[Federal Register: January 25, 2008 (Volume 73, Number 17)]
[
Notices]
[Page 4561-4563]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ja08-59]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2007-0942; FRL-8521-9]
Human Studies Review Board (HSRB); Notification of a Public
Teleconference To Review Its Draft Report from the October 24-26, 2007
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 24-26, 2007 HSRB meeting.
DATES: The teleconference will be held on February 11, 2008, from 2 to
approximately 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 the person listed under
FOR FURTHER INFORMATION
[[Page 4562]]
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.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2007-0942, by any of the following methods:
Internet: http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: ORD.Docket@epa.gov.
USPS Mail: ORD Docket, Environmental Protection Agency, Mailcode:
28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Hand or Courier 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-2007-0942. 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-
2007-0942. 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 through
http://www.regulations.gov or e-mail that you consider to be CBI or
otherwise protected. 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. By contrast, 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.
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; telephone
(202) 564-7189 or via e-mail at kleibacker.lu-ann@epa.gov. General
information concerning the EPA HSRB can be found on the EPA Web site at
http://www.epa.gov/osa/hsrb/.
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 particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by EPA and to
persons who may sponsor or conduct research with human subjects with
the intention to submit it to EPA for consideration under the Federal
Food, Drug, and Cosmetic Act (FFDCA) or the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) or section 408 of the Federal
Food, Drug and Cosmetic Act (FFDCA). 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?
You may access this Federal Register document electronically
through http://www.regulations.gov or through the EPA Web site 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 through electronically
in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, Public Reading Room, Infoterra Room (Room Number 3334), EPA West
Building, 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 used
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-2007-0942 in the subject line
on the first page of your request.
1. Oral comments. Requests to present oral comments will be
accepted up to February 4, 2008. 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 the
person listed under FOR FURTHER INFORMATION CONTACT no later than noon,
eastern time, February 4, 2008, 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
[[Page 4563]]
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 these 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. 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 5 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, February 4, 2008. You should
submit your comments using the instructions described earlier in 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 the person 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
report from the October 24-26, 2007 HSRB meeting. The Board may also
discuss planning for future HSRB meetings. Background on the October
24-26, 2007 HSRB meeting can be found at Federal Register 72 17, 54908
(September 27, 2007) and at the HSRB Web site http://www.epa.gov/osa/
hsrb/.
The October 24-26, 2007 HSRB 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 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: January 17, 2008.
George Gray,
EPA Science Advisor.
[FR Doc. E8-1327 Filed 1-24-08; 8:45 am]
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