[Federal Register Volume 72, Number 57 (Monday, March 26, 2007)]
[Notices]
[Pages 14101-14103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5492]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2007-0216; FRL-8291-4]


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 on April 18, 2007 from 10 a.m. 
to approximately 5:30 p.m., Eastern Time and April 19-20, 2007 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: [email protected]. 
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-2007-0216, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
    E-mail: [email protected].
    Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC),

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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 [email protected] 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-
2007-0216. 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.

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://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 a.m. to 4:30 a.m. Eastern Standard Time, 
Monday through Friday, excluding Federal holidays. Please call (202) 
566-1744 or e-mail the ORD Docket at [email protected] 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 late March 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-2007-0216 in the subject line 
on the first page of your request.
    a. Oral comments. Requests to present oral comments will be 
accepted up to April 11, 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 Standard Time, April 11, 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

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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 Standard Time, April 11, 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.
    At the April 2007 meeting of the HSRB, EPA will present for HSRB 
review:
     The results of two completed insect repellent efficacy 
studies on an aerosol formulation of the active ingredient IR3535, 
studies which the Agency intends to rely in making registration 
decisions. Protocols for this research were reviewed by the Board at 
its June and October 2006 meetings.
     A proposal for a new field study of the effectiveness of 
products containing oil of lemon eucalyptus in repelling mosquitoes.
     Completed studies of human skin irritation and skin 
sensitization on two pending pesticide products whose use would involve 
extensive dermal exposure. These studies were conducted before the 
effective date of EPA's human studies rules (April 7, 2006).
     EPA's assessment of the need for new research on the 
exposure received by occupational handlers who mix, load, or apply 
agricultural or antimicrobial pesticides.
     An EPA ``draft framework'' concerning best practices for 
recruiting and enrolling subjects in studies of occupational exposure.
    In addition, at the Board's request, EPA will present its 
interpretation and application of the standard in 40 CFR 26.1705: ``EPA 
shall not rely on data from any research initiated after April 7, 2006, 
unless EPA has adequate information to determine that the research was 
conducted in substantial compliance with [EPA's human studies rules].'' 
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: March 19, 2007.
George M. Gray,
Science Advisor.
[FR Doc. E7-5492 Filed 3-23-07; 8:45 am]
BILLING CODE 6560-50-P