Document ID: EPA-HQ-ORD-2006-0998-0023
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-05-16T04:00Z

April 25, 2007

Minutes of the 

United States Environmental Protection Agency (EPA) 

Human Studies Review Board (HSRB) 

April 10, 2007 Public Teleconference

Docket Number: EPA-HQ-ORD-2006-0998

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

Dates and Times:  	Tuesday, April 10, 2007, 1:00 PM – 3:00 PM 

(See Federal Register Notice – Attachment B) 

Location: 		via teleconference 

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

Attendees: 	Chair: 			Celia B. Fisher, Ph.D. 

Board Members: 	

David C. Bellinger, Ph.D. 

William S. Brimijoin, Ph.D. 

Gary L. Chadwick, PharmD, MPH, CIP 

Janice Chambers, Ph.D., D.A.B.T. 

Richard Fenske, Ph.D., MPH 

Susan S. Fish, PharmD, MPH

Suzanne C. Fitzpatrick, Ph.D., D.A.B.T. 

Kannan Krishnan, Ph.D.

KyungMann Kim, Ph.D., CCRP 

Michael D. Lebowitz, Ph.D., FCCP 

Sean M. Philpott, Ph.D. 

Richard Sharp, 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, Meeting Administrative Procedures, and Meeting
Process

Dr. Celia Fisher (HSRB Chair) opened the teleconference meeting with an
introduction and identification of the HSRB, or Board, members
participating in the call.  Dr. Fisher explained that the purpose of the
meeting was to review and approve the January 24, 2007 draft HSRB
meeting report (Attachment D) and respond to questions raised by EPA’s
Office of Pesticide Programs (OPP).  

Dr. Paul Lewis (Designated Federal Officer [DFO], HSRB, Office of the
Science Advisor [OSA], EPA) thanked Dr. Fisher and the Board for their
participation in the teleconference and the efforts they put into their
review of the report from the January 24, 2007 meeting.  Dr. Lewis
explained that the HSRB is subject to Federal Advisory Committee Act
(FACA) requirements.  As the DFO, Dr. Lewis serves as liaison between
the HSRB and EPA.  He works with the appropriate officials to ensure
compliance with all appropriate ethics regulations.  Each member of the
Board has filed a standard government financial disclosure form that has
been reviewed by EPA to ensure that all ethics disclosures have been
met.

Dr. Lewis asked Board members and public commenters to identify
themselves each time they speak for the purposes of the audio recording
and meeting minutes.  He requested that members of the public hold their
remarks until the designated public comment period and limit their
remarks to 5 minutes.

Dr. Lewis stated that the documents discussed by the HSRB, including the
draft January 24, 2007 HSRB meeting report, are available at the
public docket; the address for the docket was included in the Federal
Register notice announcing this teleconference meeting.  As per FACA
requirements, the meeting minutes will include descriptions of matters
discussed and the conclusions reached by the Board.  As the DFO,
Dr. Lewis will prepare the minutes and have them certified by the HSRB
Chair within 90 calendar days of the meeting.  In addition, the minutes
will be available at the public docket and posted on the HSRB Web site. 

Public Comments

Dr. Fisher invited oral public comment on the January 2007 HSRB meeting
report.  No oral public comments were presented.  

Board Discussion and Decision on Report

Dr. Fisher introduced the written comments submitted by EPA’s Office
of Pesticide Programs (OPP) and stated that these comments would be
discussed during the teleconference.  Dr. Alicia Carriquiry was unable
to attend the teleconference, but sent Dr. Fisher her response to
OPP’s comments.

For the tick repellency study, EMD-003, OPP suggested that the Complete
Protection Time (CPT) range of 6.5 to 12 hours be changed to 6.5 to 15
hours for the pump spray (p. 11, line 28).  This revision was accepted
by the Board.

OPP questioned the Board’s recommendation regarding use of different
statistical analysis procedures across studies EMD-003 and EMD-004, and
protocol SCI-001.  At the January 24, 2007 HSRB meeting, the Board
suggested transitioning to more accurate methods of calculating
efficacy, but recognized that a change in analytical techniques might
limit the ability to compare new studies to older studies and create
confusion for consumers (p. 13, lines 15-20 and p. 19, lines 6-12).  Dr.
Michael Lebowitz questioned how EPA, manufacturers, or investigators can
compare results of new studies to those of older studies and whether
there are clear, easily referenced EPA guidelines regarding appropriate
statistical analysis of efficacy studies.  The HSRB should review any
current EPA guidelines before suggesting changes to the current analysis
processes.  Mr. William Jordan (OPP, EPA) responded that OPP has
internal procedures for conducting efficacy studies that describe how to
conduct statistical analysis.  Given the comments at the January 24,
2007 HSRB meeting and in the Board’s draft meeting report, OPP is
reevaluating this issue.  There are consistency issues regarding
statistical analysis procedures used by different EPA offices.  EPA
intends to address this situation with input from the Board at a future
HSRB meeting.  Questions also have arisen concerning how to reconcile
protection times calculated using previous or current methods with those
determined using new methods.  Mr. Jordan expects that once a plan is
established for the conduct of new studies and analysis of results, EPA
will discuss with the Board this new process.  

Dr. Fisher asked for a description of EPA’s current guidelines and
whether the Board could have access to them.  Mr. Jordan explained that
when EPA receives results from companies, the company has typically
performed a statistical analysis and presents the analysis to EPA.  EPA
evaluates the results, but performs its own analysis if it believes the
approach used by the company is not appropriate.  Mr. Jordan added that
he did not know if there were formal documents describing EPA guidelines
and offered to obtain the information and present it to the HSRB at a
future meeting.   

Dr. KyungMann Kim commented that his impression from the January 24,
2007 HSRB meeting was that the analyses were not checked by an EPA staff
member who is trained in statistics.  He explained that the Kaplan Meier
estimate he described at the January 2007 meeting is not a new
technique, but rather has been widely used for more than 50 years in
human clinical studies.  Mr. Jordan agreed that EPA needs to revisit its
approach to the statistical analysis of these studies.  Work is underway
to address this issue, but no conclusions regarding the use of new
approaches or transitioning to these approaches have been reached.  Dr.
Fisher stated that the HSRB will have difficulty making recommendations
on this matter if specific guidelines for analytical techniques are not
available.  

Mr. Jordan commented that he did not have a full understanding of the
extent to which EPA has consistently used the same approach for
statistical analysis in past years.  In recent years, analyses have been
relatively consistent.  However, in some of the older repellant efficacy
studies evaluated by EPA, the approaches used for statistical analyses
are unknown.  Dr. Lebowitz suggested that the Board should discuss with
members of OPP and any other relevant EPA offices recommended
statistical approaches for efficacy studies at a future meeting.  Dr.
Kannan Krishnan supported this suggestion.  He added that to be fair to
the proponents and OPP, comments related to analyses should be captured
as a separate category in the report rather than being attached to a
particular protocol.  Dr. Fisher stated that she will discuss with
Dr. Lewis and members of OPP how to proceed on this issue during the
next administrative planning teleconference.

The Board discussed limiting comments pertaining to encouraging EPA to
consider different analytical techniques to the HSRB Consensus and
Rationale section of the report.  Redundant verbiage (i.e., p. 12, line
36-45) would be eliminated.  Upon review of the statement in the HSRB
Consensus and Rationale for EMD-003 (p. 13, lines 15-20), the Board
decided to remove the word “recent” and the second sentence was
changed to read, “…how a transition to more appropriate methods of
calculating efficacy for the specific data set can be introduced…” 
Because the issue of encouraging EPA to consider different analytical
techniques pertains to EMD-003, EMD-004, and SCI-001, this change would
be made in all three sections of the report.  

OPP raised questions concerning the HSRB’s comments on the
desirability of serologic or molecular testing to ensure that field
studies were conducted in areas known to be free of vector-borne
diseases.  The Board commented that such studies would have been
desirable for EMD-003 and EMD-004, but lack of such studies did not
appear to compromise the safety of the subjects (p. 21, lines 14-20). 
However, for SCI-001, the Board recommended that mosquitoes be collected
so that serologic or molecular testing could be performed (p. 25, lines
40-42).  OPP believes that these comments are inconsistent.  Three
conditions for testing were discussed, including the following:

Is it sufficient protection if field tests are conducted only in areas
where known vector-borne diseases have not been detected by county and
state health or vector/mosquito control agencies for at least one month?

If #1 is satisfied, are serologic or molecular analyses needed to
confirm the zone is free of known pathogens?

Do serologic or molecular analyses need to always be conducted
post-study to confirm the absence of pathogens for specific mosquitoes
that landed on participants?

Dr. Lebowitz commented that public health agencies usually trap and test
mosquitoes using serologic techniques in addition to monitoring a
sentinel flock and testing them serologically as well.  For the
protection of the subjects, trapping landing mosquitoes for serologic
testing is desirable because it would allow subjects to be warned of the
potential presence of vector-borne pathogens and treated if necessary. 
Option #2 would not be necessary if option #3 was performed.

Dr. Sean Philpott noted that for molecular or serologic testing,
mosquitoes are pooled.  This would provide an alert to the group as a
whole, not to individuals.  He agreed with Dr. Lebowitz that there
should be no requirement to conduct post-study testing if an independent
control agency has confirmed that the test area is pathogen-free in the
previous month.  Dr. Fisher asked Board members to consider whether a
lack of post-study testing would place subjects at unacceptable risk of
harm or if post-study testing would be ideal if possible.  The Board
agreed to change references to “recommended” post-study testing for
SCI-001 (p. 25, line 40) to “suggested” post-study testing.

Dr. Fisher related a series of questions and requests for clarification
from OPP regarding research design comments for SCI-001.  OPP asked
whether the comments made for Experimental design and Statistical
analysis (p. 23, lines 31-39) were consensus recommendations.  Drs.
Fisher and Janice Chambers said that although there is no reason to
believe the products will be more or less effective on a given limb, the
conservative approach would be to randomize the limb used in the testing
protocol.  Dr. Krishnan noted that while randomization is used in the
protocol, it is ignored in the data analysis.  The Board agreed that the
comments under Experimental design should be considered by OPP to be
suggestions, not recommendations.

Concerning the comments under Statistical analysis (p. 23, lines 36-43
and p. 24, lines 1-8), OPP explained that the goal of this research is
to establish CPT and not necessarily to compare CPTs across products. 
Dr. Kim remarked that Board comments should be taken as a suggested
approach to develop more sensitive or appropriate comparisons.  Dr.
Krishnan agreed that the primary objective of the study was to test
efficacy; comparison of products was a secondary goal.  Dr. Fisher
stated that the Board’s recommendation is that if comparisons are
made, use of the analytical approach suggested by the Board should be
considered.

Dr. Fisher introduced discussion on Interpretation of results (p. 24,
lines 9-14).  OPP questioned the Board’s comments concerning whether
the sample used in SCI-001 was a representative sample, considering the
Board had accepted use of a similar sample for EMD-003 and EMD-004.  Dr.
Kim stated that the sample sizes used in EMD-003 and EMD-004 are not
properly justified for statistical analysis.  Measures of variability
and between-treatment effect size are needed to appropriately determine
sample size.  Statements made in the analyses concerning p values and
adequate power are baseless.  Dr. Kim clarified that sample sizes will
be inconsistent across different studies because of differences in
variability and effect size.  The use of the same sample size in all of
these studies indicates that the investigators did not have adequate
justification for sample size.  Submissions of protocols to EPA should
ensure that there is appropriate justification for use of a given sample
size.  Dr. Fisher explained that the Board suggests that EPA consider
these recommendations and asks investigators to provide justification
for their analyses.  The Board will then evaluate whether the data
generated will be useful to EPA.  Board members decided that the report
should include a statement indicating that justification of sample size
and other analytical techniques is essential.

Also under Interpretation of results, the Board considered the
composition of the sample and whether it was representative.  Dr.
Chambers noted that because the sample did not include the elderly,
people sensitive to mosquitoes, children, or pregnant or nursing women,
the sample is not truly representative.  Dr. Fisher remarked that under
the ethics rules applied to these studies, these individuals cannot be
included.  Drs. Susan Fish and Chambers expressed concern about the
small sample size.  In the population, people can vary in their
“attractiveness” to mosquitoes by as much as 100-fold; additionally,
people who are sensitive to mosquito bites probably would not agree to
participate in these studies.  Differences in attractiveness could
impact efficacy of the repellants.  Given this degree of variability in
sensitivity and attractiveness to mosquitoes, it is unlikely that the 10
subjects included in the sample span this range of variability.  Dr.
Fisher agreed that because the sample is unlikely to include individuals
with a wide range of sensitivity, the data must be interpreted
judiciously.  The Board members agreed that the use of “friends,
neighbors, and academic associates” of Dr. Carroll was less of a
concern than that the sample is not a true random sample.  Drs. Chambers
and Kim noted that rarely are truly representative samples used in
intervention studies; they agreed that a statement should be made
concerning interpretation of results, given that the sample is not
random.  The Board agreed to delete the statement concerning the
inclusion of “friends, neighbors, and academic associates” of Dr.
Carroll in the study (p. 24, line 13).

The Board discussed Inclusion/Exclusion criteria (p. 24, lines 26-30). 
Dr. Fisher proposed that the bullet title be changed to “Sample Size
Considerations for Subject Drop-Outs.”  This change was accepted by
the Board.  The Board agreed that better development or explanation of
inclusion/exclusion criteria was needed, along with an explanation of
how data from these individuals would be used in the analysis.

OPP requested clarification of the Board’s comments concerning the
Assumption of normality of CPT measurements (p. 24, lines 31-37).  Dr.
Kim explained that if CPT is determined for SCI-001 the same way as for
EMD-003, the normality assumption is inappropriate.  If the sample size
is only 10 per group, the data will not be normally distributed.  Dr.
Carriquiry’s comments noted that the statistical analysis methods used
in this protocol rely on the assumption that the measurements are
normal.  Because of the small sample size, departures from normality can
have significant consequences on the validity of the proposed
methodology.  The Board agreed to recommend that the appropriate
analyses and models, given the true distribution of the data, should be
used by the investigator.  Dr. Fish proposed the text be changed to,
“In choosing the appropriate statistical analysis methods, one should
consider the distribution of the data.”  The Board agreed to this
change and determined that mention of specific models would be deleted.

The Board agreed to delete the bullets titled Comparison to Ultrathon
(p. 24, lines 44-45) and Typo (p. 24, line 46).  The Board agreed to
accept the typographical changes suggested by OPP.

The Board agreed that the HSRB Consensus and Rationale for Scientific
Considerations (p. 25, lines 2-12) should be modified to indicate that
the Board raised concerns about sample size and statistical design and
analyses that should be addressed; the statement concerning comparison
of the recommendations to Agency guideline requirements should be
deleted.  Dr. Kim questioned the wording of the first bullet under
Scientific Considerations for SCI-001 (p. 3, lines 13-15).  The Board
agreed to delete this bullet.

Dr. Fisher opened discussion on Ethical Considerations for SCI-001.  In
the report, the Board stated that the protocol does not describe how
untreated controls would be recruited (p. 26, lines 11-12).  OPP
requested clarification of the Board’s comments concerning the
qualification of the Independent Investigational Review Board (IIRB) (p.
26, lines 36-40).  OPP asked if the Board was requiring EPA to assess
IIRB qualifications for this protocol.  Dr. Fisher and the Board agreed
that although information on IIRB qualifications would be reassuring, at
this point the statement is a comment, not a recommendation.

Dr. Krishnan asked the Board to discuss the summary comments on page 3
concerning the statistical design of protocol SCI-001 (bullet 1, lines
13-15).  The Board agreed to delete this comment because they currently
do not have information on EPA guidelines concerning statistical design
of efficacy protocols.  They agreed that this issue should be discussed
at a future HSRB meeting.

Dr. Philpott asked for clarification of OPP’s suggested deletion of
Subpart L from the ethical requirements for EMD-003 (p. 16, line 11). 
Subpart L specifically excludes children and nursing or pregnant women
from studies, such as EMD-003.  Dr. Fisher agreed that Subpart L would
not be deleted and that she and Dr. Lewis would discuss with Mr. John
Carley (OPP, EPA) why OPP had indicated in its comments that only
Subpart K applied to the protocol.

Regarding the HSRB Consensus and Rationale for Scientific Considerations
for EMD-004 (p. 19, lines 1-13), no changes were made aside from the
deletion of the comments about use of different statistical analysis
techniques.  No changes were made to the HSRB Consensus and Rationale
for Ethical Considerations for EMD-004 (p. 22, lines 14-26).

Dr. Fisher asked each Board member for their approval of the revised
January 24, 2007 draft meeting report.  All Board members in attendance
at the teleconference meeting approved the report.  Dr. Fisher thanked
Board members for their participation.

Dr. Lewis reminded HSRB members that the next face-to-face meeting would
be held April 18-20, 2007 in Arlington, Virginia.  The June 2007 HSRB
meeting will cover agenda topics and also will provide time for the HSRB
to review and approve the report from the April 2007 meeting.

The meeting was adjourned by the Chair.

Respectfully submitted:

Paul I. Lewis, Ph.D.

Designated Federal Officer

Human Studies Review Board

United States Environmental Protection Agency

Certified to be true by:

Celia B. Fisher, Ph.D.

Chair

Human Studies Review Board

United States Environmental Protection Agency

NOTE AND DISCLAIMER:  The minutes of this public 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 for
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 D 		January 24, 2007 EPA Human Studies Review Board Meeting 

Proposed Final Draft Report 

Attachment A

EPA HSRB Members 

Chair

Celia B. Fisher, Ph.D.

Marie Ward Doty Professor of Psychology

Director, Center for Ethics Education

Fordham University

Bronx, NY 

Vice Chair

William S. Brimijoin, Ph.D. 

Chair and Professor 

Molecular Pharmacology and Experimental Therapeutics

Mayo Foundation

Rochester, MN  

Members

David C. Bellinger, Ph.D. 

Professor of Neurology

Harvard Medical School

Professor in the Department of Environmental Health

Harvard School of Public Health Children's Hospital

Boston, MA

Alicia Carriquiry, Ph.D. *

Professor 

Department of Statistics

Iowa State University

Ames, IA 

Gary L. Chadwick, PharmD, MPH, CIP

Associate Provost

Director, Office for Human Subjects Protection

University of Rochester

Rochester, NY  

Janice Chambers, Ph.D., D.A.B.T.

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, MS  

Richard Fenske, Ph.D., MPH 

Professor

University of Washington

Department of Environmental and Occupational Health Sciences

Seattle, WA 

Susan S. Fish, PharmD, MPH

Associate Professor, Biostatistics & Epidemiology

Boston University School of Public Health

Co-Director, MA in Clinical Investigation

Boston University School of Medicine

Boston, MA 

Suzanne C. Fitzpatrick, Ph.D., D.A.B.T.

Senior Science Policy Analyst

Office of the Commissioner

Office of Science and Health Coordination

U.S. Food and Drug Administration

Rockville, MD  

KyungMann Kim, Ph.D., CCRP

Professor and Associate Chair

Department of Biostatistics & Medical Informatics

School of Medicine and Public Health

University of Wisconsin-Madison

Madison, WI  

Kannan Krishnan, Ph.D.

Professor

Département de santé environnementale et santé au travail

Faculté de médicine 

Université de Montréal

Montréal, QC

Michael D. Lebowitz, Ph.D., FCCP

Professor of Public Health & Medicine

University of Arizona

Tucson, AZ  

Lois D. Lehman-Mckeeman, Ph.D. *

Distinguished Research Fellow, Discovery Toxicology

Bristol-Myers Squibb Company

Princeton, NJ 

Jerry A. Menikoff, M.D. *

Associate Professor of Law, Ethics & Medicine 

Director of the Institute for Bioethics, Law and Public Policy

University of Kansas Medical Center

Kansas City, KS  

Sean M. Philpott, Ph.D.

Policy and Ethics Director

Global Campaign for Microbicides

Program for Appropriate Technology in Health

Washington, DC 

Richard Sharp, Ph.D.

Assistant Professor of Medicine with the Center for Medical Ethics and
Health Policy 

Baylor College of Medicine 

Houston, TX 

* Not in attendance at teleconference

Attachment B

Federal Register Notice Announcing Meeting

Human Studies Review Board (HSRB); Notification of a Public
Teleconference To Review Its Draft Report From the January 24, 2007 HSRB
Meeting   

[Federal Register: March 13, 2007 (Volume 72, Number 48)]

[Notices]

[Page 11358-11359]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13mr07-51]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2006-0998; FRL-8287-2]

Human Studies Review Board (HSRB); Notification of a Public
Teleconference To Review Its Draft Report From the January 24, 2007 HSRB
Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The EPA Human Studies Review Board (HSRB) announces a public
teleconference meeting to discuss its draft HSRB report from the January
24, 2007 HSRB meeting.

DATES: The teleconference will be held on April 10, 2007, from 1 to
approximately 3 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 the DFO at least 10 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 Unit I.D.
of this notice.

FOR FURTHER INFORMATION CONTACT: Members of the public who wish to
obtain the call-in number and access code to participate in the
telephone conference, request a current draft copy of the Board's report
or who wish further information may contact Lu-Ann Kleibacker, EPA,
Office of the Science Advisor, (8105R), Environmental Protection Agency,
1200 Pennsylvania Avenue, NW, Washington, DC 20460; or via
telephone/voice mail at (202) 564-7189. General information concerning
the EPA HSRB can be found on the EPA Web site at   HYPERLINK
"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-2006-0998, by one of the following methods:   HYPERLINK "

http://www.regulations.gov"  

http://www.regulations.gov  Follow the on-line instructions for
submitting comments.

E-mail:   HYPERLINK "mailto:ORD.Docket@epa.gov"  ORD.Docket@epa.gov .

Mail: ORD Docket, Environmental Protection Agency, Mailcode: 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 Avenue, NW,
Washington, DC 20460, Attention Docket ID No. EPA-ORD-2006-0998.
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-2006-0998. 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://www.regulations.gov" 
http://www.regulations.gov , including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov   or e-mail.
The   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
 Web site is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA,
without going through   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov , your e-mail address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet. If you submit an
electronic comment, EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.

I. Public Meeting

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,
especially 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 action.

If you have any questions regarding the applicability of this action 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://www.epa.gov/fedrgstr/"  http://www.epa.gov/fedrgstr/      

Docket: All documents in the docket are listed in the   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is

[[Page 11359]]

restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically in  
HYPERLINK "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), EPA West Building, 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 (202) 566-1744, and the telephone
number for the ORD Docket is (202) 566-1752.

The January 24, 2007 HSRB 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
regulations.gov Web site and the HSRB Internet Home Page at   HYPERLINK
"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.

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 used
that support your views.

    4. Provide specific examples to illustrate your concerns.

    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-2006-0998 in the subject line on
the first page of your request.

1. Oral comments. Requests to present oral comments will be accepted up
to April 3, 2007. To the extent that time permits, interested persons
who have not pre-registered may be permitted by the Chair of the HSRB 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 the person listed under FOR
FURTHER INFORMATION CONTACT no later than noon, eastern time, April 3
2007, in order to be included on the meeting agenda and to provide
sufficient time for the HSRB Chair and HSRB DFO 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 5 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 these
time limitations by having numerous individuals sign up separately to
speak on their behalf. If additional time is available, there may be
flexibility in time for public comments.

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 5 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, April 3, 2007. You should submit your
comments using the instructions in Unit 1.C. of this notice. In
addition, the Agency also requests that person(s) submitting comments
directly to the docket also provide a copy of their comments to the
person 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 January 24, 2007 HSRB meeting. Background on the January 24,
2007 HSRB meeting can be found at Federal Register 71 249, 78200
(December 28, 2006) and at the HSRB Web site   HYPERLINK "

http://www.epa.gov/osa/hsrb/"  

http://www.epa.gov/osa/hsrb/ . The Board may also discuss planning for
future HSRB meetings.

Dated: March 7, 2007.

George Gray,

EPA Science Advisor.

[FR Doc. E7-4565 Filed 3-12-07; 8:45 am]

BILLING CODE 6560-50-P

Attachment C

3/16/07 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

HUMAN STUDIES REVIEW BOARD (HSRB) 

PUBLIC TELECONFERENCE MEETING 

APRIL 10, 2007 

1:00 pm -3:00 pm (Eastern Time) 

HSRB MEETING FOR REVIEW AND APPROVAL OF 

DRAFT JANUARY 24, 2007 HSRB MEETING REPORT * 

HSRB WEB SITE http://www.epa.gov/osa/hsrb/ 

Docket Telephone: (202) 566 1752 

Docket Number: EPA-HQ-ORD-2006-0998 

Meeting location via telephone only 

Members of the public may obtain the call in number at 202-564-7189 

1:00 PM	Introduction and Identification of Board Members – Celia
Fisher, 

Ph.D. (HSRB Chair) 

1:15 PM	Welcome – Warren Lux, MD (Human Studies Research Review
Official, Office of the Science Advisor, [OSA]) 

1:20 PM	Meeting Administrative Procedures - Paul Lewis, Ph.D.
(Designated Federal Officer, HSRB, OSA, EPA) 

1:25 PM	Meeting Process – Celia Fisher, Ph.D. (HSRB Chair) 

1:30 PM	Public Comments 

1:45 PM 	Board Discussion and Decision on Report - Celia Fisher, Ph.D.
(HSRB Chair) 

Completed Insect Repellent Completed Efficacy Studies 

EMD-003 

EMD-004 

Insect Repellent Efficacy Protocol SCI-001 

2:45 PM 	Summary and Next Steps - Celia Fisher, Ph.D. (HSRB Chair) and
Paul Lewis, Ph.D. (Designated Federal Officer, HSRB, EPA) 

3:00 PM 	Adjournment 

* Please be advised that agenda times are approximate. For further
information, please contact the Designated Federal Officer for this
meeting, Paul Lewis via telephone: (202) 564-8381 or email:
lewis.paul@epa.gov.

 

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