[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Notices]
[Pages 32124-32125]
[FR Doc No: 2012-13143]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0146]

Guidance for Industry on Irritable Bowel Syndrome--Clinical
Evaluation of Drugs for Treatment; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Irritable Bowel
Syndrome--Clinical Evaluation of Drugs for Treatment.'' This guidance
is intended to assist the pharmaceutical industry and investigators who
are developing drugs for the treatment of irritable bowel syndrome
(IBS), specifically the IBS indications for IBS with diarrhea (IBS-D)
and IBS with constipation (IBS-C). The guidance describes the evolution
of patient-reported outcome (PRO) measures as primary endpoints for IBS
clinical trials, and sets forth provisional endpoints and trial design
recommendations that sponsors may apply to IBS clinical trials as PRO
measurements continue to evolve. The guidance also discusses the future
development of IBS PRO instruments. This guidance finalizes the draft
guidance published in March 2010.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ruyi He, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5122, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Drugs for
Treatment.'' This guidance is intended to assist the pharmaceutical
industry and investigators who are developing drugs for the treatment
of IBS. This guidance applies to the IBS indications for IBS-D and IBS-
C.
    A well-defined and reliable PRO instrument that measures the
clinically important signs and symptoms associated with each IBS
subtype would be the ideal primary efficacy assessment tool in clinical
trials used to support labeling claims, but at this time such an
instrument is not available. We recognize that it will take some time
to develop adequate instruments and that in the meantime there is a
great need to develop effective therapies for patients with IBS.
Therefore, until the appropriate PRO instruments have been developed,
sponsors should consider the provisional endpoints and trial design
recommendations set forth in the guidance.
    This guidance was published as a draft guidance in March 2010.
Changes made to the guidance took into consideration written and verbal
comments received. In addition to editorial changes primarily for
clarification, the major changes are as follows:
     The section on trial design was modified by adding a
randomized withdrawal design to address the need for maintenance
treatment to prevent sign or symptom recurrence.
     The section on trial endpoints was modified to note that a
drug can be specifically developed to treat only one of two major signs
or symptoms of IBS (abnormal defecation or abdominal pain).
Demonstration of significant and clinically meaningful changes in the
targeted single endpoint could serve as a basis for approval, as long
as the other important symptom or sign has not worsened on treatment.
     Trial entry criteria for IBS-D were modified to allow more
IBS-D patients to participate in IBS clinical trials, and the
definition of a responder to treatments for IBS-D was modified
accordingly.
     Definitions of a responder for abdominal pain alone,
constipation, and diarrhea were added.

     The use of a daily responder analysis for IBS-D as a
primary analysis was included.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on the clinical evaluation of drugs for the
treatment of IBS. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: May 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13143 Filed 5-30-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)]
[Notices]
[Pages 23714-23715]
[FR Doc No: 2017-10621]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2016-0136]

Pipeline Safety: Meeting of the Gas Pipeline Advisory Committee

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of advisory committee meeting.

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SUMMARY: This notice announces a public meeting of the Technical
Pipeline Safety Standards Committee, also known as the Gas Pipeline
Advisory Committee (GPAC). The GPAC will meet to continue discussing
topics and provisions for the proposed rule titled ``Safety of Gas
Transmission and Gathering Pipelines.''

DATES: The committee will meet from 8:30 a.m. to 5 p.m. on both
Tuesday, June 6, 2017, and Wednesday, June 7, 2017.

ADDRESSES: The meeting will be held at the Westin Arlington Gateway,
801 North Glebe Road, Arlington, VA 22203. The meeting agenda, and any
additional information will be published on the following pipeline
advisory committee meeting and registration page: https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=123.
    The meetings will not be webcast; however, presentations will be
available on the meeting Web site and posted on the E-Gov Web site,
http://www.regulations.gov, under docket number PHMSA-2016-0136 within
30 days following the meeting.

Public Participation

    This meeting will be open to the public. Members of the public who
wish to attend in person are asked to register at the meeting links
above no later than Friday, June 2, 2017 in order to facilitate entry
and guarantee seating. Members of the public who attend in person will
also be provided an opportunity to make a statement during the meeting.
    Written comments: Persons who wish to submit written comments on
the meeting may submit them to the docket in the following ways:
    E-Gov Web site: http://www.regulations.gov. This site allows the
public to enter comments on any Federal Register notice issued by any
agency.
    Fax: 1-202-493-2251.
    Mail: Docket Management Facility; U.S. Department of Transportation
(DOT), 1200 New Jersey Avenue SE., West Building, Room W12-140,
Washington, DC 20590-0001.
    Hand Delivery: Room W12-140 on the ground level of the DOT West
Building, 1200 New Jersey Avenue SE., Washington, DC, between 9:00 a.m.
and 5:00 p.m., Monday through Friday, except on Federal holidays.
    Instructions: Identify the docket number PHMSA-2016-0136 at the
beginning of your comments. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Anyone can search the electronic form of
all comments received into any of our dockets by the name of the
individual submitting the comment (or signing the comment, if submitted
on behalf of an association, business, labor union, etc.). Therefore,
consider reviewing DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477), or view the Privacy
Notice at http://www.regulations.gov before submitting any such
comments.
    Docket: For access to the docket or to read background documents or
comments, go to http://www.regulations.gov at any time or to Room W12-
140 on the ground level of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC, between 9:00 a.m. and 5:00 p.m., Monday
through Friday, except Federal holidays.
    If you wish to receive confirmation of receipt of your written
comments, please include a self-addressed, stamped postcard with the
following statement: ``Comments on PHMSA-2016-0136.'' The docket clerk
will date stamp the postcard prior to returning it to you via the U.S.
mail.

Privacy Act Statement

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

    Services for Individuals with Disabilities: The public meeting will
be physically accessible to people with disabilities. Individuals
requiring accommodations, such as sign language interpretation or other
ancillary aids, are asked to notify Cheryl Whetsel at
<EMAIL_ADDRESS>by Friday, June 2, 2017.

FOR FURTHER INFORMATION CONTACT: For information about the meeting,
contact Cheryl Whetsel by phone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Meeting Details and Agenda

    The GPAC will be considering the proposed rule titled, ``Safety of
Gas Transmission and Gathering Pipelines,'' which was published in the
Federal Register on April 8, 2016, (81 FR 20722) and on the associated
regulatory analysis. In the proposed rule, PHMSA is proposing the
following changes to Part 192:
     Require periodic assessments of pipelines in locations
where persons are expected to be at risk that are not already covered
under the integrity management program requirements.
     Modify the repair criteria, both inside and outside of
high consequence areas (HCAs).
     Require inspections of pipelines in areas affected by
extreme weather, man-made and natural disasters, and other similar
events.
     Provide additional specificity for in-line inspections,
including explicit requirements to account for uncertainty of reported
inspection data when evaluating in-line inspection data to identify
anomalies.
     Expand integrity assessment methods to explicitly address
guided wave ultrasonic inspection and excavation with direct in-situ
examination.
     Provide clearer functional requirements for conducting
risk assessments for integrity management, including addressing seismic
risks.
     Expand the mandatory data collection and integration
requirements for integrity management, including data validation and
seismicity.
     Add requirements to address management of change.
     Repeal the use of API Recommended Practice 80 for
gathering lines.
     Apply Type B requirements along with emergency
requirements to newly regulated greater than 8-inch Type A gathering
lines in Class 1 locations (GAO Recommendation 14-667).
     Extend the reporting requirements to all gathering lines.
     Expand requirements for corrosion protection to specify
additional post-construction quality checks, and periodic operational
and maintenance checks to address coating integrity, cathodic
protection, and gas quality monitoring.
     Require operators to report maximum allowable operating
pressure exceedances.
     Require safety features on in-line inspection tool
launchers and receivers.
     Add certain types of roadways to the definition of
``identified sites'' (NTSB P-14-1).
     Address grandfathered pipe and pipe with inadequate
records.
    The GPAC meeting agenda will include a discussion on the following
topics as time permits:

--Corrosion control.
--Records.
--IM Clarifications.
--Strengthened assessment requirements.
--Assessments outside of HCAs.
--Repair criteria revisions.
--Material documentation.
--Integrity Verification Process for grandfathered segments.

    The agenda will be published on the PHMSA meeting page https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=123, once it is
finalized.

II. Committee Background

    The GPAC is a statutorily mandated advisory committee that advises
PHMSA on proposed gas pipeline safety standards and their associated
risk assessments. The committee is established in accordance with the
Federal Advisory Committee Act (5 U.S.C. App. 2, as amended) and 49
U.S.C. 60115. The committee consists of 15 members with membership
evenly divided among federal and state governments, the regulated
industry, and the general public. The committees advise PHMSA on the
technical feasibility, reasonableness, cost-effectiveness, and
practicability of each proposed pipeline safety standard.

    Issued in Washington, DC, on May 18, 2017, under authority
delegated in 49 CFR 1.97.
Alan K. Mayberry,
Associate Administrator for Pipeline Safety.
[FR Doc. 2017-10621 Filed 5-22-17; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Notices]
[Pages 76503-76505]
[FR Doc No: 2010-30804]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63416; File No. SR-BX-2010-083]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing of Proposed Rule Change Relating to The Price Improvement Period
To Permit an Initiating Participant To Designate a PIP Surrender
Quantity

December 2, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 24, 2010, NASDAQ OMX BX, Inc. (the ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the self-regulatory organization. The Commission is
publishing this notice to solicit comments on the proposed rule from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Chapter V, Section 18 (The Price
Improvement Period (``PIP'')) of the Rules of the Boston Options
Exchange Group, LLC (``BOX'') to permit an Options Participant
initiating a PIP to designate a PIP Surrender Quantity. The text of the
proposed rule change is available from the principal office of the
Exchange, on the Exchange's Web site at http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/Filings/, at the Commission's
Public Reference Room, and on the Commission's Web site at http://www.sec.gov/.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in Sections A, B, and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The proposed rule change will amend Chapter V, Section 18 (The
Price Improvement Period (``PIP'')) of the BOX Rules to permit an
Options Participant initiating a PIP (``Initiating Participant''), at
its option, to designate a lower amount for which it will retain
certain priority and trade allocation privileges upon the conclusion of
the PIP auction than the forty percent (40%) of the PIP Order to which
the Initiating Participant is entitled as set forth in Chapter V,
Sections 18(f)(i) and (f)(ii) of the BOX Rules. In certain instances,
Chapter V, Sections 18(f)(i) and (f)(ii) of the BOX Rules allow an
Initiating Participant to retain priority and trade allocation
privileges for 40% of the size of a PIP Order upon conclusion of the
PIP. This proposal will permit an Initiating Participant, when starting
a PIP, to submit the Primary Improvement Order to BOX with a
designation to identify the total size of the PIP Order that the
Initiating Participant is willing to ``surrender'' to other PIP
Participants (``PIP Surrender Quantity''), resulting in the Initiating
Participant potentially being allocated less than the forty percent
(40%) to which it may be entitled. For example, when an Initiating
Participant submits a PIP Order and a Primary Improvement Order for 100
contracts and a PIP Surrender Quantity of 70 contracts, the Initiating
Participant is designating that it is willing to surrender seventy
percent (70%) of the PIP Order to other PIP Participants. Therefore,
the Initiating Participant is only retaining priority to thirty percent
(30%) of the PIP Order,

rather than the forty percent (40%) it could have received. The Primary
Improvement Order shall yield priority to certain competing orders in
the circumstances set forth in Chapter V, Section 18(f)(iii) of the BOX
Rules.
    The proposed rule change will further provide that in no case shall
the Initiating Participant's use of the Surrender Quantity function
result in an allocation to the Initiating Participant that would be
greater than the maximum allowable allocation the Initiating
Participant would otherwise receive in accordance with the PIP
allocation procedures set forth in Chapter V, Section 18(f) of the BOX
Rules. The proposal specifies that the PIP Surrender Quantity shall not
be effective for an amount that is lesser than or equal to sixty
percent (60%) of the size of the PIP Order. In such a case, the forty
percent (40%) maximum allowable priority allocation to the Initiating
Participant would apply.
    Additionally, the proposed rule change will modify the BOX Trading
Host's trade allocation at the conclusion of the PIP to account for the
PIP Surrender Quantity. The proposal specifies that when the BOX
Trading Host determines the priority and trade allocation amounts for
the Initiating Participant upon the conclusion of the PIP auction, the
Trading Host will automatically adjust the trade allocations to the
other PIP Participants according to the priority set forth in Chapter
V, Section 18(e) of the BOX Rules, providing a total amount to the
other PIP Participants up to the PIP Surrender Quantity. The Primary
Improvement Order shall be allocated the remaining size of the PIP
Order, if any. If the aggregate size of other PIP Participants' contra
orders is not equal to or greater than the PIP Surrender Quantity, then
the remaining PIP Surrender Quantity shall be left unfilled and the
Primary Improvement Order shall be allocated the remaining size of the
PIP Order as set forth in Chapter V, Section 18(f) of the BOX Rules.
For example, an Initiating Participant submits a PIP Order and a
Primary Improvement Order for 100 contracts and a PIP Surrender
Quantity of 70 contracts. During the PIP auction only one Improvement
Order for 25 contracts is received. Even though the Initiating
Participant was willing to surrender 70 contracts to the other PIP
Participants, there is not enough competing size in this instance to
allocate 70 contracts to someone else. Therefore, the Primary
Improvement Order's requirement to completely fill the PIP Order takes
precedence, and the Initiating Participant is allocated the remaining
75 contracts.
    BOX will provide Options Participants with three (3) business days
notice, via Information Circular, about the implementation date of the
PIP Surrender Quantity prior to its implementation in the BOX trading
system.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\3\ in general, and Section
6(b)(5) of the Act,\4\ in particular. Specifically, the Exchange
believes the proposed rule change is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
for a free and open market and a national market system and, in
general, to protect investors and the public interest. In particular,
the Exchange believes that the proposed rule change will benefit
investors and Options Participants by allowing an Initiating
Participant the flexibility to designate a lower amount for which it
will retain certain priority and trade allocation privileges upon the
conclusion of the PIP auction than the forty percent (40%) of the PIP
Order to which the Initiating Participant is entitled, while providing
other PIP Participants increased trade allocations.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments Regarding the
Proposed Rule Change Received From Members, Participants or Others

    The Exchange has neither solicited nor received comments on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2010-083 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BX-2010-083. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Web site (http://www.sec.gov/rules/sro.shtml). Copies
of the submission, all subsequent amendments, all written statements
with respect to the proposed rule change that are filed with the
Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street, NE., Washington,
DC 20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of the Exchange. All comments received
will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make publicly available. All submissions
should refer to File Number SR-BX-

2010-083 and should be submitted on or before December 29, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
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    \5\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-30804 Filed 12-7-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 177 (Thursday, September 12, 2013)]
[Notices]
[Pages 56226-56227]
[FR Doc No: 2013-22220]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2013-0119; FRL 9532-6]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Motor Vehicle and Engine Compliance Program
Fees (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), Motor Vehicle and Engine
Compliance Program Fees (Renewal) (EPA ICR No.2080.05, OMB Control No.
2060-0545, to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.). This is a proposed extension of the ICR, which is currently
approved through September 30, 2013. Public comments were previously
requested via the Federal Register (78 FR 15010) on March 8, 2013
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An Agency
may not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments may be submitted on or before October 15,
2013.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2013-0019 to (1) EPA online using www.regulations.gov (our
preferred method), or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460, and (2) OMB via email to<EMAIL_ADDRESS>Address comments to OMB Desk Officer for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Lynn Sohacki, Compliance Division,
Office of Transportation and Air Quality, U.S. Environmental Protection
Agency, 2000 Traverwood, Ann Arbor, Michigan 48105; telephone number:
734-214-4851; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: As required by the Clean Air Act, EPA has regulations
establishing emission standards and other requirements for various
classes of vehicles, engines, and evaporative emissions. These
regulations require that compliance be demonstrated prior to EPA
granting a ``Certificate of Conformity.'' EPA charges fees for

administering this certification program. In 2004, the fees program was
expanded to include non-road categories of vehicles and engines, such
as several categories of marine engines, locomotives, non-road
recreational vehicles, and many non-road compression-ignition and
spark-ignition engines. In 2008, the fees program was further expanded
to include fees for certification of evaporative system components
(primarily fuel lines and fuel tanks). Manufacturers and importers of
covered vehicles, engines and components are required to pay the
applicable certification fees prior to their certification applications
being reviewed. Under section 208 of the Clean Air Act (42 U.S.C.
7542(c)) all information, other than trade secret processes or methods,
must be publicly available. Information about fee payments is treated
as confidential information prior to certification.
    Form Numbers: EPA Forms 3520-29.
    Respondents/affected entities: Manufacturers or importers of
passenger cars, motorcycles, light trucks, heavy duty truck engines,
non-road vehicles or engines, and evaporative emissions components
required to receive a certificate of conformity from EPA prior to
selling or introducing these products into commerce in the U.S.
    Respondent's obligation to respond: Required to obtain or retain a
benefit (40 CFR Part 1027)
    Estimated number of respondents: 583 (total).
    Frequency of response: Yearly and Occasionally.
    Total estimated burden: 1,513 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $112,873 (per year), which includes $24,623
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is increase of 306 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is due to an adjustment of the estimate
entirely due to the increased number of fee forms received from an
increased number of manufacturers.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2013-22220 Filed 9-11-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 21 (Tuesday, February 1, 2022)]
[Notices]
[Page 5474]
[FR Doc No: 2022-01997]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG22-47-000; EG01-301-000.
    Applicants: Geysers Power Company, LLC, Geysers Power Company, LLC.
    Description: Notice of Self-Recertification of Exempt Wholesale
Generator Status.
    Filed Date: 1/26/22.
    Accession Number: 20220126-5146.
    Comment Date: 5 p.m. ET 2/16/22.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER20-1214-002.
    Applicants: CHPE, LLC.
    Description: CHPE LLC submits Supplemental Information to the
December 9, 2021 Compliance Filing.
    Filed Date: 1/25/22.
    Accession Number: 20220125-5183.
    Comment Date: 5 p.m. ET 2/4/22.

    Docket Numbers: ER22-528-001.
    Applicants: Tucson Electric Power Company.
    Description: Tariff Amendment: Modification to Proposed Effective
Dates to be effective 2/16/2022.
    Filed Date: 1/26/22.
    Accession Number: 20220126-5100.
    Comment Date: 5 p.m. ET 2/16/22.

    Docket Numbers: ER22-864-000.
    Applicants: ConnectGen South Wrentham LLC.
    Description: ConnectGen South Wrentham LLC submits a Request for
Limited One-Time Prospective Waiver of Tariff Provisions with Expedited
Consideration.
    Filed Date: 1/20/22.
    Accession Number: 20220120-5184.
    Comment Date: 5 p.m. ET 2/10/22.

    Docket Numbers: ER22-886-000.
    Applicants: Sagebrush Line, LLC.
    Description: Compliance filing: Notice of Succession to be
effective 12/27/2021.
    Filed Date: 1/25/22.
    Accession Number: 20220125-5143.
    Comment Date: 5 p.m. ET 2/15/22.

    Docket Numbers: ER22-887-000.
    Applicants: Duke Energy Florida, LLC.
    Description: Sec.  205(d) Rate Filing: DEF--FPL Certificate of
Concurrence to be effective 1/25/2022.
    Filed Date: 1/25/22.
    Accession Number: 20220125-5148.
    Comment Date: 5 p.m. ET 2/15/22.

    Docket Numbers: ER22-888-000.
    Applicants: Energy Center Dover LLC.
    Description: Energy Center Dover LLC submits an Informational
Filing with Request for Limited One-Time Prospective Waiver of Tariff
Provisions and Expedited Consideration.
    Filed Date: 1/21/22.
    Accession Number: 20220121-5220.
    Comment Date: 5 p.m. ET 2/11/22.

    Docket Numbers: ER22-889-000.
    Applicants: Dominion Energy South Carolina, Inc.
    Description: Dominion Energy South Carolina, Inc., submits Notice
of Cancellation of Network Integration Transmission Service Agreement
and Network Operating Agreement the City of Orangeburg, South Carolina.
    Filed Date: 1/24/22.
    Accession Number: 20220124-5206.
    Comment Date: 5 p.m. ET 2/14/22.

    Docket Numbers: ER22-890-000.
    Applicants: American Electric Power Service Corporation.
    Description: American Electric Power Service Corporation, Submitted
a Notice of Cancellation of Interconnection and Operating Agreements.
    Filed Date: 1/25/22.
    Accession Number: 20220125-5191.
    Comment Date: 5 p.m. ET 2/15/22.

    Docket Numbers: ER22-891-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: Calpine Greenleaf Holdings
Amendment (SA 174) to be effective 9/17/2021.
    Filed Date: 1/26/22.
    Accession Number: 20220126-5134.
    Comment Date: 5 p.m. ET 2/16/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 26, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-01997 Filed 1-31-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Notices]
[Page 33688]
[FR Doc No: 2016-12616]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2015-0025; OMB No. 1660-NEW]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Individual & Community Preparedness Division
(ICPD) Annual Youth Preparedness Council (YPC) Application Form

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before June 27, 2016.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 500 C Street SW., Washington, DC 20472-
3100, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This information collection previously
published in the Federal Register on October 28, 2015, at 80 FR 66031
with a 60 day public comment period. No comments were received. The
purpose of this notice is to notify the public that FEMA will submit
the information collection abstracted below to the Office of Management
and Budget for review and clearance.

Collection of Information

    Title: Individual & Community Preparedness Division (ICPD) Annual
Youth Preparedness Council (YPC) Application Form.
    Type of information collection: New information collection.
    OMB Number: 1660-NEW.
    Form Titles and Numbers: FEMA Form 008-0-0-24, FEMA Youth
Preparedness Council Application Form.
    Abstract: FEMA Headquarters and regional staff review completed
applications to select council members based on dedication to public
service, efforts in making a difference in their community, and
potential for expanding their impact as a national advocate for youth
preparedness. Applicants for the YPC apply by downloading a PDF
application from FEMA's Web site. They can either complete the written
form or they can answer the questions in the form of a short video.
They must then download their application and submit the application
and related documents, including reference letters and academic
records, to FEMA via the<EMAIL_ADDRESS>email address. Fifteen youths are selected to serve as a council
member.
    Affected Public: Individuals or households.
    Estimated Number of Respondents: 100.
    Estimated Total Annual Burden Hours: 142 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $0. There are no annual costs to respondents' operations
and maintenance costs for technical services. There are no annual
start-up or capital costs. The cost to the Federal Government is
$65,662.00.

    Dated: May 18, 2016.
Richard W. Mattison
Records Management Program Chief, Mission Support, Federal Emergency
Management Agency, Department of Homeland Security.
[FR Doc. 2016-12616 Filed 5-26-16; 8:45 am]
BILLING CODE 9111-46-P


             Joanna
             Swanson/RTP/USEP
             A/US                                                    To
<EMAIL_ADDRESS>
             02/16/2007 09:44<EMAIL_ADDRESS>
             PM                                                      cc
                                      Bill Harnett/RTP/USEPA/US@EPA,
                                      Juan Santiago/RTP/USEPA/US@EPA
                                                                Subject
                                      Draft final rule regarding
                                      ethanol fuel facilities

Dear Mr. Fraas and Ms. Flynn,

Bill Harnett asked me to forward you the latest unofficial copy of the
draft final rule entitled "Prevention of Significant Deterioration,
Nonattainment New Source Review, and Title V: Treatment of Corn Milling
Facilities Under the 'Major Emitting Facility' Definition."  As you
know, this draft final rule was proposed on March 9, 2006.

Thank you for your review and consideration.
Joanna

Joanna C. Swanson
Environmental Protection Specialist
Operating Permits Group, AQPD, OAQPS, OAR
U.S. Environmental Protection Agency
919-541-5282

(See attached file: EthanolFRN2-16-07omb.doc)

 EthanolFRN2-16-07omb2.doc


1 PART A OF THE SUPPORTING STATEMENT 1. IDENTIFICATION OF THE INFORMATION COLLECTION ( a) Title and Number of the Information Collection ICR: Control Technology for Equivalent Emissions Limitations by Permit under section 112( j) OMB Control Number: 2060 0266, EPA ICR # 1648.04.

( b) Short Characterization Section 112( j) of the Clean Air Act as amended in 1990 ( CAAA) requires that if EPA fails to promulgate a standard for a category or subcategory of major sources within 18 months after its scheduled date of promulgation, then sources must submit a title V permit application by that date. For the so called 10 year maximum achievable control technology ( MACT) standards, scheduled for promulgation by November 15, 2000, sources must submit permit applications by May 15, 2002, if standards are not promulgated by that date. States ( with approved Title V operating permit programs) will issue permits containing MACT emission limitations that the State will determine on a case by case basis equivalent to what would have been promulgated by EPA.

After promulgation of the section 112( j) rule on May 20, 1994, several petitioners filed for review of the section 112( j) rule. EPA has proposed to amend the original rule based upon those petitions. As a result of internal discussions, EPA will also clarify and streamline the section 112( j) rule.

This ICR supports the amended regulations under development to implement Section 112( j) ( 40 CFR part 63, subpart B, § § 63.50 56). It addresses the information collection burden ( hours and costs) to industry respondents subject to these amended provisions; State and Local agencies that review applications made under these amended provisions; and the EPA oversight review of a percentage of State/ Local decisions.

This ICR includes about 84,000 affected sources, estimated to be subject to the revised section 112( j) rule, that we anticipate will perform the reporting that the rule requires. We anticipate that about 84,000 affected sources will have to prepare and submit a Part 1 title V permit application. Because all MACT standards will be issued before the Part 2 application is required, no Part 2 applications will be necessary ( and thus no associated burden). It should be noted that the number of affected sources is greater than the number of facilities or plant sites affected, since a plant site can contain numerous affected sources and be affected by multiple MACT standards. We have determined estimated costs based on the number of affected sources; however, we believe that the actual cost will be somewhat less for facilities that contain several 2 affected sources. The average administrative cost per affected source to perform the reporting was estimated to be $ 260. Total estimated administrative costs for existing sources are about $ 21,840,000 for all affected sources in all affected source categories during the first three years after promulgation of the revised section 112( j) rule. 3 2. NEED FOR AND USE OF THE COLLECTION ( a) Need/ Authority for the Collection Section 112( j) of the Clean Air Act as amended in 1990 contains the need and authority for this information collection. [ 42 U. S. C. 7401 ( et. seq.) as amended by Public Law 101 549]

( b) Practical Utility/ Users of the Data The information collected in the application documents will be used for the purposes of permit approval, compliance determination, and the selection of particular control technology on a case by case basis. The Federal or State administrator of the operating permits program will use the information for the case by case emission limit determinations.

3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Nonduplication The information collection activities required under the section 112( j) amended regulations are not routinely collected elsewhere by EPA. The permitting authority may have collected a few of the information items previously in support of other applications. In some cases, the source will not have been subject to previous Federal air standards, and the source's entry into the section 112( j) program will be its first encounter with information collection activities under the Clean Air Act.

3( b) Public Notice Required Prior to ICR Submission to OMB A public review and comment period will occur after proposal of the section 112( j) amended regulations in the Federal Register.

3( c) Consultations Because the section 112( j) revised regulations have resulted from legal actions filed by the petitioners, it is not appropriate or legal to conduct consultations beyond any discussion with the petitioners. Thus, to keep the section 112( j) revised regulations privileged and confidential, EPA did not consult with anyone not involved with the revision of these regulations.

3( d) Effects of Less Frequent Collection 4 Each applicant would submit the required information on a one time only basis.

3( e) General Guidelines The recordkeeping and reporting requirements contained in the section 112( j) amended regulations do not violate any of the Paperwork Reduction Act guidelines contained in 5 CFR 1320.6.

3( f) Confidentiality Any information submitted to a permitting authority with a claim of confidentiality will be safeguarded according to that agency's policies set forth prior to approval of the agency's operating permit program by EPA. Any confidential information submitted to EPA will be safeguarded according to policies in 40 CFR, Chapter 1, Party 2, Subpart B  Confidentiality of Business Information. All members of the public will have opportunity to comment on the proposed regulation.

3( g) Sensitive Questions This section is not applicable. This ICR does not contain any sensitive questions relating to sexual behavior or attitudes, religious beliefs, or other matters usually considered private.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ SIC Codes Respondents include owners/ operators of major sources of hazardous air pollutants ( HAPs). A major source is one that emits more than 10 tons per year of any HAP, 25 tons per year for the total of all HAP, or amounts exceeding any lesser quantity cutoff established pursuant to § 112( a)( 1) of the CAA. This definition of major source cuts across a wide variety of industries, including both manufacturing and nonmanufacturing sources. Thus, the proposed amendments to the section 112( j) regulations would regulate owners and manufacturers of major sources. For purposes of this information collection request period, only those sources in the 2000 source category " bin" ( the so called 10 year bin) would potentially be subject to the section 112( j) program due to a failure by the EPA to promulgate MACT standards for these categories by the section 112( j) hammer date of May 15, 2002. Table 1 lists the source categories in the 10 year bin for the respondents. As discussed in section ( 6)( b), EPA estimates that 59 of these source categories would potentially become subject to the section 112( j) program.

4( b) Information Requested 5 ( i) Data items, including recordkeeping requirements Implementation of the section 112( j) program involves information submitted with the application for a section 112( j) determination. Section 112( j) does not contain recordkeeping requirements, although the source would already keep some of the information necessary to document certain control options.

The section 112( j) revised regulations would simplify and streamline the section 112( j) process. Instead of requiring all information for a section 112( j) MACT determination at once, the section 112( j) revised regulations divide the section 112( j) application process for the case bycase MACT determination into two parts. The first part of the section 112( j) MACT application consists of submitting summary administrative information while the second part of the section 112( j) MACT application, due 24 months later, requires the technical information necessary for a MACT floor determination. Furthermore, the source is no longer required to present a recommended MACT floor or MACT limits in their application.

For a section 112( j) MACT determination under the revised rules, new or existing sources must submit the following information in a two part application:

Part 1 ( § 63.53( a)) of the application shall contain:

The name and address ( physical location) of the major source;

A brief description of the major source, and an identification of the relevant source category;

An identification of the types of major sources belonging to the relevant source category; and

An identification of any affected major sources for which a section 112( g) MACT determination has been made.

Part 2 ( § 63.53( b)( 1)) of the application shall contain:

For new affected sources, the anticipated date of startup of operation;

The HAPs emitted by each affected source in the relevant source category;

An estimated total uncontrolled and controlled emission rate for HAPs from the affected source;

Any existing Federal, State, or Local limitations or requirements applicable to the affected major source;

An identification of control technology in place for each piece of equipment or activity or major source;

Information relevant to establishing the MACT floor, and at the option of the owner or operator, a recommended MACT floor; and 6

Any other information reasonably needed by the permitting authority, including information required pursuant to subpart A of this part.

Part 2 ( § 63.53( b)( 2)) of the application may include the following:

Recommended emission limitations for the affected major source and any necessary supporting information;

A description of the control technologies that the respondent will apply to meet the emission limitation; and

Relevant parameters to be monitored and the frequency of monitoring to demonstrate continuous compliance with the MACT emission limitation over the applicable reporting period.

Because all MACT standards will be promulgated before the Part 2 application is required, no source will have to submit a Part 2 application.

( ii) Respondent Activities Activities ( Tables 2a and 2b) that the owner or operator must perform are:

Part 1 application:

Read applicable regulations to determine source applicability and compliance requirements

Collect basic information required to fulfill § 63.53( a)

Prepare and submit Part 1 application

Store, file, and maintain application information Part 2 application:

Collect basic information required to fulfill § 63.53( b)( 1)

Draft and review Part 2 application

Complete and submit Part 2 application

Store, file, and maintain application information 7 5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities This section addresses the activities of State and Local agencies, as the permitting authority, and EPA, in an oversight capacity. The permitting authority, typically the State or Local air agency, will perform the following activities ( Tables 3a and 3b):

Part 1 application:

Develop application form ( 1 time event)

Identify affected sources ( 1 time event)

Answer respondent questions about submitting the application

Receive, review, and file application Part 2 application:

Review applications for technical completeness

Analyze requests for confidentiality and provide protection

Approve or disapprove application and notify respondents of decision

Set emission limits on a case by case basis

Prepare draft permit

Allow for public review of draft permit

Issue permit containing case by case MACT

File and maintain permit Acting in an oversight capacity, EPA will perform the following activities ( Table 4):

Audit and review applications

Review the decisions of permitting authorities 5( b) Collection Methodology and Management The owners or operators of the sources affected by these amended regulations will have the responsibility of submitting a Part 1 application to the permitting authority. It is the responsibility of the permitting authority to provide information necessary for EPA oversight review.

Qualified staff that work for the permitting authority will perform the permit reviews and check the quality of data submitted by the applicant on a case by case basis. The permitting 8 authority's employees will handle confidential information submitted by the applicant according to the permitting authority's confidential information handling procedures.

The amended section 112( j) regulations will not require the request of information through any type of survey.

5( c) Small Entity Flexibility Minimizing the information collection burden for all sizes of organizations is a continuing effort on EPA's part. EPA has reduced the information required by requiring only basic information needed by the permitting authority to make a case by case MACT determination.

The section 112( j) revised regulations do not require recordkeeping. Furthermore, the section 112( j) revised regulations streamline the application process and require only 2 one time submittals of information to State/ Local agencies. ( Note that the Part 2 application will be unnecessary.)

5( d) Collection Schedule The section 112( j) amended regulations were proposed on March 23, 2001, and are scheduled for promulgation by the end of February 2002. This ICR does not require surveys. Each source affected by the section 112( j) amended regulations will be required to submit an application. Preparation of an application in compliance with the section 112( j) amended rules is a one time only activity ( there are 2 submittals for each application). The section 112( j) amended regulations will not require periodic reporting or surveys.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden This ICR requires the calculation of the amount of burden hours associated with each activity for each respondent. In the section 112( j) permitting process for major sources, each respondent must submit the permit application in two parts as specified in section 4( b)( i) of this Supporting Statement. All activities are conducted on a one time only basis and are divided into two parts in accordance to the tasks for each part. Tables 2a and 2b provide a breakdown of the burden hours per occurrence for the respondents.

For the section 112( j) revised regulations, burden for the respondents is a combination of administrative costs ( preparing the permit applications) and compliance costs. The permitting process and thus the administrative costs are divided into two parts. The first part of the permit 9 contains summary administrative information. For existing sources, the first part of the permit contains administrative information and is submitted to the permitting authority no later than that 18 months after the statutory deadline of November 15, 2000, which is May 15, 2002. The second part of the permit contains more technical information and is submitted 24 months after the first part ( May 15, 2004). After receiving the title V permit containing section 112( j) provisions, the source would then install and operate control equipment to comply with the emission limit established by the section 112( j) case by case MACT determination. The sources also would comply with any monitoring, recordkeeping, and reporting requirements set by the permitting authority and the EPA. However, we expect all the remaining MACT standards will be issued well before the Part 2 application is required, negating the need submit a Part 2 application, and eliminating the need for permitting authorities to determine case by case MACT.

Under the provisions in the section 112( j) rule, a new source is a source that is constructed after the issuance of the existing source permit. Since the earliest possible date for issuance of a permit for an existing source is well after May 2004 ( the date Part 2 applications are due) and we expect all MACT standards to be promulgated by then, there will be no permitting costs or compliance costs for new sources during the period that this ICR covers.

6( b) Estimating Respondent Costs ( i) Labor costs In this ICR, EPA has used a graded approach in calculating cost as recommended in the ICR handbook. Due to the lack of an economic analysis on the cost of the section 112( j) revised regulations, wage rates for industry respondents were retrieved from the Bureau of Labor Statistics. ( http:// www. bls. gov/ news. release/ ecec. t12. htm; accessed January 2002.) The hourly rates are listed as follows: $ 47.00 for management labor, $ 37.36 for technical labor, and $ 20.36 for clerical labor. These labor rates were multiplied by 1.5 to account for overhead costs. Therefore, we estimated the hourly cost of labor for industry sources submitting permit applications to be $ 70.50 for management labor, $ 56.04 for technical labor, and $ 30.54 for clerical labor. Tables 2a and 2b provide a breakdown of labor hours and associated costs per occurrence for each activity in each part of the application process.

( ii) Capital and Operation and Maintenance Costs As explained in 6( a), compliance with the 112( j) rule, including resultant capital and operation and maintenance costs, will occur well after May 2004. There will also be no emission reductions attributable to the section 112( j) program during the period covered by this ICR, since sources will generally have up to 3 years after permit issuance to comply.

6( c) Estimating State/ Local Agency Burden and Cost 10 Similar to sections 6( a) and 6( b), the activities for State/ Local agencies are divided into the activities that would take place for both parts of the application process as described in section 4( b)( i) of this Supporting Statement. Wage rates for State/ Local employees were retrieved from the Bureau of Labor Statistics ( http:// www. bls. gov/ news. release/ ecec. t04. htm; accessed January 2002) and are as follows: $ 26.31 per hour for management labor, $ 29.35 per hour for technical labor, and $ 12.88 per hour for clerical labor instead of the flat rate ($ 34/ hr) as mentioned in the previous ICR. We added in the value of total benefits in BLS Table 4. We chose 20 percent of the base rate as the percentage of salary that constitutes overhead. The addition of benefits and overhead to the hourly rate produces a pay rate that reflects the true cost to employ a State , Local, or Tribal agency worker. Following is a summary of the computed hourly wages for State, Local, and Tribal agency employees.

Hourly Labor Rates for State, Local and Tribal Respondents Labor Type Hourly Rate Benefits Overhead ( 20 % Salary) Adjusted Hourly Rate Management $ 26.31 $ 11.12 $ 5.26 $ 42.69 Technical $ 29.35 $ 9.92 $ 5.87 $ 45.14 Clerical $ 12.88 $ 6.39 $ 2.58 $ 21.85 Tables 3a and 3b provide a breakdown of labor hours and associated costs for State/ Local/ Tribal agencies.

6( d) Estimating Agency Burden and Cost Under the section 112( j) revised regulations, EPA would serve in an oversight capacity and audit approximately 10 percent of all applications processed by State/ Local agencies. As recommended in the ICR Handbook, wage rates for EPA employees are based upon the Federal government pay scale. We calculated the hourly rates for EPA employees using information on annual salaries from the Internet site for the Office of Personnel Management. ( http:// www. opm. gov/ oca/ 02tables/ 02rus. pdf; accessed January 2002) . We used the appropriate pay grade levels for management, technical, and clerical personnel. We divided the annual pay rate by 2080, the amount of working hours during a calendar year, to get the hourly wage rate. We then multiplied this rate by 1.6 to produce a pay rate that reflects the true cost to the Federal govenrment to employ a worker. The value of 1.6 incorporates the addition of benefits at 40 % of salary and the addition of overhead at 20% of salary to the hourly rate. Following is a summary of the computed wages for EPA personnel.

Hourly Labor Rates for EPA 11 Labor Type Pay Grade Annual Salary Hourly Rate Benefits ( 40 % Salary) Overhead ( 20 % Salary) Adjusted Hourly Rate Management GS 15 $ 89,715 $ 43.13 $ 17.25 $ 8.63 $ 69.01 Technical GS 12 $ 54,275 $ 26.09 $ 10.44 $ 5.22 $ 41.75 Clerical GS 6 $ 27,534 $ 13.24 $ 5.30 $ 2.65 $ 21.19 Table 4 provides a breakdown in the amount of hours associated with each activity and the total burden hours and cost per occurrence.

6( e) The Respondent Universe In order to estimate the number of sources subject to the section 112( j) amended regulations, EPA reviewed information in its existing source category tracking system to determine the estimated number of sources affected by the 2000 MACT standards that it anticipates will not be promulgated by May 15, 2002; we anticipate those sources affected will be covered by 31 standards covering 59 source categories ( approximately 84,000 affected sources).

6( f) Bottom Line Burden Hours and Cost Over the three year period of this ICR, the average annual burden and cost associated with the section 112( j) revised regulations are 172,200 hours and $ 9,043,440 respectively. Table 5 contains the total burden and cost breakdown associated with the section 112( j) amended regulations. Table 6 provides a summary of the bottom line burden hours and costs associated with the section 112( j) revised regulations.

It should be noted that much of this burden associated with section 112( j) is eliminated when the MACT rules are promulgated. In fact, we anticipate that all the MACT rules will be promulgated before any section 112( j) Part 2 applications are required.

6( g) Reasons for Change in Burden The ICR 1648 02 spanned the period in which the section 112( j) rule would have applied to any of the source categories covered by the 1997 MACT standards. This ICR spans the period in which the section 112( j) rule would apply to any of the source categories covered by the 2000 MACT standards, which is a completely different set of source categories. Therefore, the number of respondents is completely different and unrelated for this ICR. The total burden is based primarily on the number of respondents. The burden per occurrence has also been adjusted downward, reflecting the less burdensome requirements of only the Part 1 application. 12 Because no case by case permits will actually be developed or issued, there are no compliance costs for this ICR. Finally, EPA has updated the labor rates for respondents, State, Local, and Tribal agencies, and the EPA as discussed in sections 6( b), ( c), and ( d) of this ICR. These adjustments were made to more accurately reflect the true cost of an hour of labor for the respondents, State, Local, and Tribal agencies, and the EPA The unloaded hourly rates are different because they are based on the latest available rates from the BLS and the OPM. Table 7 provides a summary of the differences between burden hours and costs associated with each occurrence for the previous and current ICR.

The difference in the burden estimate is due to the adjustments discussed above, including number of respondents and labor rates.

6( h) Burden Statement This estimate includes all activities associated with the respondents or government agencies. Overall, the section 112( j) program will have the following average annual burden: 131,600 hours and $ 7,280,000 for respondents; 39,200 hours and $ 1,697,360 for State/ Local/ Tribal agencies; and 1,400 hours and $ 66,080 for the EPA. Table 5 presents the annual burden for respondents, State/ Local agencies, and the EPA over the 3 year period studied for existing sources.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, Office of Environmental Information, U. S. Environmental Protection Agency ( 2822), 1200 Pennsylvania Avenue, NW, Washington, DC 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB control number in any correspondence. 13 14 Part B of the Supporting Statement This section is not applicable because statistical methods are not used in the data collection associated with the section 112( j) amended regulations. 15 TABLES 16 Table 1. Year 2000 Source Categories for Respondents Fuel Combustion: Combustion Turbines Engine Test Facilities Industrial Boilers Institutional/ Commercial Boilers Process Heaters Reciprocating Internal Combustion Engines Rocket Testing Facilities Non Ferrous Metals Processing: Primary Copper Smelting Primary Magnesium Refining Ferrous Metals Processing: Coke By Product Plants Coke Ovens: Pushing, Quenching, Battery Stacks Integrated Iron and Steel Manufacturing Iron Foundries Electric Arc Furnace ( EAF) Operation Steel Foundries Mineral Products Processing: Alumina Processing Asphalt Concrete Manufacturing Asphalt Processing Asphalt Roofing Manufacturing Asphalt/ Coal Tar Application Metal Pipes Clay Products Manufacturing Lime Manufacturing Refractories Manufacturing Taconite Iron Ore Processing Petroleum and Natural Gas Production and Refining: Natural Gas Transmission and Storage Petroleum Refineries Catalytic Cracking ( Fluid and other) Units, Catalytic Reforming Units, and Sulfur Plant Units Liquids Distribution: Organic Liquids Distribution ( Non Gasoline)

Surface Coating Processes: Auto and Light Duty Truck Large Appliance Manufacture of Paints, Coatings, and Adhesives Metal Can Metal Coil Metal Furniture Miscellaneous Metal Parts and Products Paper and Other Webs Plastic Parts and Products Printing, Coating, and Dyeing of Fabrics Wood Building Products 17 Waste Treatment and Disposal: Hazardous Waste Incineration Municipal Landfills Sewage Sludge Incineration Site Remediation Solid Waste Treatment, Storage and Disposal Facilities ( TSDF)

Fibers Production Processes: Rayon Production Spandex Production Food and Agriculture Processes: Manufacturing of Nutritional Yeast Cellulose Food casing Manufacturing Vegetable Oil Production Polymers and Resins Production: Alkyd Resins Production Boat Manufacturing Carboxymethylcellulose Production Cellophane Production Cellulose Ethers Production Maleic Anhydride Copolymers Production Methylcellulose Production Nitrile Resins Production Polyester Resins Production Polymerized Vinylidene Chloride Production Polymethyl Methacrylate Resins Production Polyvinyl Acetate Emulsions Production Polyvinyl Alcohol Production Polyvinyl Butyral Production Polyvinyl Chloride and Copolymers Production Reinforced Plastic Composites Production.

Production of Inorganic Chemicals: Ammonium Sulfate Production Caprolactam By Product Plants Carbon Black Production Chlorine Production Cyanide Chemicals Manufacturing Fumed Silica Production Hydrochloric Acid Production Uranium Hexafluoride Production Production of Organic Chemicals: Ethylene Processes Quaternary Ammonium Compounds Production Miscellaneous Processes: Benzyltrimethylammonium Chloride Production. Butadiene Dimers Production Carbonyl Sulfide Production Cellulosic Sponge Manufacturing Chelating Agents Production Chlorinated Paraffins 18 Dry Cleaning ( Petroleum Solvent) Ethylidene Norbornene Production Explosives Production Flexible Polyurethane Foam Fabrication Operations. Friction Products Manufacturing Hydrazine Production Leather Tanning and Finishing Operations OBPA/ 1,3 Diisocyanate Production Paint Stripping Operations Photographic Chemicals Production Phthalate Plasticizers Production Plywood and Composite Wood Products Pulp and Paper Production Rubber Chemicals Manufacturing Rubber Tire Manufacturing Semiconductor Manufacturing Symmetrical Tetrachloropyridine Production 19 Table 2a. Summary of Activities, Labor Hours, and Administrative Costs for Respondents for Part 1 of Application Labor Hours per Occurrence ( hr/ occ)

Activity Revised 112( j)

Management Technical Clerical Total Wage Rate ($/ hr) 70.5 56.04 30.54 A. Read applicable regulations to determine source applicability 0.5 1 0 1.5 Cost of A per occurrence 35.25 56.04 0.00 91.29 B. Collect basic information to fulfill 63.53( a) 0 1 0 1 Cost of B per occurrence 0.00 56.04 0.00 56.04 C. Prepare and submit application 0.5 1 0.5 2 Cost of C per occurrence 35.25 56.04 15.27 106.56 D. File and maintain application 0 0 0.2 0.2 Cost of D per occurrence 0.00 0.00 6.11 6.11 Total Hours per Occurrence ( hr/ occ) 1.0 3.0 0.7 4.7 Total Cost per Occurrence ($/ occ) $ 70.50 $ 168.12 $ 21.38 $ 260.00 Table 2b. Summary of Activities, Labor Hours, and Administrative Costs for Respondents for Part 2 of Application Labor Hours per Occurrence ( hr/ occ)

Activity Revised 112( j)

Management Technical Clerical Total A. Collect information required by 63.53.( b)( 1) 0 4 0 4 Cost of A per occurrence 0.00 224.16 0.00 224.16 B. Fulfill any state or local requirements as set forth by 63.53( b)( 1)( vi) 1 4 0 5 Cost of B per occurrence 70.50 224.16 0.00 294.66 C. Process, compile, and review application for accuracy, and appropriateness 1 8 2 11 Cost of C per occurrence 70.50 448.32 61.08 579.90 D. Complete and submit written application 1 4 2 7 Cost of D per occurrence 70.50 224.16 61.08 355.74 E. Store, file, and maintain application information 0.5 1 1 2.5 Cost of E per occurrence 35.25 56.04 30.54 121.83 Total Hours per Occurrence ( hr/ occ) 3.5 21 5 29.5 Total Cost per Occurrence ($/ occ) $ 246.75 $ 1,176.84 $ 152.70 $ 1,576.29 20 Table 3a. Summary of Activities, Labor Hours, and Administrative Costs for S/ L/ T Agencies for Part 1 of Application Labor Hours per Occurrence ( hr/ occ)

Revised 112( j)

Activity Management Technical Clerical Total Wage Rate ($/ hr) 42.69 45.14 21.85 A. Develop application form ( 1 time event) 1 2 1 4 Cost of A per occurrence 42.69 90.28 21.85 154.82 B. Identify affected sources ( 1 time event) 0 8 2 10 Cost of B per Occurrence 0.00 361.12 43.70 404.82 C. Answer respondent questions about submitting applications. 0 0.2 0 0.2 Cost of C per occurrence 0.00 9.03 0.00 9.03 D. Review and file applciations 0.1 1 0.1 1.2 Cost of D per occurrence 4.27 45.14 2.19 51.59 Total Hours per Occurrence ( hr/ occ) 0.1 1.2 0.1 1.4 Total Cost per Occurrence ($/ occ) $ 4.27 $ 54.17 $ 2.19 $ 60.62 Table 3b. Summary of Activities, Labor Hours, and Administrative Costs for S/ L/ T Agencies for Part 2 of Application Labor Hours per Occurrence ( hr/ occ)

Revised 112( j)

Activity Management Technical Clerical Total A. Review applications for technical completeness 0 4 0 4 Cost of A per occurrence 0.00 180.56 0.00 180.56 B. Analyze requests for confidentiality and provide protection 0 1 0 1 Cost of B per occurrence 0.00 45.14 0.00 45.14 C. Approve or disapprove application and notify respondents of decision 0.5 2 1 3.5 Cost of C per occurrence 21.35 90.28 21.85 133.48 D. Set emission limitations on a case by case basis 0.1 5 2 7.1 Cost of D per occurrence 4.27 225.70 43.70 273.67 E. Prepare draft permit 0.5 4 1 5.5 Cost of E per occurrence 21.35 180.56 21.85 223.76 F. Public hearing 1 2 1 4 Cost of F per occurrence 42.69 90.28 21.85 154.82 G. Issue permit 0.5 2 1 3.5 Cost of G per occurrence 21.35 90.28 21.85 133.48 H. File and maintain permit 0 1 1 2 Cost of H per occurrence 0.00 45.14 21.85 66.99 Total Hours per Occurrence ( hr/ occ) 2.6 21 7 30.6 Total Cost per Occurrence ($/ occ) $ 110.99 $ 947.94 $ 152.95 $ 1,211.88 21 Table 4. Summary of Activities, Labor Hours, and Administrative Costs for the EPA Labor Hours per Occurrence ( hr/ occ)

Revised 112( j)

Activity Management Technical Clerical Total Wage Rate ($/ hr) 69.01 41.75 21.19 A. Audit and review application 0.1 0.2 0 0.3 Cost of A per occurrence 6.90 8.35 0.00 15.25 B. Review decisions of permitting authority 0 0.2 0 0.2 Cost of B per Occurrence 0.00 8.35 0.00 8.35 Total Hours per Occurrence ( hr/ occ) 0.1 0.4 0.0 0.5 Total Cost per Occurrence ($/ occ) $ 6.90 $ 16.70 $ 0.00 $ 23.60 22 Table 5. Administrative Burden and Cost Estimates for Respondents, State and Local Agencies, and the EPA for Existing Sources Yeara Number of Occurences Total Respondent Burden Hours ( hr) Total Respondent Costs Total State/ Local Burden Hours ( hr) Total State/ Local Costs Total EPA Burden Hours ( hr) c Total EPA Costsc Total Burden Hours ( hr) Total Cost Year 1 84,000 394,800 $ 21,840,000 117,600 $ 5,092,080 4,200 $ 198,240 516,600 $ 27,130,320 Year 2b 0 0 0 0 0 0 0 0 0 Year 3b 0 0 0 0 0 0 0 0 0 Total 84,000 394,800 $ 21,840,000 117,600 $ 5,092,080 4,200 $ 198,240 516,600 $ 27,130,320 Ann. Avg. 28,000 131,600 $ 7,280,000 39,200 $ 1,697,360 1,400 $ 66,080 172,200 $ 9,043,440 a Year 1 = Mar 2002  Mar 2003; Year 2 = Mar 2003  Mar 2004; Year 3 = Mar 2004  Mar 2005.

b All MACT rules will be issued before Part 2 applications are due.

c EPA reviews 10% of permit applications.

Table 6. Summary of Total Burden and Cost Estimate for the Section 112( j) Program Year Number of Respondents Total Annual Hours Requested ( hr) Total Annualized Costs Year 1 84,000 516,600 $ 27,130,320 Year 2 0 0 0 Year 3 0 0 0 Total 84,000 516,600 $ 27,130,320 Ann. Avg. 28,000 172,200 $ 9,043,440 23 Table 7. Comparison of Burden and Costs for 1999 ICR and Current ICR Parameter Unit 1999 ICR Current ICR Percent Difference Respondent Burden Hours per Occurrence ( hr/ occ) 175 4.7  97%

State/ Local Burden Hours per Occurrence ( hr/ occ) 90 1.4  98%

EPA Burden Hours per Occurrence ( hr/ occ) 50 0.5  99%

Total Hourly Wage Rate per Occurrence ( Respondents) ($/ hr) 45 55 22%

Total Hourly Wage Rate per Occurrence ( State/ Local Agencies) ($/ hr) 30 43 41%

Total Hourly Wage Rate per Occurrence ( EPA) ($/ hr) 32 47 47%

Respondent Cost per Occurrence ($/ occ) 8,980 260  97%

State/ Local Cost per Occurrence ($/ occ) 2,744 61  98%

EPA Cost per Occurrence ($/ occ) 1,595 24  98%