Document ID: EPA-HQ-ORD-2009-0030-0001
Agency: epa
Document Type: Notice
Title: Meetings: Human Studies Review Board; Teleconference
Posted Date: 2009-01-30T05:00Z

[Federal Register: January 30, 2009 (Volume 74, Number 19)]
[Notices]               
[Page 5653-5655]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ja09-49]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2009-0030; FRL-8769-9]

 
Human Studies Review Board (HSRB); Notice of a Public 
Teleconference Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

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. The HSRB will 
hold a Public teleconference to discuss two completed field studies by 
Carroll-Loye Biological Research of mosquito repellent efficacy, and 
spatial insect repellent technology.

DATES: The teleconference will be held on February 17, 2009, from 11:30 
to approximately 4 p.m. (Eastern Time).
    Location: The meeting will take place via telephone only.
    Meeting Access: For information on access or services for 
individuals with disabilities, please contact Lu-Ann Kleibacker prior 
to the meeting using the information under FOR FURTHER INFORMATION 
CONTACT, so that appropriate arrangements can be made.
    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

[[Page 5654]]

information concerning submission of relevant written or oral comments 
is provided in section D. of this notice.

FOR FURTHER INFORMATION CONTACT: Members of the public who wish to 
obtain the call-in number and access code to participate in the 
telephone conference, or who wish further information may contact Lu-
Ann Kleibacker, EPA, Office of the Science Advisor (8105), 
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460; or via telephone/voice mail at (202) 564-7189 or 
via e-mail at kleibacker.lu-ann@epa.gov. General information concerning 
the EPA HSRB is 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-2009-0030, by one of the following methods:
    http://www.regulations.gov: Follow the on-line instructions for 
submitting comments.
    E-mail: ORD.Docket@epa.gov.
    Mail: ORD Docket, Environmental Protection Agency, Mailcode: 
28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    Hand Delivery: EPA Docket Center (EPA/DC), Public Reading Room, 
Infoterra Room (Room Number 3334), EPA West Building, 1301 Constitution 
Avenue, NW., Washington, DC 20460, Attention Docket ID No. EPA-ORD-
2009-0030. Deliveries are only accepted from 8:30 a.m. to 4:30 p.m., 
Monday through Friday, excluding legal holidays. Special arrangements 
should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0030. 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.

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 
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 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, Infoterra Room (Room Number 3334), 1301 
Constitution Ave., NW., Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the ORD Docket is (202) 566-
1752.

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 you use 
that 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. For information on access to the teleconference, 
please contact Lu-Ann Kleibacker prior to the meeting using the 
information under FOR FURTHER INFORMATION CONTACT.

1. Oral Comments

    Requests to present oral comments will be accepted up to February 
9, 2009. 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 Lu-Ann Kleibacker listed under FOR 
FURTHER INFORMATION CONTACT in order to be included on the meeting 
agenda and to provide sufficient time for the HSRB Chair and HSRB DFO 
to review the meeting agenda to provide an appropriate public comment 
period. The request should identify the name of the individual making 
the presentation and the organization (if any) the individual will 
represent. Oral comments before the HSRB are limited to 5 minutes per 
individual or organization. Please note that this includes 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 the time limitations by 
having numerous individuals sign up separately to speak on their 
behalf. If additional time is

[[Page 5655]]

available, there may be flexibility in time for public comments.

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, EST, 
February 9, 2009. To ensure proper receipt of all written material by 
EPA, it is imperative that you identify docket ID number EPA-HQ-ORD-
2009-0030 in the subject line on the first page of your submission. In 
addition, the Agency also requests that person(s) submitting comments 
directly to the docket also provide a copy of their comments to Lu-Ann 
Kleibacker listed under FOR FURTHER INFORMATION CONTACT. There is no 
limit on the length of written comments for consideration by the HSRB.

E. Background

1. 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 reports from a completed field study of mosquito 
repellent efficacy (SPC-001) and a completed laboratory study of tick 
repellent efficacy (SPC-002) conducted by Carroll-Loye Biological 
Research using multiple skin-applied repellent products containing 
picaridin. In addition, the HSRB will consider and discuss general 
information about ``spatial'' or ``area'' insect repellent products and 
their testing, in preparation for expected future reviews of proposals 
for field efficacy testing of spatial repellents. Insect repellent 
testing reviewed by the Board in past meetings has concerned only skin-
applied repellents, which differ in important ways from spatial 
repellents. Finally, the HSRB may also discuss planning for future HSRB 
meetings.

2. Meeting Minutes and Reports

    Minutes of the meeting, summarizing the matters discussed and 
recommendations made, if any, 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: January 26, 2009.
Kevin Teichman,
EPA Acting Science Advisor.
 [FR Doc. E9-2037 Filed 1-29-09; 8:45 am]

BILLING CODE 6560-50-P