Minutes of the

United States Environmental Protection Agency (EPA)

Human Studies Review Board (HSRB)

December 13, 2010 Public Teleconference Meeting

Docket Number: EPA–HQ–ORD–2010–0919

HSRB Web Site: http://www.epa.gov/osa/hsrb

Committee Members:	(See EPA HSRB Members list – Attachment A)

Date and Time:  	Monday, December 13, 2010, 3:00 p.m. – 4:30 p.m.

(See Federal Register Notice – Attachment B)

Location: 	Via teleconference

Purpose: 	The EPA Human Studies Review Board provides advice,
information, and recommendations on issues related to the scientific and
ethical aspects of human subjects research.

Attendees: 	Chair: 			Sean Philpott, Ph.D., M.S. Bioethics

Vice Chair:		Janice Chambers, Ph.D., D.A.B.T.

Board Members: 	George C.J. Fernandez, Ph.D.

			Vanessa Northington Gamble, M.D., Ph.D.

			Sidney Green, Jr., Ph.D., Fellow ATS

Dallas E. Johnson, Ph.D.

Michael D. Lebowitz, Ph.D., FCCP

José E. Manautou, Ph.D.

Rebecca T. Parkin, Ph.D., M.P.H.

William J. Popendorf, Ph.D.

Virginia Ashby Sharpe, Ph.D.

Meeting Summary:	Meeting discussions generally followed the issues and
general timing as presented in the meeting Agenda (Attachment C), unless
noted otherwise in these minutes.

Introductory Remarks

Mr. Jim Downing (Designated Federal Officer [DFO], Human Studies Review
Board (HSRB), Office of the Science Advisor [OSA], U.S. Environmental
Protection Agency [EPA or Agency]) opened the teleconference meeting and
welcomed Board members on behalf of the EPA Science Advisor Dr. Paul
Anastas and the Program in Human Research Ethics. He noted that the
Agency appreciates the Board members’ time and work in preparing for
the meeting and deliberations. He also welcomed EPA colleagues and
members of the public. The purpose of this teleconference meeting was to
review the decisions made by the Board at the October 27-28, 2010 HSRB
meeting and to finalize the Board report from that meeting.

Meeting Administrative Procedures

As DFO, Mr. Downing serves as the liaison between the HSRB and EPA and
ensures that Federal Advisory Committee Act (FACA) requirements are met.
As DFO, he also works with the appropriate officials to ensure that all
applicable ethics regulations are satisfied. Each Board member has been
briefed on the provisions of the federal conflict of interest laws and
has filed a standard government financial disclosure form that has been
reviewed to ensure that all ethics disclosure requirements have been
met. Mr. Downing reminded participants that meeting times listed on the
agenda would be approximate, and that Board members should introduce
themselves before speaking. At the appropriate time, members of the
public may provide public comments; these must be limited to 5 minutes.

Copies of the meeting materials are available on regulations.gov under
the docket number EPA-HQ-ORD-2010-0919. According to FACA requirements,
meeting minutes, including descriptions of the discussions and
conclusions reached by the Board will be prepared. These minutes will be
certified by the Chair within 90 days of the meeting and posted at
www.regulations.gov and on the HSRB Web site.

Meeting Process

Dr. Sean Philpott explained that the Board would discuss the final draft
Board report, focusing on the charge questions presented to the Board at
the October 2010 meeting and summarizing the Board’s response. The
report is intended to be a summary of the HSRB’s consensus
recommendations and not a detailed technical document. The Agency and
study sponsors have access to detailed meeting minutes for additional
information.

	For each charge question, Board members would have an opportunity to
raise concerns they may have about Board conclusions and rationales. Dr.
Philpott requested that the HSRB focus on substantive changes to the
report that directly affect the Board’s recommendations. Board members
should submit typographical and grammatical corrections to Dr. Philpott
and Mr. Downing via e-mail and they will be incorporated into the final
report.

Public Comments

Dr. Philpott invited public comment on the draft October 2010 HSRB
meeting report. No public comments were presented. Dr. Philpott stated
that one public comment was received via e-mail in response to the
Federal Register announcement of the Board’s teleconference meeting,
but this comment focuses on the question of whether or not compounds
such as the pesticides that the HSRB reviews should be tested on animals
or humans. Because the comment does not relate directly to any of the
issues discussed at the October 2010 meeting, he did not read it into
the record.

Board Discussion and Decision on Final Report

Carroll-Loye Biological Research, Inc. Protocol No Mas-003: Field
Efficacy Test of 16% Para-menthane-3,8-diol (PMD) and 2% Lemongrass
Oil-based Repellent “No Mas” Against Mosquitoes

Dr. Philpott reviewed the Board’s conclusions regarding Carroll-Loye
Biological Research, Inc. protocol No Mas-003, which describes a study
to test the repellent efficacy of a lotion formulation containing 16%
PMD and 2% lemongrass oil (“No Mas”) against three species of
mosquitoes in the field. The Board was asked whether the proposed No
Mas-003 field repellency study, if revised as suggested in EPA’s
review and if the research is performed as described, will likely
generate scientifically reliable data useful for assessing the efficacy
of the tested material in repelling mosquitoes (page 8, line 273). The
Board concluded by concurring with the Agency’s assessment that the
proposed field repellency study protocol is likely to generate such
scientifically reliable data. Dr. Philpott inquired if the Board
members had comments on the Board’s response to the charge question.
The Board members did not have comments on the recommendation or
rationale.

The ethics charge question for this protocol asked whether the research
is likely to meet the applicable requirements of 40 Code of Federal
Regulations (CFR) Part 26, subparts K and L, if the proposed field
repellency study protocol No Mas-003 is revised as suggested in EPA’s
review and if the research is performed as described (page 9, line 309).
The Board concluded that the protocol, if modified in accordance with
EPA and HSRB recommendations, is likely to meet the applicable
requirements. No Board members had comments on the recommendation or
detailed rationale in the report.

Several Board members had recommended, during the report-writing
process, that the HSRB develop a template for writing the scientific
recommendations and rationale similar to the template for responses to
ethics questions. This topic will be included on the administrative
agenda for the January 2011 Board meeting.

Proposed Agricultural Handler Exposure Task Force (AHETF) Scenario and
Protocol AHE-400: Backpack and Handgun Application of Liquid Sprays in
Utility Rights-of-Way

Dr. Philpott explained that AHETF’s proposal presents an agricultural
handler exposure scenario involving backpack and handgun application of
liquid pesticides along utility rights-of-way. Study participants would
be asked to apply and potentially load one of four surrogate pesticides,
with a total of 21 participants (three volunteers each from seven
geographically distinct regions) enrolled using a purposive sampling
method. During the October 2010 HSRB meeting, the Board was asked to
address whether the proposed AHETF Right-of-Way application scenario and
field study proposal AHE-400, if revised as suggested in EPA’s review,
and if the research is performed as described, is likely to generate
scientifically reliable data useful for assessing the exposure of
workers who apply pesticides in utility rights-of-way using backpack or
handgun sprayers (page 13, line 475). The Board concurred with EPA’s
assessment that the proposed scenario and protocol AHE-400 is likely to
generate scientifically reliable data.

Dr. Michael Lebowitz noted that the Board’s recommendation did not
describe adequately the Board’s concerns in its discussions at the
October 2010 HSRB meeting. At that time, the HSRB concluded that the
protocol would provide useful data, but the issue of variability was
raised a number of times in comments, both at the meeting and during
preparation of the draft meeting report. There are only 21 sample points
and the variability is high. If the study was replicated, results also
could vary significantly, and concluding that the data would be
“reliable” would be inappropriate. Dr. Philpott noted that Dr.
Lebowitz had submitted comments during preparation of the report, and he
had made a change in the detailed recommendations and rationale to
remove the phrase “scientifically reliable” so that line 493 (page
13) reads “this protocol will likely generate data that may be useful
for assessing the exposure” of pesticide handlers. Dr. Philpott
suggest that a  similar change be made at lines 486 and 487 (page 13) if
the Board approved.

Dr. Janice Chambers cautioned that by removing the phrase
“scientifically reliable,” the Board would not be addressing the
charge question. Dr. Philpott asked Board members and the Agency staff
on the call for input on whether describing the data only as potentially
useful adequately addresses EPA’s charge. Mr. John Carley (Office of
Pesticide Programs [OPP], EPA) believed that EPA would prefer the HSRB
to address the charge question using the term “scientifically reliable
data.” He noted that although the concerns that the scenario could
result in highly variable data were not without basis, the Board has not
had the same concern about the term “reliable” with similar
scenarios it has reviewed previously. The sample size, with seven
clusters of three, is not statistically less reliable than a
five-by-five sample, and the variability of individual behavior is not
greater than in other scenarios. Dr. Chambers commented that the
proposed locations are more variable than an orchard or row crop field,
but she did not have a problem with the use of the term “reliable”
because this does not mean that every situation would be the same. Dr.
Lebowitz stated that the question concerned EPA’s definition of
“reliable” in the charge question; if trustworthy is meant rather
than reproducible, the response would be different. He did not recall
EPA instructing that the Board use the same words in its responses as in
the charge question.

Dr. Philpott stated that there seemed to be Board consensus that the
study would yield data that is trustworthy and useful for analysis, but
the fundamental concern is that the variability inherent in the
different proposed study environments calls into question the
reproducibility of those data, should this design be replicated. Dr.
William Popendorf suggested that the problem of variability should have
been put into the model that determined the 3X factor, and he was unsure
whether the same expected variability within the data was present in
many other scenarios. If the 3X value is valid, then the mean value of
those data should be as reliable as in any other scenario. Dr. Johnson
responded that the data would be useful, but until the study is
conducted the HSRB will not know whether the data are likely to be
reproducible.

Dr. José Manautou stated that a clear definition of “scientifically
reliable data” was needed. Dr. Chambers responded that the Board
previously had not considered reproducibility when discussing
reliability. Dr. Philpott noted that this case highlights a need for the
Board to define its interpretation of some of the terms in the charge
questions; the Board did not speak to a specific definition of
“scientifically reliable” during the October 2010 HSRB meeting and
therefore it should not be addressed within the meeting report. The
Board’s concerns have been noted by the Agency and will be captured in
the meeting minutes. He proposed that the Board come to consensus on how
to phrase its response to the charge question so that the meeting report
may be finalized. During the next HSRB meeting in January 2011, he will
ask the lead discussants to be explicit about their definitions or
interpretations of the phrase “scientifically reliable data.”

Dr. Lebowitz suggested that the statements in question be reworded to
read “is likely to generate scientific data, reliable in the sense
that it is trustworthy.” Dr. Philpott suggested that the Board not use
a value-laden term like “trustworthy.” Dr. Popendorf suggested that
the statements should be kept as written. Dr. Philpott noted general
consensus that in this case, an acceptable definition of scientific
reliability would be data that are accurate within the context of the
study, but that may not be reproducible should the scenarios be
repeated. He would like to capture this idea in the report so that the
Agency and the sponsors have an accurate assessment of the Board’s
interpretation. Dr. Lebowitz suggested leaving the recommendation as
written, but adding Dr. Philpott’s statement in the detailed
recommendations. Dr. Philpott noted that the report states, on line 507
(page 14): “However, the Board noted a few weaknesses in the proposed
study design. In particular, the variability in individual dermal and
inhalation exposure levels may be extremely high because of the
diversity of terrains and locations selected for the study and the
opportunity for large (but potentially categorical) personal differences
in application practices.” Dr. Lebowitz suggested adding the following
text after this sentence, “As such, results may not be reproducible
should the study be repeated.” Dr. Johnson added that the term
“reliable” might be appropriate and that will be assessed when the
Board reviews the data after the study is conducted. Once the data are
received, it will be clear how accurately exposure can be assessed.

Dr. Philpott suggested that the HSRB recommendation (line 486, page 13)
be changed from “is likely to generate scientifically reliable data”
to “may generate scientifically reliable data.” Drs. Rebecca Parkin,
Chambers, and Manautou agreed. Dr. Philpott stated that with this change
and the addition of the sentence Dr. Lebowitz suggested (above), the
Board achieved consensus that the study may generate scientifically
reliable data, but recognized that a high level of variability that may
result from the diversity of terrain, location, and personal differences
in application practices may call into question the data’s
reproducibility.

The ethics charge question asked whether the proposed scenario and
protocol, if revised as suggested in EPA’s review and if the research
is performed as described, is likely to meet the applicable requirements
of 40 CFR Part 26, subparts K and L (page 14, line 524). The Board
concluded that the protocol, if modified in accordance with EPA and HSRB
recommendations, is likely to meet the applicable requirements. Dr.
Philpott noted that the primary concern raised by the Board was the task
force conclusion that the risk of toxicity from pesticide-handling was
not considered and the risk of surrogate toxicity would not be listed in
the consent forms or the protocol. The HSRB strongly recommended that,
given the scripted nature of the study, the risk of exposure to
pesticides should be categorized as a risk due to study participation,
albeit one that is appropriately minimized. The Board further made minor
suggestions on how the study protocol should be modified, such as
addressing some of the discrepancies noted in the exclusion criteria,
and suggesting that study participants undergo handwashing prior to
eating or smoking to reduce the risk of accidental ingestion of the
surrogate compound. Board members had no further comments or questions
on the recommendation.

Completed Scenario Monograph and Study Report from the Antimicrobial
Exposure Assessment Task Force II (AEATF–II): Dermal and Inhalation
Exposure of Professional Janitorial Workers Applying Liquid
Antimicrobial Products to Indoor Floors Using Bucket and Mop (AEA-03)

Dr. Philpott commented that during the report writing process, Dr.
Popendorf noticed some data entry errors in the presentation of results
from the mop study; these have been adequately resolved. The corrections
did not affect the conclusions nor are they likely to affect the
Board’s recommendation, but there will be changes to EPA’s
presentation on the docket.

The Board was asked to address two scientific charge questions: (1) was
the research reported in the AEATF–II completed study report AEA-03
and associated supplemental reports faithful to the design and
objectives of the protocol and governing documents of the AEATF-II (page
17, line 674); and (2) has the Agency adequately characterized, from a
scientific perspective, the limitations that should be considered when
using these data in estimating exposure of those who apply antimicrobial
floor-cleaning products with mop and bucket (page 18, line 678).

Dr. Popendorf will submit a separate report to the Agency with
recommendations regarding some of the data limitations for the
development of exposure models that he noted at the meeting, but that
the HSRB did not have time to discuss in detail. These are mentioned in
the report as being included in an appendix, but they will be sent to
the Agency separately. The report has been modified accordingly. Line
779 (page 20) has been changed to read “Although not discussed in
detail by the Board at the October 2010 meeting, several of these
factors are discussed in a separate report submitted independently by
HSRB member Dr. William Popendorf to the Agency.” Dr. Chambers
suggested that Dr. Popendorf not be mentioned by name, and Dr. Philpott
agreed to remove his name from the sentence. All Board members will
receive a copy of these recommendations.

In response to the charge questions, the Board concurred with the
Agency’s assessment that the research was conducted in a manner that
was reasonably faithful to the design and objectives of the protocol and
governing documents of the AEATF-II. The Board also concluded that the
Agency had adequately, but not completely, characterized the limitations
on those data that should be considered when using the data in
estimating exposure of those who apply antimicrobial floor-cleaning
products with mop and bucket. Those concerns about factors that may have
been overlooked or underestimated are summarized in the Board’s
detailed recommendations and rationale (page 18, line 694).

Dr. Parkin pointed out that line 737 (page 19), which reads: “However,
although the presumption of proportionality was demonstrated for dermal
exposure and the amount of AI handled, the rationale supporting the
presumption of proportionality for inhalation exposure needs to be
recalculated but based on current data may not be as clear and
consistent as for the dermal exposure,” is unclear. Dr. Popendorf
responded that the need to recalculate arose because the correlation was
based on concentration versus dose, so it did not include time. The
current data do not correlate with the amount of active ingredient
handled (AaiH); based on that, the recalculated data may not correlate
either. He suggested adding “to include duration of exposure” after
the word “recalculated” on line 740 (page 19) and ending the
sentence at that point. Dr. Popendorf suggested that the phrase “but
based on current data may not be as clear and consistent as for the
dermal exposure” be deleted because it is speculation.

Dr. Manautou called the Board’s attention to the sentence on line 713
(page 18) that reads: “While this lack of information places
potentially important limitations on how the inhalation data should be
interpreted, in the professional opinion of at least one Board member
the impact of differences among the test sites are likely to be within a
factor of about two and thus not substantively change the overall mean
exposure levels.” He asked whether it was necessary to stress that
this comment was the opinion of one member. Dr. Philpott responded that
this was an opinion that was not discussed at the meeting and was not
part of the HSRB’s consensus recommendation. Dr. Chambers questioned
whether the Board had phrased anything like that in the past, and Dr.
Philpott replied that it had used this phrasing when there had been
disagreements in response to ethics questions when reviewing pre-rule
studies. Mr. Downing commented that the phrase “in the professional
opinion” had not been used previously by the Board. Dr. Philpott noted
that “in the professional opinion of at least one Board member”
could be changed to state “some Board members felt that…” Several
Board members agreed to this change. However, Dr. Lebowitz questioned
inclusion of the sentence. Dr. Lebowitz stated that most indoor
environment studies show a factor of at least five in difference in air
exchange due to ventilation. Dr. Popendorf asked whether this was in
buildings like those being discussed in this study. Dr. Lebowitz
responded that it was, and that the data were in the EPA Building
Assessment Survey and Evaluation (BASE) database derived from a
discussion of the Integrated Human Exposure Committee of the EPA Science
Advisory Board. It is also included in a 1981 National Academy of
Sciences (NAS) report on indoor pollutants. Dr. Chambers noted that this
should be cross-referenced to add substance to the sentence. Dr.
Lebowitz recommended removing the sentence because the Board has not had
sufficient discussion on the topic. Dr. Philpott noted that if there
were no objections, he would remove the sentence, but suggested that a
reference to the NAS report be included. Dr. Popendorf suggested that a
1981 reference would not be applicable to the buildings under
discussion. Dr. Lebowitz suggested the Integrated Human Exposure
Committee of EPA’s Science Advisory Board and the EPA BASE database be
referenced instead, but he did not have the specific reference.
Dr. Philpott asked Mr. Carley if the Agency would like additional
guidance or references for consideration of the impact of heating,
ventilating, and air conditioning (HVAC) systems on inhalation
exposures. Mr. Carley responded the statement that the topic should be
addressed with greater care is sufficient. Dr. Philpott will delete the
sentence, but asked that Mr. Downing look for the reference that Dr.
Lebowitz mentioned and send it to the HSRB members. Mr. Downing agreed
to do so.

On line 753 (page 19), Dr. Lebowitz suggested removing the phrase “One
Board member observed, however, that” and stating instead that “The
Agency’s reliance on hand wash data should be examined more closely to
ensure that it has not overcorrected face and neck residue estimates.”
Dr. Popendorf questioned the sentence on line 755 that states “Another
Board member questioned whether the model actually supports the
conclusion of proportionality for some of the dermal configurations.”
Dr. Sidney Green, Jr. stated that this sentence may relate to a question
he raised at the meeting regarding a statement made by an EPA presenter
to the effect that the data that would be generated may not be broadly
applicable, but were being used in risk assessment. His concern was that
if not broadly applicable, the data should not be used for risk
assessment. Dr. Parkin commented that her notes indicated that the Board
member who raised the issue was not in attendance. Dr. Philpott noted
that the first sentence under discussion (line 753) could be changed to
“The Agency should carefully examine the hand wash data, however, to
ensure that it does not over-correct for face and neck residue
estimates.” Mr. Carley mentioned that in reviewing the draft, Mr.
Timothy Leighton (OPP, EPA) and he had discussed the sentence, and Mr.
Leighton agrees that the hand wash data may have over-corrected for face
and neck residues. With respect to the sentence on line 755, Mr.
Leighton noted that the Agency’s conclusion was that the data do not
support proportionality for some of the clothing configurations. He
added that the Board and the Agency are in basic agreement about these
points. Dr. Philpott then suggested that the sentence on line 753 be
changed to state that the Agency has already recognized that the hand
wash data may over-correct for face and neck residue estimates. Dr.
Parkin recommended that the sentence on line 755 be simplified to state
that “additionally, the model may not always support the conclusion of
proportionality for all clothing configurations.” The Board members
agreed to these two changes.

The ethics charge question asked whether available information supports
a determination that the study was conducted in substantial compliance
with 40 CFR Part 26, subparts K and L (page 20, line 785). The Board
concurred with the Agency’s assessment that the study was conducted in
substantial compliance with the applicable requirements. The Board’s
detailed response notes that there were three minor protocol deviations,
but that they were unlikely to have affected the integrity of the
research or the safety of the study participants. For future reference,
the HSRB recommended that the sponsors clarify the criteria used to
establish participants’ health status prior to study enrollment. Dr.
Vanessa Northington Gamble noted that number 1(b) was listed twice, on
lines 817 and 832 (page 21). Dr. Philpott had found this error and
corrected it. Board members did not have further comments on the
recommendation or rationale.

Revised Scenario Design and Associated Protocol from the Agricultural
Handler Exposure Task Force (AHETF) Describing Proposed Research to
Monitor Exposure of Workers Who Mix and Load Pesticides Formulated as
Wettable Powders in Water-Soluble Packaging (AHE-120)

Dr. Philpott noted that this was a revised proposal that had originally
been reviewed favorably by the Board at the June 2009 HSRB meeting, but
one of the surrogate pesticides was no longer available in water-soluble
packaging, and the AHETF proposed to substitute three additional
surrogate compounds. The AHETF proposed to change some of the study
sites because of the use patterns of those compounds.

The scientific charge question asked whether the revised task force
protocol and field study proposal, if revised as suggested in EPA’s
review and performed as described, was likely to generate scientifically
reliable data useful for assessing the exposure of handlers who mix and
load pesticides in water-soluble packaging (page 23, line 943). The
Board concluded that it concurred with the Agency’s assessment that
the protocol will generate such scientifically reliable data. The Board
cautioned, however, that these data may not be useful for creating
distributions of worker exposure that are scientifically accurate or
precise. No Board members had comments on the recommendation or
rationale.

The ethics charge question asked if the revised AHETF scenario and field
study proposal AHE-120 is revised as suggested in EPA’s review, and if
it is performed as described, whether the research is likely to meet the
applicable requirements of 40 CFR Part 26, subparts K and L (page 25,
line 1006). The Board concluded that the protocol is likely to meet the
applicable requirements. The HSRB noted that exposure to the surrogate
chemicals should be considered a risk of study participation because of
the scripted nature of the study, and should be listed as such in the
protocol and the informed consent documents. The Board noted that the
risk, however, is appropriately minimized. In addition, the Board raised
concerns about the Institutional Review Board (IRB) review of the
protocol using an expedited procedure and recommended that future
protocol revisions that involve such major changes should be reviewed
under full IRB procedures. Dr. Philpott noted that Dr. Virginia Ashby
Sharpe is leading a small working group to address task force questions
and concerns about how to release individual study exposure data to
study participants; the findings of this group will hopefully be
presented to the HSRB at the January 2011 HSRB meeting or the subsequent
March 2011 teleconference. There were no Board comments on the
recommendation or rationale.

Summary and Next Steps

Mr. Downing noted that the next face-to-face HSRB meeting would be held
on January 26, 2011. The meeting will be held in Arlington, Virginia, at
EPA’s Potomac Yard conference center.

Dr. Philpott asked whether there were any Board member concerns or
questions about the final October 2010 HSRB meeting report. All members
present at the teleconference meeting agreed to accept the report if
amended as discussed.

Dr. Philpott thanked Board members for their participation. The
teleconference meeting was adjourned by the Chair at 4:30 p.m.

Respectfully submitted:

Jim Downing

Designated Federal Officer

Human Studies Review Board

United States Environmental Protection Agency

Certified to be true by:

Sean Philpott, Ph.D., M.S. Bioethics

Chair

Human Studies Review Board

United States Environmental Protection Agency

NOTE AND DISCLAIMER: The minutes of this public teleconference meeting
reflect diverse ideas and suggestions offered by Board members during
the course of deliberations within the meeting. Such ideas, suggestions,
and deliberations do not necessarily reflect definitive consensus advice
from the Board members. The reader is cautioned to not rely on the
minutes to represent final, approved, consensus advice and
recommendations offered to the Agency. Such advice and recommendations
may be found in the final report prepared and transmitted to the EPA
Science Advisor following the public meeting.

Attachments

Attachment A 		HSRB Members

Attachment B 		Federal Register Notice Announcing Meeting

Attachment C 		Meeting Agenda

Attachment A

EPA HUMAN STUDIES REVIEW BOARD MEMBERS

Chair

*Sean Philpott, Ph.D., M.S. Bioethics	Term: 3/27/2006-10/31/2011

Director, Research Ethics

The Bioethics Program

Union Graduate College-Mt. Sinai School of Medicine

Schenectady, NY

Vice Chair

*Janice Chambers, Ph.D., D.A.B.T.	Term: 3/27/2006-10/31/2011

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, MS

Members

*George C.J. Fernandez, Ph.D.	Term: 5/1/2010-8/31/2013

Director, Center for Research Design and Analysis

University of Nevada – Reno

Reno, NV

*Vanessa Northington Gamble, M.D., Ph.D.	Term: 10/19/2009-10/31/2012

University Professor of Medical Humanities

Gelman Library

The George Washington University

Washington, DC

*Sidney Green, Jr., Ph.D., Fellow ATS	Term: 10/19/2009-10/31/2012

Department of Pharmacology

Howard University College of Medicine

Howard University

Washington, DC

*Dallas E. Johnson, Ph.D. 	Term: 8/31/2007-8/31/2013

Professor Emeritus

Department of Statistics

Kansas State University

Manhattan, KS

*Michael D. Lebowitz, Ph.D., FCCP	Term: 3/27/2006-8/31/2012

Retired Professor of Public Health

(Epidemiology) & Medicine & Research Professor of Medicine

University of Arizona

Tucson, AZ

*José E. Manautou, Ph.D.	Term: 5/1/2010-8/31/2013

Associate Professor of Toxicology

Department of Pharmaceutical Sciences

School of Pharmacy, University of Connecticut

Storrs, CT

^Jerry A. Menikoff, M.D. 	Term: 3/27/2006-8/31/2012

Director, Office for Human Research Protections

Department of Health and Human Services

Rockville, MD

*Rebecca T. Parkin, Ph.D., M.P.H	Term: 10/1/2007-8/31/2013

Professorial Lecturer (EOH)

School of Public Health and Health Services

The George Washington University

Washington, DC

*William J. Popendorf, Ph.D.	Term: 10/19/2009-10/31/2012

Professor Emeritus

Department of Biology

Utah State University

Logan, UT

Virginia Ashby Sharpe, Ph.D.	Term: 5/1/2010-8/31/2013

National Center for Ethics in Health Care

Veterans Health Administration

Department of Veterans Affairs

Washington, DC

*^Linda J. Young, Ph.D.	Term: 3/28/2008-8/31/2012

Department of Statistics

Institute of Food and Agricultural Sciences

University of Florida

Gainesville, FL

*Special Government Employee (SGE)

^Not in attendance at the December 13, 2010 teleconference

Attachment B

FEDERAL REGISTER NOTICE ANNOUNCING MEETING

[Federal Register: November 29, 2010 (Volume 75, Number 228)]

[Notices]

[Page 73078-73080]

[DOCID:fr29no10-82]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2010-0919; FRL-9232-5]

Human Studies Review Board (HSRB); Notification of a Public
Teleconference To Review Draft Report From the October 27-28, 2010 HSRB
Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The EPA Human Studies Review Board (HSRB) announces a public
teleconference meeting to discuss its draft report from the October
27-28, 2010 HSRB meeting.

DATES: The teleconference will be held on Monday, December 13, 2010 from
3-5 p.m. (Eastern Time).

Location: The meeting will take place via telephone only.

Meeting Access: For information on access or services for individuals
with disabilities, please contact Lu-Ann Kleibacker at least ten
business days prior to the meeting using the information under FOR
FURTHER INFORMATION CONTACT, so that appropriate arrangements can be
made.

Procedures for Providing Public Input: Interested members of the public
may submit relevant written or oral comments for the HSRB to consider
during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in section
I, under subsection D, of this notice.

FOR FURTHER INFORMATION CONTACT: Members of the public who wish to
receive further information should contact Jim Downing at telephone
number:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail address:   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>, or Lu-Ann Kleibacker
at telephone number:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail
address:   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>; mailing address: U.S. Environmental
Protection Agency, Office of the Science Advisor, Mail Code 8105R, 1200
Pennsylvania Ave., NW., Washington, DC 20460. General information
concerning the EPA HSRB can be found on the EPA Web site at   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.epa.gov/osa/hsrb/"
http://www.epa.gov/osa/hsrb/ .

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2010-0919, 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>.

Mail: ORD Docket, U.S. Environmental Protection Agency, Mail Code
28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

Hand Delivery: EPA Docket Center (EPA/DC), Public Reading Room,
Infoterra Room (Room Number 3334), EPA West Building, 1301 Constitution
Ave., NW., Washington, DC 20460, Attention Docket ID No.
EPA-ORD-2010-0919. Deliveries are only accepted from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. Special
arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to Docket ID No.
EPA-HQ-ORD-2010-0919. 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 comments
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 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. 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.

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who conduct or assess human studies
on substances regulated by EPA or to persons who are or may be required
to conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA) or the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). Since other entities may also be interested,
the Agency has not attempted to describe all the specific entities that
may be affected by this notice. If you have any questions regarding the
applicability of this notice to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How can I access electronic copies of this document and other related
information?

    In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
Federal Register listings at   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.epa.gov/fedrgstr/"
http://www.epa.gov/fedrgstr/ .

Docket: All documents in the docket are listed in the index under the
docket number. Even though it will be listed by title in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Copyright material will be
publicly available only in hard copy. Publicly available docket
materials are electronically available either 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 in hard copy at the ORD Docket, EPA/DC, Public Reading Room,
Infoterra Room (Room Number 3334), 1301 Constitution Ave., NW.,
Washington, DC. The 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 Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the ORD Docket is<PHONE_NUMBER>.

C. What should I consider as 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.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you use that
support your views.

4. Provide specific examples to illustrate your concerns and suggest
alternatives.

5. 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.

D. How may I participate in this meeting?

    You may participate in this meeting by following the instructions in
this section. To ensure proper receipt by EPA, it is imperative that you
identify docket ID number EPA-HQ-ORD-2010-0919 in the subject line on
the first page of your request.

1. Oral comments. Requests to present oral comments will be accepted up
to December 6, 2010. To the extent that time permits, interested persons
who have not pre-registered may be permitted by the HSRB Chair to
present oral comments at the meeting. Each individual or group wishing
to make brief oral comments to the HSRB is strongly advised to submit
their request (preferably via e-mail) to Lu-Ann Kleibacker listed under
FOR FURTHER INFORMATION CONTACT no later than noon, Eastern Time,
December 6, 2010 in order to be included on the meeting agenda and to
provide sufficient time for the HSRB Chair and HSRB Designated Federal
Official to review the meeting agenda to provide an appropriate public
comment period. The request should identify the name of the individual
making the presentation and the organization (if any) the individual
will represent. Oral comments before the HSRB are limited to five
minutes per individual or organization. Please note that this includes
all individuals appearing either as part of, or on behalf of, an
organization. While it is our intent to hear a full range of oral
comments on the science and ethics issues under discussion, it is not
our intent to permit organizations to expand the time limitations by
having numerous individuals sign up separately to speak on their behalf.
If additional time is available, public comments may be possible.

2. Written comments. Although you may submit written comments at any
time, for the HSRB to have the best opportunity to review and consider
your comments as it deliberates on its report, you should submit your
comments at least five business days prior to the beginning of this
teleconference. If you submit comments after this date, those comments
will be provided to the Board members, but you should recognize that the
Board members may not have adequate time to consider those comments
prior to making a decision. Thus, if you plan to submit written
comments, the Agency strongly encourages you to submit such comments no
later than noon, Eastern Time, December 6, 2010. You should submit your
comments using the instructions in section I, under subsection C, of
this notice. In addition, the Agency also requests that persons
submitting comments directly to the docket also provide a copy of their
comments to Lu-Ann Kleibacker or Jim Downing listed under FOR FURTHER
INFORMATION CONTACT. There is no limit

on the length of written comments for consideration by the HSRB.

E. Background

    The EPA Human Studies Review Board will be reviewing its draft
report from the October 27-28, 2010 HSRB meeting. The Board may also
discuss planning for future HSRB meetings. Background on the October
27-28, 2010 HSRB meeting can be found at Federal Register 75 193, 61748
(October 6, 2010) and at the HSRB Web site   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.epa.gov/osa/hsrb/"
http://www.epa.gov/osa/hsrb/ . The October 27-28, 2010 meeting draft
report is now available. You may obtain electronic copies of this
document and certain other related documents that might be available
electronically from 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 and the HSRB Internet home page at   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.epa.gov/osa/hsrb/"
http://www.epa.gov/osa/hsrb/ . For questions on document availability or
if you do not have access to the Internet, consult the person listed
under FOR FURTHER INFORMATION CONTACT.

Dated: November 19, 2010.

Paul T. Anastas,

EPA Science Advisor.

[FR Doc. 2010-29814 Filed 11-26-10; 8:45 am]

BILLING CODE 6560-50-P

Attachment C

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (EPA)

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE MEETING

Monday, December 13, 2010

3:00 p.m. - 5:00 p.m. (Eastern Time)*

HSRB MEETING FOR REVIEW AND APPROVAL OF THE

DRAFT OCTOBER 27-28, 2010 HSRB MEETING REPORT

HSRB Web Site: http://www.epa.gov/osa/hsrb/

Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA–HQ–ORD–2010–0919

Meeting location via telephone only

3:00 PM	Convene Meeting and Identification of Board Members – Jim
Downing (Designated Federal Officer [DFO], HSRB, Office of the Science
Advisor [OSA], EPA)

3:10 PM*	Meeting Administrative Procedures – Jim Downing (HSRB DFO)

3:15 PM	Meeting Process – Sean Philpott, Ph.D. (HSRB Chair)

3:20 PM	Public Comments

3:30 PM	Board Discussion and Decision on Final Report – Sean Philpott,
Ph.D. (HSRB Chair)

The Board’s response to EPA charge questions presented at the October
27-28, 2010 meeting.

Carroll-Loye Biological Research, Inc. Protocol No Mas 003, a Field
Efficacy Test of PMD and Lemongrass Oil-based Repellent “No Mas”
Against Mosquitoes

Charge to the Board:

If the proposed field repellency study protocol No Mas 003 is revised as
suggested in EPA’s review and if the research is performed as
described:

Is the research likely to generate scientifically reliable data, useful
for assessing the efficacy of the tested material in repelling
mosquitoes?

Is the research likely to meet the applicable requirements of 40 CFR
part 26, subparts K and L?

A new scenario design and associated protocol from the Agricultural
Handler Exposure Task Force (AHETF) to measure dermal and inhalation
exposure to applicators who use backpack sprayers or hand gun sprayers
to apply pesticides in utility rights-of-way

Charge to the Board:

If the proposed AHETF Right-of-Way application scenario and field study
protocol AHE400 is revised as suggested in EPA’s review and if it is
performed as described:

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of workers who apply pesticides in utility
rights-of-way with backpack or hand gun sprayers?

Is the research likely to meet the applicable requirements of 40 CFR
part 26, subparts K and L?

Completed scenario monograph and study report from the Antimicrobial
Exposure Assessment Task Force II (AEATF–II): Dermal and Inhalation
Exposure of Professional Janitorial Workers Applying Liquid
Antimicrobial Products to Indoor Floors Using Bucket and Mop

Charge to the Board:

In the completed scenario monograph and study report AEA03 from the
AEATF–II:

Was the research reported in the AEATF–II completed study report AEA03
and associated supplemental reports faithful to the design and
objectives of the protocol and governing documents of AEATF-II?

Has the Agency adequately characterized, from a scientific perspective,
the limitations on these data that should be considered when using the
data in estimating exposure of those who apply antimicrobial
floor-cleaning products with mop and bucket?

Does available information support a determination that the study was
conducted in substantial compliance with 40 CFR 26, subparts K and L?

Revised scenario design and associated protocol from the Agricultural
Handler Exposure Task Force (AHETF) describing proposed research to
monitor exposure of workers who mix and load pesticides formulated as
wettable powders in water-soluble packaging

Charge to the Board:

If the revised AHETF scenario and field study proposal AHE120 is revised
as suggested in EPA’s review, and if it is performed as described:

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of handlers who mix and load pesticides in
water-soluble packaging?

Is the research likely to meet the applicable requirements of 40 CFR
part 26, subparts K and L?

4:55 PM	Summary and Next Steps – Sean Philpott, Ph.D. (HSRB Chair) and
Jim Downing (HSRB DFO)

5:00 PM 	Adjournment

* Please be advised that agenda times are approximate. For further
information, please contact the Designated Federal Officer for this
meeting, Jim Downing via telephone:<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>
  PAGE  1


[Federal Register Volume 76, Number 74 (Monday, April 18, 2011)]
[Notices]
[Pages 21784-21785]
[FR Doc No: 2011-9315]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64294; File No. SR-Phlx-2011-53]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NASDAQ OMX PHLX LLC Relating
to Amending the Option Floor Procedures Advice F-14 Regarding Executing
Hedge and Synthetic Options Orders Containing Stock Components

April 13, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on April 8, 2011, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Exchange
filed the proposal pursuant to Section 19(b)(3)(A) of the Act \3\ and
Rule 19b-4(f)(6) thereunder.\4\ 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).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend the Option Floor Procedures Advice
F-14 regarding executing hedge and synthetic options orders containing
stock components.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings,
at the principal office of the Exchange, 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 purpose of the proposed rule change is to amend the Exchange's
Option Floor Procedures Advice F-14 (the ``OFPA F-14'') regarding
executing hedge and synthetic options orders containing stock
components. Specifically, the Exchange proposes to modify the
requirement that once the credit or debit execution price to a hedge or
synthetic options order is agreed upon, the stock portion of the order
must be effected prior to the execution of the option portion.\5\
Instead, the Exchange proposes to require that the stock portion of the
order, if any, must be executed at or near the same time as the options
portion.
---------------------------------------------------------------------------

    \5\ See Options Floor Procedures Advice F-14(d).
---------------------------------------------------------------------------

    The qualified contingent trade exemption (``QCT Exemption'') \6\
exempts the component orders of a qualified contingent trade (``QCT'')
from the trade [sic] provisions of Rule 611 of

Regulation NMS.\7\ As provided in the QCT Exempt [sic] Order, a QCT is
a transaction that consists of two or more component orders that
satisfy the requirements of a QCT in the QCT Exemption Order. In the
QCT Exemption Order, the definition of a QCT requires that the
execution of one component is contingent upon the execution of all
components at or near the same time.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 54389 (August 31),
71 FR 52829 (September 7, 2006), amended by Securities Exchange Act
Release No. 57620 (April 4, 2008), 73 FR 19271 (September 7,
2006)(``QCT Exemption Order'').
    \7\ 17 CFR 242.611.
---------------------------------------------------------------------------

    Currently, OFPA F-14 provides that the stock portion of the hedge
or synthetic options order must be executed prior to the options
portion of the order. The Exchange proposes to amend OFPA F-14 to more
closely align OFPA F-14 with the language of the QCT Exemption by
stating the stock portion of a hedge or synthetic options order must
trade at or near the same time as the options order. The Exchange notes
that compliance with OFPA F-14, by itself, is not sufficient to qualify
for the QCT Exemption. A transaction must satisfy all the requirements
of the QCT Exemption Order to qualify for the QCT Exemption. The
Exchange notes that the proposed amendment to OFPA F-14 does not modify
the terms of Exchange Rule 1064, Commentary .04 in that the members
must continue to comply with all procedures concerning tied hedge
orders.\8\
---------------------------------------------------------------------------

    \8\ A tied hedge order is an options order that is tied to a
hedge transaction as defined in Commentary .04 to rule 1064,
following the receipt of an options order in a class determined by
the Exchange as eligible for ``tied hedge'' transactions. See
Exchange Rule 1066(f)(4). Commentary .04 to Rule 1064 further states
that Rule 1064(d) does not prohibit a member or member organization
from buying or selling a stock, security futures or futures position
following receipt of an option order, including a complex order, but
prior to announcing such order to the trading crowd, provided that,
among other things, all tied hedge transactions (regardless of
whether the option order is a simple or complex order) are treated
the same as complex orders for purposes of the Exchange's open
outcry allocation and reporting procedures. Tied hedge transactions
are subject to the existing NBBO trade-through requirements for
options and stock, as applicable, and may qualify for various
exceptions; however, when the option order is a simple order the
execution of the option leg of a tied hedge transaction does not
qualify it for any NBBO trade-through exception for a Complex Trade.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \9\ in general, and furthers the objectives of Section
6(b)(5) of the Act \10\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest by deleting obsolete language that is relied upon to execute
orders that are outside the PHLX market. Modifying OFPA F-14 as
proposed will promote efficiency, eliminate confusion and prevent
potential trade-through violations within the marketplace.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    No written comments were either solicited or received.

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

    The Exchange has designated the proposed rule change as one that
does not: (i) Significantly affect the protection of investors or the
public interest; (ii) impose any significant burden on competition; and
(iii) become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, if consistent
with the protection of investors and the public interest. Therefore,
the proposed rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6). Rule 19b-4(f)(6)(iii) also requires
the self-regulatory organization to provide the Commission with
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange satisfied this requirement.
---------------------------------------------------------------------------

    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.

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-Phlx-2011-53 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-Phlx-2011-53. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will be available for inspection and copying at the principal office of
the Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
Phlx-2011-53 and should be submitted on or before May 9, 2011.

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

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

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-9315 Filed 4-15-11; 8:45 am]
BILLING CODE 8011-01-P


"King, Heidi R."<EMAIL_ADDRESS> 05/29/2008 08:40 AM

To

Ron Evans/RTP/USEPA/US@EPA

cc

Rosalina Rodriguez/RTP/USEPA/US@EPA, Charles Fulcher/RTP/USEPA/US@EPA, Brian Heninger/DC/USEPA/US@EPA, Kathy Kaufman/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, Charles Fulcher/RTP/USEPA/US@EPA, Rosalina Rodriguez/RTP/USEPA/US@EPA, Tom Walton/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA

Subject

RE: Pb RIA Chapters for OMB

Hi Ron, Hope you had a good weekend

When I opened the files last week, the formatting was wonky and I

assumed these were still being edited --

I'll call

heidi

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Wednesday, May 28, 2008 4:41 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Subject: Re: Pb RIA Chapters for OMB

Heidi,

Have you had the opportunity to review these yet?   I know we are still

awaiting word on the C-R question but are we good on the front piece?

Ron

             Kathy

             Kaufman/RTP/USEP

             A/US                                                    To

                                      "King, Heidi R."

             05/19/2008 11:51<EMAIL_ADDRESS>

             AM                                                      cc

                                      Brian Heninger/DC/USEPA/US@EPA,

                                      Darryl

                                      Weatherhead/RTP/USEPA/US@EPA,

                                      Lydia Wegman/RTP/USEPA/US@EPA,

                                      Neal Fann/RTP/USEPA/US@EPA, Ron

                                      Evans/RTP/USEPA/US@EPA, Rosalina

                                      Rodriguez/RTP/USEPA/US@EPA, Tom

                                      Walton/RTP/USEPA/US@EPA, Tricia

                                      Crabtree/RTP/USEPA/US@EPA,

                                      Charles Fulcher/RTP/USEPA/US@EPA

                                                                Subject

                                      Re: Pb RIA Chapters for OMB

                                      (Document link: Ron Evans - New)

Heidi -- here's the chapters of the RIA with the new frontpiece

(chapters 1, 5, 6, 7, and the Exec Summary), as well as the new chapter

4 with added tables.  I just sent it through Eileen Pritchard in OPEI,

but in the interest of time am also forwarding courtesy copies directly

to you.

Thanks.

-- Kathy

[attachment "Pb RIA Exec Summ Draft 5-19-08.doc" deleted by Ron

Evans/RTP/USEPA/US] [attachment "Pb RIA Chapter 1 draft 5-19-08.doc"

deleted by Ron Evans/RTP/USEPA/US] [attachment "Pb RIA Chapter 4 Draft

5-19-08.doc" deleted by Ron Evans/RTP/USEPA/US] [attachment "Pb RIA

Chapter 5 Draft 5-19-08.doc" deleted by Ron Evans/RTP/USEPA/US]

[attachment "Pb RIA Chapter 6 Draft 5-19-08.doc" deleted by Ron

Evans/RTP/USEPA/US] [attachment "Pb RIA Chapter 7 Draft 5-19-08.doc"

deleted by Ron Evans/RTP/USEPA/US]

Kathy Kaufman

EPA/OAQPS Mail Code C539-03

Research Triangle Park, NC 27711

Phone<PHONE_NUMBER>

Fax<PHONE_NUMBER>


[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95618-95620]
[FR Doc No: 2016-31322]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1179; FDA-2016-E-1181; FDA-2016-E-1182]

Determination of Regulatory Review Period for Purposes of Patent
Extension; IMLYGIC

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for IMLYGIC and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are

incorrect may submit either electronic or written comments and ask for
a redetermination by February 27, 2017. Furthermore, any interested
person may petition FDA for a determination regarding whether the
applicant for extension acted with due diligence during the regulatory
review period by June 26, 2017. See ``Petitions'' in the SUPPLEMENTARY
INFORMATION section for more information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2016-E-1179, FDA-2016-E-1181, and FDA-2016-E-1182 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; IMLYGIC.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
biological product will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product IMLYGIC
(talimogene laherparepvec). IMLYGIC is indicated for the local
treatment of unresectable cutaneous, subcutaneous, and nodal lesions in
patients with melanoma recurrent after initial surgery. Subsequent to
this approval, the USPTO received patent term restoration applications
for IMLYGIC (U.S. Patent Nos. 7,063,835; 7,223,593; and 7,537,924) from
BioVex Limited, and the USPTO requested FDA's assistance in determining
the patents' eligibility for patent term restoration. In a letter dated
July 12, 2016, FDA advised the USPTO that this human biological product
had undergone a regulatory review period and that the approval of
IMLYGIC represented the first permitted commercial marketing or use of
the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
IMLYGIC is 3,809 days. Of this time, 3,352 days occurred during the
testing

phase of the regulatory review period, while 457 days occurred during
the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: May 25,
2005. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 25,
2005.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): July 28, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
IMLYGIC (BLA 125518) was initially submitted on July 28, 2014.
    3. The date the application was approved: October 27, 2015. FDA has
verified the applicant's claim that BLA 125518 was approved on October
27, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,826 days, 1,764 days, or 1400 days,
respectively, of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31322 Filed 12-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Notices]
[Pages 7817-7818]
[FR Doc No: 2017-01351]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER16-2293-003.
    Applicants: Drift Sand Wind Project, LLC.
    Description: Notice of Non-Material Change in Status of Drift Sand
Wind Project, LLC.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5175.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-787-000.
    Applicants: Southern California Edison Company.
    Description: Tariff Cancellation: Termination of 3 DSAs with ECOS
Energy, LLC to be effective 3/15/2017.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5127.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-788-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: DSA Wildomar Solar Project
SA No. 939 to be effective 3/15/2017.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5128.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-789-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: GIA and Distribution Service
Agmt Richard Moss to be effective 1/17/2017.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5129.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-790-000.
    Applicants: Cimarron Bend Wind Project II, LLC.
    Description: Baseline eTariff Filing: MBR Tariff to be effective 3/
1/2017.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5133.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-791-000.
    Applicants: Duke Energy Florida, LLC.
    Description: Sec.  205(d) Rate Filing: DEF-U.S. EcoGen Polk LGIA SA
No. 180 to be effective 3/14/2017.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5152.
    Comments Due: 5 p.m. ET 2/3/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 13, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-01351 Filed 1-19-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Pages 72503-72504]
[FR Doc No: 2023-23178]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3597-EM; Docket ID FEMA-2023-0001]

South Carolina; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of South Carolina (FEMA-3597-EM), dated August
31, 2023, and related determinations.

DATES: The declaration was issued August 31, 2023.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated

August 31, 2023, the President issued an emergency declaration under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:

    I have determined that the emergency conditions in certain areas
of the State of South Carolina resulting from Hurricane Idalia
beginning on August 29, 2023, and continuing, are of sufficient
severity and magnitude to warrant an emergency declaration under the
Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (``the Stafford Act''). Therefore, I declare
that such an emergency exists in the State of South Carolina.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), including direct Federal assistance, under the Public
Assistance program in selected areas and emergency protective
measures (Category B), limited to direct Federal assistance, under
the Public Assistance program in the remaining areas.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Brian F.
Schiller, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of South Carolina have been
designated as adversely affected by this declared emergency:

    Allendale, Bamberg, Barnwell, Beaufort, Berkeley, Calhoun,
Charleston, Clarendon, Colleton, Darlington, Dillon, Dorchester,
Florence, Georgetown, Hampton, Horry, Jasper, Lee, Marion, Marlboro,
Orangeburg, Sumter, and Williamsburg Counties for emergency
protective measures (Category B), including direct federal
assistance, under the Public Assistance program.
    Abbeville, Aiken, Anderson, Cherokee, Chester, Chesterfield,
Edgefield, Fairfield, Greenville, Greenwood, Kershaw, Lancaster,
Laurens, Lexington, McCormick, Newberry, Oconee, Pickens, Richland,
Saluda, Spartanburg, Union, and York Counties for emergency
protective measures (Category B), limited to direct federal
assistance, under the Public Assistance program.

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

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-23178 Filed 10-19-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: December 7, 2005 (Volume 70, Number 234)]
[Notices]
[Page 72824]
[DOCID:fr07de05-73]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application To Amend License and Soliciting Comments,
Motions To Intervene, and Protests

November 29, 2005.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-project use of project lands and waters.
    b. Project No.: 271-084.
    c. Date Filed: November 7, 2005.
    d. Applicant: Entergy Arkansas, Inc. (Entergy).
    e. Name of Project: Carpenter-Remmel Project.
    f. Location: The project is located on the Quachita River in Hot
Springs and Garland Counties, Arkansas. The project does not occupy any
Federal or tribal lands. The proposed non-project use would be located
on Hamilton Lake near the town of Hot Springs in Garland County,
Arkansas.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a) through
825(r).
    h. Applicant Contact: Blake Hogue, Lakes and Property Coordinator,
Hydro Operations, Entergy Arkansas, Inc., 141 West County Line Road,
Malvern, AR 72104. Phone:<PHONE_NUMBER>.
    i. FERC Contact: Gina Krump<EMAIL_ADDRESS>202-502-6704.
    j. Deadline for filing comments and or motions: December 30, 2005.
    All documents (original and eight copies) should be filed with Ms.
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's website under the ``e-Filing'' link. Please reference
``Carpenter-Remmel Project, FERC Project No.271-084'' on any comments
or motions filed.
    k. Description of the Application: Entergy requests Commission
approval to permit Hunnicutt Development, Inc. (HDI) to construct two
docks with 11 boat slips and a 500-foot-long boardwalk to be used by
patrons of a new condominium development known as Woodland Estates. HDI
also proposes to place riprap along the entire length of the boardwalk
to stabilize the shoreline. No dredging or other shoreline development
activities are proposed.
    l. Locations of the Application: This filing is available for
review at the Commission in the Public Reference Room or may be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY,

contact<PHONE_NUMBER>. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', OR ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. Any of the above-named documents must be filed
by providing the original and the number of copies provided by the
Commission's regulations to: The Secretary, Federal Energy Regulatory
Commission, 888 First Street NE., Mail Stop PJ-12.1, Washington, DC
20426. A copy of any motion to intervene must also be served upon each
representative of the Applicant specified in the particular
application.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6939 Filed 12-6-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Rules and Regulations]
[Pages 9814-9815]
[FR Doc No: 2013-03123]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0031]

Drawbridge Operating Regulations; Gulf Intracoastal Waterway,
Belle Chasse, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice for temporary deviation from regulation; change of
effective period.

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SUMMARY: The Coast Guard is modifying the effective date of a published
temporary deviation from the operating schedule that governs the
Louisiana State Route 23 (LA 23) vertical lift span bridge, also known
as the Judge Perez Bridge, across the Gulf Intracoastal Waterway
(Algiers Alternate Route), mile 3.8, at Belle Chasse, Plaquemines
Parish, Louisiana. The modification of the effective period is
necessary to further minimize the effects on navigation caused by the
temporary deviation. The deviation is necessary to complete scheduled
repairs necessitated by a bridge allision. This deviation allows the
bridge to remain closed to navigation for eight consecutive days
starting February 23, 2013, in order to perform scheduled maintenance.

DATES: This deviation amends the deviation published at 78 FR 6208 on
January 30, 2013, and establishes the effective period of the deviation
as being from 6 a.m. on Saturday, February 23, 2013, until 6 a.m. on
Sunday, March 3, 2013.

ADDRESSES: The docket for this notice, USCG-2013-0042, is available
online at www.regulations.gov by typing in the docket number in the
``SEARCH'' box and clicking ``SEARCH.'' Click on Open Docket Folder on
the line associated with this notice. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email David Frank, Bridge Administration
Branch, Coast Guard, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Barbara Hairston, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION: On January 30, 2013, the Coast published a
notice of temporary deviation from regulation in the Federal Register
(78 FR 6208-6209). C.E.C., Inc, on behalf of the Louisiana Department
of Transportation and Development (LDOTD) has requested a temporary
deviation in order to perform maintenance on the State Route 23 (LA 23)
vertical lift span bridge, also known as the Judge Perez Bridge, across
the Gulf Intracoastal Waterway (Algiers Alternate Route), mile 3.8, at
Belle Chasse, Plaquemines Parish, Louisiana. Now, C.E.C, on behalf of
LDOTD has requested to adjust the dates of the impending closure
forward one day to better serve the general public with the proposed
closure. The modification of the schedule has been vetted with waterway
users and no objections were received with regards to the proposed
change in schedule. This modified deviation will still allow the bridge
to remain closed to navigation for eight consecutive days in order to
perform scheduled maintenance, but the start date is now February 23,
2013, and the end date is now March 3, 2013.
    Notices of the deviation schedule will be published in the Eighth
Coast Guard District Local Notice to Mariners and will be broadcast via
the Coast Guard Broadcast Notice to Mariners System.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This

deviation from the operating regulations is authorized under 33 CFR
117.35.

    Dated: February 4, 2013.
David M. Frank,
Bridge Administrator, Eighth Coast Guard District.
[FR Doc. 2013-03123 Filed 2-11-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: September 27, 2006 (Volume 71, Number 187)]
[Notices]
[Page 56571]
[DOCID:fr27se06-145]

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SECURITIES AND EXCHANGE COMMISSION

[(Release No. 34-54475; File No. SR-CBOE-2005-103)]

 Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Granting Approval of Proposed Rule Change and
Amendment No. 1 Thereto To Amend CBOE Rules Relating to the Electronic
Designated Primary Market Maker Program

September 20, 2006.

I. Introduction

    On December 5, 2005, the Chicago Board Options Exchange,
Incorporated (``CBOE'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change, pursuant
to Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'')
\1\ and Rule 19b-4 thereunder,\2\ to amend CBOE rules relating to the
Electronic Designated Primary Market Maker Program (``e-DPM Program'').
On August 11, 2006, CBOE amended the proposed rule change.\3\ The
proposed rule change, as modified by Amendment No. 1, was published for
comment in the Federal Register on August 18, 2006.\4\ The Commission
received no comments on the proposal. This order approves the proposed
rule change, as amended.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaced and superseded the original
proposal in its entirety.
    \4\ See Securities Exchange Act Release No. 54311 (August 11,
2006), 71 FR 47834.
---------------------------------------------------------------------------

II. Description of the Proposal

    The Exchange's e-DPM Program allows e-DPMs to operate remotely as
competing DPMs by entering bids and offers electronically from
locations other than the trading floor. Exchange rules provide that the
Exchange will determine which option classes to include in the e-DPM
Program and, accordingly, which classes to allocate to each respective
e-DPM. The proposed rule change would give the Exchange the
corresponding authority to remove any e-DPM option class from the e-DPM
Program if certain factors no longer warranted the continued inclusion
of that option class in the e-DPM Program. The factors used in making
this determination would relate to the option class itself and would
include only the following: (i) Market share; (ii) number of exchanges
trading the product; (iii) average daily trading volume; and (iv)
liquidity in the product. The Exchange would consider any one or all of
these factors in determining whether to remove an option class from the
e-DPM Program. Persons who are aggrieved by the removal of an option
class from the e-DPM Program would be permitted to appeal the decision
in accordance with the Exchange's standard procedures on review of
Exchange actions, as set forth in Chapter XIX of the Exchange's rules.

III. Discussion

    After careful consideration, the Commission finds that the proposed
rule change, as amended, is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities exchange.\5\ In particular, the Commission finds that the
proposal is consistent with Section 6(b)(5) of the Act,\6\ in that it
is designed to promote just and equitable principles of trade and to
remove impediments to and perfect the mechanism of a free and open
market. The Commission also finds that the proposal is consistent with
Section 6(b)(7) of the Act,\7\ in that it provides a fair procedure for
the limitation by the Exchange of any person with respect to access to
services offered by the Exchange.
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    \5\ In approving the proposed rule change, the Commission has
considered its impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ 15 U.S.C. 78f(b)(7).
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    The proposed rule change permits the Exchange to remove option
classes from the e-DPM Program only if certain factors no longer
warrant the continued inclusion of that class in the program. The
Commission notes that the factors to be considered by the Exchange
(i.e., market share, number of exchanges trading the product, trading
volume, and liquidity) are objective and would limit the Exchange's
ability to act in this area. The proposed factors to be considered by
the Exchange in determining whether to remove an option class from the
e-DPM Program, coupled with the right to appeal the Exchange's
determination, should help to protect persons from an unfair limitation
of access to services offered by the Exchange, while permitting the
Exchange to further the competitive goals of the e-DPM Program.
Accordingly, the Commission believes that the amended proposal is
consistent with the Act.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\8\ that the proposed rule change (SR-CBOE-2005-103), as amended,
be, and it hereby is, approved.
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    \8\ 15 U.S.C. 78s(b)(2).
    \9\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
Nancy M. Morris,
Secretary.
 [FR Doc. E6-15794 Filed 9-26-06; 8:45 am]

BILLING CODE 8010-01-P