VALUING REDUCED ASTHMA EPISODES FOR ADULTS AND CHILDREN – FOCUS GROUPS

EPA ICR No. 2215.01

SUPPORTING STATEMENT

Part A

Section 1.  Identification of the Information Collection

1(a)  Title of the Information Collection:

Valuing Reduced Asthma Episodes for Adults and Children – Focus Groups

1(b)  Short Characterization/Abstract:

Asthma is one of the most common chronic illnesses in the United States,
particularly among children.  The disease is characterized by recurring
episodes of symptoms like cough, shortness of breath, and wheezing.
Epidemiological studies suggest that ambient air pollution may
contribute to exacerbation of these episodes.  Acute asthma episodes are
a leading cause of work and school absence and contribute to the
economic burden of the disease.  The policies and programs of many
public and private entities including EPA may affect the frequency and
severity of asthma episodes, but economic analysis of these programs is
hindered by inadequate information about the economic benefits of
reduced asthma episodes.    The proposed surveys would gather
information to support estimation of willingness to pay (WTP) to avoid
acute episodes of asthma exacerbation for adults and children.

The survey research has three main objectives.  The first is to estimate
WTP to reduce frequency of asthma episodes.  The second is to examine
how the “attributes” of asthma episodes, such as their frequency,
severity and symptoms, affect WTP.  The third is to provide some
evidence on the WTP to reduce the severity of asthma episodes, while
holding frequency constant.  WTP would be estimated in the context of
the severity of the individual’s asthma and the activities taken to
manage the disease.  The resulting estimates will help to provide
researchers and policy analysts with a systematic and credible basis for
valuing policies that influence acute asthma episodes.

Through a cooperative agreement from EPA (R-83062801-0), researchers at
the University of Central Florida (UCF) are designing and proposing to
conduct two surveys of adult individuals.  One survey would be
administered to a sample of adults with physician-diagnosed asthma who
have experienced asthma symptoms during the 12 months preceding the
survey.  The focus is on eliciting adults’ WTP to reduce the asthma
episodes that they experience.  The other survey would be administered
to a national sample of parents of children with physician-diagnosed
asthma who have experienced asthma symptoms during the 12 months
preceding the survey.  In this case, the focus is on eliciting
parents’ WTP to reduce the asthma episodes that their children
experience.

The purpose of the proposed ICR is to gain approval for the conduct of a
series of focus groups and individual interviews as part of the survey
development process.  Focus groups and cognitive interviews are a
crucial component in the survey development process.  A total of 50
interviews are anticipated, including focus group responses and
individual interviews.

Section 2.  Need for and use of the Collection

2(a)	Need/Authority for the Collection

Over the next year, the Agency plans on creating a survey that would
gather information to support the estimation of willingness to pay (WTP)
to alleviate acute exacerbations of asthma in adults and children.

Focus groups are an important part of any survey development process,
allowing researchers to identify problematic approaches, terminology,
and graphics in the survey and providing a means for explicitly testing
draft survey materials.

If this information is not collected, an opportunity to developing
methods to better understand the economic benefits associated with
reduced asthma episodes will be lost.  This loss will cause further
delays in developing an improved understanding of the nature of the
benefits of related policies and programs of many public and private
entities, including the Agency.

This data collection is conducted for research purposes; there are no
legal requirements.  The materials prepared for these discussions will
fully conform to federal regulations – specifically the Privacy Act of
1974 (5 U.S.C. 552a), the Hawkins-Stafford Amendments of 1988 (P.L
100-297), and the Computer Security Act of 1987.

2(b)	Practical Utility/Users of the Data

The information collected in the focus groups will be used to develop
and improve economics-related surveys, specifically surveys gathering
willingness to pay (WTP) information on avoidance of acute episodes of
asthma exacerbation for adults and children.  To the extent that these
surveys are ultimately successfully administered, they will serve
further the development of values for avoiding asthma episodes comprised
of different symptoms and severity levels, or occurring with different
frequency.  The results will help to provide researchers and policy
analysts with evidence on the potential benefits of actions policies
that influence acute asthma episodes.  Participation in the focus groups
will be voluntary and the identity of the participants will be kept
confidential.

Focus groups generally do not yield meaningful quantitative findings and
do not yield data about public opinion that can be generalized.  As
such, they cannot be used directly to estimate benefits and costs
associated with environmental action.  However, the use of focus groups
is an important tool in the survey development process to test and
refine the ideas and technical aspects of the survey.  The conduct of
quantitative research, such as through survey distribution, collection,
and analysis, would need to be completed to develop new estimates of
economic benefits or costs.

Section 3.  Non duplication, Consultations, and Other Collection
Criteria

3(a)	Non duplication

It is not expected that any of the information to be submitted to the
EPA during the focus group study is duplicative or is already in the
possession of the Federal Government.  The proposed focus groups will
address the needs of the Agency and significantly improve our ability to
test and redefine ideas that will allow EPA to conduct further
quantitative research on willingness to pay estimates for avoidance of
acute asthma episodes.

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

In accordance with 5 CFR 1320.8(d) on February 3, 2006, EPA published a
60-day Federal Register notice (E6 FR 1503).  See Appendix 1 for a copy
of this Federal Register notice.

Also, EPA received only one non-substantial comment from the posting of
the 60-day Federal Register notice (E6 FR 1503) published February 3,
2006.

3(c) 	Consultations

Considerable effort has been taken to consult with persons outside the
agency on a regular basis throughout the design of pilot survey
questions to serve as the basis for these focus groups and interviews.
Two of the main investigators are academic researchers who work for the
University of Central Florida; Dr. Mark Dickie and Dr. Shelby Gerking.

Dr. Mark Dickie is a Professor of Economics in the Department of
Economics at the University of Central Florida –<PHONE_NUMBER>.  Dr.
Dickie’s primary research focus is on environmental valuation through
revealed and stated preference methods, including estimating WTP for
changes in children’s health.

Dr. Shelby Gerking is a Galloway Professor of Economics in the
Department of Economics at the University of Central Florida – (407)
823-4729.  Dr. Gerking’s primary research focus is on environmental
policy and valuation.

3(d)	Effects of Less Frequent Collection

	The focus group will be a one-time collection exercise for the enrolled
participants.

3(e)	General Guidelines

This collection does not violate any of OMB’s general guidelines for
information collections.

Information will be collected according to the guidelines in 5 CFR 1320.
 Respondents will be asked to participate in one focus group and their
participation will be voluntary. There will be no need for participants
to maintain records or submit documents or proprietary trade secrets.
There will be complete protection of any demographic information
collection from participant—full names, phone numbers and addresses
will not be associated with responses.

EPA has developed EPA Information Quality Guidelines (2002) to ensure
the utility, objectivity and integrity of information that is
disseminated by the Agency.  It is EPA’s intention that collection of
information under this ICR will result in information that will be
collected, maintained, and used in ways consistent with both the EPA
Information Quality Guidelines (2002) and the OMB Information Quality
Guidelines (2002).   EPA intends to conduct a pre-dissemination review
when the Agency prepares to disseminate any information collected under
this ICR.

3(f)	Confidentiality

Each focus group will fully conform to federal regulations –
specifically the Privacy Act of 1974 (5 U.S.C. 552a), the
Hawkins-Stafford Amendments of 1988 (P.L 100-297), and the Computer
Security Act of 1987.  Each prospective respondent will be informed that
their participation in the survey is voluntary, and that their
identities will be kept confidential by the investigators and not
associated with their responses.  EPA or no other agency will have
access to the names of respondents.

3(g) 	Sensitive Questions

There are no questions on sexual behavior and attitudes, religious
beliefs, and other matters that are commonly considered private or
sensitive in this pilot survey instrument.

Section 4.  The Respondents and the Information Requested

4(a)	Respondents/SIC Codes

Up to fifty (50) individuals focus group / interview participants who
have a household experience with asthma.

4(b)	Information Requested

Data items, including record keeping requirements

Respondent Activities

Respondents will be selected from greater Orlando area, near the
University of Central Florida.  They will be elicited based on their
household experience with asthma.  These respondents are asked to come
to a local interview facility or the University of Central Florida and
participate in a 2 hour

discussion on different aspects of asthma episodes.  There will be 5
focus group interviews (of up to 6 participants for each focus group)
and 20 cognitive (one-on-one) interviews with the main investigators.
The focus groups will be providing their thoughts, perceptions and
beliefs regarding the issue of managing their own or their child’s
asthma.  The 20 individuals participating in the cognitive interviews
will be walked through one of the survey instruments (or a portion of
it) individually and will be asked to “think aloud” about what the
questions mean to them.  The survey instrument questions may be
displayed on a computer.  They may answer the questions to move on to
another question, but these responses will not be recorded or used.
They are ultimately providing feedback on whether the questions are
clearly stated, meaningful to them, whether the possible answers make
sense or if there is some response they would like to offer that is
missing.  These cognitive interviews and the focus group participants
will be helping to assess the clarity and relevance of these
asthma-related questions, and their relative merit for use in a survey
instrument.  All responses are voluntary.  The collection will be a one
time event and there will be no need for participants to maintain
records or submit documents or proprietary trade secrets.  There will be
complete protection of any demographic information collection from
participants -- names, phone numbers and addresses will not be
associated with responses.

Section 5.  The Information Collected – Agency Activities, Collection
Methodology, and Information Management

5(a) Agency Activities

Agency activities associated with this information collection include
the following, mostly performed by the principle investigators under the
cooperative agreement:

-- Drafting focus groups scripts and accompanying materials

-- Observing and moderating the focus group discussions

-- Summarizing focus group results and making changes to draft survey
materials as appropriate

5(b) Collection Methodology and Management

Focus group studies are directed group discussions that do not produce
quantitative data, but which enable skilled observers to infer the
underlying views and assumptions of the group that are expressed in the
discussion.  To facilitate interpretation, discussions will be recorded
and/or videotaped so that both a visual record and written transcript of
the discussion are available for review.  Participants are informed in
advance that the sessions will be recorded.  Transcripts and video tapes
will be maintained in the individual project files over the appropriate
time frame under records management procedures.

5(c) Small Entity Flexibility

No information will be collected from small businesses or small
organizations or small governmental jurisdictions as a result of this
information collection.

5(d) Collection Schedule

Focus groups will be scheduled very shortly after approval of this ICR.
No fixed schedule for this collection has been established otherwise.

Section 6.  Estimating the Burden and Cost of Collection

6(a)	Estimating Respondent Burden

6(b)	Estimating Respondent Costs

The only burden imposed by the interviews on respondents will be the
time required to participate in focus group discussions and answer
interview questions.  The survey developers estimate that this will
require an average of 2 hours per respondent.  With a total of 50
respondents this requires a total of 100 hours.  Based on an average
hourly rate of $27.31 (including employer costs of all employee
benefits), the survey developers expect that the average per-respondent
cost for the pilot survey will be $54.62 and the corresponding one-time
total cost to all respondents will be $2731.00.  Since this information
collection is voluntary and does not involve any special equipment,
respondents will not incur any capital or operation and maintenance
(O&M) costs.

TABLE 1. – Average Annual Respondent Burden and Costs1

Center

Subject

Number  of Focus Groups for Study

Average Number of Participants per Group

Number  of Individual Cognitive Interviews for Study

Total Number of Individuals Participating in the Study

Avg Hours of Duration for Each Group/Cognitive Interview (includes
screening)

Total Estimated “Respondent” Hours

Average per-respondent cost  ($)2

Total Estimated

Burden per Year ($)

Office of Policy, Economics and Innovation

Valuation of reduced asthma episodes for adults and children

5

6

20

50

2.0

100

$54.62

$2,731.00

TOTAL

$2,731.00

1  There are no capital costs or operating and maintenance costs
associated with this collection of

  information.

2  Hourly rate ($27.31) Employer costs per hour worked for employee
compensation and costs as a percent of total compensation: Civilian
worker, total compensation, December 2006 (  HYPERLINK
"http://stats.bls.gov/news.release/ecec.t02.htm"
http://stats.bls.gov/news.release/ecec.t02.htm

6(c)	Estimating Agency Burden and Costs

The Agency incurs costs directly through assisting the principle
investigators to develop focus group materials, and through the
cooperative agreement as principle investigators develop focus group
materials, conduct focus group discussions, and observe focus group
discussions.

Estimated Average Annual Agency Burden and Costs

Task	Costs (and Person-hours) Per Focus Group Hour	Total Hours and Cost

	EPA

($43.80/

Hour)	Estimated Contractor and Investigator Costs1	O&M Cost	Number of
focus group activities

(50 responses)	Total Cost/Year

Prepare Materials for Focus Group Discussion	$219

(5 hrs)

$1,000

--

1

$1,219

Organize and conduct focus group discussion

(contractor)	--

$4,000

--

1

$4,000

Observe focus group discussion	--	$1,000	--

1

$1,000

Total

$219.00

$5,000	--

1

$6,219

Notes:  1includes recruiting respondents, meeting space, respondent
reimbursement for participants, and recording of discussion.

6(d)	Estimating the Respondent Universe and Total Burden and Costs

6(e)	Bottom Line Burden Hours and Cost Tables

We expect the focus group hours to total 100 and Agency costs as
estimated in section 6(c).

Respondent Tally

Action	Approximate Number of Focus Groups 	Approximate Number of
Individual Cognitive Interviews	 Estimated Respondent Hours 	Total labor
Cost per Year	Total Annual Capital Costs	Total Annual O&M costs

Focus Group Discussion	5	20	100	$2,731.00	$0	$0

	(ii)	Agency Costs

Task	Costs (and Person-hours) Per Focus Group Hour	Total Hours and Cost

	EPA

($43.80/

Hour)	Estimated Contractor and Investigator Costs1	O&M Cost	Number of
focus group activities

(50 responses)	Total Cost/Year

Total

$219.00

$5,000	--

1

$6,219

6(f)	Reasons for Change in Burden

This is a new request.

6(g) 	Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to 2 hours per response.  Burden means the
total time, effort, or financial resources expended by persons to
generate, maintain, retain, or disclose or provide information to or for
a Federal agency.  This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information.  An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information unless
it displays a currently valid OMB control number.  The OMB control
numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR
chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
[EPA-HQ-OA-2006-0080], which is available for online viewing at
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the Office of Environmental Information (OEI) Docket
in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Avenue, NW, Washington, D.C.  The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays.  The telephone number for the Reading Room is
(202) 566-1744, and the telephone number for the Office of Environmental
Information (OEI) Docket is<PHONE_NUMBER>.  An electronic version of
the public docket is available at www.regulations.gov.  This site can be
used to submit or view public comments, access the index listing of the
contents of the public docket, and to access those documents in the
public docket that are available electronically.  When in the system,
select “search,” then key in the Docket ID Number identified above.
Also, you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include
the EPA Docket ID Number EPA-HQ-OA-2006-0080 in any correspondence.

Part B.

There are no tabulated results for this information collection.

Information gathered from focus groups is qualitative in nature.  They
allow for a more in-depth understanding of respondents’ attitudes,
beliefs, motivations, and feelings than do quantitative studies. It
serves the narrowly defined need for direct and informal opinion on a
specific topic.

Appendix 1

[Federal Register: February 3, 2006 (Volume 71, Number 23)]

[Notices]

[Page 5834-5836]

[DOCID:fr03fe06-53]

=======================================================================

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OA-2006-0080; FRL-8026-8]

Agency Information Collection Activities: Proposed Collection;

Comment Request; Valuing Reduced Asthma Episodes for Adults and

Children-Focus Groups; EPA ICR Number 2215.01

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501

et seq.), this document announces that EPA is planning to submit a

request for a new Information Collection Request (ICR) to the Office of

Management and Budget (OMB). Before submitting the ICR to OMB for

review and approval, EPA is soliciting comments on specific aspects of

the proposed information collection as described below.

DATES: Comments must be submitted on or before April 4, 2006.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-

OA-2006-0080, by one of the following methods:

       HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov:"
http://www.regulations.gov:  Follow the on-line

instructions for submitting comments.

     E-mail:   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

     Fax:<PHONE_NUMBER>.

     Mail: Office of Environmental Information (OEI) Docket,

Environmental Protection Agency, Mailcode 28221T, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

     Hand Deliver: Office of Environmental Information (OEI)

Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301

Constitution Ave., NW., Washington, DC. Such deliveries are only

accepted during the Docket's normal hours of operation, and special

arrangements should be made for deliveries of boxed information.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-OA-2006-

0080. EPA's policy is that all comments received will be included in

the public docket without change and may be made available online at

  HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov"  http://www.regulations.gov
, including any personal information

provided, unless the comment includes information claimed to be

Confidential Business Information (CBI) or other information whose

disclosure is restricted by statute. Do not submit information that you

consider to be CBI or otherwise protected through   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov"  http://www.regulations.gov
or e-mail. The   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov"  http://www.regulations.gov
Web site

is an ``anonymous access'' system, which means EPA will not know your

identity or contact information unless you provide it in the body of

your comment. If you send an e-mail comment directly to EPA without

going through   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov"  http://www.regulations.gov
your e-mail address will be

automatically captured and included as part of the comment that is

placed in the public docket and made available on the Internet. If you

submit an electronic comment, EPA recommends that you include your name

and other contact information in the body of your comment and with any

disk or CD-ROM you submit. If EPA cannot read your comment due to

technical difficulties and cannot contact you for clarification, EPA

may not be able to consider your comment. Electronic files should avoid

the use of special characters, any form of encryption, and be free of

any defects or viruses. For additional information about EPA's public

docket visit the EPA Docket Center homepage at   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.epa.gov/epahome/dockets.htm"
http://www.epa.gov/epahome/dockets.htm

.

FOR FURTHER INFORMATION CONTACT: Dr. Chris Dockins, Office of Policy,

Economics and Innovation, U.S. EPA, Mail Code 1809T, Environmental

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;

telephone number<PHONE_NUMBER>; fax number<PHONE_NUMBER>; e-mail address:
 HYPERLINK<EMAIL_ADDRESS>

<EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID

No. EPA-HQ-OA-2006-0080, which is available for online viewing at

  HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov"  http://www.regulations.gov
, or in person viewing at the Office of

Environmental Information (OEI) Docket in the EPA Docket Center (EPA/

DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC.

The EPA/DC Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday

through Friday, excluding legal holidays. The telephone number for the

Reading Room is<PHONE_NUMBER>, and the telephone number for the Office

of Environmental Information (OEI) Docket is<PHONE_NUMBER>.

    Use   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov"  http://www.regulations.gov
to obtain a copy of the draft

collection of information, submit or view public comments, access the

index listing of the contents of the docket, and to access those

documents in the public docket that are available electronically. Once

in the system, select ``search,'' then key in the docket ID number

identified in this document.

What Information Is EPA Particularly Interested In?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically

solicits comments and information to enable it to:

    (i) Evaluate whether the proposed collection of information is

necessary for the proper performance of the functions of the Agency,

including whether the information will have practical utility;

    (ii) Evaluate the accuracy of the Agency's estimate of the burden

of the proposed collection of information, including the validity of

the methodology and assumptions used;

    (iii) Enhance the quality, utility, and clarity of the information

to be collected; and

    (iv) Minimize the burden of the collection of information on those

who are to respond, including through the use of appropriate automated

electronic, mechanical, or other technological collection techniques or

other forms of information technology, e.g., permitting electronic

submission of responses. In particular, EPA is requesting comments from

very small businesses (those that employ less than 25) on examples of

specific additional efforts that EPA could make to reduce the paperwork

burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your

comments:

    1. Explain your views as clearly as possible and provide specific

examples.

    2. Describe any assumptions that you used.

    3. Provide copies of any technical information and/or data you used

that support your views.

    4. If you estimate potential burden or costs, explain how you

arrived at the estimate that you provide.

    5. Offer alternative ways to improve the collection activity.

    6. Make sure to submit your comments by the deadline identified

under DATES.

    7. To ensure proper receipt by EPA, be sure to identify the docket

ID number assigned to this action in the subject line on the first page

of your response. You may also provide the name, date, and Federal

Register citation.

What Information Collection Activity or ICR Does This Apply To?

    Affected Entities: Entities potentially affected by this action are

individuals volunteering to participate in focus group discussions.

    Title: Valuing Reduced Asthma Episodes for Adults and Children--

Focus Groups.

    ICR Numbers: EPA ICR No. 2215.01.

    ICR Status: This ICR is for a new information collection activity.

An Agency may not conduct or sponsor, and a person is not required to

respond to, a collection of information, unless it displays a currently

valid OMB control number. The OMB control numbers for EPA's regulations

in title 40 of the CFR, after appearing in the Federal Register when

approved, are listed in 40 CFR part 9, are displayed either by

publication in the Federal Register or by other appropriate means, such

as on the related collection instrument or form, if applicable. The

display of OMB control numbers in certain EPA regulations is

consolidated in 40 CFR part 9.

    Abstract: Asthma is one of the most common chronic illnesses in the

United States, particularly among children. The disease is

characterized by recurring episodes of symptoms like cough, shortness

of breath, and wheezing. Epidemiological studies suggest that ambient

air pollution may contribute to exacerbation of these episodes. Acute

asthma episodes are a leading cause of work and school absence and

contribute to the economic burden of the disease. The policies and

programs of many public and private entities including EPA may affect

the frequency and severity of asthma episodes, but economic analysis of

these programs is hindered by inadequate information about the economic

benefits of reduced asthma episodes. The proposed surveys would gather

information to support estimation of willingness to pay (WTP) to avoid

acute episodes of asthma exacerbation for adults and children.

    The survey research has three main objectives. The first is to

estimate WTP to reduce frequency of asthma episodes. The second is to

examine how the ``attributes'' of asthma episodes, such as their

frequency, severity and symptoms, affect WTP. The third is to provide

some evidence on the WTP to reduce the severity of asthma episodes,

while holding frequency constant. WTP would be estimated in the context

of the severity of the individual's asthma and the activities taken to

manage the disease. The resulting estimates will help to provide

researchers and policy analysts with a systematic and credible basis

for valuing policies that influence acute asthma episodes.

    Through a cooperative agreement from EPA (R-83062801-0),

researchers at the University of Central Florida (UCF) have designed

and are proposing to conduct two nationwide surveys of adult

individuals. One survey would be administered to a sample of adults

with physician-diagnosed asthma who have experienced asthma symptoms

during the 12 months preceding the survey. This survey focuses on

eliciting adults' WTP to reduce the asthma episodes that they

experience. The other survey would be administered to a national sample

of parents of children with physician-diagnosed asthma who have

experienced asthma symptoms during the 12 months preceding the survey.

In this case, the focus is on eliciting parents' WTP to reduce the

asthma episodes that their children experience.

    The purpose of the proposed ICR is to gain approval for the conduct

of a series of focus groups and individual interviews as part of the

survey development process. Focus groups and cognitive interviews are a

crucial component in the survey development process as they allow

survey developers to identify problematic approaches, terminology, and

graphics in the survey instrument. A total of 50 interviews are

anticipated, including focus group responses and individual interviews.

    An agency may not conduct or sponsor, and a person is not required

to respond to, a collection of information unless it displays a

currently valid OMB control number. The OMB control numbers for EPA's

regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15.

    The EPA would like to solicit comments in order to:

    (i) Evaluate whether the proposed collection of information is

necessary for the proper performance of the functions of the agency,

including whether the information will have practical utility;

    (ii) Evaluate the accuracy of the agency's estimate of the burden

of the proposed collection of information, including the validity of

the methodology and assumptions used;

    (iii) Enhance the quality, utility, and clarity of the information

to be collected; and

    (iv) Minimize the burden of the collection of information on those

who are to respond, including through the use of appropriate automated

electronic, mechanical, or other technological collection techniques or

other forms of information technology, e.g., permitting electronic

submission of responses.

    Burden Statement: The annual public reporting and recordkeeping

burden for this collection of information is estimated to average 2

hours per response. Burden means the total time, effort, or financial

resources expended by persons to generate, maintain, retain, or

disclose or provide information to or for a Federal agency. This

includes the time needed to review instructions; develop, acquire,

install, and utilize technology and systems for the purposes of

collecting, validating, and verifying information, processing and

maintaining information, and disclosing and providing information;

adjust the existing ways to comply with any previously applicable

instructions and requirements; train personnel to be able to respond to

a collection of information; search data sources; complete and review

the collection of information; and transmit or otherwise disclose the

information.

    The only burden imposed by the interviews on respondents will be

the time required to participate in focus group discussions and answer

interview questions. The survey developers estimate that this will

require an average of 2 hours per respondent. With a total of 50

respondents this requires a total of 100 hours. Based on an average

hourly rate of $26.05 \1\ (including employer costs of all employee

benefits), the survey developers expect that the average per-respondent

cost for the pilot survey will be $52.10 and the

corresponding one-time total cost to all respondents will be $5210.00.

Since this information collection is voluntary and does not involve any

special equipment, respondents will not incur any capital or operation

and maintenance (O&M) costs.

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

    \1\ Employer costs per hour worked for employee compensation and

costs as a percent of total compensation: Civilian workers, total

compensation, December 2005 (  HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://stats.bls.gov/news.release/ecec.t02.htm"
http://stats.bls.gov/news.release/ecec.t02.htm

).

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

What Is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as

appropriate. The final ICR package will then be submitted to OMB for

review and approval pursuant to 5 CFR 1320.12. At that time, EPA will

issue another Federal Register notice pursuant to 5 CFR

1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the

opportunity to submit additional comments to OMB. If you have any

questions about this ICR or the approval process, please contact the

technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: January 5, 2006.

Al McGartland,

Director, National Center for Environmental Economics, Office of Policy

Economics and Innovation.

[FR Doc. E6-1503 Filed 2-2-06; 8:45 am]

BILLING CODE 6560-50-P

 PAGE

 PAGE   1


[Federal Register: June 4, 2009 (Volume 74, Number 106)]
[Notices]
[Page 26897-26899]
[DOCID:fr04jn09-117]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-28751]

Notice of Applications for Deregistration under Section 8(f) of
the Investment Company Act of 1940

May 29, 2009.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
May, 2009. A copy of each application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>. An order granting each application will be
issued unless the SEC orders a hearing. Interested persons may request
a hearing on any application by writing to the SEC's Secretary at the
address below and serving the relevant applicant with a copy of the
request, personally or by mail. Hearing requests should be received by
the SEC by 5:30 p.m. on June 23, 2009, and should be accompanied by
proof of service on the applicant, in the form of an affidavit or, for
lawyers, a certificate of service. Hearing requests should state the
nature of the writer's interest, the reason for the request, and the
issues contested. Persons who wish to be notified of a hearing may
request notification by writing to the Secretary, U.S. Securities and
Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
    For Further Information Contact: Diane L. Titus at<PHONE_NUMBER>,
SEC, Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

Paradigm Funds Trust [File No. 811-21811]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. As of July
31, 2008, applicant's shareholders had tendered their shares for
redemption, based on net asset value. Applicant incurred no expenses in
connection with its liquidation.
    Filing Dates: The application was filed on January 22, 2009.
    Applicant's Address: 650 Fifth Ave., 17th Floor, New York, NY
10019.

Paradigm Multi Strategy Fund I, LLC [File No. 811-21808]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. As of July
31, 2008, applicant's shareholders had tendered their shares for
redemption, based on net asset value. Expenses of approximately
$218,740 incurred in connection with the liquidation will be paid by
applicant out of cash retained for this purpose.
    Filing Date: The application was filed on January 22, 2009.
    Applicant's Address: 650 Fifth Ave., 17th Floor, New York, NY
10019.

Nagle Funds [File No. 811-21826]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On April 1, 2009, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of approximately $1,050 incurred in connection with the
liquidation were paid by Peter J. Nagle, R.I.A., applicant's investment
adviser.
    Filing Date: The application was filed on April 20, 2009.
    Applicant's Address: 57 Willow Dr., Little Silver, NJ 07739.

Buffalo Balanced Fund, Inc. [File No. 811-8364]; Buffalo Small Cap
Fund, Inc. [File No. 811-8509]; Buffalo USA Global Fund, Inc. [File No.
811-8896]; Buffalo High Yield Fund, Inc. [File No. 811-8898]; Buffalo
Large Cap Fund, Inc. [File No. 811-8900]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On either July 29, 2008 or August 19,
2008, each applicant transferred its assets to corresponding series of
Buffalo Funds, based on net asset value. Expenses of approximately
$136,941 were incurred in connection with each reorganization and were
paid by Kornitzer Capital Management, Inc., applicants' investment
adviser, and U.S. Bancorp Fund Services, LLC, applicants'
administrative agent.
    Filing Dates: The applications were filed on January 14, 2009, and
amended on May 1, 2009 and May 13, 2009.
    Applicants' Address: 5420 W 61st Pl., Shawnee Mission, KS 66205.

The GNMA Fund Investment Accumulation Program, Inc. [File No. 811-2788]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On October 29, 2007, applicant transferred
its assets to BlackRock GNMA Portfolio, a series of BlackRock Funds II,
based on net asset value. Expenses of $730,792 incurred in connection
with the reorganization were paid by applicant and BlackRock

Advisors, LLC, investment adviser to the acquiring fund.
    Filing Dates: The application was filed on December 11, 2008, and
amended on May 12, 2009.
    Applicant's Address: 800 Scudders Mill Rd., Plainsboro, NJ 08536.

Sit Money Market Fund, Inc. [File No. 811-4032]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On March 31, 2009, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of $15,560 incurred in connection with the liquidation were
paid by Sit Investment Associates, Inc., applicant's investment
adviser.
    Filing Date: The application was filed on April 28, 2009.
    Applicant's Address: Sit Mutual Funds, 3300 IDS Center, 80 South
8th St., Minneapolis, MN 55402.

John Hancock Institutional Series Trust [File No. 811-8852]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On December 31, 2007, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Applicant incurred no expenses in connection with the liquidation.
    Filing Date: The application was filed on April 27, 2009.
    Applicant's Address: 601 Congress St., Boston, MA 02210.

Centurion Investment Trust [File No. 811-21959]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On November 26, 2008, applicant made a
liquidating distribution to it shareholders, based on net asset value.
Expenses of approximately $2,216 incurred in connection with the
liquidation were paid by Centurion Investment Partners LLC, applicant's
investment adviser.
    Filing Date: The application was filed on April 28, 2009.
    Applicant's Address: Centurion Investment Partners LLC, 5860
Ridgeway Center Parkway, Suite 330, Memphis, TN 38120.

Ziegler Exchange Traded Trust [File No. 811-21827]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On December 26, 2008, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of $37,011 incurred in connection with the liquidation were
paid by Ziegler Capital Management, LLC, applicant's investment
adviser.
    Filing Date: The application was filed on April 21, 2009.
    Applicant's Address: 200 South Wacker Dr., Suite 200, Chicago, IL
60606.

Legg Mason Permal Global Active Strategies Fund [File No. 811-22194];
Legg Mason Permal Global Active Strategies TEI Fund [File No. 811-
22195]; Legg Mason Permal Global Active Strategies Master Fund [File
No. 811-22196]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants have never made a public offering of their securities and do
not propose to make a public offering or engage in business of any
kind.
    Filing Dates: The applications were filed on February 26, 2009, and
amended on May 5, 2009.
    Applicants' Address: 55 Water St., New York, NY 10041.

BlackRock Multi-Strategy Hedge Advantage [File No. 811-21760]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On December
1, 2008, applicant transferred assets of approximately $6,758,621 to
MSHA Liquidating Trust. On December 8, 2008, applicant made a
liquidating distribution in cash to its shareholders, based on net
asset value. Expenses of approximately $154,660 incurred in connection
with the liquidation were paid by applicant and BlackRock Advisors,
LLC, applicant's investment adviser.
    Filing Dates: The application was filed on January 12, 2009, and
amended on April 24, 2009.
    Applicant's Address: 100 Bellevue Parkway, Wilmington, DE 19809.

BlackRock Multi-Strategy Hedge Opportunities LLC [File No. 811-21537]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On December
1, 2008, applicant transferred assets of approximately $9,704,202 to
MSHO Liquidating Trust. Also, on December 1, 2008, applicant made a
liquidating distribution in cash to its shareholders, based on net
asset value. Expenses of approximately $85,911 incurred in connection
with the liquidation were paid by applicant and BlackRock Advisors,
LLC, applicant's investment adviser.
    Filing Dates: The application was filed on January 12, 2009, and
amended on April 24, 2009.
    Applicant's Address: 100 Bellevue Parkway, Wilmington, DE 19809.

RIC Coinvestment Fund LP [File No. 811-21900]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On November
28, 2008, applicant made a liquidating distribution to its
shareholders, based on net asset value. Expenses of $64,125 incurred in
connection with the liquidation will be paid by applicant. Applicant
has retained $72,616 in cash to pay outstanding expenses. Any amount
left after payment of outstanding expenses will be distributed pro rata
to applicant's shareholders.
    Filing Dates: The application was filed on January 21, 2009, and
amended on February 2, 2009 and April 10, 2009.
    Applicant's Address: 1345 Avenue of the Americas, 46th Floor, New
York, NY 10105.

Rand Capital SBIC, LP [File No. 811-21097]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Effective
December 31, 2008, applicant and its general partner, Rand Capital
Management, LLC, both wholly-owned subsidiaries of Rand Capital
Corporation, merged into Rand Capital SBIC, Inc. (``Rand SBIC''),
another wholly-owned subsidiary of Rand Capital Corporation. As a
result of the merger, all of applicant's limited and general
partnership interests were converted into common stock of Rand SBIC and
distributed to Rand Capital Corporation. Expenses of $33,300 incurred
in connection with the reorganization were paid by Rand Capital
Corporation.
    Filing Dates: The application was filed on February 13, 2009, and
amended on April 17, 2009 and May 26, 2009.
    Applicant's Address: 2200 Rand Building, Buffalo, NY 14203.

Goldman Sachs Global Equity Long/Short Registered Fund, LLC [File No.
811-21375]; Goldman Sachs Global Relative Value Registered Fund, LLC
[File No. 811-21377]; Goldman Sachs Global Event Driven Registered
Fund, LLC [File No. 811-21378]; Goldman Sachs Global Tactical Trading
Registered Fund, LLC [File No. 811-21379]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants have never made a public offering of their securities and do
not propose to make a public offering or engage in business of any
kind.
    Filing Dates: The applications were filed on March 23, 2009, and
amended on May 21, 2009.
    Applicants' Address: One New York Plaza, 39th Floor, New York, NY
10004.

Man IP 220, LLC [File No. 811-21451]; Man Dual Absolute Return Fund
[File No. 811-22070]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants have never made a public offering of their securities and do
not propose to make a public offering or engage in business of any
kind.
    Filing Date: The applications were filed on May 8, 2009.
    Applicants'Address: 123 N. Wacker Dr., 28th Fl., Chicago, IL 60606.

Pax World Growth Fund, Inc. [File No. 811-8097]; Pax World High Yield
Fund, Inc. [File No. 811-9419]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On April 2, 2007, each applicant
transferred its assets to corresponding series of Pax World Funds
Series Trust I, based on net asset value. Expenses of approximately
$159,000 and $112,000, respectively, incurred in connection with the
reorganizations were paid by each applicant.
    Filing Date: The applications were filed on May 8, 2009.
    Applicants' Address: 30 Penhallow St., Suite 400, Portsmouth, NH
03801.

Access Capital Strategies Community Investment Fund, Inc. [File No.
811-21889]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On July 28,
2008, applicant transferred its assets to Access Capital Community
Investment Fund, a series of Tamarack Funds Trust, based on net asset
value. Expenses of $723,000 incurred in connection with the
reorganization were paid by Voyageur Asset Management Inc., applicant's
subadviser.
    Filing Dates: The application was filed on December 24, 2008, and
amended on May 27, 2009.
    Applicant's Address: 419 Boylston St., Suite 501, Boston, MA 02116.

Separate Account VA-2NL of Transamerica Occidental Life Insurance
Company [File No. 811-07232]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant requests deregistration based on
abandonment of registration. Applicant is not now engaged, or intending
to engage, in any business activities other than those necessary for
winding up its affairs.
    Filing Date: The application was filed on March 11, 2009.
    Applicant's Address: 4333 Edgewood Road NE, Cedar Rapids, IA 52499-
0001.

Separate Account VA-2NLNY of Transamerica Financial Life Insurance
Company [File No. 811-07370]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant requests deregistration based on
abandonment of registration. Applicant is not now engaged, or intending
to engage, in any business activities other than those necessary for
winding up its affairs.
    Filing Date: The application was filed on March 11, 2009.
    Applicant's Address: 100 Manhanttanville Road, Purchase, NY 10577.

Genworth Life & Annuity VA Separate Account 3 [File No. 811-21970]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant requests deregistration based on
abandonment of registration. At the time of filing, applicant had less
than 100 individual contract owners and was not making a public
offering nor was it intending on making a public offering in the future
and thus qualified for an exclusion from the definition of ``investment
company'' in Section 3(c)(1) of the 1940 Act.
    Filing Dates: The application was filed on December 30, 2008, and
amended and restated on February 20, 2009 and May 27, 2009.
    Applicant's Address: 610 West Broad Street, Richmond, Virginia,
23230.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-12996 Filed 6-3-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 164 (Friday, August 27, 2021)]
[Rules and Regulations]
[Pages 48022-48023]
[FR Doc No: 2021-18511]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2021-0640]

Special Local Regulations; Ironman Triathlon, Augusta, GA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notificaion of enforcement of regulation.

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

SUMMARY: The Captain of the Port (COTP) Savannah, Georgia will enforce
a special local regulation for the Ironman Triathlon in Augusta,
Georgia on September 26, 2021, to provide for the safety of life on
navigable waterways during this event. Our regulation for marine events
within the Seventh Coast Guard District identifies the regulated

area for this event in Augusta, GA. During the enforcement periods, the
operator of any vessel in the regulated area must comply with
directions from the Patrol Commander.

DATES: The regulations in 33 CFR 100.701, Table 1 to Sec.  100.701,
Section (d), Item 3, will be enforced from 6:30 a.m. until 11:30 a.m.,
on September 26, 2021.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email MST1 Stephanie Daley, Marine
Safety Unit Savannah Office of Waterways Management, U.S. Coast Guard;
telephone<PHONE_NUMBER>, extension 257, or email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a special local
regulation in 33 CFR 100.701, Table 1 to Sec.  100.701, Section (d),
Item 3, for the Ironman Triathlon, from 6:30 a.m. to 11:30 a.m., on
September 26, 2021.
    This action is being taken to provide for the safety of life on
navigable waterways during this event. Our regulation for marine events
within the Seventh Coast Guard District, 33 CFR 100.701, specifies the
location of the regulated area for the Ironman Triathlon which
encompasses portions of the Savannah River and its branches. During the
enforcement periods, as reflected in 33 CFR 100.701(c), if you are the
operator of a vessel in the regulated area you must comply with
directions from the Patrol Commander. The Coast Guard may be assisted
by other Federal, State, or local law enforcement agencies in enforcing
this regulation.

K.A. Broyles,
Commander, U.S. Coast Guard, Captain of the Port, Savannah, GA.
[FR Doc. 2021-18511 Filed 8-26-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: August 4, 2008 (Volume 73, Number 150)]
[Notices]
[Page 45227-45228]
[DOCID:fr04au08-46]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0387]

Draft Guidance for Industry on Labeling OTC Skin Protectant Drug
Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Labeling OTC
Skin Protectant Drug Products.'' This guidance provides recommendations
on how to label over-the-counter (OTC) skin protectant drug products.
An OTC skin protectant active ingredient can be combined with another
OTC skin protectant active ingredient or OTC external analgesic, first
aid antiseptic, or sunscreen active ingredients. Each of these
combinations has specific labeling requirements, and therefore labeling
of OTC skin protectant drug products is complex. This guidance is
designed to clarify the permitted combinations of active ingredients
along with the corresponding required labeling.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by October 3, 2008.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5424, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Labeling OTC Skin Protectant Drug Products.'' In the Federal
Register of June 4, 2003 (68 FR 33362), FDA published a final rule
establishing conditions under which OTC skin protectant drug products
are generally recognized as safe and effective and not misbranded. In
developing this final rule, FDA acknowledged the complex task that
manufacturers of these products would face in meeting all the pertinent
labeling requirements. This draft guidance provides recommendations on
how to meet current labeling requirements according to OTC skin
protectant active ingredient.
    Because OTC skin protectant active ingredients can be combined with
active ingredients from other OTC drug product categories, this draft
guidance is based upon the following rulemakings: (1) Final rule for
OTC skin protectant drug products (68 FR 33362, June 4, 2003); (2)
final rule for format and content of labeling of OTC drugs (64 FR
13254, March 17, 1999); (3) proposed rule for OTC sunscreen drug
products (72 FR 49070, August 27, 2007); (4) proposed rule for OTC
external analgesic drug products (48 FR 5852, February 8, 1983); and
(5) proposed rule for OTC first aid antiseptic drug products (56 FR
33644, July 22, 1991).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on labeling OTC
skin protectant drug products. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket numbers found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17835 Filed 8-1-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: May 26, 2010 (Volume 75, Number 101)]
[Notices]
[Page 29596-29597]
[DOCID:fr26my10-98]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62138; File No. SR-NASDAQ-2010-059]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify Fees for Members Using the NASDAQ Market Center

May 19, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 14, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') 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 NASDAQ. Pursuant to Section 19(b)(3)(A)(ii) of
the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\ NASDAQ has designated
this proposal as establishing or changing a due, fee, or other charge,
which renders the proposed rule change effective upon filing. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

    NASDAQ proposes to modify pricing for NASDAQ members using the
NASDAQ Market Center. NASDAQ will implement the proposed change on May
17, 2010. The text of the proposed rule change is available at http://
nasdaqomx.cchwallstreet.com/, at NASDAQ's principal office, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, NASDAQ 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. NASDAQ 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
    NASDAQ is proposing to modify its fees for orders that execute at
prices below $1. Currently, NASDAQ charges 0.2% (20 basis points) of
the total dollar value of the execution to members accessing liquidity;
provides a rebate of 0.1% (10 basis points) of the total dollar value
to members providing liquidity; and charges a fee for routing of 0.3%
(30 basis points) of the total dollar value. Through this filing,
NASDAQ will modify the rebate paid to members providing liquidity.
Specifically, the rebate will be $0.00009 per share executed for
securities priced at $0.05 or more but less than $1, and there will be
no rebate for securities priced at less than $0.05. Depending upon the
price of the stock, the change will result in a decrease in the rebate
in most cases but an increase in some cases. The change is designed to
provide a constant per share rebate and to result in a closer alignment
between the size of the rebate and the average quoted spread for
securities trading below $1.\5\
---------------------------------------------------------------------------

    \5\ The change is similar to changes recently made to the
rebates offered by other trading venues. See Securities Exchange Act
Release No. 62050 (May 6, 2010), 75 FR 27029 (May 13, 2010) (SR-ISE-
2010-37); Securities Exchange Act Release No. 62051 (May 6, 2010),
75 FR 27034 (May 13, 2010) (SR-ISE-2010-38); Securities Exchange Act
Release No. 61996 (April 28, 2010), 75 FR 23829 (May 4, 2010) (SR-
NSX-2010-04).
---------------------------------------------------------------------------

2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\6\ in general, and with Section
6(b)(4) of the Act,\7\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which NASDAQ operates or controls. The impact of the price changes upon
the net fees paid by a particular market participant will depend upon a
number of variables, including the relative availability of liquidity
on NASDAQ and other venues, the prices of the market participant's
quotes and orders relative to the national best bid and offer (i.e.,
its propensity to add or remove liquidity), and the types and prices of
the securities that it trades. NASDAQ believes that the proposed
changes are reasonable and equitable in that they

apply uniformly to all similarly situated members.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. Because the market
for order execution and routing is extremely competitive, members may
readily direct orders to NASDAQ's competitors if they object to the
proposed rule change.

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

    Written comments were neither solicited nor 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 Act \8\ and subparagraph (f)(2) of Rule 19b-4
thereunder.\9\ At any time within 60 days of the filing of the proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(a)(ii). [sic]
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2010-059 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2010-059. This
file number should be included on the subject line if e-mail is used.
    To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml ). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of such filing also will be available for inspection and copying at the
principal offices of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2010-059, and should be submitted on or before
June 16, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-12552 Filed 5-25-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 88, Number 59 (Tuesday, March 28, 2023)]
[Notices]
[Pages 18353-18356]
[FR Doc No: 2023-06323]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97186; File No. SR-CboeEDGX-2023-019]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend Its Fee Schedule

March 22, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 9, 2023, Cboe EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    Cboe EDGX Exchange, Inc. (the ``Exchange'' or ``EDGX'') proposes to
amend its fee schedule. The text of the proposed rule change is
provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/edgx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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 its Fee Schedule.\3\ Specifically,
the Exchange proposes to eliminate the rebate currently provided for
the liquidity adding side of Customer-to-Customer orders in Penny and
Non-Penny Securities (currently yielding fee codes PC and NC,
respectively) and to amend the Fee Schedule so that such orders will be
free.
---------------------------------------------------------------------------

    \3\ The Exchange initially filed the proposed fee changes on
February 1, 2023 (SR-CboeEDGX-2023-008). On March 9, 2023, the
Exchange withdrew that filing and submitting this proposal.
---------------------------------------------------------------------------

    The Exchange first notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of 16 options venues to which market participants
may direct their order flow. Based on publicly available information,
no single options exchange has more than 17% of the market share and
currently the Exchange represents only approximately 6% of the market
share.\4\ Thus, in such a low-concentrated and highly competitive
market, no single options exchange, including the Exchange, possesses
significant pricing power in the execution of option order flow. The
Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow or discontinue to reduce use of certain categories of
products, in response to fee changes. Accordingly, competitive forces
constrain the Exchange's transaction fees, and market participants can
readily trade on competing venues if they deem pricing levels at those
other venues to be more favorable.
---------------------------------------------------------------------------

    \4\ See Cboe Global Markets U.S. Options Market Monthly Volume
Summary (March 6, 2023), available at https://markets.cboe.com/us/options/market_statistics/.
---------------------------------------------------------------------------

    The Exchange's Fee Schedule sets forth standard rebates and rates
applied per contract. For example, the Exchange currently provides a
standard rebate of $0.01 per contract for Customer orders that add or
remove liquidity, in both Penny and Non-Penny Securities. The Fee Codes
and Associated Fees section of the Fee Schedule also provides for

certain fee codes associated with certain order types and market
participants that provide for various other fees or rebates.
    The Exchange no longer wishes to provide a rebate for the liquidity
adding side of Customer-to-Customer orders in Penny and Non-Penny
Securities and now proposes to amend its Fee Schedule so that such
orders will be free. As such, the Exchange also proposes to adopt new
fee codes TP and TN, which will apply to the liquidity adding side of
Customer-to-Customer (i.e., ``Customer (contra Customer)'') orders in
Penny and Non-Penny Securities, respectively; the proposed fee codes
assess no fee for such transactions. The Exchange notes that it
currently assesses no charge or a marginal charge on other types of
Customer transactions. For example, the Exchange does not charge a
transaction fee for Complex Customer-to-Customer orders (yielding fee
code ZC). The liquidity removing side of Customer-to-Customer orders in
Penny and Non-Penny Securities, as well as Customer orders that execute
against any Non-Customer as the contra-party in Penny and Non-Penny
Securities will still be eligible for the current rebate (i.e., the
standard rebate of $0.01 per contract). Accordingly, the Exchange
proposes to amend the definition of fee code PC to clarify that such
fee code (and corresponding standard rebate) applies to Customer contra
Non-Customer orders in Penny Securities, as well as the liquidity
removing side of Customer contra Customer orders in Penny Securities.
Similarly, the Exchange proposes to amend the definition of fee code NC
to clarify that such fee code (and related standard rebate) applies to
Customer contra Non-Customer orders in Non-Penny Securities, as well as
the liquidity removing side of Customer contra Customer orders in Non-
Penny Securities.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\5\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \6\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \7\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

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

    As described above, the Exchange operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. The proposed rule change
reflects a competitive pricing structure that is designed to
incentivize market participants to direct their order flow to the
Exchange, which the Exchange believes would enhance market quality to
the benefit of all market participants. While the Exchange is
eliminating a rebate for the liquidity adding side of Customer-to-
Customer orders in Penny and Non-Penny Securities, the Exchange
believes that providing that the liquidity adding side of the order
will instead be free will still continue to incentivize Customer order
flow in Penny and Non-Penny Securities as such Customer orders will
still not be subject to any transaction fees, which may lead to an
increase in liquidity on the Exchange. An overall increase in liquidity
benefits all market participants by providing more trading
opportunities, which attracts Market Makers. An increase in Market
Maker activity in turn facilitates tighter spreads, which may cause an
additional corresponding increase in order flow from other market
participants.
    The Exchange also believes the proposed change to assess no charge
for the liquidity adding side of Customer-to-Customer orders executed
in Penny and Non-Penny Securities is consistent with Section 6(b)(4) of
the Act in that the proposal is reasonable, equitable and not unfairly
discriminatory. The Exchange believes that eliminating the rebate for
the liquidity adding side of Customer-to-Customer orders in Penny and
Non-Penny Securities is reasonable because Customers will continue to
not be subject to any fees for such transactions. Additionally, the
Exchange is not required to maintain this rebate.
    Moreover, it is in line with other types of Customer orders for
which the Exchange does not assess a fee or provide a rebate. As
described above, the Exchange currently does not charge a transaction
fee or provide a rebate for various other Customer orders, including
Complex Customer-to-Customer orders. Further, Customers executing an
order in Penny and Non-Penny Securities with a Non-Customer or
Customers on the liquidity removing side of orders executed in Penny
and Non-Penny Securities will still be eligible for the current rebate,
i.e., a standard rebate of $0.01 per contract.
    The Exchange further believes that continuing to not assess any fee
to any side of a Customer order regardless of whether they are removing
or adding liquidity (as compared to other market participants that must
always pay a fee) is equitable and not unfairly discriminatory because,
as stated above, the Exchange wishes to incentivize (and at least not
discourage) Customer order flow, which can attract liquidity on the
Exchange, in turn providing more trading opportunities and attracting
Market-Makers to facilitate tighter spreads to the benefit of all
market participants. Further, the options industry has a long history
of providing preferential pricing to Customers, and the Exchange's
current Fee Schedule currently does so in many places, as do the fees
structures of multiple other exchanges.\8\ Customers executing an order
in Penny and Non-Penny Securities will continue to either receive the
benefit of a rebate or free transaction, depending on if the order is
removing or adding liquidity and whether they are transacting against a
Customer or Non-Customer.
---------------------------------------------------------------------------

    \8\ See, e.g., EDGX Options Fee Schedule, ``Fee Codes and
Associated Fees'', which, for example, provides Customer AIM Agency
orders (i.e., orders yielding fee code BC) a rebate and also which
assesses no fee (nor provides any rebate) for QCC Agency and Contra
Customer orders (i.e., yielding fee codes QA and QC, respectively).
See also Cboe Options Fees Schedule, Rate Table--All Products
Excluding Underlying Symbol List A, which, for example, assesses no
fee (nor provides any rebate) for Customer orders in equity options.
---------------------------------------------------------------------------

    The Exchange also believes the proposed changes are reasonable,
equitably allocated and not unreasonably discriminatory despite a
proposed distinction between fees for Customer orders that add
liquidity and those that remove liquidity, regardless of the capacity
of the contra party. Particularly, the Exchange believes providing
rebates for the liquidity removing side of an order is reasonable,
equitable and not unfairly discriminatory because it provides an
incentive to bring additional liquidity to the Exchange, thereby
promoting price discovery and enhancing order

execution opportunities for Members. The Exchange believes that not
providing a rebate for orders that add liquidity is reasonable,
equitable and not unfairly discriminatory because the Exchange must
balance the cost of credits for orders that remove liquidity. Further,
the Exchange is not proposing to adopt any fee for the liquidity adding
side of Customer orders, but rather merely removing the current rebate,
which as noted it's not required to maintain.
    The Exchange lastly believes that the proposal to make the
liquidity adding side of Customer-to-Customer orders free is equitable
and not unfairly discriminatory because it will apply equally to all
liquidity adding sides of Customer-to-Customer transactions in Penny
and Non-Penny Securities, i.e., all Customers will be assessed the same
amount (no fee) for these transactions.

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. In particular, the Exchange
believes the proposed rule change does not impose any burden on
intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act. Particularly, the proposal to
eliminate the rebate for the liquidity adding side of Customer-to-
Customer orders executed in Penny and Non-Penny Securities will apply
uniformly to all Customers transacting in Penny and Non-Penny
Securities. As described above, while no fee will continue to be
assessed for Customers, different market participants have different
circumstances, such as the fact that preferential pricing to Customers
is a long-standing options industry practice which serves to enhance
Customer order flow, thereby attracting Market-Makers to facilitate
tighter spreads and trading opportunities to the benefit of all market
participants. In addition to this, the Exchange notes that it currently
assesses no charge and provides no rebate for various other types of
Customer orders that execute against another Customer as a contra
party.
    The Exchange also believes the proposed rule change does not impose
any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As previously
discussed, the Exchange operates in a highly competitive market.
Members have numerous alternative venues they may participate on and
direct their order flow, including 15 other options exchanges.
Additionally, the Exchange represents a small percentage of the overall
market. Based on publicly available information, no single options
exchange has more than 17% of the market share. Therefore, no exchange
possesses significant pricing power in the execution of order flow.
Indeed, participants can readily choose to send their orders to other
exchanges if they deem fee levels at those other venues to be more
favorable. Moreover, the Commission has repeatedly expressed its
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. Specifically,
in Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and, also, recognized
that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' The fact that
this market is competitive has also long been recognized by the courts.
In NetCoalition v. Securities and Exchange Commission, the D.C. Circuit
stated as follows: ``[n]o one disputes that competition for order flow
is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers'. . . .''. Accordingly, the Exchange
does not believe its proposed fee change imposes any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act.

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

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

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 Act \9\ and Rule 19b-4(f)(2) \10\ thereunder.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \10\ 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 such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change 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 (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CboeEDGX-2023-019 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-CboeEDGX-2023-019. 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 (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for 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 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change.

Persons submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CboeEDGX-2023-019 and should
be submitted on or before April 18, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-06323 Filed 3-27-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Pages 20791-20792]
[FR Doc No: 2021-08204]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2021-0018; Notice 1]

Notice of Receipt of Petition for Decision That Nonconforming
Model Year 2020-2021 GMC Sierra 1500 Trucks are Eligible for
Importation

AGENCY: National Highway Traffic Safety Administration, Department of
Transportation (DOT).

ACTION: Receipt of petition.

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

SUMMARY: This document announces the National Highway Traffic Safety
Administration (NHTSA) receipt of a petition for a decision that model
year (MY) 2020-2021 GMC Sierra Trucks (TKs) that were not originally
manufactured to comply with all applicable Federal motor vehicle safety
standards (FMVSS) with a GVWR range of 4,520-5,270 lbs, are eligible
for importation into the United States because they are substantially
similar to vehicles that were originally manufactured for sale in the
United States and that were certified by their manufacturer as
complying with the safety standards (the U.S.-certified version of the
2020-2021 GMC Sierra TKs) and are capable of being readily altered to
conform to the standards.

DATES: The closing date for comments on the petition is May 21, 2021.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and may be
submitted by any of the following methods:
     Mail: Send comments by mail addressed to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590.
     Hand Delivery: Deliver comments by hand to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard along with
the comments. Note that all comments received will be posted without
change to https://www.regulations.gov, including any personal
information provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and

will be considered. All comments and supporting materials received
after the closing date will also be filed and will be considered to the
fullest extent possible.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

FOR FURTHER INFORMATION CONTACT: Robert Mazurowski, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for importation into and sale in the United
States, certified under 49 U.S.C. 30115, and of the same MY as the
model of the motor vehicle to be compared, and is capable of being
readily altered to conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
of each petition that it receives in the Federal Register and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    Diversified Vehicle Services Inc. (DVS), (Registered Importer R-98-
165), of Indianapolis, Indiana has petitioned NHTSA to decide whether
nonconforming 2020-2021 GMC Sierra TKs are eligible for importation
into the United States. The vehicles which DVS believes are
substantially similar are MY 2020-2021 GMC Sierra TKs sold in the
United States and certified by their manufacturer as conforming to all
applicable FMVSS.
    The petitioner claims that it compared non-U.S. certified MY 2020-
2021 GMC Sierra TKs to their U.S. certified counterparts and found the
vehicles to be substantially similar with respect to compliance with
most FMVSS.
    DVS submitted information with its petition intended to demonstrate
that non-U.S. certified MY 2020-2021 GMC Sierra TKs, as originally
manufactured, conform to many applicable FMVSS in the same manner as
their U.S.-certified counterparts, or are capable of being readily
altered to conform to those standards. Specifically, the petitioner
claims that the non-U.S. certified MY 2020-2021 GMC Sierra TKs, as
originally manufactured, conform to: FMVSS Nos.102, Transmission Shift
Position Sequence, Starter Interlock, and Transmission Braking Effect,
103, Windshield Defrosting and Defogging Systems, 104, Windshield
Wiping and Washing Systems, 106, Brake Hoses, 108, Lamps, Reflective
Devices, and Associated Equipment, 110, Tire Selection and Rims and
Motor Home/Recreation Vehicle Trailer Load Carrying Capacity
Information for Motor Vehicles with a GVWR of 4,536 kilograms (10,000
pounds) or Less, 111, Rear Visibility, 113, Hood Latch System, 114,
Theft Protection, 116, Motor Vehicle Brake Fluids, 118, Power-Operated
Window, Partition, and Roof Panel System, 119, New Pneumatic Tires,
124, Accelerator Control Systems, 126, Electronic Stability Control
Systems For Light Vehicles, 135, Light Vehicle Brake Systems, 138, Tire
pressure monitoring systems, 201, Occupant Protection in Interior
Impact, 202, Head Restraints; Mandatory Applicability Begins on
September 1, 2009, 203, Impact Protection for the Driver from the
Steering Control System, 204, Steering Control Rearward Displacement,
205, Glazing Materials, 206, Door Locks and Door Retention Components,
207, Seating Systems, 208, Occupant Crash Protection, 209, Seat Belt
Assemblies, 210, Seat Belt Assembly Anchorages, 212, Windshield
Mounting, 213, Child Restraint Systems, 214, Side Impact Protection,
216, Roof Crush Resistance; Applicable Unless a Vehicle is Certified to
Sec.  571.216a, 219, Windshield Zone Intrusion, 301, Fuel System
Integrity, 302, Flammability of Interior Materials, 49 CFR part 541,
Theft Prevention, and, 49 CFR part 565 VIN Requirements.
    The petitioner also contends that the subject non-U.S. certified
vehicles are capable of being readily altered to meet the following
FMVSS, in the manner indicated:
    FMVSS No. 101, Controls and Displays: the instrument cluster will
require the addition of the word ``BRAKE''.
    The petitioner additionally states a reference and certification
label will need to be added to the left front door post area to meet
the requirements of 49 CFR part 567.

    Authority: 49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49
CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2021-08204 Filed 4-20-21; 8:45 am]
BILLING CODE 4910-59-P