E9-28700. Human Studies Review Board (HSRB); Notification of a Public Teleconference to Review Its Draft Report From the October 20-21, 2009 HSRB Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The EPA Human Studies Review Board (HSRB) announces a public teleconference meeting to discuss its draft HSRB report from the October 20-21, 2009 HSRB meeting.

DATES:

The teleconference will be held on Wednesday, December 16, 2009, from 10 a.m.-12 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 at least 10 business days 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 information concerning submission of relevant written or oral comments is provided in Unit ID of this notice.

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, request a current draft copy of the Board's report or who wish further information may contact Lu-Ann Kleibacker, EPA, Office of the Science Advisor (8105R), Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; or via telephone/voice mail at [phone] or via e-mail at [e-mail]. General information concerning the EPA HSRB can be found on the EPA Web site at http://www.epa.gov/​osa/​hsrb/​.

ADDRESSES:

Submit your written comments, identified by Docket ID No. EPA-HQ-ORD-2009-0891, by one of the following methods:

http://www.regulations.gov: Follow the on-line instructions for submitting comments.

E-mail: [e-mail].

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-2009-0891. 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-2009-0891. 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 comments include 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 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. 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.

I. General Information

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 electronically available either through 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 [phone], and the telephone number for the ORD Docket is [phone].

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. To ensure proper receipt by EPA, it is imperative that you identify docket ID number EPA-HQ-ORD-2009-0891 in the subject line on the first page of your request.

1. Oral comments. Requests to present oral comments will be accepted up to Wednesday, December 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 no later than noon, Eastern Time, December 9, 2009, 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 available, public comments may be possible.

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 5 business days prior to the beginning of this teleconference. 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 Time, December 9, 2009. You should submit your comments using the instructions in Unit 1.C. of this notice. In addition, the Agency also requests that persons 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.

E. Background

The EPA Human Studies Review Board will be reviewing its draft report from the October 20-21, 2009, HSRB meeting. The Board may also discuss planning for future HSRB meetings. Background on the October 20-21, 2009, HSRB meeting can be found at Federal Register 74 190, 50965 (October 2, 2009) and at the HSRB Web site http://www.epa.gov/​osa/​hsrb/​. The October 20-21, 2009 meeting draft report is now available. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the http://www.regulations.gov Web site and the HSRB Internet Home Page at http://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.

Dated: November 25, 2009.

Kevin Teichman,

Acting EPA Science Advisor.