2018-21331. Human Studies Review Board; Notification of Public Meetings

AGENCY:

Environmental Protection Agency.

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 virtual public meeting will be held on Tuesday, October 23, 2018, from 1:00 p.m. to approximately 5:30 p.m. Eastern Time. A separate, subsequent teleconference meeting is planned for Thursday, December 13th, 2018, from 2 p.m. to approximately 3:30 p.m. Eastern Time for the HSRB to finalize its Report of the October 23, 2018 meeting and review other possible topics.

ADDRESSES:

All of these meetings will be conducted entirely by telephone and on the internet using Adobe Connect. For detailed access information visit the HSRB website: 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 (DFO), Thomas O'Farrell on telephone number [phone]; fax number: [phone]; email address: [e-mail]; 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 will be open to the public. The full Agenda and meeting materials will be available at the HSRB website: 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 the DFO, Thomas O'Farrell, 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 the DFO 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. To pre-register to make oral comments, please contact the DFO, Thomas O'Farrell, listed under FOR FURTHER INFORMATION CONTACT. Requests to present oral comments during the meeting will be accepted up to Noon Eastern Time on Tuesday, October 16, 2018, for the October 23, 2018 meeting and up to Noon Eastern Time on Thursday, December 6, 2018 for the December 13, 2018 meeting. 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 meeting 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 via email or Fax by Noon Eastern Time on Tuesday, October 16, 2018, for the October 23, 2018 meeting and by Noon Eastern Time on Thursday, December 6, 2018 for the December 13, 2018 meeting. 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 the DFO, Thomas O'Farrell 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 section 9. The HSRB provides advice, information, and recommendations on issues related to scientific and ethical aspects of third-party human subjects research that are submitted to the Office of Pesticide Programs (OPP) to be used for regulatory purposes.

Topic for discussion. On October 23, 2018, the Human Studies Review Board will consider a protocol titled “A Study for Measurement of Potential Dermal and Inhalation Exposure During Antimicrobial Applications Involving Immersion, Dip, and Soak” submitted by the Antimicrobial Exposure Assessment Task Force.

The Agenda and meeting materials for this topic will be available in advance of the meeting at http://www2.epa.gov/​osa/​human-studies-review-board.

On December 13, 2018, the HSRB will review and finalize their draft Final Report from the October 23, 2018 meeting, in addition to other topics that may come before the Board. The HSRB may also discuss planning for future HSRB meetings. The agenda and the draft report will be available prior to the meeting 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 Thomas O'Farrell listed under FOR FURTHER INFORMATION CONTACT.

Dated: September 19, 2018.

Jennifer Orme-Zavaleta,

EPA Science Advisor.