Document ID: EPA-HQ-ORD-2007-0942-0036
Agency: epa
Document Type: Notice
Title: Human Studies Review Board (HSRB); Notification of a Public Teleconference To Review Its Draft Report from the October 24-26, 2007 HSRB Meeting
Posted Date: 2008-01-25T05:00Z

[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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