[Federal Register Volume 77, Number 154 (Thursday, August 9, 2012)]
[Notices]
[Pages 47631-47640]
[FR Doc No: 2012-19422]

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ENVIRONMENTAL PROTECTION AGENCY

[Docket ID Numbers EPA-HQ-OECA-2012-0496-0500, 0502, 0503, 0505, 0506,
0517-0519, 0524-0535; FRL-9714-2]

Agency Information Collection Activities: Request for Comments on
Twenty-Four Proposed Information Collection Requests

AGENCY: Environmental Protection Agency (EPA)

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that EPA is planning to submit the
following twenty-four existing, approved, continuing Information
Collection Requests (ICR) to the Office of Management and Budget (OMB)
for the purpose of renewing the ICRs. Before submitting the ICRs to OMB
for review and approval, EPA is soliciting comments on specific aspects
of the information collections as described under SUPPLEMENTARY
INFORMATION.

DATES: Comments must be submitted on or before October 9, 2012.

ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier service. Follow the detailed instructions
as provided under SUPPLEMENTARY INFORMATION, section A.

FOR FURTHER INFORMATION CONTACT: The contact individuals for each ICR
are listed under SUPPLEMENTARY INFORMATION, section II. C.

SUPPLEMENTARY INFORMATION:

I. Submitting Comments

A. How can I access the docket and/or submit comments?

1. Docket Access Instructions
    EPA has established a public docket for the ICRs listed in the
SUPPLEMENTARY INFORMATION, section II. B. The docket is available for
online viewing at http://www.regulations.gov, or in person viewing at
the Enforcement and Compliance Docket and Information Center (ECDIC),
in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Avenue NW., Washington, DC. The EPA/DC Public Reading Room
is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Reading Room is (202) 566-
1744, and the telephone number for the Enforcement and Compliance
Docket and Information Center (ECDIC) docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. When
in the system, select ``search,'' then key in the docket ID number
identified in this document.
2. Instructions for Submitting Comments
    Submit your comments by one of the following methods:
    (a) Electronic Submission: Access http://www.regulations.gov and
follow the on-line instructions for submitting comments.
    (b) Email<EMAIL_ADDRESS>    (c) Fax:<PHONE_NUMBER>.
    (d) Mail: Enforcement and Compliance Docket and Information Center
(ECDIC), Environmental Protection Agency, EPA Docket Center (EPA/DC),
Mail code: 2201T, 1200 Pennsylvania Avenue NW., Washington, DC 20460.
    (e) Hand Delivery: Enforcement and Compliance Docket and
Information Center (ECDIC), Environmental Protection Agency, EPA Docket
Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue NW.,
Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. Deliveries are
only accepted during the Docket Center's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Direct your comments to the specific docket listed in SUPPLEMENTARY
INFORMATION, section II. B, and reference the OMB Control Number for
the ICR. It is EPA's policy that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

B. What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act
(PRA), EPA is soliciting comments and information to enable it to:
    (1) Evaluate whether the proposed collections of information are
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    (2) Evaluate the accuracy of the Agency's estimates of the burdens
of the proposed collections of information.
    (3) Enhance the quality, utility, and clarity of the information to
be collected.
    (4) Minimize the burden of the collections of information on those
who are to respond, including through the use of appropriate automated
or electronic collection technologies or other forms of information
technology, e.g., permitting electronic submission of responses.

C. What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing
comments:
    (1) Explain your views as clearly as possible and provide specific
examples.
    (2) Describe any assumptions that you used.
    (3) Provide copies of any technical information and/or data you
used that support your views.

    (4) If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    (5) Offer alternative ways to improve the collection activity.
    (6) Make sure to submit your comments by the deadline identified
under DATES.
    (7) To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

II. ICRs To Be Renewed

A. For All ICRs

    The Agency computed the burden for each of the recordkeeping and
reporting requirements applicable to the industry for the currently
approved ICRs listed in this notice. Where applicable, the Agency
identified specific tasks and made assumptions, while being consistent
with the concept of the PRA.
    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 to; develop, acquire, install, and
utilize technology and systems for the purposes of collecting,
validating, and verifying information, processing and maintaining
information, and disclosing and providing information; adjust the
existing ways to comply with any previously applicable instructions and
requirements which have subsequently changed; 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.
    The listed ICRs address Clean Air Act information collection
requirements in standards (i.e., regulations) which have mandatory
recordkeeping and reporting requirements. Records collected under the
New Source Performance Standards (NSPS) must be retained by the owner
or operator for at least two years and the records collected under the
National Emission Standards for Hazardous Air Pollutants (NESHAP) must
be retained by the owner or operator for at least five years. In
general, the required collections consist of emissions data and other
information deemed not to be private.
    In the absence of such information collection requirements,
enforcement personnel would be unable to determine whether the
standards are being met on a continuous basis as required by the Clean
Air Act.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information, unless the Agency displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations under Title 40 of the Code of Federal Regulations are
published in the Federal Register, or on the related collection
instrument or form. The display of OMB control numbers for certain EPA
regulations is consolidated at 40 CFR part 9.

B. What information collection activity or ICR does this apply to?

    In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et
seq.), this notice announces that EPA is planning to submit the
following twenty-four Information Collection Requests (ICR) to the
Office of Management and Budget (OMB):
    (1) Docket ID Number: EPA-HQ-OECA-2012-0518
    Title: NESHAP for Metal Furniture Surface Coating (40 CFR Part 63,
Subpart RRRR).
    ICR Numbers: EPA ICR Number 1952.05, OMB Control Number 2060-0518.
    ICR Status: This ICR is scheduled to expire on October 31, 2012.
    (2) Docket ID Number: EPA-HQ-OECA-2012-0526.
    Title: NESHAP for Aluminum, Copper and Other Non-Ferrous Metals
Foundries (40 CFR Part 63, Subpart ZZZZZZ).
    ICR Numbers: EPA ICR Number 2332.03, OMB Control Number 2060-0630.
    ICR Status: This ICR is scheduled to expire on October 31, 2012.
    (3) Docket ID Number: EPA-HQ-OECA-2012-0530.
    Title: NSPS for Metal Furniture Coating (40 CFR Part 60, Subpart
EE).
    ICR Numbers: EPA ICR Number 0649.11, OMB Control Number 2060-0106.
    ICR Status: This ICR is scheduled to expire on November 30, 2012.
    (4) Docket ID Number: EPA-HQ-OECA-2012-0529.
    Title: NESHAP for Mercury (40 CFR Part 61, Subpart E).
    ICR Numbers: EPA ICR Number 0113.11, OMB Control Number 2060-0097.
    ICR Status: This ICR is scheduled to expire on November 30, 2012.
    (5) Docket ID Number: EPA-HQ-OECA-2012-0505.
    Title: NESHAP for Secondary Aluminum Production (40 CFR Part 63,
Subpart RRR).
    ICR Numbers: EPA ICR Number 1894.07, OMB Control Number 2060-0433.
    ICR Status: This ICR is scheduled to expire on November 30, 2012.
    (6) Docket ID Number: EPA-HQ-OECA-2012-0532.
    Title: NSPS for Beverage Can Surface Coating (40 CFR Part 60,
Subpart WW).
    ICR Numbers: EPA ICR Number 0663.11, OMB Control Number 2060-0001.
    ICR Status: This ICR is scheduled to expire on December 31, 2012.
    (7) Docket ID Number: EPA-HQ-OECA-2012-0517.
    Title: NSPS for Emission Guidelines and Compliance Times for Small
Municipal Waste Combustion Units Constructed on or Before August 30,
1999 (40 CFR Part 60, Subpart BBBB).
    ICR Numbers: EPA ICR Number 1901.05, OMB Control Number 2060-0424.
    ICR Status: This ICR is scheduled to expire on December 31, 2012.
    (8) Docket ID Number: EPA-HQ-OECA-2012-0531.
    Title: NSPS for Surface Coating of Large Appliance (40 CFR Part 60,
Subpart SS).
    ICR Numbers: EPA ICR Number 0659.12, OMB Control Number 2060-0108.
    ICR Status: This ICR is scheduled to expire on December 31, 2012.
    (9) Docket ID Number: EPA-HQ-OECA-2012-0528.
    Title: NSPS for Synthetic Fiber Production Facilities (40 CFR Part
60, Subpart HHH).
    ICR Numbers: EPA ICR Number 1156.12, OMB Control Number 2060-0059.
    ICR Status: This ICR is scheduled to expire on December 31, 2012.
    (10) Docket ID Number: EPA-HQ-OECA-2012-0535.
    Title: NSPS for Secondary Lead Smelters (40 CFR Part 60, Subpart
L).
    ICR Numbers: EPA ICR Number 1128.10, OMB Control Number 2060-0080.
    ICR Status: This ICR is scheduled to expire on January 31, 2013.
    (11) Docket ID Number: EPA-HQ-OECA-2012-0506.
    Title: NSPS for Small Municipal Waste Combustors (40 CFR Part 60,
Subpart AAAA).
    ICR Numbers: EPA ICR Number 1900.05, OMB Control Number 2060-0423.
    ICR Status: This ICR is scheduled to expire on January 31, 2013.
    (12) Docket ID Number: EPA-HQ-OECA-2012-0524.
    Title: NSPS for Stationary Combustion Turbines (40 CFR Part 60,
Subpart KKKK).
    ICR Numbers: EPA ICR Number 2177.05, OMB Control Number 2060-0582.

    ICR Status: This ICR is scheduled to expire on January 31, 2013.
    (13) Docket ID Number: EPA-HQ-OECA-2012-0533.
    Title: NSPS for the Phosphate Fertilizer Industry (40 CFR Part 60,
Subparts T, U, V, W and X).
    ICR Numbers: EPA ICR Number 1061.12, OMB Control Number 2060-0037.
    ICR Status: This ICR is scheduled to expire on January 31, 2013.
    (14) Docket ID Number: EPA-HQ-OECA-2012-0497.
    Title: NSPS for Fossil Fuel Fired Steam Generating Units (40 CFR
Part 60, Subpart D).
    ICR Numbers: EPA ICR Number 1052.10, OMB Control Number 2060-0026.
    ICR Status: This ICR is scheduled to expire on January 31, 2013.
    (15) Docket ID Number: EPA-HQ-OECA-2012-0500.
    Title: NESHAP for the Secondary Lead Smelter Industry (40 CFR Part
63, Subpart X).
    ICR Numbers: EPA ICR Number 1686.10, OMB Control Number 2060-0296.
    ICR Status: This ICR is scheduled to expire on January 31, 2013.
    (16) Docket ID Number: EPA-HQ-OECA-2012-0499.
    Title: NSPS for Industrial/Commercial/Institutional Steam
Generating Units (40 CFR Part 60, Subpart Db).
    ICR Numbers: EPA ICR Number 1088.13, OMB Control Number 2060-0072.
    ICR Status: This ICR is scheduled to expire on January 31, 2013.
    (17) Docket ID Number: EPA-HQ-OECA-2012-0502.
    Title: NSPS for Hospital/Medical/Infectious Waste Incinerators (40
CFR Part 60, Subpart Ec).
    ICR Numbers: EPA ICR Number 1730.09, OMB Control Number 2060-0363.
    ICR Status: This ICR is scheduled to expire on January 31, 2013.
    (18) Docket ID Number: EPA-HQ-OECA-2012-0534.
    Title: NSPS for Surface Coating of Plastic Parts for Business
Machines (40 CFR Part 60, Subpart TTT).
    ICR Numbers: EPA ICR Number 1093.10, OMB Control Number 2060-0162.
    ICR Status: This ICR is scheduled to expire on January 31, 2013.
    (19) Docket ID Number: EPA-HQ-OECA-2012-0498.
    Title: NSPS for Coal Preparation and Processing Plants (40 CFR Part
60, Subpart Y).
    ICR Numbers: EPA ICR Number 1062.13, OMB Control Number 2060-0122.
    ICR Status: This ICR is scheduled to expire on February 28, 2013.
    (20) Docket ID Number: EPA-HQ-OECA-2012-0503.
    Title: Emission Guidelines for Large Municipal Waste Combustors
Constructed on or Before September 20, 1994 (40 CFR Part 60, Subpart
Cb).
    ICR Numbers: EPA ICR Number 1847.06, OMB Control Number 2060-0390.
    ICR Status: This ICR is scheduled to expire on February 28, 2013.
    (21) Docket ID Number: EPA-HQ-OECA-2012-0519.
    Title: NESHAP for Miscellaneous Organic Chemical Manufacturing (40
CFR Part 63, Subpart FFFF).
    ICR Numbers: EPA ICR Number 1969.05, OMB Control Number 2060-0533.
    ICR Status: This ICR is scheduled to expire on February 28, 2013.
    (22) Docket ID Number: EPA-HQ-OECA-2012-0527.
    Title: NESHAP for Paints and Allied Products Manufacturing Area
Source Category (40 CFR Part 63, Subpart CCCCCCC).
    ICR Numbers: EPA ICR Number 2348.03, OMB Control Number 2060-0633.
    ICR Status: This ICR is scheduled to expire on February 28, 2013.
    (23) Docket ID Number: EPA-HQ-OECA-2012-0525.
    Title: NESHAP for Chemical Manufacturing Area Sources (40 CFR Part
63, Subpart VVVVVV).
    ICR Numbers: EPA ICR Number 2323.04, OMB Control Number 2060-0621.
    ICR Status: This ICR is scheduled to expire on February 28, 2013.
    (24) Docket ID Number: EPA-HQ-OECA-2012-0496.
    Title: NESHAP for Asphalt Processing and Asphalt Roofing
Manufacturing (40 CFR Part 63, Subpart AAAAAAA).
    ICR Numbers: EPA ICR Number 2352.03, OMB Control Number 2060-0634.
    ICR Status: This ICR is scheduled to expire on February 28, 2013.

C. Contact Individuals for ICRs

    (1) NESHAP for Metal Furniture Surface Coating (40 CFR Part 63,
Subpart RRRR); Learia Williams of the Office of Compliance at (202)
564-4113 or via Email to<EMAIL_ADDRESS>EPA ICR Number
1952.05; OMB Control Number 2060-0518; expiration date October 31,
2012.
    (2) NESHAP for Aluminum, Copper and Other Non-Ferrous Metals
Foundries (40 CFR Part 63, Subpart ZZZZZZ); Learia Williams of the
Office of Compliance at<PHONE_NUMBER> or via Email to:
<EMAIL_ADDRESS>EPA ICR Number 2332.03; OMB Control Number
2060-0630; expiration date October 31, 2012.
    (3) NSPS for Metal Furniture Coating (40 CFR Part 60, Subpart EE);
Learia Williams of the Office of Compliance at<PHONE_NUMBER> or via
Email to<EMAIL_ADDRESS>EPA ICR Number 0649.11; OMB Control
Number 2060-0106; expiration date November 30, 2012.
    (4) NESHAP for Mercury (40 CFR Part 61, Subpart E); Learia Williams
of the Office of Compliance at<PHONE_NUMBER> or via Email to:
<EMAIL_ADDRESS>EPA ICR Number 0113.11; OMB Control Number
2060-0097; expiration date November 30, 2012.
    (5) NESHAP for Secondary Aluminum Production (40 CFR Part 63,
Subpart RRR); Learia Williams of the Office of Compliance at (202) 564-
4113 or via Email to<EMAIL_ADDRESS>EPA ICR Number 1894.07;
OMB Control Number 2060-0433; expiration date November 30, 2012.
    (6) NSPS for Beverage Can Surface Coating (40 CFR Part 60, Subpart
WW); Learia Williams of the Office of Compliance at<PHONE_NUMBER> or
via Email to<EMAIL_ADDRESS>EPA ICR Number 0663.11; OMB
Control Number 2060-0001; expiration date December 31, 2012.
    (7) NSPS for Emission Guidelines and Compliance Times for Small
Municipal Waste Combustion Units Constructed on or Before August 30,
1999 (40 CFR Part 60, Subpart BBBB); Learia Williams of the Office of
Compliance at<PHONE_NUMBER> or via Email to<EMAIL_ADDRESS>
EPA ICR Number 1901.05; OMB Control Number 2060-0424; expiration date
December 31, 2012.
    (8) NSPS for Surface Coating of Large Appliance (40 CFR Part 60,
Subpart SS); Learia Williams of the Office of Compliance at (202) 564-
4113 or via Email to<EMAIL_ADDRESS>EPA ICR Number 0659.12;
OMB Control Number 2060-0108; expiration date December 31, 2012.
    (9) NSPS for Synthetic Fiber Production Facilities (40 CFR Part 60,
Subpart HHH); Learia Williams of the Office of Compliance at (202) 564-
4113 or via Email to<EMAIL_ADDRESS>EPA ICR Number 1156.12;
OMB Control Number 2060-0059; expiration date December 31, 2012.
    (10) NSPS for Secondary Lead Smelters (40 CFR Part 60, Subpart L);
Learia Williams of the Office of Compliance at<PHONE_NUMBER> or via

Email to<EMAIL_ADDRESS>EPA ICR Number 1128.10; OMB Control
Number 2060-0080; expiration date January 31, 2013.
    (11) NSPS for Small Municipal Waste Combustors (40 CFR Part 60,
Subpart AAAA); Learia Williams of the Office of Compliance at (202)
564-4113 or via Email to<EMAIL_ADDRESS>EPA ICR Number
1900.05; OMB Control Number 2060-0423; expiration date January 31,
2013.
    (12) NSPS for Stationary Combustion Turbines (40 CFR Part 60,
Subpart KKKK); Learia Williams of the Office of Compliance at (202)
564-4113 or via Email to<EMAIL_ADDRESS>EPA ICR Number
2177.05; OMB Control Number 2060-0582; expiration date January 31,
2013.
    (13) NSPS for the Phosphate Fertilizer Industry (40 CFR Part 60,
Subparts T, U, V, W and X); Learia Williams of the Office of Compliance
at<PHONE_NUMBER> or via Email to<EMAIL_ADDRESS>EPA ICR
Number 1061.12; OMB Control Number 2060-0037; expiration date January
31, 2013.
    (14) NSPS for Fossil Fuel Fired Steam Generating Units (40 CFR Part
60, Subpart D); Learia Williams of the Office of Compliance at (202)
564-4113 or via Email to<EMAIL_ADDRESS>EPA ICR Number
1052.10; OMB Control Number 2060-0026; expiration date January 31,
2013.
    (15) NESHAP for the Secondary Lead Smelter Industry (40 CFR Part
63, Subpart X); Learia Williams of the Office of Compliance at (202)
564-4113 or via Email to<EMAIL_ADDRESS>EPA ICR Number
1686.10; OMB Control Number 2060-0296; expiration date January 31,
2013.
    (16) NSPS for Industrial/Commercial/Institutional Steam Generating
Units (40 CFR Part 60, Subpart Db); Learia Williams of the Office of
Compliance at<PHONE_NUMBER> or via Email to<EMAIL_ADDRESS>
EPA ICR Number 1088.13; OMB Control Number 2060-0072; expiration date
January 31, 2013.
    (17) NSPS for Hospital/Medical/Infectious Waste Incinerators (40
CFR Part 60, Subpart Ec); Learia Williams of the Office of Compliance
at<PHONE_NUMBER> or via Email to<EMAIL_ADDRESS>EPA ICR
Number 1730.09; OMB Control Number 2060-0363; expiration date January
31, 2013.
    (18) NSPS for Surface Coating of Plastic Parts for Business
Machines (40 CFR Part 60, Subpart TTT); Learia Williams of the Office
of Compliance at<PHONE_NUMBER> or via Email to:
<EMAIL_ADDRESS>EPA ICR Number 1093.10; OMB Control Number
2060-0162; expiration date January 31, 2013.
    (19) NSPS for Coal Preparation and Processing Plants (40 CFR Part
60, Subpart Y); Learia Williams of the Office of Compliance at (202)
564-4113 or via Email to<EMAIL_ADDRESS>EPA ICR Number
1062.13; OMB Control Number 2060-0122; expiration date February 28,
2013.
    (20) Emission Guidelines for Large Municipal Waste Combustors
Constructed on or Before September 20, 1994 (40 CFR Part 60, Subpart
Cb); Learia Williams of the Office of Compliance at<PHONE_NUMBER> or
via Email to<EMAIL_ADDRESS>EPA ICR Number 1847.06; OMB
Control Number 2060-0390; expiration date February 28, 2013.
    (21) NESHAP for Miscellaneous Organic Chemical Manufacturing (40
CFR Part 63, Subpart FFFF); Learia Williams of the Office of Compliance
at<PHONE_NUMBER> or via Email to<EMAIL_ADDRESS>EPA ICR
Number 1969.05; OMB Control Number 2060-0533; expiration date February
28, 2013.
    (22) NESHAP for Paints and Allied Products Manufacturing Area
Source Category (40 CFR Part 63, Subpart CCCCCCC); Learia Williams of
the Office of Compliance at<PHONE_NUMBER> or via Email to:
<EMAIL_ADDRESS>EPA ICR Number 2348.03; OMB Control Number
2060-0633; expiration date February 28, 2013.
    (23) NESHAP for Chemical Manufacturing Area Sources (40 CFR Part
63, Subpart VVVVVV); Learia Williams of the Office of Compliance at
(202) 564-4113 or via Email to<EMAIL_ADDRESS>EPA ICR Number
2323.04; OMB Control Number 2060-0621; expiration date February 28,
2013.
    (24) NESHAP for Asphalt Processing and Asphalt Roofing
Manufacturing (40 CFR Part 63, Subpart AAAAAAA); Learia Williams of the
Office of Compliance at<PHONE_NUMBER> or via Email to:
<EMAIL_ADDRESS>EPA ICR Number 2352.03; OMB Control Number
2060-0634; expiration date February 28, 2013.

D. Information for Individual ICRs

    (1) NESHAP for Metal Furniture Surface Coating (40 CFR Part 63,
Subpart RRRR); Docket ID Number: EPA-HQ-OECA-2012-0518; EPA ICR Number
1952.05; OMB Control Number 2060-0518; expiration date October 31,
2012.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of facilities that perform metal furniture
surface coating operations.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the General Provisions specified at 40 CFR part 63,
subpart RRRR.
    Owners or operators of the affected facilities must submit a one-
time-only of any physical or operational changes, initial performance
tests, and periodic reports and results. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Reports are also required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 109 hours per response.
    Respondents/Affected Entities: Metal furniture surface coating
facilities
    Estimated Number of Respondents: 583
    Frequency of Response: Initially, occasionally and semiannually
    Estimated Total Annual Hour Burden: 190,408
    Estimated Total Annual Cost: $16,826,397, which includes
$16,126,797 in labor costs, no capital/startup costs, and $699,600 in
operating and maintenance costs.
    (2) NESHAP for Aluminum, Copper and Other Non-Ferrous Metals
Foundries (40 CFR Part 63, Subpart ZZZZZZ); Docket ID Number: EPA-HQ-
OECA-2012-0526; EPA ICR Number 2332.03; OMB Control Number 2060-0630;
expiration date October 31, 2012.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of aluminum, copper, or other non-ferrous metal
foundries.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the General Provisions specified at 40 CFR part 63,
subpart ZZZZZZ.
    Owners or operators of the affected facilities must submit a one-
time-only of any physical or operational changes, initial performance
tests, and periodic reports and results. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Reports are also required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is

estimated to average approximately 17 hours per response.
    Respondents/Affected Entities: Aluminum, copper and other non-
ferrous metal foundries
    Estimated Number of Respondents: 318
    Frequency of Response: Initially and occasionally
    Estimated Total Annual Hour Burden: 7,160
    Estimated Total Annual Cost: $408,855, which includes $408,855 in
labor costs, no capital/startup costs, and no operating and maintenance
costs.
    (3) NSPS for Metal Furniture Coating (40 CFR Part 60, Subpart EE);
Docket ID Number EPA-HQ-OECA-2012-0530; EPA ICR Number 0649.11; OMB
Control Number 2060-0106; expiration date November 30, 2012.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of metal furniture surface coating facilities.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart EE.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 58 hours per response.
    Respondents/Affected Entities: Metal furniture surface coating
facilities
    Estimated Number of Respondents: 400
    Frequency of Response: Initially, occasionally and semiannually
    Estimated Total Annual Hour Burden: 56,074
    Estimated Total Annual Cost: $5,589,248, which includes $4,749,248
in labor costs, no capital/startup costs, and $840,000 in operating and
maintenance costs.
    (4) NESHAP for Mercury (40 CFR Part 61, Subpart E); Docket ID
Number: EPA-HQ-OECA-2012-0529; EPA ICR Number 0113.11; OMB Control
Number 2060-0097; expiration date November 30, 2012.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of stationary sources which process mercury ore
to recover mercury, use mercury chlor-alkali cells to produce chlorine
gas and alkali metal hydroxide, and incinerate or dry wastewater
treatment plant sludge.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the General Provisions specified at 40 CFR part 61,
subpart E.
    Owners or operators of the affected facilities must submit a one-
time-only of any physical or operational changes, initial performance
tests, and periodic reports and results. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Reports are also required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 160 hours per response.
    Respondents/Affected Entities: Stationary sources which process
mercury ore to recover mercury, use mercury chlor-alkali cells to
produce chlorine gas and alkali metal hydroxide, and incinerate or dry
wastewater treatment plant sludge
    Estimated Number of Respondents: 107
    Frequency of Response: Initially, semiannually and annually
    Estimated Total Annual Hour Burden: 20,490
    Estimated Total Annual Cost: $1,735,421, which includes $1,735,421
in labor costs, no capital/startup costs, and no operating and
maintenance costs.
    (5) NESHAP for Secondary Aluminum Production (40 CFR Part 63,
Subpart RRR); Docket ID Number: EPA-HQ-OECA-2012-0505; EPA ICR Number
1894.07; OMB Control Number 2060-0433; expiration date November 30,
2012.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of secondary aluminum production plants.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the General Provisions specified at 40 CFR part 63,
subpart RRR.
    Owners or operators of the affected facilities must submit a one-
time-only of any physical or operational changes, initial performance
tests, and periodic reports and results. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Reports are also required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 29 hours per response.
    Respondents/Affected Entities: Secondary aluminum production plants
    Estimated Number of Respondents: 1,624
    Frequency of Response: Initially, occasionally and semiannually
    Estimated Total Annual Hour Burden: 93,725
    Estimated Total Annual Cost: $8,163,900, which includes $7,938,150
in labor costs, $84,000 in capital/startup costs, and $141,750 in
operating and maintenance costs.
    (6) NSPS for Beverage Can Surface Coating (40 CFR Part 60, Subpart
WW); Docket ID Number EPA-HQ-OECA-2012-0532; EPA ICR Number 0663.11;
OMB Control Number 2060-0001; expiration date December 31, 2012.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of beverage can surface coating facilities.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart WW.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 43 hours per response.
    Respondents/Affected Entities: Beverage can surface coating
facilities
    Estimated Number of Respondents: 48
    Frequency of Response: Initially, occasionally and semiannually
    Estimated Total Annual Hour Burden: 5,134
    Estimated Total Annual Cost: $515,230, which includes $414,430 in
labor costs, no capital/startup costs, and $100,800 in operating and
maintenance costs.
    (7) NSPS for Emission Guidelines and Compliance Times for Small
Municipal Waste Combustion Units Constructed on

or Before August 30, 1999 (40 CFR Part 60, Subpart BBBB); Docket ID
Number EPA-HQ-OECA-2012-0517; EPA ICR Number 1901.05, OMB Control
Number 2060-0424; expiration date December 31, 2012.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of small municipal waste combustion units.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart BBBB.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 1,709 hours per response.
    Respondents/Affected Entities: Owners and operators of small
municipal waste combustion units
    Estimated Number of Respondents: 23
    Frequency of Response: Initially, occasionally, semiannually and
annually
    Estimated Total Annual Hour Burden: 100,854
    Estimated Total Annual Cost: $9,578,726, which includes $8,541,926
in labor costs, no capital/startup costs, and $1,036,800 in operating
and maintenance costs.
    (8) NSPS for Surface Coating of Large Appliance (40 CFR Part 60,
Subpart SS); Docket ID Number EPA-HQ-OECA-2012-0531; EPA ICR Number
0659.12, OMB Control Number 2060-0108; expiration date December 31,
2012.
    Affected Entities: Entities potentially affected by this action are
the owners or operators for surface coating of large appliance
facilities.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart SS.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 53 hours per response.
    Respondents/Affected Entities: Surface coating of large appliance
facilities
    Estimated Number of Respondents: 72
    Frequency of Response: Occasionally and semiannually
    Estimated Total Annual Hour Burden: 7,659
    Estimated Total Annual Cost: $657,087, which includes $648,687 in
labor costs, no capital/startup costs, $8,400 in operating and
maintenance costs.
    (9) NSPS for Synthetic Fiber Production Facilities (40 CFR Part 60,
Subpart HHH); Docket ID Number EPA-HQ-OECA-2012-0528; EPA ICR Number
1156.12; OMB Control Number 2060-0059; expiration date December 31,
2012.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of synthetic fiber production facilities.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart HHH.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 34 hours per response.
    Respondents/Affected Entities: Synthetic fiber production
facilities
    Estimated Number of Respondents: 22
    Frequency of Response: Occasionally, quarterly and semiannually
    Estimated Total Annual Hour Burden: 1,859
    Estimated Total Annual Cost: $315,119, which includes $150,119 in
labor costs, no capital/startup costs, and $165,000 in operating and
maintenance costs.
    (10) NSPS for Secondary Lead Smelters (40 CFR Part 60, Subpart L);
Docket ID Number EPA-HQ-OECA-2012-0535; EPA ICR Number 1128.10, OMB
Control Number 2060-0080; expiration date January 31, 2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of secondary lead smelting facilities.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart L.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 2 hours per response.
    Respondents/Affected Entities: Secondary lead smelting facilities
    Estimated Number of Respondents: 25
    Frequency of Response: Initially and occasionally
    Estimated Total Annual Hour Burden: 38
    Estimated Total Annual Cost: $3,538, which includes $3,538 in labor
costs, no capital/startup costs, and no operating and maintenance
costs.
    (11) NSPS for Small Municipal Waste Combustors (40 CFR Part 60,
Subpart AAAA); Docket ID Number EPA-HQ-OECA-2012-0506; EPA ICR Number
1900.05, OMB Control Number 2060-0423; expiration date January 31,
2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of small municipal waste combustors.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart AAAA.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 1,108 hours per response.

    Respondents/Affected Entities: Owners and operators of small
municipal waste combustors
    Estimated Number of Respondents: 2
    Frequency of Response: Initially, occasionally, semiannually and
annually
    Estimated Total Annual Hour Burden: 9,975
    Estimated Total Annual Cost: $1,087,204, which includes $938,068 in
labor costs, $66,000 in capital/startup costs, and $83,136 in operating
and maintenance costs.
    (12) NSPS for Stationary Combustion Turbines (40 CFR Part 60,
Subpart KKKK); Docket ID Number EPA-HQ-OECA-2012-0524; EPA ICR Number
2177.05, OMB Control Number 2060-0582; expiration date January 31,
2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of stationary combustion turbines.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart KKKK.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 37 hours per response.
    Respondents/Affected Entities: Owners and operators of stationary
combustion turbines
    Estimated Number of Respondents: 307
    Frequency of Response: Semiannually
    Estimated Total Annual Hour Burden: 32,075
    Estimated Total Annual Cost: $2,983,850, which includes $2,983,850
in labor costs, no capital/startup costs, and no operating and
maintenance costs.
    (13) NSPS for Phosphate Fertilizer Industry (40 CFR Part 60,
Subparts T,U,V,W and X); Docket ID Number EPA-HQ-OECA-2012-0533; EPA
ICR Number 1061.12, OMB Control Number 2060-0037; expiration date
January 31, 2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of wet-process phosphoric acid plants,
superphosphoric acid plants, granular diammonium phosphate plants,
triple superphosphate plants and granular triple superphosphate storage
facilities.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subparts T, U, V, W and X.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 46 hours per response.
    Respondents/Affected Entities: Wet-process phosphoric acid plants,
superphosphoric acid plants, granular diammonium phosphate plants,
triple superphosphate plants and granular triple superphosphate storage
facilities
    Estimated Number of Respondents: 13
    Frequency of Response: Initially, occasionally and semiannually
    Estimated Total Annual Hour Burden: 1,194
    Estimated Total Annual Cost: $437,702, which includes $117,512 in
labor costs, no capital/startup costs, and $320,190 in operating and
maintenance costs.
    (14) NSPS for Fossil Fuel Fired Stream Generating Units (40 CFR
Part 60, Subpart D); Docket ID Number EPA-HQ-OECA-2012-0497; EPA ICR
Number 1052.10; OMB Control Number 2060-0026; expiration date January
31, 2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of fossil fuel fired steam generating units.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart D.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 47 hours per response.
    Respondents/Affected Entities: Owners and operators of fossil
fueled fired steam generating units
    Estimated Number of Respondents: 660
    Frequency of Response: Initially, occasionally and semiannually
    Estimated Total Annual Hour Burden: 61,545
    Estimated Total Annual Cost: $15,688,147, which includes $5,788,147
in labor costs, no capital/startup costs, and $9,900,000 in operating
and maintenance costs.
    (15) NESHAP for Secondary Lead Smelter Industry (40 CFR Part 63,
Subpart X); Docket ID Number: EPA-HQ-OECA-2012-0500; EPA ICR Number
1686.10; OMB Control Number 2060-0296; expiration date January 31,
2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of secondary lead smelting facilities.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the General Provisions specified at 40 CFR part 63,
subpart X.
    Owners or operators of the affected facilities must submit a one-
time-only of any physical or operational changes, initial performance
tests, and periodic reports and results. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Reports are also required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 214 hours per response.
    Respondents/Affected Entities: Owners or operations of industrial,
commercial or institutional steam generating units
    Estimated Number of Respondents: 1,500
    Frequency of Response: Initially, occasionally, quarterly and
semiannually
    Estimated Total Annual Hour Burden: 771,889
    Estimated Total Annual Cost: $1,379,153, which includes $788,873 in
labor costs, $105,800 in capital/startup costs, and $484,480 in
operating and maintenance costs.

    (16) NSPS for Industrial/Commercial/Institutional Steam Generating
Units (40 CFR Part 60, Subpart Db); Docket ID Number EPA-HQ-OECA-2012-
0499; EPA ICR Number 1088.13; OMB Control Number 2060-0072; expiration
date January 31, 2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of industrial, commercial or institutional
steam generating units.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart Db.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 47 hours per response.
    Respondents/Affected Entities: Owners and operators of fossil
fueled fired steam generating units.
    Estimated Number of Respondents: 660
    Frequency of Response: Initially, occasionally and semiannually
    Estimated Total Annual Hour Burden: 61,545
    Estimated Total Annual Cost: $94,838,557, which includes
$63,338,557 in labor costs, $9,000,000 in capital/startup costs, and
$22,500,000 in operating and maintenance costs.
    (17) NSPS for Hospital/Medical/Infectious Waste Incinerators (40
CFR Part 60, Subpart Ec); Docket ID Number EPA-HQ-OECA-2012-0502; EPA
ICR Number 1730.09; OMB Control Number 2060-0363; expiration date
January 31, 2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of hospital, medical or infectious waste
incinerators.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart Ec.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 113 hours per response.
    Respondents/Affected Entities: Owners and operators of hospital,
medical or infectious waste incinerators
    Estimated Number of Respondents: 3
    Frequency of Response: Initially, occasionally, semiannually and
annually
    Estimated Total Annual Hour Burden: 2,705
    Estimated Total Annual Cost: $356,403, which includes $102,553 in
labor costs, $137,658 in capital/startup costs, and $116,192 in
operating and maintenance costs.
    (18) NSPS for Surface Coating of Plastic Parts for Business
Machines (40 CFR Part 60, Subpart TTT); Docket ID Number EPA-HQ-OECA-
2012-0534; EPA ICR Number 1093.10; OMB Control Number 2060-0162;
expiration date January 31, 2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of facilities that apply coatings to plastic
parts for use in the manufacture of business machines.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart TTT.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 35 hours per response.
    Respondents/Affected Entities: Owners or operators of facilities
that apply coatings to plastic parts for use in the manufacture of
business machines
    Estimated Number of Respondents: 10
    Frequency of Response: Quarterly and semiannually
    Estimated Total Annual Hour Burden: 978
    Estimated Total Annual Cost: $92,296, which includes $92,296 in
labor costs, no capital/startup costs, and no operating and maintenance
costs.
    (19) NSPS for Coal Preparation and Processing Plants (40 CFR Part
60, Subpart Y); Docket ID Number EPA-HQ-OECA-2012-0498; EPA ICR Number
1062.13; OMB Control Number 2060-0122; expiration date February 28,
2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of coal preparation and processing plants.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart Y.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 21 hours per response.
    Respondents/Affected Entities: Coal preparation and processing
plants.
    Estimated Number of Respondents: 1,027
    Frequency of Response: Initially, semiannually and annually
    Estimated Total Annual Hour Burden: 38,783
    Estimated Total Annual Cost: $3,314,442, which includes $2,601,624
in labor costs, $674,528 in capital/startup costs, and $38,290 in
operating and maintenance costs.
    (20) Emission Guidelines for Large Municipal Waste Combustors
Constructed on or Before September 20, 1994 (40 CFR Part 60, Subpart
Cb); Docket ID Number EPA-HQ-OECA-2012-0503; EPA ICR Number 1847.06;
OMB Control Number 2060-0390; expiration date February 28, 2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of large municipal waste combustors.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 62, subpart A and any changes, or
additions to the General Provisions specified at 40 CFR part 60,
subpart Cb.
    Owners or operators of the affected facilities must make an initial
notification, performance tests, periodic reports, and maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the

operation of an affected facility, or any period during which the
monitoring system is inoperative. Reports are also required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 1,725 hours per response.
    Respondents/Affected Entities: Owners or operators of large
municipal waste combustors
    Estimated Number of Respondents: 81
    Frequency of Response: Semiannually and annually
    Estimated Total Annual Hour Burden: 394,954
    Estimated Total Annual Cost: $50,457,165, which includes
$48,901,965 in labor costs, no capital/startup costs, and $1,555,200 in
operating and maintenance costs.
    (21) NESHAP for Miscellaneous Organic Chemical Manufacturing (40
CFR Part 63, Subpart FFFF); Docket ID Number: EPA-HQ-OECA-2012-0519;
EPA ICR Number 1969.05; OMB Control Number 2060-0533; expiration date
February 28, 2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of miscellaneous organic chemical manufacturing
facilities.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the General Provisions specified at 40 CFR part 63,
subpart FFFF.
    Owners or operators of the affected facilities must submit a one-
time-only of any physical or operational changes, initial performance
tests, and periodic reports and results. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Reports are also required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 254 hours per response.
    Respondents/Affected Entities: Miscellaneous organic chemical
manufacturing facilities
    Estimated Number of Respondents: 257
    Frequency of Response: Initially, occasionally and semiannually
    Estimated Total Annual Hour Burden: 416,830
    Estimated Total Annual Cost: $41,436,793, which includes
$35,303,884 in labor costs, $670,256 in capital/startup costs, and
$5,462,653 in operating and maintenance costs.
    (22) NESHAP for Paints and Allied Products Manufacturing Area
Source Category (40 CFR Part 63, Subpart CCCCCCC); Docket ID Number:
EPA-HQ-OECA-2012-0527; EPA ICR Number 2348.03; OMB Control Number 2060-
0633; expiration date February 28, 2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of paints and allied products manufacturing
facilities.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the General Provisions specified at 40 CFR part 63,
subpart CCCCCCC.
    Owners or operators of the affected facilities must submit a one-
time-only of any physical or operational changes, initial performance
tests, and periodic reports and results. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Reports are also required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 3 hours per response.
    Respondents/Affected Entities: Paint and allied product
manufacturing facilities
    Estimated Number of Respondents: 2,190
    Frequency of Response: Initially and annually
    Estimated Total Annual Hour Burden: 4,618
    Estimated Total Annual Cost: $880,818, which includes $880,818 in
labor costs, no capital/startup costs, and no operating and maintenance
costs.
    (23) NESHAP for Chemical Manufacturing Area Sources (40 CFR Part
63, Subpart VVVVVV); Docket ID Number: EPA-HQ-OECA-2012-0525; EPA ICR
Number 2323.04; OMB Control Number 2060-0621; expiration date February
28, 2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of chemical manufacturing facilities.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the General Provisions specified at 40 CFR part 63,
subpart VVVVVV.
    Owners or operators of the affected facilities must submit a one-
time-only of any physical or operational changes, initial performance
tests, and periodic reports and results. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Reports are also required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 9 hours per response.
    Respondents/Affected Entities: Chemical manufacturing facilities
    Estimated Number of Respondents: 479
    Frequency of Response: Semiannually
    Estimated Total Annual Hour Burden: 10,586
    Estimated Total Annual Cost: $905,135, which includes $806,864 in
labor costs, $69,484 in capital/startup costs, and $28,787 in operating
and maintenance costs.
    (24) NESHAP for Asphalt Processing and Asphalt Roofing
Manufacturing (40 CFR Part 63, Subpart AAAAAAA); Docket ID Number: EPA-
HQ-OECA-2012-0496; EPA ICR Number 2352.03, OMB Control Number 2060-
0634; expiration date February 28, 2013.
    Affected Entities: Entities potentially affected by this action are
the owners or operators of asphalt processing and roofing manufacturing
facilities.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the General Provisions specified at 40 CFR part 63,
subpart AAAAAAA.
    Owners or operators of the affected facilities must submit a one-
time-only of any physical or operational changes, initial performance
tests, and periodic reports and results. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Reports are also required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
approximately 28 hours per response.
    Respondents/Affected Entities: Asphalt processing and asphalt
roofing manufacturing facilities
    Estimated Number of Respondents: 75
    Frequency of Response: Semiannually and annually
    Estimated Total Annual Hour Burden: 4,147
    Estimated Total Annual Cost: $713,081, which includes $672,254 in

labor costs, $5,400 in capital/startup costs, and $35,427 in operating
and maintenance costs.
    EPA will consider any comments received and may amend any of the
above ICRs, as appropriate. Then the final ICR packages will be
submitted to OMB for review and approval pursuant to 5 CFR 1320.12. At
that time, EPA will issue one or more Federal Register notices pursuant
to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR(s) to
OMB and the opportunity to submit additional comments to OMB. If you
have any questions about any of the above ICRs or the approval process,
please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: August 1, 2012.
Lisa C. Lund,
Director, Office of Compliance.
[FR Doc. 2012-19422 Filed 8-7-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Page 42388]
[FR Doc No: C1-2016-14086]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78029; File No. SR-NYSEMKT-2016-45]

Self-Regulatory Organizations; NYSE MKT LLC; Suspension of and
Order Instituting Proceedings To Determine Whether To Approve or
Disapprove a Proposed Rule Change To Modify the NYSE Amex Options Fee
Schedule With Respect to Fees, Rebates, and Credits for Transactions in
the Customer Best Execution Auction

June 9, 2016.

Correction

    In notice document 2016-14086, beginning on page 39089 in the issue
of Wednesday, June 15, 2016, make the following corrections:
    1. On page 39091, in the third column, in the ninth and tenth
lines, ``July 5, 2016'' should read ``July 6, 2016''.
    2. On the same page, in the eleventh line, ``July 19, 2016'' should
read ``July 20, 2016''.

[FR Doc. C1-2016-14086 Filed 6-28-16; 8:45 am]
BILLING CODE 1505-01-D


[Federal Register Volume 76, Number 36 (Wednesday, February 23, 2011)]
[Notices]
[Page 10085]
[FR Doc No: 2011-3978]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending January 1, 2011

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-1999-5140.
    Date Filed: December 30, 2010.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: January 20, 2011.
    Description: Application of Arrow Air, Inc. d/b/a Arrow Air
requesting to change the name in which its operating authority has been
issued to: Alpha Cargo Airlines, Inc., d/b/a Alpha Cargo, and for
reissuance of its certificate of public convenience and necessity in
that name.

Renee V. Wright,
 Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2011-3978 Filed 2-22-11; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Notices]
[Pages 49341-49342]
[FR Doc No: 2021-18962]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2021-0628]

National Navigation Safety Advisory Committee Meeting

AGENCY: Coast Guard, Department of Homeland Security.

ACTION: Notice of federal advisory committee meeting.

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SUMMARY: The National Navigation Safety Advisory Committee (Committee)
will meet in Portsmouth, Virginia to discuss matters relating to
maritime collisions, rammings, and groundings; Inland Rules of the
Road; International Rules of the Road; navigation regulations and
equipment; routing measures; marine information; and aids to navigation
systems. The meeting will be open to the public.

DATES:
    Meeting: The Committee will meet on Tuesday, September 21, and
Wednesday, September 22, 2021, from 8 a.m. to 5:30 p.m. Eastern
Daylight Time (EDT). Please note that this meeting may adjourn early if
the Committee has completed its business.
    Comments and supporting documentations: To ensure your comments are
received by Committee members before the meeting, submit your written
comments no later than September 15, 2021.

ADDRESSES: The meeting will be held at the Renaissance Portsmouth-
Norfolk Waterfront hotel, 425 Water Street, Portsmouth, VA 23704.
https://www.marriott.com/hotels/travel/orfpt-renaissance-portsmouth-norfolk-waterfront-hotel/?scid=bb1a189a-fec3-4d19-a255-4ba596febe2&y_source=1_MTYzODkzNC03MTUtbG9jYXRpb24uZ29vZ2xlX3dlYnNpdGVfb3ZlcnJpZGU%3D.
    Pre-registration Information: Pre-registration is not required for
access. Attendees will be required to follow COVID-19 safety guidelines
promulgated by the Centers for Disease Control and Prevention (CDC).
Masks will be provided for all attendees regardless of vaccination
status. The most up to date CDC guidance can be found here: https://www.cdc.gov/coronavirus/2019-ncov/communication/guidance.html.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this notice.
    Instructions: You are free to submit comments at any time,
including orally at the meeting, but if you want Committee members to
review your comment before the meeting, please submit your comments no
later than September 15, 2021. We are particularly interested in
comments on the issues in the ``Agenda'' section below. We encourage
you to submit comments through the Federal eRulemaking Portal at
https://www.regulations.gov. If your material cannot be submitted using
https://www.regulations.gov, call or email the individual in the FOR
FURTHER INFORMATION CONTACT section of this document for alternate
instructions. You must include the words ``Department of Homeland
Security'' and the docket number USCG-2021-0628. Comments received will
be posted without alteration at https://www.regulations.gov, including
any personal information provided. You may wish to view the Privacy and
Security Notice available on the homepage of https://www.regulations.gov, and DHS's eRulemaking System of Records notice
(85FR 14226, March 11, 2020). If you encounter technical difficulties
with comment submission, contact the individual listed in the FOR
FURTHER INFORMATION CONTACT section of this notice.
    Docket Search: Documents mentioned in this notice as being
available in the docket, and all public comment, will be in our online
docket at https://www.regulations.gov and can be viewed by following
that website's instructions. Additionally, if you go to the online
docket and sign-up for email alerts, you will be notified when comments
are posted.

FOR FURTHER INFORMATION CONTACT: Mr. George Detweiler, Alternate
Designated Federal Officer of the National Navigation Safety Advisory
Committee, telephone<PHONE_NUMBER>, or email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice of this meeting is in compliance with
the Federal Advisory Committee Act (5 U.S.C. appendix). The National
Navigation Safety Advisory Committee is authorized by section 601 of
the Frank LoBiondo Act of 2018 and is codified in 46 U.S.C. 15107. The
Committee operates under the

provisions of the Federal Advisory Committee Act (5 U.S.C. appendix) in
addition to the administrative provisions applicable to all National
Maritime Transportation Advisory Committees in 46 U.S.C. 15109. The
Committee advises the Secretary of the Department of Homeland Security
through the Commandant of the Coast Guard on matters relating to
maritime collisions, rammings, and groundings; Inland Rules of the
Road; International Rules of the Road; navigation regulations and
equipment; routing measures; marine information; and aids to navigation
systems.

Agenda

Day 1

    The agenda for the September 21, 2021 is as follows:

1. Call to order.
2. Introduction.
3. Remarks by the Chairman and the Designated Federal Officer (DFO).
4. Roll call of Committee members and determination of a quorum.
5. Presentations on autonomous and unmanned systems, chart carriage
requirements, and navigation safety in and around Offshore Renewable
Energy Installations (OREI).
6. Presentation of Tasks. Following the above presentations, the
Committee Chairman and the Designated Federal Officer will form
subcommittees to discuss the following task statement:
    1. Task Statement 21-01, Autonomous and unmanned systems.
    2. Task Statement 21-02, Chart carriage requirement.
    3. Task Statement 21-03, Navigation safety in and around Offshore
Renewable Energy Installations.
7. Public comment period.
8. Report by Subcommittees on accomplishments.
9. Adjournment of meeting.

Day 2

    The agenda for September 22, 2021 meetings is as follows:

1. Call to order.
2. Introduction.
3. Remarks by the Chairman and the DFO.
4. Roll call of Committee members and determination of a quorum.
5. Subcommittee discussions continued from Tuesday, 21 September, 2021.
6. Public comment period.
7. Subcommittee reports presented to the Committee.
8. Schedule next meeting date.
9. Closing remarks by the Chairman and the DFO.
10. Adjournment of meeting.

    A copy of all meeting documentation will be available, by September
15, 2021, by going to the Coast Guard Homeport website, https://homeport.uscg.mil, selecting the Missions tab, and navigating to the
Federal Advisory Committees section. Alternatively, you may contact Mr.
George Detweiler as noted in the FOR FURTHER INFORMATION CONTACT
section above.
    A public comment period will be held during each Subcommittee and
full Committee meeting concerning matters being discussed. Speakers are
requested to limit their comments to 5 minutes. Please note that the
public comment period will end following the last call for comments.
Contact the individual listed in the FOR FURTHER INFORMATION CONTACT
section above, to register as a speaker.

    Dated: August 27, 2021.
Michael D. Emerson,
Director, Marine Transportation Systems.
[FR Doc. 2021-18962 Filed 9-1-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: August 3, 2010 (Volume 75, Number 148)]
[Proposed Rules]
[Page 45591-45592]
[DOCID:fr03au10-26]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Part 192

[Docket No. PHMSA-2009-0203]

Pipeline Safety: Notice of Technical Pipeline Safety Advisory
Committee Meetings

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

ACTION: Notice of technical pipeline safety advisory committee
meetings.

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

SUMMARY: This notice announces a public meeting of the Technical
Pipeline Safety Standards Committee (TPSSC) and of the Technical
Hazardous Liquid Pipeline Safety Standards Committee (THLPSSC). The
PHMSA staff will brief the committee members on pipeline regulatory
actions and policy concerns. The purpose of the meeting is to keep the
members updated on current safety concerns, proposed rules, and future
proposals.

DATES: The meeting will be on Thursday, August 19, 2010, from 1 p.m. to
4 p.m. EST.

FOR FURTHER INFORMATION CONTACT: Cheryl Whetsel by phone at 202-366-
4431 or by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Meeting Details

    The TPSSC and the THLPSSC will take part in the meeting by
telephone conference call. The public may attend the meeting at the
U.S. Department of Transportation, 1200 New Jersey Avenue, SE.,
Washington, DC 20590, Room E27-302. Attendees should register in
advance at http://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=66.
PHMSA will post any new information or changes on the PHMSA/Office of
Pipeline Safety web page (http://PHMSA.dot.gov) about 15 days before
the meeting takes place.
    Comments on the meeting may be submitted 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 20590-001.
    Hand Delivery: Room W12-140 on the ground level of the DOT West
Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays.
    Instructions: Identify the docket number, PHMSA-2009-0203 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. You should know that anyone is able to
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, you may want to review 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 a.m. and 5 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-2009-0203.'' The Docket Clerk
date stamps the postcard prior to returning it to you via the U.S.
mail. Please note that due to delays in the delivery of U.S. mail to
Federal offices in Washington, DC, we recommend that persons consider
an alternative method (internet, fax, or professional delivery service)
of submitting comments to the docket and ensuring their timely receipt
at DOT.

Privacy Act Statement

    Anyone may search the electronic form of comments received in
response to 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.). DOT's complete Privacy Act
Statement was published in the Federal Register on April 11, 2000 (65
FR 19477).

Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities, or to seek special assistance at the meetings, please
contact Cheryl Whetsel at<PHONE_NUMBER> by August 16, 2010.

II. Committee Background

    These two statutorily-mandated committees advise PHMSA on proposed
safety standards, risk assessments, and safety policies for natural gas
pipelines and for hazardous liquid pipelines. Both committees fall
under the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. App.
1) and both are mandated by the pipeline safety law (49 U.S.C. Chap.
601). Each committee consists of 15 members--with membership evenly
divided among the Federal and State Government, the regulated industry,
and the public. The committees advise PHMSA on technical feasibility,
practicability, and cost-effectiveness of each proposed pipeline safety
standard.

III. Preliminary Agenda

    The PHMSA staff will brief the committees on several regulatory and
policy initiatives including:
     Pipeline safety reauthorization.
     PHMSA accomplishments (National Transportation Safety
Board, General Accounting Office, Congressional mandates).
     PHMSA priorities (new construction, damage prevention),
and the status of PHMSA rulemaking initiatives.
     Administrative matters of the committee (charter, how we
can best conduct business).

    Authority:  49 U.S.C. 60102, 60115; 60118.

    Issued in Washington, DC, on July 27, 2010.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2010-19063 Filed 8-2-10; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Pages 37230-37232]
[FR Doc No: 2017-16720]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4076]

Benefit-Risk Assessments in Drug Regulatory Decision-Making;
Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public meeting to convene a discussion of topics related
to the structured assessment of benefits and risks in drug regulatory
decision-making. This meeting will focus on regulatory and industry
experiences with approaches to structured benefit-risk assessments,
approaches to incorporating patient perspectives into structured
benefit-risk assessment, and exploration of methods to advance
structured benefit-risk assessment. The format of the meeting will
include a series of presentations on the above topics related to
structured assessment of benefits and risks, followed by a discussion
on those topics with invited panelists and audience members. This
meeting satisfies an FDA commitment that is part of the fifth
authorization of the Prescription Drug User Fee Act (PDUFA V).

DATES: The public meeting will be held on September 18, 2017, from 9
a.m. to 5 p.m. Registration to attend the meeting must be received by
September 11, 2017 (see the SUPPLEMENTARY INFORMATION section for
instructions). Public comments will be accepted through November 18,
2017. See the ADDRESSES section for information about submitting
comments to the public docket.

ADDRESSES: The public meeting will be held on September 18, 2017, at
the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference
Center (the Great Room), Silver Spring, MD 20993-0002. Entrance for the
public meeting participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For more
information on parking and security procedures, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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 November 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 18, 2017. 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-2017-N-4076 for ``Benefit-Risk Assessments in Drug Regulatory
Decision-Making; Public Meeting, Request for Comments.'' 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.
    FDA will post the agenda approximately 5 days before the meeting
at: https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm378861.htm.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301-
796-5003, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed into law the Food and Drug
Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144).
Title I of FDASIA reauthorizes PDUFA V and provides FDA with the user
fee resources necessary to maintain an efficient review process for
human drug and biological products. The reauthorization of PDUFA V
includes performance goals and procedures for the Agency that
represents FDA's commitments during fiscal years 2013-2017. These
commitments are fully described in the document entitled ``PDUFA
Reauthorization Performance Goals and Procedures Fiscal Years 2013
through 2017'' (PDUFA Goals Letter), available on FDA's Web site at
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
    Section X of the PDUFA Goals Letter, entitled ``Enhancing Benefit-
Risk Assessment in Regulatory Decision-Making,'' includes development
of a plan to further develop and implement a structured approach to
benefit-risk assessment in the human drug review process. As part of
this enhancement, FDA committed to holding two public workshops on
benefit-risk considerations from the regulator's perspective that will
begin by the first quarter of fiscal year 2014. The public workshop
held in 2014 fulfilled the first of the two workshop commitments. The
workshop announced by this notice will fulfill the second of the two
workshop commitments.
    As part of its commitment, FDA has published the ``Structured
Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making:
Draft PDUFA V Implementation Plan,'' available on FDA's Web site at
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf. In this Plan, FDA identified as
an area of further development the exploration of structured approaches
to evaluate and communicate the assessment of benefits and risks. FDA's
human drug regulatory decisions are informed by an extensive body of
evidence on the safety and efficacy of a drug product, as well as other
factors affecting the benefit-risk assessment, including the nature and
severity of the condition the drug is intended to treat or prevent, the
benefits and risks of other available therapies for the condition, and
any risk management tools that might be necessary to ensure that the
benefits outweigh the risks. A structured benefit-risk framework serves
as a foundational element to FDA's benefit-risk assessments.

II. Purpose and Scope of the Meeting

    This public meeting will focus on: (1) Regulatory and industry
experiences with approaches to structured benefit-risk assessments, and
the results of implementing structured frameworks at regulatory
agencies both for premarket application review and postmarket safety
review, (2) approaches to incorporating patient perspectives into
structured benefit-risk assessment, and (3) exploration of methods to
advance structured benefit-risk assessment. This meeting will be an
opportunity to share any challenges and lessons learned in applying a
more structured approach to regulatory decision-making. The public
meeting will also explore more systematic and structured approaches to
evaluate and communicate methods of assessing benefits and risks; and
their implications on human drug regulatory decisions. Specifically,
the workshop will examine FDA, other regulatory

agencies, industry, and external perspectives and experiences with
structured benefit-risk assessment. This public meeting will have
discussion sessions focusing on the entire drug development life cycle,
including premarket drug review and postmarket safety surveillance. The
format of the meeting consists of a series of presentations on topics
related to structured assessment of benefits and risks, followed by a
discussion on those topics with invited panelists and audience members.

III. Meeting Attendance and Participation

    Registration: If you wish to attend this meeting, visit https://fdabenefitrisk.eventbrite.com. Please register by September 11, 2017.
If you are unable to attend the meeting in person, you can register to
view a live webcast of the meeting. You will be asked to indicate in
your registration if you plan to attend in person or via the webcast.
Seating will be limited, so early registration is recommended.
    Registration is free and will be on a first-come, first-served
basis. However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on space availability.
    If you need special accommodations because of a disability, please
contact Graham Thompson (see FOR FURTHER INFORMATION CONTACT) at least
7 days before the meeting.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm378861.htm.

    Dated: August 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16720 Filed 8-8-17; 8:45 am]
 BILLING CODE 4164-01-P