Draft Scientific and Ethical Approaches for Observational Exposure Studies, 56757-56758 [E7-19635]

Download as PDF pwalker on PROD1PC71 with NOTICES Federal Register / Vol. 72, No. 192 / Thursday, October 4, 2007 / Notices operation, and special arrangements should be made for deliveries of boxed information. If you provide comments by mail or hand delivery, please submit three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies. Instructions: Direct your comments to Docket ID No. EPA–HQ–ORD–2007– 0971. Please ensure that your comments are submitted within the specified comment period. Comments received after the closing date will be marked ‘‘late,’’ and may only be considered if time permits. It is EPA’s policy to include all comments it receives in the public docket without change and to make the comments available online at www.regulations.gov, including any personal information provided, unless a 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 email 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 additional information about EPA’s public docket, visit the EPA Docket Center homepage at https:// www.epa.gov/epahome/dockets.htm. Docket: 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 materials, such as copyrighted material, are publicly available only in hard copy. Publicly available docket materials are available either electronically in VerDate Aug<31>2005 16:20 Oct 03, 2007 Jkt 214001 www.regulations.gov or in hard copy at the OEI Docket in the EPA Headquarters Docket Center. Dated: September 26, 2007. Rebecca Clark, Acting Director, National Center for Environmental Assessment. [FR Doc. E7–19638 Filed 10–3–07; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–ORD–2007–0972; FRL–8477–8] Draft Scientific and Ethical Approaches for Observational Exposure Studies Environmental Protection Agency (EPA). ACTION: Notice of public comment period. AGENCY: 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, https://www.epa.gov/osa/ hsrb/. The draft document presents ‘‘stateof-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 predissemination 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. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 56757 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 https://www.epa.gov/nerl/sots. Submit your comments, identified by Docket ID No. EPA–HQ–ORD–2007–0972, by one of the following methods: • https://www.regulations.gov: Follow the on-line instructions for submitting comments. • E-mail: ORD.Docket@epa.gov. • 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 email 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 DATES: E:\FR\FM\04OCN1.SGM 04OCN1 56758 Federal Register / Vol. 72, No. 192 / Thursday, October 4, 2007 / Notices pwalker on PROD1PC71 with NOTICES 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 https:// 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: ORD.Docket@epa.gov. 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: Fortmann.Roy@epa.gov. 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-todate 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 VerDate Aug<31>2005 16:20 Oct 03, 2007 Jkt 214001 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] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION Public Information Collection Requirement Submitted to OMB for Review and Approval, Comments Requested September 26, 2007 SUMMARY: The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104–13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 information shall have practical utility; (b) the accuracy of the Commission’s burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. DATES: Written Paperwork Reduction Act (PRA) comments should be submitted on or before November 5, 2007. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible. ADDRESSES: Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget, via Internet at Nicholas_A._Fraser@omb.eop.gov or via fax at (202) 395–5167 and to Cathy Williams, Federal Communications Commission, Room 1–C823, 445 12th Street, SW., Washington, DC or via Internet at Cathy.Williams@fcc.gov. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page https:// www.reginfo.gov/public/do/PRAMain, (2) look for the section of the Web page called ‘‘Currently Under Review,’’ (3) click on the downward-pointing arrow in the ‘‘Select Agency’’ box below the ‘‘Currently Under Review’’ heading, (4) select ‘‘Federal Communications Commission’’ from the list of agencies presented in the ‘‘Select Agency’’ box, (5) click the ‘‘Submit’’ button to the right of the ‘‘Select Agency’’ box, (6) when the list of FCC ICRs currently under review appears, look for the title of this ICR (or its OMB control number, if there is one) and then click on the ICR Reference Number to view detailed information about this ICR.’’ FOR FURTHER INFORMATION CONTACT: For additional information or copies of the information collection(s), contact Cathy Williams at (202) 418–2918. SUPPLEMENTARY INFORMATION: OMB Control Number: 3060–0787. Title: Implementation of the Subscriber Carrier Selection Changes Provisions of the Telecommunications Act of 1996, Policies and Rules Concerning Unauthorized Changes of Consumers’ Long Distance Carriers, CC Docket No. 94–129, FCC 03–42. Form Number: Not Applicable. Type of Review: Extension of a currently approved collection. Respondents: Individuals or households; Business or other for-profit entities; and State, local, or tribal Governments. E:\FR\FM\04OCN1.SGM 04OCN1

Agencies

[Federal Register Volume 72, Number 192 (Thursday, October 4, 2007)]
[Notices]
[Pages 56757-56758]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19635]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, https://www.epa.gov/osa/ 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 https://www.epa.gov/nerl/sots. Submit your comments, identified 
by Docket ID No. EPA-HQ-ORD-2007-0972, by one of the following methods:
     https://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     E-mail: ORD.Docket@epa.gov.
     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 https://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: 
ORD.Docket@epa.gov.
    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: 
Fortmann.Roy@epa.gov.

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]
BILLING CODE 6560-50-P
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