Document ID: EPA-HQ-ORD-2011-0418-0001
Agency: epa
Document Type: Notice
Title: Meetings: Human Studies Review Board Public Teleconference
Posted Date: 2011-05-05T04:00Z

[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Notices]
[Pages 25686-25688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11001]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0418; FRL-9302-4]

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U. S. Environmental Protection Agency (EPA) Office of the 
Science Advisor (OSA) announces a public teleconference of the HSRB to 
discuss its draft report from the April 13-14, 2011 HSRB meeting, and 
consider a draft letter from an HSRB workgroup on providing research 
participants with individualized study results measuring the amount of 
antimicrobial cleaning products on participants' skin and the amount 
they breathe in while mopping floors.

DATES: The teleconference will be held on Tuesday, May 24, 2011 from 
approximately 1 p.m. to approximately 3 p.m. Eastern Time.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2011-0418, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the Web site 
instructions for submitting comments.
    E-mail: ORD.Docket@epa.gov.
    Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC), 
ORD Docket, Mail Code 28221T, 1200 Pennsylvania Ave., 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 25687]]

Eastern Time, 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 
online at http://www.epa.gov/epahome/dockets.htm.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0418. 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 includes information claimed to be 
Confidential Business Information (CBI) 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 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 comments 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 members of the public who wish to 
receive further information should contact Jim Downing at telephone 
number: (202) 564-2468; fax: (202) 564-2070; e-mail address: 
downing.jim@epa.gov, or Lu-Ann Kleibacker at telephone number: (202) 
564-7189; fax: (202) 564-2070; e-mail address: kleibacker.lu-ann@epa.gov; mailing address: Environmental Protection Agency, Office 
of the Science Advisor, 8105R, 1200 Pennsylvania Ave., 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 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 Jim Downing or Lu-Ann Kleibacker listed 
under FOR FURTHER INFORMATION CONTACT.

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

    In addition to using http://www.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 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 
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 Avenue, NW., Washington, DC 20460. The 
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 e-mail the ORD Docket at ord.docket@epa.gov for instructions. 
Updates to the Public Reading Room access are available on the Web site 
(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 
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-2011-0418 in the subject line 
on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to Tuesday, May 17, 2011. 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 e-mail) to Jim 
Downing or Lu-Ann Kleibacker under FOR FURTHER INFORMATION CONTACT no 
later than noon, Eastern Time, Tuesday, May 17, 2011, 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

[[Page 25688]]

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. 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, Tuesday, May 17, 2011. 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 (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: (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 April 13-14, 2011 HSRB meeting. The Board may also 
discuss planning for future HSRB meetings. Background on the April 13-
14, 2011 HSRB meeting can be found at Federal Register Volume 76, 
Number 59 (Monday, March 28, 2011), pages 17121-17123) and at the HSRB 
Web site http://www.epa.gov/osa/hsrb/. The April 13-14, 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 the http://www.regulations.gov Web site and the 
HSRB Internet home page at http://www.epa.gov/osa/hsrb. The HSRB will 
also review and consider a draft letter providing participants with 
individualized study results that was provided at a previous HSRB 
meeting. The HSRB was asked to provide feedback on the letter that will 
be sent to the participants from the Antimicrobial Exposure Assessment 
Task Force II that measured the amount of antimicrobial cleaning 
products on participants' skin and the amount they breathe in while 
mopping floors.
    For questions on document availability or if you do not have access 
to the Internet, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

    Dated: April 29, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-11001 Filed 5-4-11; 8:45 am]
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