical properties;
    [cir] recyclability;
    [cir] part reproducibility; and
    [cir] process validation.
     Printing considerations, including but not limited to:
    [cir] printing process characterization;
    [cir] software used in the process;
    [cir] post-processing steps (hot isostatic pressing, curing); and
    [cir] additional machining.
     Post-printing considerations, including but not limited
to:
    [cir] cleaning/excess material removal;
    [cir] effect of complexity on sterilization and biocompatibility;
    [cir] final device mechanics;
    [cir] design envelope; and
    [cir] verification.
    This is not an inclusive list. There will be discussion time and
breakout sessions to bring up topics that are not listed.
    The goals of the public workshop are to:
     Develop a more complete understanding of the technical
challenges and solutions in additive manufacturing across a variety of
materials and printing technologies that will affect safety and
effectiveness of medical devices;
     Create awareness of these technical challenges and
collaboratively develop solutions and best practices to ensure the
performance and reliability of these devices; create a forum for open
dialogue among stakeholders to share lessons learned and best practices
for overcoming the technical challenges presented by additive
manufacturing;
     Promote innovation in technology and processes to ensure
and improve device performance and reliability; and
     Coordinate future collaborations in the development of
educational materials, standards, and guidance.

    Dated: May 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11513 Filed 5-16-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)]
[Notices]
[Pages 75444-75446]
[FR Doc No: 2016-26204]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0042]

TUV Rheinland of North America, Inc.: Applications for Expansion
of Recognition and Proposed Modification to the List of Appropriate
NRTL Test Standards

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

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the applications of TUV
Rheinland of North America, Inc., for expansion of its recognition as a
Nationally Recognized Testing Laboratory (NRTL) and presents the
Agency's preliminary finding to grant the applications. Additionally,
OSHA proposes to add a new test standard to the NRTL listing of
Appropriate Test Standards.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before November 15, 2016.

ADDRESSES: Submit comments by any of the following methods:
    1. Electronically: Submit comments and attachments electronically
at http://www.regulations.gov, which is the Federal eRulemaking Portal.
Follow the instructions online for making electronic submissions.
    2. Facsimile: If submissions, including attachments, are not longer
than 10 pages, commenters may fax them to the OSHA Docket Office at
(202) 693-1648.
    3. Regular or express mail, hand delivery, or messenger (courier)
service: Submit comments, requests, and any attachments to the OSHA
Docket Office, Docket No. OSHA-2007-0042, Technical Data Center, U.S.
Department of Labor, 200 Constitution Avenue NW., Room N-2625,
Washington, DC 20210; telephone:<PHONE_NUMBER> (TTY number: (877) 889-
5627). Note that security procedures may result in significant delays
in receiving comments and other written materials by regular mail.
Contact the OSHA Docket Office for information about security
procedures concerning delivery of materials by express mail, hand
delivery, or messenger service. The hours of operation for the OSHA
Docket Office are 8:15 a.m.-4:45 p.m., e.t.
    4. Instructions: All submissions must include the Agency name and
the OSHA docket number (OSHA-2007-0042). OSHA places comments and other
materials, including any personal information, in the public docket
without revision, and these materials will be available online at
http://www.regulations.gov. Therefore, the Agency cautions commenters
about submitting statements they do not want made available to the
public, or submitting comments that contain personal information
(either about themselves or others) such as Social Security numbers,
birth dates, and medical data.
    5. Docket: To read or download submissions 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 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 at the OSHA Docket Office. Contact the
OSHA Docket Office for assistance in locating docket submissions.
    6. Extension of comment period: Submit requests for an extension of
the comment period on or before November

15, 2016 to the Office of Technical Programs and Coordination
Activities, Directorate of Technical Support and Emergency Management,
Occupational Safety and Health Administration, U.S. Department of
Labor, 200 Constitution Avenue NW., Room N-3655, Washington, DC 20210,
or by fax to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, 200 Constitution Avenue
NW., Room N-3647, Washington, DC 20210; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue NW., Room N-3655, Washington, DC 20210; phone:
(202) 693-2110 or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Notice of the Application for Expansion

    The Occupational Safety and Health Administration is providing
notice that TUV Rheinland of North America, Inc. (TUVRNA), is applying
for expansion of its current recognition as an NRTL. TUVRNA requests
the addition of three test standards and two additional recognized
sites to its NRTL scope of recognition.
    OSHA recognition of an NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by its
applicable test standard; and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The Agency processes applications by an NRTL for initial
recognition and for an expansion or renewal of this recognition,
following requirements in Appendix A to 29 CFR 1910.7. This appendix
requires that the Agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides its preliminary finding. In the second notice,
the Agency provides its final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational Web page for each NRTL,
including TUVRNA, which details the NRTL's scope of recognition. These
pages are available from the OSHA Web site at http://www.osha.gov/dts/otpca/nrtl/index.html.
    TUVRNA currently has three facilities (sites) recognized by OSHA
for product testing and certification, with its headquarters located
at: TUV Rheinland of North America, Inc., 12 Commerce Road, Newtown,
Connecticut 06470. A complete list of TUVRNA's scope of recognition is
available at https://www.osha.gov/dts/otpca/nrtl/tuv.html.

II. General Background on the Application

    TUVRNA submitted five applications, dated April 1, 2015 (OSHA-2007-
0042-0016), May 6, 2015 (OSHA-2007-0042-0017), August 20, 2015 (OSHA-
2007-0042-0018), December 7, 2015 (OSHA-2007-0042-0019) and March 2,
2016 (OSHA-2007-0042-0020), to expand its recognition to include three
additional test standards and two additional recognized sites. The two
proposed recognized testing sites are located at: TUV Rheinland Japan
Ltd., Global Technology Assessment Center, 4-25-2 Kita-Yamata, Tsuzuki-
ku, Yokohama, Kanagawa, 224-0021 JAPAN and TUV Rheinland LGA Products
GmbH, Am Grauen Stein 29, Koln, NRW 51105 GERMANY. OSHA performed on-
site reviews of TUV Yokohama on February 16-17, 2016, and TUV Cologne
on June 9-10, 2016, in relation to these applications, in which
assessors found some nonconformances with the requirements of 29 CFR
1910.7. TUVRNA addressed these issues sufficiently and OSHA staff
preliminarily determined that OSHA should grant the additional site
applications.
    TUVRNA's expansion application also requested the addition of three
test standards to its NRTL scope of recognition. OSHA staff performed a
detailed analysis of the application packet and reviewed other
pertinent information as well as conducted the on-site reviews
discussed above. Table 1 below lists the appropriate test standards
found in TUVRNA's applications for expansion for testing and
certification of products under the NRTL Program.

  Table 1--Proposed List of Appropriate Test Standards for Inclusion in
                   TUVRNA's NRTL Scope of Recognition
------------------------------------------------------------------------
           Test standard                     Test standard title
------------------------------------------------------------------------
UL 62368-1........................  Audio/Visual Information and
                                     Communication Technology Equipment--
                                     Part 1: Safety Requirements.
UL 1004-1.........................  Standard for Rotating Electrical
                                     Machines--General Requirements.
UL 62109-1 *......................  Safety of Power Converters for Use
                                     in Photovoltaic Power Systems--Part
                                     1: General Requirements.
------------------------------------------------------------------------
* Indicates the standard that OSHA proposes to add to the NRTL List of
  Appropriate Test Standards.

III. Proposal To Add New Test Standard to the NRTL Program's List of
Appropriate Test Standards

    Periodically, OSHA will propose to add new test standards to the
NRTL list of appropriate test standards following an evaluation of the
test standard document. To qualify as an appropriate test standard, the
Agency evaluates the document to (1) verify it represents a product
category for which OSHA requires certification by an NRTL, (2) verify
the document represents an end product and not a component, and (3)
verify the document defines safety test specifications (not
installation or operational performance specifications). OSHA becomes
aware of new test standards through various avenues. For example, OSHA
may become aware of new test standards by: (1) Monitoring notifications
issued by certain SDOs; (2) reviewing applications by NRTLs or
applicants seeking recognition to include a new test standard in their
scopes of recognition; and (3) obtaining notification from
manufacturers,

manufacturing organizations, government agencies, or other parties that
a new test standard may be appropriate to add to its list of
appropriate standards. OSHA may determine to include a new test
standard in the list, for example, if the test standard is for a
particular type of product that another test standard also covers or it
covers a type of product that no standard previously covered.
    In this notice, OSHA proposes to add a new test standard to the
NRTL Program's list of appropriate test standards. Table 2, below,
lists the test standard that is new to the NRTL Program. OSHA
preliminarily determined that this test standard is an appropriate test
standard and proposes to include it in the NRTL Program's List of
Appropriate Test Standards. OSHA seeks public comment on this
preliminary determination.

 Table 2--Test Standards OSHA Is Proposing To Add to the NRTL Program's
                   List of Appropriate Test Standards
------------------------------------------------------------------------
           Test standard                     Test standard title
------------------------------------------------------------------------
UL 62109-1........................  Safety of Power Converters for Use
                                     in Photovoltaic Power Systems--Part
                                     1: General Requirements.
------------------------------------------------------------------------

IV. Preliminary Findings on the Application

    TUVRNA submitted acceptable applications for expansion of its scope
of recognition. OSHA's review of the application files, and pertinent
documentation, indicate that TUVRNA can meet the requirements
prescribed by 29 CFR 1910.7 for expanding its recognition to include
the addition of these three test standards for NRTL testing and
certification listed above. OSHA's detailed on-site assessments
indicate that TUVRNA can meet the requirements prescribed by 29 CFR
1910.7 for expanding its recognition to include the addition of two
sites for NRTL testing and certification. This preliminary finding does
not constitute an interim or temporary approval of TUVRNA's
applications.
    OSHA welcomes public comment as to whether TUVRNA meets the
requirements of 29 CFR 1910.7 for expansion of its recognition as an
NRTL. Comments should consist of pertinent written documents and
exhibits. Commenters needing more time to comment must submit a request
in writing, stating the reasons for the request. Commenters must submit
the written request for an extension by the due date for comments. OSHA
will limit any extension to 10 days unless the requester justifies a
longer period. OSHA may deny a request for an extension if the request
is not adequately justified. To obtain or review copies of the exhibits
identified in this notice, as well as comments submitted to the docket,
contact the Docket Office, Room N-2625, Occupational Safety and Health
Administration, U.S. Department of Labor, at the above address. These
materials also are available online at http://www.regulations.gov under
Docket No. OSHA-2007-0042.
    OSHA staff will review all comments to the docket submitted in a
timely manner and, after addressing the issues raised by these
comments, will recommend to the Assistant Secretary for Occupational
Safety and Health whether to grant TUVRNA's application for expansion
of its scope of recognition. The Assistant Secretary will make the
final decision on granting the application. In making this decision,
the Assistant Secretary may undertake other proceedings prescribed in
Appendix A to 29 CFR 1910.7.
    OSHA will publish a public notice of its final decision in the
Federal Register.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on October 25, 2016.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2016-26204 Filed 10-28-16; 8:45 am]
 BILLING CODE 4510-26-P