Human Studies Review Board; Notice of Public Meeting, 56527-56528 [E6-15832]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 187 (Wednesday, September 27, 2006)]
[Notices]
[Pages 56527-56528]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15832]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2006-0798; FRL-8223-8]


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 October 18-19, 2006, from 8:30 
a.m. to approximately 5 p.m., eastern time on October 18, 2006, and 
8:30 to approximately 2 eastern time on October 19, 2006.
    Location: One Potomac Yard, 2777 Crystal Drive, Arlington, VA 
22202.
    Meeting Access: Seating at the meeting will be on a first-come 
basis. Individuals requiring special accommodations at this meeting, 
including wheelchair access and assistance for the hearing impaired, 
should contact the Designated Federal Officer (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: Any member of the public who wishes 
further information should contact Maria Szilagyi, Designated Federal 
Officer (DFO), EPA, Office of the Science Advisor, (8105R), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 564-6809; fax: (202) 564 
2070; e-mail addresses: szilagyi.maria@epa.gov. General information 
concerning the EPA HSRB can be found on the EPA Web site at https://
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:
    Internet: https://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
    E-mail: 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 
https://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 https://
www.regulations.gov or e-mail. The https://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 https://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 
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 56528]]

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 https://www.epa.gov/fedrgstr/.
    Docket: All documents in the docket are listed in the https://
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 https://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 (202) 
566-1744, and the telephone number for the ORD Docket is (202) 566-
1752. EPA's position paper(s), charge/questions to the HSRB, and the 
meeting agenda are now available. 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 https://
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.
    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-2006-0798 in the subject line 
on the first page of your request.
    a. Oral comments. Requests to present oral comments will be 
accepted up to October 10, 2006. 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 
DFO listed under FOR FURTHER INFORMATION CONTACT no later than noon, 
eastern time, October 10, 2006, in order to be included on the meeting 
agenda and to provide sufficient time for the HSRB Chair and HSRB 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 5 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 5 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, October 10, 2006. 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 DFO 
listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the 
length of written comments for consideration by the HSRB.

E. Background

    EPA will be presenting for HSRB review the results of a completed 
human toxicity study, evaluating the allergic contact dermatitis 
response in individuals with known sensitivity to hexavalent chromium 
to repeated exposure to a wood treatment solution containing hexavalent 
chromium. In addition, the Board will be asked to review two revised 
research protocols to evaluate the efficacy of new formulations of the 
repellent, IR3535, against ticks and mosquitoes and to advise on a 
draft guidance document explaining to the public how to submit proposed 
and completed human research to EPA for review by the HSRB. Finally, at 
the Board's request, EPA will present the statutory and regulatory 
procedures that EPA and its federal advisory committees are required to 
follow when handling materials claimed to be confidential business 
information (CBI) under FIFRA or other laws. The HSRB intends to 
discuss how it would like to operate in the event that EPA requests the 
Board to review materials containing CBI.

    Dated: September 22, 2006.
George Gray,
Science Advisor.
 [FR Doc. E6-15832 Filed 9-26-06; 8:45 am]
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