Document ID: EPA-HQ-ORD-2006-0998-0001
Agency: epa
Document Type: Notice
Title: Human Studies Review Board; Notice of Public Meeting
Posted Date: 2006-12-28T05:00Z

[Federal Register: December 28, 2006 (Volume 71, Number 249)]
[Notices]               
[Page 78200-78202]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de06-73]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2006-0998'; FRL-8262-7]

 
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 January 24, 2007 from 8:30 a.m. 
to approximately 5:30 p.m., Eastern time.
    LOCATION: Sheraton Crystal City Hotel, 1800 Jefferson Davis 
Highway, Arlington, VA 22202. The telephone number for the Sheraton 
Crystal City Hotel is 703-486-1111.
    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

[[Page 78201]]

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 Lu-Ann Kleibacker, EPA, Office of 
the Science Advisor, (8105R), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 
564-7189; fax: (202) 564 2070; e-mail addresses: 
kleibacker.lu-ann@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-2006-0998, 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., N.W., 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 AM to 4:30 PM Eastern Standard Time (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 website (http://www.epa.gov/epahome/dockets.htm
).

    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 
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, 
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 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 website (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 late December 2006. 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 website 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-2006-

[[Page 78202]]

0998 in the subject line on the first page of your request.
    a. Oral comments. Requests to present oral comments will be 
accepted up to January 17, 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, January 17, 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, January 17, 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 EPA will present for HSRB review the results of two completed 
insect repellent efficacy studies on which it intends to rely in making 
registration decisions. In addition, EPA will present for HSRB review a 
proposal for new research involving a field study to evaluate the 
efficacy of a mosquito repellent. 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 

from the person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: December 21, 2006.
George M. Gray,
Science Advisor .
 [FR Doc. E6-22300 Filed 12-27-06; 8:45 am]

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