Supporting Statement For

EPA Information Collection Request Number 1601.07

Outer Continental Shelf Air Regulations

Table of Contents  TOC \o "1-1" \f \u

Section 											   Page

  TOC \o "1-1" \f \u  1.          IDENTIFICATION OF THE INFORMATION
COLLECTION	  PAGEREF _Toc201638900 \h  1

1(a)  TITLE AND NUMBER OF THE INFORMATION COLLECTION	1

1(b)  CHARACTERIZATION OF THE INFORMATION COLLECTION	1

2.          NEED FOR AND USE OF THE COLLECTION	3

2(a)  NEED/AUTHORITY FOR THE COLLECTION…………	3

2(b)  USE/USERS OF THE DATA	  PAGEREF _Toc201638902 \h  4

3.           NONDUPLICATION, CONSULTATION, AND OTHER COLLECTION

             CRITERIA	  PAGEREF _Toc201638903 \h  6

3(a)  NONDUPLICATION	  PAGEREF _Toc201638904 \h  6

3(b)  PUBLIC NOTICE REQUIRED PRIOR TO ICR SUBMISSION TO OMB	  PAGEREF
_Toc201638905 \h  6

3(c)  CONSULTATIONS	  PAGEREF _Toc201638906 \h  6

3(e)  GENERAL GUIDELINES	  PAGEREF _Toc201638907 \h  7

3(f)  CONFIDENTIALITY	  PAGEREF _Toc201638908 \h  7

3(g)  SENSITIVE QUESTIONS	  PAGEREF _Toc201638908 \h  7

4.          THE RESPONDENTS AND THE INFORMATION REQUESTED	  PAGEREF
_Toc201638909 \h  8

4(a)  RESPONDENTS/STANDARD INDUSTRIAL CLASSIFICATION (SIC) CODES
PAGEREF _Toc201638910 \h  8

4(b)  INFORMATION REQUESTED	  PAGEREF _Toc201638911 \h  9

5.          THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION,
METHODOLOGY AND INFORMATION MANAGEMENT	  PAGEREF _Toc201638912 \h  16

5(a)  AGENCY ACTIVITIES	  PAGEREF _Toc201638913 \h  16

5(b)  COLLECTION METHODOLOGY AND MANAGEMENT	  PAGEREF _Toc201638914 \h
17

5(c)  SMALL ENTITY FLEXIBILITY	  PAGEREF _Toc201638915 \h  17

5(d)  COLLECTION SCHEDULE	  PAGEREF _Toc201638916 \h  18

6.          ESTIMATING THE BURDEN AND COST OF THE COLLECTION	  PAGEREF
_Toc201638917 \h  18

6(a)  ESTIMATING RESPONDENT BURDEN AND COSTS	  PAGEREF _Toc201638918 \h
18

6(b)  ESTIMATING STATE AND LOCAL AIR POLLUTION CONTROL AGENCY

          BURDEN AND   COSTS	  PAGEREF _Toc201638919 \h  23

6(c)  ESTIMATING THE EPA BURDEN AND COSTS	25

6(d)  REASONS FOR CHANGE IN BURDEN	  PAGEREF _Toc201638920 \h  27

 List of Tables

Table											               Page

1.		References for Burden Activities Associated with

OCS Air Regulations	28

2.		Respondent Data And Information Requirements For Preparing PSD
Construction Permits	29

3.		Respondent Data and Information Requirements for Preparing Part D
Construction Permits	30

List of Exhibits

	(Enclosed in separate MS Excel spreadsheet file)

Labor Rates			A-1

Universe of Respondents	A-2

Exhibit	 Page

1. New Exploration Sources Under EPA Authority (Respondents’ Burden)
Ex-1

2. New Alternative Energy Sources Under EPA Authority (Respondents’
Burden)	Ex-2

3. New Development/Production Sources Under EPA Authority
(Respondents’ Burden)	Ex-3

4. New Exploration Sources Under State/Local Authority (Respondents’
Burden)	Ex-4

5. New Alternative Energy Sources Under State/Local Authority
(Respondents’ Burden)	Ex-5

6. Existing Sources Under State/Local Authority (State/local Burden)
Ex-6

7. New Exploration Sources Under State/Local Authority (State/local
Burden)	Ex-5

8. New Alternative Energy Sources Under State/Local Authority
(State/local Burden)	Ex-8

9. Existing Sources Under State/Local Authority (State/local Burden)
Ex-9

10. New Exploration Sources Under EPA Authority (EPA’s Burden)	Ex-10

11. New Alternative Energy Sources under EPA Authority (EPA’s Burden)
Ex-11

12. New and Existing Development/Production Sources Under EPA Authority

      (EPA’s Burden) 		Ex-12

13. Consistency Updates and Overseeing State/Local Activities (EPA’s
Burden)	Ex-13

14. OCS Air Regulations Information Collection Burden	Ex-14

List of Acronyms and Abbreviations

ATC		Authority to Construct

BACT		Best Available Control Technology

BLS                Bureau of Labor

CAA		Clean Air Act as Amended in 1990

CFR		Code of Federal Regulations

COA		Corresponding Onshore Area

ECI		Employment Cost Index

EIS		Environmental Impact Statement

EPA		U.S. Environmental Protection Agency

ICR		Information Collection Request

LAER		Lowest Achievable Emission Rate

MMS		Mineral Management Service, Department of the Interior

NAAQS          National Ambient Air Quality Standards

NOA		Nearest Onshore Area

NOI		Notice of Intent

NSR                New Source Review

OCS                Outer Continental Shelf

OMB		Office of Management and Budget

O&M		Operating and Maintenance

PSD		Prevention of Significant Deterioration

SBCAPCD	Santa Barbara County Air Pollution Control District

SCAQMD	South Coast Air Quality Management District

SLOAPCD	San Luis Obispo County Pollution Control Division

VCAPCD        Ventura County Air Pollution Control District

IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	TITLE AND NUMBER OF THE INFORMATION COLLECTION

This information collection request (ICR) is entitled “Air Pollution
Regulations for Outer Continental Shelf (OCS) Activities: Reporting,
Recordkeeping, and Testing Requirements." Environmental Protection
Agency (EPA) number 1601.07, Office of Management and Budget (OMB)
number 2060-0249.

1(b)	CHARACTERIZATION OF THE INFORMATION COLLECTION

Section 328 (Air Pollution From Outer Continental Shelf Activities) of
the Clean Air Act (CAA) as amended in 1990, gives EPA responsibility for
regulating air pollution from OCS sources located offshore of the states
along the Pacific, Arctic, and Atlantic Coasts, and along the eastern
Gulf of Mexico coast (off the coast of Florida).  The U.S. Department of
Interior's Minerals Management Service (MMS) retained the responsibility
for regulating air pollution from sources located in the western Gulf of
Mexico.  To comply with the requirements of section 328 of the CAA, EPA,
on September 4, 1992 at 57 FR 40792, promulgated regulations to control
air pollution from OCS sources in order to attain and maintain federal
and state ambient air quality standards and to comply with the
provisions of part C of title I of the CAA.  Sources located within 25
miles of a state's seaward boundary must comply with the same
state/local air pollution control requirements as would be applicable if
the source were located in the corresponding onshore area (COA). Sources
located more than 25 miles from a state's seaward boundary (25 mile
limit) must comply with EPA air pollution control regulations.  The
regulations are codified as part 55 of chapter I of title 40 of the Code
of Federal Regulations (CFR).  On September 2, 1997, EPA made two
court-ordered revisions to the regulations.  The references for the
sections of the OCS regulations that pertain to the burden activities
addressed in this ICR are shown in Table 1.

This ICR addresses the information collection burden (i.e., hours and
costs) to industry respondents who are subject to the reporting,
recordkeeping, and testing requirements of the OCS air regulations.
Industry respondents include owners or operators of existing and new or
modified stationary sources.  This ICR also addresses the burden to the
agencies who are responsible for implementing and enforcing the OCS
regulations.  The EPA has delegated the authority to implement and
enforce the OCS regulations for sources located off the coast of
California to four local air pollution control agencies: Santa Barbara
County Air Pollution Control District (SBCAPCD); South Coast Air Quality
Management District (SCAQMD); Ventura County Air Pollution Control
District (VCAPCD); and San Luis Obispo County Air Pollution Control
District (SLOAPCD).  The EPA implements and enforces the regulations for
all other sources under its authority.  All burden estimates are
calculated for the 3-year period beginning February 1, 2009 and ending
January 31, 2012.

To be consistent with terminology used by the MMS, OCS sources
associated with the recovery of oil and gas resources are characterized
according to one of the following operational phases.  The first phase
consists of exploration activities, which are conducted from temporarily
placed vessels or structures.  Drilling of an exploration or delineation
well generally lasts 2 to 3 months, but can last up to 6 months.  The
second phase consists of the construction and installation of a
permanent production platform on the seabed and the associated "topside"
(above sea level) structures.  A typical construction phase lasts from 6
to 12 months.  The third phase consists of the development drilling of
wells, from which the oil and gas resources are extracted, and the
long-term operations and maintenance of the production facility over the
life of the field or structure.  A typical development/production phase
can last for over 30 years.  These three phases are referred to as
exploration, construction, and development/production, respectively,
throughout the remainder of this ICR.

In addition to oil and gas resource recovery projects, the potential
exists for alternative energy exploration projects.  The 2005 Energy
Policy Act gave MMS the responsibility of managing alternative energy
development on the OCS.  MMS is currently developing regulations to
implement an alternative energy program.  The development of offshore
wind energy involves the installation of wind turbine generators on
piles driven into the ocean bottom and the laying of power cables on the
ocean bottom.  Air emissions from a wind energy project would occur
primarily in the construction phase.  Primary emission sources would be
barges, cranes, pile drivers, transport vessels, and crew and supply
boats.  During the operation phase, there would be minor emissions from
routine inspection visits and occasional emissions from maintenance and
repair activities.  During the decommissioning, emissions would be
similar to those that would occur during construction.

Wave energy can be generated by a number of different types of
mechanical devices floating on the ocean surface and attached by
anchors.  Air emissions during installation would result from vessels
that deploy the devices and from a barge used to lay cable.  During
operation, the only emissions would be associated with occasional
service and maintenance vessel trips.  Another potential source of
energy is ocean currents.  Energy from ocean currents is harnessed from
turbines installed on the ocean bottom.  Emissions during installation
would result from a barge, transport vessels, and crew boats.

There is one wind farm that has been proposed and that will be going
though the air permitting process in the 2008-2009 timeframe.  In
addition, MMS projects a number of potential projects that involve
installation of meteorological towers by prospective developers for
assessing wind energy potential.  There is also the potential for
projects that involve deployment of equipment to assess wave energy
resources, energy from currents, and small pilot projects to test
feasibility of wave or current energy development.

The MMS receives development plans from the companies authorized to
conduct exploration and development of the OCS lease blocks.  From those
plans, the MMS estimates the following new OCS activities will occur in
the 2009 to 2012 timeframe:

Alaska Coast (EPA Region 10)

3 exploratory wells

1 development project

Pacific Coast (California/local agency)

4 alternative energy projects

Eastern Gulf (EPA Region IV)

25 exploratory wells

Atlantic (EPA Region I and Region IV))

1 alternative energy project undergoing environmental review

3 alternative energy projects

In addition to these new projects, there are 23 existing development
projects off the coast of southern California.  Four of these are
expected to obtain minor permit modifications in the next 3 years.

NEED FOR AND USE OF THE COLLECTION

2(a)	NEED/AUTHORITY FOR THE COLLECTION

The need and authority for this information collection is contained in
section 328 of the CAA and in EPA OCS Air Regulations, codified as title
40 CFR part 55.  Section 328 requires EPA to establish requirements to
control air pollution from OCS sources to attain and maintain federal
and state ambient air quality standards and to comply with the
provisions of part C of title I of the CAA.  The Administrator must
update the requirements as necessary to maintain consistency with
onshore regulations.  Each requirement established under section 328 is
treated, for purposes of sections 113 (Federal Enforcement), 114
(Inspections, Monitoring, and Entry), 116 (Retention of State
Authority), 120 (Noncompliance Authority), and 304 (Citizen Suits) of
the CAA, as a standard under section 111 and a violation of any such
requirements will be considered a violation of section 111(e) of the
CAA.

In addition, 40 CFR 55.11 establishes the procedures for states and
local agencies to request and receive delegation of authority to
implement and enforce the regulations.  The requesting agency must
demonstrate that it has:

Adopted the appropriate portions of part 55 into state law,

Adequate authority under state law to implement and enforce the
requirements of part 55,

Adequate resources to implement and enforce the requirements of part 55,
and

Adequate administrative procedures to implement and enforce the
requirements of part 55.

2(b)	USE/USERS OF THE DATA

There are five types of reporting requirements for the industrial
respondent: notice of intent (NOI) to construct, preconstruction permit
application, compliance testing, operating permit application, and
recordkeeping and reporting tasks.

NOI to Construct

The owner or operator of proposed new or modified development/production
sources that are located within the 25-mile limit will be required to
prepare a NOI to construct.  The owner or operator must submit not more
than 18 months prior to submitting a permit application, a NOI to
construct to the EPA Administrator through the EPA Regional Office and
the air pollution control agency of the nearest onshore area (NOA) and
adjacent onshore areas.  The purposes of the NOI are to: (1) trigger an
EPA review of onshore regulations to determine if they are consistent
with the OCS regulations and, (2) to allow adequate time for onshore
areas, other than the NOA, to determine if they will petition EPA for
designation as the COA.  The COA is the NOA, unless the Administrator
determines that another area with more stringent requirements may be
impacted by the source. (See CAA section 328 (a) (4) (B))

Preconstruction Permit Applications

All major sources must comply with all applicable preconstruction permit
requirements including the need to submit an application for a
preconstruction review permit.  A separate application is required at
the exploration and development phases (if the second phase occurs).
The owner or operator of an OCS source is responsible for developing a
preconstruction permit application and collecting all relevant
information not otherwise available to the permit reviewing authority
that may be needed to complete the permit application.  The permit
reviewing authority reviews the application materials and determines if
the proposed source meets all the applicable requirements.  For example,
this includes any pollution control technology requirements that may be
required under the preconstruction review program in effect in that
location or under federal regulations promulgated under section 111.
For sources which will be constructed or modified in attainment areas,
the emissions controls required under the New Source Review (NSR)
program under title I of the Act must represent the best available
control technology (BACT) and must be shown not to violate the NAAQS,
the prevention of significant deterioration increments, or adversely
affect air quality related values in any Class I areas.  For sources
which will be constructed or modified in nonattainment areas the
emissions controls required by the Nonattainment NSR program must
represent the lowest achievable emission rate (LAER) and also
demonstrate emission reduction offsets.  In addition, EPA operates a
BACT/LAER Clearinghouse, which contains many BACT and LAER
determinations to aid sources and application reviewers in identifying
reasonable control technology proposals.  The BACT or LAER information
in each permit will be gathered and submitted for entry into the
BACT/LAER Clearinghouse data base as a reference for making future
control technology determinations.  Information on BACT and LAER
determinations is available to the public through the National Technical
Information Service and the EPA's Office of Air Quality Planning and
Standards' Technology Transfer Network.

Minor sources also must submit preconstruction permit applications.
However, emissions control technology such as BACT and LAER are not
typically required by these programs and much less detailed modeling is
required to show compliance with NAAQS, resulting in a much lower level
of effort to prepare such permit applications.

Compliance Testing

Within 6 months of the start of operations, each new or modified major
source is required to complete initial compliance tests to demonstrate
compliance with control equipment design and performance specifications
in its preconstruction permit.  In addition, annual compliance tests are
required for existing sources in California.

Operating Permit Application

A second type of permit which an owner or operator of a major source or
any other OCS source must obtain is the operating permit.  The source
must develop an operating permit application, which contains much of the
same information required in the preconstruction review permit
application with some differences.  The operating permit identifies the
specific applicable requirements of the CAA that apply to the source,
including those related to preconstruction review, any national emission
standards (such as National Emissions Standards for Hazardous Air
Pollutants or maximum achievable control technology) and any
implementation plan requirements that may apply, including those from
any state implementation plan in effect in the COA.  In addition to
these requirements, operating permits independently impose compliance
requirements, such as recordkeeping, reporting, and in limited cases,
monitoring requirements, in addition to those that may be required by
the underlying applicable requirements.

Recordkeeping and Reporting Tasks

Sources, in addition, are required to monitor emissions and operating
parameters to ensure compliance with operating requirements.  The
regulatory agencies will use the compliance test results and the
monitoring information to ensure compliance with the appropriate
regulations.  The emission data will also be used by the regulatory
agencies to model the air quality in the area and to evaluate control
strategies.  Records are generally required to be retained for 5 years,
consistent with the title V operating permitting requirements.

NONDUPLICATION, CONSULTATION, AND OTHER COLLECTION CRITERIA

3(a)	NONDUPLICATION

The information collection activities that will be required under the
OCS regulations are not routinely required elsewhere by EPA.  However,
similar information may be collected during the development of certain
environmental impact statements (EIS).  In such cases, regulations and
policies require that information collected for EIS and OCS programs be
coordinated to the maximum extent possible to minimize duplicating the
collection of data.  Some of the required information may also be
available from state or other federal agencies.  However, even when
these data are available, they are not generally adequate to address
completely the relevant requirements of the OCS regulations.

	Section 328 of the CAA requires the OCS sources within 25 miles of the
states' seaward boundaries to meet the same requirements as are
applicable in the COA.  This includes the permitting, monitoring,
recordkeeping and reporting requirements.  The OCS Air Regulations
require sources located beyond 25 miles from the states' seaward
boundaries to meet the requirements of the nationally promulgated
programs (e.g., prevention of significant deterioration (PSD), new
source performance standards programs, and title V operating permit
program) including the monitoring, recordkeeping and reporting
requirements of those programs.  The only additional information
collection requirement for sources is the need to file a NOI.  This
information is not available elsewhere in the Agency and is necessary to
identify the COA and to ensure that the regulatory requirements are
updated.

3(b) 	PUBLIC NOTICE REQUIRED PRIOR TO ICR SUBMISSION TO OMB

On April 29, 2008 (73 FR 23249), EPA published a notice announcing its
intention to submit this ICR to the OMB and the availability of the
draft supporting statement.  The comment period ended on June 30, 2008
and no comments were received.

3(c)	CONSULTATIONS

In developing this ICR renewal, EPA worked closely with Mr. Dirk
Herkhof, who is a meteorologist with the Minerals Management Service
(MMS) in Washington, D.C.  The MMS is the lead agency for the OCS
program, and Mr. Herkhof oversees all air quality issues for OCS.  Mr.
Herkhof was closely involved in developing the estimate of the number
and types of sources expected to occur during the ICR clearance period.
He also reviewed the supporting statement for accuracy and relevance,
and EPA has addressed his comments in this package.

Mr. Herkhof works with the EPA Regional Offices who are responsible for
reviewing and developing air permits for new and existing OCS projects.
Over time, relatively few Regions (9 and 10) have been active in
traditional oil and gas projects off the coast of California and Alaska.
 These projects typically involve relatively few sources and State
and/or local jurisdictions.  In the case of California, all of the
projects are existing sources, and all of the affected parties have
several years of experience in implementing the program.  Mr. Herkhof is
not aware of any issues on these projects that would affect the
assumptions we are making today in this ICR regarding the number and
types of sources and the burden associated with complying with the air
rules.

EPA does recognize in this ICR that alternative energy projects
represent a new area of activity in the OCS program.  The Cape Wind wind
farm project off the coast of Massachusetts is the furthest along, but
the source is still in the process of preparing a permit application.
As far as we can tell, this project has proceeded as anticipated and
will most likely emerge with a minor source permit because of the
estimated low level of operational air emissions.  At Cape Fear and
other potential alternative energy projects, conformity issues
associated with indirect impacts from vessels are the real concern,
which is not the result of the rules underlying this ICR.  The other
types of alternative energy projects under consideration at this time
are meteorological towers, which will not likely even trigger a 40 CFR
part 55 review because of the lack of source emissions during operation.
 In the future, should these projects reach the development stage, or
new areas become subject to OCS air regulations, we would assess whether
our underlying assumptions are still valid, but at this point we believe
they are.

3(d)	EFFECTS OF LESS FREQUENT COLLECTION

The information required to be submitted by each preconstruction permit
applicant will be submitted on a one-time-only basis.  When an existing
OCS source wishes to modify or expand a facility already in operation,
most of the information submitted will pertain to the new construction.
New development/production sources and platforms are expected to obtain
an operating permit approximately 1 year after the source commences
operation.  For this ICR we are projecting one new development project
off the coast of Alaska and one alternative energy project, both of
which are subject to EPA authority.  We assume that both of these
sources will obtain their operating permits during the 3-year ICR
clearance period.  For the existing development/production sources
assumed to be under the regulatory authority of local agencies, it was
projected that each source would renew its operating permit during the
3-year time period covered by this ICR to comply with local agency
regulations.  These sources are also subject to compliance testing,
recordkeeping, and reporting requirements to demonstrate compliance with
their applicable requirements.  Less frequent collection of information
than that required by these requirements would jeopardize the ability of
regulatory agencies to evaluate a source's compliance with the OCS
regulations.

3(e)	GENERAL GUIDELINES

This ICR adheres to the guidelines stated in the 1995 Paperwork
Reduction Act, the OMB's implementing regulations, EPA's Information
Collection Request Handbook, and other applicable OMB guidance.

3(f)	CONFIDENTIALITY

Any information submitted to EPA for which a claim of confidentiality is
made will be safeguarded according to the EPA's policies set forth in
title 40, chapter 1, part 2, subpart B--Confidentiality of Business
Information (see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43
FR 39999, September 8, 1978; 43 FR 42251, September 28, 1978; 44 FR
17674, March 23, 1979).

3(g)	SENSITIVE QUESTIONS

No questions of a sensitive nature are included in any of the
information collection requirements.  Therefore, this section is not
applicable.

THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	RESPONDENTS/STANDARD INDUSTRIAL CLASSIFICATION (SIC) CODES

Section 328(a)(4)(C) of the CAA defines "OCS sources" as ". . . any
equipment, activity, or facility which:

Emits or has the potential to emit any air pollutant,

Is regulated or authorized under the Outer Continental Shelf Lands Act,
and

Is located on the Outer Continental Shelf or in or on waters above the
Outer        Continental Shelf.

Such activities include, but are not limited to, platform and drill ship
exploration, construction, development, production, processing, and
transportation.  Emissions from any vessel servicing or associated with
an OCS source, including emissions while at the OCS source or en route
to or from the OCS source within 25 miles of the OCS source, will be
considered direct emissions from the OCS source."

The SIC codes (with accompanying NAICS codes in brackets), for sources
which may be subject to the OCS regulations, include the following:

Major Group 13 [211] - Oil and Gas Extraction

SIC code 1311 [211111] - Crude petroleum and natural gas

SIC code 1321 [211112] - Natural gas liquids

SIC code 1382 [213112] - Oil and gas field exploration services

Major Group 44 [483] - Water Transportation

SIC code 4449 [483211] - Water transportation of freight, not elsewhere
classified

SIC code 4492 [48833] - Towing and tugboat services

Major Group 46 [486] - Pipelines, Except Natural Gas

SIC code 4612 [48611] - Crude petroleum pipelines

Major Group 49 [221] - Electric, Gas, and Sanitary Services

SIC code 4911 [221119] - Electric services (other electric power
generation)

SIC code 4922 [48621] - Natural gas transmissions

4(b)	INFORMATION REQUESTED

Since the OCS Air Regulations essentially extend the coverage of other
regulations, the data and information requirements associated with the
regulations will vary depending on the underlying regulations.  For
example, sources locating within a 25-mile limit off the coast of a
nonattainment area will generally have more stringent NSR regulations
than those locating off the coast of an attainment area.  The data and
information requirements will also vary depending on the size and type
of source.  The exploration sources are generally smaller sources and
not subject to the permit requirements of larger sources.

Based on the MMS projections, the following OCS facilities were assumed
for the purposes of this ICR:

Sources under EPA authority

Existing development/production sources	0

New exploratory wells within 25-mile limit	3

New exploratory wells beyond 25-mile limit	25

New alternative energy projects	4

New development/production sources						1

Sources under the authority of the state/local agencies

Existing development/production sources 	23

New alternative energy projects	4

One of the alternative energy projects under EPA authority is expected
to result in a major source permit.  The remaining three alternative
energy projects are minor permitting efforts.  In general, minor sources
will be required to obtain a minor new source review permit and a minor
source operating permit.  Of the 25 exploratory wells, we have assumed
that half will require minor source permits and half will require major
source permits.  A single exploration vessel may be used to drill
multiple exploratory wells or service alternative energy exploration
sites.  For this ICR, we have assumed that seven exploration vessels
would be required to obtain operating permits to conduct these
activities.

(i)	Data Items(i) Data Items

NOI to Construct

New or modified sources will have to prepare and submit a NOI to
construct not more than 18 months before submitting a permit
application.  The data and information requirements which a source must
include in a NOI to construct must include the following minimum
information:

General company information, including company name and address, owner's
name and agent, and facility site contact.

Facility description in terms of the process and products, including
identification by SIC code.

Estimate of the proposed project's potential emissions of any air
pollutant, expressed in total tons per year and in such other terms as
may be necessary to determine the applicability of requirements of
section 55.4 of the regulation.  Potential emissions for the project
must include all vessel emissions associated with the proposed project
in accordance with the definition of potential emissions in section 55.2
of the regulation.

Description of all emission points including associated vessels.

Estimate of quantity and type of fuels and raw materials to be used.

Description of proposed air pollution control equipment.

Proposed limitations on source operations or any work practice standards
affecting emissions.

Other information affecting emissions, including where applicable,
information related to stack parameters (including height, diameter, and
plume temperature), flow rates, and equipment and facility dimensions.

Such other information as may be necessary to determine the
applicability of onshore requirements.

Such other information as may be necessary to determine the source's
impact in onshore areas.  Exploration sources are exempt from this
requirement.

In the past, owners or operators of new sources have had to include
these data items in parts C and D preconstruction permit applications.
Therefore, collection of these data items for a NOI to construct is not
considered an additional burden over the data items presently required
in preconstruction permit applications.

Preconstruction Permit Applications

All new or modified major sources are required to prepare and submit a
preconstruction permit application.  Table 2 summarizes the data and
information requirements which must be included in all part C PSD
preconstruction permit applications.

Table 2 also shows the references for the data and information
requirements specified in the CAA and the current regulations specified
in the CFR.  The first CFR reference shown for each requirement in Table
2 pertains to the requirements under part 51 which govern the way states
implement part C programs.  The second CFR reference (shown in brackets)
pertains to the requirements under part 52 that govern the way EPA
implements part C programs when states fail to implement part C
programs.

Table 3 summarizes the data and information requirements that must be
included in all part D construction permit applications.  Table 3 also
shows the references for the data and information requirements specified
in the CAA and the current regulations specified in the CFR.

Compliance Testing

This projection includes a new development/production platform off of
the coast of Alaska.  This source will be required to conduct an initial
emissions test.  However, we do not believe that emissions tests will be
required at the four alternative energy projects.  While these projects
will generate air emissions due to vessels that must be used to
construct the projects and then repair and maintain them, the projects
themselves would generate air emissions of much lower magnitude and be
subject to fewer applicable requirements compared to mineral extraction
projects.

	Annual compliance tests are required for the 23 existing
development/production sources located within the 25-mile limit of
California.  The purpose of the annual testing requirements is to
demonstrate that each source is in compliance with its applicable
requirements related to emissions control.  For the purpose of this
analysis, it was assumed that these sources would be subject to 3 years
of annual compliance testing.

Operating Permits

For the purpose of this analysis, it was assumed that the new
development/production source and the one of the new alternative energy
project which will be under the EPA's regulatory authority will be
required to obtain title V operating permits before becoming fully
operational.  In addition, seven exploration vessels will be required to
obtain title V operating permits.  Operating permits typically contain
the following minimum information requirements:

Ownership and location of the source;

An inventory of the type and amount of emissions associated with each
piece of equipment used at the source;

Identification of emissions control techniques required by applicable
requirements for each piece of equipment; such techniques may include
process design or operational changes to equipment, add-on control
equipment, and inspection and maintenance procedures;

Identification of recordkeeping requirements, including those required
by applicable requirements (such as NSPS or SIP) and those required by
operating permits regulations (e.g., 6-month monitoring reports,
deviation reports, and annual compliance certification) to ensure that
control techniques and inspection and maintenance procedures are being
properly implemented;

Annual compliance testing requirements;

Reporting requirements for the periodic submittal of recordkeeping or
test data for review by the regulatory authority, whether required by
the applicable requirements or by the operating permit regulations.

All 23 existing sources are required to obtain operating permits.
Therefore, for this ICR, we will assume that all of the 23 existing
sources off the coast of Southern California will renew their existing
operating permits during the 3-year clearance period.  This effort will
include the estimated four sources that will also need to make minor
permit modifications to their operating permits over the next 3 years.

Recordkeeping and Reporting Tasks

The recordkeeping and reporting tasks will vary depending on the type of
source and the applicable requirements that apply.  For example,
exploration sources off the Santa Barbara coast must maintain a log book
and provide a copy of the book to the SBCAPCD when the exploration is
complete.  Development and production sources typically are required to
monitor certain emissions and operational parameters and submit annual
reports to the local districts.

(ii) Respondent Activities(ii) Respondent Activities tc \l3 "(ii)
Respondent Activities

NOI to Construct

The following items are a comprehensive list of the activities that the
owner or operator of a new development/ production OCS source will have
to perform to prepare and submit a NOI to construct:

Read applicable regulations to determine compliance requirements;

Inquire or meet with the appropriate permit reviewing authority to
obtain guidance on what data are needed to meet the applicable
requirements;

Prepare NOI to construct;

Submit the NOI to construct to the EPA Administrator through the EPA
Regional Office and to the air pollution control agency of the NOA and
adjacent onshore areas.

Preconstruction Permit Applications

	The following items are a comprehensive list of the activities that the
owner or operator of a new development/ production source will have to
perform to prepare a preconstruction permit application if the source is
subject to part C PSD regulations:

Read applicable regulations to determine compliance requirements;

Inquire or meet with the appropriate permit reviewing authority to
obtain guidance on what data are needed to assure compliance with the
applicable requirements;

Prepare BACT engineering analysis;

Perform air quality modeling;

Perform pre- and post-construction air quality monitoring (if not
already available);

Determine impacts on air quality related values in Federal Class I
areas;

Submit application to the U.S. Fish and Wildlife Service for endangered
species impact analysis;

Prepare and submit permit application;

Attend public hearing;

Revise permit application per comments received from the permit
reviewing authority and/or public comments.

For the purpose of this analysis, it was assumed that a permit
application for the development off the coast of Alaska and the
alternative Energy Project in the Atlantic would be submitted.  However,
the level of effort associated with performing the activities as shown
above will vary depending on the types and amounts of pollutants emitted
by the source, location of the source, and availability of existing
information such as air quality and modeling data.  For example, an
owner or operator will not have to perform dispersion modeling analyses
to determine impacts on air quality related values in a Federal Class I
area if the source's emissions will not impact a Federal Class I area.
In addition, an owner or operator will only have to perform monitoring
if requested by the permit reviewing authority.

Compliance Testing

For the purposes of this analysis, it was assumed that
development/production sources would use Reference Method 20 to test for
nitrogen oxide emissions from gas turbines.  For development/production
and exploration sources that have internal combustion engines, it was
assumed that the instrumental methods of Reference Methods 3A, 6C, and
7E using the electro-chemical cell methodology would be used to test for
nitrogen oxide, carbon monoxide, hydrocarbon, and sulfur dioxide
emissions.  The activities associated with completing compliance tests
are as follows:

Prepare a pretest plan and submit the plan to the appropriate permit
reviewing authority for review and approval at least 30 days before
conducting the tests;

Clean and calibrate test equipment for tests;

Perform tests;

Analyze samples, summarize data, and write report.

Operating Permits

In general, the activities that new or modified and existing sources
will have to perform to prepare an operating permit application include
the following:

Read applicable regulations to determine compliance requirements;

Inquire or meet with the appropriate permit reviewing authority to
obtain guidance on which data, compliance testing, and recordkeeping and
reporting activities are needed to assure compliance with the applicable
requirements;

Prepare and submit the permit application;

Attend public hearing, if one is conducted;

Revise permit application per comments received from the permit
reviewing authority and/or public comments.

Recordkeeping and Reporting Tasks

Once an owner or operator has obtained an operating permit, the owner or
operator will have to submit its log book for each well drilled to the
SBCAPCD (or other local agency) within 60 days after drilling has been
terminated.  The SBCAPCD's regulation requires the drilling contractor
to certify and submit a copy of the fuel log book records, or summary
thereof, showing the total amount of fuel used during the drilling of
each well.

Authority to implement and enforce the regulations for the existing
development/production sources has been delegated to the local air
pollution control districts.  Therefore, the existing
development/production sources are subject to annual reporting
requirements through their operating permits, as implemented by local
agencies.

THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION, METHODOLOGY
AND INFORMATION MANAGEMENT

5(a)	AGENCY ACTIVITIES

State and Local Agency Activities

Agencies delegated authority for the OCS program are responsible for
processing NOI's to construct, reviewing and acting on preconstruction
and operating permit applications, conducting enforcement activities
such as inspections, reviewing pretest plans and test reports, attending
tests (if desired by the agency), and reviewing reports that sources
must submit to comply with their operating permits.

Agencies responsible for processing NOI's to construct and
preconstruction and operating permit applications will typically perform
the following activities:

Answer respondent questions;

Log-in and review data submissions;

Request additional information for incomplete applications;

Analyze requests for confidentiality and provide appropriate protection;

Prepare completed applications for processing and approval;

Prepare notices of public hearings on permit applications for
publication in newspapers, arrange and attend public hearings, and
summarize and respond to public comments;

Submit information on BACT/LAER determinations to the EPA's BACT/LAER
Clearinghouse for entry into a data base.

EPA Activities

The EPA will perform reviews of new regulations adopted by state and
local COA's to determine if the regulations are applicable to OCS
sources.  If it is determined that a new onshore regulation is
applicable to OCS sources and EPA determines that the new regulation
does not conflict with federal law, then EPA will update the OCS
regulations by the incorporation of such regulation.  Such an update
will require formal notice in the Federal Register and opportunities for
public comment.

The EPA will consult with the MMS to prepare air quality impact analyses
for environmental impact statements for OCS leasing activities, and to
comply with the consultation process requirement of the Endangered
Species Act.  However, this consultation process is not expected to
increase EPA's burden associated with the OCS program.  Therefore, a
burden estimate was not calculated for this activity.

5(b)	 COLLECTION METHODOLOGY AND MANAGEMENT

It is the responsibility of each owner and operator of an OCS source
affected by the OCS regulations to prepare and submit a NOI to
construct, a preconstruction permit, and an operating permit application
to the permit reviewing authority.  The permit reviewing authority will
log in permit applications and store them in a central file at the
location of the permit reviewing authority.  Once preconstruction
permits have been approved, the permits will be submitted to EPA's
BACT/LAER Clearinghouse where control technology information will be
entered into a data base.  Because the preconstruction permits and
associated control technology determinations are performed on a
case-by-case basis, the OCS regulations will not contain forms which
owners or operators will have to fill out and submit to the permit
reviewing authority.

Qualified personnel that work for the permit reviewing authority will
perform permit reviews and check the quality of data submitted by the
applicant on a case-by-case basis.  The applicant will be required to
submit information on how the data were obtained (e.g., indicate whether
emissions data were obtained through the use of emissions factors or
test data) and how calculations were performed.  The permit reviewing
authority personnel will check data quality by reviewing test data and
checking engineering calculations, and by reviewing control technology
determinations for similar sources.  The BACT/LAER Clearinghouse data
base will be reviewed for information on control technology
determinations made for sources similar to the sources included in a
permit application.  Confidential information submitted by the applicant
will be handled by the permit reviewing authority's confidential
information handling procedures.  The public will be provided the
opportunity to review a permit application by obtaining a copy of the
application from the permit reviewing authority and by attending the
public hearing.

The OCS regulations do not require the request of information through
any type of survey.

5(c)	SMALL ENTITY FLEXIBILITY

This section is not applicable because the NOI to construct,
preconstruction and operating permit, annual compliance testing,
recordkeeping, and reporting requirements associated with the OCS
regulations do not directly affect small entities.

5(d)	COLLECTION SCHEDULE

Existing development/production sources are currently subject to the OCS
regulations, and authority to implement and enforce the regulations for
those sources has been delegated to the local air pollution control
districts.  Therefore, the existing development/production sources are
subject to annual reporting requirements through their applicable
requirements and/or operating permits required by local agencies.  It is
not known when the new exploration sources under EPA authority will
begin construction.  For the purpose of this analysis, it was assumed
that these sources would conduct activities throughout the time period
covered by this ICR.  For the new development/production sources under
EPA's regulatory authority, it was assumed that they would become
operational by January 2012.

ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a)	ESTIMATING RESPONDENT BURDEN AND COSTS

This section presents estimates of the burden to exploration and
development/production sources associated with the OCS regulations.  The
respondent burden estimates are based on the data items and respondent
activities described in section 4(b).

All costs are presented in 2007 dollars.  The cost estimates are based
on a respondent in-house wage rate of $29.88 per hour and contractor
wage rates of $44.68 per hour.  These rates are from the Table 2,
Employment Costs for Civilian Workers by Occupational and Industry Group
(in house based on “Construction, Extraction, Farming, Fishing and
Forestry,” and contractor based on “Professional and related”)
U.S. Department of Commerce, Bureau of Labor Statistics (BLS), December
2007.  The rates are from column 1, “Total compensation” and have
been increased by 110 percent to account for overhead.  The resultant
in-house rate is $63/hour and the contractor rate is $94/hour.  The wage
rates represent average rates for the various types of individuals
(e.g., managers, engineers, technicians, legal staff, and clerical)
required to complete the tasks and include direct personnel and overhead
costs.  The respondent's annual labor hours and costs for the 3-year
time period covered by this ICR are presented in exhibits 1 through 4.

According to the Paperwork Reduction Act, capital/start-up cost should
include among other items, preparations for collecting information such
as purchasing computers and software, monitoring, sampling, drilling,
and testing equipment.  As a practical matter, these costs are not
typical of the costs associated with preparing permit applications.
Therefore, the only O&M costs are those associated with scenarios
involving the purchase and/or use of capital equipment for monitoring at
new or existing development/production sources.

New Exploration Sources Under EPA Authority: Respondents' Burden
(Exhibit 1)

There are 25 projects estimated to occur greater than 25 miles off the
coast of Florida and 3 projects off the coast of Alaska.  However, for
the purposes of this ICR, it was assumed that all exploratory sources
under EPA authority would have the same burden for basic activities
including reading the regulations, preparing a NOI to construct, and
conducting some recordkeeping and reporting tasks.  We estimate that
half (12) of the sources off the coast of Florida will be major sources
and will have to prepare preconstruction permit applications to comply
with PSD requirements under part C of title I of the CAA.  The remaining
sources will be required to prepare and submit minor source
preconstruction permit applications.  See the discussion under Exhibit 3
for a summary of activities that are expected to occur.  We have assumed
that preparing a major source exploration permit application for sources
under Exhibit 1 is half of the burden of preparing a PSD application as
described in Exhibit 3.  We also assumed that preparing a minor source
exploration permit application under exhibit 1 is one-quarter the burden
of preparing a PSD application under Exhibit 3.  We assumed that seven
exploration vessels will be required to obtain an operating permit using
the same burden estimated for this activity under Exhibit 3.  It is
anticipated that the exploration sources will not have to install any
additional monitoring equipment to comply with the regulatory
requirements.  Therefore, there will be no capital cost or O&M cost for
these sources.

Exhibit 1 provides a breakdown of the burden and costs for these
activities.  For the estimated 9.3 responses, the average annual burden
for the respondents is estimated to be 3,054 hours and $252,873.  Since
the exploration vessels are expected to have all necessary monitoring
equipment to meet the OCS Air Regulations, no capital cost or O&M cost
is projected to be necessary.

New Alternative Energy Sources Under EPA Authority:  Respondents’
Burden (Exhibit 2)

There are four alternative energy projects projected to occur during
this ICR clearance period.  One is a major project undergoing
environmental review and permitting, and it is expected to be completed
sometime in 2009.  Three other projects are potential meteorological
towers and/or current energy pilot projects.  These are minor source
projects and might occur off the coasts of New Jersey, Delaware,
Georgia, or Florida.  For purposes of estimating burden, we have assumed
that these sources will be treated the same as new exploration sources
described above as Exhibit 1.  We have assumed to two exploration
vessels would be required to obtain title V operating permits to service
these projects.

Exhibit 2 provides a breakdown of the burden and costs for these
activities.  For the estimated 1.3 responses, the average annual burden
for the respondents is estimated to be 409 hours and $33,342.  Since the
support vessels are expected to have all necessary monitoring equipment
to meet the OCS Air Regulations, no capital cost or O&M cost is
projected to be necessary.

New Development/Production Sources Under EPA Authority: Respondents'
Burden (Exhibit 3)

Exhibit 3 provides a breakdown of the burden and cost to the respondents
for these activities.  There is one projected development project
expected to occur in the 3-year clearance period.  A new source is
expected to read the regulations, consult with EPA or the state/local
agencies, prepare a NOI to construct, prepare a PSD application, perform
a compliance test, submit an operating permit application and conduct
recordkeeping and reporting tasks.  Because of the expertise required to
prepare a preconstruction permit application and to conduct a compliance
emission test, the source would most likely use a contractor for these
operations.  Typical tasks which the contractor would perform in the
preparation of the preconstruction permit application include:

        Inquire or meet with the appropriate permit reviewing authority
to obtain guidance on what data are needed to meet the applicable
requirements;

        Prepare BACT engineering analysis;

        Perform air quality modeling;

        Perform preconstruction air quality monitoring (if not already
available);

Determine impacts on air quality related values in Federal Class I
areas;

Prepare a DRAFT permit application;

Attend public hearing;

Revise permit application per comments received from the permit
reviewing authority

            and/or public comments.

Typical tasks which the contractor would perform in conducting
compliance tests include:

Prepare a pretest plan and submit the plan to the appropriate permit
reviewing authority for review and approval at least 30 days before
conducting the tests;

Clean and calibrate test equipment for tests;

Perform tests;

Analyze samples, summarize data, and write report.

The contractors would be expected to bill the services on a hourly
basis.

Generally, development/production sources are required to monitor
process parameters, fuel consumption, exhaust gas flow rates and sulfur
concentrations in the gases.  When the OCS rules were adopted, existing
platforms had to install some additional gas flow and sulfur monitoring
equipment.  One platform reportedly had to install a complex monitoring
system, which cost almost $100,000.  In addition, the vessels servicing
the platforms also had to install fuel-monitoring meters, which cost
between $30,000 and $50,000 each.  However, in most cases new sources
under EPA authority are not expected to have to install additional
monitoring equipment beyond that which is required by the MMS.  Even if
the new sources have to install additional monitoring equipment, the
cost of installing that equipment on new facilities would be less than
the cost of retrofitting older units and it is anticipated that the
service vessels would be servicing more than one platform.

The capital cost for the monitoring equipment was estimated in 1998 to
be $25,000 per development/production source.  The Chemical Engineering
Plant Index for process instruments was used to update the cost to 2007
dollars.  Using the March 2008 estimates of December 2007 (preliminary)
index for process instruments compared to the final December 1998 index,
the updated capital cost value is $28,517 and that cost is paid for over
the 3-year clearance period.  We estimate that O&M costs associated with
this equipment is 5% of the total capital costs.

Exhibit 3 provides a breakdown of the burden and costs for these
activities.  For the estimated 0.3 responses, the average annual burden
for the respondents is estimated to be 565 hours and $48,464 for labor.
O&M costs per year are $475 and annual capital costs are $9,507.

New Exploration Sources Under State/Local Authority: Respondents' Burden
(Exhibit 4)

	There are no new exploration sources projected to be under state/local
authority, e.g., sources expected to be located within 25 miles of
Alaska's boundary and under the state's regulatory authority.  If there
were any sources, they would have to read the regulations, prepare NOIs
to construct and ATC permit applications to comply with the district
regulations.  In addition, the sources would have to conduct a
compliance test and recordkeeping and reporting tasks.  The sources
would be subject to preconstruction permit requirements for
nonattainment and attainment pollutants.  SBAPCD's section 3.a of Rule
205 contains the requirements for complying with part D of title I, and
section 3.b of Rule 205 contains the requirements for complying with
part C of title I of the CAA.  Because of the expertise required to
conduct a compliance emission test, the sources will most likely use a
contractor to conduct the tests

Typical tasks which the contractor will perform in conducting compliance
tests include:

Prepare a pretest plan and submit the plan to the appropriate permit
reviewing authority for review and approval at least 30 days before
conducting the tests;

Clean and calibrate test equipment for tests;

Perform tests;

Analyze samples, summarize data, and write report.

It is anticipated that the exploration sources would not have to install
any additional monitoring equipment to comply with the regulatory
requirements.  Therefore, there would be no capital cost or O&M cost for
these sources.

New Alternative Energy Sources Under State/Local Authority:
Respondents’ Burden (Exhibit 5)

We estimate that there are four new alternative energy sources involving
wave energy pilot projects or studies off the coast of Northern
California.  These minor sources would be subject to the same
requirements as described for Exhibit 4.

Exhibit 5 provides a breakdown of the burden and costs for these
activities.  For the estimated 1.3 responses, the average annual burden
for the respondents is estimated to be 1,323 hours and $114,245.  Since
the support vessels are expected to have all necessary monitoring
equipment to meet the OCS Air Regulations, no capital cost or O&M cost
is projected to be necessary.

Existing Sources Under State/Local Authority: Respondents' Burden
(Exhibit 6)

The existing 23 development/production sources off the southern
California coast are located within 25 miles of the state's seaward
boundary and EPA has delegated to the local districts the authority to
implement and enforce OCS Air Regulations for those sources.  These 23
existing sources are expected to prepare a title V operating permit
renewal application once during the 3-year period covered by this ICR,
perform annual compliance tests, and conduct recordkeeping and reporting
tasks.  We believe that four of these sources will also require minor
permit modifications; however this burden will be addressed under the
title V operating permit renewal burden.  Because of the expertise
required to conduct a compliance emission test, the sources will most
likely use a contractor to conduct the tests.

Typical tasks which the contractor will perform in conducting compliance
tests include:

Preparing a pretest plan and submit the plan to the appropriate permit
reviewing authority for review and approval at least 30 days before
conducting the tests;

Cleaning and calibrating test equipment for tests;

Performing tests; and

Analyzing samples, summarizing data, and writing report.

The existing development/production sources have already installed their
monitoring equipment; therefore, they are not expected to incur any
additional capital cost for new monitoring equipment.  We assume that
they will face the same O&M costs faced by new development sources (5%
of the capital cost of monitoring equipment), or $1,426 per source.
Exhibit 6 provides a breakdown of the burden and cost to the respondents
for these activities.  The average annual burden for the respondents is
estimated to be 21,666 hours and $1,835,791 plus $32,775 for O&M costs.

Total Industry Respondent Burden and Costs

Exhibit 14 summarizes the industry burden for the OCS Air Regulations.
The average annual industry respondent burden for the period February 1,
2009 through January 31, 2012 is estimated to be 27,017 hours and
$2,284,714 plus $33,250 for O&M costs and $9,506 capital costs.  As
discussed below, the total respondent burden also includes the burden on
the state and local air pollution control agencies that have been
delegated the implementation and enforcement authority for the
regulation.

6(b)	ESTIMATING STATE AND LOCAL AIR POLLUTION CONTROL AGENCY BURDEN AND
COSTS

This section presents estimates of the burden to state and local
agencies associated with the OCS Air Regulations.  The burden estimates
are based on the data items and respondent activities described in
section 4(a) of this ICR.

	All costs are presented in 2007 dollars.  A total compensation wage
rate of $37.73 per hour was based on state/local rates obtained from
"Employer Costs for Employee Compensation, Table 4: Employment Costs for
State and Local Government Workers" U.S. Dept. of Commerce, BLS,
December 2007.  110% overhead assumed.

Prepare Delegation Requests

EPA has delegated the authority to implement and enforce the OCS
regulations to four local air pollution control districts in California
(SBCAPCD, SCAQMD, VCAPCD, SLOCAPCD).  No additional delegation requests
are expected during the period February 1, 2009 to January 31, 2012.
The previous ICR noted that there were projects costs for consultations
with tribes.  At that time, there were potential new exploration sources
off the coast of Alaska and we would have expected heavy involvement by
one or more tribes for Beaufort Sea permitting actions with higher
travel costs and personnel commitments.  In order to avoid delays in
permitting, we estimated that the annual average burden for tribes
should be at least equivalent to the burden faced by the State of
Alaska.  If in the future, such sources are expected to locate off the
coast of Alaska, we would add this burden to the ICR.

New Exploration Sources Under State/Local Authority: S/L Burden
(Exhibit 7)

No new exploration sources under state/local authority are expected
during the 3-year period covered by this ICR.  If in the future, such
sources are located, the state/local agency would expend burden to
consult, review the NOI, review the permit application, oversee the
compliance test, conduct inspections and review data reports.  Exhibit 7
provides a breakdown of the cost to the local air pollution control
district for implementing and enforcing the OCS Air Regulations.

New Alternative Energy Sources Under State/Local Authority:  S/L Burden
(Exhibit 8)

There are four new alternative energy sources expected to take place off
the coast of Northern California.  These minor sources would be subject
to the same requirements as described for Exhibit 7.  Exhibit 8 provides
a breakdown of the burden and costs for these activities.  The average
annual burden for the state/local agencies is estimated to be 276 hours
and $20,700.

Existing Sources Under State/Local Authority: S/L Burden (Exhibit 9)

The 23 existing development/production sources are located within 25
miles of the state's seaward boundary off of southern California and are
under the authority of the local districts.  The sources are generally
required to conduct annual compliance tests and submit data reports to
the local districts.  In addition, the local district conducts quarterly
compliance inspections of the facilities.  It is assumed that these
sources will renew their operating permits during the time period
covered by this ICR to comply with local agency regulations.  Exhibit 9
provides a breakdown of the burden and cost to the local air pollution
control district for implementing and enforcing the OCS Air Regulations
for these sources.  The average annual burden for the local districts is
estimated to be 3,504 hours and $262,775.

Total State and Local Agency Burden and Costs

The average annual state/local burden to implement and enforce the OCS
Air Regulations for the period from February 1, 2009 to January 31, 2012
is estimated to be 3,780 hours and $283,475 and is shown in Exhibit 14.

Total Respondents Burden

The total respondent burden includes: 27,017 hours and $2,284,714, plus
$33,250 for O&M costs and $9,506 for capital costs for industry and
3,780 hours at a cost of $283,475 for state and local agencies.  This
gives a total of 30,797 hours at a cost of $2,568,189 and $33,250 for
O&M costs and $9,506 for capital costs per year as shown in Exhibit 14.

6(c)	ESTIMATING THE EPA BURDEN AND COSTS

This section presents estimates of the burden to EPA associated with the
OCS regulations.  The burden estimates are based on the data items and
respondent activities described in section 4(a) of this ICR.

All costs are presented in 2007 dollars.  The federal labor cost was
obtained from the U.S. Office of Personnel Management 2007 General
Schedule Table 2007-GS.  The hourly labor rate assumed is GS-12, Step 1
(Technical Labor).  The corresponding salary is loaded with benefits at
the rate of 60%.  This approach to determining the loaded labor rate is
consistent with the ICR Handbook, which states that salary is to be
multiplied by a 1.6 benefits multiplication factor.

Review Requests for Delegation of Authority

The EPA has delegated the authority to implement and enforce the OCS
regulations to four local air pollution control districts in California
(SBCAPCD, SCAQMD, VCAPCD, SLOCAPCD).  No additional delegation requests
are expected during the period May 1, 2005 to April 30, 2008.
Therefore, there is no burden associated with the processing of
delegation requests for the 3-year time period covered by this ICR.

New Exploration Sources Under EPA Authority: EPA Burden (Exhibit 10)

The 28 new exploration sources which will be under the regulatory
authority of EPA will be required to prepare and submit NOI to construct
before they begin operation and submit data reports to EPA.  Exhibit 10
provides a breakdown of the burden and cost to EPA for implementing and
enforcing the OCS Air Regulations for these sources in areas where EPA
has not delegated its authority to a state or local air pollution
control district.  The average annual burden is estimated to be 448
hours and $19,264.

New Alternative Energy Sources Under EPA Authority:  EPA Burden (Exhibit
11)

	There are four new alternative energy sources anticipated to occur
during the 3-year clearance period.  We have assumed that EPA will face
the same burden as it would for new exploration sources, as described in
Exhibit 10, except that the major alternative energy project will
require review of a major PSD permit.  Exhibit 11 shows the average
annual burden to be 137 hours and $5,905.

New and Existing Development/Production Sources Under EPA Authority: EPA
Burden (Exhibit 12)

There is one new development/production source projected to occur under
EPA's authority.  EPA will conduct consultations, and review submittals
of NOIs to construct, submittals of a PSD application, performances of a
compliance tests, and recordkeeping and reporting tasks.  Exhibit 12
shows the average annual burden to be 161 hours at a cost of $9,288.

Consistency Updates of OCS Regulations and Overseeing State/Local
Activities: EPA Burden (Exhibit 13)

As required by section 55.12, Consistency Updates, EPA is required to
update the OSC rules as needed to maintain consistency with the
regulations of onshore areas in order to attain and maintain Federal and
State ambient standards and comply with part C of title I of the Act.
Where an OCS activity is occurring within 25 miles of a state seaward
boundary, consistency reviews will occur at least annually.  In
addition, consistency reviews will occur upon receipt of an NOI and when
a state or local agency submits a rule to EPA to be considered for
incorporation by reference in this part 55.

We assumed that the annual consistency reviews that are not triggered by
an NOI or regulatory review will be minimal efforts (4 hours/review)
related to the areas with OSC activity.  For this clearance period, we
anticipate that up to six states (Alaska, California, Delaware, Florida,
Georgia, and New Jersey) and the four California local agencies will
require annual reviews to confirm that the OCS continues to be
consistent with the existing on-shore regulations.  This will result in
up to 10 reviews per year.

We estimated the universe of NOI/regulatory reviews to be conducted in
the 3-year clearance period by considering the projects that are
projected in the next 3 years and whether the states currently have
onshore OCS regulations.  For states that currently have regulations, we
expect that most of the consistency reviews to be fairly minor efforts
(40 hours/review) related to evaluating the impact of changes.  However,
for states that do not currently have regulations or if the project that
triggers the NOI results in major changes to the onshore rules, the
consistency review will be a more significant effort (150 hours/review).
 We assume the following distribution of sources and levels of review:

Alaska Coast (EPA Region 10)

1 major review

3 minor reviews

Pacific Coast (California/local agency)

1 major review

3 minor reviews

Atlantic (EPA Region I and Region IV))

3 major reviews

Southern California (Local agency)

1 major review

3 minor reviews

There are no reviews needed for the Eastern Gulf sources, because these
sources are located outside of the 25-minle boundary.

Exhibit 13 provides a breakdown of the cost and burden to EPA to
implement and conduct the consistency updates and to oversee the
regulatory implementation in the districts where the authority has been
delegated.  The average annual burden for EPA is estimated to be 460
hours and $19,780.

Total EPA Burden and Costs

The average annual EPA burden to implement and enforce the OCS Air
Regulations for the period from February 1, 2009 through January 31,
2012 is estimated to be 1,206 hours and $54,237 and is presented in
Exhibit 14.

6(d)	REASONS FOR CHANGE IN BURDEN

The burden estimates for the OCS Air Regulations have been revised due
to two main factors:

The MMS has projected changes in the mix and type of sources projected
to occur in the upcoming clearance period.  Most notably, there is a
significant increase in the number of exploratory wells under EPA
authority and the addition of eight alternative energy projects.  In
contrast, the number of existing development/production wells under EPA
jurisdiction has been changed from 15 to 0 in the upcoming period.

The estimates have been calculated using 2007 dollars and some
assumptions regarding overhead, O&M costs, and capital costs have been
adjusted to meet current guidelines and common procedures for preparing
ICRs.

Table 1

 Requirements References for Burden Activities

Associated with OCS Air Regulations

Applicable

Sections of OCS Air Regulations

Burden Activities

55.4

R  Requirements to Submit a Notice of Intent

55.5

C  Corresponding Onshore Area Designation

55.6

P   Permit Requirements

55.8

M Monitoring, Reporting, Inspections, and Compliance

55.9

E  Enforcement

55.11

D  Delegation

55.12

C  Consistency Updates

55.13

F  Federal Requirements that Apply to OCS Sources

                55.14

F  Federal, State, and Local Requirements that Apply to OCS Sources
Located Within 25 Miles of States' Seaward Boundaries, by State

Table 2

Respondent Data and Information Requirements for

     Preparing PSD Construction Permits

Requirements

Current Regulation Reference 40 CFR

CAA Reference

Description of the nature, location, design capacity, and typical
operating schedule

51.166(n)(2)(i) [52.21(n)(1)(i)]

110(a)(2)(A)

Detailed schedule for construction

51.166(n)(2)(ii)

[52.21(n)(1)(ii)]

110(a)(2)(A)

Description of continuous emission reduction system, emission estimates,
and other information needed to determine that BACT is used

51.166(n)(2)(iii) [52.21(n)(1)(iii)]

165(a)(4)

Air quality impact, meteorological, and topographical data

51.166(n)(3)(i) [52.21(n)(2)(i)]

165(a)(3)

Nature and extent of general commercial, residential, industrial, and
other growth in area of source

51.166(n)(3)(ii) [52.21(n)(2)(ii)]

165(a)(6)

Use of air quality models to demonstrate compliance with NAAQS

51.166(k)&(l)

[52.21(k)&(l)]

165(a)(3)&(e)(3)(D)

Information necessary to determine adverse impacts on any air quality
related values (including visibility) for Federal Class I areas

51.166(o)

[52.21(o)]

51.166(p)(4)

[52.21(p)(5)]

165(a)(5)

165(d)(2)(C)(iii)& (iv)

Air quality monitoring data

51.166(m)(1)(b) [52.21(m)(1)(b)]

165(a)(7)

110(a)(2)(B)&(F)

Impairment of visibility, soils, and vegetation

51.166(o)(1) [52.21(o)(1)]

165(e)(3)

Air quality impact resulting from general commercial, residential,
industrial, and other growth associated with source

51.166(o)(2) [52.21(o)(2)]

165(e)(3)

Written notice of proposed relocation of portable source

51.166(i)(4)(iii)(d) [52.21(i)(4)(viii)]

301

Description of the location, design construction, and operation of
building, structure, facility, or installation

51.160(c)(2)

110(a)(2)(A)

Description of the nature and amounts of emissions to be emitted

51.160(c)(1)

110(a)(2)(F)(ii)

Description of the air quality data and dispersion or other air quality
modeling used

51.160(f)

110(a)(2)(B)&(K)

Sufficient information to ensure attainment and maintenance of NAAQS

51.160(c)-(e)

51.161

51.162

51.163

110(a)(2)(A)

Table 3

Respondent Data and Information Requirements for Preparing

Part D Construction Permits

Requirements

Regulation Reference

40 CFR

CAA Reference

Documentation that LAER is being applied

51.165(a)(2)

173(2)

Documentation that all sources owned or operated by same person are in
compliance

51.165(a)(2)

173(3)

Documentation that sufficient emissions reductions are occurring to
ensure reasonable further progress (RFP)

51.165(a)(2)

173(1)

Documentation that benefits of proposed source significantly outweigh
the environmental and social costs imposed as a result of its location,
construction, or modification

   - - -

173(a)(5)

Description of the location, design construction, and operation of
building, structure, facility, or installation

51.160(c)(2)

110(a)(2)(A)

Description of the nature and amounts of emissions to be emitted

51.160(c)(1)

110(a)(2)(F)(ii)

Description of the air quality data and dispersion or other air quality
modeling used

51.160(f)

110(a)(2)(B)&(K)

Sufficient information to ensure attainment and maintenance of NAAQS

51.160(c)-(e)

51.161

51.162

51.163

110(a)(2)(A)

172(c)(6)

Part C of title I of the CAA specifies requirements for the prevention
of significant deterioration of air quality in areas where the air
quality is better than the national ambient air quality standards
(NAAQS) for criteria pollutants.  Sources which will be located within
25 miles of the State seaward boundary, and for which the corresponding
onshore area is designated as nonattainment for one or more criteria
pollutants, will have to comply with part D (Plan Requirements For
Nonattainment Areas) of title I of the CAA. ADVANCE \d12

Section 328 of the 1990 CAA defines "corresponding onshore area," with
respect to any OCS source, as the onshore attainment or nonattainment
area that is closest to the source, unless the EPA Administrator
determines that another area, with more stringent requirements with
respect to the control and abatement of air pollution, may reasonably be
expected to be affected by such emissions. ADVANCE \d12

E-mail communications from Dirk Herkhof, Minerals Management Service,
Department of Interior, to Beth Friedman, EC/R, Inc. on April 21, 2008
and May 12, 2008.   ADVANCE \d12

   The federal regulations that implement the title V operating permit
requirements (40 CFR part 70 and 40 CFR part 71) define “applicable
requirement” as all substantive requirements originating from
non-title V, federal air quality standards and other similar
requirements, including implementation plans, under various titles of
the Act.  The title V regulations impose certain monitoring,
recordkeeping and reporting requirements independently, but they are not
“applicable requirements.”

 Although not applicable to sources covered by this ICR, the there are
California District regulations that would apply to new sources that
would be under the jurisdiction of the delegated Districts.  For
example, SBCAPCD's Rule 201 (Permits Required) requires the owner or
operator of a new OCS source to obtain an ATC permit before the owner or
operator can begin construction of the source.  In addition, the
SBCAPCD's Rule 205 (Standards for Granting Applications) specifies the
requirements that the owner or operator of a new source must meet before
the SBCAPCD will issue an ATC permit.  See the supporting statement
1601.06 for example text.

 Under operating permit programs, sources are required to submit permit
applications for initial permit issuance, for permit revisions (as
needed), and for permit renewals every 5 years.  After permit issuance,
sources are required to report deviations from permit requirements,
report summaries of monitoring every six months, perform an annual
compliance certification, and annually pay fees.  In some cases,
sources are required to develop gap-filling monitoring and/or
recordkeeping to serve as monitoring and operate that
monitoring/recordkeeping to help them meet the compliance certification
requirement.

 Estimates of burdens and costs for various types of sources subject to
operating permit programs have been approved separately by OMB.  40 CFR
part 70 is generally implemented by State, local, or Tribal permitting
authorities, while 40 CFR part 71 is implemented in cases where EPA is
required to issue permits (e.g., in areas of sole Federal
jurisdiction).  Specifically, section 71.4(d) provides for the
permitting of OCS sources and the ICR for Part 71 discusses such
permitting.  See Information Collection Request for Part 71 Federal
Operating Permit Regulations, EPA #1713.06, April 2007.

Based on a 2002 telephone conversation with Craig Strommen, Chief
Inspector for the SBCAPCD. ADVANCE \d12

Based on a 2002 telephone conversation with Marianne Strange, M. Strange
and Associates. ADVANCE \d12

  PAGE   \* MERGEFORMAT  i

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29


[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Notices]
[Page 54227]
[FR Doc No: 2022-19032]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4663-DR; Docket ID FEMA-2022-0001]

Kentucky; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Commonwealth of Kentucky (FEMA-4663-DR), dated July
29, 2022, and related determinations.

DATES: The declaration was issued July 29, 2022.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 29, 2022, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the
Commonwealth of Kentucky resulting from severe storms, flooding,
landslides, and mudslides beginning on July 26, 2022, and
continuing, is of sufficient severity and magnitude to warrant a
major disaster declaration under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''). Therefore, I declare that such a major disaster
exists in the Commonwealth of Kentucky.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program in the designated
areas, Hazard Mitigation throughout the Commonwealth, and any other
forms of assistance under the Stafford Act that you deem appropriate
subject to completion of Preliminary Damage Assessments (PDAs).
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Brett H. Howard, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the Commonwealth of Kentucky have been
designated as adversely affected by this major disaster:

    Breathitt, Clay, Floyd, Johnson, Knott, Leslie, Letcher,
Magoffin, Martin, Owsley, Perry, Pike, and Wolfe Counties for
emergency protective measures (Category B), including direct federal
assistance, under the Public Assistance program.
    All areas within the Commonwealth of Kentucky are eligible for
assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-19032 Filed 9-1-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 73 (Tuesday, April 16, 2019)]
[Notices]
[Pages 15621-15623]
[FR Doc No: 2019-07468]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4839]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Registering With the Center
for Veterinary Medicine's Electronic Submission System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the Center for Veterinary Medicine (CVM) Guidance for
Industry (GFI) #108 entitled ``Registering with CVM's Electronic
Submission System.''

DATES: Submit either electronic or written comments on the collection
of information by June 17, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 17, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 17, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

do not wish to be made available to the public, submit the comment as a
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-4839 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry on
Registering with the Center for Veterinary Medicine's Electronic
Submission System.'' 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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Registering With the Center for Veterinary
Medicine's Electronic Submission System--21 CFR 11.2

OMB Control Number 0910-0454--Extension

    FDA's Electronic Records; Electronic Signatures regulation (21 CFR
part 11) requires that we identify in the Electronic Submission Docket
(Docket No. FDA-1992-S-0039) the types of documents or parts of
documents acceptable for official electronic submission. FDA's CVM has
placed notifications in that docket identifying documents acceptable
for electronic submission to the Center, as required by 21 CFR 11.2.
CVM's ability to receive and process information submitted
electronically is limited by its current information technology
capabilities and the requirements of FDA's Electronic Records;
Electronic Signatures regulation.
    The FDA Electronic Submissions Gateway (ESG) is an Agency-wide
solution for accepting electronic regulatory submissions. The FDA ESG
enables the secure submission of premarket and postmarket regulatory
information for review. The FDA ESG is the central transmission point
for sending information electronically to FDA. Within that context, the
FDA ESG is a conduit along which submissions travel to reach the proper
FDA Center or Office. CVM's Electronic Submission System (ESS) is a
Center-wide solution for accepting electronic regulatory submissions.
The CVM ESS is used to accept electronic submissions for animal and
veterinary products.
    Our guidance entitled ``Guidance for Industry (GFI) #108:
Registering with the Center for Veterinary Medicine's Electronic
Submission System'' outlines general standards to be used for the
submission of any electronic information to CVM using the FDA ESG,
including how to register with the CVM ESS using Form FDA 3538,
Electronic Submission System Participant Management Form.
    The reporting associated with new animal drug applications and
related submissions is necessary to ensure that new animal drugs are in
compliance with section 512(b)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(b)(1)). We use the information collected
to review the data, labeling and manufacturing controls and procedures
to evaluate the safety and effectiveness of the proposed new animal
drug. The reporting associated with new animal drug applications is
approved under OMB control number 0910-0032. Respondents use GFI #108

and Form FDA 3538 to facilitate the electronic submission of such
information. We use the information collected with Form FDA 3538 to
register respondents to use the CVM ESS.
    Description of Respondents: The respondents are sponsors of new
animal drug applications.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
         21 CFR section                  FDA Form No.            Number of     responses per   Total annual       Average burden per        Total hours
                                                                respondents     respondent       responses             response
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.2............................  Form FDA 3538.............             179             1.3             233  .08 (5 minutes)...........              19
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimates on our experience with the submission of
electronic information using the CVM ESS and the number of electronic
registration or change requests received between January 1, 2018, and
November 30, 2018. Our estimated burden for the information collection
reflects an overall increase of 16 hours and a corresponding increase
of 195 responses. We attribute this adjustment to the reauthorizations
of both the Animal Drug User Fee Act and the Animal Generic Drug User
Fee Act, which require sponsors to submit information electronically to
the CVM's Office of New Animal Drug Evaluation. Because of this
requirement, sponsors are now registering to use the CVM ESS in greater
numbers than in previous years.

    Dated: April 10, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-07468 Filed 4-15-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Notices]
[Pages 21120-21121]
[FR Doc No: 2013-08253]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0121; FRL-9383-6]

Registration Review; Pesticide Dockets Opened for Review and
Comment and Other Docket Acts; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; correction.

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

SUMMARY: EPA issued a notice in the Federal Register of Wednesday,
March 27, 2013, concerning registration review, pesticide dockets
opened for review and comment, and other docket acts. This document is
being issued to correct a typographical error.

FOR FURTHER INFORMATION CONTACT: Margaret Hathaway, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    The Agency included in the notice a list of those who may be
potentially affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2013-0121, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. 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 (202)
566-1744, and the telephone number for the OPP

Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. What does this correction do?

    FR Doc. 2013-07076 published in the Federal Register of Wednesday,
March 27, 2013 (78 FR 18586) (FRL-9381-9) is corrected as follows:
    On page 18587, in the table entitled ``Registration Review Dockets
Opening,'' the docket number for Bromoxynil and esters (Case
2070), shown in the second column of the table, is corrected
to read ``EPA-HQ-OPP-2012-0896.''

List of Subjects

    Environmental protection; Pesticides and pests.

    Dated: April 2, 2013.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division Office of Pesticide
Programs.
[FR Doc. 2013-08253 Filed 4-8-13; 8:45 am]
BILLING CODE 6560-50-P