[Federal Register Volume 72, Number 192 (Thursday, October 4, 2007)]
[Notices]
[Pages 56757-56758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19635]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2007-0972; FRL-8477-8]
Draft Scientific and Ethical Approaches for Observational
Exposure Studies
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of public comment period.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) announces
a 45-day public comment period for the draft document titled,
``Scientific and Ethical Approaches for Observational Exposure
Studies.'' This public comment period will overlap an external peer
review of the draft document by EPA's Human Studies Review Board (HSRB)
and discussion at their meeting on October 24, 2007. Notice of the HSRB
meeting was published in the Federal Register on September 27, 2007, at
72 FR 54908 (Docket ID No. EPA-HQ-ORD-2007-0942) and is posted on the
EPA HSRB Web site, http://www.epa.gov/osa/hsrb/ hsrb/.
The draft document presents ``state-of-the-science'' approaches for
conducting observational exposure studies based on sound science and
conforming to the highest ethical standards. These studies, which
collect information on how people come into contact with chemicals as
they go about their everyday activities, are critical to EPA's mission
to protect human health. This document is intended to serve as a
resource and reference for researchers and is not meant to represent an
official Agency ``guidance document.''
EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination. EPA will consider any public comments
submitted in accordance with this notice when revising the document.
DATES: Comments must be received on or before November 19, 2007.
ADDRESSES: The draft document is available primarily via the Internet
on the National Exposure Research Laboratory's home page under the
Scientific and Ethical Approaches for Observational Exposure Studies
link at http://www.epa.gov/nerl/sots. Submit your comments, identified
by Docket ID No. EPA-HQ-ORD-2007-0972, by one of the following methods:
http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: [email protected].
Fax: 202-566-1753.
Mail: Docket ID No. EPA-HQ-ORD-2007-0972, Office of
Research and Development (ORD) Docket, Environmental Protection Agency,
Mail Code: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Hand Delivery: EPA Headquarters Docket Center, EPA West
Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0972. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
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 www.regulations.gov or e-mail.
The 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 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
[[Page 56758]]
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the
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 www.regulations.gov or in hard copy at the EPA Headquarters Docket
Center, EPA West Building, Room 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. Public comments
received on the document titled, ``Scientific and Ethical Approaches
for Observational Exposure Studies,'' may be listed under Docket ID No.
EPA-HQ-ORD-2007-0972 or Docket ID No. EPA-HQ-ORD-2007-0942.
FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Research and Development (ORD) Docket;
telephone: 202-566-1752; facsimile: 202-566-9744; or e-mail:
[email protected].
For technical information, contact Roy Fortmann, National Exposure
Research Laboratory, Environmental Protection Agency, Mail Code E205-
01, 109 T.W. Alexander Dr., Research Triangle Park, NC 27711; telephone
number: (919) 541-2454; fax number: (919) 541-0239; e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Information About the Document
EPA researchers conduct observational exposure studies to
understand how and the extent to which people come into contact with
chemicals in their everyday lives. The researchers and their managers
take the protection of human subjects who participate in these
observational studies very seriously. EPA wants to ensure that the
procedures used in their studies meet or exceed the most up-to-date
scientific and ethical standards. To address this goal, researchers at
the Agency's National Exposure Research Lab (NERL) have prepared this
document to identify key scientific and ethical issues and to provide
information and resources to assist researchers as they plan and
implement observational exposure studies. This document is not meant to
represent an official Agency ``guidance document.'' Moreover, it
recognizes that researchers will work with others--EPA's Human Subjects
Research Review Official, Institutional Review Board (IRB) members, the
participants and their community, and other stakeholders--to identify
and address all of the relevant issues for any specific study to ensure
that all participants are respected and protected. The draft document
was developed through recommendations from nationally-recognized
experts, public comment and external peer review in an open and
transparent process. As part of this process, the document is being
submitted to EPA's Human Studies Review Board (HSRB), which was
established to provide advice, information, and recommendations on
issues related to scientific and ethical aspects of human subjects
research.
Dated: September 26, 2007.
Lawrence W. Reiter,
Director, National Exposure Research Laboratory, Office of Research and
Development.
[FR Doc. E7-19635 Filed 10-3-07; 8:45 am]
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