Document ID: EPA-HQ-ORD-2008-0629-0022
Agency: epa
Document Type: Notice
Title: Human Studies Review Board (HSRB); Notification of a Public Teleconference To Review Its Draft Report From the October 21-22, 2008 HSRB Meeting
Posted Date: 2008-12-08T05:00Z

[Federal Register: December 8, 2008 (Volume 73, Number 236)]
[Notices]               
[Page 74486-74488]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08de08-50]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2008-0629; FRL-8748-8]

 
Human Studies Review Board (HSRB); Notification of a Public 
Teleconference To Review Its Draft Report From the October 21-22, 2008 
HSRB Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The EPA Human Studies Review Board (HSRB) announces a public 
teleconference meeting to discuss its draft HSRB report from the 
October 21-22, 2008 HSRB meeting.

DATES: The teleconference will be held on December 18, 2008, from 2-5 
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 Paul Lewis 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 information concerning 
submission of relevant written or oral comments is provided in Unit 
I.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, request a current draft copy of the Board's 
report or who wish further information may contact Paul Lewis, EPA, 
Office of the Science Advisor (8105), Environmental Protection Agency, 
1200 Pennsylvania Avenue, NW., Washington, DC 20460; or via telephone/
voice mail at (202) 564-8381 or via e-mail at lewis.paul@epa.gov. 
General information concerning the EPA HSRB can be 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-2008-0629, 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-
2008-0629. 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-
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 that you 
consider to be CBI or otherwise protected through http://

[[Page 74487]]

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.

I. General Information

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. 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.
    1. Oral comments. 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 Paul Lewis 
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 available, there may be flexibility in 
time for public comments.
    2. Written comments. Please submit your comments using the 
instructions in Unit 1.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 Paul Lewis listed under FOR FURTHER 
INFORMATION CONTACT. There is no limit on the length of written 
comments for consideration by the HSRB.

E. Background

    The EPA Human Studies Review Board will be reviewing and approving 
its draft report from the October 21-22, 2008, HSRB meeting. The 
October 2008 meeting reviewed six proposed protocols submitted by the 
Agricultural Handlers' Exposure Task Force (AHETF) that would collect 
data on the exposures received by handlers who apply liquid pesticides 
using airblast equipment with open- or closed-cab vehicles. The AHETF 
indicated that they were planning to conduct research associated with 
these protocols during the 2009 growing season. In order to allow EPA 
adequate time to consider the HSRB's advice and to work with the AHETF 
to make any necessary revisions to the protocols prior to their 
execution, the Agency asked the HSRB to provide a final report as soon 
as possible. Thus, based on these expedited and time critical 
circumstances, the Agency is announcing this teleconference with less 
than 15 calendar days public notice.
    Background on the October 21-22, 2008, HSRB meeting can be found at 
Federal Register 73 180, 53422 (September 16, 2008) and at the HSRB Web 
site http://www.epa.gov/osa/hsrb/. The October 21-22, 2008, meeting 
draft report is now available. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from http://www.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. Finally, the 
Board may also discuss planning for future HSRB meetings.

[[Page 74488]]

    Dated: December 2, 2008.
George Gray,
EPA Science Advisor.
[FR Doc. E8-28983 Filed 12-5-08; 8:45 am]

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