

[Federal Register: March 9, 2006 (Volume 71, Number 46)]
[Notices]               
[Page 12194-12196]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr06-52]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2006-0187; FRL-8042-6]

 
Human Studies Review Board; Notice of Public Meeting and Proposed 
Candidates for Membership to the Board

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. In addition, 
OSA is soliciting public comment on its proposed list of candidates for 
membership to the HSRB.

DATES: The public meeting will be held April 4-6, 2006 from 8:30 a.m. 
to approximately 5 p.m., eastern time.
    Location: Holiday Inn Rosslyn at Key Bridge, 1900 North Fort Myer 
Drive, Arlington, VA 22209. The telephone number for the Holiday Inn 
Rosslyn at Key Bridge is 703-807-2000.
    Requests to Present Oral Comments and Special Accommodations: To 
submit requests for special accommodation arrangements or requests to 
present oral comments, notify the DFO listed under FOR FURTHER 
INFORMATION CONTACT. To ensure proper receipt by EPA, your request must 
identify docket ID number EPA-HQ-ORD-2006-0187 in the subject line on 
the first page of your response. Additional information concerning the 
submission of requests to present oral comments and submission of 
written comments is provided in Unit I.E.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes 
further information should contact Paul I. Lewis, Designated Federal 
Official (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 addresses: lewis.paul@epa.gov.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2006-018, 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, 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-2006-0187. 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-
2006-0187. 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

[[Page 12195]]

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.

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://.

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, charge/questions to the HSRB, HSRB 
composition and the meeting agenda will be available by mid March 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/.


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.
    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 unit. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number EPA-HQ-ORD-2006-0187 in the subject line 
on the first page of your request.
    1. Oral comments. Oral comments presented at the meetings should 
not be repetitive of previously submitted oral or written comments. 
Although requests to present oral comments are accepted until the date 
of the meeting (unless otherwise stated), to the extent that time 
permits, interested persons 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 DFO listed under FOR 
FURTHER INFORMATION CONTACT no later than noon, eastern time, March 29, 
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 
approximately 5 minutes unless prior arrangements have been made. In 
addition, each speaker should bring 30 copies of his or her comments 
and presentation slides for distribution to the HSRB at the meeting.
    2. Written comments. Although written comments will be accepted 
until the date of the meeting (unless otherwise stated), the Agency 
strongly encourages that written comments be submitted, using the 
instructions in Unit 1.C. no later than noon, eastern time, March 29, 
2006 to provide the HSRB the time necessary to consider and review the 
written comments. It is requested that persons submitting comments 
directly to the docket also notify the DFO listed under FOR FURTHER 
INFORMATION CONTACT. There is no limit on the extent of written 
comments for consideration by the HSRB.
    3. Seating at the meeting. 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.

F. Background

    At the inaugural meeting of the HSRB, EPA will provide a broad 
overview of the Agency's approach to the assessment of the potential 
risk to human health from the use of pesticides and how EPA uses data 
from human studies in such risk assessments. The Agency will then 
present to the HSRB its scientific and ethics reviews of approximately 
two dozen completed human studies concerning the following pesticide 
active ingredients: aldicarb, amitraz, azinphos-methyl, dichlorovos 
(DDVP), ethephon, methomyl, oxamyl, and sodium cyanide. The studies 
being reviewed 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 ethical or scientific reasons. The Agency will ask the HSRB to 
advise the Agency on a range of scientific issues and on how the 
studies should be assessed against the provisions in sections 26.1701-
26.1704 of EPA's final human studies rule.

II. Proposed Candidates for Membership to the Board

    On January 3, 2006, the EPA, OSA announced a request for 
nominations of qualified individuals to serve on the HSRB (Federal 
Register 71 116). Per the Federal Register notice, the OSA requested 
nominees who are nationally-

[[Page 12196]]

recognized experts in one or more of the following disciplines:
    (a) Biostatistics. Expertise in statistical design and analysis of 
human subjects research studies.
    (b) Human toxicology. Expertise in pharmacokinetic and 
toxicokinetic studies, clinical trials, and toxicology of 
cholinesterase inhibitors and other classes of environmental 
substances.
    (c) Bioethics. Expertise in the ethics of research on human 
subjects; research ethics.
    (d) Human health risk assessment.
    EPA carefully considered the qualifications of nominees who agreed 
to be further considered and has identified candidates from whom EPA 
expects to select members to serve on the HSRB. EPA now invites 
comments from members of the public for relevant information or other 
documentation that the OSA should consider in the selection of HSRB 
members. The names of the candidates, together with a short 
biographical description of their qualifications, appear on the 
Agency's Web site at http://www.epa.gov/osa/hsrb/. Please e-mail your 

comments no later than noon, eastern time, March 14, 2006, listed under 
FOR FURTHER INFORMATION CONTACT.
    Any information furnished by the public in response to this Web 
site posting will be combined with information already provided by the 
candidates, and gathered independently by the OSA. Prior to final 
selection of HSRB members, the combined information will be reviewed 
and evaluated for any possible financial conflict of interest or a 
possible appearance of a lack of impartiality. The information will 
also be used to ensure appropriate balance and breadth of expertise 
needed to address the charge to the Board. The EPA Science Advisor will 
make the final decision concerning who will serve on the HSRB.

    Dated: March 2, 2006.
George Gray,
EPA Science Advisor.
 [FR Doc. E6-3339 Filed 3-8-06; 8:45 am]

BILLING CODE 6560-50-P
