[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Rules and Regulations]
[Pages 34231-34240]
[FR Doc No: 2014-14030]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 49

[EPA-HQ-OAR-2011-0151; FRL-9911-46-OAR]
RIN 2060-AS24

Review of New Sources and Modifications in Indian Country
Amendments to the Registration and Permitting Deadlines for True Minor
Sources

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing final amendments to the ``Federal Minor New
Source Review Program in Indian Country'' (we refer to this new source
review rule as the ``Indian Country Minor NSR Rule''). We are amending
the Indian Country Minor NSR Rule in two ways. First, we are extending
the NSR minor source permitting deadline for true minor sources in the
oil and natural gas sector from September 2, 2014, to March 2, 2016.
Second, we are changing the registration deadline for new true minor
sources in the oil and natural gas sector to conform with the changes
to the NSR minor source permitting deadline. We are also eliminating a
requirement for all true minor sources that begin operation before
September 2, 2014, to obtain a minor NSR permit 6 months after EPA
publishes a general permit because the provision no longer affects any
source.

DATES: The final rule is effective on July 16, 2014.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2011-0151. All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available

either electronically in http://www.regulations.gov or in hard copy at
the Air and Radiation Docket, EPA/DC, William Jefferson Clinton West
Building, Room 3334, 1301 Constitution Avenue NW., Washington, DC
20460. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays. The telephone number
for the Public Reading Room is<PHONE_NUMBER>, and the telephone number
for the Air and Radiation Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For general questions about this
document, please contact Mr. Christopher Stoneman, Outreach and
Information Division, Office of Air Quality Planning and Standards
(C304-01), Environmental Protection Agency, Research Triangle Park,
North Carolina 27711; telephone number<PHONE_NUMBER>; fax number (919)
541-0072; email address<EMAIL_ADDRESS>For questions about
the applicability of this action to a particular source, please contact
the appropriate EPA region contact for your state:
    EPA Region 6 (Arkansas, Louisiana, New Mexico, Oklahoma, and
Texas)--Ms. Bonnie Braganza, Air Permits Section, Multimedia Permitting
and Planning Division, Environmental Protection Agency Region 6,
Dallas, Texas 75202; telephone number<PHONE_NUMBER>; fax number (214)
665-6762; email address<EMAIL_ADDRESS>    EPA Region 8 (Colorado, Montana, North Dakota, South Dakota, Utah,
and Wyoming)--Ms. Claudia Smith, Air Program, Mail Code 8P-AR,
Environmental Protection Agency Region 8, Denver, Colorado 80202;
telephone number<PHONE_NUMBER>; fax number<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    EPA Region 9 (Arizona, California, Hawaii, Nevada, and Pacific
Islands)--Ms. Lisa Beckham, Permits Office, Air Division, Air-3,
Environmental Protection Agency Region 9, San Francisco, California
94105; telephone number<PHONE_NUMBER>; fax number<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>    All other EPA regions--The permit reviewer for minor sources in
Indian country for your EPA region. You can find the list of the EPA
permit reviewers at http://www.epa.gov/air/tribal/tribalnsr.html.
Scroll down to the heading, ``Existing Source Registration,'' and click
on ``Reviewing Authority'' to access ``Environmental Protection
Agency's Reviewing Authorities for Permits.''

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    Entities potentially affected by this final rule include owners and
operators of true minor emission sources in all industry groups
planning to locate or already located in Indian country. Categories and
entities potentially affected by this action are expected to include,
but are not limited to, the following:

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                                                 Examples of regulated
             Category               NAICS \a\           entities
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Industry..........................      21111  Oil and gas production/
                                                operations.
                                       211111  Crude petroleum and
                                                natural gas extraction.
                                       211112  Natural gas liquid
                                                extraction.
                                       212321  Sand and gravel mining.
                                       213111  Drilling oil and gas
                                                wells.
                                       213112  Support activities for
                                                oil and gas operations.
                                        22111  Electric power
                                                generation.
                                       221210  Natural gas distribution.
                                        22132  Sewage treatment
                                                facilities.
                                        23899  Sand and shot blasting
                                                operations.
                                       311119  Animal food
                                                manufacturing.
                                         3116  Beef cattle complex,
                                                slaughter house and meat
                                                packing plant.
                                       321113  Sawmills.
                                       321212  Softwood veneer and
                                                plywood manufacturing.
                                        32191  Millwork (wood products
                                                manufacturing).
                                       323110  Printing operations
                                                (lithographic).
                                       324121  Asphalt hot mix.
                                         3251  Chemical preparation.
                                        32711  Clay and ceramics
                                                operations (kilns).
                                        32732  Concrete batching plant.
                                         3279  Fiber glass operations.
                                       331511  Casting foundry (iron).
                                         3323  Fabricated structural
                                                metal.
                                       332812  Surface coating
                                                operations.
                                         3329  Fabricated metal
                                                products.
                                        33311  Machinery manufacturing.
                                        33711  Wood kitchen cabinet
                                                manufacturing.
                                        42451  Grain elevator.
                                        42471  Gasoline bulk plant.
                                         4471  Gasoline station.
                                        54171  Professional, scientific,
                                                and technical services.
                                       562212  Solid waste landfill.
                                        72112  Casino hotels.
                                       811121  Auto body refinishing.
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\a\ North American Industry Classification System.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be subject to the Indian
Country Minor NSR Program, and, therefore, potentially affected by this
action. To determine whether your facility is affected by this action,
you should examine the applicability criteria in 40 CFR 49.151 through
49.161 (i.e., the Indian Country Minor NSR Rule). If you have any
questions regarding the applicability of

this action to a particular entity, contact the appropriate person
listed under FOR FURTHER INFORMATION CONTACT.

B. Where can I get a copy of this document and other related
information?

    In addition to being available in the docket, an electronic copy of
this final rule will also be available on the World Wide Web. Following
signature by the EPA Administrator, a copy of this final rule will be
posted in the regulations and standards section of our NSR home page
located at http://www.epa.gov/nsr and on the tribal NSR page at http://www.epa.gov/air/tribal/tribalnsr.html.

II. Purpose

    In July 2011, EPA finalized a rule that includes a minor new source
review NSR permitting program for sources in Indian country. We call
the minor source permitting part of the rule: The ``Indian Country
Minor NSR Rule.'' \1\ We call a permit issued under this program a
minor NSR permit. Under the rule issued in 2011, new and modified minor
sources and major sources that make minor modifications, located in
Indian country, must obtain a permit prior to commencing construction
(a pre-construction permit) beginning on September 2, 2014.
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    \1\ The Indian Country Minor NSR Rule is a component of ``Review
of New Sources and Modifications in Indian Country, Final Rule''
July 1, 2011 (76 FR 38748) that applies to new and modified minor
sources and minor modifications at major sources. It is codified at
40 CFR 49.151-49.161.
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    The purpose of today's rulemaking is to finalize the following two
amendments to the Indian Country Minor NSR Rule:
    (1) Extend the minor NSR permitting deadline for true minor sources
in the oil and natural gas sector located, or planning to locate, in
Indian country; and
    (2) Adjust the registration deadline to conform to the extended
permitting deadline for true minor sources in the oil and natural gas
sector; and
    (3) We are also eliminating a requirement for all true minor
sources that begin operation before September 2, 2014, to obtain a
minor NSR permit 6 months after EPA publishes a general permit. No
general permits have been finalized to date, so the provision is now
moot.

III. Background

A. Proposed Amendments to the Indian Country Minor NSR Rule

    On January 14, 2014, EPA published a proposed rule, ``General
Permits and Permits by Rule for the Federal Minor New Source Review
Program in Indian Country,'' \2\ that included proposed amendments to
Sec.  49.151(c)(1)(iii)(B) and Sec.  49.160(c)(1)(ii) and (c)(1)(iii)
of the Indian Country Minor NSR Rule. Two of the proposed amendments
affect only true minor sources in the oil and natural gas sector: (1)
The extension of the deadline by which true minor sources in the oil
and natural gas sector must receive minor NSR permits prior to
commencing construction; and (2) the deadline by which true minor
sources in the oil and natural gas sector must register. The third
proposed amendment would affect all true minor sources by eliminating
the requirement to obtain a permit beginning 6 months after EPA
publishes a general permit for a source category in the Federal
Register, if that date is before September 2, 2014.
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    \2\ The ``General Permits and Permits by Rule for the Federal
Minor New Source Review Program in Indian Country'' was proposed on
January 14, 2014 (79 FR 2546). Proposed changes to the Indian
Country Minor NSR rule are on pages 79 FR 2570-2572.
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    EPA proposed other changes to the Indian Country Minor NSR Rule in
the ``General Permits and Permits by Rule for the Federal Minor New
Source Review Program in Indian Country.'' These other proposed changes
are not part of today's final rule and will be addressed in a separate
final rulemaking.
    EPA also proposed amendments to the Indian Country Minor NSR Rule
in the proposed rule, ``Review of New Sources and Modifications in
Indian Country--Amendments to the Indian Country Minor New Source
Review Rule,'' published in the Federal Register on June 4, 2013 (78 FR
33266). These proposed amendments addressed the list of emissions units
and activities that are exempt from the Indian Country Minor NSR
Program and definitions of ``commence construction'' and ``begin
construction.'' We finalized these amendments in a final rule published
in the Federal Register on May 30, 2014 (79 FR 31035).

B. How might EPA streamline NSR permitting for true minor sources in
the oil and natural gas sector?

    When we proposed the extension of the permit deadline for true
minor sources in the oil and natural gas sector, we explained that an
extension of the deadline was necessary, in part, because of the
additional time required to appropriately address issues associated
with this sector. To begin the process of addressing these issues, EPA
published an Advance Notice of Proposed Rulemaking (ANPR) to solicit
broad feedback on the most effective and efficient means of
implementing the Indian Country Minor NSR Rule for new and modified
true minor sources and minor modifications at major sources in the oil
and natural gas sector located in Indian Country.\3\ In particular, the
ANPR discusses various approaches, including a federal implementation
plan (FIP), which would establish requirements for new and modified
true minor sources and minor modifications at major sources (and
possibly existing sources as well); and a general permit, which would
establish a streamlined permitting approach for new and modified minor
sources and minor modifications at major sources under the Indian
Country Minor Source NSR Rule. EPA is also seeking feedback on other
possible approaches such as a permit by rule.
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    \3\ See 79 FR 32502, published on June 5, 2014.
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    After considering feedback received in response to the ANPR,\4\ EPA
intends to propose action on regulating new and modified true minor
sources and minor modifications at major sources, and possibly also
existing sources of oil and natural gas production operations in Indian
country, in a way that: (1) Ensures the timely implementation of
environmental protections; (2) maximizes the efficient use of
resources; (3) minimizes preventable delays in economic development;
and (4) proactively mitigates potential adverse air quality-related
environmental and public health impacts that could result from the
rapid growth in emissions from these sources.
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    \4\ Electronic copies of the ANPR are available in the docket
and in the regulations and standards section of our NSR home page
located at http://www.epa.gov/nsr.
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IV. What final action is EPA taking on amendments to the Indian Country
Minor NSR Rule?

    Today's final rule promulgates three amendments to the Indian
Country Minor NSR Rule. This section discusses those three amendments
and our rationale for adopting them.
    This final rule amends Sec.  49.151(c)(1)(iii)(B) in two ways.
First, we are eliminating the requirement to obtain a permit beginning
6 months after the general permit for a source category is published in
the Federal Register, if that date is before September 2, 2014. The
purpose of this provision was to ensure that sources would obtain
preconstruction permits as soon as practicable after a general permit
had been issued rather than waiting until September 2, 2014. However,
today's date is fewer than 6 months from September 2, 2014, making the
provision unnecessary. Eliminating it

de-clutters and clarifies the regulatory text.
    Second, we are extending the permitting deadline for all true minor
sources (both new and modified true minor sources and minor
modifications at existing major sources) within the oil and natural gas
sector located in Indian country.\5\ Today's final rule changes the
deadline from September 2, 2014, to March 2, 2016, for true minor
sources in the oil and natural gas sector that either begin new
construction or modifications to an existing source on or after that
date.
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    \5\ Typically, sources in the oil and natural gas sources sector
will be assigned to one of the following NAICS codes: 21111 Oil and
gas production/operations; 211111 Crude petroleum and natural gas
extraction; 211112 Natural gas liquid extraction; 21311 Drilling oil
and gas wells; 213112 Support activities for oil and gas operations;
and 221210 Natural gas distribution.
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    This final rule also amends a provision in the Indian Country Minor
NSR Rule governing existing minor source registration timeframes (Sec.
49.151(c)(1)(iii)(A)) to conform to the changes to the registration
date that we made to another provision in the Indian Country Minor NSR
rule on the same topic (Sec.  49.160(c)(1)(ii) and (c)(1)(iii)) and to
eliminate redundant text that addresses the effective date of the
Indian Country Minor NSR Rule. We did not propose either change, but
had intended to make the changes we proposed throughout the regulatory
text to ensure consistency. The first change to Sec.
49.151(c)(1)(iii)(A), which addresses the registration date for true
minor sources in Indian Country, is necessary to ensure consistency
with the changes we proposed in Sec.  49.160(c)(1)(ii) and (c)(1)(iii).
Without the change in Sec.  49.151(c)(1)(iii)(A), the regulatory text
would have conflicting requirements. The second change in Sec.
49.151(c)(1)(iii)(A) eliminates ``you must register your source with
your reviewing authority in your area within 18 months after the
effective date of this program, that is.'' This change eliminates
unnecessary existing regulatory text and does not change any
requirements.
    Today's final rule also amends Sec.  49.160(c)(1)(ii) and
(c)(1)(iii) to make registration deadlines consistent with the minor
NSR permitting deadline for true minor sources in the oil and natural
gas sector. The Indian Country Minor NSR Rule currently requires true
minor sources that commence construction between August 30, 2011, and
September 2, 2014, to register with the appropriate reviewing authority
within 90 days after the source begins operation. If a source commences
construction or modification on or after September 2, 2014, its permit
application fulfills the registration requirement. Today's rule changes
the September 2, 2014, date to March 2, 2016, for true minor sources in
the oil and natural gas sector, thereby extending the period during
which sources in the oil and natural gas sector must register.

V. Summary of Significant Comments and Responses

    We received comments from 28 commenters (twelve tribes or tribal
entities, two state or local agencies, and fourteen industry entities)
overall on the ``General Permits and Permits by Rule for the Federal
Minor New Source Review Program in Indian Country'' proposed rule. The
subsections that follow provide a summary of the comments, and our
responses to those comments, that relate to the changes discussed in
Unit IV. and that we are addressing in today's final rule. The
remainder of the comments will be addressed as part of a separate final
rule that relates to the general permits (or permits by rule) and other
changes to the Indian Country Minor NSR Rule proposed in the ``General
Permits and Permits by Rule for the Federal Minor New Source Review
Program in Indian Country'' proposed rule.

A. Consultation With Tribal Governments

    Comment: One commenter stated that much of EPA's proposed rule
violated Executive Order No. 13175 on Consultation and Coordination
with Indian Tribal Governments and EPA's May 2011 Policy on
Consultation and Coordination with Indian Tribes.
    Response: The EPA coordinated with tribal environmental
professionals on the development of the ``General Permits and Permits
by Rule for the Federal Minor New Source Review Program in Indian
Country'' proposed rule, including the proposed amendments to extend
the permitting and registration deadlines for true minor sources in the
oil and natural gas sector located in Indian country. The coordination
consisted of participating in monthly teleconferences. Specifically, on
December 19, 2013, we presented an overview of the proposal and
welcomed feedback and questions. On March 4, 2014, we met with
representatives of the Ute Indian Tribe to hear their concerns
regarding the proposed rule.
    On December 16, 2013, EPA mailed letters to over 600 tribal leaders
to offer consultation. To assist tribes in deciding whether to accept
our offer of consultation, we held a conference call on January 6,
2014, during which EPA provided an overview of the proposed changes and
answered questions. We did not receive any requests for consultation
from tribal governments in response to our letters offering
consultation. However, prior to mailing the consultation letters, EPA
began consulting with two tribes. Senior EPA officials consulted with
the elected Ute Indian Tribe tribal leader and other members of the Ute
Indian Tribe, including business committee members, on August 27, 2013,
September 12, 2013, and March 21, 2014. Senior EPA officials also
consulted with the designated representatives of the elected leaders of
the Ute Indian Tribe and the Three Affiliated Tribes on July 26, 2013.

B. Removing the Requirement To Obtain a Permit Beginning 6 Months After
the Publication Date of a General Permit

    Comment: Two commenters supported eliminating the 6 month
requirement, noting that the general permits have not been published,
and cannot be finalized prior to 6 months before September 2, 2014. One
commenter also noted that the change clarifies that September 2, 2014,
is the applicable permitting deadline.
    Response: For the reasons explained in this document, this final
rule eliminates the requirement.

C. Extending the True Minor Source Permitting Deadline of the Indian
Country Minor NSR Rule for True Minor Sources in the Oil and Natural
Gas Sector

1. Extension Date
    Comment: No commenters opposed extending the true minor source
permitting deadline for the Indian Country Minor NSR Rule, although two
commenters did express concerns about how the extension would affect
air quality. Sixteen commenters supported an extension, citing the need
for a streamlined approach to permitting minor sources in the oil and
natural gas sector.
    One commenter noted that an extension of the deadline is
reasonable, given the complexity of the oil and natural gas sector.
Another commenter noted that without an extension, companies will have
to get individual permits for every facility. One commenter stated that
if oil and natural gas sources have to obtain site-specific permits
before commencing construction, the delays could have ``profoundly
negative effects on the Tribe's mineral estate, its economy and its
ability to fund the tribal

government,'' which could affect the tribal government's ability to
provide ``much needed social services to its tribal members.'' Other
commenters stated that obtaining site-specific permits for true minor
sources in the oil and natural gas sector would cause significant and
harmful delays due to the resources required to prepare and submit
permit applications and the inability of the EPA to review and issue
permits in a timely manner. One commenter noted that ``EPA will be
inundated with hundreds, maybe thousands, of permit applications'' and
has ``insufficient staff to review and approve'' these permits. Another
commenter noted that the number of applications for minor source
permits would ``overwhelm EPA's limited resources and likely lead to
unrealistic lead times and increased uncertainty for sources seeking
permits.'' Another commenter stated that even if a general permit was
proposed soon for the oil and natural gas sector, five-and-a-half
months lead time is not enough for companies to make control decisions
and equipment purchases, which often involve waiting lists or require
testing to assure controls will work in specific locations.
    One commenter stated that EPA should not pick an arbitrary fixed
future date for the permitting deadline. Several commenters asked EPA
to set the deadline for permitting as a conditional date, i.e., a date
12 months from the publication date or effective date of the general
permit for a source category. Commenters were concerned about EPA's
ability to issue a final general permit by March 2, 2016. One commenter
stated that if a deadline of March 2, 2016, does not provide enough
time for EPA to issue a general permit or permit by rule, we ``could
end up in the same predicament we find ourselves in today,'' with no
general permit or permit by rule in place and a fast-approaching
deadline. One commenter noted that it makes no sense to have an
effective date until a general permit or permit by rule is issued and
effective for a sector.
    One commenter requested that EPA allow adequate lead time between
the date a final oil and natural gas sector general permit, or permit
by rule, is published and the permitting deadline. One commenter noted
that 12 months would give oil and natural gas operators sufficient time
to read and understand the general permit, or permit by rule, and to
prepare hundreds of individual permit applications.
    Response: We are aware that EPA's ability to review and issue minor
NSR permits for the oil and natural gas sector would be strained
without a streamlined approach to permitting for true minor sources in
the oil and natural gas sector. We are also aware that delays in
issuing permits can be costly to industry and to tribes. To help
address these concerns, we are developing a streamlined approach to
permitting minor sources in the oil and natural gas sector. As
discussed in Unit III.B., we published an ANPR that addresses various
aspects of permitting oil and natural gas sources and requests comment
from the public on how EPA might best apply federally enforceable
limits that protect air quality in Indian country and minimize
potentially costly delays.
    Following the ANPR, EPA will develop a notice of proposed
rulemaking and a final rule. A permitting deadline prior to March 2,
2016, does not allow sufficient time to propose and promulgate a
general permit, FIP, or other possible approach (i.e., a permit by
rule) for sources in the oil and natural gas sector. However, a
deadline date of March 2, 2016, should provide sufficient time for us
to complete the regulatory development process and to finalize a
streamlined approach for addressing the potential impact of true minor
sources in the oil and natural gas sector. Therefore, today's final
rule is extending the permitting deadline for true minor sources in the
oil and natural gas sector to March 2, 2016.
    We do not believe that an open-ended extension of the permit
deadline is appropriate for a number of reasons. First, while we
believe that an extension of the permitting deadline is necessary in
practical terms for the successful implementation of the minor source
permitting program for oil and natural gas sources, this means that a
true minor source in the oil and natural gas sector that begins
construction before March 2, 2016, will not be required to have an NSR
permit. We recognize that the extended period of time true minor
sources in the oil and natural gas sector will be able to construct
without first obtaining an NSR permit could have a negative impact on
air quality in Indian country. We believe that establishing a date of
March 2, 2016, as the date by which true minor sources must obtain an
NSR permit prior to commencing construction will help to minimize any
such impacts. A nonspecific deadline conditional on the timing of
publication in the Federal Register of a general permit could
exacerbate any such impacts. Second, an open-ended extension would not
provide the certainty that industry representatives have consistently
said they need in order to make informed decisions regarding the
purchase and locating of equipment. Third, one of the reasons
commenters asked EPA for a conditional permitting deadline is the
amount of lead time they said sources require to develop permit
applications. When public comments were submitted, EPA had not
published the ANPR, which discusses the possibility of issuing
federally enforceable requirements using a FIP instead of a general
permit for true minor sources in the oil and natural gas sector in
Indian country. As discussed in the ANPR, an oil and natural gas
production FIP would apply directly by regulation and would authorize
construction or modification of sources complying with the requirement;
sources would not need to submit a permit application or obtain
coverage under a permit. This would mean that a source in compliance
with the FIP could begin construction at any point after meeting
notification requirements, potentially eliminating the need for
significant lead time. If EPA issues a general permit or follows
another approach instead of a FIP for minor sources in the oil and
natural gas sector, then we will take into consideration the need for
lead time.
2. Source Categories and Sources in the Oil and Natural Gas Sector
Subject to the Permitting Deadline Extension
    Comment: Several commenters stated that the permitting deadline
extension should apply to all true minor sources at oil and natural gas
facilities. One commenter further specified that the permitting
deadline extension should apply to glycol dehydrators, compressor
stations, natural gas processing plants, and any other gas gathering
facilities. Another commenter linked the equipment covered by a general
permit to equipment covered by the extension deadline and stated that
the general permit should be for storage tanks, dehydrators, and
compressor stations. One commenter stated that the permitting deadline
extension should include gas gathering activities and asked that the
EPA clarify the NAICS code that includes oil and gas gathering
activities. One commenter stated that a general permit for stationary
engines would be especially relevant for facilities in the oil and gas
industry. The commenter also stated that it ``makes no sense to make
the program effective for the oil and gas industry until after a
general permit or permit by rule has been issued and is effective for .
. . all source types used in that sector.''
    Several commenters stated that EPA should provide a permitting
extension to true minor sources in all source categories.

    Response: EPA agrees with the commenters that the permitting
extension should apply to all affected emissions units that are located
at a true minor source in the oil and natural gas sector.\6\ An
affected emissions unit, such as a boiler or an internal combustion
engine, does not have to be exclusive to the industry, but it must be
necessary for, and used in conjunction with, the extraction,
production, processing, storage, transmission or distribution of oil or
natural gas to be part of the oil and natural gas sector. We decided to
apply the extension to all affected emissions units at true minor
sources in the oil and natural gas sector because we have yet to
determine which affected emissions units will be covered by a general
permit, FIP or other approach. Before we decide in a subsequent notice
of proposed rulemaking which affected emission units we want to propose
to be covered, we want to consider the public comments received on a
host of issues outlined in the ANPR. We expect that most affected
emissions units at true minor sources in the oil and natural gas sector
will be covered by one of the approaches outlined in the ANPR or which
come to light in comments received on the ANPR; however, we believe it
best to extend the deadline for all affected emissions units at true
minor sources in the oil and natural gas sector until we determine
exactly which affected emissions units will be covered.
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    \6\ ``Affected emissions units'' is defined in the definitions
section (Sec.  49.152) of the Indian Country Minor NSR Rule.
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    EPA is not extending the permitting deadline for all true minor
sources because we do not believe an extension is warranted for other
source categories. If general permits, or permits by rule, are not in
place for other source categories by September 2, 2014, we would issue
site-specific permits for the sources in those source categories that
seek minor source permits during what we anticipate to be a short
period of time between that date and the date when general permits or
permits by rule are available.\7\ We believe that the time during which
the issuance of site-specific permits may be necessary will be short
because we have proposed general permits, or permits by rule, for five
source categories in Indian country and expect to propose additional
general permits, or permits by rule, later this year.
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    \7\ We are basing our sense of the number of potential sources
in other source categories on information from two sources. First,
it is based on the mix of existing minor sources that registered
with EPA in response to the March 2013 deadline. The number of oil
and natural gas sources that have registered far outweighs the
number of sources that have registered in other source categories.
Second, EPA's projections of minor source growth in Indian country
also indicates far higher growth in oil and natural gas sources
versus sources in other categories. A copy of the economic analysis
can be found in the following docket: Docket ID No. EPA-HQ-OAR-2011-
0151.
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    For the purposes of the permitting and registration deadlines, as
specified in Sec. Sec.  49.151(c)(1)(iii)(A) and (c)(1)(iii)(B), and
49.160(c)(1)(i) through (c)(1)(iii), for true minor sources, an ``oil
and natural gas source'' is part of the oil and natural gas sector. The
oil and natural gas sector encompasses all operations in the extraction
and production of oil and natural gas, as well as the processing,
transmission and distribution of natural gas. Specifically for oil, the
sector includes all operations from the well to the point of custody
transfer at a petroleum refinery. For natural gas, the sector includes
all operations from the well to the final end user. The oil and natural
gas sector can generally be separated into four segments: (1) Oil and
natural gas production; (2) natural gas processing; (3) natural gas
transmission and storage; and (4) natural gas distribution.
    The oil and natural gas production segment includes the wells and
all related processes used in the extraction, production, recovery,
lifting, stabilization, and separation or treatment of oil and/or
natural gas (including condensate). Production components may include,
but are not limited to, wells and related casing head, tubing head and
``Christmas tree'' piping, as well as pumps, compressors, heater
treaters, separators, storage vessels, pneumatic devices and
dehydrators. Production operations also include the well drilling,
completion and workover processes and include all the portable non-
self-propelled apparatus associated with those operations. Production
sites include not only the sites where the wells themselves are
located, but also include stand-alone ``pads'' where oil, condensate,
produced water, and natural gas from several wells may be separated,
stored, and treated. The production segment also includes the low to
medium pressure, smaller diameter, gathering pipelines and related
components that collect and transport the oil, natural gas and other
materials and wastes from the wells or well pads. We believe most true
minor sources in the oil and natural gas sector that will need a minor
NSR permit are in the oil and natural gas production segment.
    The natural gas production segment ends where the natural gas
enters a processing plant. In situations where there is no processing
plant, the natural gas production segment ends at the point where the
natural gas enters the transmission segment for long-line transport.
The crude oil production segment ends at the storage and load-out
terminal which is used for transport of the crude oil to a petroleum
refinery via trucks or railcars. The petroleum refinery is not
considered a part of the oil and natural gas sector. Thus, with respect
to crude oil, the oil and natural gas sector ends where crude oil
enters the petroleum refinery.
    The second segment, natural gas processing, consists of separating
certain hydrocarbons and fluids from the natural gas to produce
``pipeline quality'' dry natural gas. Pipeline quality natural gas
leaves the natural gas processing segment and enters the third segment,
natural gas transmission and storage, which includes pipelines,
reciprocating or centrifugal compressors, and underground storage
facilities. The fourth segment is the natural gas distribution segment.
Local distribution companies comprise the natural gas distribution
segment and deliver natural gas to the final end user. As explained
earlier in this comment response, we believe that most true minor
sources that will need a minor NSR permit will be in the oil and
natural gas production segment.
3. Protection of Air Quality in Indian Country During the Period of the
Extension
    Comment: One commenter expressed concern that extending the
permitting deadline may provide yet additional time for oil and natural
gas sources to commence new operations or make modifications to
existing sources without a permit. The commenter noted that the oil and
gas sector is one of the most prolific sources in some areas of Indian
country and it might not be beneficial to have so many unpermitted
sources during the extension period. Another commenter asked how EPA
will protect air quality in Indian country during the period of the
extension.
    Response: EPA recognizes that extending the minor NSR permitting
deadline for the oil and natural gas sector could have negative impacts
on air quality in Indian country, because some sources will not have to
install air pollution controls that might otherwise have been required.
Such impacts should be minimized, because many new, modified and
reconstructed sources in Indian country will have to meet the
requirements of the Agency's oil and natural gas New Source

Performance Standard (NSPS).\8\ The NSPS covers most emission sources
in the production segment of the oil and natural gas sector, including
completions of hydraulically fractured gas wells, storage vessels,
compressors, and pneumatic controllers. Sources constructed, modified
or reconstructed after August 23, 2011, must comply with the
requirements of the NSPS. The NSPS will be fully implemented in 2015.
Thus, the NSPS will help protect air quality during the extension.
Moreover, the permitting extension applies only to true minor sources;
the requirement that major sources and synthetic minor sources obtain
pre-construction permits in Indian country is not affected.
---------------------------------------------------------------------------

    \8\ See 40 CFR part 60, subpart OOOO, ``Standards of Performance
for Crude Oil and Natural Gas Production, Transmission, and
Distribution.''
---------------------------------------------------------------------------

    EPA does not have the necessary resources to deal with the
anticipated number of site-specific permit applications that would be
submitted between the current September 2, 2014, deadline and the date
by which we are able to issue a FIP, general permit or other
streamlined mechanism for the permitting of true minor sources in the
oil and natural gas sector. This could result in significant delays in
construction of oil and natural gas sources in Indian country.
Commenters representing both tribes and industry expressed concerns
about the negative impacts of delays in obtaining permits.
    The permitting extension also gives us an opportunity to coordinate
among all of the ongoing efforts to better manage the regulatory
challenges posed by this large, rapidly growing, complex sector. Three
activities are highlighted here. First, as previously mentioned, we
have promulgated an NSPS regulation for this source category \9\ that
applies directly to new, modified, and reconstructed sources in the
industry and requires emission controls for some sources. These
requirements are independent of any NSR permit. Second, on April 15,
2014, we released several technical white papers for peer review that
address emerging data on volatile organic compounds and methane
emissions from certain sources in the oil and natural gas sector, as
well as techniques for mitigating those emissions.\10\ These white
papers, and the comments they elicit, will help us solidify our
understanding of the sector and will help inform future policy
decisions as we consider potential voluntary and regulatory approaches.
Third, we are working to improve our emissions inventory and emissions
factors for the oil and natural gas sector. These improvements will
allow us to better assess the potential impacts of increased
production.
---------------------------------------------------------------------------

    \9\ See 40 CFR part 60, subpart OOOO, ``Standards of Performance
for Crude Oil and Natural Gas Production, Transmission, and
Distribution.''
    \10\ The white papers can be found at http://www.epa.gov/airquality/oilandgas.
---------------------------------------------------------------------------

    An extension to the permitting deadline also gives us time to
evaluate public comments on the ANPR (discussed in Unit III.),
including comments that address whether EPA should cover existing
sources in an oil and natural gas FIP. Covering existing oil and
natural gas sources in a FIP, if we decide to do so, could allow us to
better manage emissions increases in those areas of Indian country that
exceed, or are close to exceeding, the ozone National Ambient Air
Quality Standards (NAAQS) because of emissions from the oil and natural
gas sector. This could also ensure greater consistency with the
requirements in minor NSR permits previously issued by surrounding
states.

D. Registration

    Comment: Two commenters supported the proposed change to the
registration date for true minor sources in the oil and natural gas
sector. We did not receive any adverse comments on the proposed change.
    Response: We changed the registration date for true minor sources
in the oil and natural gas sector to be consistent with the permitting
deadline of March 2, 2016.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993)
and is therefore not subject to review under Executive Orders 12866 and
13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This action does not impose any new information collection burden
under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et
seq. The action will not create any new requirements under the Indian
Country Minor NSR Program, but rather extends permitting and
registration deadlines for true minor sources in the oil and natural
gas sector, potentially reducing burden. However, the Office of
Management and Budget (OMB) has previously approved the information
collection requirements contained in the existing regulations for the
Indian Country Minor NSR Program (40 CFR 49.151 through 49.161) under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.,
and has assigned OMB control number 2060-0003. The OMB control numbers
for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedures
Act or any other statute unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations
and small governmental jurisdictions.
    For purposes of assessing the impacts of this final action on small
entities, small entity is defined as: (1) A small business as defined
in the U.S. Small Business Administration size standards at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; or (3) a small organization that is any
not-for-profit enterprise that is independently owned and operated and
is not dominant in its field.
    After considering the economic impacts of this final action on
small entities, I certify that this final action will not have a
significant economic impact on a substantial number of small entities.
In determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analysis is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604.
Thus, an agency may certify that a rule will not have a significant
economic impact on a substantial number of small entities if the rule
relieves regulatory burden, or otherwise has a positive economic
effect, on all of the small entities subject to the rule.
    This final action will not create any new requirements under the
Indian Country Minor NSR Program. It merely extends the permit and
registration deadlines for true minor sources in the oil and natural
gas sector in Indian country. Therefore, it would not impose any
additional burden on any sources

(including small entities). We have therefore concluded that this final
rule will be neutral or relieve the regulatory burden for all affected
small entities.

D. Unfunded Mandates Reform Act

    This action contains no federal mandate under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local or tribal governments in the aggregate, or
the private sector in any 1 year. This action will not create any new
requirements under the Indian Country Minor NSR Program, but rather
extends the permitting and registration deadlines for true minor
sources in the oil and natural gas sector in Indian country. Therefore,
this action is not subject to the requirements of sections 202 or 205
of UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. As noted
previously, the effect of this final rule will be neutral or relieve
regulatory burden.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. This final rule will revise the
Indian Country Minor NSR Program, which applies only in Indian country,
and will not, therefore, affect the relationship between the national
government and the states or the distribution of power and
responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Subject to the Executive Order 13175 (65 FR 67249, November 9,
2000), EPA may not issue a regulation that has tribal implications,
that imposes substantial direct compliance costs and that is not
required by statute, unless the Federal government provides the funds
necessary to pay the direct compliance costs incurred by tribal
governments or EPA consults with tribal officials early in the process
of developing the proposed regulation and develops a tribal summary
impact statement.
    EPA has concluded that this final rule will have tribal
implications. However, it will neither impose substantial direct
compliance costs on tribal governments, nor preempt tribal law. This
final rule will have tribal implications since it revises the Indian
Country Minor NSR Program, which applies to both tribally-owned and
privately-owned sources in Indian country. As with the existing rule,
the revised rule will be implemented by EPA, or a delegate tribal
agency assisting EPA with administration of the rules, until replaced
by an EPA-approved tribal implementation plan. The effect of this final
rule will be to extend the permitting and registration deadlines for
true minor sources in the oil and natural gas sector.
    EPA coordinated with tribal environmental professionals on the
development of the ``General Permits and Permits by Rule for the
Federal Minor New Source Review Program in Indian Country'' proposed
rule, including the proposed amendments to extend the permitting and
registration deadlines for true minor sources in the oil and natural
gas sector located in Indian country. The coordination consisted of
participating in monthly teleconferences. Specifically, on December 19,
2013, we presented an overview of the proposal and welcomed feedback
and questions. On March 4, 2014, we met with representatives of the Ute
Indian Tribe to hear their concerns regarding the proposed rule. On
December 16, 2013, EPA mailed letters to over 600 tribal leaders to
offer consultation. To assist tribes in deciding whether to accept our
offer of consultation, we held a conference call on January 6, 2014,
during which EPA provided an overview of the proposed changes and
answered questions. We did not receive any requests for consultation
from tribal governments in response to our letters offering
consultation. However, prior to mailing the consultation letters, EPA
began consulting with two tribes. Senior EPA officials consulted with
the elected Ute Indian Tribe tribal leader and other members of the Ute
Indian Tribe, including business committee members, on August 27, 2013,
September 12, 2013, March 4, 2014, and March 21, 2014. Senior EPA
officials also consulted with the designated representatives of the
elected leaders of the Ute Indian Tribe and the Three Affiliated Tribes
on July 26, 2013.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it does not
establish an environmental standard intended to mitigate health or
safety risks.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through the OMB, explanations when the Agency decides not to
use available and applicable voluntary consensus standards.
    This rulemaking does not involve technical standards. Therefore,
EPA has not considered the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations. This final rule will
extend the true minor source permit deadlines for oil and natural gas
sources under the Indian Country Minor

NSR Program. EPA recognizes that this will result in some sources not
installing air pollution controls that might otherwise have been
required by a permit, but believes that any negative impacts on air
quality associated with such activities will not be significant and
that the practical need for the extension justifies any such impacts in
the near term. Many new, modified and reconstructed sources in Indian
country will have to meet the requirements of the Agency's oil and
natural gas NSPS. The NSPS covers most emission sources in the
production segment of the oil and natural gas sector, including
completions of hydraulically fractured gas wells, storage vessels,
compressors, and pneumatic controllers. Sources constructed, modified
or reconstructed after August 23, 2011, must comply with the
requirements of the NSPS. The NSPS will be fully implemented in 2015.
Thus, the NSPS will help protect air quality during the extension.
Moreover, the permitting extension applies only to true minor sources;
the requirement that major sources and synthetic minor sources obtain
pre-construction permits in Indian country is not affected.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq, as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective July 16, 2014.

L. Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the District of Columbia Circuit by August 15, 2014. Any
such judicial review is limited to only those objections that are
raised with reasonable specificity in timely comments. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review, nor does it extend the time within which a petition for
judicial review may be filed and shall not postpone the effectiveness
of such rule or action. Under section 307(b)(2) of the Clean Air Act,
the requirements of this final action may not be challenged later in
civil or criminal proceedings brought by us to enforce these
requirements.

VII. Statutory Authority

    The statutory authority for this action is provided by sections
101, 110, 112, 114, 116 and 301 of the Clean Air Act as amended (42
U.S.C. 7401, 7410, 7412, 7414, 7416 and 7601).

List of Subjects in 40 CFR Part 49

    Environmental protection, Administrative practices and procedures,
Air pollution control, Indians, Intergovernmental relations, Reporting
and recordkeeping requirements.

    Dated: May 22, 2014.
Gina McCarthy,
Administrator.

    Therefore, 40 CFR part 49 is amended as follows:

PART 49--[AMENDED]

0
1. The authority citation for part 49 continues to read as follows:

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

0
2. In Sec.  49.151, revise paragraphs (c)(1)(iii)(A) and (c)(1)(iii)(B)
to read as follows:

Sec.  49.151  Program overview.

* * * * *
    (c) * * *
    (1) * * *
    (iii) * * * (A) If you own or operate an existing true minor source
in Indian country (as defined in 40 CFR 49.152(d)), you must register
your source with the reviewing authority in your area by March 1, 2013.
If your true minor source is not an oil and natural gas source, and you
commence construction after August 30, 2011, and before September 2,
2014, you must also register your source with the reviewing authority
in your area within 90 days after the source begins operation. If your
true minor source is an oil and natural gas source, and you commence
construction after August 30, 2011, and before March 2, 2016, you must
register your source with the reviewing authority in your area within
90 days after the source begins operation. You are exempt from these
registration requirements if your true minor source is subject to Sec.
49.138.
    (B) If your true minor source is not an oil and natural gas source
and you wish to begin construction of a new true minor source or a
modification at an existing true minor source on or after September 2,
2014, you must first obtain a permit pursuant to Sec. Sec.  49.154 and
49.155 (or a general permit pursuant to Sec.  49.156, if applicable).
If your true minor source is an oil and natural gas source and you wish
to begin construction of a new true minor source or a modification at
an existing true minor source on or after March 2, 2016, you must first
obtain a permit pursuant to Sec. Sec.  49.154 and 49.155 (or a general
permit pursuant to Sec.  49.156, if applicable). The proposed new
source or modification will also be subject to the registration
requirements of Sec.  49.160, except for sources that are subject to
Sec.  49.138.
* * * * *

0
3. In Sec.  49.160, revise paragraphs (c)(1)(i), (c)(1)(ii), and
(c)(1)(iii) to read as follows:

Sec.  49.160  Registration program for minor sources in Indian country.

* * * * *
    (c) * * *
    (1) * * *
    (i) If you own or operate an existing true minor source (as defined
in 40 CFR 49.152(d)), you must register your source with the reviewing
authority by March 1, 2013.
    (ii) If your true minor source is not an oil and natural gas source
and you commence construction after August 30, 2011, and before
September 2, 2014, you must register your source with the reviewing
authority within 90 days after the source begins operation. If your
true minor source is an oil and natural gas source, and you commence
construction after August 30, 2011, and before March 2, 2016, you must
register your source with the reviewing authority within 90 days after
the source begins operation.
    (iii) If your true minor source is not an oil and natural gas
source, and you commence construction or modification of your source on
or after September 2, 2014, and your source is subject to this rule,
you must report your source's actual emissions (if available) as part
of your permit application and your permit application information will
be used to fulfill the registration requirements described in Sec.
49.160(c)(2). If your true minor source is an oil and natural gas
source, and you commence construction or modification of your source on
or after March 2, 2016, and your source is subject to this rule, you
must report your source's actual emissions (if available) as part of
your permit application and your permit application information will be
used to fulfill the

registration requirements described in Sec.  49.160(c)(2).
* * * * *
[FR Doc. 2014-14030 Filed 6-13-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11266-11267]
[FR Doc No: 2018-05171]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Form PF, SEC File No. 270-636, OMB Control No. 3235-0679.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (``Paperwork Reduction Act''), the
Securities and Exchange Commission (the ``Commission'') has submitted
to the Office of Management and Budget (``OMB'') a request for
extension of the previously approved collection of information
discussed below.
    Rule 204(b)-1 (17 CFR 275.204(b)-1) under the Investment Advisers
Act of 1940 (15 U.S.C. 80b-1 et seq.) implements sections 404 and 406
of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the
``Dodd-Frank Act'') by requiring private fund advisers that have at
least $150 million in private fund assets under management to report
certain information regarding the private funds they advise on Form PF.
These advisers are the respondents to the collection of information.
    Form PF is designed to facilitate the Financial Stability Oversight
Council's (``FSOC'') monitoring of systemic risk in the private fund
industry and to assist FSOC in determining whether and how

to deploy its regulatory tools with respect to nonbank financial
companies. The Commission and the Commodity Futures Trading Commission
may also use information collected on Form PF in their regulatory
programs, including examinations, investigations and investor
protection efforts relating to private fund advisers.
    Form PF divides respondents into two broad groups, Large Private
Fund Advisers and smaller private fund advisers. ``Large Private Fund
Advisers'' are advisers with at least $1.5 billion in assets under
management attributable to hedge funds (``large hedge fund advisers''),
advisers that manage ``liquidity funds'' and have at least $1 billion
in combined assets under management attributable to liquidity funds and
registered money market funds (``large liquidity fund advisers''), and
advisers with at least $2 billion in assets under management
attributable to private equity funds (``large private equity
advisers''). All other respondents are considered smaller private fund
advisers.
    The Commission estimates that most filers of Form PF have already
made their first filing, and so the burden hours applicable to those
filers will reflect only ongoing burdens, and not start-up burdens.
Accordingly, the Commission estimates the total annual reporting and
recordkeeping burden of the collection of information for each
respondent is as follows:

(a) For smaller private fund advisers making their first Form PF
filing, an estimated amortized average annual burden of 23 hours for
each of the first three years;
(b) For smaller private fund advisers that already make Form PF
filings, an estimated amortized average annual burden of 15 hours for
each of the next three years;
(c) For large hedge fund advisers making their first Form PF filing, an
estimated amortized average annual burden of 610 hours for each of the
first three years;
(d) For large hedge fund advisers that already make Form PF filings, an
estimated amortized average annual burden of 560 hours for each of the
next three years;
(e) For large liquidity fund advisers making their first Form PF
filing, an estimated amortized average annual burden of 588 hours for
each of the first three years;
(f) For large liquidity fund advisers that already make Form PF
filings, an estimated amortized average annual burden of 280 hours for
each of the next three years;
(g) For large private equity advisers making their first Form PF
filing, an estimated amortized average annual burden of 67 hours for
each of the first three years; and
(h) For large private equity advisers that already make Form PF
filings, an estimated amortized average annual burden of 50 hours for
each of the next three years.

    With respect to annual internal costs, the Commission estimates the
collection of information will result in 92 burden hours per year on
average for each respondent. With respect to external cost burdens, the
Commission estimates a range from $0 to $50,000 per adviser.
    Estimates of average burden hours and costs are made solely for the
purposes of the Paperwork Reduction Act and are not derived from a
comprehensive or even representative survey or study of the costs of
Commission rules and forms. Compliance with the collection of
information requirements of Form PF is mandatory for advisers that
satisfy the criteria described in Instruction 1 to the Form. Responses
to the collection of information will be kept confidential to the
extent permitted by law. The Commission does not intend to make public
information reported on Form PF that is identifiable to any particular
adviser or private fund, although the Commission may use Form PF
information in an enforcement action. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
    The public may view background documentation for this collection at
the following website, www.reginfo.gov. Please direct your written
comments to Pamela Dyson, Director/Chief Information Officer,
Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street
NE, Washington, DC 20549; or send an email to: [email protected].
Comments must be submitted to OMB within 30 days of this notice.

    Dated: March 8, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-05171 Filed 3-13-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26540-26541]
[FR Doc No: 2018-12224]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2018-0048]

Petition for Waiver of Compliance

    Under part 211 of Title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on May 25, 2018, the Santa
Clara Valley Transportation Authority (SCVTA) and the American
Federation of State, County and Municipal Employees (AFSCME) petitioned
the Federal Railroad Administration (FRA) for a waiver of compliance
from certain provisions of the Federal hours of service laws contained
at 49 U.S.C. 21105, which in part prohibit a dispatching service
employee from being on duty for more than a total of 9 hours during a
24-hour period. FRA assigned the petition Docket Number FRA-2018-0048.
    Specifically, Petitioners seek approval of a pilot project under 49
U.S.C. 21108, which allows railroads and labor organizations to jointly
petition for a waiver of compliance from the hours of service laws to
enable the establishment of a pilot project. The proposed pilot project
would permit a 4-day, 10 hours-per-day work week for the affected
employees, ``the controllers'' on the SCVTA system. Petitioners allege
the pilot project will enhance safety of operations due to the
increased flexibility in terms of staff assignments and covering
unanticipated occurrences on the system, be beneficial to morale, and
will provide more flexibility in arranging for ongoing training for
employees without having to ask them to sacrifice days off from work.
    Petitioners explain that SCVTA is a public agency, with light rail
transit operations on three lines, including the Vasona Corridor, which
shares a corridor and grade crossings, but not tracks, with Union
Pacific Railroad Company (UP). AFSCME is the authorized collective
bargaining representative for the controllers, the employees on the
SCVTA system that dispatch SCVTA light rail trains. UP train crews
contact the SCVTA Operating Control Center prior to operating in the
shared corridor, but SCVTA controllers do not otherwise communicate
directly with UP train crews, nor do they share a radio frequency with
UP.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE, W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by July 23, 2018 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
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notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the privacy notice of regulations.gov.

    Issued in Washington, DC.
Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2018-12224 Filed 6-6-18; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Pages 57736-57739]
[FR Doc No: 2019-23461]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3708]

InvaGen Pharmaceuticals, Inc.; Proposal To Withdraw Approval of
an Abbreviated New Drug Application for Trandolapril Tablets;
Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is proposing to withdraw approval
of an abbreviated new drug application (ANDA) for trandolapril tablets
and is announcing an opportunity for the holder of the ANDA to request
a hearing on this proposal. The basis for the proposal is that the
holder of the ANDA has repeatedly failed to submit the required data to
support a finding of bioequivalence for this ANDA.

DATES: InvaGen Pharmaceuticals, Inc. may submit a request for a hearing
by November 27, 2019. Submit all data, information, and analyses upon
which the request for a hearing relies by December 27, 2019. Submit
electronic or written comments by December 27, 2019.

ADDRESSES: The request for a hearing may be submitted by InvaGen
Pharmaceuticals, Inc. by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments to submit your request
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a
hearing, will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     Because your request for a hearing will be made public,
you are solely responsible for ensuring that your request does not
include any confidential information that you or a third party may not
wish to be posted, such as medical information, your or anyone else's
Social Security number, or confidential business information, such as a
manufacturing process. The request for a hearing must include the
Docket No. FDA-2019-N-3708 for ``InvaGen Pharmaceuticals, Inc.;
Proposal to Withdraw Approval of an Abbreviated New Drug Application
for Trandolapril Tablets; Opportunity for a Hearing.'' The request for
a hearing will be placed in the docket and publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
    InvaGen Pharmaceuticals, Inc. may submit all data and analyses upon
which the request for a hearing relies in the same manner as the
request for a hearing except as follows:
     Confidential Submissions--To submit any data and analyses
with confidential information that you do not wish to be made publicly
available, submit your data and analyses only as a written/paper
submission. You should submit two copies total of all data and
analyses. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy,
including the claimed confidential information, in its consideration of
any decisions on this matter. The second copy, which

will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov or available at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday. Submit both copies to
the Dockets Management Staff. Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law.
    Comments Submitted by Other Interested Parties: For all comments
submitted by other interested parties, submit comments as follows.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-3708 for ``InvaGen Pharmaceuticals, Inc.; Proposal to
Withdraw Approval of an Abbreviated New Drug Application for
Trandolapril Tablets; Opportunity for a Hearing.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Maryll W. Toufanian, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1720, Silver Spring, MD 20993-0002, 240-
402-7944.

SUPPLEMENTARY INFORMATION:

I. Background

A. Approval of ANDA 078320 for Trandolapril Tablets

    FDA's Office of Generic Drugs (OGD) approved ANDA 078320, held by
InvaGen Pharmaceuticals, Inc. (InvaGen), for a generic version of
trandolapril tablets, 1 milligram (mg), 2 mg, and 4 mg, under the
requirements of section 505(j) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355(j)) and FDA's implementing regulations.
OGD approved ANDA 078320 on June 12, 2007.
    In seeking approval of its ANDA 078320, InvaGen relied on the
reference listed drug (RLD) product, MAVIK (trandolapril) tablets, 1
mg, 2 mg, and 4 mg, approved under new drug application (NDA) 020528
(see Sec.  314.94 (21 CFR 314.94)). As an applicant under section
505(j) of the FD&C Act, InvaGen was not required to conduct clinical
studies to demonstrate the safety and effectiveness of its drug
product. Rather, in addition to meeting the other requirements for ANDA
approval enumerated in section 505(j) of the FD&C Act and applicable
FDA regulations, InvaGen was required to demonstrate that its product
was bioequivalent to the RLD, MAVIK (see section 505(j)(2)(A)(iv) and
(j)(4)(F) of the FD&C Act; Sec.  314.94(a)(7); 21 CFR
314.127(a)(6)(i)). The information that InvaGen submitted to show that
its ANDA 078320 was bioequivalent to the RLD included bioequivalence
studies, with the bioanalytical analysis conducted by Cetero Research
at the Houston, TX site during 2005-2006.

B. Investigations Regarding Bioequivalence Studies Conducted by Cetero
Research

    In May 2010 and December 2010, FDA conducted comprehensive
inspections of bioequivalence studies conducted by Cetero Research at
the Houston, TX site. The inspections were part of FDA's Bioresearch
Monitoring Program, which includes inspections to evaluate the conduct
of research, to confirm that data intended for submission to FDA are
reliable as a basis for FDA approval and regulatory decisions, and to
verify compliance with the bioavailability and bioequivalence
requirements in section 505 of the FD&C Act and 21 CFR part 320. The
findings of these inspections of bioequivalence studies conducted by
Cetero Research raised significant concerns about the validity of the
reported results of analytical studies conducted between April 1, 2005,
and June 15, 2010, in support of drug applications (see Ref. 1). The

inspections and a third-party audit identified significant instances of
misconduct and violations of Federal regulations, including document
falsification and sample manipulation. The pattern of misconduct was
serious enough to raise concerns about the integrity of the data that
Cetero Research generated during the 5-year time frame between 2005 and
2010. On July 26, 2011, FDA notified pharmaceutical companies that
bioanalytical studies conducted at Cetero Research between April 1,
2005, and June 15, 2010, in support of marketing applications may need
to be repeated or confirmed (see Ref. 2).
    On August 9, 2011, FDA issued a letter to InvaGen regarding ANDA
078320 because this drug product application was supported by
bioequivalence studies with the bioanalytical analysis conducted by
Cetero Research at the Houston, TX site between April 1, 2005, and June
15, 2010 (see Ref. 3). As FDA noted in its August 9, 2011,
correspondence, inspection findings regarding Cetero Research's
bioequivalence studies raised significant concerns about the validity
of the reported results of the analytical studies conducted between
April 2005 and June 2010 in support of drug applications, and as such,
steps needed to be taken to demonstrate the bioequivalence of InvaGen's
drug product approved under ANDA 078320. FDA informed InvaGen that ANDA
078320 needed to be supplemented by conducting new bioequivalence
studies or re-assaying the samples from the original bioequivalence
study. FDA recommended to InvaGen that the results of the requested
bioequivalence studies, or re-assays, be submitted to ANDA 078320
within 6 months of the date of the August 9, 2011, letter. As noted in
the August 9, 2011, correspondence, if the necessary information was
not submitted within the recommended timeframe, FDA would consider
downgrading the therapeutic equivalence evaluation of approved
applications in the Agency's ``Approved Drug Products With Therapeutic
Equivalence Evaluations'' (Orange Book) from an ``AB'' to a ``BX''
rating because of new information raising a significant question as to
bioequivalence. FDA did not receive a response from InvaGen to this
August 9, 2011, correspondence.
    On August 19, 2016, FDA issued another letter to InvaGen requesting
that, within 30 calendar days, InvaGen either: (1) Supplement ANDA
078320 with the requested bioequivalence data or (2) voluntarily seek
withdrawal of ANDA 078320 under Sec.  314.150 (21 CFR 314.150(d)) and
waive the opportunity for a hearing under Sec.  314.150(a) (see Ref.
4). As noted in the August 19, 2016, correspondence, if InvaGen did not
submit new bioequivalence data within 30 calendar days, if the new data
did not support a finding of bioequivalence, or if InvaGen did not
agree to voluntarily seek withdrawal of ANDA 078320 within 30 calendar
days, FDA would commence downgrading the therapeutic equivalence
evaluation of approved applications in the Orange Book from an ``AB''
to a ``BX'' rating. FDA also stated that if the aforementioned
conditions were not met, FDA would consider all other appropriate
regulatory action, including commencing steps to withdraw approval of
ANDA 078320 under section 505(e) of the FD&C Act and Sec.  314.150. In
response to the August 19, 2016, correspondence, FDA received a letter
from InvaGen dated September 16, 2016, requesting a 9-month extension
and stating that InvaGen was working to conduct new studies to submit
to the Agency (see Ref. 5).
    On April 24, 2017, FDA issued a third letter to InvaGen notifying
them that FDA was denying InvaGen's request for a 9-month extension
because InvaGen had already had a lengthy period to provide the
requested data (see Ref. 6). In the April 24, 2017, correspondence, FDA
also notified InvaGen that FDA had changed the therapeutic equivalence
evaluation of ANDA 078320 in the Orange Book from an ``AB'' to a ``BX''
rating. Further, in the April 24, 2017, correspondence, FDA requested
that InvaGen voluntarily seek withdrawal for ANDA 078320 under Sec.
314.150(d) and waive the opportunity for a hearing under Sec.
314.150(a). FDA requested that InvaGen provide such a withdrawal
request or a letter stating that InvaGen would not voluntarily seek
withdrawal of the approval of ANDA 078320 no later than May 24, 2017.
As noted in the April 24, 2017, correspondence, FDA advised InvaGen
that if InvaGen did not agree to voluntarily seek withdrawal of the
approval of ANDA 078320 under Sec.  314.150(d), FDA would plan to
commence steps to withdraw approval of this ANDA under 505(e) of the
FD&C Act and Sec.  314.150. FDA did not receive a response from InvaGen
to this April 24, 2017, correspondence.
    In the June 2017 Cumulative Supplement to the 37th Edition of the
Orange Book, ANDA 078320 was moved to the Discontinued Section of the
Orange Book based on notification by InvaGen to the Agency that InvaGen
was no longer marketing its drug product approved under ANDA 078320.
Because drug products that are in the Discontinued Section of the
Orange Book do not have therapeutic equivalence codes and because ANDA
078320 is currently in the Discontinued Section of the Orange Book,
ANDA 078320 is not currently assigned a therapeutic equivalence code.

II. Conclusions and Proposed Action

    An NDA applicant must submit ``full reports of investigations'' to
show that the drug for which the applicant is seeking approval is safe
and effective. In other words, NDAs must meet the safety and
substantial evidence of effectiveness standard (see section 505(b)(1)
and (2), (c), and (d) of the FD&C Act). An NDA applicant can meet the
standard by conducting its own clinical studies (stand-alone
application) or relying, in part, on the Agency's previous finding of
safety and/or effectiveness or literature (a 505(b)(2) application). An
ANDA applicant does not submit independent clinical studies to
demonstrate safety and effectiveness. Rather, an ANDA applicant relies
on the Agency's previous finding of safety and effectiveness for its
RLD and is required to meet other requirements, such as demonstrating
bioequivalence to the RLD to support approval. In the absence of
information showing bioequivalence between the generic drug at issue
and the RLD, there is no basis for concluding that the Agency's finding
of safety and efficacy supporting approval of the RLD can be used as a
basis to support approval of the generic drug. Section 505(e) of the
FD&C Act provides FDA the authority to withdraw approval of an ANDA in
these circumstances. While the InvaGen application was approved on the
basis of a bioequivalence study, new information about the facility
that conducted the bioanalytical analysis for that study leads CDER to
conclude that the results of that study are not credible.
    Therefore, based on all available data and information, notice is
given to InvaGen Pharmaceuticals, Inc. and to all other interested
persons that the Director of CDER proposes to issue an order, under
section 505(e) of the FD&C Act and Sec.  314.150, withdrawing approval
of ANDA 078320 and all amendments and supplements to it on the grounds
that InvaGen has failed to submit the required bioequivalence data
necessary to demonstrate the bioequivalence of its drug product.

III. Hearing Procedures

    In accordance with section 505(e) of the FD&C Act, InvaGen
Pharmaceuticals, Inc. is hereby provided an opportunity to request a
hearing to show why approval of ANDA 078320 should not be withdrawn and
an

opportunity to raise, for administrative determination, all issues
relating to the legal status of the drug product covered by this
application.
    An applicant who decides to seek a hearing must file the following:
(1) A written notice of participation and request for a hearing (see
DATES and ADDRESSES) and (2) the data, information, and analyses relied
on to demonstrate that there is a genuine and substantial issue of fact
that requires a hearing (see DATES and ADDRESSES). Any other interested
person may also submit comments on this notice. The procedures and
requirements governing this notice of opportunity for a hearing, notice
of participation and request for a hearing, the information and
analyses to justify a hearing, other comments, and a grant or denial of
a hearing are contained in Sec.  314.200 (21 CFR 314.200) and in 21 CFR
part 12.
    The failure of an applicant to file a timely written notice of
participation and request for a hearing, as required by Sec.  314.200,
constitutes an election by that applicant not to avail itself of the
opportunity for a hearing concerning CDER's proposal to withdraw
approval of the application and constitutes a waiver of any contentions
concerning the legal status of the drug product. FDA will then withdraw
approval of the application, and the drug product may not thereafter be
lawfully introduced or delivered for introduction into interstate
commerce. Any new drug product introduced or delivered for introduction
into interstate commerce without an approved application is subject to
regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or
denials but must present specific facts showing that there is a genuine
and substantial issue of fact that requires a hearing. If a request for
a hearing is not complete or is not supported, the Commissioner of Food
and Drugs will enter summary judgment against the person who requests
the hearing, making findings and conclusions, and denying a hearing.
    Paper submissions under this notice of opportunity for a hearing
must be filed in two copies. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen at the Dockets Management Staff (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at https://www.regulations.gov.
    This notice is issued under section 505(e) of the FD&C Act and
under authority delegated to the Director of CDER by the Commissioner
of Food and Drugs.

IV. References

    The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

1. Letter from Leslie Ball, FDA, to Roger Hayes, Cetero Research,
July 26, 2011.
2. FDA, ``Notification to Pharmaceutical Companies: Acceptance of
third-party data integrity audit for Cetero studies conducted from
March 1, 2008, to August 31, 2009'' (https://wayback.archive-it.org/7993/20170113203457/http:/www.fda.gov/Drugs/DrugSafety/ucm265559.htm), accessed September 10, 2019.
3. Letter from Keith Webber, FDA, to InvaGen Pharmaceuticals, Inc.,
August 9, 2011.
4. Letter from Carol A. Holquist, FDA, to InvaGen Pharmaceuticals,
Inc., August 19, 2016.
5. Letter from Ram Mohan Kathuroju, InvaGen Pharmaceuticals, Inc.,
to FDA, September 16, 2016.
6. Letter from Carol A. Holquist, FDA, to InvaGen Pharmaceuticals,
Inc., April 24, 2017.

    Dated: October 21, 2019.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2019-23461 Filed 10-25-19; 8:45 am]
BILLING CODE 4164-01-P