[Federal Register Volume 76, Number 19 (Friday, January 28, 2011)]
[Rules and Regulations]
[Pages 5068-5070]
[FR Doc No: 2011-1800]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0688; Airspace Docket No. 09-AGL-23]
RIN 2120-AA66

Establishment of Low Altitude Area Navigation Routes (T-281, T-
283, T-285, T-286, and T-288); Nebraska and South Dakota

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes five low altitude Area Navigation
(RNAV) routes, designated T-281, T-283, T-285, T-286, and T-288, over
Nebraska and South Dakota; controlled by Denver Air Route Traffic
Control Center (ARTCC) and Minneapolis ARTCC. T-routes are low altitude
Air Traffic Service routes, based on RNAV, for use by aircraft that
have instrument flight rules (IFR) approved Global Positioning System
(GPS)/Global Navigation Satellite System (GNSS) equipment. This action
enhances safety and improves the efficient use of the navigable
airspace within Denver and Minneapolis ARTCC airspace.

DATES: Effective date 0901 UTC, May 5, 2011. 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: Colby Abbott, Airspace, Regulations
and ATC Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On August 5, 2010, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to establish five low altitude
RNAV routes within Denver and Minneapolis ARTCC airspace (75 FR 47252).
Previously, the pilot's only options are to either fly Visual Flight
Rules (VFR), VFR-On-Top, file a flight plan with an altitude high
enough for air traffic control to maintain radar surveillance and
communication frequency coverage, or fly many miles out of their way to
use established airways. Interested parties were invited to participate
in this rulemaking effort by submitting written comments on the
proposal. One comment was received, from the Aircraft Owners and Pilots
Association, supporting the proposal.

The Rule

    The FAA is amending Title 14 Code of Federal Regulations (14 CFR)
part 71 to establish five low altitude RNAV routes within Denver and
Minneapolis ARTCC airspace. This action establishes five T-routes where
none exist today and enables aircraft to navigate between the sites
identified in the regulatory route descriptions. The routes, designated
as T-281, T-283, T-285, T-286, and T-288, will be depicted on the
appropriate IFR En Route Low Altitude charts and will only be available
for use by GPS/GNSS equipped aircraft. This action enhances safety and
facilitates the efficient use of navigable airspace for en route IFR
operations within Denver and Minneapolis ARTCC airspace.
    Low altitude RNAV routes are published in paragraph 6011 of FAA
Order 7400.9U dated August 18, 2010, and effective September 15, 2010,
which is incorporated by reference in 14 CFR 71.1. The low altitude
RNAV routes listed in this document will be published subsequently in
the Order.
    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 Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that will only affect air
traffic procedures and air navigation, it is certified that this 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 United States Code. Subtitle I, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes low altitude RNAV routes (T-routes) over Nebraska and
South Dakota.

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).

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 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 FAA Order 7400.9U,
Airspace Designations and Reporting Points, signed August 18, 2010 and
effective September 15, 2010, is amended as follows:

Paragraph 6011 Area Navigation Routes

* * * * *

T-281 YOZLE, NE to Pierre,
 SD [New]

YOZLE, NE...................  Fix.................  (Lat. 41[deg]01'33'' N., long. 99[deg]39'06'' W.)
BOKKI, NE...................  Fix.................  (Lat. 41[deg]39'55'' N., long. 99[deg]52'17'' W.)
Ainsworth, NE (ANW).........  VOR/DME.............  (Lat. 42[deg]34'09'' N., long. 99[deg]59'23'' W.)
LKOTA, SD...................  WP..................  (Lat. 43[deg]15'28'' N., long. 100[deg]03'14'' W.)
Pierre, SD (PIR)............  VORTAC..............  (Lat. 44[deg]23'40'' N., long. 100[deg]09'46'' W.)

                                                  * * * * * * *
T-283 Scottsbluff, NE to
 Pierre, SD [New]

Scottsbluff, NE (BFF).......  VORTAC..............  (Lat. 41[deg]53'39'' N., long. 103[deg]28'55'' W.)
Gordon, NE (GRN)............  NDB.................  (Lat. 42[deg]48'04'' N., long. 102[deg]10'46'' W.)
WNDED, SD...................  WP..................  (Lat. 43[deg]19'14'' N., long. 101[deg]32'19'' W.)
Pierre, SD (PIR)............  VORTAC..............  (Lat. 44[deg]23'40'' N., long. 100[deg]09'46'' W.)

                                                  * * * * * * *
T-285 North Platte, NE to Huron, SD [New]

North Platte, NE (LBF)......  VORTAC..............  (Lat. 41[deg]02'55'' N., long. 100[deg]44'50'' W.)
Thedford, NE (TDD)..........  VOR/DME.............  (Lat. 41[deg]58'54'' N., long. 100[deg]43'09'' W.)
MARSS, NE...................  Fix.................  (Lat. 42[deg]27'49'' N., long. 100[deg]36'15'' W.)
Valentine, NE (VTN).........  NDB.................  (Lat. 42[deg]51'42'' N., long. 100[deg]32'59'' W.)
LKOTA, SD...................  WP..................  (Lat. 43[deg]15'28'' N., long. 100[deg]03'14'' W.)
Winner, SD (ISD)............  VOR.................  (Lat. 43[deg]29'16'' N., long. 99[deg]45'41'' W.)
Huron, SD (HON).............  VORTAC..............  (Lat. 44[deg]26'24'' N., long. 98[deg]18'40'' W.)

T-286 Rapid City, SD to Grand Island, NE [New]

Rapid City, SD (RAP)........  VORTAC..............  (Lat. 43[deg]58'34'' N., long. 103[deg]00'44'' W.)
Gordon, NE (GRN)............  NDB.................  (Lat. 42[deg]48'04'' N., long. 102[deg]10'46'' W.)
EFFEX, NE...................  WP..................  (Lat. 42[deg]19'59'' N., long. 101[deg]20'11'' W.)
Thedford, NE (TDD)..........  VOR/DME.............  (Lat. 41[deg]58'54'' N., long. 100[deg]43'09'' W.)
BOKKI, NE...................  Fix.................  (Lat. 41[deg]39'55'' N., long. 99[deg]52'17'' W.)
Grand Island, NE (GRI)......  VORTAC..............  (Lat. 40[deg]59'03'' N., long. 98[deg]18'53'' W.)

                                                  * * * * * * *
T-288 Rapid City, SD to Wolback, NE [New]

Rapid City, SD (RAP)........  VORTAC..............  (Lat. 43[deg]58'34'' N., long. 103[deg]00'44'' W.)
WNDED, SD...................  WP..................  (Lat. 43[deg]19'14'' N., long. 101[deg]32'19'' W.)
Valentine, NE (VTN).........  NDB.................  (Lat. 42[deg]51'42'' N., long. 100[deg]32'59'' W.)
Ainsworth, NE (ANW).........  VOR/DME.............  (Lat. 42[deg]34'09'' N., long. 99[deg]59'23'' W.)
FESNT, NE...................  WP..................  (Lat. 42[deg]03'57'' N., long. 99[deg]17'18'' W.)
Wolbach, NE (OBH)...........  VORTAC..............  (Lat. 41[deg]22'33'' N., long. 98[deg]21'13'' W.)

    Issued in Washington, DC, on January 20, 2011.
Edith V. Parish,
Manager, Airspace, Regulations and ATC Procedures Group.
[FR Doc. 2011-1800 Filed 1-27-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 169 (Wednesday, August 31, 2011)]
[Notices]
[Pages 54290-54291]
[FR Doc No: 2011-22234]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2011-0124]

Decision That Certain Nonconforming Motor Vehicles Are Eligible
for Importation

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Notice of decision by National Highway Traffic Safety
Administration (NHTSA) that certain nonconforming motor vehicles are
eligible for importation.

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SUMMARY: This document announces decisions by NHTSA that certain motor
vehicles not originally manufactured to comply with all applicable
Federal Motor Vehicle Safety Standards (FMVSS) are eligible for
importation into the United States because they are substantially
similar to vehicles originally manufactured for sale in the United
States and certified by their manufacturers as complying with the
safety standards, and they are capable of being readily altered to
conform to the standards or because they have safety features that
comply with, or are capable of being altered to comply with, all
applicable FMVSS.

DATES: These decisions became effective on the dates specified in Annex
A.

FOR FURTHER INFORMATION CONTACT: George Stevens, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for importation into and/or sale in the United
States, certified under 49 U.S.C. 30115, and of the same model year as
the model of the motor vehicle to be compared, and is capable of being
readily altered to conform to all applicable FMVSS.
    Where there is no substantially similar U.S.-certified motor
vehicle, 49 U.S.C. 30141(a)(1)(B) permits a nonconforming motor vehicle
to be admitted into the United States if its safety features comply
with, or are capable of being altered to comply with, all applicable
FMVSS based on destructive test data or such other evidence as NHTSA
decides to be adequate.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    NHTSA received petitions from registered importers to decide
whether the vehicles listed in Annex A to this notice are eligible for
importation into the United States. To afford an opportunity for public
comment, NHTSA published notice of these petitions as specified in
Annex A. The reader is referred to those notices for a thorough
description of the petitions.
    Comments: Safe Ride News (Safe Ride), a Division of the Willapa Bay
Company, Inc., submitted comments to petition dockets NHTSA-2011-0057,
NHTSA-2011-0019, and NHTSA-2011-0061 expressing its concern that a
nonconforming vehicle's ability to meet all safety requirements
intended to protect child occupants (specifically those required by
FMVSS Nos. 208 Occupant Crash Protection and 225 Child Restraint
Anchorage Systems) be verified before the vehicle is released by a
Registered Importer (RI). Safe Ride also questioned whether it is
advisable for the agency to permit the importation of older vehicles
that cannot be required to meet safety standards put into place after
their date of manufacture.
    Addressing the first issue raised by Safe Rides, it is worth noting
that under the agency's existing regulations, a nonconforming vehicle
cannot be found eligible for importation unless it is shown to be
capable of being modified to conform to all applicable FMVSS in effect
on its date of manufacture. Moreover, such a vehicle cannot be released
by an RI for the purpose of being licensed or registered for on-road
use until the RI proves to NHTSA's satisfaction that the vehicle does
in fact comply with all such standards. In instances where
modifications are necessary to achieve compliance, the RI must provide
descriptions of the modifications required along with documentary and
photographic evidence that the modifications have been made. When
modifications require components that are different from those
installed in a substantially similar U.S.-certified version of a
vehicle, proof that the substituted components will bring the vehicle
into compliance with all applicable FMVSS are also necessary. With
regard to the second issue raised by Safe Rides, the agency notes that
it lacks authority to deny import eligibility to an older model vehicle
on the basis that the vehicle could not be made to comply with FMVSS
put into place after the vehicle's date of manufacture.
    No other substantive comments were received in response to the
subject petitions.
    Based on its review of the information submitted by the
petitioners, NHTSA has decided to grant the petitions.
    Vehicle Eligibility Number for Subject Vehicles: The importer of a
vehicle admissible under any final decision must indicate on the form
HS-7 accompanying entry the appropriate vehicle eligibility number
indicating that the vehicle is eligible for entry. Vehicle eligibility
numbers assigned to vehicles admissible under this decision are
specified in Annex A.
    Final Decision: Accordingly, on the basis of the foregoing, NHTSA
hereby decides that each motor vehicle listed in Annex A to this
notice, which was not originally manufactured to comply with all
applicable FMVSS, is either substantially similar to a motor vehicle
manufactured for importation into and/or sale in the United States, and
certified under 49 U.S.C. 30115, as

specified in Annex A, and is capable of being readily altered to
conform to all applicable FMVSS or has safety features that comply
with, or is capable of being altered to comply with, all applicable
Federal Motor Vehicle Safety Standards.

    Authority:  49 U.S.C. 30141(a)(1)(A), (a)(1)(B) and (b)(1); 49
CFR 593.8; delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on: August 24, 2011.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.

Annex A--Nonconforming Motor Vehicles Decided To Be Eligible for
Importation

1. Docket No. NHTSA-2011-0061:
    Nonconforming Vehicles: 2007 Dodge Durango multipurpose passenger
vehicles manufactured for the Mexican market.
    Substantially Similar U.S. Certified Vehicles: 2007 Dodge Durango
multipurpose passenger vehicles manufactured for the Mexican market.
    Notice of Petition:
    Published at: 76 FR 32391 (June 6, 2011).
    Vehicle Eligibility Number: VSP-534 (effective date July 19, 2011).
2. Docket No. NHTSA-2011-0055:
    Nonconforming Vehicles: 2007-2011 Suzuki GSX1300R Motorcycles.
    Substantially Similar U.S. Certified Vehicles:
    2007-2011 Suzuki GSX1300R Motorcycles.
    Notice of Petition:
    Published at: 76 FR 30425 (May 25, 2011).
    Vehicle Eligibility Number: VSP-533 (effective date July 11, 2011).
3. Docket No. NHTSA-2011-0057:
    Nonconforming Vehicles: 2006 Mercedes-Benz CLS class passenger cars
manufactured prior to September 1, 2006.
    Substantially Similar U.S. Certified Vehicles: 2006 Mercedes-Benz
CLS class passenger cars manufactured prior to September 1, 2006.
    Notice of Petition:
    Published at: 76 FR 30426 (May 25, 2011).
    Vehicle Eligibility Number: VSP-532 (effective date July 7, 2011).
4. Docket No. NHTSA-2011-0028:
    Nonconforming Vehicles: 2005-2006 Porsche Carrerra (997) passenger
cars manufactured prior to September 1, 2006.
    Substantially Similar U.S. Certified Vehicles: 2005-2006 Porsche
Carrerra (997) passenger cars manufactured prior to September 1, 2006.
    Notice of Petition:
    Published at: 76 FR 14117 (March 15, 2011).
    Vehicle Eligibility Number: VSP-531 (effective date April 26,
2011).
5. Docket No. NHTSA-2010-0170:
    Nonconforming Vehicles: 2006 and 2007 Aston Martin Vantage
passenger cars.
    Substantially Similar U.S. Certified Vehicles: 2006 and 2007 Aston
Martin Vantage passenger cars.
    Notice of Petition:
    Published at: 76 FR 6841 (February 8, 2011).
    Vehicle Eligibility Number: VSP-530 (effective date March 23,
2011).
6. Docket No. NHTSA-2010-0173:
    Nonconforming Vehicles: 1991 Rice Beaufort Double trailers.
    Substantially Similar U.S. Certified Vehicles: 1991 Rice Beaufort
Double trailers.
    Notice of Petition:
    Published at: 75 FR 81711 (December 28, 2010).
    Vehicle Eligibility Number: VSP-529 (effective date February 3,
2011).
7. Docket No. NHTSA-2010-0161:
    Nonconforming Vehicles: 2010 Harley Davidson FL Series Motorcycles.
    Substantially Similar U.S. Certified Vehicles: 2010 Harley Davidson
FL Series Motorcycles.
    Notice of Petition:
    Published at: 75 FR 74145 (November 30, 2010).
    Vehicle Eligibility Number: VSP-528 (effective date January 28,
2011).
8. Docket No. NHTSA-2011-0062:
    Nonconforming Vehicles: 2008-2010 M&V GmbH Siegmar Fzb trailers.
    Because there are no substantially similar U.S.-certified version
2008-2010 M&V GmbH Siegmar Fzb trailers, the petitioner sought import
eligibility under 49 U.S.C. 30141(a)(1)(B).
    Notice of Petition:
    Published at: 76 FR 32019 (June 2, 2011).
    Vehicle Eligibility Number: VCP-46 (effective date July 18, 2011).
9. Docket No. NHTSA-2011-0019:
    Nonconforming Vehicles: 2005 Mercedes-Benz 350 CLS passenger cars.
    Because there are no substantially similar U.S.-certified version
2005 Mercedes-Benz 350 CLS passenger cars, the petitioner sought import
eligibility under 49 U.S.C. 30141(a)(1)(B).
    Notice of Petition:
    Published at: 76 FR 28501 (May 17, 2011).
    Vehicle Eligibility Number: VCP-45 (effective date July 11, 2011).
10. Docket No. NHTSA-2011-0034:
    Nonconforming Vehicles: 2002 Kawasaki Ninja ZX-6R motorcycles.
    Because there are no substantially similar U.S.-certified version
2002 Kawasaki Ninja ZX-6R motorcycles, the petitioner sought import
eligibility under 49 U.S.C. 30141(a)(1)(B).
    Notice of Petition:
    Published at: 76 FR 14116 (March 15, 2011).
    Vehicle Eligibility Number: VCP-44 (effective date April 26, 2011).
11. Docket No. NHTSA-2010-0108:
    Nonconforming Vehicles: 1989-1996 ALPINA B12 2-door Coupe model
passenger cars.
    Because there are no substantially similar U.S.-certified version
1989-1996 ALPINA B12 2-door Coupe model passenger cars, the petitioner
sought import eligibility under 49 U.S.C. 30141(a)(1)(B).
    Notice of Petition:
    Published at: 75 FR 51164 (August 18, 2010).
    Vehicle Eligibility Number: VCP-43 (effective date October 4,
2010).

[FR Doc. 2011-22234 Filed 8-30-11; 8:45 am]
BILLING CODE 4910-59-P


IMPORTANT NOTE TO USER: July 27, 2004 This OMB form has been recreated in WP6.0 by OPPTS staff. The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font ( Times New Roman 8pt).

 Do not change table lines ( although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5.1, so the text will scramble.

If you have any problems or questions, please call your RID Desk Officer @ 260 2706. PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ OAR/ OAQPS 2. OMB control number b. G None a_ 2 _ 0 _ 6 _ 0  _ 0 _ 2 _ 4 _ 3 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. x Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one)

a.

Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a.

Three years from approval date b. G Other Specify: / /___

7. Title State Operating Permits Regulations ( 40 CFR part 70) ( Renewal)

8. Agency form number( s) ( If applicable) EPA ICR Number 1587.06 9. Keywords Reporting and Recordkeeping Requirements, Permits, Air Pollution Control 10. Abstract Sources monitor operations and submit to permitting authorities semi annual monitoring reports, annual compliance certifications, and applications for new permits, permit revisions and renewals. Permitting authorities review reports, prepare permits and permit revisions, and submit proposed permits and permit revisions to EPA.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c.

Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 17,738 b. Total annual responses 17,738 1. Percentage of these responses collected electronically 50 % c. Total annual hours requested 5,109,548 d. Current OMB inventory 4,779,620 e. Difference 329,928 f. Explanation of difference 1. Program Change 2. Adjustment 329,928 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. X _ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P_ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply)

a.

Recordkeeping b. Q Third party disclosure c.

Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5.

Semi annually 6.

Annually 7. Q Biennually 8.

Other ( describe) One time 17. Statistical methods Does this information collection employ statistical methods?

Q Yes

No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Grecia Castro Phone: 919 541 1351 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OPPE) Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( i) the reasons the information is planned to be and/ or has been collected; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

10/ 95


[Federal Register Volume 88, Number 119 (Thursday, June 22, 2023)]
[Rules and Regulations]
[Pages 40715-40719]
[FR Doc No: 2023-13147]

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

40 CFR Part 52

[EPA-R03-OAR-2023-0104; FRL10907-02-R3]

Air Plan Approval; Virginia; Startup, Shutdown, and Malfunction
Amendments to Facility and Control Equipment Maintenance or Malfunction
Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a state
implementation plan (SIP) revision submitted by the Commonwealth of
Virginia. The revision pertains to several state regulatory changes
affecting startup, shutdown and malfunction. This SIP revision was
submitted in response to a finding of substantial inadequacy and SIP
call published on June 12, 2015, for provisions in the Virginia SIP.
EPA is approving these revisions to the Virginia SIP and determining
that the SIP revision corrects the deficiencies in the Virginia SIP
identified in the June 12, 2015 SIP call. This action is being taken in
accordance with the requirements of the Clean Air Act (CAA).

DATES: This final rule is effective on July 24, 2023.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2023-0104. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available,

e.g., confidential business information (CBI) or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through www.regulations.gov, or please contact
the person identified in the For Further Information Contact section
for additional availability information.

FOR FURTHER INFORMATION CONTACT: Sean Silverman, Planning &
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1600 John F. Kennedy
Boulevard, Philadelphia, Pennsylvania 19103. The telephone number is
(215) 814-5511. Mr. Silverman can also be reached via electronic mail
at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On April 20, 2023 (88 FR 24377), EPA proposed to approve a SIP
revision submitted by the Commonwealth of Virginia through the Virginia
Department of Environmental Quality (VADEQ) on August 1, 2016. In that
proposal we proposed to determine that the SIP revision corrects the
deficiencies with respect to Virginia's SIP that were identified in the
June 12, 2015 action entitled ``State Implementation Plans: Response to
Petition for Rulemaking; Restatement and Update of EPA's SSM Policy
Applicable to SIPs; Findings of Substantial Inadequacy; and SIP Calls
to Amend Provisions Applying to Excess Emissions During Periods of
Startup, Shutdown, and Malfunction'' (2015 SSM SIP Action). 80 FR 33840
(June 12, 2015). The reasons for our proposed approval and
determination are stated in the proposal for this action and will not
be restated here. 88 FR 24377 (April 20, 2023). The public comment
period for our proposed approval and determination ended on May 22,
2023. Two comments were received and are described below in section III
of this preamble.

II. Summary of Virginia's SIP Revision Related to This Action

    With respect to the Virginia SIP, in the 2015 SSM SIP Action, EPA
determined that one provision, 9 Virginia Administrative Code (VAC) 5-
20-180(G), was substantially inadequate to meet CAA requirements.\1\ In
the August 1, 2016 SIP revision, Virginia amended the portion of 9VAC5-
20-180(G) \2\ to address the deficiencies in the 2015 SSM SIP Action,
and made several other administrative amendments in 9VAC5-20-180 and
other sections.\3\ In this action, EPA is determining Virginia's August
1, 2016 SIP revision addressed the provision identified as
substantially inadequate in the 2015 SSM SIP Action. Additionally, EPA
has identified a typographical error previously incorporated by
reference in the Code of Federal Regulations (CFR) for one of the
provisions being updated in this notice. This final rule contains the
text to correct this error in the amendments to 40 CFR part 52 set
forth below.
---------------------------------------------------------------------------

    \1\ See 80 FR 33840 at 33961 (June 12, 2015).
    \2\ This document will hereafter use the abbreviated form of 9
Virginia Administrative Code (VAC) Sec.  5-20-180(G), which is
9VAC5-20-180(G) or 9 Va. Admin Code. 5-20-180(G).
    \3\ Administrative changes to other sections consist of
references to 9VAC5-20-180 added to 9VAC5-40-8416, 9VAC5-40-8470,
9VAC5-40-8640, 9VAC5-40-8790 and 9VAC5-40-8940 to state ``The
provisions of 9VAC5-20-180 (Facility and control equipment
maintenance or malfunction) apply.''
---------------------------------------------------------------------------

    Other specific requirements of Virginia's August 1, 2016 submittal
and the rationale for EPA's proposed action are explained in the notice
of proposed rulemaking (NPRM) and will not be restated here.

III. EPA's Response to Comments Received

    EPA received two sets of comments in response to the NPRM that are
available in the docket for this action. Of these two sets of comments,
one was outside of the scope of this rulemaking. The other comment,
submitted by the Sierra Club, was supportive. As such, neither of these
comments require a response by EPA.

IV. Final Action

    EPA is approving Virginia's August 1, 2016 SIP revision as a
revision to the Virginia SIP. EPA has determined that the amendments in
the August 1, 2016 SIP revision correct the deficiencies identified in
the 2015 SSM SIP Action.

V. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information that: (1) are generated or developed
before the commencement of a voluntary environmental assessment; (2)
are prepared independently of the assessment process; (3) demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by Federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
Federally authorized environmental programs in a manner that is no less
stringent than their Federal counterparts. . . .'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by Federal law to maintain program delegation, authorization or
approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the extent consistent with requirements imposed by Federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998, opinion states that the quoted language renders this statute
inapplicable to enforcement of any federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent

with Federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
program consistent with the Federal requirements. In any event, because
EPA has also determined that a state audit privilege and immunity law
can affect only state enforcement and cannot have any impact on Federal
enforcement authorities, EPA may at any time invoke its authority under
the CAA, including, for example, sections 113, 167, 205, 211 or 213, to
enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort. In addition, citizen
enforcement under section 304 of the CAA is likewise unaffected by
this, or any, state audit privilege or immunity law.

VI. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Virginia's
Revised 9VAC5-20-180 (Pertaining to Facility Control Equipment and
Malfunction) which regulates periods of excess emissions from the
shutdown or bypassing of emissions control equipment for maintenance,
and malfunction of emissions control equipment or sources at affected
facilities, including 9VAC5-40-8416 (Letterpress Printing Operations),
9VAC5-40-8470 (Offset Lithographic Printing Operations), 9VAC5-40-8640
(Industrial Solvent Cleaning Operations), 9VAC5-40-8790 (Miscellaneous
Industrial Adhesive Application Processes), and 9VAC5-40-8940
(Miscellaneous Metal Parts and Products Coating Application Systems) in
section 52.2420, which corrects the deficiency in the Virginia SIP, as
set forth below in the amendments to 40 CFR part 52. EPA has made, and
will continue to make, these materials generally available through
www.regulations.gov and at the EPA Region III Office (please contact
the person identified in the For Further Information Contact section of
this preamble for more information). Therefore, these materials have
been approved by EPA for inclusion in the SIP, have been incorporated
by reference by EPA into that plan, are fully federally enforceable
under sections 110 and 113 of the CAA as of the effective date of the
final rulemaking of EPA's approval, and will be incorporated by
reference in the next update to the SIP compilation.\4\
---------------------------------------------------------------------------

    \4\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

VII. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. 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);
     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); and
     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.
    The SIP is not approved to apply on any Indian reservation land as
defined in 18 U.S.C. 1151 or in any other area where 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).
    Executive Order 12898 (Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    The VADEQ did not evaluate environmental justice considerations as
part of its SIP submittal; the CAA and applicable implementing
regulations neither prohibit nor require such an evaluation. EPA did
not perform an EJ analysis and did not consider EJ in this action. Due
to the nature of the action being taken here, this action is expected
to have a neutral to positive impact on the air quality of the affected
area. Consideration of EJ is not required as part of this action, and
there is no information in the record inconsistent with the stated goal
of E.O. 12898 of achieving environmental justice for people of color,
low-income populations, and Indigenous peoples.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it

is published in the Federal Register. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 21, 2023. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action which corrects the deficiencies in Virginia's SIP
identified in the 2015 SSM SIP Action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Reporting and recordkeeping requirements.

Adam Ortiz,
Regional Administrator, Region III.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart VV--Virginia

0
2. In Sec.  52.2420, the table in paragraph (c) is amended by:
0
a. Revising the entry ``5-20-180'';
0
b. Adding the entry ``5-40-8416'' in numerical order under the heading
``Article 56, Emission Standards for Letterpress Printing Operations in
the Northern Virginia Volatile Organic Compound Emissions Control Area,
8-hour Ozone Standard (Rule 4-56)'';
0
c. Adding the entry ``5-40-8470'' in numerical order under the heading
``Article 56.1. Emission Standards for Offset Lithographic Printing
Operations in the Northern Virginia Volatile Organic Compound Emissions
Control Area, 8-hour Ozone Standard (Rule 4-56.1)'';
0
d. Adding the entry ``8-40-8640'' in numerical order under the heading
``Article 57. Emission Standards for Industrial Solvent Cleaning
Operations in the Northern Virginia Volatile Organic Compound Emissions
Control Area, 8-hour Ozone Standard (Rule 4-57)'';
0
e. Adding the entry ``5-40-8790'' in numerical order under the heading
``Article 58. Emission Standards for Miscellaneous Industrial Adhesive
Application Processes in the Northern Virginia Volatile Organic
Compound Emissions Control Area, 8-hour Ozone Standard (Rule 4-58)'';
0
f. Removing the subject heading ``Article 59. Emission Standards for
Miscellaneous Metal Parts and Products Coating Application Systems in
the Northern Virginia Volatile Organic Compound Emissions Control Area,
8-hour Ozone Standard (Rule 4-58)'' and adding the subject heading
``Article 59. Emission Standards for Miscellaneous Metal Parts and
Products Coating Application Systems in the Northern Virginia Volatile
Organic Compound Emissions Control Area, 8-hour Ozone Standard (Rule 4-
59)'' in its place; and
0
g. Adding the entry ``5-40-8940'' in numerical order under the new
heading ``Article 59. Emission Standards for Miscellaneous Metal Parts
and Products Coating Application Systems in the Northern Virginia
Volatile Organic Compound Emissions Control Area, 8-hour Ozone Standard
(Rule 4-59)''.
    The revision and additions read as follows:

Sec.  52.2420  Identification of plan.

* * * * *
    (c) * * *

----------------------------------------------------------------------------------------------------------------
                                                           State                             Explanation [former
        State citation             Title/subject      effective date    EPA approval date       SIP citation]
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                     9 VAC 5, Chapter 20 General Provisions
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                          Part II Air Quality Programs
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
5-20-180.....................  Facility and control         6/1/2016  6/22/2023, [INSERT    Revised 9VAC5-20-
                                equipment                              FEDERAL REGISTER      180(A) through
                                maintenance or                         CITATION].            9VAC5-20-180(D) and
                                malfunction.                                                 9VAC5-20-180(F)
                                                                                through 9VAC5-20-
                                                                                180(J).

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                            9 VAC 5, Chapter 40 Existing Stationary Sources [Part IV]
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                           Part II Emission Standards
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
  Article 56. Emission Standards for Letterpress Printing Operations in the Northern Virginia Volatile Organic
                       Compound Emissions Control Area, 8-Hour Ozone Standard (Rule 4-56)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
5-40-8416....................  Facility and control         2/1/2016  6/22/2023, [INSERT    Added.
                                equipment                              FEDERAL REGISTER
                                maintenance or                         CITATION].
                                malfunction.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
 Article 56.1. Emission Standards for Offset Lithographic Printing Operations in the Northern Virginia Volatile
                  Organic Compound Emissions Control Area, 8-hour Ozone Standard (Rule 4-56.1)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
5-40-8470....................  Facility and control         2/1/2016  6/22/2023, [INSERT    Added.
                                equipment                              FEDERAL REGISTER
                                maintenance or                         CITATION].
                                malfunction.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
   Article 57. Emission Standards for Industrial Solvent Cleaning Operations in the Northern Virginia Volatile
                   Organic Compound Emissions Control Area, 8-hour Ozone Standard (Rule 4-57)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
8-40-8640....................  Facility and control         2/1/2016  6/22/2023, [INSERT    Added.
                                equipment                              FEDERAL REGISTER
                                maintenance or                         CITATION].
                                malfunction.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
   Article 58. Emission Standards for Miscellaneous Industrial Adhesive Application Processes in the Northern
          Virginia Volatile Organic Compound Emissions Control Area, 8-hour Ozone Standard (Rule 4-58)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
5-40-8790....................  Facility and control         2/1/2016  6/22/2023, [INSERT    Added.
                                equipment                              FEDERAL REGISTER
                                maintenance or                         CITATION].
                                malfunction.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
  Article 59. Emission Standards for Miscellaneous Metal Parts and Products Coating Application Systems in the
      Northern Virginia Volatile Organic Compound Emissions Control Area, 8-hour Ozone Standard (Rule 4-59)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
5-40-8940....................  Facility and control         2/1/2016  6/22/2023, [INSERT    Added.
                                equipment                              FEDERAL REGISTER
                                maintenance or                         CITATION].
                                malfunction.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-13147 Filed 6-21-23; 8:45 am]
BILLING CODE 6560-50-P


NHEERL NTD CMTB SP/ 98 002 000 February 10, 1998 Page 1 Procedural Section 1.0 Scope and Application 1.1 The Hitachi 911 Automatic Analyzer ( Boehringer Mannheim, Indianapolis, IN) is used to run a wide range of chemistries, e. g., cholinesterase.

1.2 The Hitachi 911 is a spectrophotometer equipped with sophisticated robotics that automatically dispense samples and appropriate reagents into cuvettes suspended in a 37

C water bath. Absorbance readings are taken and enzyme activity is calculated by the analyzer.

1.3 These analyzers are used extensively in many testing and clinical laboratories to ensure reproducibility and increase sample throughput. However, these instruments are not appropriate to use in the determination of cholinesterase activity in carbamate treated tissues, e. g., carbaryl, due to reactivation of cholinesterase activity that occurs during the analyzer's performance of the assay.

2.0 Prerequisites 2.1 Equipment and Supplies Hitachi 911 Automatic Analyzer* Sample Cups* Reagent Bottles* Pipet, 200  l Laboratory Glassware Analytical Balance Ice * Analyzer and its supplies obtained from Boehringer Mannheim, Indianapois, IN All other equipment and supplies are considered standard laboratory devices or items and do not need to meet critical specifications.

2.2 Chemicals Acetylthiocholine Iodide ( Sigma, A 5751) 5,5' dithio bis( 2 nitrobenzoic) Acid ( DTNB) ( Sigma, D 8130) 0.2M Sodium Phosphate, monobasic ( Sigma, S 9638): 27.6 g NaH2PO4 in1000 ml ddH2O 0.2M Sodium Phosphate, dibasic ( Sigma, S 9763): 28.4 g Na2HPO4 in 1000 ml ddH2O 0.1M Sodium Phosphate Buffer, pH 8.0: 380 ml 0.2M Na2HPO4 ( dibasic) + 20 NHEERL NTD CMTB SP/ 98 002 000 February 10, 1998 Page 2 ml 0.2M NaH2PO4 ( monobasic), adjust pH to 8.0, double volume by adding ddH2O and refrigerate 0.1M Sodium Phosphate Buffer, pH 8.0 + 1% Triton ( Sigma, T 6878) 0.1M Sodium Phosphate Buffer, pH 7.0: 61 ml 0.2M Na2HPO4 ( dibasic) + 39 ml 0.2M NaH2PO4 ( monobasic), adjust pH to 7.0, double volume by adding ddH2O and refrigerate DTNB Stock Solution: 118.8 mg DTNB 45.0 mg Sodium Bicarbonate ( Sigma, S 233) 30.0 ml 0.1M Sodium Phosphate Buffer, pH 7.0 Freeze Saline Laboratory grade 2.3 Biological Samples should be stored at  80

C in an alarm equipped freezer Tissues will be received already appropriately diluted and homogenized in 0.1M Sodium Phoshate Buffer, pH 8.0 containing 1% Triton Keep samples on ice during preparation 2.4 Personnel Training Personnel must complete the manufacturer's 8 day Hitachi 911 Basic Operator Course at the Boehringer Mannheim Training Center, Indianapolis, IN to become knowledgable in the operation of the automatic analyzer.

3.0 Special Considerations 3.1 Because tissues need to be more dilute to accomodate the robotics of the analyzer and the analyzer employs a manufacturer's set preincubation period, tissues that have been treated with a carbamate pesticide should not be assayed using an automatic analyzer. These situations lead to reactivation of cholinesterase activity and thus, results will not be accurate.

4.0 Procedure 1. Tissues may require additional dilution using 0.1M Sodium Phosphate Buffer, pH 8.0 containing 1% Triton to be run on the analyzer. Based on historical data generated in the laboratory using the automatic analyzer, tissues should be diluted as follows: Plasma undiluted Erythrocytes ( 1: 25) dilution Brain ( 1: 50) dilution Heart ( 1: 50) dilution 2. Prepare substrate as follows: a. 2.444 mg Acetylthiocholine Iodide + 1.0 ml ddH2O NHEERL NTD CMTB SP/ 98 002 000 February 10, 1998 Page 3 b. Each cholinesterase test requires 50  l of substrate c. Prepare the proper amount of substrate according to the following formula: X* 2= Y Y* 50  l= Z Where: X= single # of samples to be run Y= total # of samples Z= ml of substrate required d. Weigh out acetylthiocholine iodide and divide by 2.444 to determine the volume of ddH2O to be added. Example: 32 samples are to be run. 32* 2= 64 64* 50= 3.2 ml of substrate required 26.4 mg of acetylthiocholine iodide is weighed out 26.4 mg/ 2.444= 10.8 ml of ddH2O added 3. Similarly prepare the DTNB/ Buffer solution according to the following: a. 1 ml DTNB ( from frozen stock) + 29 ml 0.1M Sodium Phosphate, pH 8.0 Buffer b. Each cholinesterase test and its blank requires 300  l of DTNB/ Buffer c. Prepare the proper volume of DTNB/ Buffer according to the following formula: X* 4= Y Y* 300  l= Z Where: X= single # of samples to be run Y= total # of samples Z= ml of DTNB/ Buffer required Example: Same 32 samples to be run. 32* 4= 128 128* 300= 38.4 ml DTNB/ Buffer required 3 ml DTNB + 87 ml 0.1M Sodium Phosphate Buffer, pH 8.0 4. Pour substrate into a barcoded reagent bottle. Split the volume of DTNB/ Buffer into reagent bottles. Fill a third reagent bottle with saline to be run as a blank. Place reagent bottles into their assigned positions on the reagent disk. 5. Perform a calibration of the analyzer and run controls 6. Pipet 200  l of sample into sample cup and place it on sample disk 7. When sample disk is filled, place on analyzer and program analyzer 8. Analyzer will calculate cholinesterase activity and print results Quality Control Section NHEERL NTD CMTB SP/ 98 002 000 February 10, 1998 Page 4 1.0 All samples are run in duplicate.

1.1 The analyzer uses the analysis of blanks.

1.2 The analyzer operator runs a set of brains at the following dilutions: ( 1: 50), ( 1: 100), ( 1: 200) and ( 1: 400) to be used as controls to verify that reagents were prepared correctly and the machine is operating properly prior to any samples being run. Control values are archived bythe analyzer and are checked in the QC Parameter function to verify that the values reported for each activity remain in a tight range (  50 units).

1.3 A calibration of the analyzer is performed each day that the machine is used.

1.4 Calculations: a. The analyzer reports results in an undefined unit/ liter. b. Since this measurement is not significant in the science field, all data collected from the analyzer is expressed as % of control. c. To ensure that the data generated from the automatic analyzer is accurate, a subset of samples are run on both the analyzer and by the radiometric method. When the data from both methods are calculated as % of control, the percentages are within  5%.

1.5 Recordkeeping Requirements All sample inventories, correspondance, etc. for a study are kept in a labeled hanging file folder in the laboratory's file cabinet. As assays are run, notations on procedure, including any problems, are documented in the technician's laboratory notebook. Resulting data is organized in Excel ( Microsoft Office ` 97) files. Hardcopies are printed and placed in the study file. The printouts generated by the automatic analyzer are labeled at the top with the study name, tissue assayed, tissue dilution and assay date before being placed in the study file.


[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Notices]
[Pages 2459-2461]
[FR Doc No: 2018-00684]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-3619]

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

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 AXUMIN 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-3619 for ''Determination of Regulatory Review Period for
Purposes of Patent Extension; AXUMIN.'' 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 AXUMIN
(fluciclovine F-18). AXUMIN is indicated for positron emission
tomography imaging in men with suspected prostate cancer recurrence
based on elevated blood prostate specific antigen levels following
prior treatment. Subsequent to this approval, the USPTO received a
patent term restoration application for AXUMIN (U.S. Patent No.
5,808,146) from Emory University, and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated December 1, 2016, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of AXUMIN 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
AXUMIN is 4,006 days. Of this time, 3,763 days occurred during the
testing phase of the regulatory review period, while 243 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 (FD&C Act) (21 U.S.C. 355(i)) became effective:
June 10, 2005. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on June 10,
2005
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: September
28, 2015. FDA has verified the applicant's claim that the new drug
application (NDA) for AXUMIN (NDA 208054) was initially submitted on
September 28, 2015.
    3. The date the application was approved: May 27, 2016. FDA has
verified the applicant's claim that NDA 208054 was approved on May 27,
2016.

    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 5 years 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. 2018-00684 Filed 1-16-18; 8:45 am]
 BILLING CODE 4164-01-P