Document ID: EPA-HQ-ORD-2008-0033-0001
Agency: epa
Document Type: Notice
Title: Human Studies Review Board; Notice of Public Meeting
Posted Date: 2008-03-07T05:00Z

[Federal Register: March 7, 2008 (Volume 73, Number 46)]
[Notices]               
[Page 12413-12415]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr08-78]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2008-0033; FRL-8539-8]

 
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 review of human subjects research.

DATES: The public meeting will be held from April 9-April 10, 2008 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.

[[Page 12414]]

    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-2008-0033, 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. 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 Web site (http://www.epa.gov/epahome/dockets.htm).
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2008-0033. 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 will be 
available by mid March 2008. 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 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-2008-0033 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 1, 2008. To the extent that time

[[Page 12415]]

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, April 1, 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, Eastern Time, April 1, 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.
B. Topics for Discussion
    The EPA will present for HSRB review scientific and ethical issues 
surrounding:
     An update on revisions to the EPA document, ``Scientific 
and Ethical Approaches for Observational Exposure Studies,'' which the 
HSRB previously reviewed and commented on at the October 24-26, 2007 
HSRB meeting.
     Two closely related product-specific reports from a single 
completed field study by Carroll-Loye Biological Research of the 
mosquito repellent efficacy of two registered pesticide products 
containing Deet.
     A research proposal from Insect Control & Research, Inc. 
to evaluate the laboratory efficacy in repelling stable flies of a 
registered pesticide product containing picaridin.
     Two research proposals from the Antimicrobial Exposure 
Assessment Task Force II (AEATF) to monitor exposures of subjects who 
apply an antimicrobial pesticide by wiping and by mopping. The AEATF 
proposals will consist of multiple documents including a ``Governing 
Document'' describing the larger research initiative of which these two 
studies are a part, a set of ``Standard Operating Procedures'' for the 
execution of the studies, a ``Scenario Justification'' describing the 
AEATF's rationale for key elements of each study design, and protocols 
for the mop study and for the wipe study.
    In addition, the Agency will report to the Board on how it has 
resolved issues relating to the design of sampling strategies for 
handler research programs proposed by the Agricultural Handlers 
Exposure Task Force and the Antimicrobials Exposure Assessment Task 
Force II. Finally, the HSRB may also discuss planning for future HSRB 
meetings.

C. 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: February 14, 2008.
George Gray,
Science Advisor.
 [FR Doc. E8-4583 Filed 3-6-08; 8:45 am]

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