January 29, 2007

Minutes of the 

United States Environmental Protection Agency (EPA) 

Human Studies Review Board (HSRB) 

January 18, 2007 Public Teleconference

Docket Number: EPA-HQ-ORD-2006-0798

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

Dates and Times:  	Thursday, January 18, 2007, 1:30 PM – 4:00 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: 	William S. Brimijoin, Ph.D. 

David C. Bellinger, Ph.D. 

Alicia Carriquiry, 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. 

KyungMann Kim, Ph.D., CCRP 

Michael D. Lebowitz, Ph.D., FCCP 

Jerry A. Menikoff, M.D. 

Sean M. Philpott, 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 Board members participating
in the call.  Dr. Fisher explained that the purpose of the meeting was
to review and approve the October 18-19, 2006 draft HSRB meeting report
(Attachment D).  

Following Dr. Fisher’s opening remarks, Dr. William Benson (Acting
Chief Scientist, Office of the Science Advisor [OSA], EPA) thanked HSRB
members for their participation and expressed appreciation for their
comprehensive and thoughtful analyses of topics reviewed by the HSRB. 
He welcomed members of the public to the meeting and informed them that
EPA is fully committed to an open and transparent process.

Dr. Paul Lewis (Designated Federal Officer [DFO], HSRB, 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 October 18-19, 2006 meeting.  Dr. Lewis explained that the HSRB
is subject to Federal Advisory Committee Act (FACA) requirements.  As
the DFO, Dr. Lewis serves as a liaison between the HSRB and EPA.  He
works with the appropriate officials to ensure that all appropriate
ethics regulations are satisfied.  Each member of the Board has filed a
standard government financial disclosure form that has been reviewed by
the Agency to ensure that all ethics disclosures have been met.

Dr. Lewis noted that there would be slight changes in the order of items
listed in the Agenda because of scheduling conflicts.  He 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
October 2006 HSRB meeting report and public comments submitted, 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 October 2006 HSRB meeting
report.  No oral public comments were presented  Dr. Fisher stated that
one written public comment was received from Exponent, Inc. 

Draft EPA Guidance to the Public Concerning Submission of Proposed and
Completed Human Research to EPA for Review by the HSRB

Dr. Fisher requested comments from the Board on the 11 recommendations
made by the HSRB concerning the Draft EPA Guidance to the Public
Concerning Submission of Proposed and Completed Human Research to EPA
for Review by the HSRB and EPA (p. 27-29).  No comments were received
and Dr. Fisher proceeded.

Handling of Material Claimed to be Confidential Business Information
(CBI) for HSRB Consideration

Dr. Fisher asked for comments from the Board on the five recommendations
made to EPA about the handling of material claimed to be CBI (p. 29). 
No comments were received from the Board.  Dr. Fisher added that this
topic would be discussed in more detail at future meetings.  She
indicated that during the Chair’s planning meeting teleconference
between herself and EPA, productive discussions on this topic have
continued and EPA has been responsive to the Board’s concerns about
this issue.

IR3535 Insect Repellent Product Efficacy Protocols

Study EMD-003 from Carroll-Loye Biological Research 

Following a reading by the HSRB Chair of the Board’s conclusions on
the scientific and ethical considerations of study EMD-003 (p. 2, lines
27-41), Dr. Fisher asked for comments from the Board.   No other
comments were received and Dr. Fisher proceeded.

Study EMD-004 from Carroll-Loye Biological Research 

Dr. Fisher read the Board’s conclusions on the scientific and ethical
considerations of study EMD-004 (p. 3, lines 1-18).  Dr. Fisher
requested comments from the Board.  No other comments were received and
Dr. Fisher proceeded.  

Letter to Dr. George Gray, EPA’s Science Advisor

Dr. Fisher informed the Board that EPA had suggested adding a sentence
to the transmittal letter to Dr. Gray.  The sentence should read, “In
addition, at the Board’s request, EPA provided background information
and discussion regarding the handling of material claimed to be CBI.” 
This revision was accepted by the Board.

Chromium Repeat Open Application Test (ROAT)

Dr. Fisher introduced the written comments submitted by Exponent, Inc.
and indicated that the comments provided additional information and
suggested changes to the meeting report for the Board’s consideration.

Dr. Fisher stated that points A, B, C, E, and F on pages 8 and 9 of
Exponent’s report provided comments related to factual details.  She
asked the Board if any of these suggested changes should be incorporated
into the meeting report.  Dr. Richard Fenske discussed Exponent’s
comments.  For Point A, he stated that the Board’s report misstated
the issue associated with the test solution; this mistake should be
corrected.  Thus, the sentence on page 11, lines 24-25 “Ten additional
subjects not sensitive to hexavalent chromium serves as controls using
the highest concentration of copper contained within the wood treatment
solution” was deleted.  Dr. Fenske indicated that Point B was a
clarification; therefore, it was not necessary to include this in the
report.  He stated that Point C provided corrected numbers and
percentages, 

which were initially incorrect in the draft report and thus should be
changed.  Thus page 13, beginning on line 32 should read “There was a
clear gender discrepancy regarding the severity of patch test responses:
for the 1+ responses, 33% occurred in males (11/33), and 67% in females
(22/33); whereas, for the 2+ or 3+ responses, 52% occurred in males
(14/27), and 48% in females (13/27).”  Dr. Fenske noted that Point D
provided a commentary that did not include specific corrections and that
Point F referred to an ethics issue.  Dr. Michael Lebowitz agreed with
Dr. Fenske that the suggested changes provided in Points A and C should
be incorporated into the report.

Dr. Sean Philpott suggested two changes to the report to more accurately
reflect both Exponent’s and the Board’s points of view.  The draft
language (p. 16, line 7) was: “One hundred subjects agreed to
participate and met the initial inclusion criteria.”  Dr. Philpott
recommended that the sentence be changed to:  “100 subjects agreed to
participate and met the initial inclusion criteria, including completion
of chromium sensitivity testing.”  The second change would address
concerns raised by Exponent about issues of verbal consent in the
initial telephone interview (p. 18, lines 8-16).  The draft language (p.
18, line 13-15) was:  “Although verbal consent may have been obtained
for the telephone interview, no documentation of such consent was
provided to the HSRB.”  Dr. Philpott recommended the sentence be
changed to:  “Verbal consent was obtained for the telephone interview,
but no documentation of such consent was provided to the HSRB.”  All
Board members agreed with these corrections.

Dr. Fisher read the Board’s conclusions on the ethical considerations
of the ROAT study (p. 2, lines 12-21).  Dr. Fisher requested any further
comments from the Board on the ethics recommendations for this study. 
No other comments were received.

Dr. Fisher read the Board’s four conclusions on the scientific
considerations of the study and requested Board comments.  No comments
were received on the first and second conclusions; however, discussion
on the third and fourth conclusions ensued. 

Concerning the third conclusion (p. 2, lines 1-6), Exponent’s report
inquired whether it would be possible for EPA to examine each test item
or data to determine whether the response is allergic or irritant.  Dr.
Fenske commented that EPA could not perform a case-by-case evaluation
without employing an expert dermatologist.  He added that he did not
know to what degree the 10 percent minimum elicitation threshold value
(MET10) would be affected if a few cases that would be considered
allergic under the current protocol would instead be considered
irritant.  Dr. Lebowitz agreed that it would be difficult for EPA to
assess individual cases and that the MET10 would not be changed
considerably.  The Board agreed that no changes would be made to the
third conclusion.

Dr. Fisher stated that Exponent’s report devoted several pages to
discussion on the use of the North American Contact Dermatitis Group
(NACDG) database for adjustment or normalization of study results.  She
asked for comments from the Board on the fourth conclusion (p. 2, lines
8-10).  Dr. Fenske explained that the normalization process was
described in Exponent’s original submission, and involves using patch
test data, determining the proportions of responses, and making a
proportional adjustment.  

Dr. Fisher asked for comments from the Board on the fourth conclusion. 
Dr. Fenske commented that the additional information provided by
Exponent was helpful, but the NACDG database was unlikely to be
sufficiently representative of the population to be used to adjust the
numbers that will be used for this risk assessment activity.  The NACDG
database was not designed to collect data from a representative sample
of the United States population.  Dr. Lebowitz agreed that, given the
critical differences in populations, the NACDG database should not be
used for normalization.  Dr. Fisher concluded that the fourth conclusion
would not be modified.

General Board Discussion/Decision

Dr. Fisher summarized the changes to be made to the Board’s report.
The Board agreed to the following changes to the October 2006 meeting
report:

Incorporating the factual information in Points A and C listed on page 8
of Exponent’s report

Accepting Dr. Philpott’s suggested changes to the ethics section on
the chromium repeat open application test, and 

Accepting EPA’s suggested change to the letter to Dr. Gray.  

Dr. Fisher asked each Board member for their approval of the revised
October 18-19, 2006 HSRB draft meeting report.  All Board members in
attendance at the teleconference approved the report.

Dr. Lewis stated that he will work with Dr. Fisher to revise the report
based on the Board’s discussion and decisions at this teleconference. 
He noted that the next face-to-face meeting will be held on January 24,
2007.  

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 		October 18-19, 2006 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.

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, MS 

Richard Fenske, Ph.D., MPH 

Professor

Department of Environmental and Occupational Health Sciences

University of Washington

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., DABT

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  Canada

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.

Associate Professor of Clinical Ethics

Albany Medical College 

Associate Director

Alden March Bioethics Institute

Albany Medical Center 

Albany, NY

Richard Sharp, Ph.D. *

Assistant Professor of Medicine 

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 October 18-19, 2006
HSRB Meeting 

  

[Federal Register: December 26, 2006 (Volume 71, Number 247)]

[Notices]

[Page 77395-77397]

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

[DOCID:fr26de06-50]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2006-0798; FRL-8261-1]

Human Studies Review Board (HSRB); Notification of a Public
Teleconference to Review Its Draft Report from the October 18-19, 2006
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 October
18-19, 2006 HSRB meeting.

DATES: The teleconference will be held on January 18, 2007, from 1:30 to
approximately 4 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 person listed 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; telephone (202)
564-7189 or via e-mail at   HYPERLINK "mailto:kleibacker.lu-ann@epa.gov"
 kleibacker.lu-ann@epa.gov .  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-2006-0798, 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-2006-0798.  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-2006-0798. 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,
including such 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 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 October 18-19, 2006 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 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-2006-0798 in the subject line on
the first page of your request.

 	1. Oral comments.  Requests to present oral comments will be accepted
up to January 11, 2007.  To the extent that time permits, interested
persons who have

[[Page 77397]]

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, January 11, 2007,
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 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 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, January 11, 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 October 18-19, 2006 HSRB meeting.  Background on the October
18-19, 2006 HSRB meeting can be found at Federal Register 71 187, 56527
(September 27, 2006) and at the HSRB Web site   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/ .  Finally,
the Board may discuss planning for future HSRB meetings.

Dated: December 19, 2006.

George M. Gray,

EPA Science Advisor.

[FR Doc. E6-22052 Filed 12-22-06; 8:45 am]

BILLING CODE 6560-50-P

Attachment C

1/08/07

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE MEETING

JANUARY 18, 2006

1:30 pm -4:00 pm (Eastern Time)

HSRB MEETING FOR REVIEW AND APPROVAL OF

DRAFT OCTOBER 18-19, 2006 HSRB MEETING REPORT *

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

Docket Telephone: (202) 566 1752

Docket Number: EPA-HQ-ORD-2006-0798

Meeting location via telephone only

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

1:30 PM 	Introduction and Identification of Board Members – Celia
Fisher, 

Ph.D. (HSRB Chair)

1:45 PM 	Welcome – William Benson, Ph.D. (Acting Chief Scientist,
Office of the 

Science Advisor, [OSA], EPA)

1:55 PM 	Meeting Administrative Procedures – Paul Lewis, Ph.D.
(Designated Federal Officer [DFO], HSRB, OSA, EPA)

2:00 PM 	Meeting Process – Celia Fisher, Ph.D. (HSRB Chair)

2:05 PM 	Public Comments

2:20 PM 	Board Discussion and Decision on Report – Celia Fisher, Ph.D.
(HSRB Chair)

Chromium Repeat Open Application Test

IR3535 Insect Repellent Product Efficacy Protocols

Study EMD-003 from Carroll-Loye Biological Research

Study EMD-004 from Carroll-Loye Biological Research

Draft EPA Guidance to the Public Concerning Submission of Proposed and
Completed Human Research to EPA for Review by the HSRB

Handling of Material Claimed to be Confidential Business Information for
HSRB Consideration

3:45 PM 	Summary and Next Steps – Celia Fisher, Ph.D. (HSRB Chair) and
Paul Lewis, Ph.D. (DFO, HSRB, EPA)

3:50 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:   HYPERLINK
"mailto:lewis.paul@epa.gov"  lewis.paul@epa.gov . 

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