Human Studies Review Board; Notification of Public Meetings

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (EPA) Office of the Science Advisor announces two separate public meetings of the Human Studies Review Board (HSRB) to advise the Agency on the ethical and scientific review of research involving human subjects.

DATES:

A public virtual meeting will be held on October 19-20, 2016, from 1:00 p.m. to approximately 5:00 p.m. Eastern Time each day. A separate, subsequent teleconference meeting is planned for Tuesday, December 13, 2016, from 2:00 p.m. to approximately 3:30 p.m. for the HSRB to finalize its Final Report of the October 19-20, 2016 meeting.

ADDRESSES:

Both of these meetings will be conducted entirely by telephone and on the Internet using Adobe Connect. For detailed access information visit the HSRB Web site: http://www2.epa.gov/osa/human-studies-review-board.

FOR FURTHER INFORMATION CONTACT:

Any member of the public who wishes to receive further information should contact the HSRB Designated Federal Official, Jim Downing on telephone number (202) 564-2468; fax number: (202) 564-2070; email address: downing.jim@epa.gov; or mailing address: Environmental Protection Agency, Office of the Science Advisor, Mail code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC 20460.

SUPPLEMENTARY INFORMATION:

Meeting access: These meetings are open to the public. Meeting materials are available at the HSRB Web site: http://www2.epa.gov/osa/human-studies-review-board for questions on document availability, or if you do not have access to the Internet, consult with Jim Downing listed under FOR FURTHER INFORMATION CONTACT.

Special accommodations. For information on access or services for individuals with disabilities, or to request accommodation of a disability, please contact Jim Downing listed under FOR FURTHER INFORMATION CONTACT at least 10 days prior to the meeting to give EPA as much time as possible to process your request.

How may I participate in this meeting?

The HSRB encourages the public's input. You may participate in these meetings by following the instructions in this section.

1. Oral comments. Requests to present oral comments during either conference call will be accepted up to Noon Eastern Time on Wednesday, October 12, 2016, for the October 19-20, 2016 meeting and up to Noon Eastern Time on Thursday, December 8, 2016 for the December 13, 2016 conference call. To the extent that time permits, interested persons who have not pre-registered may be permitted by the HSRB Chair to present oral comments during either call at the designated time on the agenda. Oral comments before the HSRB are generally limited to five minutes per individual or organization. If additional time is available, further public comments may be possible.

2. Written comments. Submit your written comments prior to the meetings. For the Board to have the best opportunity to review and consider your comments as it deliberates, you should submit your comments by Noon Eastern Time on Wednesday, October 12, 2016, for the October 19-20, 2016 conference call, and by noon Eastern Time on Thursday, December 8, 2016 for the December 13, 2016 teleconference. If you submit comments after these dates, those comments will be provided to the HSRB members, but you should recognize that the HSRB members may not have adequate time to consider your comments prior to their discussion. You should submit your comments to Jim Downing listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the length of written comments for consideration by the HSRB.

Background

The HSRB is a Federal advisory committee operating in accordance with the Federal Advisory Committee Act 5 U.S.C. App. 2 § 9. The HSRB provides advice, information, and recommendations on issues related to scientific and ethical aspects of human subjects research that are submitted to the Office of Pesticide Programs to be used for regulatory purposes. 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 EPA's programs for protection of human subjects of research.

Topics for discussion. On Wednesday, October 19, 2016, EPA's Human Studies Review Board will consider a Protocol for Laboratory Evaluation of Mosquito Bite Protection from Permethrin-treated Clothing for the U.S. Army after 0, 20 and/or 50 washings. On Thursday, October 20, 2016 the HSRB will consider: A Study for Measurement of Potential Dermal and Inhalation Exposure during Manual Pouring of Two Solid Formulations Containing an Antimicrobial. Meeting materials for these two topics will be available in advance of the meeting at http://www2.epa.gov/osa/human-studies-review-board.

On December 13, 2016, the Human Studies Review Board will review and finalize their draft Final Report from the October 19-20, 2016 meeting. The draft report will be available prior to the conference call at http://www2.epa.gov/osa/human-studies-review-board.

Meeting minutes and final reports. Minutes of these meetings, summarizing the matters discussed and recommendations made by the HSRB, will be released within 90 calendar days of the meeting. These minutes will be available at http://www2.epa.gov/osa/human-studies-review-board. In addition, information regarding the HSRB's Final Report, will be found at http://www2.epa.gov/osa/human-studies-review-board or from Jim Downing listed under FOR FURTHER INFORMATION CONTACT.