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 andFederal Registercitation.
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-2012-0175 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 Wednesday, March 21, 2012. 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 underFOR FURTHER INFORMATION CONTACTno later than noon, Eastern Time, Wednesday, March 21, 2012, 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, Wednesday, March 21, 2012. 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 underFOR 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 26, 2012, HSRB meeting. The HSRB may also discuss planning for future HSRB meetings. Background on the January 26, 2012 HSRB meeting can be found at the HSRB Web site:http://www.epa.gov/osa/hsrb.The January 26, 2012 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 regulations.gov and the HSRB Web site athttp://www.epa.gov/osa/hsrb.For questions on document availability or if you do not have Internet access, consult the persons listed underFOR 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 athttp://www.epa.gov/osa/hsrb/andhttp://www.regulations.gov.In addition, information regarding the HSRB final meeting report will be found athttp://www.epa.gov/osa/hsrbor from the persons listed underFOR FURTHER INFORMATION CONTACT.
Dated: March 7, 2012.
Lek Kadeli,
Acting Assistant Administrator.