2013-07263. Human Studies Review Board; Notification of a Public Webinar/Teleconference

AGENCY:

U. S. Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The EPA Office of the Science Advisor announces a public Webinar/teleconference of the Human Studies Review Board (HSRB) to discuss its draft report on the HSRB meeting held January 17, 2013.

DATES:

The Webinar/teleconference will be held on Friday, April 12, 2013, from approximately 11:00 a.m. to approximately 12:30 p.m. Eastern Time. Comments may be submitted on or before Friday, April 5, 2013. Information regarding the HSRB final meeting report will be found at http://www.epa.gov/​osa/​hsrb and http://www.regulations.gov or from the persons listed under FOR FURTHER INFORMATION CONTACT.

Webcast: This meeting may be webcast. Please refer to the HSRB Web site http://www.epa.gov/​osa/​hsrb for information on how to access the webcast. If difficulties arise resulting in webcasting outages, the meeting will continue as planned.

ADDRESSES:

Submit your written comments, identified by Docket ID No. EPA-HQ-ORD-2013-0115, by one of the following methods:

Internet: http://www.regulations.gov: Follow the Web site instructions for submitting comments.

Email: [e-mail].

Mail: Environmental Protection Agency, EPA Docket Center EPA/DC, ORD Docket, Mail Code 28221T, 1200 Pennsylvania Avenue 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 Avenue NW., Washington, DC 20460. The Reading Room's hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday, excluding Federal holidays. Please call [phone] or email the ORD Docket at [e-mail] for instructions. Updates to Public Reading Room access are available online at http://www.epa.gov/​epahome/​dockets.htm.

Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-2013-0115. The Agency'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 or other information the disclosure of which is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site is an “anonymous access” system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through http://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, the EPA recommends that you include your name and other contact information in the body of your comments and with any disk or CD-ROM you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the 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 FURTHER INFORMATION CONTACT:

Any members of the public who wish to receive further information about this Webinar/Teleconference should contact Jim Downing at telephone number [phone]; fax [phone]; email address [e-mail] or Lu-Ann Kleibacker on telephone number [phone]; fax: [phone]; email address [e-mail]; mailing address Environmental Protection Agency, Office of the Science Advisor, Mail Code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC 20460. General information concerning the HSRB can be found on the EPA Web site at http://www.epa.gov/​osa/​hsrb.

SUPPLEMENTARY INFORMATION:

 

Location: The meeting will take place via the Internet and telephone only. Access information can be found on the HSRB Web site: http://www.epa.gov/​osa/​hsrb/​ or by contacting the persons listed under the FOR FURTHER INFORMATION CONTACT section of this Notice.

Meeting access: For detailed information on access or services for individuals with disabilities, please contact Lu-Ann Kleibacker at least ten 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 Section I, “Public Meeting,” under subsection D, “How May I Participate in this Meeting?” of this notice.

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 particular interest to persons who conduct or assess human studies, especially studies on substances regulated by the EPA, or to persons who are, or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act or the Federal Insecticide, Fungicide, and Rodenticide Act. Since other entities may also be interested, the EPA 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 Jim Downing or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION CONTACT.

B. How can I access electronic copies of this document and other related information?

You may use http://www.regulations.gov,, or you may access this Federal Register document via the EPA's Internet site under the “Federal Register” listings at http://www.epa.gov/​fedrgstr.

Docket: All documents in the docket are listed in the http://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 at http://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 Avenue NW., Washington, DC 20460; its hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday, excluding federal holidays. Please call [phone], or email the ORD Docket at [e-mail] for instructions. Updates regarding the Public Reading Room access are available at http://www.epa.gov/​epahome/​dockets.htm.

C. What should I consider as I prepare my comments for the 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 used that support your views.

4. Provide specific examples to illustrate your concerns and suggest alternatives.

5. To ensure proper receipt by the 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 by providing comments in this meeting by following the instructions in this section. To ensure proper receipt of your comments by the EPA, it is imperative that you identify Docket ID No. EPA-HQ-ORD-2013-0115 in the subject line on the first page of your request.

1. Oral comments. Requests to present oral comments will be accepted up to and including Friday, April 5, 2013. 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 during 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 Jim Downing or Lu-Ann Kleibacker under FOR FURTHER INFORMATION CONTACT no later than noon, Eastern Time, Friday, April 5, 2013, in order to be included on the meeting agenda and to provide sufficient time for the HSRB Chair and HSRB Designated Federal Official 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 generally limited to five 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, further public comments may be possible.

2. Written comments. Please submit written comments prior to the meeting. 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 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, Friday, April 5, 2013. You should submit your comments using the instructions in Section I, under subsection C, “What Should I Consider as I Prepare My Comments for the EPA?” In addition, the EPA also requests that persons submitting comments directly to the docket also provide a copy of their comments to Jim Downing or 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 HSRB is a Federal advisory committee operating in accordance with the Federal Advisory Committee Act 5 U.S.C. App. 2 Section 9. The HSRB provides advice, information, and recommendations to the 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: (1) Research proposals and protocols; (2) reports of completed research with human subjects; and (3) how to strengthen the EPA's programs for protection of human subjects of research. The HSRB reports to the EPA Administrator through the EPA Science Advisor.

1. Topics for Discussion. The HSRB will be reviewing its draft report from the January 17, 2013, HSRB meeting. The HSRB may also discuss planning for future HSRB meetings. Background on the January 17, 2013 HSRB meeting can be found at the HSRB Web site: http://www.epa.gov/​osa/​hsrb. The January 17, 2013 meeting draft report is available. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from regulations.gov and the HSRB Web site at http://www.epa.gov/​osa/​hsrb. For questions on document availability or if you do not have internet access, consult the persons listed under FOR FURTHER INFORMATION.

2. 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 http://www.epa.gov/​osa/​hsrb/​ and http://www.regulations.gov. In addition, information regarding the HSRB final meeting report will be found at http://www.epa.gov/​osa/​hsrb and http://www.regulations.gov or from the persons listed under FOR FURTHER INFORMATION CONTACT.

Dated: March 20, 2013.

Glenn Paulson,

Science Advisor.