[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Rules and Regulations]
[Pages 59551-59554]
[FR Doc No: 2012-23855]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0767]
RIN 1625-AA00

Safety Zone, Changes to Original Rule; Boston Harbor's Rock
Removal Project, Boston Inner Harbor, Boston, MA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing three temporary safety zones
within Sector Boston's Captain of the Port (COTP) Zone for the
drilling, blasting, and dredging operation on the navigable waters of
Boston Inner Harbor, in the main ship channel near Castle Island. These
temporary safety zones are necessary to enhance navigation, vessel
safety, marine environmental protection, and provide for the safety of
life on the navigable waters during the drilling, blasting and dredging
operations in support of the U.S. Army Corps of Engineers rock removal
project. Entering into, transiting through, mooring or anchoring within
these safety zones is prohibited unless authorized by the COTP or the
designated on-scene representative.

DATES: This rule is effective with actual notice from September 4,
2012, until September 28, 2012. This rule is effective in the Code of
Federal Regulations from September 28, 2012 until September 30, 2012.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2012-0767. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' Box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with the rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation, West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary final rule, call or email Mr. Mark Cutter, Coast Guard Sector
Boston Waterways Management Division, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
COTP Captain of the Port

A. Regulatory History and Information

    On August 23, 2012, the Coast Guard published a temporary final
rule establishing a safety zone for rock removal operations in Boston
Harbor, entitled ``Safety Zone; Boston Harbor's Rock Removal Project,
Boston Inner Harbor, Boston, MA'' (77 FR 50916). This new rule retains
the original provisions of that temporary final rule, but adds two
additional safety zones necessary for the safety of life at sea.
    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.''
    Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause
exists for not publishing a notice of proposed rulemaking (NPRM) with
respect to this rule. Publication of an NPRM would be impracticable
because critical information regarding the scope of the event was not
received from the U.S. Army Corps of Engineers until July 15, 2012,
providing insufficient time for the Coast Guard to solicit public
comments before the start date of the project. A delay or cancellation
of the project in order to accommodate a notice and comment period
would be contrary to the public interest because immediate action is
necessary to ensure the safety of the personnel involved in the rock
removal project and any public vessels in the vicinity of the drilling,
dredging and blasting operations being conducted. For the safety
concerns noted, it is in the public interest to have these regulations
in effect during the rock removal project.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. For the reasons stated above, any
delay in the effective date of this rule would expose personnel
involved in the rock removal project and any public vessels in the
vicinity to any hazards associated with the drilling, dredging and
blasting operations.

B. Basis and Purpose

    Starting from August 13, 2012, daily from 5 a.m. to 8 p.m. until
September 30, 2012, the contractor Burnham Associates Inc. has been
conducting drilling, blasting and dredging operations in support of the
U.S. Army Corps of Engineers Boston Harbors main ship channel rock
removal project.
    The U.S. Army Corps of Engineers discussed the rock removal project
at the Boston's Port Operators Group monthly meeting on July 15, 2012.
The Coast Guard hosted a meeting on August 2, 2012 inviting
stakeholders from the maritime industry in Boston Harbor to discuss and
mitigate any impacts this project will have on maritime community. The
feedback from the meeting was that these safety zones will have minimum
impact on local mariners based on the location and the fact that the
majority of boating traffic will be able to transit around the safety
zones and that the vessels involved in the rock removal operations will
move as needed for deep draft vessels.
    The legal basis for the temporary rule is 33 U.S.C. 1226, 1231, 46
U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; Public Law 107-295,
116 Stat. 2064; and Department of Homeland Security Delegation No.
0170.1, which collectively authorize the Coast Guard to define safety
zones.

C. Discussion of Final Rule

    The COTP Boston has determined that hazards associated with the
drilling, dredging and blasting operations pose a significant risk to
safety of life on navigable waters. Three safety zones will be
established to help ensure the safety of the personnel involved in the
rock removal project and any public vessels in the vicinity, and help
minimize associated risks with this project. For those reasons, safety
zones are being issued to provide for the safety of life on the
navigable waters during the drilling, blasting and dredging operations
in support of the U.S. Army Corps of Engineers rock removal project.
    The first safety zone will be a 100-yard radius around the workboat
``MANTIS'' while transiting to and from the work site with explosives
onboard. The second safety zone will be a 100-yard radius centered on
the various worksites while actively engaged in drilling, blasting and
dredging operations are on-going. The final safety zone will be a 500-
yard radius centered on the worksite on each day of blasting, to be
established once explosives are laid and ready for detonation, and
subsequently suspended once a successful detonation has been confirmed.
These safety zones will be enforced only while the vessel is on scene
conducting operations involved in the rock removal project in Boston
Harbor's main ship near Castle Island.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) Executive Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under that Order.
    The Coast Guard has determined that this rule is not a significant
regulatory action for the following reasons: the Coast Guard expects
minimal adverse impact to mariners from the activation of the zones;
vessels have sufficient room to transit around the safety zones, with
exception given to the final zone, which will stop traffic for short
periods of time each day; the vessel conducting the operations will
move out of the channel for deep draft vessels that need to pass
through that area and vessels may enter or pass through the affected
waterway with the permission of the Captain of the Port (COTP) or the
COTP's designated on-scene representative; and notification of these
safety zones will be made to mariners through the local Notice to
Mariners, Broadcast Notice to Mariners, and by Safety Marine
Information Broadcasts in advance of the event.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended requires federal agencies to consider the potential impact of
regulations on small entitles during rulemaking. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule would not have a
significant economic impact on a substantial number of small entities
for the following reasons: Vessels have sufficient room to transit
around the safety zone; the vessel conducting the operations will move
out of the channel for deep draft vessels that need to pass through
that area and vessels may enter or pass through the affected waterway
with the permission of the Captain of the Port (COTP) or the COTP's
designated on-scene representative; notification of the safety zone
will be made to mariners through the Local Notice to Mariners,
Broadcast Notice to Mariners, and by Safety Marine Information
Broadcasts well in advance of the event.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that it does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``Significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human

environment. This rule involves the establishment of three safety
zones. This rule is categorically excluded from further review under,
paragraph 34(g) of figure 2-1 of the Commandant Instruction. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Revise Sec.  165.T01-0767 to read as follows:

Sec.  165.T01-0767  Safety Zone; Boston Harbor's Rock Removal Project,
Boston Inner Harbor, Boston, MA.

    (a) General. Three temporary safety zones are established for the
Boston Harbor's Rock Removal Project as follows:
    (1) Location. (i) All navigable waters from surface to bottom,
within a 100-yard radius around the vessel or vessels conducting
drilling, blasting, dredging, and other related operations related to
rock removal in Boston's Inner Harbor near Castle Island.
    (ii) All navigable waters from surface to bottom, with a 100-yard
radius around the vessel ``MANTIS'' while transporting explosives to
and from the work site.
    (iii) All navigable waters from surface to bottom, with a 500-yard
radius around the blasting site while setting up for blasting,
blasting, and in the immediate aftermath.
    (2) Definitions. For the purposes of this section, ``Designated on-
scene representative'' is any Coast Guard commissioned, warrant, or
petty officer who has been designated by the Captain of the Port Boston
(COTP) to act on the COTP's behalf. The designated representative may
be on an Official Patrol Vessel. An ``Official Patrol Vessel'' may
consist of any Coast Guard, Coast Guard Auxiliary, state, or local law
enforcement vessels assigned or approved by the COTP or the designated
on-scene representative may be on shore and will communicate with
vessels via VHF-FM radio or loudhailer. In addition, members of the
Coast Guard Auxiliary may be present to inform vessel operators of this
regulation.
    (3) Enforcement Period. This rule will be enforced daily from 5
a.m. to 8 p.m. from September 4, 2012, until September 30, 2012.
    (b) Regulations. (1) The general regulations contained in 33 CFR
165.23, as well as the following regulations, apply.
    (2) No vessels, except for participating or public vessels, will be
allowed to enter into, transit through, or anchor within these safety
zones without the permission of the COTP or the designated on-scene
representative.
    (3) All persons and vessels shall comply with the instructions of
the COTP or the designated on-scene representative. Upon being hailed
by a U.S. Coast Guard vessel by siren, radio, flashing light, or other
means, the operator of a vessel shall proceed as directed.
    (4) Vessel operators desiring to enter or operate within the
regulated area shall contact the COTP or the designated on-scene
representative via VHF channel 16 or<PHONE_NUMBER> (Sector Boston
command Center) to obtain permission.

    Dated: September 4, 2012.
J.C. O'Connor III,
Captain, U.S. Coast Guard, Captain of the Port Boston.
[FR Doc. 2012-23855 Filed 9-27-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 50 (Wednesday, March 15, 2023)]
[Rules and Regulations]
[Pages 15905-15906]
[FR Doc No: 2023-05291]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 43, 65, and 147

[Docket No.: FAA-2021-0237; Amdt. No. 43-52A, 65-63A, 147-9A]
RIN 2120-AL67

Aviation Maintenance Technician Schools

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation.

ACTION: Interim final rule; reopening of comment period for regulatory
impact analysis only.

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SUMMARY: This action reopens the comment period for the regulatory
evaluation associated with the FAA's interim final rule, Aviation
Maintenance Technician Schools, which was published in the Federal
Register on May 24, 2022. The regulatory evaluation associated with
this rule was not posted to the docket prior to the close of the
comment period. Therefore, the FAA is reopening the comment period to
allow the public the opportunity to adequately analyze the full
regulatory evaluation of the interim final rule. The FAA will accept
comments on the regulatory evaluation only and not on the regulatory
changes in the interim final rule.

DATES: The comment period for the interim final rule published on May
24, 2022 (87 FR 31391), closed on June 23, 2022, is reopened until
April 14, 2023.

ADDRESSES: You may send comments identified by docket number FAA-2021-
0237 using any of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov and
follow the online instructions for sending your comments
electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments,

without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
www.regulations.gov at any time. Follow the online instructions for
accessing the docket or visit Docket Operations in Room W12-140 of the
West Building Ground Floor at 1200 New Jersey Avenue SE, Washington,
DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact Tanya Glines, Aircraft Maintenance Division,
Federal Aviation Administration, 800 Independence Avenue SW,
Washington, DC 20591; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION: See the ``Additional Information'' section
for information on how to comment on this action and how the FAA will
handle comments received. The ``Additional Information'' section also
contains information on obtaining copies of related rulemaking
documents.

Background

    On December 27, 2020, Congress passed the Consolidated
Appropriations Act (Pub. L. 116-260), which includes the Aircraft
Certification, Safety, and Accountability Act (the ``Act''). Section
135 of the Act, titled ``Promoting Aviation Regulations for Technician
Training,'' directed the FAA to issue interim final regulations to
establish requirements for issuing aviation maintenance technician
school (AMTS) certificates and associated ratings and the general
operating rules for the holders of those certificates and ratings in
accordance with the requirements set forth within section 135.
    On May 24, 2022, the FAA published the interim final rule (IFR),
titled ``Aviation Maintenance Technician Schools'' (87 FR 31391). The
comment period for this rulemaking closed on June 23, 2022. On July 26,
2022, the Office of Management and Budget (OMB) approved the collection
under the existing information collection OMB Control Number 2120-0040.
The rule became effective on September 21, 2022, except for amendatory
instructions 6 and 9, which will become effective on August 1, 2023.
    The regulatory evaluation (also referred to as the regulatory
impact analysis) associated with this IFR was not posted to the docket
before the close of the comment period. To ensure that the public has
the opportunity to provide comments specifically on the regulatory
evaluation now posted in the docket (FAA-2021-0237), the FAA is
reopening the comment period for 30 days to allow for the comments on
the regulatory evaluation only. The FAA will not address comments on
the substance of the IFR itself because the comment period for the IFR
closed on June 23, 2022.
    Accordingly, the comment period for the interim final rule is
reopened only as it pertains to the regulatory evaluation that is now
in the docket until April 14, 2023.

Additional Information

A. Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. The most
helpful comments reference a specific portion of the regulatory
evaluation, explain the reasons for any recommended change, and include
supporting data. To ensure the docket does not contain duplicate
comments, commenters should send only one copy of written comments, or
if comments are filed electronically, commenters should submit only one
time.
    The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. The FAA will consider
all comments it receives on or before the closing date for comments.
The FAA will also consider comments filed late to the extent
practicable. The IFR may be amended based on comments received.

B. Availability of the Regulatory Impact Analysis

    An electronic copy of rulemaking documents may be obtained by using
the internet--
    1. Search the Federal eRulemaking Portal at www.regulations.gov;
    2. Visit the FAA's Regulations and Policies web page at
www.faa.gov/regulations_policies/; or
    3. Access the Government Printing Office's web page at GovInfo.gov.
    Copies may also be obtained by sending a request (identified by
notice, amendment, or docket number of this rulemaking) to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW, Washington, DC 20591, or by calling<PHONE_NUMBER>.

    Issued in Washington, DC, on March 10, 2023.
Brandon Roberts,
Executive Director, Office of Rulemaking.
[FR Doc. 2023-05291 Filed 3-14-23; 8:45 am]
BILLING CODE 4910-13-P


A 2000 48 IV B 7 From: Brian Shrager To: Mary Johnson EPA/ ESD/ CG ( C439 01) U. S. Environmental Protection Agency Research Triangle Park, NC 27711 Date: February 28, 2003 Project: Clay Ceramics Manufacturing NESHAP Re: Final Rule: Beyond the floor Analysis I. Introduction The purpose of this memorandum is to present the beyond the floor ( BTF) analyses for the clay ceramics manufacturing industry maximum achievable control technology ( MACT) standards development project. Beyond the floor analyses, including estimates of nationwide emission reductions, secondary air impacts, non air quality impacts, cost impacts, and cost effectiveness, were completed for the following sources: ( 1) existing tile tunnel kilns; and ( 2) existing sanitaryware tunnel kilns. After identifying the MACT floors for the existing kilns, regulatory alternatives more stringent than the MACT floor levels were investigated. These regulatory alternatives are discussed in Section II of this memorandum. Sections III through V of this memorandum present the results of the BTF analyses for the three types of clay ceramics kilns.

II. Beyond the floor Options Available data on the performance of add on air pollution control devices ( APCDs) and pollution prevention techniques ( i. e., substitution of raw materials and/ or fuels) were reviewed to identify the MACT floor and regulatory alternatives for clay ceramics kilns. No existing clay ceramics kilns are equipped with APCDs that reduce hydrogen fluoride ( HF), hydrogen chloride ( HCl), and hazardous air pollutant ( HAP) metals. Therefore, the MACT floor for all existing clay ceramics kilns does not include use of an APCD. Low HAP raw material use is not a viable MACT option for the clay ceramics industry because all facilities use product specific raw materials that are integral to the various products. Changes in raw materials would change the end products, and because of this, it would not be feasible for facilities to meet requirements based on the use of low HAP raw materials. With respect to requiring kilns to fire low HAP fuels, all clay ceramics kilns for which EPA has information are fired with natural gas or propane. 2 Thus, a requirement to use natural gas ( or equivalent fuel) to fire all existing kilns would not have any impact on the end products of existing kilns. Therefore, the MACT floor for all existing clay ceramics periodic kilns, tunnel kilns, and roller kilns is based on firing the kilns with natural gas or an equivalent fuel ( such as propane or other clean burning fuel).

Regulatory alternatives more stringent than the MACT floor for clay ceramics kilns include use of an APCD such as a dry limestone adsorber ( DLA), dry lime injection fabric filter ( DIFF), dry lime scrubber/ fabric filter ( DLS/ FF), wet scrubber ( WS). Based on comments received following proposal of the brick and structural clay products ( BSCP) MACT rule, it appears that DLAs are the only available APCD that can be used to retrofit existing tunnel kilns without changing the production process and product characteristics. Therefore, DLAs were the only APCD considered for the BTF analyses for tunnel kilns. No APCDs have been demonstrated to control HAP emissions from roller kilns and periodic kilns. Therefore, beyond the floor control options for roller kilns and periodic kilns were not considered.

II. Tile Tunnel Kilns The available data show 14 existing tunnel kilns at ceramic tile facilities that are estimated to be major sources. 1 The largest of these tunnel kilns produces 10 tons per hour ( tph) of fired product. This BTF analysis assumes that each existing tile tunnel kiln would be retrofitted with a DLA to control HAP emissions. The BTF analysis includes: ( 1) estimates of primary air pollution impacts ( emission reductions); ( 2) estimates of secondary air impacts; ( 3) estimates of solid waste impacts; ( 4) estimates of energy impacts; and ( 5) an evaluation of costs and costeffectiveness

A. Primary Air Pollution Impacts. Primary HAP air pollution impacts consist of the reduction of HF, HCl, and HAP metals emissions. Implementation of the BTF regulatory approach would reduce total HAP emissions from existing tile tunnel kilns by 99 tons per year ( tpy), or 70 percent, from a baseline HAP emission level of 141 tpy. Particulate matter ( PM) emission reductions ( PM is used as a surrogate for HAP metals) and co control of sulfur dioxide ( SO 2) emissions ( from the baseline level) also would result from implementation of the BTF approach. The estimated baseline emissions and reductions for the BTF approach for existing tile tunnel kilns are summarized in Table 1, and are based on average emission factors for ceramics kilns and brick kilns ( if ceramics data are not available) and DLA control efficiencies from the brick industry applied to model tile tunnel kilns. 2 4 B. Secondary Air Pollution Impacts. Table 2 shows a summary of secondary air pollution impacts associated with the BTF regulatory approach. These impacts were estimated according to the methodology outlined in Reference 5. In general, the methodology assumes that the secondary air impacts consist of the emissions from the generation of electricity to power the DLAs that would be installed on 14 tile tunnel kilns. 3 C. Solid Waste Impacts. Table 2 shows a summary of solid waste impacts associated with implementation of the BTF regulatory approach. These impacts were estimated according to the methodology outlined in Reference 5. In general, the methodology assumes that the solid waste impacts consist of the solid waste ( spent limestone and reaction products) generated by the DLAs that would be installed on 14 tile tunnel kilns.

D. Energy Impacts. Table 2 shows a summary of energy impacts associated with implementation of the BTF regulatory approach. These impacts were estimated according to the methodology outlined in Reference 5. In general, the methodology assumes that the energy impacts consist of the energy requirements of the DLAs that would be installed on 14 tile tunnel kilns.

E. Cost Impacts. The estimated capital cost of a DLA on a tile tunnel kiln is $ 510,000. The annualized capital, operation, and maintenance costs are estimated at $ 172,000. Emission testing, monitoring, and recordkeeping and reporting costs are estimated at $ 23,500. Table 2 shows a summary of cost impacts associated with implementation of the BTF regulatory approach. These impacts were estimated by applying the estimated control, monitoring, testing, and recordkeeping and reporting costs for DIFFs to each of the 14 tile tunnel kilns included in this analysis. 2, 6 8 F. Cost Effectiveness. To estimate the cost effectiveness of controlling HF, HCl, HAP metals, PM, and SO 2, the estimated emission reductions, shown in Table 1, were used in conjunction with the total estimated costs for installation and operation of DLA systems shown in Table 2. The estimated nationwide cost effectiveness of requiring BTF control of existing tile tunnel kilns is $ 28,000 per ton of HAP removed. Nationwide cost effectiveness numbers for each pollutant are presented in Table 3.

TABLE 1. PRIMARY AIR IMPACTS FOR EXISTING TILE TUNNEL KILNS Tile tunnel kilnsa Pollutant Baseline emissions, tpya BTF emission reductions, tpyb HF 88.0 82.5 HCl 52.8 16.2 HAP metals 0.54 0.27 Total HAP Emissions 141 99.0 PM 75.4 37.7 SO 2 379 126 a Emission estimates based on average emission factors from brick tunnel kilns applied to 14 model tile tunnel kilns, each producing 2.5 tons per hour of fired tile. b Emission reductions based on 93.7 percent HF control, 30.7 percent HCl control, 50 percent HAP metals and PM control, and 33.2 percent SO 2 control. 4 TABLE 2. SUMMARY OF SECONDARY AIR, ENERGY, AND SOLID WASTE IMPACTS OF BTF CONTROL FOR EXISTING TILE TUNNEL KILNS Type of impact BTF impact Comments Secondary air: NO x 1 ton per year NO x increase Based on electricity provided by gas turbines Solid waste 4,480 tons per year Assumes facilities must dispose of all waste lime as solid waste Energy 9,350 MMBtu/ yr Energy required to power DIFFs Cost $ 2.74 million TABLE 3. SUMMARY OF COST EFFECTIVENESS OF BTF CONTROL FOR EXISTING TILE TUNNEL KILNS Cost effectiveness, $/ ton of pollutant removed Pollutant DIFF HF 33,000 HCl 169,000 HAP metals 10,000,000 Total HAP 28,000 PM 73,000 SO 2 22,000 All criteria pollutants 17,000 All pollutants 10,000 IV. Sanitaryware Tunnel Kilns The available data show 23 existing tunnel kilns at sanitaryware facilities that are estimated to be major sources. All of these tunnel kilns produce less than 10 tph of fired product. This BTF analysis assumes that each existing sanitaryware tunnel kiln would be retrofitted with a DLA to control HAP emissions. The BTF analysis includes: ( 1) estimates of primary air pollution impacts ( emission reductions); ( 2) estimates of secondary air impacts; ( 3) estimates of solid waste impacts; ( 4) estimates of energy impacts; and ( 5) an evaluation of costs and cost effectiveness.

A. Primary Air Pollution Impacts. Primary HAP air pollution impacts consist of the reduction of HF, HCl, and HAP metals emissions. Implementation of the BTF regulatory approach would reduce total HAP emissions from existing sanitaryware tunnel kilns by 150 tpy, or 70 percent, from a baseline HAP emission level of 214 tpy. Particulate matter emission reductions ( PM is used as a surrogate for HAP metals), and co control of SO 2 emissions ( from 5 the baseline level) also would be directly attributable to implementation of the regulation. The estimated baseline emissions and emission reductions for the BTF approach for existing sanitaryware tunnel kilns are summarized in Table 4, and are based on average emission factors for ceramics kilns and brick kilns ( if ceramics data are not available) and DLA control efficiencies from the brick industry applied to model sanitaryware tunnel kilns. 2 4 B. Secondary Air Pollution Impacts. Table 5 shows a summary of secondary air pollution impacts associated with the BTF regulatory approach. These impacts were estimated according to the methodology outlined in Reference 5. In general, the methodology assumes that the secondary air impacts consist of the emissions from the generation of electricity to power the DLAs that would be installed on 23 sanitaryware tunnel kilns.

C. Solid Waste Impacts. Table 5 shows a summary of solid waste impacts associated with implementation of the BTF regulatory approach. These impacts were estimated according to the methodology outlined in Reference 5. In general, the methodology assumes that the solid waste impacts consist of the solid waste ( spent limestone and reaction products) generated by the DLAs that would be installed on 23 sanitaryware tunnel kilns.

D. Energy Impacts. Table 5 shows a summary of energy impacts associated with implementation of the BTF regulatory approach. These impacts were estimated according to the methodology outlined in Reference 5. In general, the methodology assumes that the energy impacts consist of the energy requirements of the DLAs that would be installed on 23 sanitaryware tunnel kilns.

E. Cost Impacts. The estimated capital cost of a DLA on a sanitaryware tunnel kiln is $ 510,000. The annualized capital, operation, and maintenance costs are estimated at $ 172,000. Emission testing, monitoring, and recordkeeping and reporting costs are estimated at $ 23,500. Table 5 shows a summary of cost impacts associated with implementation of the BTF regulatory approach. These impacts were estimated by applying the estimated control, monitoring, testing, and recordkeeping and reporting costs for DLAs to each of the 23 sanitaryware tunnel kilns included in this analysis. 2, 6 8 F. Cost Effectiveness. To estimate the cost effectiveness of controlling HF, HCl, HAP metals, PM, and SO 2, the estimated emission reductions, shown in Table 4, were used in conjunction with the total estimated costs for installation and operation of DLA systems shown in Table 5. The estimated nationwide cost effectiveness of requiring BTF control of existing sanitaryware tunnel kilns is $ 30,000 per ton of HAP removed. Nationwide cost effectiveness numbers for each pollutant are presented in Table 6. 6 TABLE 4. PRIMARY AIR IMPACTS FOR EXISTING SANITARYWARE TUNNEL KILNS Pollutant Baseline emissions, tpya BTF emission reductions, tpyb HF 133 125 HCl 79.8 24.5 HAP metals 1.43 0.71 Total HAP Emissions 214 150 PM 198 99.1 SO 2 995 330 a Emission estimates based on average emission factors for sanitaryware tunnel kilns applied to 23 model sanitaryware tunnel kilns, each producing 4 tons per hour of fired sanitaryware. b Emission reductions based on 93.7 percent HF control, 30.7 percent HCl control, 50 percent HAP metals and PM control, and 33.2 percent SO 2 control.

TABLE 5. SUMMARY OF SECONDARY AIR, ENERGY, AND SOLID WASTE IMPACTS OF BTF CONTROL FOR EXISTING SANITARYWARE TUNNEL KILNS Type of impact BTF impact Comments Secondary air: NO x 2 tons per year NO x increase Based on electricity provided by gas turbines Solid waste 7,450 tons per year Assumes facilities must dispose of all waste lime as solid waste Energy 15,400 MMBtu/ yr Energy required to power DIFFs Cost $ 4.51 million TABLE 6. SUMMARY OF COST EFFECTIVENESS OF BTF CONTROL FOR SANITARYWARE TUNNEL KILNS Cost effectiveness, $/ ton of pollutant removed Pollutant DIFF HF 36,000 HCl 18,000 HAP metals 6,400,000 Total HAP 30,000 PM 46,000 SO 2 14,000 All criteria pollutants 10,000 All pollutants 7,800 7 V. References 1. Memorandum from B. Shrager, MRI, to M. Johnson, EPA: ESD. Documentation of Database of Responses to the 1997 EPA Information Collection Request for Clay Ceramics Manufacturing. December 6, 2001.

2. Memorandum from B. Shrager and M. Abraczinskas, MRI, to M. Johnson, EPA: ESD. Model Plants   Clay Ceramics Kilns. Clay Ceramics Manufacturing NESHAP. November 15, 2000.

3. Memorandum from B. Shrager and M. Abraczinskas, MRI, to M. Johnson, EPA: ESD. Abbreviated Summary of Clay Ceramics Emissions Test Data. Clay Ceramics Manufacturing NESHAP. July 10, 2000.

4. Memorandum from B. Shrager, RTI, to M. Johnson, EPA: ESD. Final Rule: Test Data Summary. Brick and Structural Clay Products Manufacturing NESHAP. February 27, 2003.

5. Memorandum from B. Shrager, RTI, to M. Johnson, EPA: ESD. Final Rule: Environmental and Energy Impacts. Brick and Structural Clay Products Manufacturing NESHAP and Clay Ceramics Manufacturing NESHAP. February 27, 2003.

6. Memorandum from B. Shrager, RTI, to M. Johnson, EPA: ESD. Final Rule: Costs for Air Pollution Control Devices on Clay Ceramics Kilns. Clay Ceramics Manufacturing NESHAP. February 26, 2003.

7. Memorandum from B. Shrager, RTI, to M. Johnson, EPA: ESD. Final Rule: Monitoring and Monitoring Costs. Brick and Structural Clay Products Manufacturing and Clay Ceramics Manufacturing NESHAP. February 26, 2003.

8. OMB 83I Form Supporting Statement, for OMB Review of ICR No. 2023.01. Information Collection Request for the National Emission Standards for Hazardous Air Pollutants for the Clay Ceramics Source Category. U. S. Environmental Protection Agency, February 2003.

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[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66019-66022]
[FR Doc No: 2015-27472]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2015-0001]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final 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: The effective date for each LOMR is indicated 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 www.msc.fema.gov.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at 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 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 also 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 www.msc.fema.gov.

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

    Dated: October 8, 2015.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Chief executive officer of      Community map            Effective date of         Community
         State and county           Location and case No.           community                repository                modification              No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arkansas:
    Drew (FEMA Docket No.: B-1516)  City of Monticello     The Honorable Zackery       City Hall, 203 West    Aug. 13, 2015................       050074
                                     (14-06-3181P).         Tucker, Mayor, City of      Gaines Street,
                                                            Monticello, P.O. Box 505,   Monticello, AR 71655.
                                                            Monticello, AR 71657.
    Drew (FEMA Docket No.: B-1516)  Unincorporated areas   The Honorable Robert Akin,  Drew County            Aug. 13, 2015................       050430
                                     of Drew County (14-    Drew County Judge, 210      Courthouse, 210
                                     06-3181P).             South Main Street,          South Main Street,
                                                            Monticello, AR 71655.       Monticello, AR 71655.
Arizona:
    Pima (FEMA Docket No.: B-1526)  Town of Marana (14-09- The Honorable Gilbert       Town Hall, 11555 West  Aug. 24, 2015................       040118
                                     3997P).                Davidson, Manager, Town     Civic Center Drive,
                                                            of Marana, 11555 West       Marana, AZ 85653.
                                                            Civic Center Drive,
                                                            Marana, AZ 85653.
    Pima (FEMA Docket No.: B-1526)  Unincorporated areas   The Honorable Sharon        Pima County Flood      Aug. 24, 2015................       040073
                                     of Pima County (14-    Bronson, Chair, Pima        Control District, 97
                                     09-3997P).             County Board of             East Congress
                                                            Supervisors, 130 West       Street, 3rd Floor,
                                                            Congress Street, 11th       Tucson, AZ 85701.
                                                            Floor, Tucson, AZ 85701.
Colorado:
    Eagle (FEMA Docket No.: B-      Unincorporated areas   The Honorable Kathy         Eagle County Building  Aug. 7, 2015.................       080051
     1514).                          of Eagle County (14-   Chandler-Henry, Chair,      and Engineering
                                     08-1086P).             Eagle County Board of       Department, 500
                                                            Commissioners, P.O. Box     Broadway Street,
                                                            850, Eagle, CO 81631.       Eagle, CO 81631.
    Fremont (FEMA Docket No.: B-    City of Canon City     The Honorable Tony Greer,   City Hall, 128 Main    Aug. 3, 2015.................       080068
     1514).                          (14-08-0930P).         Mayor, City of Canon        Street, Canon City,
                                                            City, 901 Main Street,      CO 81212.
                                                            Canon City, CO 81212.
    Fremont (FEMA Docket No.: B-    Unincorporated areas   The Honorable Ed Norden,    Fremont County         Aug. 3, 2015.................       080067
     1514).                          of Fremont County      Chairman, Fremont County    Administrator, 615
                                     (14-08-0930P).         Board of Commissioners,     Macon Avenue, Canon
                                                            615 Macon Avenue, Room      City, CO 81212.
                                                            105, Canon City, CO 81212.
Florida:
    Bay (FEMA Docket No.: B-1522).  Unincorporated areas   The Honorable Robert        Bay County Government  Aug. 24, 2015................       120004
                                     of Bay County (15-04-  Majka, Jr., Bay County      Offices, 707 Jenks
                                     1287P).                Manager, 840 West 11th      Avenue, Suite B,
                                                            Street, Panama City, FL     Panama City, FL
                                                            32401.                      32401.
    Charlotte (FEMA Docket No.: B-  Unincorporated areas   The Honorable Bill Truex,   Charlotte County       Aug. 24, 2015................       120061
     1522).                          of Charlotte County    Chairman, Charlotte         Community
                                     (15-04-3689P).         County Board of             Development
                                                            Commissioners, 18500        Department, 18500
                                                            Murdock Circle, Port        Murdock Circle, Port
                                                            Charlotte, FL 33948.        Charlotte, FL 33948.
    Collier (FEMA Docket No.: B-    City of Naples (15-04- The Honorable John Sorrey,  City Hall, 735 8th     Aug. 24, 2015................       125130
     1522).                          4054P).                III, 735 8th Street         Street South,
                                                            South, Naples, FL 34102.    Naples, FL 34102.
    Lee (FEMA Docket No.: B-1522).  Unincorporated areas   The Honorable Brian         Lee County Community   Aug. 20, 2015................       125124
                                     of Lee County (14-04-  Hamman, Chairman, Lee       Development
                                     5866P).                County Board of             Department, 1500
                                                            Commissioners, P.O. Box     Monroe Street,, 2nd
                                                            398, Fort Myers, FL 33902.  Floor, Fort Myers,
                                                                                FL 33901.
    Lee (FEMA Docket No.: B-1514).  Unincorporated areas   The Honorable Brian         Lee County Community   Jul. 31, 2015................       125124
                                     of Lee County (15-04-  Hamman, Chairman, Lee       Development
                                     2532P).                County Board of             Department, 1500
                                                            Commissioners, P.O. Box     Monroe Street,, 2nd
                                                            398, Fort Myers, FL 33902.  Floor, Fort Myers,
                                                                                FL 33901.
    Manatee (FEMA Docket No.: B-    Unincorporated areas   The Honorable Betsy Benac,  Manatee County         Jul. 3, 2015.................       120153
     1526).                          of Manatee County      Chair, Manatee County       Building and
                                     (14-04-A642P).         Board of Comminssioners,    Development Services
                                                            P.O. Box 1000, Bradenton,   Department, 1112
                                                            FL 34206.                   Mantee Avenue West,
                                                                                Bradenton, FL 34205.
    Monroe (FEMA Docket No.: B-     City of Key West (15-  The Honorable Craig Cates,  Planning Department,   Aug. 24, 2015................       120168
     1522).                          04-1481P).             Mayor, City of Key West,    605A Simonton
                                                            3126 Flagler Avenue, Key    Street, Key West, FL
                                                            West, FL 33040.             33040.
    Monroe (FEMA Docket No.: B-     Unincorporated areas   The Honorable Danny         Department of          Aug. 24, 2015................       125129
     1522).                          of Monroe County (15-  Kolhage, Mayor, Monroe      Planning and
                                     04-2332P).             County, 1100 Simonton       Environmental
                                                            Street, Key West, FL        Resources, 2798
                                                            33040.                      Overseas Highway,
                                                                                Marathon FL 33050.
    Monroe (FEMA Docket No.: B-     Unincorporated Areas   The Honorable Danny         Department of          Aug. 24, 2015................       125129
     1522).                          of Monroe County (15-  Kolhage, Mayor, Monroe      Planning and
                                     04-2377P).             County, 1100 Simonton       Environmental
                                                            Street, Key West, FL        Resources, 2798
                                                            33040.                      Overseas Highway,
                                                                                Marathon FL 33050.

    Monroe (FEMA Docket No.: B-     Unincorporated areas   The Honorable Danny         Department of          Aug. 24, 2015................       125129
     1522).                          of Monroe County (15-  Kolhage, Mayor, Monroe      Planning and
                                     04-2859P).             County, 1100 Simonton       Environmental
                                                            Street, Key West, FL        Resources, 2798
                                                            33040.                      Overseas Highway,
                                                                                Marathon FL 33050.
    Orange (FEMA Docket No.: B-     City of Orlando (15-   The Honorable Buddy Dyer,   City Hall, 400 South   Aug. 24, 2015................       120186
     1522).                          04-1669P).             Mayor, City of Orlando,     Orange Avenue,
                                                            City Hall, 400 South        Orlando, FL 32802.
                                                            Orange Avenue, Orlando,
                                                            FL 32802.
    Orange (FEMA Docket No.: B-     City of Orlando (15-   The Honorable Buddy Dyer,   City Hall, 400 South   Aug. 24, 2015................       120186
     1522).                          04-4657X).             Mayor, City of Orlando,     Orange Avenue,
                                                            City Hall, 400 South        Orlando, FL 32802.
                                                            Orange Avenue, Orlando,
                                                            FL 32802.
    St. Johns (FEMA Docket No.: B-  Unincorporated areas   The Honorable Rachael L.    St. Johns County,      Aug. 25, 2015................       125147
     1522).                          of St. Johns County    Bennett, Chair, St. Johns   Administration
                                     (15-04-2346P).         County Board of             Building, 4040 Lewis
                                                            Commissioners, 500 San      Speedway, St.
                                                            Sebastian View, St.         Augustine, FL 32084.
                                                            Augustine, FL 32084.
Maryland: Frederick (FEMA Docket    Unincorporated areas   The Honorable Jan H.        Public Works           Aug. 31, 2015................       240027
 No.: B-1526).                       of Frederick County    Gardner, Frederick County   Department, 355
                                     (15-03-0484P).         Executive, 12 East Church   Montevue Lane, Suite
                                                            Street, Frederick, MD       200, Frederick, MD
                                                            21701.                      21702.
New Mexico: Eddy (FEMA Docket No.:  City of Carlsbad (14-  The Honorable Dale W.       City Hall, 101 North   Aug. 28, 2015................       350017
 B-1526).                            06-4548P).             Janway, Mayor, City of      Halagueno Street,
                                                            Carlsbad, P.O. Box 1569,    Carlsbad, NM 88220.
                                                            Carlsbad, NM 88221.
North Carolina:
    Guilford (FEMA Docket No.: B-   City of Greensboro     The Honorable Nancy         Central Library, 219   Jan. 9, 2015.................       375351
     1448).                          (14-04-2255P).         Vaughan, Mayor, City of     North Church Street,
                                                            Greensboro, P.O. Box        Greensboro, NC 27401.
                                                            3136, Greensboro, NC
                                                            27402.
    Pitt (FEMA Docket No.: B-1526)  City of Greenville     The Honorable Allen M.      City Hall, 200 West    Aug. 26, 2015................       370191
                                     (15-04-3563P).         Thomas, Mayor, City of      5th Street,
                                                            Greenville, 200 West 5th    Greenville, NC 27834.
                                                            Street, Greenville, NC
                                                            27834.
    Pitt (FEMA Docket No.: B-1526)  Unincorporated areas   The Honorable Glen Webb,    Pitt County Planning   Aug. 26, 2015................       370372
                                     of Pitt County (15-    Chairman, Pitt County       Department, 1717
                                     04-3563P).             Board of Commissioners,     West 5th Street,
                                                            1717 West 5th Street,       Greenville, NC 27834.
                                                            Greenville, NC 27834.
    Wayne (FEMA Docket No.: B-      City of Goldsboro (15- The Honorable Alfonzo       Engineering            Aug. 25, 2015................       370255
     1526).                          04-2620P).             King, Mayor, City of        Department, 200
                                                            Goldsboro, P.O. Drawer A,   North Center Street,
                                                            Goldsboro, NC 27533.        Goldsboro, NC 27530.
Pennsylvania: Luzerne (FEMA Docket  Borough of Dallas (14- The Honorable Lee W.        Administration         Aug. 20, 2015................       421825
 No.: B-1516).                       03-0189P).             Eckert, President,          Building, 25 Main
                                                            Borough of Dallas           Street, Dallas, PA
                                                            Council, 25 Main Street,    18612.
                                                            Dallas, PA 18612.
South Carolina: Oconee (FEMA        Unincorporated areas   The Honorable Wayne         Oconee County          Aug. 21, 2015................       450157
 Docket No.: B-1522).                of Oconee County (15-  McCall, Chairman, Oconee    Administrator, 415
                                     04-2201P).             County Council, 260         South Pine Street,
                                                            Mountain Springs Road,      Walhalla, SC 29691.
                                                            West Union, SC 29696.
Texas:
    Bexar (FEMA Docket No.: B-      City of San Antonio    The Honorable Ivy R.        Transportation and     Aug. 19, 2015................       480045
     1516).                          (15-06-1148P).         Taylor, Mayor, City of      Capital Improvements
                                                            San Antonio, P.O. Box       Department, Storm
                                                            839966, San Antonio, TX     Water Division, 1901
                                                            78283.                      South Alamo Street,
                                                                                2nd Floor, San
                                                                                Antonio, TX 78283.
    Brazoria (FEMA Docket No.: B-   City of Pearland (14-  The Honorable Tom Reid,     City Hall Annex, 3523  Jul. 31, 2015................       480077
     1516).                          06-3203P).             Mayor, City of Pearland,    Liberty Drive,
                                                            3519 Liberty Drive,         Pearland, TX 77581.
                                                            Pearland, TX 77581.
    Dallas (FEMA Docket No.: B-     City of Carrollton     The Honorable Leonard       Engineering            Aug. 24, 2015................       480167
     1522).                          (15-06-1351P).         Martin, Manager, City of    Department, 1945
                                                            Carrollton, 1945 East       East Jackson Road,
                                                            Jackson Road, Carrollton,   Carrollton, TX 75006.
                                                            TX 75006.
    Denton (FEMA Docket No.: B-     City of Highland       The Honorable Charlotte     City Hall, 1000        Aug. 6, 2015.................       481105
     1516).                          Village (14-06-        Wilcox, Mayor, City of      Highland Village
                                     4109P).                Highland Village, 1000      Road, Highland
                                                            Highland Village Road,      Village, TX 75077.
                                                            Highland Village, TX
                                                            75077.
    Harris (FEMA Docket No.: B-     Unincorporated areas   The Honorable Edward M.     Harris County Permit   Aug. 26, 2015................       480287
     1522).                          of Harris County (15-  Emmett, Harris County       Office, 10555
                                     06-0175P).             Judge, 1001 Preston         Northwest Freeway,
                                                            Street, Suite 911,          Suite 120, Houston,
                                                            Houston, TX 77002.          TX 77092.
    Hays (FEMA Docket No.: B-1516)  City of San Marcos     The Honorable Daniel        Permit Center, 630     Aug. 5, 2015.................       485505
                                     (14-06-1023P).         Guerrero, Mayor, City of    East Hopkins Street,
                                                            San Marcos, 630 East        San Marcos, TX 78666.
                                                            Hopkins Street, San
                                                            Marcos, TX 78666.
    Tarrant (FEMA Docket No.: B-    City of Fort Worth     The Honorable Betsy Price,  City Hall, 1000        Aug. 3, 2015.................       480596
     1522).                          (14-06-3506P).         Mayor, City of Fort         Throckmorton Street,
                                                            Worth, 1000 Throckmorton    Fort Worth, TX 76102.
                                                            Street, Fort Worth, TX
                                                            76102.
    Tarrant (FEMA Docket No.: B-    City of North          The Honorable Oscar         City Hall, 7301        Aug. 5, 2015.................       480607
     1526).                          Richland Hills (14-    Trevino, Jr., P.E.,         Northeast Loop 820,
                                     06-2312P).             Mayor, City of North        North Richland
                                                            Richland Hills, 7301        Hills, TX 76180.
                                                            Northeast Loop 820, North
                                                            Richland Hills, TX, 76180.
    Travis (FEMA Docket No.: B-     City of Pflugerville   The Honorable Brandon       Planning Department,   Aug. 27, 2015................       481028
     1526).                          (14-06-4534P).         Wade, Manager, City of      201-B East Pecan
                                                            Pflugerville, P.O. Box      Street,
                                                            589, Pflugerville, TX       Pflugerville, TX
                                                            78691.                      78691.
    Walker (FEMA Docket No.: B-     City of Huntsville     The Honorable Mac           Engineering            Aug. 27, 2015................       480639
     1522).                          (14-06-3819P).         Woodward, Mayor, City of    Department, 448
                                                            Huntsville, 1212 Avenue     State Highway 75
                                                            M, Huntsville, TX 77340.    North, Huntsville,
                                                                                TX 77340.
Utah:

    Salt Lake (FEMA Docket No.: B-  City of West Jordan    The Honorable Kim V.        City Hall, 8000 South  Aug. 24, 2015................       490108
     1522).                          (14-08-1329P).         Rolfe, Mayor, City of       Redwood Road, West
                                                            West Jordan, 8000 South     Jordan, UT 84088.
                                                            Redwood Road, West
                                                            Jordan, UT 84088.
    Weber (FEMA Docket No.: B-      City of North Ogden    The Honorable Brent         City Hall, 505 East    Aug. 24, 2015................       490214
     1522).                          (14-08-1297P).         Taylor, Mayor, City of      2600 North, North
                                                            North Ogden, 505 East       Ogden, UT 84414.
                                                            2600 North, North Ogden,
                                                            UT 84414.
    Weber (FEMA Docket No.: B-      Unincorporated areas   The Honorable Kerry         Weber County           Aug. 24, 2015................       490187
     1522).                          of Weber County (14-   Gibson, Chairman, Weber     Government Building,
                                     08-1297P).             County Commission, 2380     2380 Washington
                                                            Washington Boulevard,       Boulevard, Ogden, UT
                                                            Suite 360, Ogden, UT        84401.
                                                            84401.
Virginia: Fauquier (FEMA Docket     Unincorporated areas   Mr. Paul McCulla, Fauquier  Fauquier County        Jul 30, 2015.................       510055
 No.: B-1516).                       of Fauquier County     County Administrator, 10    Zoning and
                                     (14-03-2615P).         Hotel Street, Suite 204,    Development Services
                                                            Warrenton, VA 20186.        Department, 29 Ashby
                                                                                Street, Suite 310,
                                                                                Warrenton, VA 20186.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-27472 Filed 10-27-15; 8:45 am]
 BILLING CODE 9110-12-P


    Final Report Whole-Body Inhalation Developmental Toxicity Study in Rats
         With Gasoline with MTBE Vapor Condensate (MRD-00-713: 171334)

           211(b) Research Group Response to EPA Second Draft Report
                         Comments dated June 24, 2008

EPA June 24, 2008 Comment #1:
Although the inferential statistics now used to analyze the fetal examination data are valid, the report tables still inappropriately show fetal incidences.  As currently presented, these data are still difficult to properly evaluate.  Table 4-2 and Appendix H should present the group mean + SD values for the percentage affected per litter.
RG response to EPA June 24, 2008 comment:
The RG considers this to be a valuable comment, and acknowledges that it would be desirable for the tables to reflect the litter data.  However, the appendices contain the full data set, including the results of the statistical analysis by litters.  Further, it would be a lengthy procedure for the laboratory to revise report tables as EPA has suggested, as such revisions would require programming changes.  Programming changes require computer validation and subsequently also require additional Quality Assurance review.  These tasks would need to be completed before the report could be resubmitted for QA review as required under GLP.  For those reasons, the work group has not requested that the lab revise the report as described in this comment.  However, the results can be presented in the suggested format at later stages of data utilization, such as publication/risk assessment, where the change would not delay completion of the 211(b) testing requirement.
EPA June 24, 2008 Comment #2:
The results/discussion section should address the dose-related response for rudimentary lumbar ribs.
RG response to EPA June 24, 2008 comment:
The following text was added to the Results.
There was a dose-related increase (not statistically significant) in the number of fetuses with rudimentary ribs.  However, this was not considered toxicologically significant because the fetal incidence in the 20,000 mg/m[3] target group (6.04%) was just slightly higher that the historical control range (5.52%) and the litter incidence (20.8%) was less than the historical control range (25.0%).  Additionally, the litter incidence did not show a dose-related increase.
EPA June 24, 2008 Comment #3:
Although some fetal-examination endpoints are combined for analysis as shown in Appendix K, there are additional sets of observations that warrant a combined analysis.  In particular, dumbbell-shaped and bifid anlage of thoracic centra are clearly related findings and neither occur in the control group.  Their combined incidence should be evaluated statistically.  On a similar note, cartilage-based observations should be combined with related ossification findings.  For example, page K-3 lists a combined analysis for hypoplastic vertebral anlage centra (item 31) and a combined analysis for hypoplastic vertebral centra (item 32).  These two sets of findings, one for cartilaginous anlage and one for bone, are clearly related; their combined incidence should be evaluated statistically.
RG response to EPA June 24, 2008 comment:
We agree with the comment that additional combined statistical analyses could be appropriately performed.  Dumbbell-shaped and bifid anlage of centra are combined in Skeletal analysis #31.  The combined statistical analysis for skeletal analysis 31 and 32 would be unlikely to alter results, as there was only one litter affected in each of the low and middle exposure groups, and the litter at the low exposure group was already included in the analysis for hypoplastic vertebral anlage centra.

EPA June 24, 2008 Comment #4:
Some findings listed in Appendix H still do not clearly denote an abnormality.  In particular, "presacral vertebrae" does not indicate an abnormality.  Appendix K, in combining the findings of cervical and lumbar presacral vertebrae, indicates that these denote "extra presacral vertebrae." This should be clarified in Appendix H as well.
RG response to EPA June 24, 2008 comment:
The individual table lists the "presacral vertebrae" as "extra presacral vertebrae" in the individual data (the location is also given).  The summary data before the individual data lists the findings as "extra cervical vertebrae" or "extra lumbar vertebrae".
The remaining noted observations were also revised.

EPA June 24, 2008 Comment #5:
The authors should consider classifying the finding of an extra cervical vertebrae as a malformation rather than a variation.  Although variations in the number of thoracic and lumbar vertebrae are not uncommon, changes in the number of cervical vertebrae are rare.  Note that this does not affect study interpretation as this finding was observed only in a low dose fetus that, based on other findings, was already regarded as malformed.
RG response to EPA June 24, 2008 comment:
For GLP compliance, the laboratory must record observations according to the classification designated in their SOP.  However, we agree in principle with the comment.
In the report, there is a note with the individual data for this fetus that discusses the laboratory SOP.


[Federal Register: June 17, 2010 (Volume 75, Number 116)]
[Notices]
[Page 34512-34513]
[DOCID:fr17jn10-129]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62268; File No. SR-BX-2010-039]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Halting Trading Whenever Trading in the Underlying Security Has Been
Paused by the Primary Listing Market

June 10, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 10, 2010, NASDAQ OMX BX, Inc. (the ``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I and II below, which Items have been
prepared by the Exchange. The Exchange filed the proposed rule change
pursuant to Section 19(b)(3)(A) of the Act,\3\ and Rule 19b-4(f)(6)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Chapter V, Section 10 of the
Rules of the Boston Options Exchange Group, LLC (``BOX'') to state that
trading in any option contract shall be halted whenever trading in the
underlying security has been paused by the primary listing market. The
text of the proposed rule change is available from the principal office
of the Exchange, on the Commission's Web site at http://www.sec.gov, at
the Commission's Public Reference Room and also on the Exchange's
Internet Web site at http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/
Filings/.

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

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

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

1. Purpose
    The Securities and Exchange Commission recently approved rules
changes relating to trading pauses due to extraordinary market
volatility (``trading pause'').\5\ The purpose of the proposed rule
change is to ensure that the Exchange maintains a fair and orderly
market upon the imposition of a trading pause. Accordingly, as
proposed, trading in any option contract shall be halted whenever
trading in the underlying security has been paused by the primary
listing market. Trading in such options contracts may be resumed upon a
determination by the Exchange that the conditions that led to the pause
are no longer present and that the interests of a fair and orderly
market are best served by a resumption of trading, which in no
circumstances will be before the Exchange has received notification
that the underlying security has resumed trading on at least one
exchange. The Exchange anticipates that all U.S. options exchanges will
be submitting similar proposals.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 34-62252 (June 10,
2010), (SR-BATS-2010-014; SR-EDGA-2010-01; SR-EDGX-2010-01; SR-BX-
2010-037; SR-ISE-2010-48; SR-NYSE-2010-39; SR-NYSEAmex-2010-46; SR-
NYSEArca-2010-41; SR-NASDAQ-2010-061; SR-CHX-2010-10; SR-NSX-2010-
05; SR-CBOE-2010-047). The term trading pause is not defined in the
BOX Trading Rules, but is described in these recently approved
rules.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and furthers the objectives of Section
6(b)(5) of the Act \7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and

open market and a national market system, and, in general to protect
investors and the public interest. Specifically, the Exchange believes
that the proposal benefits Participants by halting trading in options
during times of uncertainty regarding the price of the underlying
security due to a trading pause in such underlying security.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

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

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

    Because the foregoing proposed rule change does not:
    (i) Significantly affect the protection of investors or the public
interest;
    (ii) Impose any significant burden on competition; and
    (iii) Become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, if
consistent with the protection of investors and the public interest, it
has become effective pursuant to Section 19(b)(3)(A) of the Act \8\ and
Rule 19b-4(f)(6) thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the self-regulatory organization to submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange requested that the Commission waive the 30-day
operative delay. The Exchange notes that such a waiver will permit it
to immediately implement the proposed rule change in order to benefit
customers by halting trading in options during times of uncertainty
regarding the price of the underlying security due to a trading pause
in such underlying security. The Commission approved filings from the
exchanges and the Financial Industry Regulatory Authority to institute
a single stock trading pause for equity securities that experience a
10% change in price during a five minute period.\10\
---------------------------------------------------------------------------

    \10\ See Securities Exchange Act Release Nos. 62251 and 62252
(June 10, 2010).
---------------------------------------------------------------------------

    The Commission hereby grants the Exchange's request and believes
such waiver is consistent with the protection of investors and the
public interest.\11\ Accordingly, the Commission designates the
proposed rule change operative upon filing with the Commission.
---------------------------------------------------------------------------

    \11\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. See 15
U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2010-039 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2010-039. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will be available for inspection and copying at the principal office of
the Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-BX-
2010-039 and should be submitted on or before July 8, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-14602 Filed 6-16-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 165 (Tuesday, August 25, 2020)]
[Notices]
[Pages 52353-52354]
[FR Doc No: 2020-18602]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0908]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Submission of
Petitions--Food Additive, Color Additive (Including Labeling),
Submission of Information to a Master File in Support of Petitions; and
Electronic Submission Using Food and Drug Administration Form 3503

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: Submit written comments (including recommendations) on the
collection of information by September 24, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0016. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<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.

Submission of Petitions: Food Additive, Color Additive (Including
Labeling); Submission of Information to a Master File in Support of
Petitions; Electronic Submission Using Form FDA 3503--21 CFR 70.25,
71.1, 171.1, 172, 173, 179, and 180

OMB Control Number 0910-0016--Revision

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed
to be unsafe, unless: (1) The additive and its use, or intended use,
are in conformity with a regulation issued under section 409 that
describes the condition(s) under which the additive may be safely used;
(2) the additive and its use, or intended use, conform to the terms of
an exemption for investigational use; or (3) a food contact
notification submitted under section 409(h) of the FD&C Act is
effective. Food additive petitions (FAPs) are submitted by individuals
or companies to obtain approval of a new food additive or to amend the
conditions of use permitted under an existing food additive regulation.
Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the
information that a petitioner must submit to establish that the
proposed use of a food additive is safe and to secure the publication
of a food additive regulation describing the conditions under which the
additive may be safely used. Parts 172, 173, 179, and 180 (21 CFR parts
172, 173, 179, and 180) contain labeling requirements for certain food
additives to ensure their safe use.
    Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a
color additive shall be deemed to be unsafe unless the additive and its
use are in conformity with a regulation that describes the condition(s)
under which the additive may safely be used, or the additive and its
use conform to the terms of an exemption for investigational use issued
under section 721(f) of the FD&C Act. Color additive petitions (CAPs)
are submitted by individuals or companies to obtain approval of a new
color additive or a change in the conditions of use permitted for a
color additive that is already approved. Section 71.1 of the Agency's
regulations (21 CFR 71.1) specifies the information that a petitioner
must submit to establish the safety of a color additive and to secure
the issuance of a regulation permitting its use. FDA's color additive
labeling requirements in Sec.  70.25 (21 CFR 70.25) require that color
additives that are to be used in food, drugs, devices, or cosmetics be
labeled with sufficient information to ensure their safe use.
    FDA scientific personnel reviews FAPs to ensure the safety of the
intended use of the additive in or on food, or that may be present in
food as a result of its use in articles that contact food. Likewise,
FDA personnel review CAPs to ensure the safety of the color

additive prior to its use in food, drugs, cosmetics, or medical
devices.
    Respondents may transmit FAP or CAP regulatory submissions in
electronic format or paper format to the Office of Food Additive Safety
in the Center for Food Safety and Applied Nutrition (CFSAN) using Form
FDA 3503. Form FDA 3503 helps the respondent organize their submission
to focus on the information needed for FDA's safety review. Form FDA
3503 can also be used to organize information within a master file
submitted in support of petitions according to the items listed on the
form. Master files can be used as repositories for information that can
be referenced in multiple submissions to the Agency, thus minimizing
paperwork burden for food and color additive approvals. FDA estimates
that the amount of time for respondents to complete Form FDA 3503 will
continue to be 1 hour.
    We are revising the information collection to reflect ongoing
modernization efforts. We have augmented our FDA Unified Registration
and Listing System (FURLS) with the CFSAN Online Submission Module
(COSM). COSM provides a real-time user interface process we believe
will assist respondents in preparing and making submissions to Offices
in CFSAN. COSM is a web-based tool that supports electronic
submissions, thereby eliminating the need for printing and mailing of
paper submissions. COSM is available 24 hours a day and seven days a
week. Information submitted to COSM is the same information respondents
would submit to FURLS. Information about COSM, including user
instruction, is available on the internet at: https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm.
    Description of Respondents: Respondents are businesses engaged in
the manufacture or sale of food, food ingredients, color additives, or
substances used in materials that come into contact with food.
    In the Federal Register of March 17, 2020 (85 FR 15188), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                             Number of       Number of     Total annual       Average                      operating and
                  21 CFR section; form                      respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           CAP
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.25, 71.1.............................................               2               1               2           1,337           2,674          $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          FAPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1...................................................               3               1               3           7,093          21,279               0
Form FDA 3503...........................................               6               1               6               1               6               0
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............          23,959           5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    Our estimate of burden attributable to FAPs or CAPs is based on our
experience with the information collection, which has not changed since
our last review, and we therefore retain the currently approved burden.
This estimate reflects the average number of petitions we have received
annually over a period of 10 years. The attendant burden we estimate
also reflects an industry average, although burden associated with
individual petitions may vary depending on the complexity of the
petition, and the amount and type of data needed for scientific
analysis.
    CAPs are subject to fees. The listing fee for a CAP ranges from
$1,600 to $3,000, depending on the intended use of the color additive
and the scope of the requested amendment. A complete schedule of fees
is set forth in Sec.  70.19. An average of one Category A and one
Category B color additive petition is expected per year. The maximum
CAP fee for a Category A petition is $2,600 and the maximum color
additive petition fee for a Category B petition is $3,000. Because an
average of 2 CAPs are expected per calendar year, the estimated total
annual cost burden to petitioners for this startup cost would be less
than or equal to $5,600 ((1 x $2,600) + (1 x $3,000) listing fees =
$5,600). There are no capital costs associated with CAPs. The labeling
requirements for food and color additives were designed to specify the
minimum information needed for labeling in order that food and color
manufacturers may comply with all applicable provisions of the FD&C Act
and other specific labeling acts administered by FDA. Label information
does not require any additional information gathering beyond what is
already required to assure conformance with all specifications and
limitations in any given food or color additive regulation. Label
information does not have any specific recordkeeping requirements
unique to preparing the label. Therefore, because labeling requirements
under Sec.  70.25 for a particular color additive involve information
required as part of the CAP safety review process, the estimate for
number of respondents is the same for Sec. Sec.  70.25 and 71.1, and
the burden hours for labeling are included in the estimate for Sec.
71.1. Also, because labeling requirements under parts 172, 173, 179,
and 180 for particular food additives involve information required as
part of the FAP safety review process under Sec.  171.1, the burden
hours for labeling are included in the estimate for Sec.  171.1.

    Dated: August 17, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18602 Filed 8-24-20; 8:45 am]
BILLING CODE 4164-01-P