[Federal Register Volume 71, Number 73 (Monday, April 17, 2006)]
[Notices]
[Pages 19725-19727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3635]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2006-0316; FRL-8158-8]


Human Studies Review Board; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency's (EPA or Agency) 
Office of the Science Advisor (OSA) announces a public meeting of the 
Human Studies Review Board (HSRB) to advise the Agency on EPA's 
scientific and ethical reviews of human subjects research.

DATES: The public meeting will be held May 2-4, 2006 from 8:30 a.m. to 
approximately 5 p.m., eastern time (However, the third day may not be 
needed).
    Location: Holiday Inn Hotel & Suites, Alexandria-Historic District, 
625 First Street, Alexandria, VA 22314. The telephone number for the 
Holiday Inn Hotel & Suites, Alexandria-Historic District is (703) 548-
6300.
    Meeting Access: Seating at the meeting will be on a first-come 
basis. Individuals requiring special accommodations at this meeting, 
including wheelchair access and assistance for the hearing impaired, 
should contact the DFO at least 10 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 Unit 
I.E. of this notice.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes 
further information should contact Paul I. Lewis, Designated Federal 
Officer (DFO), EPA, Office of the Science Advisor, (8105), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 564-8381; fax: (202) 564-
2070; e-mail address: [email protected].

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2006-0316, by one of the following methods: http://www.regulations.gov: Follow the on-line instructions for submitting 
comments.
    E-mail: [email protected].
    Mail: ORD Docket, Environmental Protection Agency, Mailcode: 
28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    Hand Delivery: EPA Docket Center (EPA/DC), Room B102, EPA West 
Building, 1301 Constitution Avenue, NW., Washington, DC 20460, 
Attention Docket ID No. EPA-HQ-ORD-2006-0316. 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-
2006-0316. 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 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 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

[[Page 19726]]

special characters, any form of encryption, and be free of any defects 
or viruses.

SUPPLEMENTARY INFORMATION:

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 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 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?

    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/. A 
frequently updated electronic version of the Code of Federal 
Regulations (CFR) is available at http://www.gpoaccess.gov/ecfr/.
    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, EPA West Room B102, 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.
    EPA's position paper(s), charge/questions to the HSRB, and the 
meeting agenda will be available by mid to late April 2006. In 
addition, the Agency may provide additional background documents as the 
materials become available. You may obtain electronic copies of these 
documents, 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.

C. What Should I Consider as I Prepare May 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.
    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.

E. 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-2006-0316 in the subject line 
on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to April 26, 2006. 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 e-mail) to the 
DFO listed under FOR FURTHER INFORMATION CONTACT no later than noon, 
eastern time, April 26, 2006, in order to be included on the meeting 
agenda. The request should identify the name of the individual making 
the presentation, the organization (if any) the individual will 
represent, and any requirements for audiovisual equipment (e.g., 
overhead projector, 35 mm projector, chalkboard). Oral comments before 
the HSRB are limited to 5 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 
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. Each speaker 
should being 25 copies of his or her comments and presentation slides 
for distribution to the HSRB at the meeting.
    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 
the meeting. If you submit comments after the 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, April 26, 2006. You should submit your 
comments using the instructions in Unit 1.C. of 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 DFO 
listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the 
length of written comments for consideration by the HSRB.

F. Background

    The HSRB will meet to consider and review EPA's scientific and 
ethics analyses of six completed human toxicity studies concerning 
three different compounds, including: Hexavalent chromium, a 
constituent of a wood preservative; and the following pesticide active 
ingredients--carbofuran and methyl isothiocyanate (MITC). The studies 
being considered at this meeting will include both studies on which the 
Agency proposes to rely in actions under the pesticide laws and studies 
that the Agency has decided not to use in its risk assessments, either 
for scientific reasons or because they do not meet the standards in 
EPA's final human studies rule, 40 CFR part 26. The Agency will ask the 
HSRB to advise the Agency on a range of scientific and ethics issues 
and on how the studies should be assessed against the provisions in 40 
CFR 26.1701-26.1704 of EPA's final human studies rule. In addition, the 
Board may be reviewing draft HSRB reports for subsequent Board 
approval.


[[Page 19727]]


    Dated: April 11, 2006.
William H. Farland,
Acting EPA Science Advisor.
[FR Doc. 06-3635 Filed 4-14-06; 8:45 am]
BILLING CODE 6960-50-M