Supporting Statement for

An Information Collection Request (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title of the Information Collection

Submission of Protocols and Study Reports for Environmental Research
Involving Human Subjects

OMB No. 2070-0169   	EPA No. 2195.03

1(b)	Short Characterization/Abstract

	The Environmental Protection Agency (EPA or the Agency) is responsible
for the regulation of pesticides under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and
Cosmetic Act (FFDCA).  In January 2006, EPA issued a final rule to amend
the Federal Policy for the Protection of Human Subjects (also known as
the Common Rule) at 40 CFR part 26.  EPA’s January 2006 final rule
significantly strengthens and expands the protections for subjects of
“third-party” human research (i.e., research that is not conducted
or supported by EPA).  In addition to other protections, the final rule
requires affected entities to submit information to EPA and an
institutional review board (IRB) prior to initiating, and to EPA upon
the completion of, certain studies that involve human research
participants.  The information collection activity imposed by this final
rule consists of activity-driven reporting and recordkeeping
requirements for those who intend to conduct research for submission to
EPA under the pesticide laws.  If such research involves intentional
dosing of human subjects, these individuals (respondents) are required
to submit study protocols to EPA and a cognizant local Human Subjects
IRB before such research is initiated so that the scientific design and
ethical standards that will be employed during the proposed study may be
reviewed and approved.  Also, respondents are required to submit
information about the ethical conduct of completed research that
involved human subjects when such research is submitted to EPA.

This renewal ICR estimates the third party response burden from
complying with the January 2006 final rule requirements. Information is
typically submitted by registrants of pesticide products to support the
registration of their products. It is estimated that the annual response
burden is approximately 20,572 hours valued at about $1,579,098.

2.	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection

The 2006 Appropriations Act, Pub. L. No. 109-54, required EPA to issue a
final rule (Attachment C) addressing third-party intentional dosing
human toxicity studies for pesticides, and EPA conduct of intentional
dosing human toxicity studies for pesticides.  This ICR applies to all
of the information collection activities identified in the final rule
EPA promulgated in response to the Congressional mandate.  EPA’s
statutory authority to require and collect information identified in the
final rule already existed under FIFRA and FFDCA.

  Sections 3(c)(5), 3(g) and 4(g)(2)(D) of FIFRA generally require EPA
to determine that a pesticide would not present any “unreasonable
adverse effects on the environment” when deciding to grant a new or
amended pesticide registration or to continue an existing registration.
Section 4(g)(2)(E) of FIFRA and section 408(b)(2)(A)(ii) of FFDCA
generally require EPA to determine that   SEQ CHAPTER \h \r 1 that there
is a reasonable certainty that no harm will result from aggregate
exposure to the residue of a pesticide chemical, including all
anticipated dietary exposures and all other exposures for which there is
reliable information when making pesticide tolerance decisions.  FIFRA
section 12(a)(2)(P) forbids any person “to use any pesticide in tests
on human beings unless such human beings (i) are fully informed of the
nature and purposes of the test and of any physical and mental health
consequences which are reasonably foreseeable from, and (ii) freely
volunteer to participate in the test.”  EPA established this
collection of information as part of the final rule as authorized under
section 25 of FIFRA and section 408(e)(1)(C) of FFDCA to:

(1)	ensure that sound and appropriate scientific data are available to
EPA when 			making regulatory decisions about pesticides as described in
the previous 				paragraph; and,

(2)	protect the interests, rights and safety of human research subjects,
as required under FIFRA section 12(a)(2)(P).

Sections 3(c)(5), 3(g), 4(g)(2), and 25 of FIFRA and sections
408(b)(2)(A)(ii) and 408(e)(1)(C) of FFDCA are included as Supporting
Statement attachments A and B, respectively.

2(b)	Practical Utility/Users of the Data

In order to ensure the availability of sound and appropriate scientific
data in its decisions, and to protect the interests, rights and safety
of human research subjects, EPA extended the requirements of the
Agency’s Common Rule, 40 CFR Part 26, prospectively to third-party
research intended for submission to EPA under the pesticide laws and
involving intentional exposure of non-pregnant, non-nursing adult human
subjects.  The information provided allows   SEQ CHAPTER \h \r 1 EPA to
review protocols and related information before research involving human
subjects is initiated, after it has been reviewed and approved by a
local IRB.  In addition, anyone who submits to EPA a report of research
with human subjects must submit concurrently documentation of the
ethical conduct of the research.  This information collection activity
allows EPA to ensure all human subjects in research conducted by EPA
(first party), conducted by entities with support from EPA (second
parties), or conducted by third parties with the intention to submit it
to EPA are treated ethically.

3.		NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a)	Non duplication

		The information requirements identified in the final rule do not
duplicate other federal agency information collections.  Other federal
agencies have adopted the Common Rule and FDA has established
requirements similar to those in the Common Rule for third-party
researchers who perform human testing intended for submission to FDA.
None of those requirements, however, apply to third-party research that
is intended for submission to EPA.

3(b)	Public Notice Required Prior to ICR submission to OMB

 Pursuant to 5 CFR 1320.8(d), in preparing to renew this ICR, EPA
published a notice in the Federal Register which provided a 60-day
public notice and comment period on the draft ICR (see 73 FR 33811; June
13, 2008).  The FR notice and the proposed renewal ICR as well as the
public comments received are located in the docket for this action,
which can be accessed at   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov  using the docket identifier
EPA-HQ-OPP-2008-0414.

The Agency received two public comments on this renewal ICR, from the
Agricultural Handler Exposure Task Force (AHETF) and Antimicrobial
Exposure Assessment Task Force II (AEATF).  These task forces also
responded to questions from the Agency, as two of five participants in
the consultation process with respondents to this ICR (see section 3(c),
below).  Both task forces’ comments and consultation responses focused
primarily on the burdens and costs associated with the human subjects
research requirements at 40 CFR part 26 and the input they provided in
their public comments was essentially the same as that included in the
consultation responses. In particular, both task forces commented that
the actual burden and costs associated with complying with the rule
substantially exceed the estimates contained in the proposed ICR.
Copies of the comments may be accessed at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  using the
docket identifier EPA-HQ-OPP-2008-0414.

Based on the comments received, as well as the consultation responses
and EPA’s experience since the enactment of 40 CFR part 26, the Agency
acknowledges that the burden and cost estimates in the original ICR are
lower than actual costs.  Therefore, this renewal ICR contains revised
burden and cost estimates that are drawn from the five consultation
responses and the public comments.  For an explanation of the
methodology, data, and assumptions used to calculate the revised
estimated respondent burdens and costs (see Attachment G).

3(c)	Consultations

		During preparation of this ICR renewal, EPA staff contacted the
following respondent representatives to seek feedback on the burden
estimates in the ICR and the clarity of guidance provided.

David Johnson

Agricultural Handlers Exposure Task Force

1720 Prospect Drive, Macon, MO 63552

E-mail<EMAIL_ADDRESS>
Tel. No.:<PHONE_NUMBER>

	Scott Carroll

Carroll-Loye Biological Research

711 Oak Avenue, Davis, CA 95616

E-mail<EMAIL_ADDRESS>
Tel. No.:<PHONE_NUMBER>

Hasmukh Shah

Antimicrobial Exposure Assessment Task Force II;

1300 Wilson Boulevard, Arlington, VA 22209

E-mail<EMAIL_ADDRESS>
Tel. No.:<PHONE_NUMBER>

Robin Todd

ICR, Inc.

1330 Dillon Heights Avenue, Baltimore, MD 21228

E-mail<EMAIL_ADDRESS>
Tel. No.:<PHONE_NUMBER>

Joel Panara

Grayson Research LLC

1040 Grayson Farm Rd, Creedmoor, NC , 27522

E-mail<EMAIL_ADDRESS>
Tel. No.:<PHONE_NUMBER>

Full copies of the respondents’ responses to EPA’s consultation
efforts are contained in Attachment D, which may be accessed at
HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
using the docket identifier EPA-HQ-OPP-2008-0414.

		All five of the parties consulted agreed that the respondent burden
and cost estimates included in the proposed ICR renewal were
considerably lower than the actual paperwork burden and costs associated
with complying with the rule.  As stated above, in section 3(b), this
renewal ICR contains revised burden and cost estimates that are drawn
from the five consultation responses and the public comments.  For an
explanation of the methodology, data, and assumptions used to calculate
the revised estimated respondent burdens and costs (see Attachment G).
Additionally, the parties consulted stated that the data collected is
not available from another source and the frequency of collection could
not be reduced and still produce the same outcome.  The consultation
participants explained that the instructions to respondents on what to
submit and how to submit it are not entirely clear.  Some consulted said
that the Agency’s draft guidance has helped, but that once the
procedure is fully refined EPA should provide final guidance.  The
Agency is considering the need to issue further guidance.

3(d)	Effects of Less Frequent Collection

  SEQ CHAPTER \h \r 1 	Not applicable.  This is an event-driven
information collection activity and is conducted only as information is
submitted to EPA for consideration.  As such there is no set collection
frequency for the collection of this information.

3(e)	General Guidelines

		  SEQ CHAPTER \h \r 1 The only guideline established under the
Paperwork Reduction Act (PRA) that may be exceeded in this collection is
the time period for retaining records.  EPA’s requirement at 40 CFR
169.2(k) states that records containing research data relating to
registered pesticides be retained for as long as the registration is
valid and the producer remains in business.  Registrations are valid
until they are either voluntarily canceled or withdrawn by the
registrant or until EPA has cause to suspend or cancel the registration.
 Since the average period of marketability of a pesticide ranges from 15
to 30 years, the PRA guidelines specifying that data other than health,
medical or tax records not be required to be retained for more than
three years will be exceeded in this collection activity.  This is an
existing requirement that was not changed by the final rule.  In any
case, EPA asserts that recordkeeping requirement merely codifies the
usual and customary business practices of IRBs and third-party
researchers; therefore no burden is attributed to the activity.

  SEQ CHAPTER \h \r 1 OMB regulations require agencies to provide a
statement indicating whether the collection of information involves the
use of automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses, and an explanation of the
decision (5 CFR

1320.5(a)(iii)(E)).  EPA is not   SEQ CHAPTER \h \r 1 offering a fully
electronic submission option at this time.  EPA is developing an
internet portal that would adequately secure any confidential and/or
sensitive information submitted electronically; however, EPA is not yet
ready to accept such information in this way.

		Respondents that submit study protocols and/or reports to EPA may
elect to submit certain information  SEQ CHAPTER \h \r 1
“electronically” via compact disc.  Ordinarily, registrants would be
required to submit 3 paper copies of study data to EPA.  Under this
hybrid option, registrants need only submit 2 paper copies if they
submit the required study data in Adobe Acrobat Portable Document Format
(PDF) on a compact disc.  Once EPA staff have become familiar with the
electronic submission process and the technology, OPP believes that this
option will allow the Agency to achieve operating efficiencies in the
regulation of pesticides through the promotion and facilitation of the
electronic submission process, including the delivery, review, data
interchange capability and archiving of data supporting national
pesticide registration.    SEQ CHAPTER \h \r 1 OPP expects that
registrants will spend less time and money preparing copies and sending
their submissions using the hybrid paper-electronic submission option,
and stand to benefit from the efficiencies that EPA expects to
experience during data reviews.

3(f)		Confidentiality

		  SEQ CHAPTER \h \r 1 EPA has implemented procedures to protect any
confidential, trade secret or proprietary information from disclosure
that provide strict instructions regarding access to and contact with
documents confidential business information (CBI).  These procedures
comply with EPA’s CBI regulations at 40 CFR Part 2, Subpart B.

3(g)	Sensitive Questions

This information collection activity complies with the provisions of the
Privacy Act of 1974 and OMB Circular A-108.  No information of a
sensitive or private nature is requested in conjunction with this
information collection activity.  The protection of human research
subjects’ privacy is a basic, long-standing principle within the
scientific community.  Reports of human research submitted to federal
agencies should not identify subjects by name, or include recognizable
photographs, or otherwise identify them.  On the rare occasion that the
Agency receives identifying information, such information will be
treated as confidential and not released to third parties unless
required by law.

4. 		THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents/NAICS Codes

		This collection of information applies to any entity that submits
protocols and study reports for environmental research involving human
subjects under FIFRA and/or FFDCA. Although EPA has only received such
third-party research in conjunction with FIFRA from pesticide
registrants, it is conceivable that other entities could submit such
information to EPA under FIFRA and/or FFDCA in the future.    SEQ
CHAPTER \h \r 1 The North American Industrial Classification System
(NAICS) code for the principal respondents to this ICR is 541710
(Research and Development in the Physical, Engineering, Life Sciences).

		4(b)	Information Requested

Data items, including record keeping requirements

		The final rule sets forth those additional information activities that
are necessary to ensure the protection of human subjects of research
when such research is submitted to EPA for consideration under FIFRA
and/or FFDCA.

Respondent Activities

	The following information activities are required:

Rule Familiarization and Training - read, and understand what data are
to be submitted and understand the protocols must be developed to comply
with the Common Rule.

Submit Protocol to an IRB and EPA – Prepare and submit a proposal for
test protocol to IRB for review.  After approval by the IRB, submit the
proposal and related documentation, including a record of the IRB
approval, to EPA.

Prepare and Submit Ethics Information for EPA Review - once a study is
conducted, compile applicable records to document ethical conduct of the
research.

Store, File and Maintain Information – ensure that research
information is placed in central records as required by FIFRA and
consistent with section 3(e) of this ICR.

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

5(a)	Agency Activities

		EPA’s information-related activities associated with this collection
consist of the following:

Conduct Prior review on study protocol – review and comment on study
protocol, document comments/review.

Review Ethical Aspect of a Protocol and Study Report – make formal EPA
determination on usefulness and ethical aspects of the study.

Record and Report Information – Document any formal decisions made.

Store, File and Maintain Information – compile information into
appropriate databases and archive.

5(b)	Collection Methodology and Management

  SEQ CHAPTER \h \r 1 	OPP completed a major review of its information
tracking systems to improve their efficiency and accuracy. This review
resulted in the development of a new integrated information system,
which, when complete, will improve the quality of the Agency's databases
and allows the EPA to respond more timely and accurately to queries from
registrants and the public, including requests made under the FOIA.

	OPP is also investigating the possibility of providing optional
electronic data transfer services to the industry as a means of
minimizing the burden of registration activities. The Agency's pesticide
program, along with the pesticide industry, recognizes the advantages in
terms of accuracy, speed, cost and personnel from electronic data
transfer technologies. In addition, OPP is consulting with industry
associations and other federal agencies, and participating in an
Agency-wide workgroup to develop electronic reporting standards intended
to facilitate collection of information from industry.

		OPP does not publish the studies submitted.  However, it maintains
records of each study in the Office of Pesticide Programs Information
Network (OPPIN), and provides public access to OPPIN bibliographies
through the National Pesticides Information Retrieval System (NPIRS).
NPIRS supports searches of the PDMS database by chemical, subject,
submission date, laboratory, guideline number, and document type, and
the public may request copies of studies that are non-confidential by
submitting a FOIA request.

5(c)	Small Entity Flexibility

Although the Agency cannot predict whether or how many small entities
might engage in the subject matter research, the burden and related cost
for researchers to comply with these information collection activities
is estimated to be a comparatively small portion of the overall cost of
performing such studies.  After reviewing the history of EPA’s
consideration on human research in its various program offices, EPA
estimates that only a limited number of third-party human studies will
be impacted by these activities each year.  Because both the number of
affected studies is relatively small and the estimated current costs of
compliance with the Common Rule are low, the potential overall burden
and costs from these activities to third parties are also estimated to
be small, regardless of their size.  As a result, EPA has not provided
any special flexibility for small entities.

5(d)	Collection Schedule

		A   SEQ CHAPTER \h \r 1 periodic collection schedule is not
appropriate for the information collection activity.  The information
collection activity is initiated by the respondents and therefore EPA
expects that respondents will engage in the activities described in this
ICR only once, whenever developing and performing a given research study
that involves human subjects as governed by EPA’s regulations.

6. 		ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a)	Estimating Respondent Burden

		EPA is estimating only the incremental burden imposed upon respondents
for compliance with the paperwork requirements established in the final
rule.  EPA is neither estimating, de novo, the estimated paperwork
burden for compliance with the 1991 Common Rule in this ICR nor the
paperwork burden associated with the generation of certain study data
that is already covered by other ICRs, such as those requested by EPA in
a Data Call-In under FIFRA section 3(c)(2)(B).  EPA does assume that
IRBs are already in compliance with the 1991 Common Rule requirements
and therefore believes that there is no additional burden imposed upon
IRBs for compliance with the paperwork requirements established in the
final rule and discussed in this document.

		Based upon responses received to the Agency’s consultation
questions, as well as historical data, EPA anticipates that respondents
will submit to OPP an average of 34 pesticide research studies per year
under FIFRA and/or FFDCA that will involve intentional exposure of human
subjects.  EPA also expects to receive other types of pesticide research
involving human subjects; an average of 20 studies annually.  While EPA
assumes that researchers conducting these studies would already be
required to comply with the 1991 Common Rule requirements, they will be
subject to some additional paperwork requirements under EPA’s
amendments.  Therefore, EPA is estimating only the burden and costs
associated with the paperwork activities that are described in the final
rule.

		Respondent activities that are within the scope of this ICR include:
preparing and submitting protocols, supporting documents, and completed
study reports for IRB, EPA, and HSRB review; communicating with IRB and
EPA staff regarding required changes to a protocol; communicating with
EPA about HSRB recommendations; and documenting protocol changes made at
the recommendation of an IRB, EPA, or the HSRB.  Activities which are
unrelated to the paperwork and recordkeeping requirements of the final
rule, such as the costs of conducting the research, are not incremental
paperwork or recordkeeping costs and therefore are not within the scope
of this ICR.

	The consultation responses indicated that EPA’s previous estimates
significantly underestimated the actual burden and costs.  Thus, to
calculate new burden and cost estimates for this renewal ICR, EPA relied
upon the figures provided in the five consultation responses.  Two of
the five participants in the consultation process were also the two
parties that submitted comments during the public comment period; the
input they provided in their public comments was essentially the same as
that included in the consultation responses.  EPA calculated a weighted
average of the estimates contained in each of the responses, to account
for the fact that some study types are more complex than others.  See
Attachment G for an explanation of the methodology, data, and
assumptions used to calculate the revised estimated respondent burdens
and costs used in this ICR renewal.

As shown in Tables 1 and 2, the total annual estimated burden associated
with this information collection activity is 20,332 hours for all
submitted pesticide research that involves intentional exposure of human
subjects, and 240 hours for all other pesticide research that involves
human subjects.  Therefore the total annual burden for this information
collection activity is estimated to be 20,572 hours.

Table 1. Respondent Burden and Cost Estimates – Research Involving
Intentional Exposure of Human Subjects

Activities	Average Burden Hours Per Response	Total Per Response

	Management

$138	Technical

$73	Clerical

$42	Hours	Cost ($)

Rule familiarization and training	2	4	2	8	652

Prepare and submit protocol for IRB review	31	83	33	147	11,723

Prepare and submit protocol for EPA and HSRB review	25	181	37	243	18,217

Document ethical conduct of a completed study for which EPA and the HSRB
have reviewed the protocol	19	113	21	153	11,753

Document ethical conduct of a pre-rule study for which EPA and the HSRB
have not reviewed the protocol	5	16	8	29	2,194

Store, file, and maintain records	4	8	6	18	1,388

Total per response	86	405	107	598	45,927

Annual Burden:	598 hours per protocol or completed study * 34 protocols
or 				completed studies per year = 20,332 hours

Annual Costs:		$45,927 per study * 34 protocols or completed studies per
year = 				$1,561,518

Table 2. Respondent Burden and Cost Estimates – All Other Submitted
Research with Human Subjects

Activities	Average Burden Hours Per Response	Total Per Response

	Management

$138	Technical

$73	Clerical

$42	Hours	Cost ($)

Rule familiarization and training	1	1	0	2	211

Prepare and Submit Ethics Information of Completed Human Studies to EPA
0	8	1	9	626

Store, file, and maintain records	0	0	1	1	42

Total per response	1	9	2	12	879

Annual Burden:	12 hours per study * 20 studies submitted per year = 240
hours

Annual Costs:		$879 per study * 20 studies submitted per year = $17,580

6(b)	Estimating Respondent Costs

The estimated annual cost for all respondents is $1,579,098.  Respondent
labor rates are estimated to be $138, $73, and $42 per hour,
respectively, for managerial, technical and clerical labor.  These labor
rates were derived from the Bureau of Labor Statistics’ May 2007
National Industry-Specific Occupational Employment and Wage Estimates
for NAICS code 541710 (Research and Development in the Physical,
Engineering, and Life Sciences).  These labor rates are fully loaded and
include benefits and overhead costs, using a methodology developed by
OPP’s Biological and Economic Analysis Division (see Attachment E).

6(c)	Estimating Agency Burden and Cost

The estimated Agency annual cost is $636,060.  EPA activities include:
communicating with respondents, reviewing the ethical aspects of
submitted study protocols and completed study reports, making
presentations to the HSRB, documenting decisions, and information
management activities to record, file, and track the submissions.    SEQ
CHAPTER \h \r 1 Agency labor rates are $103, $71, and $41 per hour for
management, technical, and clerical staff, respectively.  These labor
rates were derived from the Bureau of Labor Statistics’ May 2007
National Industry-Specific Occupational Employment and Wage Estimates
for NAICS code 999100 (Federal Executive Branch).  These labor rates are
fully loaded and include benefits and overhead costs, using a
methodology developed by OPP’s Biological and Economic Analysis
Division (see Attachment E).

 The details of the calculations are identified in Tables 3 and 4.

Table 3. Agency Burden & Cost Estimates – Review of Research Involving
Intentional Exposure of Human Subjects

Activities	Average Burden Hours Per Response	Total Per Response

	Management

$103	Technical

$71	Clerical

$41	Hours	Cost ($)

Rule familiarization and training	2	2	0	4	348

Primary Review of Scientific and Ethical Aspects of a Protocol	1	113	0
114	8,126

Primary Review of Ethical Aspects of a Completed Study Report	1	57	0	58
4,150

Secondary Review of Scientific and Ethical Aspects of a Protocol or
Review of Ethical Aspects of a Completed Study

4,144*

Store, file, and maintain records	0	0	2	2	82

Total per protocol or completed study	4	172	2	178	16,850

Cost of HSRB members working on the HSRB report (collectively spending
240 hours per HSRB report in FY 2008, compensated at the rate of
$53/hour), plus the cost of EPA Office of the Science Advisor technical
staff working on the HSRB report (171 hours per report, at the technical
staff rate of $71/hour).  Each HSRB report covers an average of 6
protocols and/or completed studies per report.

240 hours/HSRB Members/report * $53/hour = $12,720/report

171 hours/OSA Staff/report*$71/hour = $12,141/report

Total Cost for HSRB Member and OSA Staff Review Time Per Report =
$12,720 + $12,141 = $24,861

If 1 report = 6 protocols

Total Cost for HSRB Member and OSA Staff Review Time Per Protocol =
$24,861/6 = $4,144/protocol

Annual Burden:  	178 hours per study or protocol * 34 protocols or
completed studies = 6,052 hours

Annual Costs:		16,850 * 34 protocols or completed studies = $572,900

Table 4. Agency Burden & Cost Estimates – Review of All Other
Submitted Research with Human Subjects

Activities 	Average Burden Hours Per Study	Total Per Study

	Mgmt. $103/hr 	Tech. $71/hr 	Cler. $41/hr 	Hours 	Cost ($)

Rule Familiarization And Training 	1 	1 	0 	2 	174

Primary Review Ethical Aspects of a Completed Study Report 	1 	40 	0 	41
	2,943

Store, File and Maintain Information 	0 	0 	1 	1 	41

Total per study	2 	41 	1 	44 	$3,158

	Annual Burden:	44 hours/study * 20 studies = 880 hours

	Annual Costs:		$3,158/study * 20 studies = $63,160

6(d)	Bottom Line Burden Hours and Cost Tables

		  SEQ CHAPTER \h \r 1 The total estimate represents the information
collection activities expected to occur annually over the next three
years.  Table 5 provides the total estimated annual burden and costs for
respondents, as well as the total estimated annual burden and costs for
the Agency:

Table 5.  Total   SEQ CHAPTER \h \r 1 Annual Bottom Line Burden and
Costs / Master Table

Collection Activity	Annual Burden Hours	Annual Costs

Annual Respondent Burden and Costs

Research Involving Intentional Exposure of Human Subjects (Table 1)
20,332	$1,561,518

All Other Submitted Research with Human Subjects (Table 2)	240	$17,580

Respondent Total	20,572	$1,579,098

Annual Agency Burden

Research Involving Intentional Exposure of Human Subjects (Table 3)
6,052	$572,900

All Other Submitted Research with Human Subjects (Table 4)	880	$63,160

Agency Total	6,932	$636,060

6(e)	Reasons for Change in Burden

		The estimated burden to respondents has increased, based on input
received during the consultation process from entities that have
submitted human subjects research since the implementation of the rule.
The burden estimates in the previous ICR were developed before the rule
was implemented, and were based on EPA’s predictions of how long it
would take study sponsors to prepare submissions.  Based on the
information provided in the consultation responses, it appears that the
actual amount of time necessary to comply with the paperwork and
recordkeeping requirements is higher than originally estimated.

		The estimated Agency burden has decreased due to the fact that the
actual cost of operating the HSRB has proven to be lower than the cost
that was estimated in the original ICR.  The estimates for this renewal
ICR are based on actual costs of operating the HSRB during Fiscal Year
2008.

6(f)		Burden Statement

The total estimated annual paperwork burden to comply with this
information collection activity is 20,572  SEQ CHAPTER \h \r 1  hours.
The average burden is estimated to be 598 hours per response for
research involving intentional exposure of human subjects, and 12 hours
per response for all other submitted research with human subjects.

According to the Paperwork Reduction Act, “burden” means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, disclose, or provide information to or for a Federal
agency.  The 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 number for this
information collection appears at the beginning and end of this
document. In addition OMB control numbers for EPA’s regulations, after
initial display in the final rule, are listed in 40 CFR Part 9 (see
Attachment F).

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2008-0414, which is available for online viewing at
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA.
This docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.  The docket telephone number is (703)
305-5805.  You may submit comments regarding 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.

Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2008-0414 and
OMB Control No. 2070-0169, to (1) EPA online using www.regulations.gov
(our preferred method), or by mail to: Public Information and Records
Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs
(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.

ATTACHMENTS TO THE SUPPORTING STATEMENT:

Attachments to the supporting statement are available in the public
docket established for this ICR under docket identification number
EPA-HQ-OPP-2008-0414.  These attachments are available for online
viewing at   HYPERLINK "http://www.regulations.gov_"
www.regulations.gov  or otherwise accessed as described in section 6(f)
of the supporting statement.

Attachment A:	FIFRA Sections 3(c)(5), 3(g), 4(g)(2), and 25

Attachment B:	FFDCA Sections 408(b)(2)(A)(ii) and 408(e)(1)(C)

Attachment C:	Final Rule; Protections for Test Subjects in Human
Research

Attachment D:	Record of EPA Consultations With Respondents Regarding the
ICR Renewal

Attachment E:	Wage Rate Tables for Pesticide Registrants and EPA

Attachment F:	Display Related to OMB Control #2070-0169 -Listings of
Related Regulations in 40 CFR 9.1

Attachment G:	Memorandum on Calculation of Burden and Cost, from Kelly
Sherman to File, September 2, 2008.

 Defined at FIFRA section 2(bb) as “. . . (1) any unreasonable risk to
man or the environment, taking into account the economic, social, and
environmental costs and benefits of the use of any pesticide, or (2) a
human dietary risk from residues that result from a use of a pesticide
in or on any food inconsistent with the standard under section 408 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) . . . .”

 Bureau of Labor Statistics.  “May 2007 National Industry-Specific
Occupational Employment and Wage Estimates: 541710 – Research and
Development in the Physical, Engineering, and Life Sciences.” Accessed
at   HYPERLINK "http://www.bls.gov/oes/current/naics5_541710.htm"
http://www.bls.gov/oes/current/naics5_541710.htm .

 Bureau of Labor Statistics.  “May 2007 National Industry-Specific
Occupational Employment and Wage Estimates: NAICS 999100 – Federal
Executive Branch.” Accessed at   HYPERLINK
"http://www.bls.gov/oes/current/naics4_999100.htm"
http://www.bls.gov/oes/current/naics4_999100.htm .

November 18, 2008

Page   PAGE  12  of   NUMPAGES  15


[Federal Register Volume 77, Number 131 (Monday, July 9, 2012)]
[Notices]
[Pages 40394-40396]
[FR Doc No: 2012-16625]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67333; File No. SR-OCC-2012-07]

Self-Regulatory Organizations; The Options Clearing Corporation;
Order Approving Proposed Rule Change Relating to Adjustment Panel
Voting

July 2, 2012.

I. Introduction

    On May 7, 2012, The Options Clearing Corporation (``OCC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change SR-OCC-2012-07 pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder.\2\ The proposed rule change was published for comment in
the Federal Register on May 24, 2012.\3\ The Commission received no
comment letters on the proposal. This order approves the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 67021 (May 18, 2012), 77
FR 31060 (May 24, 2012).
---------------------------------------------------------------------------

II. Description

    OCC is updating the procedures applied to adjustment panel voting
and eliminating the requirement that an adjustment panel be convened to
vote on certain specific types of standard

contract adjustments affecting equity options. These changes are
intended to improve overall operational efficiency in responding to
events for which a contract adjustment may be made.
    Certain panels may be convened under OCC's by-laws to (i) determine
contract adjustments to the terms of outstanding options when certain
events occur (e.g., stock distribution, stock dividend, merger,
consolidation or reorganization) and (ii) fix certain amounts or values
in respect of certain options in the event a required value is
unreported, inaccurate, unreliable, unavailable, or inappropriate. Such
panels are convened in accordance with Article VI, Section 11 of OCC's
by-laws and currently consist of two representatives of each options
exchange on which options affected by the event are traded and one
representative of OCC, who votes only in case of a tie. The decision to
adjust (and the nature of the adjustment to be made) or to fix an
amount or value is made by majority vote of the adjustment panel. Most
often, panels are convened to determine adjustments to the terms of
outstanding equity options in response to certain corporate events.
    The procedures for panel voting, as described in Article VI,
Section 11, have not been updated for over 25 years. In the past, a
smaller number of OCC options exchanges posed few problems in convening
panels to consider adjustments for equity options. Currently, however,
there are ten options exchanges and multiple listing of equity options
on several, if not all, exchanges is common. It is increasingly
difficult to convene two members from each exchange to consider
adjustments on a timely basis. This difficulty is magnified when it is
necessary to convene panel meetings to address late-breaking events
which often occur outside of normal business hours. Additionally,
although all equity option adjustments must currently be addressed by
an adjustment panel, certain corporate events and their corresponding
option adjustments are so regular and predictable that it no longer
appears necessary for an adjustment panel to be convened to address
them.
    The OCC Securities Committee has unanimously endorsed the proposed
changes and OCC's Board of Directors and stockholders have authorized
OCC to submit the proposed rule change. OCC is continuing to evaluate
the rules applicable to adjustment determinations and additional
changes may be proposed in the future.

Proposed By-Law Changes

    OCC is making several changes to the voting procedures for the
Securities Committee and adjustment panels. OCC believes the changes
will provide significant operational efficiencies, allowing OCC and the
option exchanges to respond more quickly to corporate events affecting
listed options. The changes to the procedures governing adjustment
panel voting (1) change the requirement that each exchange be
represented by two persons to one person,\4\ (2) allow that adjustment
panel actions be determined by votes accomplished by such means as the
Securities Committee may designate for that purpose, (3) provide that
certain kinds of corporate events shall not require an adjustment panel
vote, (4) define a quorum for adjustment panels and provide for
majority vote,\5\ and (5) allow the Chairman of OCC to designate a non-
officer as his representative on adjustment panels.\6\
---------------------------------------------------------------------------

    \4\ Panels convened by OCC to fix a required amount or value (as
provided for in the by-laws) would continue to include two
representatives from each exchange on which the affected series is
open for trading. (Such panels also include an OCC representative,
who votes only in case of a tie.) OCC believes it appropriate to
retain this requirement as the need to fix such amount or value
generally would involve series that are less likely to be traded on
multiple exchanges. However, certain of the procedural changes being
made to Article VI, Section 11 will be applied to the by-laws that
permit panels to be convened to fix a required amount or value in
order to improve efficiency. These changes include eliminating the
requirement that at least one panel member from an exchange be a
member of the Securities Committee and allowing such panels to
transact its business by such means as determined by the Securities
Committee.
    \5\ The intent is to ensure that any adjustment decision is
determined by a majority of the exchanges (including a
representative of OCC if a voting member) that trade the affected
option. For example, if eight exchanges trade an option, five
exchanges would constitute a quorum for an adjustment panel.
However, a majority vote of these five exchanges would require only
three exchanges. In this case an adjustment decision would be
determined by a distinct minority of the exchanges trading the
option. Specifying an additional requirement that the action be
determined by a majority of the exchanges trading the option
provides for an additional level of assurance that a majority of
eligible voting members will determine an adjustment.
    \6\ Currently, the Chairman is allowed to designate an OCC
officer as his representative. OCC believes the Chairman should be
able to designate a non-officer as his representative.
---------------------------------------------------------------------------

    The specific corporate events which would no longer require a panel
vote to effect an adjustment to the terms of an option would be limited
to stock splits or stock distributions where additional shares of the
underlying security are issued, reverse splits, and cash mergers or
similar events where all shares are exchanged exclusively for cash.
Adjustments for stock splits, stock distributions, and reverse splits
are generally the most routine option adjustments executed by OCC.
Option adjustments for these events, when executed, are the result of
well understood formulae and consistent precedent. The Securities
Committee does not believe it is necessary to convene adjustment panels
for ``boiler plate'' adjustments of this kind. In like manner, mergers
and other events where the affected security is exchanged exclusively
for cash have always occasioned option adjustments which have called
for the delivery of cash. The Securities Committee does not believe it
necessary to convene panel meetings to authorize these adjustments.
    While an adjustment panel vote would not be required in these
cases, an adjustment panel could be convened at any time at the request
of any exchange or OCC in order to address any aspect of the corporate
event or option contract adjustment deemed to need discussion by such
panel. Also, in all cases of option adjustments, OCC and the exchanges
would naturally coordinate the operational execution of the adjustments
(effective date, option symbol, strike prices, etc).
    The changes also allow convened panels the ability to conduct their
business by any means determined by the Securities Committee.
Currently, the Securities Committee and panels are allowed to conduct
business in person or by phone. For the purposes of exchanging
information and registering votes, OCC and the Securities Committee
believe that electronic means of communication (e.g., email) should
also be allowed as well as other means of communication which may be
available in the future (e.g., OCC systems applications developed for
this purpose).

III. Discussion

    Section 19(b)(2)(B) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\7\ Section 17A(b)(3)(F) of the Act requires that a
clearing agency, among other things, have the capacity to facilitate
the prompt and accurate clearance and settlement of securities
transactions for which it is responsible.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(2)(B).
    \8\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The Commission finds that the proposed change is consistent with
the purposes and requirements of Section

17A of the Act \9\ and the rules and regulations thereunder applicable
to OCC. In particular, the Commission believes that the proposed change
provides for more efficient procedures that further the purposes of the
Act by facilitating the prompt and accurate clearance and settlement of
securities transactions for which OCC is responsible.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \10\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\11\ that the proposed rule change (File No. SR-OCC-2012-07) be,
and hereby is, approved.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).
    \12\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin O'Neill,
Deputy Secretary.
[FR Doc. 2012-16625 Filed 7-6-12; 8:45 am]
BILLING CODE 8011-01-P


SF83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY Standards of Performance for New Stationary Sources; Rubber Tire Manufacturing, Subpart BBB 1. Identification of the Information Collection 1( a) Title of the Information Collection Standards of Performance for New Stationary Sources; Rubber Tire Manufacturing, Subpart BBB.

1( b) Short Characterization/ Abstract The New Source Performance Standards ( NSPS) for rubber tire manufacturing plants were proposed on January 20, 1983, and promulgated on September 15, 1987. Minor revisions to the standards of performance for the rubber tire manufacturing industry were proposed on February 14, 1989 and promulgated on September 19, 1989. These standards apply undertread cementing operations, sidewall cementing operations, tread end cementing operations, bead cementing operations, green tire spraying operations, Michelin A operations, Michelin B operations, and Michelin C automatic operations, commencing construction, modification or reconstruction after January 20, 1993. This information is being collected to assure compliance with 40 CFR Part 60, Subpart BBB.

In general, all NSPS standards require initial notifications, performance tests, and periodic reports. Owners or operators are also required to maintain records of the occurrence and duration of any start up, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. Monitoring requirements specific to rubber tire manufacturing plants provide information on the operation of the emissions control device and compliance with the VOCs standards. Semiannual reports of excess emissions are required. These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to NSPS. Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least two years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated State or Local authority. In the event that there is no such delegated authority, the reports are sent directly to the EPA Regional Office.

Approximately 43 rubber tire manufacturing plants are currently subject to the standard. It is estimated that there will be no industry growth over the next three years. Although some plants may conduct operational changes, these changes will not trigger applicability of this rule. We are also assuming that all plants are now using the water based sprays that meet the NSPS green tire spray limits without having to use add on control equipment. These estimates are based on the consultation with the EPA Office of Air Quality and Standards. The assumptions used for the burden estimate in this ICR are substantially different from the previous one due to better information EPA has acquired regarding the number of sources subject to the rule and the lack of 2 industry growth ( i. e., no new sources). The cost of this ICR for industry will be $ 727,797 dollars ( rounded).

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 111 of the Clean Air Act, as amended, to establish standards of performance for new stationary sources that reflect:

" Application of the best technological system of continuous emissions reduction which ( taking into consideration the cost of achieving such emissions reduction, or any non air quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated [ Section 111( a)( l)]."

The Agency refers to this charge as selecting the best demonstrated technology ( BDT). Section 111 also requires that the Administrator review and, if appropriate, revise such standards every four years.

In addition, Section 114( a) states that:

. . . the Administrator may require any owner or operator subject to any requirement of this Act to ( A) establish and maintain such records, ( B) make such reports, ( C) install, use, and maintain such monitoring equipment or methods ( in accordance with such methods at such locations, at such intervals, and in such manner as the Administrator shall prescribe, and ( D) sample such emissions, ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical, ( F) submit compliance certifications, and ( G) provide such other information as he may reasonably require.

In the Administrator's judgment, VOC emissions from rubber tire manufacturing plants cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, this NSPS was promulgated for this source category at 40 CFR Part 60, Subpart BBB ( the rule).

2( b) Practical Utility/ Users of the Data The control of emissions of VOCs from rubber tire manufacturing plants requires not only the installation of properly designed control devices, but also continuing operation and maintenance ( O& M) of the emission measurement equipment. VOCs from rubber tire manufacturing plants are emitted from the following affected facilities: undertread cementing operations, sidewall cementing operations, tread end cementing operations, bead cementing operations, green tire spraying operations, Michelin A operations, Michelin B operations, and 3 Michelin C automatic operations. The reduction of VOC emissions is accomplished by employing thermal incinerators, and catalytic incinerators, carbon absorbers and/ or other recovery devices.

The required notifications in the rule are used to inform the Agency or delegated authority when a source becomes subject to the standard. The reviewing authority may then inspect the source to check if the standard is being met. Performance test reports are needed to document for the Agency that a source is capable of complying with the emission standard, and under what operating conditions was compliance achieved. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the NSPS continue to operate the control equipment used to achieve compliance with the NSPS. Adequate monitoring, recordkeeping, and reporting is necessary to ensure compliance with these standards, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The recordkeeping and reporting requested is required under 40 CFR Part 60, Subpart BBB.

3( a) Nonduplication If the standard has not been delegated, the information is sent to the appropriate EPA Regional Office. Otherwise, the information is sent directly to the delegated State or Local Agency. If a State or Local Agency has adopted their own similar regulation to implement the Federal Regulation, a copy of the report submitted to the State or Local Agency can be sent to the Administrator in lieu of the report required by the Federal Standard. Therefore, no duplication exists.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on February 1, 2001,( 66FR8588). No comments were received on the burden published in the Federal Register.

3( c) Consultations No comments were received on the industry burden published in the Federal Register. The estimated number of sources and the assumptions regarding industry growth were based on consultations with the Regulatory Affairs Division of the Rubber Manufacturers Association. 4 3( d) Effects of Less Frequent Collection Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the required standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB in 5 CFR 1320.5.

3( f) Confidentiality The required information consists of emissions data and other information that have been determined not to be private. However, any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents of the recordkeeping and reporting requirements are rubber tire manufacturing plants that commenced construction, modification, or reconstruction after January 20, 1983. The SIC code for the respondents affected by the standards is SIC ( U. S. Standard Industrial Classification) 3011 which corresponds to the NAICS ( The North American Industry Classification System) 326211 for Tire Manufacturing ( except Retreading).

4( b) Information Requested ( i) Data Items All data in this ICR that is recorded and/ or reported is required by 40 CFR Part 60, Subpart BBB. 5 A source must make the following reports:

Reports for NSPS, Subpart BBB Notification of construction/ reconstruction 60.7( a)( 1)

Notification of anticipated start up 60.7( a)( 2)

Notification of actual start up. 60.7( a)( 3)

Initial performance test results. 60.8 ( a)

Initial compliance report that includes initial performance test, monthly schedule to be used in making compliance determinations, design and equipment specifications and compliance method. 60.8( d), 60.8 ( a), 60.546 ( a) through ( e)

Demonstration of continuous monitoring system. 60.7( a)( 5)

Physical or operational change. 60.7( a)( 4)

Periodic start up, shutdown, malfunction reports, and periods where the continuous monitoring system is inoperative. 60.7( b)

Seeking to comply with an alternative method, from use of applicable percent emission reduction requirement to applicable total ( uncontrolled) monthly VOC use limit. 60.546 ( h)

Initial and annual formulation data or Method 24 results to verify VOC content of water based sprays. 60.456 ( j)

Excess emissions report. 60.546 ( f) and ( g)

A source must maintain the following records:

Recordkeeping for NSPS, Subpart BBB Startups, shutdowns, malfunctions, periods where the continuous monitoring system is inoperative. 60.7( b)

Maintain a file of all measurements including, performance test measurements, and all other information required by this part recorded in a permanent file suitable for inspection. The file shall be retained for at least two years. 60.7( f)

Maintain records of operating parameters of monitoring device results for catalytic or thermal incinerator, or carbon absorber. 60.545 ( a), ( b) and ( c) 6 Recordkeeping for NSPS, Subpart BBB Maintain records of monthly VOCs use, number of days in compliance period, and other information needed to verify results of all monthly tests. 60.545( d) and ( e)

Maintain records of formulation data or results of Method 24 analysis of water based sprays containing less than 1.0 percent of VOC. 60.545( f)

( ii.) Respondent Activities Respondent Activities Read instructions.

Install, calibrate, maintain, and operate a temperature monitoring device with a continuous recorder, an organics monitoring device with a continuous recorder to detect the concentration level of organic compounds, or a recovery device, as applicable.

Perform initial performance test, Reference Method 24 test and Method 25A, and repeat performance test if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of 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.

Transmit, or otherwise disclose the information. 7 5. The Information Collected  Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Aerometric Information Retrieval System ( AIRS) Facility Subsystem ( AFS) database.

5( b) Collection Methodology and Management Performance test reports are used by the Agency to discern a source's initial capability to comply with the emission standard, and note the operating conditions specified above under which compliance was achieved. Data obtained during periodic visits by Agency personnel from records maintained by the respondents are tabulated and published for internal Agency use in compliance and enforcement activities. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

After reviewing the various reports submitted by industry, the Agency enters the results of the reviews into the Aerometric Information Retrieval System ( AIRS) Facility Subsystem ( AFS) which is operated and maintained by EPA's Office of Air Quality Planning and Standards. The AFS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for over 100,000 industrial and government owned facilities. EPA uses AFS for tracking air pollution compliance and enforcement by local and State regulatory agencies, and EPA Regional Offices and Headquarters. EPA can edit, store, retrieve and analyze the data via PC terminals.

The records required by this NSPS must be retained by the owner or operator for two years. 8 5( c) Small Entity Flexibility A majority of the affected facilities are large entities ( e. g., large businesses). However, the impact on small entities was taken into consideration during the development the regulation.

Due to technical considerations involving the process operations and the types of control equipment employed , the recordkeeping and reporting requirements are the same for both small and large entities. The Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small entities. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 2., Annual Burden and Cost of Reporting and Recordkeeping Requirements, 40 CFR Part 60, Subpart BBB.

6. Estimating the Burden and Cost of the Collection Table 2 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the subpart included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory.

The 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.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated at 13,151 ( rounded) person hours. These hours are based on Agency studies and background documents from the development of the standards or test methods, Agency knowledge and experience with the NSPS program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses a technical labor rate of $ 55.34 per hour. This rate is from the United States Department of Commerce Bureau of Labor Statistics, March 2000, " Table 10. Private industry, by occupational and industry group." The rate is from column 1, " Total compensation." The wage 9 rate has been increased by 110% to account for the benefit packages available to those employed by private industry.

We are using this technical labor rate since employees at this level are responsible for conducting the required activities to meet the rule's recordkeeping and reporting requirements for the rubber tire manufacturing source category.

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs There are both capital/ startup and operation and maintenance ( O& M) costs associated with this rule. Two types of monitoring devices are used to collection information: the gas stream monitoring device and the VOC monitoring device. The gas stream temperature monitoring device has continuous recorder to measure the temperature before and after the emission reduction at the control device. The VOC monitoring device has a continuous analyzer to measure the outlet gas concentration when a VOC recovery device is used.

( iii) Capital/ Start up vs. Operating and Maintenance ( O& M) Costs Capital/ Startup vs. Operation and Maintenance ( O& M) Costs ( A) Continuous Monitoring Device ( B) Start up Cost ($) for One Affected Facility ( C) No. of New Affected Facilities to Startup ( D) Total Start up Costs ( B X C) ( E) Annual O& M Costs ($) for One Affected Facility ( F) No. of Affected Facilities with O& M ( G) Total O& M ( E X F)

VOC ( organics) monitor $ 35,000 0 0 $ 7,500 0 0 temperature monitors at incinerators $ 7,500 0 0 $ 4,000 4.3 ( 43* 0.1) $ 17,200 Total Cost 0 $ 17,200 The total capital start up costs are one time costs when an affected facility becomes subject to the standard. Since we have assumed that no new plants will be built in the next three years and operational changes at existing facilities will not trigger applicability of this rule, there will be no start up costs associated with this rule during the three year period that this ICR addresses. The total of Column D is therefore zero.

The total annual operations and maintenance ( O& M) costs for this ICR are $ 17,200 dollars. This O& M estimate is based on the assumption that 10 percent of the 43 existing plants have a temperature monitor with a continuous recorder per combustion control device for VOC 10 emission reduction ( e. g., an incinerator). This is the total of column G. This number is then multiplied by $ 4,000 for O& M. This cost is shown on the OMB 83 I form in block 14 ( b) Total annual costs ( O& M). The numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars The average annual burden for capital and start up costs for this ICR is estimated to be zero. This is the total of column D. This cost is shown on the OMB 83 I form in block 14 ( a), Total annualized capital/ startup costs. The numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars.

6( c) Estimating Agency Burden and Cost The costs to the Agency are user costs associated with analysis of the reported information. Publication and distribution of the information are part of the AIRS program. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

The average annual Agency cost during the 3 years of the ICR is estimated to be $ 14,613 ( see Table 1 attached). This cost is based on a GS 12, Step 1 average hourly labor rate times a 1.6 benefit multiplication factor to account for government overhead expenses for a total hourly rate of $ 36.97. This rate is from OPM's " 2001 General Schedule" which excludes locality rates of pay. Details upon which this estimate is based appear in Table 1., Average Annual EPA Burden and Cost.

6( d) Estimating the Respondent Universe and Total Burden and Costs Respondent Universe Regulation Requirement ( A) No. of New Sources/ Year ( B) No. of Initial Reports for New Sources ( C) No. of Existing Sources it Applies ( D) No. of Reports for Existing Sources per year ( E) Total Annual Responses ( AxB)+( CxD)

Method 25A 0 0 3 1 3 Annual Report of Formulation Data/ Method 24 0 0 43 1 43 Semiannual Report of Excess Emissions 0 0 14.3 ( 43* 1/ 3) 2 28.6 Report on Physical/ Operation Change 0 0 4.3 ( 43* 0.1) 1 4.3 TOTAL 78.9 The number of total respondents is 43. This is the number of existing sources plus the number of new sources averaged over the three year period. This number is shown on the OMB 83 I form in block 13( a). 11 The " Total annual responses" is 79 ( rounded). This number is in column E of the Respondent Universe table above. It is shown on the OMB 83 I form in block 13( b). The total annual labor costs are 13,151 person hours ( rounded). This number is not shown on the OMB 83 I form in block 13( c), only the burden hours are reflected in block 13( c). Details upon which this estimate is based appear in Table 2., Annual Burden and Cost of Reporting and Recordkeeping Requirements, 40 CFR Part 60, Subpart BBB.

The total annual capital and O& M costs to the regulated entity are $ 17,200. This number is shown on the OMB 83 I form in block 14( c). These costs are detailed in section 6( d)( iii), Capital/ Start up vs. Operating and Maintenance ( O& M) Costs.

6( e) Respondent Burden And Cost Table See attached Table 2., Annual Burden and Cost of Reporting and Recordkeeping Requirements, 40 CFR Part 60, Subpart BBB.

6( f) Reasons for Change in Burden The decrease in burden hours from the most recently approved ICR is due to an adjustment. The adjustment decrease is due to a decrease in the number of new sources. The ICR preparer assumed that there will be no industry growth based on consultation with EPA's Office of Air Quality and Standards ( OAQPS).

OAQPS provided recent information regarding the number of sources affected by the rule and on the current status of industry in meeting rule requirements due to recent efforts to obtain data on this sector for a potential new rule targeted at this sector. The number of new affected facilities per year has decreased to zero and the number of existing sources has increased to 43 when compared to the previous ICR which listed 7 new and 33 existing sources subject to the rule. Also, OAQPS indicated that all of the plants are using water based sprays that meet the requirements of the rule and will not need to use an organic monitoring device. Therefore, the annualized capital and operation and maintenance costs have decrease significantly due to decreases in costs associated with the organic monitoring device and the fact that there will be no new affected facilities per year.

6( g) Burden Statement 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 12 currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing a respondent burden, including through the use of automated collection techniques to the Ms. Susan Auby, Collection Strategies Division ( Mail Code 2822), Office of Environmental Information, United States Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, D. C. 20460 0001; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number 1158.07 and OMB Control Number 2060 0156 in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information.


[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38926-38929]
[FR Doc No: 2023-12663]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97673; File No. SR-BOX-2023-15]

Self-Regulatory Organizations; BOX Exchange LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Establish
Separate Fees and Rebates on Non-Auction Transactions for Options
Overlying the Standard and Poor's Depositary Receipts Trust

June 8, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 31, 2023, BOX Exchange LLC (``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been prepared by the Exchange.
---------------------------------------------------------------------------

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

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

The Exchange filed the proposed rule change pursuant to Section
19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange is filing with the Securities and Exchange Commission
(``Commission'') a proposed rule change to amend the Fee Schedule to
establish separate fees and rebates on Non-Auction transactions for
options overlying the Standard and Poor's Depositary Receipts Trust
(``SPY'') on the BOX Options Market LLC (``BOX'') options facility.
While changes to the fee schedule pursuant to this proposal will be
effective upon filing, the changes will become operative on June 1,
2023. The text of the proposed rule change is available from the
principal office of the Exchange, at the Commission's Public Reference
Room and also on the Exchange's internet website at https://rules.boxexchange.com/rulefilings.

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

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

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

1. Purpose
    The Exchange proposes to amend Section IV, Non-Auction
Transactions, of the BOX Fee Schedule. Specifically, the Exchange
proposes to establish separate fees and rebates on Non-Auction
transactions for options overlying the Standard and Poor's Depositary
Receipts Trust (``SPY'').\5\
---------------------------------------------------------------------------

    \5\ Options overlying Standard and Poor's Depositary Receipts/
SPDRs (``SPY'') are based on the SPDR exchange-traded fund
(``ETF''), which is designed to track the performance of the S&P 500
Index.
---------------------------------------------------------------------------

Non-Auction Transactions
    Currently, in Section IV.A of the BOX Fee Schedule, fees and
credits for Non-Auction transactions are assessed depending on three
factors: (i) the account type of the Participant submitting the order;
(ii) whether the Participant is a liquidity provider or liquidity
taker; and (iii) the account type of the contra party.
    The Exchange now proposes to assess separate fees for SPY Non-
Auction transactions. Specifically, when a Public Customer SPY order
interacts with a Public Customer or non-Public Customer SPY order, the
Exchange will not assess a fee or credit.
    Further, when a Professional Customer or Broker Dealer SPY order
interacts with a Public Customer SPY order, the Exchange proposes to
assess a $0.60 fee when making liquidity or $0.50 when taking
liquidity. When a Professional Customer or Broker Dealer SPY order
interacts with a Professional Customer, Broker Dealer, or Market Maker
SPY order, the Exchange proposes to assess $0.15 for making liquidity
or $0.50 for taking liquidity. The Exchange notes that these fees are
currently assessed to SPY transactions today as SPY is a Penny Interval
Class.\6\
---------------------------------------------------------------------------

    \6\ See BOX Informational Circular 2022-11 available at https://boxoptions.com/assets/IC-2022-11-Penny-Program-Class-Removals-1.pdf.
---------------------------------------------------------------------------

    When a Market Maker SPY order interacts with a Public Customer SPY
order, the Exchange proposes to assess no fee when making liquidity or
$0.50 when taking liquidity. When a Market Maker SPY order interacts
with a Professional Customer, Broker Dealer, or Market Maker SPY order,
the Exchange proposes to assess no fee when making liquidity or $0.50
when taking liquidity.
    The proposed fee structure for SPY Non-Auction Transactions will be
as follows:

----------------------------------------------------------------------------------------------------------------
                                                                                SPY
                 Account type                             Contra party           -------------------------------
                                                                                Maker           Taker
----------------------------------------------------------------------------------------------------------------
Public Customer...............................  Public Customer.................           $0.00           $0.00
                                                Professional Customer/Broker                0.00            0.00
                                                 Dealer.
                                                Market Maker....................            0.00            0.00
Professional Customer or Broker Dealer........  Public Customer.................            0.60            0.50
                                                Professional Customer/Broker                0.15            0.50
                                                 Dealer.
                                                Market Maker....................            0.15            0.50
Market Maker..................................  Public Customer.................            0.00            0.50
                                                Professional Customer/Broker                0.00            0.50
                                                 Dealer.
                                                Market Maker....................            0.00            0.50
----------------------------------------------------------------------------------------------------------------

    For example, under the proposal, if a Public Customer submitted a
SPY order to the BOX Book (making liquidity), the Public Customer would
not be offered a rebate or charged a fee if the order interacted with a
Market Maker's SPY order and the Market Maker (taking liquidity) would
be charged $0.50.
Tiered Volume Rebate for Non-Auction Transactions
    The Exchange also proposes to amend Section IV.A.1 of the Fee
Schedule, Tiered Volume Rebate for Non-Auction Transactions.
Specifically, the Exchange proposes to adopt separate rebates for SPY
transactions for Public Customers in Non-Auction Transactions. For Tier
1, where percentage thresholds of Public Customer volume is 0.000%-
0.129%, the Exchange proposes no rebates. For Tier 2, where percentage
thresholds of Public Customer volume is 0.130%-0.339%, the Exchange
proposes to assess a $0.05 rebate when making liquidity or no rebate
when taking liquidity. For Tier 3, where percentage thresholds of
Public Customer volume is 0.340%-0.549%, the Exchange proposes

a $0.10 rebate when making liquidity or no rebate when taking
liquidity. For Tier 4, where percentage thresholds of Public Customer
volume is 0.550% and above, the Exchange proposes a $0.27 rebate when
making liquidity or no rebate for taking liquidity. The proposed rebate
structure will be as follows:

------------------------------------------------------------------------
                           Percentage           Per contract rebate
                          thresholds of  -------------------------------
                            national                    SPY
                         customer volume -------------------------------
         Tier             in multiply-
                         listed options
                             classes           Maker           Taker
                            (monthly)
------------------------------------------------------------------------
1.....................  0.000%-0.129%...           $0.00           $0.00
2.....................  0.130%-0.339%...          (0.05)            0.00
3.....................  0.340%-0.549%...          (0.10)            0.00
4.....................  0.550% and Above          (0.27)            0.00
------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act, in general, and Section
6(b)(4) and 6(b)(5) of the Act,\7\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees, and other
charges among BOX Participants and other persons using its facilities
and does not unfairly discriminate between customers, issuers, brokers
or dealers.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange's proposal to adopt separate fees for SPY Non-Auction
Transactions is reasonable, equitable, and not unfairly discriminatory
because pricing by symbol is a common practice on many U.S. options
exchanges as a means to incentivize order flow to be sent to an
exchange for execution in the most actively traded options classes. The
Exchange believes that eliminating maker fees for Market Makers when
trading against Public Customers will incentivize Market Makers to
provide tighter spreads in SPY which may lead to increased order flow
to BOX and result in increased liquidity on the Exchange, benefitting
all market participants. The Exchange also proposes to eliminate Public
Customer rebates for transactions when the Market Maker is a maker and
the Public Customer is a taker because BOX will no longer receive fees
when the Market Maker is a maker and the Public Customer is a taker.
The Exchange notes that other exchanges assess separate fees and
credits for SPY transactions,\8\ and that it currently assesses
separate fees and rebates for SPY transactions for PIP and COPIP
Transactions on BOX.\9\ The Exchange also notes that SPY has the most
actively traded options \10\ and therefore the Exchange believes that
separate fees are appropriate to more effectively attract order flow to
BOX.
---------------------------------------------------------------------------

    \8\ See Nasdaq Phlx LLC (``Phlx'') Fee Schedule, Section 3
(Rebates and Fees for Adding and Removing Liquidity in SPY). The
Exchange notes that while PHLX differentiates SPY from other symbols
for fee purposes, the structure and amount of the fees are different
than the proposal discussed herein.
    \9\ See BOX Fee Schedule, Section IV.B (PIP and COPIP
Transactions).
    \10\ See https://www.optionseducation.org/toolsoptionquotes/today-s-most-active-options (providing a daily list of the most
active options by type).
---------------------------------------------------------------------------

Non-Auction Transactions
    The Exchange believes the proposed Non-Auction Transaction fees for
Public Customer SPY transactions are reasonable. Under the proposal,
Public Customers will never pay a fee for their SPY Non-Auction
Transactions and may be eligible for a rebate depending on their
monthly volume for all transactions executed on BOX under Section
IV.A.1. The Exchange believes that charging no fee to Public Customers
for SPY Non-Auction Transactions is equitable and not unfairly
discriminatory. The securities markets generally, and BOX in
particular, have historically aimed to improve markets for investors
and develop various features within the market structure for Public
Customer benefit. Accordingly, the Exchange believes that charging no
fee for Public Customers for their SPY transactions is appropriate and
not unfairly discriminatory. The Exchange notes that where the Public
Customer is a taker against Professional Customer/Broker Dealer or
Market Maker, the Public Customer will no longer receive a rebate. The
Exchange believes that any disincentive created by removing this rebate
will be more than offset by Market Makers providing tighter spreads in
response to the elimination of maker fees for Market Makers trading
against Public Customers. Tighter spreads may attract a higher level of
Public Customer order flow to the BOX Book and create liquidity, which
will ultimately benefit all Participants trading on BOX.
    The Exchange believes that charging Professional Customers and
Broker Dealers higher fees than Public Customers for SPY Non-Auction
Transactions is equitable and not unfairly discriminatory. Professional
Customers, while Public Customers by virtue of not being Broker
Dealers, generally engage in trading activity more similar to Broker
Dealer proprietary trading accounts (submitting more than 390 standard
orders per day on average). The Exchange believes that the higher level
of trading activity from these Participants will draw a greater amount
of BOX system resources than that of non-professional, Public
Customers. Because this higher level of trading activity will result in
greater ongoing operational costs, the Exchange aims to recover its
costs by assessing Professional Customers and Broker Dealers higher
fees for transactions. The Exchange notes that the proposed SPY
transaction fees for Professional Customers and Broker Dealers is
identical to what their SPY transactions are assessed today.
    The Exchange believes it is reasonable, equitable and not unfairly
discriminatory to assess no maker fee for BOX Market Makers trading
against Public Customers and to eliminate rebates when the Public
Customer is a taker against a Professional Customer, Broker Dealer, or
Market Maker for SPY Non-Auction Transactions because, when being
charged no fee for their transactions, Market Makers may tighten their
spreads in SPY and therefore will increase market quality in SPY
options. Specifically, Market Makers can provide higher volumes of
liquidity and lowering certain fees will help attract a higher level of
Market Maker order flow to the BOX Book and create liquidity, which the
Exchange believes will make Public Customer taker rebates unnecessary
to attract order flow. As such, the Exchange believes it is appropriate
that Market Makers be charged lower transaction fees than Professional
Customers and Broker Dealers for SPY Non-Auction Transactions and that
Public Customers not receive rebates when the Public Customer is a
taker against a

Professional Customer, Broker Dealer, or Market Maker.
Tiered Volume Rebate for Non-Auction Transactions
    The Exchange believes that the proposed Public Customer SPY rebates
in the Tiered Volume Rebate for Non-Auction Transactions structure are
reasonable, equitable, and not unfairly discriminatory. The proposed
volume thresholds and applicable rebates for SPY are meant to
incentivize Public Customers to post orders on the Exchange to obtain
the benefit of the rebate, which will in turn benefit all market
participants by increasing liquidity on the Exchange. The Exchange
notes that the proposed SPY maker rebates are identical to the rebates
that are currently assessed to SPY transactions today. The Exchange
believes that offering no rebate for SPY taker transactions is
reasonable and appropriate because assessing no maker fee for Market
Makers may result in tighter spreads in SPY, thus eliminating the need
for additional volume-based incentives for Public Customers to take
liquidity on BOX.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
    The Exchange believes the proposed changes to the fees in the Non-
Auction Transactions fee structure will not impose a burden on
intramarket competition as BOX believes that the changes will result in
the Participants being charged appropriately for their SPY transactions
and are designed to incentivize order flow to BOX by incentivizing
Market Makers to provide tighter spreads. Submitting an order is
entirely voluntary and Participants can determine which type of order
they wish to submit, if any, to BOX. Further, the Exchange believes the
proposed changes in the Non-Auction Transaction fee structure will not
impose a burden on intermarket competition as another exchange
currently assesses separate fees for SPY transactions.\11\
---------------------------------------------------------------------------

    \11\ See supra note 8.
---------------------------------------------------------------------------

    The Exchange believes the proposed changes to the rebate structure
for Public Customer Non-Auction Transactions will not impose a burden
on competition among various Exchange Participants. The Exchange
believes that the proposed changes will result in Public Customers
being rebated appropriately for their SPY transactions. Further, the
Exchange believes that this proposal will enhance competition between
exchanges because it is designed to allow the Exchange to better
compete with other exchanges for this order flow.
    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues. In such an environment, the Exchange must continually
review, and consider adjusting, its fees and rebates to remain
competitive with other exchanges. For the reasons described above, the
Exchange believes that the proposed rule change reflects this
competitive environment.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Exchange Act \12\ and Rule 19b-4(f)(2)
thereunder,\13\ because it establishes or changes a due, or fee.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \13\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend the rule
change if it appears to the Commission that the action is necessary or
appropriate in the public interest, for the protection of investors, or
would otherwise further the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-BOX-2023-15 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-BOX-2023-15. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-BOX-2023-15 and should be
submitted on or before July 5, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-12663 Filed 6-13-23; 8:45 am]
BILLING CODE 8011-01-P