Environmental Protection Agency (EPA).
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 review of human subjects research. The HSRB will hold a Public teleconference to discuss two completed field studies by Carroll-Loye Biological Research of mosquito repellent efficacy, and spatial insect repellent technology.
The teleconference will be held on February 17, 2009, from 11:30 to approximately 4 p.m. (Eastern Time).
Location: The meeting will take place via telephone only.
Meeting Access: For information on access or services for individuals with disabilities, please contact Lu-Ann Kleibacker 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 Start Printed Page 5654information concerning submission of relevant written or oral comments is provided in section D. of this notice.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Members of the public who wish to obtain the call-in number and access code to participate in the telephone conference, or who wish further information may contact Lu-Ann Kleibacker, EPA, Office of the Science Advisor (8105), Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; or via telephone/voice mail at (202) 564-7189 or via e-mail at firstname.lastname@example.org. General information concerning the EPA HSRB is on the EPA Web site at http://www.epa.gov/osa/hsrb/.End Further Info
Submit your written comments, identified by Docket ID No. EPA-HQ-ORD-2009-0030, by one of the following methods:
http://www.regulations.gov: Follow the on-line instructions for submitting comments.
Mail: ORD Docket, Environmental Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Hand Delivery: EPA Docket Center (EPA/DC), Public Reading Room, Infoterra Room (Room Number 3334), EPA West Building, 1301 Constitution Avenue, NW., Washington, DC 20460, Attention Docket ID No. EPA-ORD-2009-0030. 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-2009-0030. 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 special characters, any form of encryption, and be free of any defects or viruses.
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/.
Docket: All documents in the docket are listed in the index under the docket number. Even though it will be listed by title in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Copyright 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, Public Reading Room, Infoterra Room (Room Number 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, and the telephone number for the ORD Docket is (202) 566-1752.
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 use that support your views.
4. Provide specific examples to illustrate your concerns and suggest alternatives.
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.
D. How May I Participate in This Meeting?
You may participate in this meeting by following the instructions in this section. For information on access to the teleconference, please contact Lu-Ann Kleibacker prior to the meeting using the information under FOR FURTHER INFORMATION CONTACT.
1. Oral Comments
Requests to present oral comments will be accepted up to February 9, 2009. 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 Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION CONTACT in order to be included on the meeting agenda and to provide sufficient time for the HSRB Chair and HSRB DFO to review the meeting agenda to provide an appropriate public comment period. The request should identify the name of the individual making the presentation and the organization (if any) the individual will represent. 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 the time limitations by having numerous individuals sign up separately to speak on their behalf. If additional time is Start Printed Page 5655available, there may be flexibility in time for public comments.
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 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, EST, February 9, 2009. To ensure proper receipt of all written material by EPA, it is imperative that you identify docket ID number EPA-HQ-ORD-2009-0030 in the subject line on the first page of your submission. In addition, the Agency also requests that person(s) submitting comments directly to the docket also provide a copy of their comments to Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the length of written comments for consideration by the HSRB.
1. Human Studies Review Board
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.
The EPA will present for HSRB review scientific and ethical issues surrounding the reports from a completed field study of mosquito repellent efficacy (SPC-001) and a completed laboratory study of tick repellent efficacy (SPC-002) conducted by Carroll-Loye Biological Research using multiple skin-applied repellent products containing picaridin. In addition, the HSRB will consider and discuss general information about “spatial” or “area” insect repellent products and their testing, in preparation for expected future reviews of proposals for field efficacy testing of spatial repellents. Insect repellent testing reviewed by the Board in past meetings has concerned only skin-applied repellents, which differ in important ways from spatial repellents. Finally, the HSRB may also discuss planning for future HSRB meetings.
2. Meeting Minutes and Reports
Minutes of the meeting, summarizing the matters discussed and recommendations made, if any, by the advisory committee regarding such matters will be released within 90 calendar days of the meeting. Such minutes will be available at http:// www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition, information concerning a Board meeting report, if applicable, can be found at http://www.epa.gov/osa/hsrb/ or from the person listed under FOR FURTHER INFORMATION CONTACT.Start Signature
Dated: January 26, 2009.
EPA Acting Science Advisor.
[FR Doc. E9-2037 Filed 1-29-09; 8:45 am]
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