Document ID: EPA-HQ-ORD-2010-0919-0001
Agency: epa
Document Type: Notice
Title: Human Studies Review Board (HSRB); Notification of a Public Teleconference To Review Draft Report From the October 27–28, 2010 HSRB Meeting
Posted Date: 2010-11-29T05:00Z

[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]               
[Page 73078-73080]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no10-82]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2010-0919; FRL-9232-5]

 
Human Studies Review Board (HSRB); Notification of a Public 
Teleconference To Review Draft Report From the October 27-28, 2010 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 report from the October 27-
28, 2010 HSRB meeting.

DATES: The teleconference will be held on Monday, December 13, 2010 
from 3-5 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 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, under subsection D, of this notice.

FOR FURTHER INFORMATION CONTACT: 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: U.S. Environmental Protection Agency, 
Office of the Science Advisor, Mail Code 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/.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2010-0919, 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, U.S. Environmental Protection Agency, Mail Code 
28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

[[Page 73079]]

    Hand Delivery: EPA Docket Center (EPA/DC), Public Reading Room, 
Infoterra Room (Room Number 3334), EPA West Building, 1301 Constitution 
Ave., NW., Washington, DC 20460, Attention Docket ID No. EPA-ORD-2010-
0919. 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-
2010-0919. 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 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 
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 notice. If you have any questions regarding the 
applicability of this notice 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 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 
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-2010-0919 in the subject line 
on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to December 6, 2010. To the extent that time permits, 
interested persons who have not pre-registered may be permitted by the 
HSRB Chair 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 no later than 
noon, Eastern Time, December 6, 2010 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 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 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 possible.
    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 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, December 6, 2010. You should 
submit your comments using the instructions in section I, under 
subsection C, of this notice. 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 or Jim Downing listed under 
FOR FURTHER INFORMATION CONTACT. There is no limit

[[Page 73080]]

on the length of written comments for consideration by the HSRB.

E. Background

    The EPA Human Studies Review Board will be reviewing its draft 
report from the October 27-28, 2010 HSRB meeting. The Board may also 
discuss planning for future HSRB meetings. Background on the October 
27-28, 2010 HSRB meeting can be found at Federal Register 75 193, 61748 
(October 6, 2010) and at the HSRB Web site http://www.epa.gov/osa/
hsrb/. The October 27-28, 2010 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/. 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: November 19, 2010.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2010-29814 Filed 11-26-10; 8:45 am]
BILLING CODE 6560-50-P