Document ID: EPA-HQ-ORD-2008-0629-0001
Agency: epa
Document Type: Notice
Title: Human Studies Review Board; Notice of Public Meeting
Posted Date: 2008-09-16T04:00Z

[Federal Register: September 16, 2008 (Volume 73, Number 180)]
[Notices]               
[Page 53422-53424]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se08-47]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2008-0629; FRL-8716-5]

 
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 review of human subjects research.

DATES: The public meeting will be held from October 21-22, 2008, from 
8:30 a.m. to approximately 5:30 p.m., Eastern Standard Time (EST).
    Location: Environmental Protection Agency, Conference Center--Lobby

[[Page 53423]]

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.
    Addresses: Submit your written comments, identified by Docket ID 
No. EPA-HQ-ORD-2008-0629, by any of the following methods:
    Internet: http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
    E-mail: ORD.Docket@epa.gov.
    USPS Mail: Environmental Protection Agency, EPA Docket Center (EPA/
DC), ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.
    Hand or Courier 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., 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-
2008-0629. 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 through 
http://www.regulations.gov or e-mail that you consider to be CBI or 
otherwise protected from disclosure. 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.

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/.

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 particular interest to persons who conduct or assess 
human studies, especially studies on substances regulated by EPA and to 
persons who may sponsor or conduct research with human subjects with 
the intention to submit it to EPA for consideration under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) or section 408 
under the Federal Food, Drug, and Cosmetic Act (FFDCA). 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?

    You may access this Federal Register document electronically either 
through http://www.regulations.gov or through the EPA Web site 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 under the docket number. Even though it will 
be listed by title in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Copyright 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 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 are 
anticipated to be available by late September 2008, if not earlier. 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 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.

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 our 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.

[[Page 53424]]

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-2008-0629 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 14, 2008. 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, October 14, 2008 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 multiple individuals sign up separately to speak on their 
behalf. Each speaker should bring 25 copies of his or her comments and 
presentation slides for distribution to the HSRB at the meeting. At the 
discretion of the Board Chair and DFO, public commenters, if present 
during the Board's discussion, may be asked to provide clarification of 
their comments to assist the Board in their discussion.
    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, EST, October 14, 2008. 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. Human Studies Review Board
    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 EPA will present for HSRB review scientific and ethical issues 
surrounding:
     The scenario design document and three associated 
protocols from the Agricultural Handlers Exposure Task Force (AHETF) 
for research to monitor the exposure of subjects in closed cabs who 
apply an agricultural pesticide using airblast equipment. The scenario 
design document is identical to the one that was reviewed by the HSRB 
in June 2008, except that chlorothalonil has been added to the list of 
test chemicals.
     The scenario design document and three associated 
protocols from the AHETF for research to monitor exposure of subjects 
in open cabs who apply an agricultural pesticide using airblast 
equipment.
     The report from a completed field study (LNX-001) by 
Carroll-Loye Biological Research of the mosquito repellent efficacy of 
two pesticide products containing picaridin. The HSRB previously 
reviewed the proposed study at its June 2007 meeting.
    The Agency will brief the HSRB on its draft document, Guideline for 
Efficacy Testing of Skin-Applied Repellents. The guideline provides 
recommendations for the design and execution of studies to evaluate the 
performance of pesticide products intended to repel insects and other 
arthropods. In addition, the Board may be reviewing its draft meeting 
report from the June 24-25, 2008 HSRB meeting for subsequent Board 
approval. Finally, the HSRB 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.

    Dated: September 4, 2008.
George Gray,
Science Advisor.
[FR Doc. E8-21590 Filed 9-15-08; 8:45 am]

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