[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Pages 77825-77827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32060]



[EPA-HQ-ORD-2011-0953; FRL-9506-6]

Human Studies Review Board; Notification of a Public 

AGENCY: Environmental Protection Agency.

ACTION: Notice.


SUMMARY: The EPA Office of the Science Advisor announces a public 
teleconference of the HSRB to discuss its draft report from the October 
19-20, 2011 HSRB meeting.

DATES: The teleconference will be held on Wednesday, January 11, 2012 
from approximately 1 p.m. to approximately 4 p.m. Eastern Time. 
Comments may be submitted on or before Wednesday, January 4, 2012.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2011-0953, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the Web site 
instructions for submitting comments.
    Email: [email protected].
    Mail: Environmental Protection Agency, EPA Docket Center EPA/DC, 
ORD Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW., Washington, 
DC 20460.
    Hand 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 Avenue NW., Washington, DC 20460. The 
hours of operation are 8:30 a.m. to 4:30 p.m.

[[Page 77826]]

Eastern Time, Monday through Friday, excluding Federal holidays. Please 
call (202) 566-1744 or email the ORD Docket at [email protected] for 
instructions. Updates to Public Reading Room access are available 
online at http://www.epa.gov/epahome/dockets.htm.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0953. The Agency'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 includes information claimed 
to be Confidential Business Information or other information the 
disclosure of which is restricted by statute. Do not submit information 
that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site 
is an ``anonymous access'' system, which means the EPA will not know 
your identity or contact information unless you provide it in the body 
of your comment. If you send an email comment directly to the EPA 
without going through http://www.regulations.gov, your email 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, the EPA recommends that you include 
your name and other contact information in the body of your comments 
and with any disk or CD-ROM you submit. If the EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, the 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 members of the public who wish to 
receive further information should contact Jim Downing on telephone 
number (202) 564-2468; fax (202) 564-2070; email address 
[email protected] or Lu-Ann Kleibacker on telephone number (202) 564-
7189; fax: (202) 564-2070; email address [email protected]; 
mailing address Environmental Protection Agency, Office of the Science 
Advisor, Mail Code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC 
20460. General information concerning the EPA HSRB can be found on the 
EPA Web site at http://www.epa.gov/osa/hsrb.

SUPPLEMENTARY INFORMATION: 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 ten 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, ``Public Meeting,'' under subsection D, ``How May I Participate in 
this Meeting?'' of this notice.

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 the EPA, 
or to persons who are, or may be required to conduct testing of 
chemical substances under the Federal Food, Drug, and Cosmetic Act or 
the Federal Insecticide, Fungicide, and Rodenticide Act. 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 Jim Downing or Lu-Ann Kleibacker listed 

B. How can I access electronic copies of this document and other 
related information?

    You may use http://www.regulations.gov, or you may access this 
Federal Register document via the EPA's Internet 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. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
at 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 Avenue NW., Washington, DC 20460; its 
hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday 
through Friday, excluding Federal holidays. Please call (202) 566-1744, 
or email the ORD Docket at [email protected] for instructions. Updates 
regarding the Public Reading Room access are available at http://www.epa.gov/epahome/dockets.htm.

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 used 
that support your views.
    4. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    5. To ensure proper receipt by the 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 the EPA, it is imperative 
that you identify Docket ID No. EPA-HQ-ORD-2011-0953 in the subject 
line on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to and including Wednesday, January 4, 2012. 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 during 
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 Jim Downing or Lu-Ann Kleibacker under FOR 
FURTHER INFORMATION CONTACT no later than noon, Eastern Time, 
Wednesday, January 4, 2012, in order to be included on the meeting 
agenda and to provide sufficient time for the HSRB Chair and HSRB 
Designated Federal Official to review the meeting agenda to provide an

[[Page 77827]]

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, further public 
comments may be possible.
    2. Written comments. Please submit written comments prior to the 
meeting. 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, Wednesday, January 4, 2012. 
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 Jim Downing or 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 HSRB is a Federal advisory committee operating in accordance 
with the Federal Advisory Committee Act 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: (1) Research proposals and protocols; (2) reports 
of completed research with human subjects; and (3) how to strengthen 
EPA's programs for protection of human subjects of research. The HSRB 
reports to the EPA Administrator through the EPA Science Advisor.
    1. Topics for Discussion. The HSRB will be reviewing its draft 
report from the October 19-20, 2011, HSRB meeting. The Board may also 
discuss planning for future HSRB meetings. Background on the October 
19-20, 2011 HSRB meeting can be found at the HSRB Web site: http://www.epa.gov/osa/hsrb. The October 19-20, 2011 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 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 Internet access, consult the persons listed under FOR 
    2. 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 regarding the Board's final meeting report will be found at 
http://www.epa.gov/osa/hsrb or from the persons listed under FOR 

    Dated: December 7, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-32060 Filed 12-13-11; 8:45 am]