Human Studies Review Board; Notice of Public Meeting, 14101-14103 [E7-5492]

Download as PDF cprice-sewell on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices and (2) a summary of the above in a biographical sketch (‘‘biosketch’’) of no more than one page. The qualifications of nominees received in reply to this notice will be assessed in terms of the specific expertise sought for the HSRB. Qualified nominees who agree to be considered further will be included in a smaller subset (known as the ‘‘Short List’’). This Short List consisting of nominee’s name and biosketch will be posted for public comment on the OSA Web site https:// www.epa.gov/osa/index.htm. The public will be requested to provide relevant information or other documentation on nominees that OSA should consider in evaluating the candidates. Public comments will be accepted for 14 calendar days on the Short List. Board members will be selected from the Short List. Short List candidates not selected for HSRB membership may be considered for future HSRB membership as vacancies become available or as HSRB consultants for future HSRB meetings. The Agency estimates posting the names of Short List candidates sometime in late May. However, please be advised that this is an approximate time frame and the date could change. Thus, if you have any questions concerning posting of Short List candidates on the OSA Web site, please consult the person listed under FOR FURTHER INFORMATION CONTACT. For the HSRB, a balanced panel is characterized by inclusion of members who possess the necessary domains of knowledge, the relevant technical perspectives, and the collective breadth of experience to adequately address the Agency’s charge. Interested candidates who are employees of a federal department or agency (other than EPA) or are members of another federal advisory committee are eligible to serve on the HSRB, and their nominations are welcome. Other factors that will be considered include: Availability to participate in the Board’s scheduled meetings, absence of any conflicts of interest and absence of an appearance of a lack of impartiality, independence with respect to the matters under review, and public comments in response to the Short List. Though financial conflicts of interest or the appearance of a lack of impartiality, lack of independence, or bias may lead to nonselection, the absence of such concerns does not ensure that a candidate will be selected to serve on the HSRB. Numerous qualified candidates are likely to be identified. Selection decisions will involve careful weighing a number of factors including, but not limited to, the candidates’ areas of expertise and professional VerDate Aug<31>2005 15:30 Mar 23, 2007 Jkt 211001 qualifications, and responses to the Short List in achieving an overall balance of different perspectives on the Board. People who are hired to serve on the Board are subject to the provisions of 5 CFR part 2634, Executive Branch Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. In anticipation of this requirement, each nominee will be asked to submit a Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection Agency (EPA Form 3110–48 [5–02]). This form seeks information regarding the candidate’s financial interests, the candidate’s employment, stocks, and bonds, and where applicable, sources of research support. However, this form is confidential and will not be disclosed to the public. The EPA will evaluate the candidate’s financial disclosure form to assess whether there are financial conflicts of interest, appearance of a lack of impartiality, or any prior involvement with the development of the documents under consideration, including previous scientific peer review, before the candidate is considered further for service on the HSRB. Candidates selected from the Short List will be appointed to the HSRB. HSRB members are to perform several activities including reviewing extensive background materials between meetings of the Board, preparing draft responses to Agency charge questions, attending Board meetings, participating in the discussion and deliberations at these meetings, drafting assigned sections of meeting reports, and reviewing and helping to finalize Board reports. Nominations should be submitted by one of the methods listed under ADDRESSEES. The Agency will consider all nominations for HSRB membership that are received on or before April 25, 2007. However, final selection of members is a discretionary function of the Agency and will be announced on the OSA Web site https://www.epa.gov/osa/index.htm soon after comments are received on the Short List. Dated: March 19, 2007. George M. Gray, Science Advisor. [FR Doc. E7–5484 Filed 3–23–07; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 14101 ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–ORD–2007–0216; FRL–8291–4] Human Studies Review Board; Notice of Public Meeting Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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 on April 18, 2007 from 10 a.m. to approximately 5:30 p.m., Eastern Time and April 19–20, 2007 from 8:30 a.m. to approximately 5:30 p.m., Eastern Time. Location: Environmental Protection Agency, Conference Center—Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA 22202. Meeting Access: Seating at the meeting will be on a first-come basis. To request accommodation of a disability please contact the person listed under FOR FURTHER INFORMATION CONTACT at least 10 business days prior to the meeting, to allow EPA as much time as possible to process your request. 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. FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes further information should contact Paul Lewis, EPA, Office of the Science Advisor, (8105R), 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. General information concerning the EPA HSRB can be found on the EPA Web site at https://www.epa.gov/osa/hsrb/. ADDRESSES: Submit your written comments, identified by Docket ID No. EPA–HQ–ORD–2007–0216, by one of the following methods: Internet: https://www.regulations.gov: Follow the on-line instructions for submitting comments. E-mail: ORD.Docket@epa.gov. Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC), E:\FR\FM\26MRN1.SGM 26MRN1 14102 Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices cprice-sewell on PROD1PC66 with NOTICES ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Hand Delivery: The EPA/DC Public Reading Room is located in the EPA Headquarters Library, Room Number 3334 in the EPA West Building, located at 1301 Constitution Ave., NW., Washington DC. The hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Standard Time (EST), Monday through Friday, excluding Federal holidays. Please call (202) 566–1744 or e-mail the ORD Docket at ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available on the Web site (https://www.epa.gov/epahome/ dockets.htm). Instructions: Direct your comments to Docket ID No. EPA–HQ–ORD–2007– 0216. EPA’s policy is that all comments received will be included in the public docket without change and may be made available online at https:// 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 https:// www.regulations.gov or e-mail. The https://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 https:// 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. 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, especially studies on substances regulated by EPA or to VerDate Aug<31>2005 15:30 Mar 23, 2007 Jkt 211001 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 https:// www.epa.gov/fedrgstr/. Docket: All documents in the docket are listed in the https:// 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 https:// www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, Public Reading Room. The EPA/DC Public Reading Room is located in the EPA Headquarters Library, Room Number 3334 in the EPA West Building, located at 1301 Constitution Ave., NW., Washington, DC. The hours of operation are 8:30 a.m. to 4:30 a.m. Eastern Standard Time, Monday through Friday, excluding Federal holidays. Please call (202) 566–1744 or e-mail the ORD Docket at ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available on the Web site (https://www.epa.gov/epahome/ dockets.htm). EPA’s position paper(s), charge/ questions to the HSRB, and the meeting agenda will be available by late March 2007. 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 https:// www.epa.gov/osa/hsrb/. For questions on document availability or if you do not have access to the Internet, consult PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 the person listed under FOR FURTHER INFORMATION CONTACT. C. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: a. Explain your views as clearly as possible. b. Describe any assumptions that you used. c. Provide copies of any technical information and/or data you used that support your views. d. Provide specific examples to illustrate your concerns and suggest alternatives. e. 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– 0216 in the subject line on the first page of your request. a. Oral comments. Requests to present oral comments will be accepted up to April 11, 2007. 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 Standard Time, April 11, 2007 in order to be included on the meeting agenda and to provide sufficient time for the HSRB Chair and HSRB Designated Federal Officer (DFO) to review the agenda to provide an appropriate public comment period. 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, LCD projector, chalkboard). Oral comments before the HSRB are limited to five minutes per individual or organization. Please note that this limit applies to the cumulative time used by 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 E:\FR\FM\26MRN1.SGM 26MRN1 Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices 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 bring 25 copies of his or her comments and presentation slides for distribution to the HSRB at the meeting. b. 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 five business days prior to the beginning of the meeting. 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 Standard Time, April 11, 2007. You should submit your comments using the instructions in Unit I.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 person listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the length of written comments for consideration by the HSRB. cprice-sewell on PROD1PC66 with NOTICES E. Background A. Topics for Discussion The HSRB is a Federal advisory committee operating in accordance with the Federal Advisory Committee Act (FACA) 5 U.S.C. app.2 section 9. The HSRB provides advice, information, and recommendations to EPA on issues related to scientific and ethical aspects of human subjects research. The major objectives of the HSRB are to provide advice and recommendations on: (a) Research proposals and protocols; (b) reports of completed research with human subjects; and (c) how to strengthen EPA’s programs for protection of human subjects of research. The HSRB reports to the EPA Administrator through EPA’s Science Advisor. At the April 2007 meeting of the HSRB, EPA will present for HSRB review: • The results of two completed insect repellent efficacy studies on an aerosol formulation of the active ingredient IR3535, studies which the Agency intends to rely in making registration VerDate Aug<31>2005 15:30 Mar 23, 2007 Jkt 211001 decisions. Protocols for this research were reviewed by the Board at its June and October 2006 meetings. • A proposal for a new field study of the effectiveness of products containing oil of lemon eucalyptus in repelling mosquitoes. • Completed studies of human skin irritation and skin sensitization on two pending pesticide products whose use would involve extensive dermal exposure. These studies were conducted before the effective date of EPA’s human studies rules (April 7, 2006). • EPA’s assessment of the need for new research on the exposure received by occupational handlers who mix, load, or apply agricultural or antimicrobial pesticides. • An EPA ‘‘draft framework’’ concerning best practices for recruiting and enrolling subjects in studies of occupational exposure. In addition, at the Board’s request, EPA will present its interpretation and application of the standard in 40 CFR 26.1705: ‘‘EPA shall not rely on data from any research initiated after April 7, 2006, unless EPA has adequate information to determine that the research was conducted in substantial compliance with [EPA’s human studies rules].’’ Finally, the Board may also discuss planning for future HSRB meetings. B. Meeting Minutes and Reports Minutes of the meeting, summarizing the matters discussed and recommendations, if any, made by the advisory committee regarding such matters will be released within 90 calendar days of the meeting. Such minutes will be available at https:// www.epa.gov/osa/hsrb/ and https:// www.regulations.gov In addition, information concerning a Board meeting report, if applicable, can be found at https://www.epa.gov/osa/hsrb/ or from the person listed under FOR FURTHER INFORMATION CONTACT. Dated: March 19, 2007. George M. Gray, Science Advisor. [FR Doc. E7–5492 Filed 3–23–07; 8:45 am] BILLING CODE 6560–50–P COUNCIL ON ENVIRONMENTAL QUALITY The National Environmental Policy Act—Collaboration Handbook Council On Environmental Quality. ACTION: Notice and request for comments. AGENCY: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 14103 SUMMARY: The Council on Environmental Quality (CEQ) used an interagency work group to develop a handbook to help NEPA practitioners improve the effectiveness of their NEPA processes through collaboration. The handbook focuses on collaboration in the context of the NEPA process, outlines general principles, presents useful steps, and provides information on methods of collaboration. CEQ invites comments on the proposed handbook, ‘‘Collaboration in NEPA—A Handbook for NEPA Practitioners,’’ that is available from CEQ directly or at https://www.NEPA.gov in the Current Developments section. DATES: Written comments should be submitted on or before May 4, 2007. ADDRESSES: Copies of the proposed handbook can be requested from CEQ. Electronic comments on the proposed handbook and requests for a copy of the proposed handbook can be sent to horst_greczmiel@ceq.eop.gov with the subject line reading ‘‘NEPA Modernization (Collaboration).’’ Fax written comments and requests to (202) 456–0753 with the subject line reading ‘‘NEPA Modernization (Collaboration).’’ Electronic or facsimile comments or requests are preferred because Federal offices experience intermittent mail delays caused by security screening. Written comments and requests may also be submitted to ‘‘NEPA Modernization (Collaboration), Attn: Associate Director for NEPA Oversight, 722 Jackson Place, NW., Washington, DC 20503.’’ FOR FURTHER INFORMATION CONTACT: Horst Greczmiel, 202–395–5750. SUPPLEMENTARY INFORMATION: The Council on Environmental Quality (CEQ) established a National Environmental Policy Act (NEPA) Task Force and is now implementing recommendations designed to modernize the implementation of NEPA and make the NEPA process more effective and efficient. Additional information is available on the task force Web site at https://ceq.eh.doe.gov/ ntf. The proposed handbook, ‘‘Collaboration in NEPA—A Handbook for NEPA Practitioners,’’ was developed to assist those responsible for conducting National Environmental Policy Act (NEPA) analyses in expanding the effective use of collaboration as part of the NEPA process. Collaboration is defined for purposes of the handbook as seeking agreements at one or more stages of the NEPA process by cultivating shared vision, trust, and communication. The main goal of the handbook is to E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 72, Number 57 (Monday, March 26, 2007)]
[Notices]
[Pages 14101-14103]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5492]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2007-0216; FRL-8291-4]


Human Studies Review Board; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

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 on April 18, 2007 from 10 a.m. 
to approximately 5:30 p.m., Eastern Time and April 19-20, 2007 from 
8:30 a.m. to approximately 5:30 p.m., Eastern Time.
    Location: Environmental Protection Agency, Conference Center--Lobby 
Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, 
Arlington, VA 22202.
    Meeting Access: Seating at the meeting will be on a first-come 
basis. To request accommodation of a disability please contact the 
person listed under FOR FURTHER INFORMATION CONTACT at least 10 
business days prior to the meeting, to allow EPA as much time as 
possible to process your request.
    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.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes 
further information should contact Paul Lewis, EPA, Office of the 
Science Advisor, (8105R), 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. 
General information concerning the EPA HSRB can be found on the EPA Web 
site at https://www.epa.gov/osa/hsrb/.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2007-0216, by one of the following methods:
    Internet: https://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
    E-mail: ORD.Docket@epa.gov.
    Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC),

[[Page 14102]]

ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, 
DC 20460.
    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA 
Headquarters Library, Room Number 3334 in the EPA West Building, 
located at 1301 Constitution Ave., NW., Washington DC. The hours of 
operation are 8:30 a.m. to 4:30 p.m. Eastern Standard Time (EST), 
Monday through Friday, excluding Federal holidays. Please call (202) 
566-1744 or e-mail the ORD Docket at ord.docket@epa.gov for 
instructions. Updates to Public Reading Room access are available on 
the Web site (https://www.epa.gov/epahome/dockets.htm).
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0216. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
https://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 https://
www.regulations.gov or e-mail. The https://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 https://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.

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, 
especially 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 https://www.epa.gov/fedrgstr/.
    Docket: All documents in the docket are listed in the https://
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 https://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, Public Reading Room. The EPA/DC Public Reading Room is located in 
the EPA Headquarters Library, Room Number 3334 in the EPA West 
Building, located at 1301 Constitution Ave., NW., Washington, DC. The 
hours of operation are 8:30 a.m. to 4:30 a.m. Eastern Standard Time, 
Monday through Friday, excluding Federal holidays. Please call (202) 
566-1744 or e-mail the ORD Docket at ord.docket@epa.gov for 
instructions. Updates to Public Reading Room access are available on 
the Web site (https://www.epa.gov/epahome/dockets.htm).
    EPA's position paper(s), charge/questions to the HSRB, and the 
meeting agenda will be available by late March 2007. 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 https://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 My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    a. Explain your views as clearly as possible.
    b. Describe any assumptions that you used.
    c. Provide copies of any technical information and/or data you used 
that support your views.
    d. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    e. 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-2007-0216 in the subject line 
on the first page of your request.
    a. Oral comments. Requests to present oral comments will be 
accepted up to April 11, 2007. 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 Standard Time, April 11, 2007 in order to be included on the 
meeting agenda and to provide sufficient time for the HSRB Chair and 
HSRB Designated Federal Officer (DFO) to review the agenda to provide 
an appropriate public comment period. 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, LCD projector, 
chalkboard). Oral comments before the HSRB are limited to five minutes 
per individual or organization. Please note that this limit applies to 
the cumulative time used by 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

[[Page 14103]]

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 bring 25 copies of his or 
her comments and presentation slides for distribution to the HSRB at 
the meeting.
    b. 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 five business days prior to the beginning 
of the meeting. 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 Standard Time, April 11, 2007. You should 
submit your comments using the instructions in Unit I.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 person listed under FOR FURTHER INFORMATION CONTACT. There is no 
limit on the length of written comments for consideration by the HSRB.

 E. Background

A. Topics for Discussion
    The HSRB is a Federal advisory committee operating in accordance 
with the Federal Advisory Committee Act (FACA) 5 U.S.C. app.2 section 
9. The HSRB provides advice, information, and recommendations to EPA on 
issues related to scientific and ethical aspects of human subjects 
research. The major objectives of the HSRB are to provide advice and 
recommendations on: (a) Research proposals and protocols; (b) reports 
of completed research with human subjects; and (c) how to strengthen 
EPA's programs for protection of human subjects of research. The HSRB 
reports to the EPA Administrator through EPA's Science Advisor.
    At the April 2007 meeting of the HSRB, EPA will present for HSRB 
review:
     The results of two completed insect repellent efficacy 
studies on an aerosol formulation of the active ingredient IR3535, 
studies which the Agency intends to rely in making registration 
decisions. Protocols for this research were reviewed by the Board at 
its June and October 2006 meetings.
     A proposal for a new field study of the effectiveness of 
products containing oil of lemon eucalyptus in repelling mosquitoes.
     Completed studies of human skin irritation and skin 
sensitization on two pending pesticide products whose use would involve 
extensive dermal exposure. These studies were conducted before the 
effective date of EPA's human studies rules (April 7, 2006).
     EPA's assessment of the need for new research on the 
exposure received by occupational handlers who mix, load, or apply 
agricultural or antimicrobial pesticides.
     An EPA ``draft framework'' concerning best practices for 
recruiting and enrolling subjects in studies of occupational exposure.
    In addition, at the Board's request, EPA will present its 
interpretation and application of the standard in 40 CFR 26.1705: ``EPA 
shall not rely on data from any research initiated after April 7, 2006, 
unless EPA has adequate information to determine that the research was 
conducted in substantial compliance with [EPA's human studies rules].'' 
Finally, the Board may also discuss planning for future HSRB meetings.
B. Meeting Minutes and Reports
    Minutes of the meeting, summarizing the matters discussed and 
recommendations, if any, made by the advisory committee regarding such 
matters will be released within 90 calendar days of the meeting. Such 
minutes will be available at https://www.epa.gov/osa/hsrb/ and https://
www.regulations.gov In addition, information concerning a Board meeting 
report, if applicable, can be found at https://www.epa.gov/osa/hsrb/ or 
from the person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: March 19, 2007.
George M. Gray,
Science Advisor.
[FR Doc. E7-5492 Filed 3-23-07; 8:45 am]
BILLING CODE 6560-50-P
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