[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Proposed Rules]
[Pages 85907-85914]
[FR Doc No: 2016-28673]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2007-0989; FRL-9955-03-Region 6]

Approval and Promulgation of Implementation Plans; Oklahoma;
Revisions to Minor New Source Review Permitting Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve severable portions of revisions to the Oklahoma New Source
Review (NSR) State Implementation Plan (SIP) submitted by the State of
Oklahoma on February 14, 2002 (the February 14, 2002, SIP submittal).
This action addresses revisions to the Oklahoma Administrative Code
(OAC), Title 252, Chapters 4 and 100, concerning the State's Minor New
Source Review air permitting program. Many revisions are administrative
in nature and modify redundant or incorrect text within the SIP. The
revisions also include renumbered or codified portions of the SIP and
new sections that incorporate Federal rules. This rulemaking is being
taken in accordance with section 110 of the Clean Air Act (CAA).

DATES: Written comments must be received on or before December 29,
2016.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2007-0989, at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be

accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e., on the Web,
cloud, or other file sharing system). For additional submission
methods, please contact Rick Barrett,<PHONE_NUMBER>,
<EMAIL_ADDRESS>For the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at the EPA
Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available at either location
(e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Mr. Rick Barrett,<PHONE_NUMBER>,
<EMAIL_ADDRESS>To inspect the hard copy materials, please
schedule an appointment with Rick Barrett or Mr. Bill Deese at 214-665-
7253.

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,'' or
``our'' means the EPA.

I. Background
II. Oklahoma's Program for Minor New Source Review
III. EPA's Evaluation of Proposed SIP Revisions
IV. Proposed Action
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. Background

    The SIP is a set of air pollution regulations, control strategies
and technical analyses developed by the state, to ensure that the state
meets the National Ambient Air Quality Standards (NAAQS). These ambient
standards are established under section 109 of the Act and they
currently address six criteria pollutants: Carbon monoxide, nitrogen
dioxide, ozone, lead, particulate matter, and sulfur dioxide. The SIP
is required by section 110 of the Act and can be extensive, containing
state regulations or other enforceable documents and supporting
information such as emission inventories, monitoring networks, and
modeling demonstrations. EPA has promulgated implementing regulations
for the preparation, adoption, and submittal of SIPs. 40 CFR part 51.
    The Clean Air Act at section 110(a)(2)(C) requires states to
develop and implement permitting programs (called new source review or
NSR) for attainment and nonattainment areas; these NSR programs cover
both construction and modification of stationary sources.\1\ Each SIP
must include legally enforceable procedures that enable the state to
determine whether the construction or modification of a stationary
source will result in a violation of applicable portions of a control
strategy or the interference with the attainment or maintenance of a
NAAQS. 40 CFR 51.160. EPA rules set forth detailed requirements for the
development of approvable SIP provisions related to the construction of
new major stationary sources and major modifications to existing major
stationary sources (Major NSR) located in both attainment and
nonattainment areas. See, e.g., 40 CFR 51.165-166; however, the
requirements for the development of approvable SIP provisions related
to the construction and modification of minor sources and minor
modifications to existing major stationary sources (Minor NSR) are
governed by the more general provisions of 40 CFR 51.160-51.164. EPA
has previously approved rules submitted by Oklahoma to implement the
Major NSR permitting program, including revisions to rules that are
also the subject of this rulemaking, but only as those rules relate to
the Major NSR program. See, e.g., 75 FR 72695, November 26, 2010. The
next section provides a description of Oklahoma's Minor NSR program and
the portions of the February 14, 2002 SIP submittal related to
Oklahoma's Minor NSR program that are being acted upon in this proposed
rulemaking.
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    \1\ The definition of ``stationary source'' or ``source'' used
herein is equivalent to ODEQ's definition of ``facility,'' as
defined at OAC 252:100-1-3.
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    Some severable provisions submitted by the State of Oklahoma on
February 14, 2002, are not addressed in today's action. For these
provisions, the EPA has severed the submitted provisions from today's
proposed rulemaking and will address them at a later date. The table
below and the TSD accompanying our rulemaking identifies the submitted
provisions that we are proposing to approve and those provisions we are
neither evaluating nor acting upon in this proposed rulemaking.

II. Oklahoma's Program for Minor New Source Review

    A. Overview--The EPA-approved Oklahoma SIP rules comprising
Oklahoma's Minor New Source Review (NSR) program may be found in
Regulation 1.4, Air Resources Management Permits Required. A revision
to Regulation 1.4 was approved by EPA on November 8, 1999 (64 FR 60683)
as part of the Oklahoma visibility SIP. The EPA's November 26, 2010
rulemaking mentioned above also revised Regulation 1.4 of the Oklahoma
SIP, but only as it applied to Oklahoma's Major NSR program. See 75 FR
72695 and OAC 252:100-8. Oklahoma's Minor NSR program has been
significantly modified and expanded. Elements of Oklahoma's Minor NSR
program may now be found in OAC 252:4-1 (General Provisions), OAC
252:4-7 (Environmental Permit Process), Appendix C (Permitting Process
Summary), OAC 252:100-5 (Registration, Emission Inventory and Annual
Operating Fees), OAC 252:100-7 (Permits for Minor Facilities), Appendix
H (De Minimis Facilities) and OAC 252:100-8 (Permits for Part 70
Sources). Those rules before us for action are limited to Minor NSR,
and the effect of our rulemaking action, if finalized, will be the
removal of Regulation 1.4 from the Oklahoma SIP (except as it applies
to Minor NSR permitting under OAC 252:100-8) and the incorporation of
specific provisions in the other regulations referenced above into the
Oklahoma SIP.
    B. Types of Minor NSR Permitting Actions--Oklahoma divides its
permitting program between ``Permits for Minor Facilities'' found in
OAC 252:100-7, and ``Permits for Part 70 Sources'' which includes Major
New Source Review (NSR) Sources, found in OAC 252:100-8. Oklahoma's
February 14, 2002 SIP submittal includes OAC 252:100-7 which
establishes three types of construction and operating permits for minor
facilities: A permit by rule (PBR), a general permit, and an individual
permit. The PBR program applies to facilities emitting less than 40
tons per year (TPY) of any regulated pollutant, in an industry group
for which a rule has been promulgated. The general permitting program
generally applies to facilities emitting between 40 TPY and 100 TPY, in
an industry group for which a general permit has been issued. Minor
facilities which do not qualify for either of these shall obtain an
individual permit. De minimis facilities are those facilities which
emit less than 5 TPY and are not required to obtain a permit. As
discussed later, Oklahoma's Minor NSR Program also applies to minor
modifications of existing major stationary sources, covered by OAC
252:100-8, although we are not proposing action on the Minor NSR-

related rules in OAC 252:100-8 at this time. We also note that OAC:252
100-7 and OAC:252:100-8 have requirements for both construction and
operating permits; however, only the construction permitting
requirements are required under the CAA and 40 CFR part 51, subpart I.
    OAC 252:100-7 also deletes the lower limit of 5 TPY for PBR
facilities. This allows facilities subject to New Source Performance
Standards (NSPS) with emissions less than 5 TPY to apply for a PBR
instead of obtaining an individual permit.
    A PBR or general permit may be issued if there are a sufficient
number of facilities that have similar operations, emissions, and
activities that are subject to the same standards, limitations, and
operating and monitoring requirements. OAC 252:100-7 Part 9 and OAC
252:100-7 Part 3 outline the criteria required to qualify for these
permits: (1) A facility may apply for a PBR if the facility's actual
emissions are less than 40 TPY, except hazardous air pollutants (HAPs);
the facility does not emit or have the potential to emit 10 TPY or more
of any single hazardous air pollutant (HAP) or 25 TPY or more of any
combination of HAPs; the ODEQ must have established a permit by rule
for the industry; the facility certifies that it will comply with the
applicable PBR; and the facility is not operated in conjunction with
another facility or source that is subject to air quality permitting;
and (2) A minor facility may apply for a general permit if its actual
emissions are less than 100 TPY of each regulated air pollutant, except
for HAPs; the facility does not emit or have the potential to emit 10
TPY or more of any single HAP or 25 TPY or more of any combination of
HAPs; and ODEQ has issued a general permit for the industry.
    In general, a facility may apply for an individual permit if the
facility's actual emissions are less than 100 TPY; the facility does
not emit or have the potential to emit 10 TPY or more of any single
hazardous air pollutant (HAP) or 25 TPY or more of any combination of
HAPs; the facility submits an application form from the ODEQ that
provides all data and information required by OAC 252:100-7, such as
site information, process description, emission data; and the facility
provides information necessary for any required BACT \2\ determination,
modeling and sampling point data. Individual permits may be applied for
even if the facility qualifies for a PBR or a general permit.
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    \2\ See definition of ``Best Available Control Technology'' or
``BACT'' at OAC 252:100-7.1.1 as it applies to Oklahoma's Minor NSR
program, as compared to the BACT requirements for Oklahoma's Major
NSR program at OAC 252:100-8-34, as previously approved by EPA into
the Oklahoma SIP (75 FR 72695, November 26, 2010).
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    C. Permitting Practice and Procedures for Minor Facilities and
Minor Revisions--OAC 252:4 (Rules of Practice and Procedure) provides
administrative procedures for permit issuance, public notice, and
administrative proceedings. OAC 252:4 was adopted to meet the
requirements of the Oklahoma Administrative Procedures Act, which
requires each State agency to adopt rules describing its organization,
method of operation and methods by which the public may obtain or
provide information to the agency. These rules also specify the
requirements of all formal and informal procedures available, including
a description of forms and instructions.
    OAC 252:4-1 (General Provisions) includes the practices and
procedures of the Environmental Quality Board, Advisory Councils, and
the Department of Environmental Quality; the availability of records;
and fees for copying, faxing, records search and mail services.
    OAC 252:4-7 (Environmental Permit Process) includes Part 1 (The
Process) and Part 3 (Air Quality Division Tiers and Time Lines).
Representative sections of Part 1 include OAC 252:4-7-2 (Preamble), OAC
252:4-7-13 (Notices) and OAC 252:4-7-15 (Permit issuance or denial).
Representative sections of Part 3 include OAC 252:4-7-31 (Air quality
time lines) and OAC 252:4-7-33 (Air quality applications--Tier II). OAC
252:4-7 is briefly discussed in more detail below.
    The Preamble of OAC 252:4-7 is the introductory section,
referencing the Uniform Environmental Permitting Act (UEPA), which
requires that DEQ fit licenses, permits, certificates, approvals and
registrations into a category, or Tier, established under the uniform
environmental permitting rules. The UEPA was created to streamline the
permitting process and is located in Oklahoma Statute Title 27A
Environment and Natural Resources, Chapter 2: Oklahoma Environmental
Quality Code, Sections 1 through 12. Tier I are administrative
decisions made by a technical supervisor without public participation,
aside from the landowner. Tier II are administrative decisions made by
the Division Director with some public participation, including notice
to the public, and the opportunity for a public meeting and public
comment. Tier III are administrative decisions made by the Executive
Director with extensive public participation, e.g., an administrative
evidentiary hearing.
    The UEPA requires an applicant to give notice. Notice requirements
include providing notice to the landowner if the applicant does not own
the property, providing a draft notice for approval to DEQ prior to
publication, and proof of publication; these are in addition to the
notice requirements for permits under the UEPA.
    OAC 252:4, Appendix C (Permitting Process Summary) lists the permit
processing steps required under each of the three Tiers. As explained
below, Tier I covers permitting for minor facilities and minor
revisions to facilities.
    D. Oklahoma's Permitting Regulations and Revisions Submitted in the
February 14, 2002 SIP Submittal--OAC 252:100 (Air Pollution Control)
provides, in part, details regarding permitting fees, permitting for
minor facilities, permitting for Part 70 Sources, and Prevention of
Significant Deterioration (PSD) requirements for major stationary
sources.
    Oklahoma's February 14, 2002 SIP submittal includes three separate
revisions to OAC 252:100-5 (Registration, Emission Inventory and Annual
Operating Fees). The first revision to OAC 252:100-5 was adopted by
Oklahoma in 1998 and includes requirements to file an emission
inventory, formerly located in OAC 252:100-7; requirements to pay
annual operating fees, formerly located in OAC 252:100-7 and OAC
252:100-8; and increases to the annual operating fees for minor
facilities and non-Part 70 sources. The second revision to OAC 252:100-
5 was adopted by Oklahoma in 1999, to modify the base annual operating
fee for minor facilities and the annual operating fee for Part 70
sources. The third revision to OAC 252:100-5 was adopted by Oklahoma in
2000, allowing the agency to bill annual operating fees on a flexible
schedule and providing edits that define billing dates and identifying
how errors will be handled. The changes allow fees to be based on the
most recent emissions data and require inventories to be submitted
prior to March 1. Miscellaneous edits delete redundant text and clarify
text; the revisions are not substantive.
    Oklahoma's February 14, 2002 SIP submittal also included several
revisions to OAC 252:100-7 (Permits for Minor Facilities). As stated in
Part I above, the EPA took no action on OAC 252:100-7 in Oklahoma's
1994 SIP submittal, so Regulation 1.4 remained in the SIP. Today's
rulemaking proposes to approve revisions to eliminate Regulation 1.4
from the Oklahoma SIP, with the exception of its applicability to Minor
NSR permitting under OAC

252:100-8, while also taking action on identified revisions to OAC
252:100-7 that have been adopted by the State since the EPA's November
8, 1999 rulemaking.
    A brief discussion of each of the revisions related to what is now
OAC 252:100-7 (hereinafter ``Subchapter 7''), as submitted by Oklahoma
on February 14, 2002, for EPA review and approval into the Oklahoma
SIP, is presented below. Please note that rules adopted by Oklahoma in
the first five revisions listed below are superseded by the last three
revisions listed, and they are provided for background information
purposes.
    The first set of revisions was adopted by Oklahoma effective May 6,
1988, and affect the permitting regulations for new and existing
sources of air pollution by increasing construction and operating
permit fees for new sources and requiring all permits to be renewable
on an annual basis. Renewal fees are assessed annually on all regulated
sources.
    In 1990, the State Legislature passed the Oklahoma Administrative
Procedures Act which mandated a common format for Oklahoma's rules and
regulations. The Oklahoma State Department of Health was assigned to
Title 310 in the OAC, the Air Pollution Control Rules were assigned to
Chapter 200, and each regulation was assigned to a Subchapter.
Regulation 1.4 became OAC Title 310, Chapter 200, Subchapter 7 or OAC
310:200-7, and was renamed ``Permits.'' This recodification of
Regulation 1.4 to OAC 310:200-7 and change in fee provisions were the
second revisions to Subchapter 7, adopted by Oklahoma and effective
June 1, 1993.
    In 1993, the Oklahoma Air Quality Service became the Air Quality
Division (AQD) of the newly created ODEQ. As a result, the Air
Pollution Control Rules were recodified to OAC 252:100, adopted by
Oklahoma effective May 26, 1994, and submitted by the Governor of
Oklahoma to the EPA as a revision to the Oklahoma SIP on May 16, 1994.
    The fourth set of revisions to Subchapter 7 was adopted by
Oklahoma, effective July 1, 1996, and affects operating time limits for
permitted and unpermitted minor sources.
    The fifth set of revisions to Subchapter 7 was adopted by Oklahoma,
effective June 2, 1997, and excludes total suspended particulates (TSP)
from being considered as regulated air pollutants for purposes of fee
calculation only.
    The sixth set of revisions to Subchapter 7 was adopted by Oklahoma,
effective June 25, 1998. These revisions incorporate a new permit
classification system that includes environmental impact, emission
levels, and source changes in Oklahoma. Other changes remove
requirements for Part 70 and major sources (which are relocated to
Subchapter 8); define and exempt ``de minimis'' facilities (less than 5
tons); revise minor permit application fees; and introduce the PBR,
general and individual permits.
    The seventh set of revisions to Subchapter 7 was adopted by
Oklahoma, effective June 11, 1999, and includes modifications to
language applicable to de minimis facilities, PBR, and general permits.
Additional changes increase various application fees for minor
facilities.
    The eighth set of revisions to Subchapter 7 was adopted by
Oklahoma, effective June 1, 2001. Provisions of Regulation 1.4 were
moved into OAC 252:100-7-2, requiring applications be signed by the
applicant; the signature constitutes an implied agreement that the
applicant shall be responsible for assuring construction or operation,
as applicable, in accordance with the application and OAC 252:100; and
the applicant's duty to correct any errors or omissions on the
application.
    In addition to the revisions to OAC 252:100-7 discussed above,
Oklahoma's February 14, 2002 SIP submittal includes revisions to OAC
252:100, Subchapter 8 (Permits for Part 70 Sources). The State reasons
that it would be difficult to separate the Subchapter 8 rules that are
based solely on Title V program requirements from those Subchapter 8
rules that are based upon SIP requirements, without omitting essential
requirements. As such, Oklahoma submitted all of the Subchapter 8 rule
revisions noted herein for approval into the Oklahoma SIP.
    Oklahoma's February 14, 2002 SIP submittal revises OAC 252:100-8,
Part 1 (General Provisions), OAC 252:100-8, Part 5 (Permits for Part 70
Sources), OAC 252:100-8, Part 7 (Prevention of Significant
Deterioration (PSD) Requirements for Attainment Areas), and OAC
252:100-8, Part 9 (Major Sources Affecting Nonattainment Areas). These
sections include general information, including eligibility criteria
for general and individual permits; sources subject to the permit
requirements and permit contents; administrative requirements,
including format, transmission of information, review and petitions;
applicability of new sources to NSR requirements; demonstration of best
available control technology and evaluation of air quality impact. As
stated in Section I discussion above, the EPA's November 26, 2010
rulemaking (75 FR 72695) approved OAC 252:100-8, Parts 7 and 9 as well
as OAC 252:100-8, Parts 1 and Part 5 (as they apply to sources subject
to the Major NSR program requirements) into the Oklahoma SIP. EPA
considers the Minor NSR provisions in Subchapter 8 for Part 70 sources
severable from the Subchapter 7 Minor NSR requirements for minor
facilities. We also note that additional SIP submittals with Subchapter
8 revisions are currently before the EPA for action. In today's
proposal, the EPA is not proposing approval of those portions of OAC
252:100-8, Parts 1 and 5 as they apply to Oklahoma's Minor NSR
permitting program; the EPA will address the Minor NSR program aspects
of OAC 252: 100-8 in a separate action.
    Finally, OAC 252:100, Appendix H (De Minimis Facilities) is
referenced in Section 252:100-7-1.1. Appendix H lists the facilities
that qualify as De Minimis, such as agricultural (lawn care),
woodworking (portable wood chipping operations), office/janitorial, and
cleaning/surface preparation (cold degreasing operations).
    Additional discussion of the above SIP revisions is located below
and also in the Technical Support Document (TSD) which is in the docket
for this proposed rule.

III. EPA Evaluation of Proposed SIP Revisions

    A. EPA Evaluation of Requirements for Minor NSR--As stated above,
the EPA regulations governing the criteria that states must satisfy for
EPA SIP approval of regulations specific to Minor NSR programs are
contained in 40 CFR Sections 51.160-51.164. More specifically, the
provisions of a Minor NSR program must include legally enforceable
procedures that enable the permitting authority to determine whether
the construction or modification of a source will result in a violation
of applicable portions of the control strategy or interfere with
attainment or maintenance of a NAAQS. 40 CFR 51.160(a). To accomplish
this goal, the state's Minor NSR program must include the means by
which the permitting authority will prevent such construction or
modification if it would result in a violation of applicable portions
of a control strategy or interfere with the attainment or maintenance
of a NAAQS. 40 CFR 51.160(b). Other requirements for an approvable
Minor NSR program are contained in 40 CFR 51.160(c)-(f) as well as in
40 CFR 51.161-51.164. As discussed in Section

II above, elements of Oklahoma's Minor NSR program may be found in both
OAC 252:100-7 (Permits for Minor Facilities) as well as in OAC 252:100-
8 (Permits for Part 70 Sources); however, the EPA will not be taking
action on the Minor NSR program elements located in OAC 252:100-8 at
this time. Regulation 1.4 of the currently approved SIP will continue
to apply to the minor NSR program as it applies to sources subject to
Part 70 (See OAC 252:100-8).The TSD which accompanies this proposed
rulemaking contains a detailed review of Oklahoma's February 14, 2002
SIP submittal and how the submitted regulations being acted upon in
this proposed rulemaking meet the requirements for an approvable Minor
NSR program. A summary of our evaluation is provided below.
    Under the permitting requirements for minor facilities in OAC
252:100-7 Permits for Minor Facilities, no person may commence
construction or modification of any minor facility, may operate any new
minor facility, or may relocate any minor portable source without
obtaining a permit from ODEQ, except for de minimis facilities.
    The provisions in OAC 252:100-7 Permits for Minor Facilities
establish both an initial construction permit and a subsequent
operating permit. Under OAC 252:100-7-15(b) three types of construction
permits are available: A permit by rule (PBR), a general permit, and an
individual permit. These provisions allow ODEQ to develop and issue
PBR, general, and individual minor source permits. Minor NSR sources
may seek authorization under the PBR or general permit, in lieu of an
individual permit, if they meet the requirements of the PBR provisions
or general permitting program and the specific requirements of each PBR
or general permit. Regardless of the type of permit applied for, the
applicant must provide specific information which is evaluated by the
ODEQ both in the application process and on an ongoing basis. For
example, OAC 252:100-7-15(d) requires that all three types of minor
construction permits contain provisions that: (1) Require the permittee
to comply with all applicable air pollution rules, (2) prohibit the
exceedance of ambient air quality standards, and (3) may establish
permit conditions and limitations as necessary to assure compliance
with all rules. The specific PBR or general permit rule and application
form requires that data and information be provided which includes, but
is not limited to, process description, emission data, any required
BACT \3\ determination, modeling and sampling point data. Under OAC
252:100-7-18(d)(1), Operating permit conditions, the emission
limitations established and made a part of the construction permit are
incorporated into and become enforceable limitations of the
subsequently issued operating permit. Under OAC 252:100-5-2.1 Emission
Inventory, any facility that is a source of air emissions shall submit
a complete emission inventory annually, except every 5 years for a PBR
with emissions less than 5 tons per year. Therefore, as required by the
provisions of Chapter 4 and Chapter 100, the PBR, general and
individual permits must contain terms and conditions that assure
sources authorized via the construction permit and subsequent operating
permit will meet all applicable requirements under the Act (e.g., NSR,
NSPS, NESHAP) and will not cause or contribute to an exceedance of the
NAAQS. Also, see OAC 252:4-7-32 and OAC 252:100-7-15(d)(2).
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    \3\ Id.
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    As discussed above, the EPA believes that provisions of OAC
252:100-7 satisfy the requirements of 40 CFR 51.160(a) and enable the
permitting authority to determine whether the construction or
modification will result in a violation of applicable portions of the
control strategy or interfere with attainment or maintenance of a
national ambient air quality standard. Further, these provisions
satisfy the requirements of 40 CFR 51.160(d) which require that
approval of any construction or modification must not affect the
responsibility of the owner or operator to comply with applicable
portions of the control strategy.
    Based on our evaluation, we propose to find that the severable
portions of the Minor NSR program requirements in OAC 252:4-1 (General
Provisions), OAC 252:4-7 (Environmental Permit Process), Appendix C
(Permitting Process Summary), OAC 252:100-5 (Registration, Emission
Inventory and Annual Operating Fees), OAC 252:100-7 (Permits for Minor
Facilities) and Appendix H are approvable as meeting CAA requirements
for a Minor NSR program. These severable Minor NSR permit provisions
provide for the necessary procedures and applicable requirements for
approvable Minor NSR programs. Additional details regarding our
evaluation are found in the TSD accompanying this proposed rulemaking.
The TSD is available in the docket and from the EPA Region 6 office.
    B. CAA 110(l) Analysis--Each revision to an implementation plan
submitted by a state under the Clean Air Act shall be adopted by such
state after reasonable notice and public hearing. ODEQ adopted the
proposed revisions after reasonable notice and public hearing. CAA
section 110(l) also states that the Administrator shall not approve a
revision of a plan if the revision would interfere with any applicable
requirement concerning attainment and reasonable further progress (as
defined in CAA section 171), or any other applicable requirement of the
Act. For purposes of the analysis under CAA section 110(l), we have
taken into account the overall effect of the revisions included in this
action. Given that these revisions primarily concern recodified
portions of the Oklahoma SIP, new sections that incorporate Federal and
state rules, deletions of duplicative and outdated rules, and edits
that simplify text and correct errors, we propose to find that the
overall effect of the revisions would improve the Oklahoma SIP, and our
approval would not interfere with any CAA requirement.
    EPA's review of the proposed revisions and appendix, in accordance
with section 110 of the CAA, forms the basis for demonstrating
noninterference with applicable CAA requirements for attainment,
including violation of any NAAQS or contribution to a PSD increment
exceedance. The TSD contained in the docket for this action contains
our review of the individual sections for each regulation associated
with this proposed SIP revision rulemaking. Our review demonstrates
that the changes made to the Oklahoma rules being acted upon in today's
proposed rulemaking reflect either the same regulatory language or are
consistent with the requirements found in the federal rules related to
Minor NSR SIP programs. The TSD also contains references to supporting
technical documentation in the docket regarding specific aspects of the
proposed revisions, including Appendix H. De Minimis Facilities.
    In its review of the proposed revisions and appendix identified
above, the EPA also took into consideration the following factors.
There is no currently designated nonattainment area for any air
pollutant in the State of Oklahoma. The entire State is currently in
attainment for all criteria pollutants, and has been since the original
promulgation and subsequent revisions of the NAAQS and PSD increments.
Also, air quality has generally remained at the same level or has
steadily improved both statewide and in the largest metropolitan
statistical areas of Oklahoma City and Tulsa, as shown in

the EPA's ``Air Quality System'' repository, and the EPA's ``Air
Quality Trends by City'' monitoring data averages from 1990 through
2015. Furthermore, since the list of exempted source categories
(Appendix H) included in the proposed revisions have historically
operated without coverage by an air permit and there are no anticipated
increases in emissions or in the number of these types of sources
resulting from the approval of the de minimis exemption list into the
Oklahoma SIP, the EPA finds there is a low possibility of adverse
impacts on ambient air quality from the emission sources and activities
included in Appendix H. Our conclusion is supported by ambient air
monitoring trends in Oklahoma, as more specifically discussed in the
TSD associated with this proposed rulemaking. Our noninterference
determination and proposed approval of OAC 252:100, Appendix H is
consistent with our assessment of the environmental significance
associated with emissions covered by this Appendix. The ODEQ has been
implementing the Minor NSR air permitting program based on the
codification of their permitting policy without any indication that the
de minimis facilities listed in Appendix H have interfered with
attainment or any other applicable requirement of the CAA. Therefore,
the EPA proposes to approve Appendix H into the Oklahoma SIP since it
meets CAA requirements for Minor NSR and the requirements of CAA
section 110.
    Based on historical trends and supporting air quality monitoring
data documenting air quality improvements throughout the State, we
believe the proposed Minor NSR SIP revision meets the requirements of
CAA section 110(l) and is consistent with the provisions of 40 CFR
51.160(e) which provide state agencies the latitude to define the types
and sizes of facilities, buildings, structures, or installations
subject to review. We believe the implementation of these rules will
not interfere with any applicable requirement concerning attainment,
reasonable further progress, maintaining PSD increment, or any other
applicable requirement of the CAA.
    Accordingly, the EPA is proposing approval of these revisions under
section 110 of the Act. Further discussion of CAA section 110(l) is
contained in the TSD for this proposed rule. The TSD is available in
the docket and from the EPA Region 6 office.

IV. Proposed Action

    We are proposing to approve severable portions of revisions
relating to the Minor NSR program of the Oklahoma SIP, as submitted to
the EPA on February 14, 2002. The revisions include portions of OAC
252:4, Rules of Practice and Procedure, and OAC 252:100, Air Pollution
Control. These revisions replace the corresponding regulations in the
Oklahoma SIP found in Regulation 1.4, Air Resources Management Permits
Required, with the exception of the continued applicability of
Regulation 1.4 to Minor NSR permitting under OAC 252:100-8. EPA has
made its determination in accordance with the CAA and the EPA
regulations at 40 CFR 51.160--51.164. Therefore, under section 110 of
the Act, and for the reasons presented above and in our accompanying
TSD, the EPA proposes approval of severable portions of revisions to
the Oklahoma Minor NSR SIP identified in Table 1 below.

                          Table 1--Revisions to the Oklahoma SIP Proposed for Approval
----------------------------------------------------------------------------------------------------------------
             Section                     Title                Effective date                Submittal date
----------------------------------------------------------------------------------------------------------------
                             Chapter 4 (OAC 252:4). Rules of Practice and Procedure
----------------------------------------------------------------------------------------------------------------
                                        Subchapter 1. General Provisions
----------------------------------------------------------------------------------------------------------------
OAC 252:4-1-1...................  Purpose and          June 11, 2001...............  February 14, 2002.
                                   Authority.
OAC 252:4-1-2...................  Definitions........  June 11, 2001...............  February 14, 2002.
OAC 252:4-1-3...................  Organization.......  June 11, 2001...............  February 14, 2002.
OAC 252:4-1-4...................  Office hours and     June 11, 2001...............  February 14, 2002.
                                   locations;
                                   communications.
OAC 252:4-1-5, except (a) 2nd     General Provisions,  June 11, 2001...............  February 14, 2002.
 sentence, which EPA will          Availability of a
 address in a separate action.     record.
OAC 252:4-1-6...................  Administrative fees  June 11, 2001...............  February 14, 2002.
OAC 252:4-1-7...................  Fee credits for      June 11, 2001...............  February 14, 2002.
                                   regulatory fees.
OAC 252:4-1-8...................  Board and Councils.  June 11, 2001...............  February 14, 2002.
OAC 252:4-1-9...................  Severability.......  June 11, 2001...............  February 14, 2002.
----------------------------------------------------------------------------------------------------------------
                                   Subchapter 7. Environmental Permit Process
----------------------------------------------------------------------------------------------------------------
OAC 252:4-7-1...................  Authority..........  June 11, 2001...............  February 14, 2002.
OAC 252: 4-7-2, except 2nd        Preamble...........  June 11, 2001...............  February 14, 2002.
 sentence, which EPA will
 address in a separate action.
OAC 252: 4-7-3..................  Compliance.........  June 11, 2001...............  February 14, 2002.
OAC 252:4-7-4, except (a) 1st     Filing an            June 11, 2001...............  February 14, 2002.
 sentence, which EPA will          application.
 address in a separate action..
OAC 252:4-7-5...................  Fees...............  June 11, 2001...............  February 14, 2002.
OAC 252: 4-7-6..................  Receipt of           June 11, 2001...............  February 14, 2002.
                                   Applications.
OAC 252:4-7-7...................  Administrative       June 11, 2001...............  February 14, 2002.
                                   completeness
                                   review.
OAC 252:4-7-8...................  Technical review...  June 11, 2001...............  February 14, 2002.
OAC 252:4-7-9...................  When review times    June 11, 2001...............  February 14, 2002.
                                   stops.
OAC 252:4-7-10..................  Supplemental time..  June 11, 2001...............  February 14, 2002.
OAC 252:4-7-11..................  Extensions.........  June 11, 2001...............  February 14, 2002.
OAC 252:4-7-12..................  Failure to meet      June 11, 2001...............  February 14, 2002.
                                   deadline.
OAC 252:4-7-13, except (a),       Notices............  June 11, 2001...............  February 14, 2002.
 which EPA will address in a
 separate action.
OAC 252:4-7-14..................  Withdrawing          June 11, 2001...............  February 14, 2002.
                                   applications.
OAC 252:4-7-15..................  Permit issuance or   June 11, 2001...............  February 14, 2002.
                                   denial.
OAC 252:4-7-17..................  Permit decision-     June 11, 2001...............  February 14, 2002.
                                   making authority.
OAC 252:4-7-18..................  Pre-issuance permit  June 11, 2001...............  February 14, 2002
                                   review and
                                   correction.

OAC 252:4-7-19..................  Consolidation of     June 11, 2001...............  February 14, 2002.
                                   permitting process.
----------------------------------------------------------------------------------------------------------------
                                Part 3. Air Quality Division Tiers and Timelines
----------------------------------------------------------------------------------------------------------------
OAC 252:4-7-31..................  Air quality time     June 11, 2001...............  February 14, 2002.
                                   lines.
OAC 252: 4-7-32, except (a) and   Air quality          June 11, 2001...............  February 14, 2002.
 (c)(1), which EPA will address    applications--Tier
 in a separate action.             I.
----------------------------------------------------------------------------------------------------------------
                                        Appendices for OAC 252: Chapter 4
----------------------------------------------------------------------------------------------------------------
OAC 252: 4. Appendix C, except    Permitting process   June 11, 2001...............  February 14, 2002.
 the Tier I column, which EPA      summary.
 will address in a separate
 action.
----------------------------------------------------------------------------------------------------------------
                                 Chapter 100 (OAC 252:100) Air Pollution Control
----------------------------------------------------------------------------------------------------------------
                    Subchapter 5. Registration, Emission Inventory and Annual Operating Fees
----------------------------------------------------------------------------------------------------------------
OAC 252: 100-5-1................  Purpose............  June 12, 2000...............  February 14, 2002.
OAC 252: 100-5-1.1..............  Definitions........  June 12, 2000...............  February 14, 2002.
OAC 252: 100-5-2................  Registration of      June 12, 2000...............  February 14, 2002.
                                   potential sources
                                   of air
                                   contaminants.
OAC 252: 100-5-2.1..............  Emission inventory.  June 12, 2000...............  February 14, 2002.
OAC 252: 100-5-2.2..............  Annual operating     June 12, 2000...............  February 14, 2002.
                                   fees.
OAC 252: 100-5-3................  Confidentiality of   June 12, 2000...............  February 14, 2002.
                                   proprietary
                                   information.
----------------------------------------------------------------------------------------------------------------
                                   Subchapter 7. Permits for Minor Facilities
----------------------------------------------------------------------------------------------------------------
                                           Part 1. General Provisions
----------------------------------------------------------------------------------------------------------------
OAC 252: 100-7-1................  Purpose............  June 25, 1998...............  February 14, 2002.
OAC 252: 100-7-1.1..............  Definitions........  June 11, 1999...............  February 14, 2002.
OAC 252: 100-7-2, except (a) 2nd  Requirement for      June 1, 2001................  February 14, 2002.
 sentence, which EPA will          permits for minor
 address in a separate action.     facilities.
----------------------------------------------------------------------------------------------------------------
                                          Part 3. Construction Permits
----------------------------------------------------------------------------------------------------------------
OAC 252: 100-7-15...............  Construction permit  June 11, 1999...............  February 14, 2002.
----------------------------------------------------------------------------------------------------------------
                                            Part 4. Operating Permits
----------------------------------------------------------------------------------------------------------------
OAC 252: 100-7-17...............  Relocation permits   June 25, 1998...............  February 14, 2002.
                                   for portable
                                   sources.
OAC 252: 100-7-18...............  Operating permit...  June 11, 1999...............  February 14, 2002.
----------------------------------------------------------------------------------------------------------------
                                             Part 9. Permits by Rule
----------------------------------------------------------------------------------------------------------------
OAC 252: 100-7-60...............  Permit by rule.....  June 11, 1999...............  February 14, 2002.
OAC 252: 100-7-60.1.............  Cotton gins........  June 11, 1999...............  February 14, 2002.
OAC 252: 100-7-60.2.............  Grain elevators....  June 11, 1999...............  February 14, 2002.
----------------------------------------------------------------------------------------------------------------
                                    Subchapter 8. Permits for Part 70 Sources
         EPA will address applicability to Minor NSR permitting under OAC 252:100-8 in a separate action
----------------------------------------------------------------------------------------------------------------
OAC 252: 100. Appendix H........  DE MINIMIS           June 25, 1998...............  February 14, 2002.
                                   FACILITIES.
----------------------------------------------------------------------------------------------------------------

V. Incorporation by Reference

    In this action, we are proposing to include in a final rule
regulatory text that includes incorporation by reference. In accordance
with the requirements of 1 CFR 51.5, we are proposing to incorporate by
reference revisions to the Oklahoma regulations as described in the
Proposed Action section above. We have made, and will continue to make,
these documents generally available electronically through
www.regulations.gov and/or in hard copy at the EPA Region 6 office.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve 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);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation
land or in any other area where the EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

List of Subjects in 40 CFR Part 52

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

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

    Dated: November 16, 2016.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2016-28673 Filed 11-28-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28961-28965]
[FR Doc No: 2020-10336]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3065]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Human Drug
Compounding Under Sections 503A and 503B of the Federal Food, Drug, and
Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by June 15, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0800. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Human Drug Compounding Under Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act

OMB Control Number 0910-0800--Revision

    This information collection supports Agency implementation of
sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
(FD&C Act). For efficiency of Agency operations, we are revising the
information collection currently approved under OMB control number
0910-0800 pertaining to human drug compounding and section 503B of the
FD&C Act (21 U.S.C. 355b) to include reference to Agency guidance
regarding section 503A of the FD&C Act (21 U.S.C. 355a), and to also
include information collection that we attribute to a final standard
memorandum of understanding (MOU) provided for by section 503A (``final
standard MOU''). Finally, we are revising the title of the information
collection from ``Adverse Event Reporting for Outsourcing Facilities
Under Section 503B of the Federal Food, Drug, and Cosmetic Act'' to
``Human Drug Compounding Under Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act.'' As information collection activity is
planned and undertaken by FDA, we find consolidating related collection
elements better utilizes our resources.

Agency Guidance Regarding Section 503A

    We are revising the information collection to include reference to
the guidance entitled ``Pharmacy Compounding of Human Drug Products
Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' The
guidance is available from our website at: https://www.fda.gov/media/94393/download. The guidance was issued consistent with our Good
Guidance Practice regulations (21 CFR 10.115), which provide for
comment at any time. The guidance communicates FDA's intention with
regard to enforcement of section 503A of the FD&C Act to regulate
entities that compound drugs and notes that parts of section 503A
require rulemaking and consultation with a Pharmacy Compounding
Advisory Committee to implement and explains how the provisions will be
applied pending those consultations and rulemaking. Although the
guidance does not include recommended information collection, we are
including the guidance as a supplemental reference for respondents.

The Final Standard MOU

    We are also revising the information collection to include
information collection associated with the standard MOU pursuant to the
provisions of the Food and Drug Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105-115) found in section 503A of the FD&C Act.
Section 503A of the FD&C Act describes the conditions under which
certain drug products compounded by a licensed pharmacist in a State-
licensed pharmacy or Federal facility, or by a licensed physician are
exempt from certain sections of the FD&C Act. One of the conditions to
qualify for the exemptions listed in section 503A of the FD&C Act is
that: (1) The drug product is compounded in a State that has entered
into an MOU with FDA that addresses the distribution of inordinate
amounts of compounded drug products interstate and provides for
appropriate investigation by a State agency of complaints relating to
compounded drug products distributed outside such a State or (2) if the
drug product is compounded in a State that has not entered into such an
MOU, the licensed pharmacist, licensed pharmacy, or licensed physician
does not distribute, or cause to be distributed, compounded drug
products out of the State in which they are compounded, in quantities
that exceed 5 percent of the total prescription orders dispensed or
distributed by such pharmacy or physician (see section 503A(b)(3)(B) of
the FD&C Act).
    Section 503A(b)(3)(B) of the FD&C Act directs FDA, in consultation
with the National Association of Boards of Pharmacy (NABP), to develop
a standard MOU for use by States in complying with the provision that
references an MOU that addresses the distribution of inordinate amounts
of compounded drug products interstate and provides for appropriate
investigation by a State agency of complaints relating to drug products
compounded in the State and distributed outside such State.
Accordingly, we have developed the document entitled, ``Memorandum of
Understanding Addressing Certain Distributions of Compounded Human Drug
Products Between the [Insert State Board of Pharmacy or Other
Appropriate State Agency] and the U.S. Food and Drug Administration,''
available in docket number FDA-2018-N-3065, which is available at:
https://www.regulations.gov/docket?D=FDA-2018-N-3065.
    For purposes of this analysis, FDA assumes that 45 States will sign
the standard MOU with FDA.
    Under section III.a of the final standard MOU, the State Board of
Pharmacy (BOP) or other appropriate State agency will notify FDA by
submission to an information sharing network or by sending an email to
<EMAIL_ADDRESS>as soon as possible, but no later than 5 business
days, after receiving a complaint relating to a human drug product
compounded at a pharmacy and distributed outside the State involving a
serious adverse drug experience or serious product quality issue. The
notification will include the following information: (1) The name and
contact information of the complainant, if available; (2) the name and
address of the pharmacy that is the subject of the complaint; and (3) a
description of the complaint, including a description of any compounded
human drug product that is the subject of the complaint. After the
State BOP or other appropriate State agency concludes its investigation
of a complaint assessed to involve a serious adverse drug experience or
serious product quality issue relating to a drug product compounded at
a pharmacy and distributed outside the State, the State BOP or other
appropriate State agency will share with FDA the results of the
investigation as permitted by State law. The information will include:
(1) The State BOP or other appropriate State agency's assessment of
whether the complaint was substantiated, if available and (2) a
description and date of any actions the State BOP or other appropriate
State agency has taken to address the complaint. In addition, the State
BOP or other appropriate State agency will maintain records of the
complaints they receive, the investigation of each complaint, and any
response to or action taken as a result of a complaint, beginning when
the State BOP or other appropriate State agency receives notice of the
complaint. The State BOP or other appropriate State agency will
maintain these records for at least 3 years, beginning on the date of
final action on a complaint or the date of a decision that the
complaint requires no action.
    The State BOP or other appropriate State agency will notify the
appropriate regulator of physicians within the State and will notify
FDA by email at<EMAIL_ADDRESS>or by submission to an information
sharing network as soon as possible, but no later than 5 business days,
after receiving any complaint relating to a drug product compounded by
a physician and distributed outside the State involving an adverse drug
experience or product quality issue. The information will include, if
available: (1) The name and contact information of the complainant; (2)
the name and address of the physician that is the subject of the
complaint; and (3) a description of the complaint, including a
description of any compounded human drug product that is the subject of
the complaint.
    In the Federal Register of September 10, 2018 (83 FR 45631), we
published a 60-day notice requesting public comment on the proposed
collection of information. We note that in the final MOU we changed the
title from ``Memorandum of Understanding Addressing Certain
Distributions of Compounded Drug Products Between the State of [insert
State] and the U.S. Food and Drug Administration'' to ``Memorandum of
Understanding Addressing Certain Distributions of Compounded Human Drug
Products Between the [insert State Board of Pharmacy or other
appropriate State Agency] and the U.S. Food and Drug Administration.''
A number of comments were received. Most comments focused on State
resource issues including whether the extent, nature, and frequency of
information collection and sharing was overly burdensome and whether or
not the information collection imposed an unfunded mandate on State
agencies. In consideration of the comments, FDA has made the following
changes to the MOU:
     We have increased the time period, from 3 days to 5
business days, to communicate information about complaints that involve
serious adverse drug experiences or serious product quality issues
relating to a human drug product compounded at a pharmacy and
complaints that involve adverse drug experiences or product quality
issues relating to a human drug product compounded by a physician;
     we have increased the amount of time after the final
standard MOU is available for signature from 180 days to 365 days
before FDA intends to enforce the 5 percent limit in States that have
not signed the final standard MOU; and
     we have coordinated with NABP to develop an information-
sharing network to help reduce the information collection and sharing
burden on the State BOPs or other appropriate State agencies.
    We disagree that the information collections in the MOU create
unfunded mandates. Entering into the MOU is voluntary. We believe the
proposed collection of information satisfies the statutory objectives
of providing FDA with the information it needs through the least
burdensome means available. None of the comments received

provided alternative figures to the burden estimates proffered, and we
therefore estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
  Compounding MOU between FDA and    Number of    responses      Total        Average burden per
  State BOPs or other appropriate   respondents      per         annual            response          Total hours
          State Agencies                          respondent   responses
----------------------------------------------------------------------------------------------------------------
State BOP or other appropriate               45            3          135  0.5 (30 minutes)........         67.5
 State agency notifies FDA of
 compounding complaints.
State BOP or other appropriate               45          145        6,525  1.......................        6,525
 State agency identifies
 pharmacies that distribute
 inordinate amounts of compounded
 human drugs interstate using
 surveys or inspections or data
 submitted to an information
 sharing network.
State BOP or other appropriate               45           44        1,980  0.5 (30 minutes)........          990
 State agency notifies FDA of the
 distribution of inordinate
 amounts of compounded human drug
 products.
State BOP or other appropriate               45            5          225  0.5 (30 minutes)........        112.5
 State agency notifies FDA and
 appropriate State regulator of
 physicians about physicians who
 distribute compounded human drug
 products interstate.
State BOP or other appropriate               13            1           13  0.2 (12 minutes)........          2.6
 State agency notifies FDA of a
 new liaison to the MOU.
State BOP or other appropriate                1            1            1  0.2 (12 minutes)........          0.2
 State agency notifies FDA of its
 intent to terminate participation
 in the MOU.
                                   -----------------------------------------------------------------------------
    Total.........................  ...........  ...........  ...........  ........................      7,697.8
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and mainenance costs associated with this collection of information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
 Compounding MOU between FDA and State                     Number of       Total     Average burden
    BOPs or other appropriate State        Number of      records per      annual          per       Total hours
               Agencies                  recordkeepers   recordkeeper     records     recordkeeping
----------------------------------------------------------------------------------------------------------------
State BOP or other appropriate State                45               2           90               1           90
 Agency Recordkeeping for 3 Years of
 Compounding Complaints about Drug
 Products Compounded at a Pharmacy....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                              Number of       Total       Average
Compounding MOU between FDA and State BOP or   Number of     disclosures      annual     burden per  Total hours
      other appropriate State Agencies        respondents  per respondent  disclosures   disclosure
----------------------------------------------------------------------------------------------------------------
State BOP or other appropriate State agency             1               1            1            1            1
 notifies pharmacies that compound human
 drugs, and the State authority that
 licenses or regulates physicians that its
 participation in the MOU has terminated....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on our knowledge of State regulation of compounding practices
and related complaints, we estimate that annually a total of
approximately 45 State BOPs or other appropriate State agencies (``No.
of Respondents'' in table 1, row 2) will notify FDA within 5 business
days of receiving any complaint relating to a human drug product
compounded by a pharmacy and distributed outside the State involving a
serious adverse drug experience or serious product quality issue or any
complaint relating to a drug product compounded by a physician and
distributed outside the State involving any adverse drug experience or
product quality issue. We estimate that each State BOP or other
appropriate State agency will notify FDA annually of approximately 3
complaints it receives (``No. of Responses per Respondent'' in table 1,
row 2), for a total of 135 notifications of complaints sent to FDA
(``Total Annual Responses'' in table 1, row 2). We estimate that
preparing and submitting this information to FDA as described in the
MOU will take approximately 0.5 hours per response (``Average Burden
per Response'' in table 1, row 1), for a total of 67.5 hours (``Total
Hours'' in table 1, row 2).
    We also estimate that a total of approximately 45 State BOPs or
other appropriate State agencies (``No. of Recordkeepers'' in table 2)
will prepare and maintain records for 3 years of the complaints they
receive, investigations of complaints, and any State action taken or
response to complaints involving drug products compounded at a pharmacy
and distributed outside the State. We estimate that each State BOP or
other appropriate State agency will receive annually approximately 2
complaints about adverse drug experiences or product quality issues
relating to human drug products compounded at a pharmacy and will
prepare and maintain approximately 1 record per each complaint the
State BOP or other appropriate State agency receives, for a total of 2
records per State BOP or other appropriate State agency (``No. of
Records per Recordkeeper'' in table 2), and a total of 90 records
annually across all States (``Total Annual Records'' in table 2). We
further estimate that preparing and maintaining these records will take
approximately 1 hour per record (``Average Burden per Recordkeeping (in
hours)'' in table 2), for a total of 90 hours (``Total Hours'' in table
2).
    Under section III.b of the final standard MOU, on an annual basis,
the State BOP or other appropriate State agency will identify, using
surveys, reviews of records during inspections, data submitted to an
information sharing network, or other mechanisms available to the State
BOP or other appropriate State agency, pharmacies that distribute
inordinate amounts of compounded human drug products interstate by
collecting information regarding the number of prescription

orders for compounded human drug products distributed interstate during
any calendar year and the number of prescription orders for compounded
human drug products that the pharmacy sent out of (or caused to be sent
out of) the facility in which the drug products were compounded during
that same calendar year and the number of prescription orders for
compounded human drug products that were dispensed (e.g., picked up by
a patient) at the facility in which they are compounded during that
same calendar year. If a pharmacy has been identified as distributing
inordinate amounts of compounded human drug products interstate, the
State BOP or other appropriate State agency will also collect
information regarding: (1) The total number of prescription orders for
sterile compounded human drug products distributed interstate; (2) the
names of States in which the pharmacy is licensed; (3) the names of
States into which the pharmacy distributed compounded human drug
products; and (4) whether the State inspected for and found during its
most recent inspection that the pharmacy distributed compounded human
drug products without valid prescription orders for individually
identified patients.
    The State BOP or other appropriate State agency will notify FDA by
submission to an information sharing network or by sending an email to
<EMAIL_ADDRESS>within 30 business days of identifying a pharmacy
that has distributed inordinate amounts of compounded human drug
products interstate, as described in the final standard MOU. The
notification will include the name and address of the pharmacy and the
information that the State BOP or other appropriate State agency
collected, described in the previous paragraph.
    The State BOP or other appropriate State agency will notify the
appropriate regulator of physicians within the State and FDA by
submission to an information sharing network or by sending an email to
<EMAIL_ADDRESS>within 30 business days of identifying a physician
that has distributed compounded human drug products interstate.
    We estimate that annually a total of approximately 45 State BOPs or
other appropriate State agencies (``No. of Respondents'' in table 1,
row 3) will identify pharmacies that distribute inordinate amounts of
compounded human drug products interstate. We estimate that each State
agency will perform surveys or inspections of 145 pharmacies or use the
information sharing network to identify this information (``No. of
Responses per Respondent'' in table 1, row 3). We estimate that this
will take approximately 1 hour per response (``average burden per
response'' in table 1, row 3), for a total of 6,525 hours (``Total
Hours'' in table 1, row 3). We estimate that annually a total of 45
State BOPs or other appropriate State agencies (``No. of Respondents''
in table 1, row 4) will find that a pharmacy has distributed inordinate
amounts of compounded human drug products interstate and notify FDA of
this finding. We estimate that each State BOP or other appropriate
State agency will notify FDA annually of approximately 44 findings it
makes (``No. of Responses per Respondent'' in table 1, row 4), for a
total of 1,980 notifications (``Total Annual Responses'' in table 1,
row 4). We estimate that preparing and submitting this information to
FDA as described in the MOU will take approximately 0.5 hours per
response (``Average Burden per Response'' in table 1, row 4), for a
total of 990 hours (``Total Hours'' in table 1, row 4).
    We estimate that annually a total of approximately 45 State BOPs or
other appropriate State agencies (``No. of Respondents'' in table 1,
row 5) will become aware of physicians that distribute compounded human
drug products interstate. We estimate that each State BOP or other
appropriate State agency will notify the appropriate regulator of
physicians within the State and FDA annually of approximately five
physicians that distribute compounded human drug products interstate
(``No. of Responses per Respondent'' in table 1, row 5), for a total of
225 notifications of physicians that distribute compounded human drug
products interstate sent to FDA (``Total Annual Responses'' in table 1,
row 5). We estimate that preparing and submitting this information to
us as described in the MOU will take approximately 0.5 hours per
response (``Average Burden per Response'' in table 1, row 1), for a
total of 112.5 hours (``Total Hours'' in table 1, row 5).
    Under section V of the final standard MOU, a State BOP or other
appropriate State agency may designate a new liaison to the MOU by
notifying FDA's liaison in writing. If a State BOP or other appropriate
State agency's liaison becomes unavailable to fulfill its functions
under the MOU, the State BOP or other appropriate State agency will
name a new liaison within 2 weeks and notify FDA.
    We estimate that annually a total of approximately 13 State BOPs or
other appropriate State agencies (``No. of Respondents'' in table 1,
row 5) will notify FDA of a new liaison to the MOU. We estimate that
each State BOP or other appropriate State will submit to FDA annually
approximately 1 notification of a new liaison (``No. of Responses per
Respondent'' in table 1, row 6), for a total of 13 notifications of a
new liaison (``Total Annual Responses'' in table 1, row 6). We estimate
that preparing and submitting each notification as described in the MOU
will take approximately 0.2 hours per response (``Average Burden per
Response'' in table 1, row 6), for a total of 2.6 hours (``Total
Hours'' in table 1, row 6).
    Under section VI of the revised final standard MOU, a State BOP or
other appropriate State agency may terminate its participation in the
MOU by submitting to FDA a 60 calendar day notice of termination.
    We estimate that annually a total of approximately one State BOP or
other appropriate State agency (``No. of Respondents'' in table 1, row
7) will notify FDA that it intends to terminate its participation in
the MOU. We estimate that this State BOP or other appropriate State
agency will submit to FDA annually approximately one notification of
termination (``No. of Responses per Respondent'' in table 1, row 7),
for a total of one notification (``Total Annual Responses'' in table 1,
row 7). We estimate that preparing and submitting the notification as
described in the MOU will take approximately 0.2 hours per notification
(``Average Burden per Response'' in table 1, row 7), for a total of 0.2
hours (``Total Hours'' in table 1, row 7).
    We estimate that annually a total of approximately one State BOP or
other appropriate State agency (``No. of Respondents'' in table 3, row
2) will notify pharmacists and the State authority that licenses or
regulates physicians that its participation in the MOU has terminated.
We estimate that this State BOP or other appropriate State agency will
distribute approximately one notification of termination (``No. of
Responses per Respondent'' in table 1, row 7), for a total of one
notification (``Total Annual Responses'' in table 3, row 2).
    We estimate that preparing and submitting the notification as
described in the MOU will take approximately 1 hour per notification
(``Average Burden per Response'' in table 3, row 2), for a total of 1
hour (``Total Hours'' in table 3, row 2).

    Dated: May 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10336 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76361-76362]
[FR Doc No: 2016-26398]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0797]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Tissue Intended for Transplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by
December 2, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0302.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Human Tissue Intended for Transplantation--21 CFR Part 1270

OMB Control Number 0910-0302--Extension

    Under section 361 of the Public Health Services Act (42 U.S.C.
264), FDA issued regulations under part 1270 (21 CFR part 1270) to
prevent the transmission of human immunodeficiency virus, hepatitis B,
and hepatitis C through the use of human tissue for transplantation.
The regulations provide for inspection by FDA of persons and tissue
establishments engaged in the recovery, screening, testing, processing,
storage, or distribution of human tissue. These facilities are required
to meet provisions intended to ensure appropriate screening and testing
of human tissue donors and to ensure that records are kept documenting
that the appropriate screening and testing have been completed.
    Section 1270.31(a) through (d) requires written procedures to be
prepared and followed for the following steps: (1) All significant
steps in the infectious disease testing process under Sec.  1270.21;
(2) all significant steps for obtaining, reviewing, and assessing the
relevant medical records of the donor as prescribed in Sec.  1270.21;
(3) designating and identifying quarantined tissue; and (4) for
prevention of infectious disease contamination or cross-contamination
by tissue during processing. Section 1270.31(a) and (b) also requires
recording and justification of any deviation from the written
procedures.

Section 1270.33(a) requires records to be maintained concurrently with
the performance of each significant step required in the performance of
infectious disease screening and testing of human tissue donors.
Section 1270.33(f) requires records to be retained regarding the
determination of the suitability of the donors and of the records
required under Sec.  1270.21. Section 1270.33(h) requires all records
to be retained for at least 10 years beyond the date of transplantation
if known, distribution, disposition, or expiration of the tissue,
whichever is the latest. Section 1270.35(a) through (d) requires
specific records to be maintained to document the following: (1) The
results and interpretation of all required infectious disease tests;
(2) information on the identity and relevant medical records of the
donor; (3) the receipt and/or distribution of human tissue, and (4) the
destruction or other disposition of human tissue.
    Respondents to this collection of information are manufacturers of
human tissue intended for transplantation. Based on information from
the Center for Biologics Evaluation and Research's (CBER's) database
system, FDA estimates that there are approximately 383 tissue
establishments, of which 262 are conventional tissue banks and 121 are
eye tissue banks. Based on information provided by industry, there are
estimated totals of 2,141,960 conventional tissue products and 130,987
eye tissue products distributed per year with an average of 25 percent
of the tissue discarded due to unsuitability for transplant. In
addition, there are an estimated 29,799 deceased donors of conventional
tissue and 70,027 deceased donors of eye tissue each year.
    Accredited members of the American Association of Tissue Banks
(AATB) and Eye Bank Association of America (EBAA) adhere to standards
of those organizations that are comparable to the recordkeeping
requirements in part 1270. Based on information provided by CBER's
database system, 90 percent of the conventional tissue banks are
members of AATB (262 x 90% = 236), and 95 percent of eye tissue banks
are members of EBAA (121 x 95% = 115). Therefore, recordkeeping by
these 351 establishments (236 + 115 = 351) is excluded from the burden
estimates as usual and customary business activities (5 CFR
1320.3(b)(2)). The recordkeeping burden, thus, is estimated for the
remaining 32 establishments, which is 8.36 percent of all
establishments (383 - 351 = 32, or 32/383 = 8.36%).
    FDA assumes that all current tissue establishments have developed
written procedures in compliance with part 1270. Therefore, their
information collection burden is for the general review and update of
written procedures estimated to take an annual average of 24 hours, and
for the recording and justifying of any deviations from the written
procedures under Sec.  1270.31(a) and (b), estimated to take an annual
average of 1 hour. The information collection burden for maintaining
records concurrently with the performance of each significant screening
and testing step and for retaining records for 10 years under Sec.
1270.33(a), (f), and (h) include documenting the results and
interpretation of all required infectious disease tests and results and
the identity and relevant medical records of the donor required under
Sec.  1270.35(a) and (b). Therefore, the burden under these provisions
is calculated together in table 1. The recordkeeping estimates for the
number of total annual records and hours per record are based on
information provided by industry and FDA experience.
    In the Federal Register of June 6, 2016 (81 FR 36310), we published
a 60-day notice requesting public comment on the proposed extension of
this collection of information. No comments were received.
    FDA estimates the burden of this information collection as follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                           21 CFR Section                               Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d) \2\..................................               32                1               32               24              768
1270.31(a) and 1270.31(b) \3\......................................               32                2               64                1               64
1270.33(a), (f), and (h), and 1270.35(a) and (b)...................               32         6,198.84          198,363                1          198,363
1270.35(c).........................................................               32        11,876.12          380,036                1          380,036
1270.35(d).........................................................               32         1,484.50           47,504                1           47,504
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ...............  ...............  ...............  ...............          626,735
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Review and update of standard operating procedures (SOPs).
\3\ Documentation of deviations from SOPs.

    Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26398 Filed 11-1-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Page 35097]
[FR Doc No: 2017-15922]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2017-0346]

Safety Zone; Wheeling Heritage Port Sternwheel Festival
Foundation/Wheeling Heritage Port Sternwheel Festival, Ohio River,
Miles 90.2 to 90.7, Wheeling, WV

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the subject safety zone for the
Wheeling Heritage Port Sternwheel Festival Foundation/Wheeling Heritage
Port Sternwheel Festival Fireworks on the Ohio River on September 16,
2017 to protect vessels transiting the area and event spectators from
the hazards associated with the barge-based fireworks display. During
the enforcement period, entry of vessels or persons into this zone is
prohibited unless specifically authorized by the Captain of the Port
Marine Safety Unit Pittsburgh (COTP) or a designated representative.

DATES: The regulations in 33 CFR 165.801, Table 1 Sector Ohio Valley,
No. 58 will be enforced from 10 p.m. through 11:15 p.m., on September
16, 2017.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email MST1 Jennifer Haggins, Marine
Safety Unit Pittsburgh, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Safety Zone
for the annual Wheeling Heritage Port Sternwheel Festival Foundation/
Wheeling Heritage Port Sternwheel Festival Fireworks listed in 33 CFR
165.801, Table 1 Sector Ohio Valley from 10 p.m. to 11:15 p.m. on
September 16, 2017. Entry into the safety zone is prohibited unless
authorized by the Captain of the Port Marine Safety Unit Pittsburgh
(COTP) or a designated representative. Persons or vessels desiring to
enter into or passage through the safety zone must request permission
from the COTP or a designated representative. If permission is granted,
all persons and vessels shall comply with the instructions of the COTP
or designated representative.
    This notice of enforcement is issued under authority of 33 CFR
165.801 and 5 U.S.C. 552(a). In addition to this notice of enforcement
in the Federal Register, the Coast Guard will provide the maritime
community with advance notification of these enforcement periods via
Local Notice to Mariners and updates via Marine Information Broadcasts.

    Dated: July 20, 2017.
L. McClain, Jr.,
Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit
Pittsburgh.
[FR Doc. 2017-15922 Filed 7-27-17; 8:45 am]
 BILLING CODE 9110-04-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on February 18, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-99-5111

________________________________________________________________________
________________________________________________________

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:  Japan Asia Airways Co., Ltd.						Date Filed:  January 29,
2004

Relief requested: Renew exemption from 49 U.S.C. § 41301 to engage in
scheduled foreign air transportation of persons, property and mail
between Nagoya, Japan, and Guam and Saipan.

If renewal, date and citation of last action:  February 27, 2003, in
this docket

Applicant representative:  William Karas<PHONE_NUMBER>

DOT Analyst:  Gordon H. Bingham<PHONE_NUMBER>

Responsive pleadings:  None filed

	DISPOSITION

Action:  Approved								Action date:  February 18, 2004

Effective dates of authority granted:  February 18, 2004-February 18,
2005

Basis for approval (bilateral agreement/reciprocity): 1998 Memorandum of
Understanding between the United States and Japan (1998 MOU)

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

X  Standard exemption conditions (attached)

Special conditions/Partial grant/Denial basis/Remarks:  Under the
authority granted above, Japan Asia must perform all services consistent
with existing agreements between the United States and Japan.

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) the applicant was qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (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

				Attachment

Foreign Carrier Conditions

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.  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 Principal Security Inspector (PSI) to advise the PSI 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.

08/2003