[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Notices]
[Pages 35023-35030]
[FR Doc No: 2013-13838]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0298, 0303, 0311--0312, 0315, 0317, 0319, 0321--0328,
0347--0349, 0350--0356; FRL--9822-8]

Proposed Information Collection Request; Comment Request; See
Item Specific ICR Titles Provided in the Text

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR) (See item specific ICR title, EPA
ICR Number, and OMB Control Number provided in the text) 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.). Before doing
so, EPA is soliciting public comments on specific aspects of the
proposed information collection as described below. This is a proposed
extension of the ICR, see expiration date for each ICR provided in the
text. 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: Comments must be submitted on or before August 12, 2013.

ADDRESSES: Submit your comments, referencing the Docket ID numbers
provided for each item in the text, online using www.regulations.gov
(our preferred method), by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460.
    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: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, Mail Code 2227A,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; 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, EPA 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.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    (1) Docket ID Number: EPA-HQ-OECA-2013-0303; Title: NSPS for
Equipment Leaks of VOC in Petroleum Refineries (40 CFR Part 60,
Subparts GGG and GGGa); ICR Numbers: EPA ICR Number 0983.13, OMB
Control Number 2060-0067; ICR Status: This ICR is scheduled to expire
on April 30, 2014.
    Abstract: Owners or operators of the affected facilities must make
one-time-only notifications. 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.
Monitoring requirements specific to equipment leaks of VOC in petroleum
refineries provide information on which components are leaking VOCs.
NSPS Subpart GGG references the compliance requirements of NSPS subpart
VV, and NSPS subpart GGGa references the compliance requirements of
NSPS subpart VVa. Owners or operators are required to periodically
record information identifying leaking equipment, repair methods used
to stop the leaks, and dates of repair. Semiannual reports are required
to measure compliance with the standards of NSPS Subparts VV and VVa as
referenced by NSPS subparts GGG and GGGa. These notifications, reports,
and records are essential in determining compliance and are required,
in general, of all sources subject to NSPS. Any owner or operator
subject to the provisions of this part shall maintain a file of these
measurements, and retain the file for at least two years following the
date of such measurements, maintenance reports, and records.
    Form Numbers: None
    Respondents/affected entities: Petroleum refineries.
    Respondent's obligation to respond: mandatory (40 CFR part 60,
subparts GGG and GGGa)
    Estimated number of respondents: 160 (total).
    Frequency of response: Semiannually.
    Total estimated burden: 24,525 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $2,319,816 (per year), includes no annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (2) Docket ID Number: EPA-HQ-OECA-2013-0319; Title: NSPS for VOC
Emissions from Petroleum Refinery Wastewater Systems (40 CFR Part 60,
Subpart QQQ); ICR Numbers: EPA ICR Number 1136.11, OMB Control Number

2060-0172; ICR Status: This ICR is scheduled to expire on April 30,
2014.
    Abstract: Owners and operators of petroleum refinery wastewater
systems are required to keep records of design and operating
specifications of all equipment installed to comply with the standards
such as water seals, roof seals, control devices, and other equipment.
This information is necessary to ensure that equipment design and
operation specifications are met, and the source is in compliance with
NSPS subpart QQQ.
    Form Numbers: None
    Respondents/affected entities: Petroleum refinery wastewater
systems.
    Respondent's obligation to respond: mandatory (40 CFR part 60,
subpart QQQ)
    Estimated number of respondents: 135 (total).
    Frequency of response: Initially, occasionally, quarterly, and
semiannually
    Total estimated burden: 9,237 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $840,361 (per year), includes $17,550
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (3) Docket ID Number: EPA-HQ-OECA-2013-0325; Title: NESHAP for
Benzene Emission from Benzene Storage Vessels and Coke By-Product
Recovery Plants (40 CFR Part 61, Subparts L and Y); ICR Numbers: EPA
ICR Number 1080.14, OMB Control Number 2060-0185; ICR Status: This ICR
is scheduled to expire on April 30, 2014.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 61, subpart A, and to the
provisions at 40 CFR part 61, subpart L. Owners or operators of the
affected facilities must submit a one-time-only report 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 required semiannually
at a minimum.
    Form Numbers: None
    Respondents/affected entities: Owners or operators of benzene
storage vessels and coke by product recovery plants.
    Respondent's obligation to respond: mandatory (40 CFR part 61,
subparts L and Y)
    Estimated number of respondents: 17 (total).
    Frequency of response: Semiannually and occasionally.
    Total estimated burden: 3,137 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $294,347 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) the regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (4) Docket ID Number: EPA-HQ-OECA-2013-0350; Title: The
Consolidated Air Rule (CAR) for the Synthetic Organic Chemical
Manufacturing Industry (SOCMI) (Renewal); ICR Numbers: EPA ICR Number
1854.09, OMB Control Number 2060-0443; ICR Status: This ICR is
scheduled to expire on April 30, 2014.
    Abstract: The synthetic organic chemical manufacturing industry
(SOCMI) is regulated by the New Source Performance Standards (NSPS) and
National Emission Standards for Hazardous Air Pollutants (NESHAP)
standards. 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 Ka, Kb,
VV, VVa, DDD, III, NNN and RRR. The affected entities are also 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, subparts BB, Y, V, F, G, H and I. As an alternative, SOCMI
sources may choose to comply with the above standards under the
consolidated air rule (CAR) at 40 CFR Part 65 as promulgated December
14, 2000. Synthetic organic chemical manufacturing facilities subject
to NSPS requirements must notify EPA of construction, modification,
startups, shutdowns, date and results of initial performance test and
excess emissions. Semiannual reports are also required. Synthetic
organic chemical manufacturing facilities subject to NESHAP
requirements must submit one-time-only reports of any physical or
operational changes and the results of initial performance tests.
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. Periodic reports are also required
semiannually at a minimum.
    Form Numbers: None
    Respondents/affected entities: Owners or operators of synthetic
organic chemical manufacturing facilities.
    Respondent's obligation to respond: mandatory (40 CFR part 60,
subpart A, Ka, Kb, VV, VVa, DDD, III, NNN and RRR; and 40 CFR part 63,
subpart A, BB, Y, V, F, G, H and I)
    Estimated number of respondents: 3,311 (total).
    Frequency of response: Initially, occasionally, semiannually and
annually.
    Total estimated burden: 1,988,952 hours (per year). Burden is
defined at 5 CFR 1320.03(b)
    Total estimated cost: $283,462,406 (per year), includes $95,329,000
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (5) Docket ID Number: EPA-HQ-OECA-2013-0355; Title: NESHAP for Clay
Ceramics Manufacturing, Glass Manufacturing and Secondary Nonferrous
Metals Processing Area Sources (40 CFR Part 63, Subparts RRRRRR,
SSSSSS, and TTTTTT); ICR Numbers: EPA ICR Number 2274.04, OMB Control
Number 2060-0606; ICR Status: This ICR is scheduled to expire on April
30, 2014.
    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 Provisions specified at 40 CFR part 63, subparts RRRRRR, SSSSSS,
and TTTTTT. Owners or operators of the affected facilities must submit
a one-time-only report 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 required semiannually at a minimum.
    Form Numbers: None
    Respondents/affected entities: Owners or operators of clay ceramics
manufacturing, glass manufacturing, and secondary nonferrous metals
processing area sources.
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subparts RRRRRR, SSSSSS, and TTTTTT)
    Estimated number of respondents: 82 (total).
    Frequency of response: Initially, occasionally and annually.
    Total estimated burden: 1,763 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $178,380 (per year), includes $12,964
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (6) Docket ID Number: EPA-HQ-OECA-2013-0353; Title: NSPS for
Stationary Spark Ignition Internal Combustion Engines (40 CFR Part 60,
Subpart JJJJ); ICR Numbers: EPA ICR Number 2227.04, OMB Control Number
2060-0610; ICR Status: This ICR is scheduled to expire on April 30,
2014.
    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 specified at 40 CFR part 63, subpart YYYYY. Owners or
operators of the affected facilities must submit a one-time-only report
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 required semiannually at a minimum.
    Form Numbers: None
    Respondents/affected entities: Owners or operators of electric arc
furnace steelmaking facilities.
    Respondent's obligation to respond: mandatory (40 CFR part 60,
subpart JJJJ)
    Estimated number of respondents: 91 (total).
    Frequency of response: Initially, semiannually and occasionally.
    Total estimated burden: 1,481 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $138,991 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is an increase in both respondent and
Agency burden costs from the most recently approved ICR is due to an
increase in the number of new or modified sources and an adjustment in
labor rates.
    (7) Docket ID Number: EPA-HQ-OECA-2013-0321; Title: NSPS for Sewage
Sludge Incinerators (40 CFR Part 60, Subpart LLLL); ICR Numbers: EPA
ICR Number 2369.03, OMB Control Number 2060-0658; ICR Status: This ICR
is scheduled to expire on April, 30, 2014.
    Abstract: The Standards of Performance for New Stationary Sources:
Sewage Sludge Incineration (SSI) Units Subpart LLLL, fulfill the
requirements of sections 111 and 129 of the Clean Air Act (CAA), which
require EPA to promulgate NSPS for solid waste incineration units. The
information collection activities required by the NSPS include: siting
requirements, operator training and qualification requirements,
testing, monitoring and reporting requirements, one-time and periodic
reports, and the maintenance of records. These activities will enable
the Designated Administrator to determine initial compliance with the
emission limits for the regulated pollutants, monitor compliance with
operating parameters, and ensure that facilities conduct the proper
planning and operator training.
    Form Numbers: None
    Respondents/affected entities: Owners and operators of sewage
sludge incineration units.
    Respondent's obligation to respond: mandatory (40 CFR part 60,
subpart LLLL)
    Estimated number of respondents: 2 (total).
    Frequency of response: Initially, annually, and occasionally.
    Total estimated burden: 701 hours (per year). Burden is defined at
5 CFR 1320.03(b)
    Total estimated cost: $271,590 (per year), includes $231,753
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is an adjustment in the total estimated
burden as currently identified in the OMB Inventory of Approved
Burdens. The change in the burden and cost estimates occurred because
the standard has been in effect for more than three years and the
requirements are different during initial compliance (new facilities)
as compared to on-going compliance (existing facilities). The previous
ICR reflected those burdens and costs associated with the initial
activities for subject facilities. This includes purchasing monitoring
equipment, conducting performance test(s) and establishing
recordkeeping systems. This ICR, by in large, reflects the on-going
burden and costs for existing facilities. Activities for existing
source include continuously monitoring of pollutants and the submission
of semiannual reports.
    (8) Docket ID Number: EPA-HQ-OECA-2013-0317; Title: NESHAP for Gold
Mine Ore Processing (40 CFR Part 63, Subpart EEEEEEE); ICR Numbers: EPA
ICR Number 2383.03, OMB Control Number 2060-0659; ICR Status: This ICR
is scheduled to expire on April 30, 2014.
    Abstract: The NESHAP for Gold Mine Ore Processing (40 CFR Part 63,
Subpart EEEEEEE) were proposed April 28, 2010, and promulgated on
December 16, 2010. The owner or operator of an existing or new affected
source is required to prepare and submit an initial notification of
applicability and an initial notification of compliance status. Each
owner or operator of an affected source is required to keep records to
document compliance with the mercury emission limits and also maintain
records of all monitoring data and specified process throughput data.
If a deviation from the rule requirements occurs, an affected source is
required to submit a compliance report for that semi-annual reporting
period.
    Form Numbers: None
    Respondents/affected entities: Owners or operators of gold mine ore
processing facilities.
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subpart EEEEEEE)

    Estimated number of respondents: 21 (total).
    Frequency of response: Initially and quarterly.
    Total estimated burden: 483 hours (per year). Burden is defined at
5 CFR 1320.03(b)
    Total estimated cost: $444,777 (per year), includes $417,930
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is an adjustment in the total estimated
burden because the standard has been in effect for more than three
years and the requirements are different during initial compliance (new
facilities) as compared to on-going compliance (existing facilities).
The previous ICR reflected those burdens and costs associated with the
initial activities for subject facilities. This includes purchasing
monitoring equipment, conducting performance test(s) and establishing
recordkeeping systems. This ICR, by in large, reflects the on-going
burden and costs for existing facilities. Activities for existing
source include continuously monitoring of pollutants and the submission
of semiannual reports.
    (9) Docket ID Number: EPA-HQ-OECA-2013-0311; Title: Emission
Guidelines for Sewage Sludge Incinerators (40 CFR Part 60, Subpart
MMMM); ICR Numbers: EPA ICR Number 2403.03, OMB Control Number 2060-
0661; ICR Status: This ICR is scheduled to expire on May 31, 2014.
    Abstract: This supporting statement addresses information
collection activities imposed by the Sewage Sludge Incineration (SSI)
Unit Emission Guidelines Subpart MMMM. The guidelines do not apply
directly to SSI unit owners and operators. The guidelines can be
thought of as model regulations that States use in developing State
plans to implement the emission guidelines. If a State does not
develop, adopt, and submit an approvable State plan, the Environmental
Protection Agency (EPA) must develop a Federal plan to implement the
emission guidelines. This ICR presents the burden to respondents
(owners or operators of SSI units) and the Designated Administrator
(State or Federal Government) that will be imposed by State plans
developed to implement the emission guidelines. Respondents are owners
or operators of existing SSI units, including fluidized bed or multiple
hearth units.
    Form Numbers: None
    Respondents/affected entities: Owners and operators of sewage
sludge incinerators.
    Respondent's obligation to respond: mandatory (40 CFR part 60,
subpart MMMM)
    Estimated number of respondents: 110 (total).
    Frequency of response: Initially and annually.
    Total estimated burden: 39,350 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $7,388,899 (per year), includes $7,388,899
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is an adjustment decrease in the total
estimated burden since the standard has been in effect for three years.
The previous ICR covers the burden for initial compliance during the
first three years of rule promulgation. This ICR reflects the burden
for ongoing compliance (existing sources).
    (10) Docket ID Number: EPA-HQ-OECA-2013-0315; Title: NSPS for
Commercial and Industrial Solid Waste Incineration (CISWI) units (40
CFR Part 60, Subpart CCCC); ICR Numbers: EPA ICR Number 2384.05, OMB
Control Number 2060-0662; ICR Status: This ICR is scheduled to expire
on May 31, 2014.
    Abstract: The NSPS fulfills the requirements of sections 111 and
129 of the Clean Air Act (CAA), which require EPA to promulgate NSPS
for solid waste incineration units. This final rule will amend the 2000
CISWI NSPS currently in affect.
    The information collection activities required by the NSPS include:
siting requirements, operator training and qualification requirements,
testing, monitoring and reporting requirements, one-time and periodic
reports, and the maintenance of records. These activities will enable
EPA to determine initial compliance with the emission limits for the
regulated pollutants, monitor compliance with operating parameters, and
ensure that facilities conduct the proper planning and operator
training.
    Form Numbers: None
    Respondents/affected entities: Owners and operators of commercial
and industrial solid waste incineration units.
    Respondent's obligation to respond: mandatory (40 CFR part 60,
subpart CCCC)
    Estimated number of respondents: 1 (total).
    Frequency of response: Initially, occasionally, and annually.
    Total estimated burden: 858 hours (per year). Burden is defined at
5 CFR 1320.03(b)
    Total estimated cost: $171,524 (per year), includes $140,997
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (11) Docket ID Number: EPA-HQ-OECA-2013-0326; Title: NSPS for
Asphalt Processing and Roofing Manufacturing (40 CFR Part 60, Subpart
UU); ICR Numbers: EPA ICR Number 0661.11, OMB Control Number 2060-0002;
ICR Status: This ICR is scheduled to expire on June 30, 2014.
    Abstract: Owners and operators must notify EPA of construction
modification startups, shutdowns, malfunctions, and data and results of
performance test. Owners/operators must continually monitor and record
temperature in specified pollution control devices. EPA determines
parameters to be recorded in other control devices upon description of
that device by the source.
    Form Numbers: None
    Respondents/affected entities: Asphalt processing and roofing
manufacturers
    Respondent's obligation to respond: mandatory (40 CFR part 60,
subpart UU)
    Estimated number of respondents: 144 (total).
    Frequency of response: Initially, and semiannually.
    Total estimated burden: 33,912 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $8,686,825 (per year), includes $5,240,000
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is an increase in both respondent and
Agency burden costs from the most recently approved ICR is due to an
increase in the number of new or modified sources and an adjustment in
labor rates.
    (12) Docket ID Number: EPA-HQ-OECA-2013-0328; Title: NESHAP for
Vinyl Chloride (40 CFR Part 61, Subpart F); ICR Numbers: EPA ICR Number
0186.13, OMB Control Number 2060-0071; ICR Status: This ICR is
scheduled to expire on June 30, 2014.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 61, subpart A, and any changes,
or additions to the

General Provisions specified at 40 CFR part 61, subpart F.
    Owners or operators of the affected facilities must submit a one-
time-only report 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 required quarterly at a minimum.
    Form Numbers: None
    Respondents/affected entities: Owners or operators of vinyl
chloride production facilities
    Respondent's obligation to respond: mandatory (40 CFR part 61,
subpart F)
    Estimated number of respondents: 28 (total).
    Frequency of response: Initially, quarterly, and occasionally.
    Total estimated burden: 11,826 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $2,369,531 (per year), includes $1,260,000
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (13) Docket ID Number: EPA-HQ-OECA-2013-0349; Title: NESHAP for
Pharmaceutical Production (40 CFR Part 63, Subpart GGG); ICR Numbers:
EPA ICR Number 1781.07, OMB Control Number 2060-0358; ICR Status: This
ICR is scheduled to expire on June 30, 2014.
    Abstract: The NESHAP for Pharmaceuticals Production were proposed
on April 2, 1997, and promulgated on September 21, 1998. In general,
all NESHAP standards require initial notifications, performance tests,
and periodic reports. Owners or operators are also required to maintain
records of the occurrence and duration of any malfunctions in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance and, in general, are
required of all sources subject to NESHAP. This information is used by
the Agency to identify sources subject to the standards to insure that
the maximum achievable control technologies are being applied.
Semiannual summary reports are also required.
    Form Numbers: None
    Respondents/affected entities: Pharmaceutical manufacturing
operations.
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subpart GGG)
    Estimated number of respondents: 27 (total).
    Frequency of response: Initially and semiannually.
    Total estimated burden: 44,266 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $4,299,575 (per year), includes $112,266
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (14) Docket ID Number: EPA-HQ-OECA-2013-0322; Title: NESHAP for
Beryllium Rocket Motor Fuel Firing (40 CFR Part 61, Subpart D); ICR
Numbers: EPA ICR Number 1125.07, OMB Control Number 2060-0394; ICR
Status: This ICR is scheduled to expire on June 30, 2014.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 61, subpart A, and any changes
or additions to the Provisions are specified at 40 CFR part 61, subpart
D. Owners or operators of the affected facilities must submit a one-
time-only report 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.
    Form Numbers: None
    Respondents/affected entities: Owners or operators of beryllium
rocket motor fuel firing facilities.
    Respondent's obligation to respond: mandatory (40 CFR part 61,
subpart D)
    Estimated number of respondents: 1 (total).
    Frequency of response: Initially and annually.
    Total estimated burden: 8 hours (per year). Burden is defined at 5
CFR 1320.03(b)
    Total estimated cost: $784 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (15) Docket ID Number: EPA-HQ-OECA-2013-0312; Title: Emission
Guidelines for Commercial and Industrial Solid Waste Incineration
(CISWI) units (40 CFR Part 60, Subpart DDDD); ICR Numbers: EPA ICR
Number 2385.06, OMB Control Number 2060-0664; ICR Status: This ICR is
scheduled to expire on June 30, 2014.
    Abstract: The affected entities are subject to the General
Provisions of the Emission Guidelines at 40 CFR part 60, subpart A, and
any changes, or additions to the General Provisions specified at 40 CFR
part 60, subpart DDDD.
    Owners or operators of the affected facilities must submit initial
notification, 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 required semiannually at
a minimum.
    Form Numbers: None
    Respondents/affected entities: Owners and operators of commercial
and industrial solid waste incineration units.
    Respondent's obligation to respond: mandatory (40 CFR part 60,
subpart DDDD)
    Estimated number of respondents: 70 (total).

    Frequency of response: Initially, occasionally, and annually.
    Total estimated burden: 17,093 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $4,030,921 (per year), includes $3,422,428
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (16) Docket ID Number: EPA-HQ-OECA-2013-0356; Title: NESHAP for
Group I Polymers and Resins (40 CFR Part 63, Subpart U); ICR Numbers:
EPA ICR Number 2410.03, OMB Control Number 2060-0665; ICR Status: This
ICR is scheduled to expire on June 30, 2014.
    Abstract: EPA is promulgating revisions for the National Emission
Standards for Hazardous Air Pollutants (NESHAP) for Group I Polymers
and Resins. Potential respondents subject to the new requirements of
the NESHAP include an estimated 5 existing facilities that produce
butyl rubber, epichlorohydrin elastomer, ethylene-propylene rubber,
neoprene rubber, and nitrile butadiene rubber. The total annual
responses attributable to this ICR consist of notification of front-end
process vent limits, notification of back-end operation limits,
recordkeeping related to the new limits, and reports submitted to
satisfy affirmative defense provisions.
    Form Numbers: None
    Respondents/affected entities: Owners and operators of facilities
that produce butyl rubber, epichlorohydrin elastomer, ethylene-
propylene rubber, neoprene rubber, and nitrile butadiene rubber.
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subpart U)
    Estimated number of respondents: 5 (total).
    Frequency of response: Initially, occasionally, and semiannually.
    Total estimated burden: 251 hours (per year). Burden is defined at
5 CFR 1320.03(b)
    Total estimated cost: $12,222 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is an adjustment increase in the total
estimated burden compared to the previous ICR. The increase reflects
additional requirements associated with the revision of the standard.
    (17) Docket ID Number: EPA-HQ-OECA-2013-0327; Title: NSPS for
Portland Cement Plants (40 CFR Part 60, Subpart F); ICR Numbers: EPA
ICR Number 1051.12, OMB Control Number 2060-0025; ICR Status: This ICR
is scheduled to expire on July 31, 2014.
    Abstract: Entities potentially affected by this action are Portland
cement plants with the following facilities; kilns, clinker coolers,
raw mill systems, raw mill dryers, raw material storage, clinker
storage, finished product storage, conveyor transfer points, bagging
and bulk loading and unloading systems. Entities are required to submit
initial notifications, conduct initial performance tests, and submit
semi-annual reports for exceedances and startups, shutdown and
malfunctions.
    Form Numbers: None
    Respondents/affected entities: Portland cement plants
    Respondent's obligation to respond: mandatory (40 CFR part 60,
subpart F)
    Estimated number of respondents: 118 (total).
    Frequency of response: Initially and semiannually
    Total estimated burden: 17,666 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $2,766,659 (per year), includes $939,014
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (18) Docket ID Number: EPA-HQ-OECA-2013-0348; Title: NESHAP for
Primary Aluminum Reduction Plants (40 CFR Part 63, Subpart LL); ICR
Numbers: EPA ICR Number 1767.07, OMB Control Number 2060-0360; ICR
Status: This ICR is scheduled to expire on July 31, 2014.
    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 Provisions specified at 40 CFR part 63, subpart LL.
    Owners or operators of the affected facilities must submit a one-
time-only report 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 required semiannually at a minimum.
    Form Numbers: None
    Respondents/affected entities: Owners or operators of primary
aluminum reduction plants.
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subpart LL)
    Estimated number of respondents: 16 (total).
    Frequency of response: Initially, semiannually and annually.
    Total estimated burden: 80,398 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $7,599,556 (per year), includes $91,348
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is an increase in both respondent and
Agency burden costs from the most recently approved ICR is due to an
increase in the number of new or modified sources and an adjustment in
labor rates.
    (19) Docket ID Number: EPA-HQ-OECA-2013-0324; Title: NESHAP for
Marine Tank Vessel Loading Operations (40 CFR Part 63, Subpart Y); ICR
Numbers: EPA ICR Number 1679.09, OMB Control Number 2060-0289; ICR
Status: This ICR is scheduled to expire on August 31, 2014.
    Abstract: This rule applies to marine tank vessel loading
operations that are major sources of HAP, have an annual throughput of
10 million or more barrels of gasoline, and/or have an annual
throughput of 200 million or more barrels of crude oil. This ICR also
covers owners or operators of existing MTVLO, that emit less than 10
tons per year of each individual HAP, and less than 25 tons/year of all
HAP combined, located at major sources of HAP that loads more than 1
million barrels/yr of gasoline, as well as owners or operators of
existing off-shore terminals that load gasoline.
    Form Numbers: None
    Respondents/affected entities: owners or operators of existing
marine tank vessel loading operations.
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subpart Y)
    Estimated number of respondents: 54 (total).

    Frequency of response: Initially and semiannually.
    Total estimated burden: 2,489 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $169,298 (per year), includes $3,888
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is an adjustment in the total estimated
burden as currently identified in the OMB Inventory of Approved
Burdens. This is due to proposed program changes. Additional controls
are being proposed, which will need reporting and recordkeeping to
ensure compliance. Additionally, there is an increase in both
respondent and Agency burden costs from the most recently approved ICR
is due to an adjustment in the labor rates.
    (20) Docket ID Number: EPA-HQ-OECA-2013-0347; Title: NESHAP for
Epoxy Resin and Non-Nylon Polyamide Production (40 CFR Part 63, Subpart
W); ICR Numbers: EPA ICR Number 1681.08, OMB Control Number 2060-0290;
ICR Status: This ICR is scheduled to expire on August 31, 2014.
    Abstract: Sources are owners/operators of facilities which produce
polymers and resins from epichlorohydrin and sources which manufacture
epichlorohydrin-modified non-nylon polyamide resins. EPA and delegated
states will use the information identify new, modified, reconstructed,
or existing sources, or process changes which may affect the source's
status and to ensure that affected sources are meeting the standards.
    Form Numbers: None
    Respondents/affected entities: Epoxy resin and non-nylon polyamide
production
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subpart W)
    Estimated number of respondents: 7 (total).
    Frequency of response: Semiannually, quarterly, and initially.
    Total estimated burden: 3,853 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $370,463 (per year), includes $9,000
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (21) Docket ID Number: EPA-HQ-OECA-2013-0351; Title: NESHAP for
Solvent Extraction for Vegetable Oil Production (40 CFR Part 63,
Subpart GGGG); ICR Numbers: EPA ICR Number 1947.06, OMB Control Number
2060-0471; ICR Status: This ICR is scheduled to expire on August 31,
2014.
    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 Provisions specified at 40 CFR part 63, subpart
GGGG. Owners or operators of the affected facilities must submit a one-
time-only report 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 required semiannually at a minimum.
    Form Numbers: None
    Respondents/affected entities: Owners or operators of vegetable oil
production facilities.
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subpart GGGG)
    Estimated number of respondents: 101 (total).
    Frequency of response: Initially, occasionally, and annually.
    Total estimated burden: 39,385 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $2,512,947 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (22) Docket ID Number: EPA-HQ-OECA-2013-0354; Title: NESHAP for
Paint Stripping and Miscellaneous Surface Coating at Area Sources (40
CFR Part 63, Subpart HHHHHH); ICR Numbers: EPA ICR Number 2268.04, OMB
Control Number 2060-0607; ICR Status: This ICR is scheduled to expire
on August 31, 2014.
    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 Provisions specified at 40 CFR part 63, subpart
HHHHHH. Owners or operators of the affected facilities must submit a
one-time-only report 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 required semiannually at a minimum.
    Form Numbers: None
    Respondents/affected entities: Owners or operators of paint
stripping and miscellaneous surface coating operations area sources.
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subpart HHHHHH)
    Estimated number of respondents: 39,812 (total).
    Frequency of response: Initially, annually and occasionally.
    Total estimated burden: 124,527 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $11,423,194 (per year), includes $142,220
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is an increase in both respondent and
Agency burden costs from the most recently approved ICR is due to an
increase in the number of new or modified sources and an adjustment in
labor rates.
    (23) Docket ID Number: EPA-HQ-OECA-2013-0323; Title: NESHAP for
Area Sources: Electric Arc Furnace Steelmaking Facilities (40 CFR Part
63, Subpart YYYYY); ICR Numbers: EPA ICR Number 2277.04, OMB Control
Number 2060-0608; ICR Status: This ICR is scheduled to expire on August
31, 2014.
    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 specified at 40 CFR part 63, subpart YYYYY. Owners or
operators of the affected facilities must submit a one-time-only report
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 required semiannually at a minimum.
    Form Numbers: None
    Respondents/affected entities: Owners or operators of electric arc
furnace steelmaking facilities.
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subpart YYYYY)
    Estimated number of respondents: 91 (total).
    Frequency of response: Initially, semiannually and occasionally.
    Total estimated burden: 1,481 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $138,991 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the labor hours in this
ICR compared to the previous ICR. This is due to two considerations:
(1) The regulations have not changed over the past three years and are
not anticipated to change over the next three years; and (2) the growth
rate for the respondents is very low, negative or non-existent.
Therefore, the labor hours in the previous ICR reflect the current
burden to the respondents and are reiterated in this ICR. However,
there is an increase in burden costs due to an adjustment in labor
rates.
    (24) Docket ID Number: EPA-HQ-OECA-2013-0352; Title: NESHAP for
Industrial, Commercial, and Institutional Boilers and Process Heaters
(40 CFR Part 63, Subpart DDDDD); ICR Numbers: EPA ICR Number 2028.08,
OMB Control Number 2060-0551; ICR Status: This ICR is scheduled to
expire on September 30, 2014.
    Abstract: The standard affects new and existing industrial/
commercial/institutional boilers and process heaters that are major
sources of HAPs. Each owner or operator of a source affected by the
standards is required to submit an initial notification that the source
is subject to the standard. Each respondent submits semiannual
compliance reports. Additional records and notifications depend on
which subcategory the boilers or process heaters are in.
    Form Numbers: None
    Respondents/affected entities: Owners and operators of industrial,
commercial, and institutional boilers and process heaters.
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subpart DDDDD)
    Estimated number of respondents: 14,111 (total).
    Frequency of response: Initial and annually.
    Total estimated burden: 32,664 hours (per year). Burden is defined
at 5 CFR 1320.03(b)
    Total estimated cost: $97,110,020 (per year), includes $66,211,113
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is an increase in both respondent and
Agency burden costs from the most recently approved ICR is due to an
increase in the number of new or modified sources, and an adjustment in
labor rates.
    (25) Docket ID Number: EPA-HQ-OECA-2013-0298; Title: NESHAP for
Industrial, Commercial, and Institutional Boilers Area Sources (40 CFR
Part 63, Subpart JJJJJJ); ICR Numbers: EPA ICR Number 2253.03, OMB
Control Number 2060-0668; ICR Status: This ICR is scheduled to expire
on September 30, 2014.
    Abstract: The NESHAP for Industrial, Commercial, and Institutional
Boilers Area Sources, at 40 CFR part 63 subpart JJJJJJ (Area Boilers
NESHAP) fulfills the requirements of section 112 of the Clean Air Act
(CAA), which requires the United States Environmental Protection Agency
(EPA) to promulgate national emission standards for industrial,
commercial, and institutional boilers. Records and reports required by
the NESHAP for industrial, commercial, and institutional boilers area
sources are necessary to enable EPA to identify sources subject to the
standards and to ensure that the standards are being achieved. Records
and reports must be maintained at the facility and/or submitted to EPA.
All reports are sent to the delegated state or local authority. In the
event that there is no such delegated authority, the reports are sent
directly to the EPA regional office.
    Form Numbers: None
    Respondents/affected entities: Owners and operators of industrial,
commercial, or institutional boilers.
    Respondent's obligation to respond: mandatory (40 CFR part 63,
subpart JJJJJJ)
    Estimated number of respondents: 182,671 (total).
    Frequency of response: Initially, annually, and occasionally.
    Total estimated burden: 2,681,826 hours (per year). Burden is
defined at 5 CFR 1320.03(b)
    Total estimated cost: $406,793,797 (per year), includes
$153,122,174 annualized capital or operation & maintenance costs.
    Changes in Estimates: There is an increase in both respondent and
Agency burden costs from the most recently approved ICR is due to an
increase in the number of new or modified sources and an adjustment in
labor rates.

    Dated: May 30, 2013.
Lisa C. Lund,
Director, Office of Compliance.
[FR Doc. 2013-13838 Filed 6-10-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 3005-3008]
[FR Doc No: 2013-00607]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1248]

Creating an Alternative Approval Pathway for Certain Drugs
Intended to Address Unmet Medical Need; Public Hearing; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing to obtain input on a potential new pathway to expedite the
development of drugs, including biological products, for serious or
life-threatening conditions that would address an unmet medical need.
The drug's safety and effectiveness would be studied in a smaller
subpopulation of patients with more serious manifestations of a
condition. Such a pathway could involve smaller and more rapid clinical
trials than would occur if the drug were studied in a broader group of
patients with a wide range of clinical manifestations. The labeling of
drugs approved using this pathway would make clear that the drug is
narrowly indicated for use in limited, well-defined subpopulations in
which the drug's benefits have been shown to outweigh its risks. The
purpose of the public hearing is to obtain information and comments
from the public on the need for and feasibility of this pathway and its
potential advantages and disadvantages.

DATES: Dates and Time: The public hearing will be held on February 4
and 5, 2013, from 9 a.m. to 4 p.m. The public hearing may be extended
or may end early depending on the level of public participation.
    Attendance, Presentations, and Comments: Individuals who wish to
attend or present at the public hearing must register on or before 5
p.m. e.s.t. on January 22, 2013. To register for the

public hearing, email your registration information to
<EMAIL_ADDRESS>Section IV of this document
provides attendance and registration information. Either electronic or
written comments will be accepted after the hearing until March 1,
2013.

ADDRESSES: The public hearing will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503), 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 parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments 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:
Jonas Santiago, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-5346, Fax:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
or

Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA is announcing a public hearing to obtain
input on a potential new pathway for approving drugs, including
biological products, targeted at serious or life-threatening conditions
and intended to address an unmet medical need. The drug's safety and
effectiveness would be studied in a smaller subpopulation of patients
with more serious manifestations of a condition. Such a pathway could
involve smaller and more rapid clinical trials than would occur if the
drug were studied in a broader group of patients with a wide range of
clinical manifestations. The labeling of drugs approved using this
pathway would make clear that the drug is narrowly indicated for use in
limited, well-defined subpopulations in which the drug's benefits have
been shown to outweigh the risks.

I. Background

    In the last two decades, major advances in molecular and cellular
biology have greatly expanded our understanding of a broad range of
complex disease processes and have led to major advances in the
treatment of conditions such as cystic fibrosis, HIV, hepatitis C, and
multiple sclerosis. In some cases, however, the resource-intensive
programs needed for approval of drugs to treat a broad condition with a
wide range of clinical manifestations require very large study
populations and can hinder the ability to make promising new drugs
available in a timely manner to subpopulations of patients with
important unmet medical needs. FDA recognizes its role in fostering the
application of scientific advances to the treatment of disease through
drug development, including the use of novel approaches that can
facilitate development of treatment for unmet needs.
    Traditional drug development programs are designed to evaluate the
benefits and risks of treatment with a high degree of precision for the
range of manifestations of a disease or condition. Often this will
involve studies that expose a large number of patients to the drug,
normally for an extended period of time. In some cases, such as when
safety issues have arisen with prior drugs in a class, additional
trials are needed to help identify serious but infrequent risks.
Typically, these studies are needed when there is an expectation that
the drug will be used broadly in patients with less severe
manifestations of the condition.
    Existing processes to expedite drug development and review of
important new therapies have worked effectively in many circumstances.
For example, more than 100 new therapies and indications have been
approved under the accelerated approval process (21 CFR part 314,
subpart H; 21 CFR part 601, subpart E).\1\ In addition, FDA's existing
flexibility in applying the statutory requirements for approval has
effectively facilitated development of drugs for conditions where the
entire intended patient population has serious unmet medical needs.
However, FDA believes that it is important to explore the need for and
feasibility of a new process focused on developing drugs for
subpopulations of patients with serious or life-threatening conditions,
including patients with serious or life-threatening infections caused
by antibiotic-resistant bacteria.
---------------------------------------------------------------------------

    \1\ See a list of Center for Drug Evaluation and Research Drug
and Biologic Accelerated Approvals as of September 30, 2011,
available at http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/UCM278506.pdf.
---------------------------------------------------------------------------

II. New Pathway

    FDA is seeking input on a potential new pathway to approve drugs
for use in limited, well-defined subpopulations of patients with
serious or life-threatening conditions for whom the benefits of the
drug have been shown to outweigh the risks. The pathway could include
product labeling with a specific designation to make clear that the
drug indication is limited to the narrow subpopulation and the
rationale for limiting use to that population. The pathway also might
provide for the designation and an appropriate logo to appear on a
drug's container label.
    This designation could be designed to inform the health care
community, including practitioners, payers, and patients, of compelling
reasons to carefully manage use of such drugs, limiting use to
appropriate patients, as the benefit-risk profile only warrants use in
the identified subpopulation. In addition, the potential new pathway
could be used to help reduce the development of resistance to important
antibacterial drugs by limiting their use to those patients in whom use
is appropriate and necessary.
    This approval of a narrow indication could be broadened if
additional data become available which demonstrate the safety and
effectiveness of the drug in treating a broader condition or patient
population. For example, a drug could be initially approved using this
pathway for a narrow subpopulation of patients because of uncertainty
about a cardiovascular risk that would not be acceptable in a broad
population. If a long-term study subsequently demonstrates that the
benefit-risk profile makes the drug appropriate for broader use, the
designation could be removed. Alternatively, there may be drugs for
which we would not anticipate the possibility of approval in the
broader population, such as when there is a known toxicity that, while
acceptable in patients with serious manifestations of a condition,
would not be appropriate for use in patients with milder manifestations
of the condition.
    The proposed pathway was recommended by the President's Council of
Advisors on Science and Technology (PCAST) in their September 2012
``Report to the President on Propelling Innovation in Drug Discovery,
Development, and Evaluation,'' as a way to improve drug evaluation. The
PCAST recommendations support the goal of increasing the output of
innovative, new medicines for patients with important unmet medical
needs, while increasing drug efficacy and safety, through

industry, academia, and government working together to decrease
clinical failure, clinical trial costs, time to market, and regulatory
uncertainty.\2\
---------------------------------------------------------------------------

    \2\ For more information on the PCAST Report to the President on
Propelling Innovation in Drug Discovery, Development, and
Evaluation, see http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-fda-final.pdf.
---------------------------------------------------------------------------

III. Scope of the Public Hearing and Discussion Questions

    FDA is holding this public hearing to seek input from interested
members of the public including patients and consumers, practitioners
and other members of the medical community, regulated industry,
insurers, and managed care organizations on a potential new pathway to
approve drugs shown to be safe and effective in a subpopulation of
patients with serious or life-threatening conditions in which an unmet
medical need exists. FDA is interested in obtaining information and
public comment on the following issues:
    1. Considering existing processes to expedite drug development and
review of important new therapies (i.e., accelerated approval, fast-
track designation), would this new pathway increase the therapeutic
options for serious or life-threatening conditions for which an unmet
medical need exists? If not, what might be some alternative approaches?
    2. Can you identify specific serious or life-threatening conditions
for which an unmet medical need exists and for which this approval
pathway may benefit subpopulations of patients?
    3. What approaches could be undertaken (by FDA or by people or
organizations other than FDA) to monitor use of drugs approved under
this pathway to determine whether they are being used inconsistent with
the terms of approval? What approaches could be undertaken to prevent,
manage, or monitor use in a broader population where safety and
efficacy has not been demonstrated? For example, if this pathway were
adopted to approve new antibacterial drugs when limited use was needed
(e.g., to prevent the emergence of further antimicrobial resistance),
what other measures (by FDA or by people or organizations other than
FDA) might ensure that these products are used appropriately only in
the indicated subpopulations?
    4. Would this pathway help to address some of the current
challenges in antibacterial drug development, particularly for serious
or life-threatening infections for which there is an unmet medical
need?
    5. This potential pathway could be used to approve drugs for a
limited subpopulation based upon smaller clinical trials, when benefit-
risk is appropriate for the limited population but safety and efficacy
have not been demonstrated for use in a broader population of patients
or patients with less severe manifestations of the condition. For the
serious or life-threatening conditions you identified in question 2,
what benefit-risk considerations need to be taken into account before
and after marketing and how should they be addressed?
    6. Would the use of a formal designation and logo to reflect
approval under this pathway, with clear labeling of clinical
information that only supports use in the indicated subpopulation, but
without other constraints from FDA be effective in limiting use to the
indicated subpopulation? Why or why not?

IV. Attendance, Registration, and Requests for Oral Presentations

    The public hearing is free and seating will be on a first-come,
first-served basis. Attendees, including those not presenting, need to
register for the public hearing.
    If you wish to attend or make an oral presentation during the
hearing, you must register by submitting either an electronic or
written request received on or before January 22, 2013. (See FOR
FURTHER INFORMATION CONTACT.) You must provide your name, title,
business affiliation (if applicable), address, telephone and fax
numbers, email address, and type of organization you represent (e.g.,
industry, consumer organization). If requesting to present, you also
should submit a brief summary of the presentation, including the
discussion question(s) that will be addressed and the approximate time
requested for your presentation. FDA has included discussion questions
in section III of this document. You should identify the question(s)
and the number of each question you wish to address in your
presentation. We encourage individuals and organizations with common
interests to consolidate or coordinate their presentations to allow
adequate time for each request for presentation. FDA will do its best
to accommodate requests to speak and will determine the amount of time
allotted for each oral presentation, and the approximate time that each
oral presentation is scheduled to begin. Persons registered to make an
oral presentation should submit to FDA an electronic copy of their
presentation and an abstract to<EMAIL_ADDRESS>on or before January 30, 2013.
    If you need special accommodations because of a disability, please
contact Jonas Santiago (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the meeting.

V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management.
    Under Sec.  15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
    Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10, subpart C)). Under Sec.  10.205,
representatives of the electronic media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see section VII of this document).
    To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of those provisions as specified in Sec.
15.30(h).

VI. Comments

    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this document to the
Division of Dockets Management (see ADDRESSES). 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. In addition, when
responding to specific questions as discussed in section III of this
document, please identify the question you are addressing. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday, and will be posted to the
docket at http://www.regulations.gov.

VII. Transcripts

    Transcripts of the public hearing will be available for review at
the Division of Dockets Management (see ADDRESSES) and on the Internet
at http://www.regulations.gov approximately 30 days after the public
hearing. A transcript will also be made available in either hard copy
or on CD-ROM, upon submission of a Freedom of Information request.
Written requests are to be sent to the Division of Freedom of
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857.

    Dated: January 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00607 Filed 1-14-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50145-50147]
[FR Doc No: 2021-19210]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: New or modified Base (1-percent annual chance) Flood
Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA)
boundaries or zone designations, and/or regulatory floodways
(hereinafter referred to as flood hazard determinations) as shown on
the indicated Letter of Map Revision (LOMR) for each of the communities
listed in the table below are finalized. Each LOMR revises the Flood
Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance
Study (FIS) reports, currently in effect for the listed communities.
The flood hazard determinations modified by each LOMR will be used to
calculate flood insurance premium rates for new buildings and their
contents.

DATES: Each LOMR was finalized as in the table below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online
through the FEMA Map Service Center at https://msc.fema.gov.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and 90 days have elapsed since that publication.
The Deputy Associate Administrator for Insurance and Mitigation has
resolved any appeals resulting from this notification.
    The modified flood hazard determinations are made pursuant to
section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4105, and are in accordance with the National Flood Insurance Act of
1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The new or modified flood hazard information is the basis for the
floodplain management measures that the community is required either to
adopt or to show evidence of being already in effect in order to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    This new or modified flood hazard information, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities.
    This new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at https://msc.fema.gov.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Location and case        Chief  executive officer of                                                                    Community
  State and county           No.                        community                 Community map repository        Date of  modification          No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama:
    Lee (FEMA        City of Auburn, (20- The Honorable Ron Anders, Jr.,        City Hall, 144 Tichenor       August 20, 2021..............       010144
     Docket No.: B-   04-4301P).           Mayor, City of Auburn, 144 Tichenor   Avenue, Auburn, AL 36830.
     2136).                                Avenue, Suite 1, Auburn, AL 36830.
    Lee (FEMA        City of Opelika,     The Honorable Gary Fuller, Mayor,     Public Works Department, 700  August 20, 2021..............       010145
     Docket No.: B-   (20-04-2856P).       City of Opelika, P.O. Box 390,        Fox Trail, Opelika, AL
     2136).                                Opelika, AL 36803.                    36803.
    Lee (FEMA        Unincorporated       The Honorable Bill English,           Lee County Building           August 20, 2021..............       010250
     Docket No.: B-   areas of Lee         Chairman, Lee County Commission,      Inspections Department, 100
     2136).           County, (20-04-      P.O. Box 666, Opelika, AL 36803.      Orr Avenue, Opelika, AL
                      4301P).                                                    36804.
    Shelby (FEMA     City of Helena, (21- The Honorable J. Brian Puckett,       City Hall, 816 Highway 52     August 23, 2021..............       010294
     Docket No.: B-   04-0379P).           Mayor, City of Helena, 846 Highway    East Helena, AL 35080.
     2136).                                52 East Helena, AL 35080.
    St. Clair,       City of Margaret,    The Honorable Jeffery G. Wilson,      St. Clair County Flood        August 20, 2021..............       010393
     (FEMA Docket     (20-04-4314P).       Mayor, City of Margaret, P.O. Box     Management Department,, 165
     No.: B-2136).                         100, Margaret, AL 35953.              5th Avenue, Suite 100,
                                                                                Ashville, AL 35953.
    St. Clair,       Unincorporated       The Honorable Paul Manning,           St. Clair County Flood        August 20, 2021..............       010290
     (FEMA Docket     areas of St. Clair   Chairman, St. Clair County            Management Department,, 165
     No.: B-2136).    County, (20-04-      Commission, 165 5th Avenue, Suite     5th Avenue, Suite 100,
                      4314P).              100, Ashville, AL 35953.              Ashville, AL 35953.

Colorado:
    Arapahoe, (FEMA  City of Centennial,  Mr. Matt Sturgeon, Manager, City of   Southeast Metro Stormwater    July 30, 2021................       080315
     Docket No.: B-   (20-08-0573P).       Centennial, 13133 East Arapahoe       Authority, 7437 South
     2133).                                Road, Centennial, CO 80112.           Fairplay Street,
                                                                                Centennial, CO 80112.
    Arapahoe, (FEMA  Unincorporated       The Honorable Nancy Jackson, Chair,   Arapahoe County Public Works  July 30, 2021................       080011
     Docket No.: B-   areas of Arapahoe    Arapahoe County Board of              and Development Department,
     2133).           County, (20-08-      Commissioners, 5334 South Prince      6924 South Lima Street,
                      0573P).              Street, Littleton, CO 80120.          Centennial, CO 80112.
    Douglas, (FEMA   Town of Castle       The Honorable Jason Gray, Mayor,      Stormwater Department, 175    August 6, 2021...............       080050
     Docket No.: B-   Rock, (20-08-        Town of Castle Rock, 100 North        Kellog Street, Castle Rock,
     2130).           0649P).              Wilcox Street, Castle Rock, CO        CO 80109.
                                           80104.
    Douglas, (FEMA   Unincorporated       The Honorable Lora Thomas, Chair,     Douglas County Department of  August 6, 2021...............       080049
     Docket No.: B-   areas of Douglas     Douglas County Board of               Public Works, Engineering,
     2130).           County, (20-08-      Commissioners, 100 3rd Street,        100 3rd Street, Castle
                      0649P).              Castle Rock, CO 80104.                Rock, CO 80104.
    Douglas, (FEMA   Unincorporated       The Honorable Lora Thomas, Chair,     Douglas County Department of  July 30, 2021................       080049
     Docket No.: B-   areas of Douglas     Douglas County Board of               Public Works Engineering,
     2133).           County, (21-08-      Commissioners, 100 3rd Street,        100 3rd Street, Castle
                      0166P).              Castle Rock, CO 80104.                Rock, CO 80104.
    Eagle, (FEMA     Town of Gypsum, (20- The Honorable Steve Carver, Mayor,    Town Hall, 50 Lundgren        August 6, 2021...............       080002
     Docket No.: B-   08-0718P).           Town of Gypsum, P.O. Box 130,         Boulevard, Gypsum, CO
     2141).                                Gypsum, CO 81637.                     81637.
    Eagle, (FEMA     Unincorporated       Mr. Jeff Shroll, Eagle County         Eagle County Engineering      August 6, 2021...............       080051
     Docket No.: B-   areas of Eagle       Manager, P.O. Box 850, Eagle, CO      Department, 500 Broadway
     2141).           County, (20-08-      81631.                                Street, Eagle, CO 81631.
                      0718P).
    Jefferson,       City of Arvada, (20- The Honorable Marc Williams, Mayor,   Engineering Division, 8101    August 13, 2021..............       085072
     (FEMA Docket     08-0711P).           City of Arvada, 8101 Ralston Road,    Ralston Road, Arvada, CO
     No.: B-2136).                         Arvada, CO 80002.                     80002.
Connecticut: New     Town of Waterford,   The Honorable Robert J. Brule, First  Town Hall, 15 Rope Ferry      August 6, 2021...............       090107
 London, (FEMA        (20-01-1005P).       Selectman, Town of Waterford Board    Road, Waterford, CT 06385.
 Docket No.: B-                            of Selectmen, 15 Rope Ferry Road,
 2136).                                    Waterford, CT 06385.
Florida:
    Bay, (FEMA       City of Lynn Haven,  The Honorable Dan Russell, Mayor,     Development and Planning      August 16, 2021..............       120009
     Docket No.: B-   (20-04-2912P).       City of Lynn Haven, 817 Ohio          Department, 817 Ohio
     2133).                                Avenue, Lynn Haven, FL 32444.         Avenue, Lynn Haven, FL
                                                                                32444.
    Bay, (FEMA       Unincorporated       The Honorable Robert Carroll,         Bay County Planning           August 16, 2021..............       120004
     Docket No.: B-   areas of Bay         Chairman, Bay County Board of         Department, 840 West 11th
     2133).           County, (20-04-      Commissioners, 840 West 11th          Street, Panama City, FL
                      2912P).              Street, Panama City, FL 32401.        32401.
    Lee, (FEMA       City of Bonita       The Honorable Rick Steinmeyer,        Community Development         August 10, 2021..............       120680
     Docket No.: B-   Springs, (21-04-     Mayor, City of Bonita Springs, 9101   Department, 9220 Bonita
     2133).           1316P).              Bonita Beach Road, Bonita Springs,    Beach Road, Bonita Springs,
                                           FL 34135.                             FL 34135.
    Monroe, (FEMA    Unincorporated       The Honorable Michelle Coldiron,      Monroe County Building        August 9, 2021...............       125129
     Docket No.: B-   areas of Monroe      Mayor, Monroe County Board of         Department, 2798 Overseas
     2133).           County, (21-04-      Commissioners, 25 Ships Way, Big      Highway, Suite 300,
                      1580P).              Pine Key, FL 33042.                   Marathon, FL 33050.
    Pinellas, (FEMA  Town of Belleair,    Mr. J. P. Murphy, Manager, Town of    Building Department, 901      August 5, 2021...............       125088
     Docket No.: B-   (21-04-0918P).       Belleair, 901 Ponce de Leon           Ponce de Leon Boulevard,
     2136).                                Boulevard, Belleair, FL 33756.        Belleair, FL 33756.
    Polk, (FEMA      Unincorporated       The Honorable Rick Wilson, Chairman,  Polk County Land Development  August 5, 2021...............       120261
     Docket No.: B-   areas of Polk        Polk County Board of Commissioners,   Division, 330 West Church
     2130).           County, (20-04-      P.O. Box 9005, Drawer BC01, Bartow,   Street, Bartow, FL 33831.
                      2054P).              FL 33831.
    Volusia, (FEMA   City of Port         The Honorable Donald O. Burnette,     Community Development         August 13, 2021..............       120313
     Docket No.: B-   Orange, (20-04-      Mayor, City of Port Orange, 1000      Department, 1000 City
     2133).           5567P).              City Center Circle, Port Orange, FL   Center Circle, Port Orange,
                                           32129.                                FL 32129.
    Volusia, (FEMA   Unincorporated       Mr. George Recktenwald, Volusia       Volusia County Planning and   August 13, 2021..............       125155
     Docket No.: B-   areas of Volusia     County Manager, 123 West Indiana      Development Services
     2133).           County, (20-04-      Avenue, Deland, FL 32720.             Department, 123 West
                      5567P).                                                    Indiana Avenue, Deland, FL
                                                                                32720.
Louisiana:
    St. Tammany,     City of Mandeville,  The Honorable Clay Madden, Mayor,     City Hall, 3101 East          August 11, 2021..............       220202
     (FEMA Docket     (20-06-2506P).       City of Mandeville, 3101 East         Causeway Approach,
     No.: B-2133).                         Causeway Approach, Mandeville, LA     Mandeville, LA 70448.
                                           70448.
    St. Tammany,     Unincorporated       The Honorable Michael B. Cooper,      St. Tammany Parish            August 10, 2021..............       225205
     (FEMA Docket     areas of St.         President, St. Tammany Parish,        Inspections and Enforcement
     No.: B-2133).    Tammany Parish,      21490 Koop Drive, Mandeville, LA      Department, 21454 Koop
                      (21-06-0797P).       70471.                                Drive, Mandeville, LA
                                                                                70471.
South Carolina:      Unincorporated       Ms. Angela Christian, Georgetown      Georgetown County Building    August 5, 2021...............       450085
 Georgetown, (FEMA    areas of             County Administrator, 716 Prince      Department, 129 Screven
 Docket No.: B-       Georgetown County,   Street, Georgetown, SC 29440.         Street, Georgetown, SC
 2130).               (21-04-0982P).                                             29440.
Tennessee:

    Wilson, (FEMA    City of Lebanon,     The Honorable Rick Bell, Mayor, City  Engineering Department, 200   July 28, 2021................       470208
     Docket No.: B-   (20-04-4425P).       of Lebanon, 106 North Castle          Castle Heights Avenue
     2133).                                Heights Avenue, Lebanon, TN 37087.    North, Lebanon, TN 37087.
    Wilson, (FEMA    Unincorporated       The Honorable Randall Hutto, Mayor,   Wilson County Planning        July 28, 2021................       470207
     Docket No.: B-   areas of Wilson      Wilson County, 228 East Main          Department, 228 East Main
     2133).           County, (20-04-      Street, Room 104, Lebanon, TN         Street, Room 5, Lebanon, TN
                      4425P).              37087.                                37087.
Texas:
    Bexar, (FEMA     Unincorporated       The Honorable Nelson W. Wolff, Bexar  Bexar County Public Works     August 9, 2021...............       480035
     Docket No.: B-   areas of Bexar       County Judge, 101 West Nueva          Department, 1948 Probandt
     2141).           County, (20-06-      Street, 10th Floor, San Antonio, TX   Street, San Antonio, TX
                      3173P).              78205.                                78214.
    Collin, (FEMA    Unincorporated       The Honorable Chris Hill, Collin      Collin County Engineering     August 16, 2021..............       480130
     Docket No.: B-   areas of Collin      County Judge, 2300 Bloomdale Road,    Department, 4690 Community
     2141).           County, (20-06-      Suite 4192, McKinney, TX 75071.       Avenue, Suite 200,
                      3461P).                                                    McKinney, TX 75071.
    Dallas, (FEMA    City of Irving, (20- The Honorable Rick Stopfer, Mayor,    Engineering Department, 825   August 2, 2021...............       480180
     Docket No.: B-   06-2875P).           City of Irving, 825 West Irving       West Irving Boulevard,
     2133).                                Boulevard, Irving, TX 75060.          Irving, TX 75060.
    Denton and       City of Fort Worth,  The Honorable Betsy Price, Mayor,     Transportation and Public     August 16, 2021..............       480596
     Tarrant, (FEMA   (21-06-0261P).       City of Fort Worth, 200 Texas         Works Department,
     Docket No.: B-                        Street, Fort Worth, TX 76102.         Engineering Vault, 200
     2133).                                                                      Texas Street, Fort Worth,
                                                                                TX 76102.
    Harris, (FEMA    City of Houston,     The Honorable Sylvester Turner,       Floodplain Management         August 2, 2021...............       480296
     Docket No.: B-   (20-06-2472P).       Mayor, City of Houston, P.O. Box      Department, 1002 Washington
     2133).                                1562, Houston, TX 77251.              Avenue, Houston, TX 77002.
    Rockwall, (FEMA  City of Royse City,  The Honorable Clay Ellis, Mayor,      Engineering Department, 305   August 13, 2021..............       480548
     Docket No.: B-   (20-06-3180P).       City of Royse City, 305 North Arch    North Arch Street, Royse
     2136).                                Street, Royse City, TX 75189.         City, TX 75189.
    Tarrant, (FEMA   City of Fort Worth,  The Honorable Betsy Price, Mayor,     Department of Transportation  August 2, 2021...............       480596
     Docket No.: B-   (21-06-0615P).       City of Fort Worth, 200 Texas         and Public Works, 200 Texas
     2133).                                Street, Fort Worth, TX 76102.         Street, Fort Worth, TX
                                                                                76102.
    Tarrant, (FEMA   City of North        The Honorable Oscar Trevino, Jr.,     City Hall, 4301 City Point    August 16, 2021..............       480607
     Docket No.: B-   Richland Hills,      Mayor, City of North Richland         Drive, North Richland
     2133).           (21-06-0066P).       Hills, 4301 City Point Drive, North   Hills, TX 76180.
                                           Richland Hills, TX 76180.
    Williamson,      City of Cedar Park,  The Honorable Corbin Van Arsdale,     Engineering Department, 450   July 30, 2021................       481282
     (FEMA Docket     (21-06-0028P).       Mayor, City of Cedar Park, 450        Cypress Creek Road,
     No.: B-2133).                         Cypress Creek Road, Building 1,       Building 1, Cedar Park, X
                                           Cedar Park, TX 78613.                 78613.
Virginia:
    Frederick,       City of Winchester,  The Honorable John David Smith, Jr.,  Engineering Division, 15      August 10, 2021..............       510173
     (FEMA Docket     (21-03-0704X).       Mayor, City of Winchester, 15 North   North Cameron Street,
     No.: B-2133).                         Cameron Street, Winchester, VA        Winchester, VA 22601.
                                           22601.
    Frederick,       Unincorporated       The Honorable Charles S. DeHaven,     Frederick County Zoning       August 10, 2021..............       510063
     (FEMA Docket     areas of Frederick   Jr., Chairman-at-Large, Frederick     Department, 107 North Kent
     No.: B-2133).    County, (21-03-      County Board of Supervisors, 107      Street, Suite 202,
                      0704X).              North Kent Street, Winchester, VA     Winchester, VA 22601.
                                           22601.
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[FR Doc. 2021-19210 Filed 9-3-21; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 77, Number 204 (Monday, October 22, 2012)]
[Notices]
[Pages 64523-64524]
[FR Doc No: 2012-25898]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0471]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prescription Drug
User Fee Cover Sheet; Form FDA 3397

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by
November 21, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0297.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Prescription Drug User Fee Cover Sheet; Form FDA 3397--(OMB Control
Number 0910-0297)--Extension

    Under the prescription drug user fee provisions of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21
U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and
collect user fees for certain drug and biologics license applications
and supplements to those applications. Under this authority,
pharmaceutical companies pay a fee for certain new drug applications
(NDAs), biologics license applications (BLAs), or supplements submitted
to the Agency for review. Because the submission of user fees
concurrently with applications and supplements is required, review of
an application by FDA cannot begin until the fee is submitted. The
Prescription Drug User Fee Cover Sheet, Form FDA 3397, is designed to
provide the minimum necessary information to determine whether a fee is
required for review of an application, to determine the amount of the
fee required, and to account for and track user fees. The form provides
a cross-reference of the fee submitted for an application by using a
unique number tracking system. The information collected is used by
FDA's Center for Drug Evaluation and Research (CDER) and Center for
Biologics Evaluation and Research (CBER) to initiate the administrative
screening of NDAs, BLAs, and/or supplemental applications to those
applications.
    Respondents to this collection of information are new drug and
biologics manufacturers. Based on FDA's database system for fiscal year
(FY) 2011, there are an estimated 260 manufacturers of products subject
to the Prescription Drug User Fee Act (Pub. L. 105-115). The total
number of annual responses is based on the number of submissions
received by FDA in FY 2011. CDER received 3,363 annual responses that
include the following submissions: 114 NDAs; 4 BLAs; 1,900
manufacturing supplements; 1,209 labeling supplements; and 136 efficacy
supplements. CBER received 768 annual responses that include the
following submissions: 6 BLAs; 698 manufacturing supplements; 44
labeling supplements; and 20 efficacy supplements. The estimated hours
per response are based on past FDA experience with the various
submissions.
    FDA is revising Form FDA 3397 in the following ways: (1) By
updating the applicable Web sites; (2) by adding a Privacy Act Notice
pursuant to the Privacy Act of 1974, 5 U.S.C. 552a(3)j; (3) by adding
351(k) applications to the CDER and CBER lists of applications and
supplements for which Form FDA 3397 need not be submitted; (4) by
adding ``or proper name'' to instruction number 3; and (5) by making
minor editorial changes.
    In the Federal Register of May 18, 2012 (77 FR 29663), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of
                  FDA Form No.                      Number of      responses per     Total annual      Average  burden per  response       Total hours
                                                   respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3397..................................             260            15.89            4,131   0.5 (30 min.)                               2,065.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: October 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-25898 Filed 10-19-12; 8:45 am]
BILLING CODE 4160-01-P