[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Pages 48683-48684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19815]



[EPA-HQ-ORD-2010-0617; FRL-9188-3]

Human Studies Review Board (HSRB); Notification of a Public 
Teleconference To Review Draft Final Report From the June 23, 2010 HSRB 

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


SUMMARY: The EPA Human Studies Review Board (HSRB) announces a public 
teleconference meeting to discuss its Draft HSRB Final Report from the 
June 23, 2010 HSRB meeting.

DATES: The teleconference will be held on Thursday, September 9, 2010, 
from 1:30-3 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 at 
least 10 business days 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 section 
I., under subsection D., ``How I May Participate in this Meeting'' 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 Lu-Ann Kleibacker, 
EPA, Office of the Science Advisor, (8105R), Environmental Protection 
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; or via 
telephone/voice mail at (202) 564-7189 or via e-mail at [email protected]. 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-2010-0617, by one of the following methods: http://www.regulations.gov: Follow the on-line instructions for submitting 
    E-mail: [email protected].
    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-
2010-0617. Deliveries are accepted between 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-
2010-0617. 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 comments include 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 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. 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

[[Page 48684]]

and included as part of the comment that is placed in the public docket 
and made available on the Internet.

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 

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 electronically available either through 
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 
between 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-

C. What should I consider as I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your 
    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-2010-0617 in the subject line 
on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to Thursday, September 2, 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 
email) to Lu-Ann Kleibacker, listed under FOR FURTHER INFORMATION 
CONTACT, no later than noon, Eastern Time, Thursday, September 2, 2010, 
in order to be included on the meeting agenda and to provide sufficient 
time for the HSRB Chair and HSRB Designated Federal Official (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 generally limited to five 
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, public comments may be 
    2. Written comments. Submit your written comments prior to the 
conference call, 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 this teleconference. 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, September 2, 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?'' In addition, the Agency also requests that persons 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

    The EPA Human Studies Review Board will be reviewing its draft 
Final Report from the June 23, 2010, HSRB meeting. The Board may also 
discuss planning for future HSRB meetings. Background on the June 23, 
2010, HSRB meeting can be found at Federal Register: June 8, 2010 
(Volume 75, Number 109, Page 32461-32463), and at the HSRB Web site 
http://www.epa.gov/osa/hsrb/. The June 23, 2010 meeting draft Final 
Report is now available. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the 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 Lu-Ann Kleibacker using the information listed under FOR 

    Dated: August 4, 2010.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2010-19815 Filed 8-10-10; 8:45 am]