[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Proposed Rules]
[Pages 38586-38589]
[FR Doc No: 2011-16541]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0575]
RIN 1625-AA00

Safety Zone; Swim Around Charleston, Charleston, SC

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary moving
safety zone during the Swim Around Charleston, a swimming race
occurring on waters of the Wando River, the Cooper River, Charleston
Harbor, and the Ashley River, in Charleston, South Carolina. The Swim
Around Charleston is scheduled to take place on Sunday, October 23,
2011. The temporary safety zone is necessary for the safety of the
swimmers, participant vessels, spectators, and the general public
during the event. Persons and vessels would be prohibited from
entering, transiting through, anchoring in, or remaining within the
safety zone unless authorized by the Captain of the Port Charleston or
a designated representative.

DATES: Comments and related material must be received by the Coast
Guard on or before August 19, 2011. Requests for public meetings must
be received by the Coast Guard on or before July 28, 2011.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0575 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed

rule, call or e-mail Chief Warrant Officer Robert B. Wilson, Sector
Charleston Office of Waterways Management, Coast Guard; telephone 843-
740-3180, e-mail<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:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2011-0575), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2011-0575'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit comments by mail and
would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period and may change
the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2011-0575'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
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. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before July 28, 2011 using one of the four
methods specified under ADDRESSES. Please explain why you believe a
public meeting would be beneficial. If we determine that one would aid
this rulemaking, we will hold one at a time and place announced by a
later notice in the Federal Register.

Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish regulated navigation areas and other limited access areas: 33
U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191,
195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat.
2064; Department of Homeland Security Delegation No. 0170.1.
    The purpose of the rule is to ensure the safety of the swimmers,
participant vessels, spectators, and the general public during the Swim
Around Charleston.

Discussion of Proposed Rule

    On Sunday, October 23, 2011, the Swim Around Charleston is
scheduled to take place on the waters of the Wando River, the Cooper
River, Charleston Harbor, and the Ashley River, in Charleston, South
Carolina. The Swim Around Charleston will consist of a 10 mile swim
that starts at Remley's Point on the Wando River, crosses the main
shipping channel of Charleston Harbor, and finishes at the General
William B. Westmoreland Bridge on the Ashley River.
    The proposed rule would establish a temporary moving safety zone of
a 75-yard radius around the Swim Around Charleston participant vessels
that are officially associated with the swim on the waters of the Wando
River, the Cooper River, Charleston Harbor, and the Ashley River, in
Charleston, South Carolina. The temporary safety zone would be enforced
from 10 a.m. until 4 p.m. on October 23, 2011. Persons and vessels
would be prohibited from entering, transiting through, anchoring in, or
remaining within the safety zone unless specifically authorized by the
Captain of the Port Charleston or a designated representative. Persons
and vessels would be able to request authorization to enter, transit
through, anchor in, or remain within the safety zone by contacting the
Captain of the Port Charleston by telephone at<PHONE_NUMBER>, or a
designated representative via VHF radio on channel 16.

Regulatory Analyses

    We developed this proposed 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.

Executive Order 12866 and Executive Order 13563

    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, and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that Order. The Office of Management and Budget has not reviewed it
under that Order.
    The economic impact of this rule is not significant for the
following reasons: (1) The safety zone would only be enforced for a
total of six hours; (2) the safety zone would move with the participant
vessels so that once the swimmers clear a portion of the waterway, the
safety zone would no longer be enforced in that portion of the
waterway; (3) although persons and vessels would not be able to enter,
transit through, anchor in, or remain

within the safety zone without authorization from the Captain of the
Port Charleston or a designated representative, they would be able to
operate in the surrounding area during the enforcement period; (4)
persons and vessels would still be able to enter, transit through,
anchor in, or remain within the safety zone if authorized by the
Captain of the Port Charleston or a designated representative; and (5)
the Coast Guard would provide advance notification of the safety zone
to the local maritime community by Local Notice to Mariners and
Broadcast Notice to Mariners.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities. This rule may affect the following entities,
some of which may be small entities: The owners or operators of vessels
intending to enter, transit through, anchor in, or remain within that
portion of the Wando River, the Cooper River, Charleston Harbor, and
the Ashley River in Charleston, South Carolina encompassed within the
safety zone from 10 a.m. until 4 p.m. on October 23, 2011. For the
reasons discussed in the Executive Order 12866 and Executive Order
13563 section above, this proposed rule would not have a significant
economic impact on a substantial number of small entities.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

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 proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. 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 Chief Warrant Officer Robert B.
Wilson, Sector Charleston Office of Waterways Management, Coast Guard;
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>The Coast
Guard will not retaliate against small entities that question or
complain about this proposed rule or any policy or action of the Coast
Guard.

Collection of Information

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

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

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 or more in any
one year. Though this proposed rule would not result in such an
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.

Taking of Private Property

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

Civil Justice Reform

    This proposed 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.

Protection of Children

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

Indian Tribal Governments

    This proposed rule does not have Tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed 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 made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. A preliminary
environmental analysis checklist supporting this determination is
available in the docket where indicated under ADDRESSES. This proposed
rule involves establishing a temporary moving safety zone as described
in figure 2-1, paragraph (34)(g), of the Instruction. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    2. Add a temporary Sec.  165.T07-0575 to read as follows:

Sec.  165.T07-0575  Safety Zone; Swim Around Charleston, Charleston,
SC.

    (a) Regulated Area. The following regulated area is a moving safety
zone: All waters within a 75-yard radius around Swim Around Charleston
participant vessels that are officially associated with the swim. The
Swim Around Charleston swimming race consists of a 10-mile course that
starts at Remley's Point on the Wando River in approximate position
32[deg]48'49'' N, 79[deg]54'27'' W, crosses the main shipping channel
of Charleston Harbor, and finishes at the General William B.
Westmoreland Bridge on the Ashley River in approximate position
32[deg]50'14'' N, 80[deg]01'23'' W. All coordinates are North American
Datum 1983.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Charleston in the enforcement of the regulated
area.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area unless authorized by the Captain of the Port Charleston
or a designated representative.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated area may contact the Captain of the
Port Charleston by telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to request authorization.
If authorization to enter, transit through, anchor in, or remain within
the regulated area is granted by the Captain of the Port Charleston or
a designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Charleston or a designated representative.
    (3) The Coast Guard will provide notice of the regulated area by
Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene
designated representatives.
    (d) Effective Date. This rule is effective from 10 a.m. until 4
p.m. on October 23, 2011.

    Dated: June 21, 2011.
M.F. White,
Captain, U.S. Coast Guard, Captain of the Port Charleston.
[FR Doc. 2011-16541 Filed 6-30-11; 8:45 am]
BILLING CODE 9110-04-P


 			INFORMATION COLLECTION REQUEST (ICR)
				Part A of the Supporting Statement
					(Draft - March 2014)

 	IDENTIFICATION OF THE INFORMATION COLLECTION

      1(a)	Title:	Regulation of Fuels and Fuel Additives: Detergent Gasoline (Renewal)
			EPA ICR No. 1655.09, OMB Control No. 2060-0275

      1(b)	Abstract

	Gasoline combustion results in the formation of engine deposits.  The accumulation of deposits, particularly in the orifices of fuel injectors and on intake valves, typically results in increased emissions and reduced engine performance.  As fuel injectors replaced carburetors in the 1980's, a number of vehicle manufacturers experienced problems with deposit formation.  Detergent additives, which had been available for years to control deposits in carbureted vehicles, were improved to accommodate the new technology.  However, their use was voluntary and there were no regulatory standards by which to gauge their effectiveness.  Congress recognized the importance of effective detergent additives in minimizing vehicle emissions, and added Section 211(1) in the Clean Air Act Amendments of 1990.  It required gasoline to contain detergent additives, effective January 1, 1995, and provided the Environmental Protection Agency (EPA) with the authority to establish specifications for such additives.  The regulations at 40 CFR 80 - Subpart G implemented certification requirements for detergents and imposed a variety of recordkeeping and reporting requirements for certain parties involved with detergents, gasoline, or post-refinery component (any gasoline blending stock or any oxygenate that is blended with gasoline subsequent to the gasoline refining process (PRC)).  All gasolines must contain certified detergents, with the exception of research, racing, and aviation gasolines.

	The EPA maintains a list of certified gasoline detergents at http://www.epa.gov/otaq/additive.htm.  As of March 2014 there were 374 certified detergents and 17 detergent manufacturers.  Most of the certification activity occurred during the early years of the program.  In 2012, 12 detergents were certified.  In 2013, only 3 new detergents were certified.

	There are approximately 250 refiners and importers of gasoline, 1,350 blenders of detergent into gasoline or PRC, 8,000 carriers of gasoline or PRC, 200,000 gasoline retail outlets, and 100,000 fleet facilities which handle gasoline.  The estimated total annual burden for respondents for this collection is 220,181 hours and $20,180,587, including $335,040 in annualized capital or O&M costs.  The estimated total annual Agency burden is 200 hours and $16,400 in labor costs.

 	NEED FOR AND USE OF THE COLLECTION

      2(a) 	Need/Authority for the Collection

	Motor vehicles comprise the major source of air pollution in most urban areas, and account for about half of the toxic air emissions in the United States.  Gasoline detergents help to minimize emissions.  Detergents are typically added to gasoline as it is loaded into tank trucks at terminals.  Section 211(l) of the Clean Air Act (Act) requires that all gasoline contain effective detergent additives.  Section 114 of the Act provides EPA with the authority to impose recordkeeping and reporting requirements if necessary for enforcement of statutory requirements.  The recordkeeping and reporting requirements for this program, at 40 CFR 80 - Subpart G, are necessary in order for EPA to certify detergents, to demonstrate that certified detergents are effective, to assure that gasoline contains certified detergents at the minimum concentration (also known as the lowest additive concentration (LAC)) necessary to be effective, and to deter violations.  There is no standard test procedure for testing qualitatively and quantitatively for specific detergents in gasoline, thus necessitating reliance on recordkeeping and reporting as detergents, gasoline, and PRC pass through the distribution system.  Blenders of detergent into gasoline or PRC are required to maintain records that demonstrate that the LAC is met, on average, each month at each automated blending facility, and by batch at non-automated facilities.  These records are known as volumetric additive reconciliation (VAR) records.  There is economic incentive to violate because uncertified detergents are typically less expensive, and blending a certified detergent at less than the minimum specified concentration will also save money.

	A detergent manufacturer has a variety of options under which it may certify a detergent.  The primary option is "National Generic Certification," which allows the detergent to be used in any gasoline.  We estimate that over 99% of detergents have been certified under this option.  Other options include limiting a detergent to a Petroleum Administrative Defense District (PADD Certification), a specific gasoline pool (Fuel-specific Certification), or California gasoline (CARB-based Certification), under California's detergent certification rule.  All the options may be found at 40 CFR 80.163.

      2(b)	Practical Utility/Users of the Data

	The list of certified detergents is publicly available.  The fuel, additive, and motor vehicle industries are well aware that gasoline must contain certified detergents.  The list is monitored by the additive manufacturers in order to maintain an awareness of competitors.  Manufacturers and distributors of gasoline, and blenders of detergent into gasoline, monitor the list to ensure that gasoline contains certified detergents and that the documentation accompanying gasoline indicates such.

	Most of the data submitted by the detergent manufacturers are confidential.  Thus access is restricted to authorized EPA personnel and authorized contractors.  Review of the data is necessary to determine if the detergent manufacturer has met the certification requirements for a specific detergent and can be certified by EPA.  The documentation accompanying the detergent, with the LAC and any use restrictions, is used by the detergent blender to ensure proper additization.  Product transfer documents (PTDs) are monitored by transferors and transferees to ensure that they are handling legal detergents and gasolines.  VARs are necessary for detergent blenders to demonstrate that they have additized properly.

	As mentioned above, there is not a method of analyzing gasoline for the proper level of a certified detergent.  Thus, the records required by this rule, particularly the VAR and certification records, are essential in EPA's monitoring for compliance.

 	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

      3(a)	Nonduplication

	The records required here are not available elsewhere.  In many instances the records are already produced as a customary business practice.

      3(b)	Public Notice

	In compliance with the Paperwork Reduction Act, EPA has solicited comments for a 60-day period prior to submission of the ICR to OMB.  Notice has been published in the Federal Register.

      3(c)	Consultations

	EPA consulted with the following people regarding this collection:

May Thomas
Sr HSES Analyst
Afton Chemical Corporation
330 S. Fourth Street, 3[rd] Floor
Richmond, VA  23219
<EMAIL_ADDRESS>
Chris J Fogarty
Product Manager  -  Fuel Additives
BASF Corporation
Mail Stop 4A2
100 Park Avenue
Florham Park, NJ 07932
<EMAIL_ADDRESS>
      Certification by the detergent manufacturers, and the development of VAR and QA records by blenders of detergent into gasoline or PRC, account for the regulatory burden.  The other burdens discussed above are minor or customary business practices upon which the regulations did not impose significant additional burdens.  As this program has matured, nearly all of the applications for detergent certification now rely on previous vehicle testing.  We estimate only one application annually is based on new testing.

	Consultations with detergent manufacturers indicate that they have become quite familiar with submitting applications based on previous testing, with burden estimates ranging from one to four hours for preparation and submittal of the application.  For an application based on new testing, however, there have been broad ranges of estimates, from 16 hours to 2000 hours.  We believe that, as with the previous ICR, a reasonable average continues to be 60 hours for a detergent certification.

	Past consultations with detergent blenders that use automated blending equipment (the vast majority of blenders) also indicates a range of estimated VAR/QA burden, from about 30 to 260 hours per year per facility.  This is to be expected since there is a wide range in the size of these facilities and a wide range in the degree of sophistication utilized in implementing the VAR requirements and voluntary QA procedures.  The estimate for a detergent blender that does not use automated equipment is 500 hours per year.  A major reason for the difference in burden between automated and non-automated equipment is the VAR period, which may be up to 30 days for automated equipment, but is by batch for non-automated equipment and calculated manually.

      3(d)	Effects of Less Frequent Collection

	Certification of an additive is one-time, with the exception of an annual fuel-property report in the case of a fuel-specific certification.  (As of March 2014, there were no fuel-specific certifications, and no indication that any would be forthcoming.)  VAR records and PTDs are ongoing and necessary for enforcement.  The generation and transfer of PTDs are customary business practices.  Researchers using gasoline without a certified detergent are required to submit a brief annual report on their activities.  EPA believes that the annual reporting requirements are reasonable and that a less frequent collection would hamper enforcement.  Thus, less frequent collection is not a practicable alternative.

	3(e)	General Guidelines

	All Office of Management and Budget (OMB) guidelines are met.

      3(f)	Confidentiality

	Most of the information reported to EPA is business confidential and is governed by the Freedom of Information Act regulations for EPA at 40 CFR 2.

      3(g)	Sensitive Questions

	There is no sensitive information requested.

 	THE RESPONDENTS AND THE INFORMATION COLLECTED

      4(a)	Respondents/SIC/NAICS Codes

	The respondents are related to the following major group Standard Industrialization Classification (SIC) codes:

5172 - Petroleum Products

2911 - Petroleum Refining

	The respondents are related to the following major group NAICS codes:

324110 - Petroleum Refineries

324199 - All Other Petroleum and Coal Products Manufacturing

325110 - Petrochemical Manufacturing

325199 - All Other Basic Organic Chemical Manufacturing
424710 - Petroleum Bulk Stations and Terminals

424720 - Petroleum and Petroleum Products Merchant Wholesalers (except Bulk Stations and                       Terminals)

      4(b)	Information Requested

       	Data Items

REPORTING REQUIREMENTS

Detergent Manufacturers

	For each detergent, the detergent manufacturer (includes an importer or a party which is not the manufacturer but is requesting certification as a detergent for a product manufactured by another party) is required to:

(1) submit a certification letter to EPA containing a variety of information concerning the certification testing and options for which certification is requested (80.161(b)(3), 80.163(c)(1)(iii), 80.164(a));

(2) submit certification test data, and/or the acceptance criteria a supplier must meet for detergent reactant materials, upon EPA request (80.165, 80.162(b)(1));

(3) submit a detailed description of the detergent's composition to EPA pursuant to the registration requirements for fuel additives at 40 CFR 79, addressing specific compositional descriptions identified in 40 CFR 80 and the LAC for each certification option (80.161(b)(1)(i),(ii),(ii)(A), 80.162);

(4) ship a sample of the detergent and certain information concerning the sample to EPA, and if requested by EPA, ship an additional sample (80.161(b)(2), 80.167(d));

(5) notify EPA in writing, with supporting data, if there is a change in the LAC for which the additive is effective (80.161(b)(1)(ii)(C));

(6) notify, in writing, gasoline manufacturers (includes importers), detergent blenders, and all others who purchase the detergent, of the LAC and any use restrictions (80.161(c));

(7) submit certain information annually for each fuel-specific certification option (80.164(c)(3));

(8) notify customers if a fuel-specific certification is no longer valid (80.164(c)(3)(iii));

(9) if, upon receipt from EPA of a notice of intent of detergent disqualification, wishing to respond, submit written comments in an attempt to demonstrate compliance (80.161(e)(3), (4); and

(10) submit a list of customers to EPA if EPA should issue a final decision to disqualify a certified detergent (80.161(e)(6)).

Detergent Blenders

	A blender of detergent into gasoline or PRC:

(1) is required to notify EPA in writing if it intends to use a detergent at lower than its LAC, and, if requested by EPA, must submit the data supporting the use of the lower concentration (80.161(d)(1), (2), (3));

(2) who has certified under a fuel-specific option, is required to supply, upon request,  EPA with a sample of the test fuel or with blendstocks with which to formulate the test fuel (80.167(d)); and

(3) is required to generate VAR records (80.170), and, upon request, to provide EPA with VAR records and supporting documentation (80.170(g)).

Transferors and Transferees

	A transferor of gasoline, detergent, or PRC, including any gasoline refiner, importer, reseller, distributor, carrier, retailer, wholesale purchaser-consumer (WPC), oxygenate blender, detergent manufacturer, distributor, carrier, or blender, shall:

(1) generate or obtain documentation for each shipment and provide this documentation (product transfer document (PTD)) to the transferee (with exception of delivery of detergent-additized gasoline to motorists and small volumes to fleets) identifying the product, its detergent status if gasoline or PRC, and certain additional information (80.171); and

(2) as a defense against liability, along with transferees, may establish quality assurance (QA) procedures that involve the development of records in addition to those required by the rules (80.169).

Researchers

	A party conducting research on gasoline that does not contain a certified detergent is required to notify EPA annually, in writing (80.173(a)(3)).

Racing Gasoline/Aviation Gasoline

	Parties handling racing gasoline or aviation gasoline are required to generate or transfer PTDs indicating that these products are limited to those uses (80.173(b)(1)).  Pump stands for racing gasoline or aviation gasoline must be appropriately labeled if located at a facility that dispenses gasoline to motor vehicles (80.173(b)(2)).

RECORDKEEPING REQUIREMENTS

	Most records are required to be kept for five years, with exceptions for certain small businesses and California gasoline (80.164(c)(4), 80.169(c)(8), 80.170(g), 80.171(d)).  This retention period is necessary in order to provide EPA with adequate time for inspection, is consistent with the relevant civil statute of limitations, and is consistent with the retention period for PTDs under the reformulated gasoline/anti-dumping rules at 40 CFR 80 - Subpart D (except for retailers in anti-dumping areas).  There is no regulatory burden because businesses retain such records as a customary business practice.

Detergent Manufacturers

	For each detergent, the detergent manufacturer is required to maintain records for:

(1) the acceptance criteria for suppliers of detergent reactive materials (80.162(b)(1));

(2) the test data for fuel parameters supporting a fuel-specific certification (80.164(c)(1));

(3) the fuel composition survey results, and documentation on test methods and statistical procedures, used to support a fuel-specific certification (80.164(c)(4));

(4) the certification test (80.165); and

(5) in order to have an affirmative defense for a potential violation of the certification program controls and prohibitions, the fourier transform infrared spectroscopy (FTIR) and related data for each detergent batch (80.169(c)(4)(i)(C),(D)).

Detergent Blenders

	A blender of detergent into gasoline or PRC is required to maintain the VAR records on the use of the detergent (80.170).  Gasoline or PRC additized in California is exempt, provided the records required by California are maintained (80.173(c)).

Transferors and Transferees

	Transferors and transferees of gasoline, detergent, or PRC:

(1) are required to maintain the PTDs for each shipment (80.171); and

(2) as a defense against liability, may establish QA procedures that involve retaining records in addition to those required to be retained by the rules (80.169).

Researchers

	A party conducting research on gasoline that does not contain a certified detergent is required to maintain documentation demonstrating that the gasoline has been used only for research (80.173(a)(1)).

Racing Gasoline/Aviation Gasoline

	Parties handling racing gasoline or aviation gasoline are required to maintain the PTDs for each shipment (80.173(b)(1)).

	(ii)       Respondent Activities

	The following are required:

(1) 	Read and comprehend the regulatory requirements.
(2) 	Train personnel to meet the requirements, employing new technology and procedures as    necessary.
(3)   	Develop the information that is not already available.
(4) 	Gather and organize the information.
(5) 	Review the information and, if necessary, take corrective action such that it can be concluded that the regulatory requirements have been met.
(6) 	Report the information to EPA and/or retain the information in storage, as specified in the regulations.

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

	5(a)	Agency Activities

	The following are required:

(1) 	Develop a thorough understanding of the regulatory requirements.
(2) 	Develop the skills necessary to convey the requirements to the respondents and others such that it can be comprehended easily.
(3) 	Respond to inquiries on the requirements.
(4) 	Provide access to the regulations and the list of certified detergents.
(5) 	Review the reported information.
(6) 	Contact the respondent when the information has not been submitted properly and discuss how the deficiency can be corrected.
(7) 	Store the information.
(8) 	Enter the information into the database.
(9) 	Upon concluding that all requirements have been met, issue a letter to the manufacturer indicating that the detergent has been certified, and update the list of certified detergents.
(10) Maintain rigorous security for the protection of confidential business information.
(11) Maintain computer hardware and software.
(12) Monitor compliance via on-site inspections.

      5(b)	Collection Methodology and Management

	The EPA has not issued forms.  The respondents may submit and store the information in the format of their choice, including electronically.  Because most of the information reported to EPA is confidential, it is housed in an office with an advanced security system.  The computers on which the data are handled have no linkage outside this office.

      5(c)	Small Entity Flexibility

	The reporting requirements have been made as simple as practical in order to minimize the burden on all parties, large and small.  For small businesses subject to this rule, the vast majority are merely transporters or retailers of gasoline.  Their only burden is the transfer and storage of PTDs, which is a customary business practice.  Transfers of small volumes of additized gasoline to WPCs and other ultimate consumers are exempt from the PTD requirements (80.171(c)).

	5(d) Collection Schedule

	Reporting only required on occasion.

 	ESTIMATING THE BURDEN AND THE COST OF THE COLLECTION

      6(a) and (b)	Estimating Respondent Burden and Costs

 	Estimating the burden is straightforward.  Capital/start-up costs were incurred by industry in 1995.  Third party activity, the transmittal or storage of PTDs, is a customary business practice.  Operating and maintenance (O&M) costs are in three categories.  First, the on-road engine testing to demonstrate that the detergent meets the deposit-control standards is performed at contractor facilities.  The cost of this testing is about $200,000.  As discussed above, this testing is being performed for only one new certified detergent each year, with the other certifications based on previous testing. The second O&M cost is for copying and postage for the estimated three submissions annually for detergent certification and one submission annually for research notification.  At an estimated $10 per submission, the annual cost is $40.  The third O&M cost is for the storage of the VAR records at the 1300 automated detergent blending facilities and 50 non-automated detergent blending facilities.  The estimated annual cost per facility is $100, for a total of $135,000.

      Thus, the total annual O&M cost is $200,000 + $40 + $135,000 = $335,040.

 	Three labor categories are involved: managerial (includes legal and professional review), technical, and clerical.  According to the Bureau of Labor Statistics, May 2011 National Industry-Specific Occupational Employment and Wage Estimates, mean wages were:

 Wages
 Managerial 	$67.44 per hour
 Technical	$65.56 per hour
 Clerical	$22.17 per hour

 	Doubling for company overhead and employing a 2% annual inflation factor to bring the rates up to date, and, for convenience, rounding up to the nearest dollar, gives the following rates that will be used in this ICR:

 Total Employer Cost
 Managerial	$135 per hour
 Technical	$131 per hour
Clerical	$ 44 per hour
Worksheet 1: Detergent Manufacturer Submissions for Certification

	Our review of the submissions indicates a fairly wide range of burden.  Many submissions are minor changes to existing certified detergents and are able to rely on previously submitted data.  We estimate that they require about four hours to prepare.  About one out of 10 undergoes the complete development cycle with estimates of 16 to 2000 hours of burden.
Thus, we continue to believe that the average burden per detergent is estimated at about 60 hours, with the hours and costs allocated as follows (we estimate three submissions annually (17 manufacturers) for the next three years):

Activity	Management		Technical		Clerical

Read		2 hours/$270		4 hours/$524		1 hour/$44

Train		2 hours/$270		2 hours/$262		1 hour/$44

Develop
data		2 hours/$270		20 hours/$2620	1 hour/$44

Organize
data		2 hours/$270		4 hours/$524		1 hour/$44

Review	2 hours/$270		10 hours/$1310	1 hour/$44

Report or
retain		2 hours/$270		1 hour/$131		2 hours/$88

TOTALS	12 hours/$1620	41 hours/$5371	7 hours/$308

GRAND
TOTAL	60 hours/$7299

Worksheet 2: VAR and QA by Detergent Blenders with Automated Equipment

	As noted above, respondents indicated a fairly wide range of burden, from 30 to 260 hours per year per blending facility, for the 1300 facilities nationwide.  The VAR period may be as long as 30 days, but can be shorter due to changes in detergents, maintenance downtime, etc.  We believe that a reasonable average burden is 150 hours per year per facility, representing 15 VAR periods, for a total of 1300 x 15 = 19,500 responses annually.  Thus, the estimated hours and costs per VAR period are:

Activity	Management		Technical		Clerical

Read		0.1 hour/$13.50	0.8 hour/$104.64	0.4 hour/$17.52

Train		0.1 hour/$13.50	0.8 hour/$104.64	0.4 hour/$17.52

Develop
data		0.1 hour/$13.50	1.4 hour/$183.32	1.33 hour/$56.60

Organize
data		0.1 hour/$13.50	0.8 hour/$104.64	1.33 hour/$56.60

Review	0.1 hour/$13.50	0.8 hour/$104.64	0.73 hour/$26.28

Retain		0.1 hour/$13.50	0.2 hour/$26.16	0.4 hour/$17.52

TOTALS	0.6 hour/$81.00	4.8 hours/$628.04	4.6 hours/$192.04

GRAND
TOTAL	10 hours/$901.08

Worksheet 3: VAR and QA by Detergent Blenders with Non-automated Equipment

	There appears to be little blending occurring with non-automated equipment.  However, since it is done manually, and the VAR is done per batch, we estimate 500 hours per year for such blenders.  It is estimated that a blender of this type will do about a thousand batches per year, or a burden of 0.5 hour per batch.  Using the same labor mix as Worksheet 2 gives a per batch cost of $45.05.  We estimate that there are 50 blenders in this category, for a total of 50,000 responses annually.

Worksheet 4: Notification by Researchers

	We estimate that we will receive one letter annually from researchers notifying us that a gasoline without a certified detergent will be used for research purposes.  Assuming a management official spent one-half hour on each letter and a clerical person also spent one-half hour, gives a burden of one hour and $89.50 per letter.
      6(c)	Estimating Agency Burden and Cost

	The Agency activities described in section 5(a) are handled by engineers and scientists at the GS-13 level ($82 per hour, including 160% overhead, as per OMB policy).  It is estimated that 200 hours are spent annually, for a cost to the government of $16,400.  The program is running smoothly and, as noted above, the number of requests for certification has decreased from the previous ICR.  Lease, computer, and security costs are covered in the ICR for the Fuel and Fuel Additive Registration requirements at 40 CFR 79 (EPA ICR Number 309.11, OMB Control Number 2060-1050), with which this program is closely integrated.

      6(d) and (e)	Estimating the Respondent Universe and Total Burden and Costs, and
			Bottom Line Burden and Costs

	The following worksheet is based on the above discussions.

Worksheet 5: Annual Industry Burden

Activity		Responses		Hours/Cost		Total Hours/Cost
Detergent
Certification		3			60/$7299.00		180/$21,897
(3 respondents)

Automated
VAR/QA		19,500			10/$901.08		195,000/$17,571,060
(1300 respondents)

Non-automated
VAR/QA		50,000			0.5/$45.05		25,000/$2,252,500
(50 respondents)

Researcher
Letters		1			1.0/$89.50		1/$89.50
(1 respondents)

TOTALS		69,504					         220,181/$19,845,547

	Thus, the net annual burden to industry is 220,181 hours (3.17 hours per response).  Labor costs are $19,845,547, and O&M costs are $335,040, for a total cost of $20,180,587.

	6(f)	Reasons for Change in Burden

      The previous clearance consisted of 220,181 hours (3.17 hours per response), labor costs of $18,500,528, and O&M costs of $335,040, for a total cost of $18,835,568. There is no increase of hours in the total estimated respondent burden compared with the ICR currently approved by OMB. The respondent universe and responses also remained the same in this collection.  There was an increase in cost to the industry of $1,345,019 per year due to updated numbers used to calculate the industry burden and to account for inflation.
	6(g)	Burden Statements

       The annual public reporting and recordkeeping burden for this collection of information is estimated to average 3.6 hours per response.  Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency.  This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.  An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

 	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OAR-2007-0595, which is available for online viewing at www.regulations.gov, or in person viewing at the Air and Radiation Docket in the EPA Docket Center (EPA/DC), WJC West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C.  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Air and Radiation Docket is<PHONE_NUMBER>.  An electronic version of the public docket is available at www.regulations.gov.  This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  When in the system, select "search," then key in the Docket ID Number identified above.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-OAR-2007-0595 and OMB Control Number 2060-0275 in any correspondence.


[Federal Register Volume 86, Number 203 (Monday, October 25, 2021)]
[Notices]
[Page 58962]
[FR Doc No: 2021-23161]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-028, OMB Control No. 3235-0032]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 17f-1(b)

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 17f-1(b) (17 CFR
240.17f-1(b)), under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.). The Commission plans to submit this existing collection of
information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Under Rule 17f-1(b) under the Exchange Act, approximately 10,000
entities in the securities industry are registered in the Lost and
Stolen Securities Program (``Program''). Registration fulfills a
statutory requirement that entities report and inquire about missing,
lost, counterfeit, or stolen securities. Registration also allows
entities in the securities industry to gain access to a confidential
database that stores information for the Program.
    The Commission staff estimates that 10 new entities will register
in the Program each year. The staff estimates that the average number
of hours necessary to comply with Rule 17f-1(b) is one-half hour.
Accordingly, the staff estimates that total annual burden for all
participants is 5 hours (10 x one-half hour). The Commission staff
estimates that compliance staff work at subject entities results in an
internal cost of compliance, at an estimated hourly wage of $283, of
$141.50 per year per entity (.5 hours x $283 per hour = $141.50 per
year). Therefore, the aggregate annual internal cost of compliance is
approximately $1,415 ($141.50 x 10 = $1,415).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or send an email
to: [email protected].

    Dated: October 19, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-23161 Filed 10-22-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)]
[Notices]
[Page 73459]
[FR Doc No: 2016-25827]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a closed meeting on Thursday, October
27, 2016 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the closed meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii) and (a)(10), permit
consideration of the scheduled matter at the closed meeting.
    Commissioner Piwowar, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matter of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims;
    Adjudicatory matters; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed; please contact Brent J. Fields from
the Office of the Secretary at<PHONE_NUMBER>.

    Dated: October 20, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-25827 Filed 10-21-16; 11:15 am]
BILLING CODE 8011-01-P


(4)  Statistical Analysis.  Histopathology data are in the form of severity scores or developmental stages.  A test termed RSCABS (Rao-Scott Cochran-Armitage by Slices) uses a step-down Rao-Scott adjusted Cochran-Armitage trend test on each level of severity in a histopathology response (Greene et al., 2014). The Rao-Scott adjustment incorporates the replicate vessel experimental design into the test.  The "by slices" procedure incorporates the biological expectation that severity of effect tends to increase with increasing doses or concentrations, while retaining the individual subject scores and revealing the severity of any effect found. The RSCABS procedure not only determines which treatments are statistically different than controls (i.e., have more severe pathology than controls), but it also determines at which severity score the difference occurs thereby providing much needed context to the analysis.  In the case of developmental staging of gonads and reproductive ducts, an additional manipulation should be applied to the data since an assumption of RSCABS is that severity of effect increases with dose or concentration. The effect observed could be a delay OR acceleration of development. Therefore, developmental staging data should be analyzed as reported to detect acceleration in development and then manually inverted prior to a second analysis to detect a delay in development.
Advantages of using RSCABS as a statistical method for analyzing histopathology data include the ability to account for: 1) experimental designs with multiple replicates, 2) lesion severity scores of individual animals in addition to group-wise lesion prevalence, and 3) dose-response relationships.  Additionally, the RSCABS test is relatively easy to perform and interpret.

      (5)  Data Interpretation.  Once the microscopic examinations have been completed and statistical analyses have been performed on the resulting data, the pathologist interprets the histopathologic findings.  The initial task is to determine which, if any, of the recorded findings are related to administration of the test article, and which are not.  The goal is to classify each type of recorded finding (i.e., diagnosis) into one of three categories: 1) Treatment-related, 2) Potentially treatment-related, and 3) Non-treatment-related.  Criteria for these determinations are listed below.

      (i)  Determining Relationship to Treatment.  A weight-of-evidence (WOE) approach is used to determine if a particular finding should be considered treatment-related.  Such evidence may include any or all of the following as available:
Differences between groups of control and treated animals in terms of lesion prevalence and severity, utilizing statistical analytical results to test for significance as warranted.
Ancillary data from the current study, involving information such as behavioral observations, liver and body weights, genotypic sex, time-to-metamorphosis, and age at sacrifice.
Results from other submitted or pending agency studies. The at-large scientific literature, giving greater weight to studies in which the quality of the research can be established and is considered superior.
Overall biological, physiological, and toxicological plausibility.

Findings that are considered potentially treatment-related may be those that have borderline statistical significance, or those in which the relationship to treatment is considered equivocal for other reasons (e.g., lack of corroborating evidence from other sacrifices or other studies, biological or toxicological implausibility, or commonality of the diagnosis as a background finding).
There are several points to be made regarding the determination of treatment-relatedness. First, it is possible for a finding to be treatment-related but not be caused by the test chemical.  This can include situations in which group-wise differences may be associated with an uncontrolled (and possibly unrecognized) variable involving conduct of the in-life assay, specimen preparation, or some other non-systemic bias.  Second, not all statistically significant differences are real, as a p-value significance level of 0.05 allows for the probability that in 5% of cases the result occurred by chance.  Third, a finding may be statistically significant and not necessarily biologically or toxicologically important.  Fourth, in some instances, treatment-related findings may not be statistically significant.  For example, this can occur when treatment induces a low frequency of a lesion type that rarely occurs spontaneously.

      (ii)  Determining Relationship to Endocrine Disruption.  A similar weight-of-evidence (WOE) approach can be used to determine if a particular finding is likely to be endocrine-related; however, in this case the WOE will more heavily depend on ancillary data, results of other assays, and the published literature, including mechanistic studies where available.

      (6)  Report Format.  The pathologist is responsible for deliverables that include: 1) Pathology Narrative Report, 2) Spreadsheet with recorded data, and 3) TIFF image files of figures.

      (i)  Pathology Narrative.  Each histopathology narrative report should contain at least the first five of the following sections: Introduction, Materials and Methods, Results, Discussion, Summary / Conclusions, References, Tables, and Figures.  The Introduction section briefly outlines the experimental design.  The Materials and Methods section briefly describes procedures used during the slide preparation and examination phases of the study.  If specific severity grading criteria were created for a particular finding, they should also be listed in this section.  The Results section should report findings that are: 1) treatment-related; 2) potentially treatment-related; and 3) non-treatment-related findings that are novel or unusual.  Detailed histomorphologic descriptions need only be included for findings that differ substantially from diagnoses presented the Histopathology Atlas.  It is intended that the Results section should be as objective as possible (i.e., opinions and hypotheses should be reserved for the Discussion section).  The Discussion section, which contains subjective information, should address relevant findings that were reported in the Results section.  Opinions and hypotheses can be included in this section, preferably backed by references from peer-reviewed sources, but unsupported speculation should be avoided.  The Summary / Conclusions section should encapsulate the most important information from the Results and Discussion sections.  The References section should include only material that is cited specifically in the narrative report.  A separate Tables section may not be necessary if tables are embedded in the Results section.  The Figures section should include photomicrographic examples of treatment-related findings, plus unusual or noteworthy lesions.  The Figures section should include normal tissues for comparison, and digital images should be taken at magnifications that clearly illustrate the salient features of the findings.  Figures embedded in the narrative should be in a universally readable compressed file format such as JPEG.

      (ii)  Spreadsheet.  In addition to the recorded histopathology findings, the completed spreadsheet should indicate the animals from which figure images were photographed, and the number of images obtained per photographed organism.  An example spreadsheet is provided on the EDSP website: http://www.epa.gov/endo/.

      (iii) Figures.  For record-keeping purposes, a complete set of unannotated photomicrographic figures should be submitted electronically on portable media as uncompressed TIFF files.

      (7)  Pathology Peer Review.  Following the initial slide evaluation and creation of a draft report by the study pathologist (SP), it is encouraged that at least a subset of the original histologic sections be assessed by a second reviewing pathologist (RP). Known as pathology peer review, the purpose of this exercise is to increase confidence in the histopathology data by ensuring diagnostic accuracy and consistency.  Commonly, this procedure involves the targeted examination of one or more tissue types in which treatment-related findings were initially detected (this helps to guard against false positive results), plus all tissues from a randomly selected percentage (e.g., 10-20%) of animals from the control and high-dose groups (this helps guard against false negatives). The RP is tasked with determining the accuracy and consistency of diagnostic criteria, diagnostic terminology, severity grading, and the interpretation of findings.  The peer review can be performed in-house or (preferably) by an external pathologist, and frequently the reviewing pathologist has at least equal or greater expertise than the SP.  Following the peer review, the SP and RP typically meet to resolve diagnostic differences. In unusual cases in which such differences cannot be resolved, a panel of experts (Pathology Working Group) may be convened to determine the final diagnoses.  In addition to enhancing confidence in the histopathology results, benefits of peer review may include decreased inter-laboratory variability, and cross-training of pathologists (i.e., the initial study pathologist may not always need to be an avian expert).  Examples of recommended procedures for conducting pathology peer reviews have been described (e.g., Morton et al., 2010; The Society of Toxicologic Pathologists, 1991; 1997).

	(8)  Summary of Diagnostic Criteria for Selected Histopathologic Findings. Table 1 lists diagnostic criteria for selected findings in LAGDA studies according to tissue type.
Table 1.  Diagnostic Criteria for Potential Histopathological Findings in LAGDA Studies

Tissue
Diagnostic Criteria
Thyroid
                                       Criteria for thyroid gland assessment are available in Grim et al. (2009).
Liver
Decreased (Glycogen) Vacuolation
1
Hepatocellular vacuolation is decreased slightly relative to controls, but at least 75% of the cytoplasm is vacuolated.

2
50-75% of the cytoplasm is vacuolated.

3
25-50% of the cytoplasm is vacuolated.

4
Less than 25% of the cytoplasm is vacuolated.
Gonad
Testis Stage
1
Undifferentiated gonad

2
Individual primary spermatogonia and undifferentiated somatic cells populate the medullary region

3
Seminiferous tubules with primary spermatogonia and cysts of secondary spermatogonia

4
Primary spermatocytes with rete testis formation; may have occasional spermatocysts that contain round or elongated spermatids

5
All stages of spermatogenesis evident

Tubule Development Score
1
Less than 50% of seminiferous tubules have visible lumens

2
50% or greater seminiferous tubules have visible lumens

Ovary Stage
1
Undifferentiated gonad

2
Gonad identifiable as an ovary based on the presence of a discontinuously open lumen lined with epithelial cells; germ cells within the cortex consist of primary oogonia, cysts of primary mitotic oogonia, secondary oogonia, and very early meiotic oocytes

3
First appearance of diplotene oocytes in cortex; the most prevalent germ cell types at this stage are cysts of secondary oogonia and cysts of leptotene-pachytene primary meiocytes

4
Pre-vitellogenic (Dumont Stage I) diplotene oocytes are the most prevalent germ cell type observed by area and absolute cell counts; the central lumen is proportionately smaller while the whole ovary grows greatly in size and volume due to the growth of the oocytes; cysts in earlier stages of oogenesis become fewer in number and are located along the periphery of ovary

5
Ovary consists almost entirely of vitellogenic oocytes (Dumont Stage IV); pre-vitellogenic diplotene oocytes can be found along the periphery of the ovary and germ patches of primary and secondary oogonia are difficult to locate

Gonad Phenotype Score
0
Gonad phenotype matches genotype

1
Gonad phenotype primarily matches genotype, with a relatively smaller portion of opposite sex gonad tissue

2
Gonad is approximately equal parts testis and ovary

3
Gonad phenotype primarily matches opposite genotype, with a relatively smaller portion of genotypic sex gonad tissue

4
Gonad phenotype matches opposite genotype (sex reversed)

Germ Cell Degeneration
1
A single degenerating germ cell to less than three clusters of degenerating germ cells per gonad

2
Three or more clusters of degenerating germ cells, but less than 25% of gonad affected

3
Gonad consists of greater than 25% but less than 50% of degenerating germ cells

4
Gonad consists of 50% or more of degenerating germ cells

Mononuclear Cell Infiltrates
1
Small, focal infiltrates in one gonad

2
Small focal infiltrates in both gonads, or large area of infiltrates in one gonad

3
Large areas of infiltrates in both gonads

4
Gonads contain greater than 50% of infiltrates by area
Oviduct
Oviduct Stage
1
The oviduct is either a fibrous connective tissue tag, or is essentially non-existent

2
The oviduct has an epithelial cell lining (1-3 cell layers), and is comparable in size to the Wolffian duct

3
The oviduct has convoluted, multilayered epithelial cell lining, and is substantially larger (1.5x or greater) than the size of the Wolffian duct

4
The oviduct is dwarfs the size of the Wolffian duct.  Epithelial cells have formed large, basophilic glandular structures
Wolffian Duct
Wolffian Duct Stage
1
Epithelial lining of Wolffian duct is completely or focally less than two cell layers thick

2
Epithelial lining of Wolffian duct is two cell layers thick or greater, but clear apical portion of cell (if present) is less than half the cell height

3
Epithelial lining of Wolffian duct is two cell layers thick or greater, and clear apical portion of the columnar cells is at least half the cell height but less than 2/3 of the cell height

4
The clear apical portion of the columnar cells represents 2/3 or greater of the total cell height
Kidney
Mineralization
1
Less than three small foci of mineralization per kidney

2
Three or more small foci of mineralization per kidney, or less than three large foci

3
Three or more large foci of mineralization per kidney

4
Mineralized deposits in 50% or more tubules

Tubule Dilation
1
Minimal to mild dilation of less than three tubule clusters

2
Mild to moderate dilation of three or more tubule clusters

3
Moderate dilation affecting 50% or more tubules

4
Massive dilation of one or more tubules

      (9)  Atlas of Histopathologic Findings (Figures 4-39).  The purpose of this section is to provide: 1) a common technical "language" for describing findings and 2) a reference atlas of both normal microanatomical structures and potential pathological findings. This atlas is organized first by organ type, followed by an alphabetical list of terms, then working definitions, and finally photomicrographic examples. The information in this section is derived from a number of sources including scientific articles, conference proceedings, related guidelines, toxicologic pathology textbooks, medical dictionaries, and the personal experience of various pathologists.

      (i)  Thyroid Glands

Figure 4. Normal versus Hypertrophic Thyroid Glands.  A. Transverse section through the neck region to demonstrate thyroid glands (arrows and inset) in control frog.  B. Severely hypertrophic thyroid glands.  Morphologic criteria for the histopathologic evaluation of the thyroid glands are described and illustrated in Grim et al., 2009.  Bar = 500 microns.
      (ii)  Liver

Figure 5. Hepatocellular Vacuolation, Increased.  Relative to the control liver, affected hepatocytes in the treated frog liver contain greater amounts of pale granular cytoplasm, the contents of which are morphologically consistent with glycogen.  Alterations in cell size can only be made by careful comparison of the treated frog livers to those of the concurrent controls.  Bar = 50 microns.

Figure 6. Hepatocellular Vacuolation, Decreased.  Relative to the livers of control frogs (see previous figure), affected hepatocytes contain lesser amounts of cytoplasmic glycogen.  This loss of glycogen vacuolation tends to occur preferentially in the basal (avascular) region of the cells, in the area adjacent to the biliary canals of Hering (arrow).  As vacuolation decreases, the liver progressively acquires a more basophilic overall appearance. Bar = 50 microns.
      (iii)  Gonads.

Figure 7. Normal Testes, Oviducts and Wolffian Ducts.  The testes (T) are attached to the peritoneal surface of the kidneys (K) by suspensory ligaments.  The black arrows indicate the oviduct (Müllerian duct) remnants (Stage 1 oviducts in this case), whereas the white arrows indicate the Wolffian ducts.
Bar = 500 microns.

Figure 8. Normal Testis, Spermatogenic Stages.  Germ cell maturation occurs as follows: primary spermatogonia  secondary spermatogonia  primary spermatocytes  secondary spermatocytes  round spermatids  elongated spermatids  spermatozoa.  The majority of visible spermatocytes, which are primary spermatocytes, represent only prophase I of meiosis.  These include leptotene  zygotene  pachytene  diplotene phases.  Secondary spermatocytes, which are haploid representatives of meiosis II, are comparatively rare.  Sertoli cells are sparse, and those that are visible are usually surrounded by elongating spermatids.  Interstitial areas contain low numbers of Leydig cells (not indicated).
Bar = 25 microns.

Figure 9. Meiotic Phases in the Vertebrate Testis.  Schematic diagram included for reference.

Figure 10. Staging of the Testis.  Stage numbers increase with increasing maturity of the testis.  Control males 10 weeks post NF stage 62 (LAGDA termination) typically have Stage 4 or 5 testes.

Figure 11. Stage 4 Versus 5 Testes, Higher Magnification.  Stage 4 testes can have elongating spermatids (arrow), but spermatocysts that contain spermatozoa are rare or not apparent.  Conversely, spermatozoa (S) are abundant in Stage 5 testes. Bar = 25 microns.

Figure 12. Germinal Epithelium Thinning and Dilation.  This finding is characterized by focal to diffuse attenuation of the testicular germinal epithelium (arrows), with expansion of the adjacent tubular lumen.  Germ cell degeneration is also evident.  In a previous report, similar changes were termed "dilated testis tubules" (Wolf et al., 2010). Bar = 100 microns. Grade 4 is left intentionally blank.

Figure 13. Testis, Germ Cell Degeneration.  This finding is characterized by the scattered presence of individual or clustered apoptotic germ cells (black arrows and inset), or germ cell syncytia (white arrow), within the germinal epithelium.  Affected testes may also have increased numbers of exfoliated cells and cellular debris in tubular lumina.  Bar = 25 microns (Grade 1), 50 microns (Grade 2).  Grades 3-4 are left intentionally blank.

Figure 14. Spermatogonia, Increased.  This finding is characterized by a greater frequency of spermatogonia (arrows) in the testes of affected frogs as compared to those of the average control frog.  Bar = 50 microns. Grades 2-4 are left intentionally blank.

Figure 15. Mononuclear Cell Infiltrates.  Mononuclear cell infiltrates (arrows), which appear to consist primarily of lymphocytes, are relatively common in the testes.  Bar = 25 microns. Histogram provided for Grade 1 only.  Grades 2-4 are intentionally left blank.

Figure 16. Germ Cell Vacuolation.  This finding is characterized by increased amounts of clear cytoplasm in clusters of zygotene-phase primary spermatocytes.  Bar = 25 microns. Illustration for Grade 1 only.  Grades 2-4 are left intentionally blank.

Figure 17. Normal Ovaries, Oviducts and Wolffian Ducts.  The ovaries (O) are attached to the peritoneal surface of the kidneys (K) by suspensory ligaments.  The black arrows indicate the oviduct (Müllerian duct) remnants (Stage 2 oviducts in this case), whereas the white arrows indicate the Wolffian ducts.  Bar = 500 microns.

Figure 18. Staging of the Ovary.  Control females 10 weeks post NF stage 62 (LAGDA termination) typically have Stage 3 or 4 ovaries.

Figure 19. Mixed Sex Gonads.  The gonads contain both testicular (T) and ovarian (arrows) components.  Each of these gonads received a Phenotype Score of 2. Bar = 50 microns.

Figure 20. Complete Sex Reversal.  This normal appearing ovary was a treatment-related phenotypic finding in a genetic male frog.  This ovary would receive a Gonad Phenotype Score of 5.  Bar = 50 microns.

Figure 21. Hermaphroditism.  In addition to left and right testes (T), this animal had a small amount of ovarian tissue (arrow) within the abdominal mesentery.  K = kidney.  Bar = 250 microns.

Figure 22. Proteinaceous Fluid.  Proteinaceous fluid (arrows) appears as homogenous dark pink material within the central and subcapsular regions of the ovarian interstitium.  Bar = 100 microns (Grade 1), 50 microns (Grade 2). Grades 2-4 are left intentionally blank.

Figure 23. Oocyte atresia.  Spontaneous oocyte atresia appears to be relatively uncommon in the Stage 3 or 4 ovaries of most untreated control frogs.  Bar = 50 microns. Grades 2-4 are left intentionally blank.

Figure 24. Oocyte atresia, Additional Examples.  A. In this example, early oocyte degeneration is characterized by a loss of nuclear detail and increased nuclear density.  B. In this later stage of atresia, oocyte remnants are being scavenged by nests of macrophages (black arrows).  The white arrow indicates what appear to be hypertrophic granulosa cells from an atretic follicle.  Bar = 25 microns.

Figure 25. Ovary, Germ Cell Degeneration.  The term "germ cell degeneration" is used rather than "atresia" to characterize the in vivo deterioration of stem cells or oogonia, or the deterioration of phenotypically undifferentiated cells in early stage gonads.  Ovarian germ cell degeneration in the form of apoptotic-like cells (arrows) was observed as a treatment-related response in the Grade 2 image.  Bar = 25 microns.  Grade 1, 3, and 4 are left intentionally blank.
      (iv)  Gonadal Ducts.

Figure 26. Oviduct Staging.  As the oviduct (Müllerian duct) matures in the female, it becomes progressively larger, with an expanded lumen and a more convoluted mucosal lining.  Conversely, oviducts regress over time in male frogs.  Control male frogs typically have Stage 1 or 2 oviducts 10 weeks post NF stage 62 (LAGDA termination), and the average stage in males is usually less than the average stage in same-aged females of the same study.  In borderline cases, the size of the oviduct relative to the Wolffian duct is a useful criterion for differentiating between Stage 2 and Stage 3 oviducts.  Bar = 50 microns (Stages 1, 2, and 3), 100 microns (Stage 4).

Figure 27. Oviduct Staging, Additional Examples of Stage 1 Oviducts.  Stage 1 oviducts (arrows) range from small fibrous protuberances, to suspensory ligaments in which there is no apparent residual oviduct (e.g., Fig. D).  These oviducts do not have lumens or mucosal linings.  Bar = 50 microns.

Figure 28. Oviduct Staging, Additional Examples of Stage 2 Oviducts.  Stage 2 oviducts (arrows), which are comparable in size to the Wolffian ducts, all have a visible lumen and are lined by one to a few layers of mucosal epithelial cells, with or without slight mucosal folding.  Bar = 50 microns (Figures 28A-C), 25 microns (Figure 28D).

Figure 29. Oviduct Staging, Additional Examples of Stage 3 Oviducts.  Stage 3 oviducts (arrows), which greater than 1.5 times the size of Wolffian ducts, have intricate mucosal folding.  Bar = 500 microns (Figure 29A), 100 microns (Figures 29B-C), 25 microns (Figure 29D).

Figure 30. Oviduct Staging, Additional Examples of Stage 4 Oviducts.  Stage 4 oviducts (arrows) are markedly larger than Wolffian ducts, and the mucosal epithelium is forming, or has formed, large glandular structures.  Fig. D is enlarged relative to the other figures.  The oviduct in Fig. D represents the borderline between Stages 3 and 4.  Bar = 500 microns (Figure 30A- B), 100 microns (Figure 30C), 50 microns (Figure 30D).

Figure 31. Wolffian Duct Staging.  The Wolffian ducts, which are located within the lateral extremities of the right and left kidneys, also function as ureters in Xenopus spp.  With maturity, the Wolffian ducts become progressively larger, although not to the extent of oviducts in female frogs.  The mucosal lining of the ducts also becomes thicker and contains more mucous cells with age.  Generally, mean Wolffian duct scores are slightly higher in control males than in control females of the same study.  Bar = 25 microns (Stages 1-3), 50 microns (Stage 4).
      (v)  Kidneys.

FIGURE 32. Normal Kidney from a Control Frog.  Glomeruli (G) are located in the ventral third of the kidneys, whereas proximal tubules (T) occupy the dorsal portions.  Bar = 100 microns (Figure 32A), 50 microns (Figure 32B).
FIGURE 33. Proteinaceous Fluid.  Proteinaceous fluid (arrows) appears as homogenous dark pink material within the renal interstitium, blood vessels, tubules, and/or Bowman's spaces.  Bar = 25 microns (Grade 1), 100 microns (Grade 4). Grades 2-3 are left intentionally blank.
FIGURE 34. Proteinaceous Fluid, Grade 4, Additional Examples.  Tubules, glomeruli, and the renal interstitium are flooded by proteinaceous fluid in these examples.  BS = dilated Bowman's space.  Bar = 500 microns (Figure 34A), 100 microns (Figure 34B), 50 microns (Figures 34C-D).

FIGURE 35. Fibrosis.  This finding, which is characterized by excessive amounts of fibrous connective tissue (F) within the renal interstitium, usually occurs as a sequel to chronic inflammation or other long standing parenchymal damage.  Bar = 100 microns (Grade 3). Grades 1, 2, and 4 are left intentionally blank.
FIGURE 36. Glomerulomegaly and Glomerular Hypercellularity.  This finding can be a consequence of low level chronic glomerular damage.  The arrow indicates a small deposit of proteinaceous material within a glomerular capillary.  Bar = 20 microns (Grade 3).  Grades 1, 2, and 4 are left intentionally blank.
FIGURE 37. Regenerative Blast Cell Hyperplasia.  This finding, which is another consequence of chronic renal damage and tubular loss, is characterized by streaming proliferations of cells with large, hyperchromatic (dark) nuclei (arrows).  Figure 37B is a higher magnification of Figure 37A.  This particular case was assigned a severity score of Grade 2 (mild).  Bar = 50 microns (Figure 37A), 25 microns (Figure 37B).

Figure 38. Mineralization with Tubular Dilation.  Mineralization appears to be a common background finding in laboratory reared X. laevis, and the severity of this finding appears to vary from facility to facility.  Husbandry factors (e.g., issues involving feed and/or water composition) are suspected causes.  The occurrence of mineralization is associated with focal to diffuse renal tubular dilation, presumably due to obstruction of urine flow.  Tubular dilation and mineralization are usually graded separately. In a given frog, the severity grade for tubular dilation is typically one grade less than that of mineralization (see example below).  Bar = 25 microns (Grade 1), 100 microns (Grades 2 and 3). Grade 4 is left intentionally blank.

Figure 39. Mineralization, Additional Examples.  Figure A represents another case of Grade 3 mineralization and Grade 2 tubular dilation.  Figure B illustrates a small amount of mineral (arrow) within a multinucleated giant cell macrophage.  Bar = 100 microns (Figure 39A), 25 microns (Figure 39B).
      (e)  References.

(1)  Green J.W., Springer T.A., Saulnier A.N., Swintek J. (2014). Statistical analysis of histopathology endpoints.  Environ Toxicol Chem. 33(5):1108-1116.

(2)  Grim K.C., Wolfe M., Braunbeck T., Iguchi T., Ohta Y., Tooi O., Touart L., Wolf D.C., Tiege J. (2009). Thyroid histopathology assessments for the amphibian metamorphosis assay to detect thyroid-active substances.  Toxicol Pathol. 37:415-424.

(3)  Morton D., Sellers R.S., Barale-Thomas E., Bolon B., George C., Hardisty J.F., Irizarry A., McKay J.S., Odin M., Teranishi M.  (2010). Recommendations for pathology peer review.  Toxicol Pathol. 38(7):1118-1127.

(4)  Nieuwkoop P.D., Faber J.  (1994). Normal Table of Xenopus laevis (Daudin). Garland Publishing, Inc.  New York and London.

(5)  The Society of Toxicologic Pathologists. (1991). Peer review in toxicologic pathology: some recommendations.  Toxicol Pathol. 19:290-292.

(6)  The Society of Toxicologic Pathologists. (1997). Documentation of pathology peer review.  Position of the Society of Toxicologic Pathologists.  Toxicol Pathol. 25(6):655.

(7)  Wolf J.C., Lutz I., Kloas W., Springer T.A., Holden L.R., Krueger H.O., Hosmer A.J. (2010).  Effects of 17 beta-estradiol exposure on Xenopus laevis gonadal histopathology.  Environ Toxicol Chem. 29(5):1091-1105.


Comment Info: =================

General Comment:Request please extend response period to 180 days. The proposed rule is complicated and addresses a range of issues impacting the rights, livelihood and health of millions of people. There needs to be ample time for these issues to be considered or understood. For example: Why are rules about smoking and tobacco products being applied to a product which is not smoked [combusted] and which contains no tobacco? In the meantime perhaps a much simpler measure to address a fundamental safety concern could be enacted without delay:

The only known hazard of "vaping" [apart from battery safety in devices] is that nicotine in the amounts typically present in e-liquid could be poisonous if ingested in sufficient quantity and therefore any e-liquid sold containing nicotine should be required to have a "poison, do not ingest" warning on the label.


[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Page 16419]
[FR Doc No: 2018-07793]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Form F-X, SEC File No. 270-336, OMB Control No. 3235-0379

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form F-X (17 CFR 239.42) is used to appoint an agent for service of
process by Canadian issuers registering securities on Forms F-7, F-8,
F-9 or F-10 under the Securities Act of 1933 (15 U.S.C. 77a et seq.),
or filing periodic reports on Form 40-F under the Exchange Act of 1934
(15 U.S.C. 78a et seq.). The information collected must be filed with
the Commission and is publicly available. We estimate that it takes
approximately 2 hours per response to prepare Form F-X and that the
information is filed by approximately 114 respondents for a total
annual reporting burden of 228 hours (2 hours per response x 114
responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the performance of the
functions of the agency, including whether the information will have
practical utility; (b) the accuracy of the agency's estimate of the
burden imposed by the collection of information; (c) ways to enhance
the quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE, Washington, DC 20549; or send an email
to: [email protected].

    Dated: April 9, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-07793 Filed 4-13-18; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Page 50747]
[FR Doc No: 2011-20799]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1950-DR; Docket ID FEMA-2011-0001]

Arizona; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Arizona (FEMA-1950-DR), dated December 21, 2010, and
related determinations.

DATES: Effective Date: August 4, 2011.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 4, 2011, the President amended the cost-sharing
arrangements regarding Federal funds provided under the authority of
the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (the ``Stafford Act''), in a letter to W. Craig
Fugate, Administrator, Federal Emergency Management Agency, Department
of Homeland Security, under Executive Order 12148, as follows:

    I have determined that the damage in the Sovereign Tribal Nation
of the Havasupai Tribe of Arizona resulting from severe storms and
flooding during the period of October 3-6, 2010, is of sufficient
severity and magnitude that special cost sharing arrangements are
warranted regarding Federal funds provided under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act'').
    Therefore, I amend my declaration of December 21, 2010, to
authorize Federal funds for all categories of Public Assistance at
90 percent of total eligible costs for the Sovereign Tribal Nation
of the Havasupai Tribe.
    This adjustment to the local cost sharing applies only to Public
Assistance costs and direct Federal assistance eligible for such
adjustments under the law. The Robert T. Stafford Disaster Relief
and Emergency Assistance Act specifically prohibits a similar
adjustment for funds provided for Other Needs Assistance (Section
408), and the Hazard Mitigation Grant Program (Section 404). These
funds will continue to be reimbursed at 75 percent of total eligible
costs.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-20799 Filed 8-15-11; 8:45 am]
BILLING CODE 9111-23-P


Comment Info: =================

General Comment:ToWhom it May Concern:

These products have been instrumental to my ongoing commitment to quitting tobacco. I was never a heavy smoker, a pack a week, but after trying a vaporizer, I have stopped tobacco and now only vape twice a week. My journey to being tobacco free would not have happened if these products were not available and easily accessible. The majority of people who I have met who do vape, are fully aware of the risks they are taking but also thrilled that they are now taking the risks of tobacco off their minds. Vaping is not tobacco. It is a water vapor that is inhaled. They are not mutually exclusive.

 A 75 day comment period is insufficient time for the vaping industry and the wider vaping community to comment on the proposed deeming regulations. I would respectfully request that the period for comment be extended to 180 days.


[Federal Register Volume 76, Number 137 (Monday, July 18, 2011)]
[Notices]
[Page 42143]
[FR Doc No: 2011-18067]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

Federal Register Citation of Previous Announcement: [76 FR 40948, July
12, 2011].

STATUS: Closed Meeting.

PLACE: 100 F Street, NW., Washington, DC.

DATE AND TIME OF PREVIOUSLY ANNOUNCED MEETING: July 14, 2011 at 2 p.m.

CHANGE IN THE MEETING: Deletion of Items.

    The following items will not be considered during the Closed
Meeting on Thursday, July 14, 2011:
    Adjudicatory Matters.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

     Dated: July 14, 2011.
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-18067 Filed 7-14-11; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register: December 12, 2006 (Volume 71, Number 238)]
[Notices]
[Page 74498]
[DOCID:fr12de06-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-84-000]

Gas Transmission Northwest Corporation; Notice of Tariff Filing

December 5, 2006.
    Take notice that on November 30, 2006, Gas Transmission Northwest
Corporation (GTN) tendered for filing workpapers supporting the
restatement of its fuel and line loss surcharge in compliance with
Paragraph 37 of the general terms and conditions of its FERC Gas
Tariff, Third Revised Volume No. 1-A.
    GTN further states that a copy of this filing has been served on
GTN's jurisdictional customers and interested state regulatory
agencies.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21077 Filed 12-11-06; 8:45 am]

BILLING CODE 6717-01-P