
[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]               
[Page 32461-32463]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn10-91]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2010-0381; FRL-9159-9]

 
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 research with human subjects.

DATES: The public meeting will be held on June 23, 2010, from 
approximately 10 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 section 
I., under subsection D., SUPPLEMENTARY INFORMATION of this notice.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes 
further information should contact Jim Downing, EPA, Office of the 
Science Advisor, (8105R), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 
564-2468; fax: (202) 564-2070; e-mail addresses: downing.jim@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-2010-0381, 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 20460. The hours 
of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, 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-
2010-0381. 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 the 
disclosure of which 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

[[Page 32462]]

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 20460. 
The hours of operation are 8:30 am to 4:30 p.m. 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). EPA's position paper(s), charge/
questions to the HSRB, and the meeting agenda will be available by 
early June 2010. 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 EPA HSRB Web site 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:
    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 that you 
used to 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-2010-0381 in the subject line 
on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to June 16, 2010. 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 
person listed under FOR FURTHER INFORMATION CONTACT no later than noon, 
Eastern Time, June 16, 2010, 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.
    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 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 16, 2010. You should submit your 
comments using the instructions in section I., under subsection C., 
``What should I consider as I prepare my comments for EPA?'' above in 
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

    1. 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: (1) Research proposals 
and protocols; (2) reports of completed research with human subjects; 
and (3) 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 its meeting on June 23, 2010, EPA's Human Studies Review Board 
will consider scientific and ethical issues surrounding these topics:
    (a) The unpublished report of the completed Carroll-Loye Biological 
Research, Inc. study LNX-002: Field Repellency of Two Picaridin-Based 
Personal Insect Repellents to Black Flies. The protocol for this study 
was

[[Page 32463]]

reviewed favorably by the HSRB at their meeting in June 2009. EPA seeks 
the advice of the HSRB on the scientific soundness of this completed 
study for use to estimate the duration of complete protection against 
black flies provided by the tested repellents, and on whether available 
information supports a determination that the study was conducted in 
substantial compliance with subparts K and L of 40 CFR part 26.
    (b) The unpublished report of the completed Carroll-Loye Biological 
Research, Inc. study LNX-003: Laboratory Repellency of Two Picaridin-
Based Personal Insect Repellents to Two Species of Ticks. The protocol 
for this study was reviewed favorably by the HSRB at their meeting in 
October 2009. EPA seeks the advice of the HSRB on the scientific 
soundness of this completed study for use to estimate the duration of 
complete protection against ticks provided by the tested repellents, 
and on whether available information supports a determination that the 
study was conducted in substantial compliance with subparts K and L of 
40 CFR Part 26.
    (c) In addition, EPA will present to the HSRB update reports on two 
topics of interest:
    (1) The revised guideline for performance testing of topically 
applied repellent products, for use by investigators and sponsors of 
new studies
    (2) The terms of a recent settlement of litigation related to EPA's 
2006 rule for the protection of human subjects of research, in which 
EPA has agreed to initiate rulemaking to amend the 2006 rule.
    2. 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.

Kevin Teichman,
EPA Science Advisor.
[FR Doc. 2010-13684 Filed 6-7-10; 8:45 am]
BILLING CODE 6560-50-P

