

[Federal Register: June 6, 2007 (Volume 72, Number 108)]
[Notices]               
[Page 31323-31325]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jn07-88]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2007-0403; FRL-8322-7]

 
Human Studies Review Board; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency's (EPA or Agency) 
Office of the Science Advisor (OSA) announces a public meeting of the 
Human Studies Review Board (HSRB) to advise the Agency on EPA's 
scientific and ethical reviews of human subjects' research.

DATES: The public meeting will be held from June 27-June 29, 2007 
approximately from 8:30 a.m. to approximately 5:30 p.m., Eastern Time.
    Location: Environmental Protection Agency, Conference Center--Lobby 
Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, 
Arlington, VA 22202.
    Meeting Access: Seating at the meeting will be on a first-come 
basis. To request accommodation of a disability please contact the 
person listed under FOR FURTHER INFORMATION CONTACT at least 10 
business days prior to the meeting, to allow EPA as much time as 
possible to process your request.
    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: Any member of the public who wishes 
further information should contact Paul Lewis, EPA, Office of the 
Science Advisor, (8105R), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 
564-8381; fax: (202) 564 2070; e-mail addresses: lewis.paul@epa.gov. 
General information concerning the EPA HSRB can be found on the EPA Web 
site at http://www.epa.gov/osa/hsrb/.


ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2007-0403, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the on-line 

instructions for submitting comments.
    E-mail: ORD.Docket@epa.gov.
    Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC), 
ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, 
DC 20460.
    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA 
Headquarters Library, Room Number 3334 in the EPA West Building, 
located at 1301 Constitution Ave., NW., Washington DC. The hours of 
operation are 8:30 a.m. to 4:30 p.m. Eastern Standard Time (EST), 
Monday through Friday, excluding Federal holidays. Please call (202) 
566-1744 or e-mail the ORD Docket at ord.docket@epa.gov for 
instructions. Updates to Public Reading Room access are available on 
the Web site (http://www.epa.gov/epahome/dockets.htm).

    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0403. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
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 http://www.regulations.gov or e-mail. The 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 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.

SUPPLEMENTARY INFORMATION:

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.

[[Page 31324]]

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 http://www.epa.gov/fedrgstr/    Docket: All documents in the docket are listed in the http://.

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 http://www.regulations.gov or in hard copy at the ORD Docket, EPA/

DC, Public Reading Room. The EPA/DC Public Reading Room is located in 
the EPA Headquarters Library, Room Number 3334 in the EPA West 
Building, located at 1301 Constitution Ave., NW., Washington, DC. The 
hours of operation are 8:30 AM to 4:30 PM EST, Monday through Friday, 
excluding Federal holidays. Please call (202) 566-1744 or email the ORD 
Docket at ord.docket@epa.gov for instructions. Updates to Public 
Reading Room access are available on the Web site (http://www.epa.gov/epahome/dockets.htm
).

    EPA's position paper(s), charge/questions to the HSRB, and the 
meeting agenda will be available by early June 2007. In addition, the 
Agency may provide additional background documents as the materials 
become available. You may obtain electronic copies of these documents, 
and certain other related documents that might be available 
electronically, from the regulations.gov Web site and the HSRB Internet 
Home Page at 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:
    a. Explain your views as clearly as possible.
    b. Describe any assumptions that you used.
    c. Provide copies of any technical information and/or data you used 
that support your views.
    d. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    e. 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-2007-0403 in the subject line 
on the first page of your request.
    a. Oral comments. Requests to present oral comments will be 
accepted up to June 20, 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 email) to the 
person listed under FOR FURTHER INFORMATION CONTACT no later than noon, 
Eastern Time, June 20, 2007 in order to be included on the meeting 
agenda and to provide sufficient time for the HSRB Chair and HSRB 
Designated Federal Officer (DFO) to review the agenda to provide an 
appropriate public comment period. The request should identify the name 
of the individual making the presentation, the organization (if any) 
the individual will represent, and any requirements for audiovisual 
equipment (e.g. overhead projector, LCD projector, chalkboard). Oral 
comments before the HSRB are limited to five minutes per individual or 
organization. Please note that this limit applies to the cumulative 
time used by 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. Each speaker should bring 25 copies of his or 
her comments and presentation slides for distribution to the HSRB at 
the meeting.
    b. 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 the meeting. 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, June 20, 2007. You should submit your 
comments using the instructions in Unit I.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

    a. Topics for Discussion. The HSRB is a Federal advisory committee 
operating in accordance with the Federal Advisory Committee Act (FACA) 
5 U.S.C. App.2 section 9. The HSRB provides advice, information, and 
recommendations to EPA on issues related to scientific and ethical 
aspects of human subjects research. The major objectives of the HSRB 
are to provide advice and recommendations on: (a) Research proposals 
and protocols; (b) reports of completed research with human subjects; 
and (c) how to strengthen EPA's programs for protection of human 
subjects of research. The HSRB reports to the EPA Administrator through 
EPA's Science Advisor.
    The June 27-29, 2007 meeting of the Human Studies Review Board will 
address scientific and ethical issues surrounding:
     A research proposal from Carroll-Loye Biological Research 
to evaluate the efficacy of two conditionally registered products 
containing picaridin in repelling mosquitoes in the field.
     A research proposal from Insect Control & Research, Inc. 
to evaluate the efficacy of two unregistered products containing 
picaridin in repelling mosquitoes in the field.
     A completed study measuring the effects on human subjects 
of acute inhalation exposure to acrolein. Acrolein is an active 
ingredient used in biocides in agricultural and industrial water supply 
systems and is currently undergoing reregistration.
     Three completed clinical studies of the efficacy and side 
effects of 4-aminopyridine when used as a therapeutic agent to treat 
neurological

[[Page 31325]]

symptoms in patients with either spinal cord injury or multiple 
sclerosis. 4-aminopyridine is an active ingredient used in bird 
repellents that is currently undergoing reregistration.
     Extensive background materials concerning research to 
quantify the level of exposure received by people who mix, load, and 
apply pesticides. These materials, which were prepared by the 
Agricultural Handlers Exposure Task Force and by the Antimicrobial 
Exposure Assessment Task Force, generally explain the scope of the 
research programs being proposed by the Task Forces and describe the 
general scientific framework for conducting the research. In addition, 
each Task Force has provided Standard Operating Procedures which will 
guide the conduct of the studies.
    The Board may also be reviewing draft HSRB reports for subsequent 
Board approval. Finally, the Board may also discuss planning for future 
HSRB meetings.
    b. Meeting Minutes and Reports. Minutes of the meeting, summarizing 
the matters discussed and recommendations, if any, made by the advisory 
committee regarding such matters will be released within 90 calendar 
days of the meeting. Such minutes will be available at http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition, 

information concerning a Board meeting report, if applicable, can be 
found at http://www.epa.gov/osa/hsrb/ or from the person listed under 

FOR FURTHER INFORMATION CONTACT.

    Dated: May 31, 2007.
Kevin Teichman,
Acting EPA Science Advisor.
[FR Doc. E7-10859 Filed 6-5-07; 8:45 am]

BILLING CODE 6560-50-P
