E9-10008. Public Consultation Meeting of the Working Group on Strengthening the Biosecurity of the United States

AGENCY:

Department of Health and Human Services, Office of the Secretary.

ACTION:

Notice.

SUMMARY:

The U.S. Department of Health and Human Services is hereby giving notice that the Working Group on Strengthening the Biosecurity of the United States will be holding a public consultation meeting. The meeting is open to the public.

DATES:

The Working Group on Strengthening the Biosecurity of the United States will hold a public consultation meeting on May 13, 2009 from 8:30 a.m. to 5 p.m. EDT and May 14, 2009 from 8:30 a.m. to 3:15 p.m. EDT.

ADDRESSES:

The Hyatt Regency-Bethesda, 7400 Wisconsin Ave., Bethesda, MD 20814. Phone [phone].

FOR FURTHER INFORMATION CONTACT:

Laura Kwinn, PhD, Office of Medicine, Science and Public Health, Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, 330 C Street, SW., Room 5123, Washington, DC 20201; phone: [phone]; fax: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

The Working Group on Strengthening the Biosecurity of the United States, was established by Executive Order (EO) 13486 on January 9, 2009, with the mission of reviewing, evaluating, analyzing and making recommendations to the President regarding the current laws, regulations, guidance, and practices of laboratories (including clinical and environmental facilities) that conduct research on, handle, store, or transport biological select agents and toxins in the United States. Within 180 days, the Working Group must issue a report to the President containing “recommendations for any new legislation, regulations, guidance, or practices for security and personnel assurance” and “options for establishing oversight mechanisms.” The report will also include a comparison of personnel security and reliability programs for access to biological select agents and toxins to similar programs in other fields and industries. Given the importance of biosecurity to protecting public health and agriculture, a public consultation meeting is being held to discuss biosecurity issues related to the Select Agent Regulations (The U.S. Department of Health and Human Services regulations for Select Agents and Toxins, 42 CFR Part 72, and the United States Department of Agriculture regulations for Possession, Use, and Transfer of Select Agents and Toxins, 9 CFR Part 121). Topics will include the definition of select agents, transportation of select agents, physical and personnel security of select agent entities, oversight and inspections of laboratories, and fostering a culture of security and responsibility.

Procedures for Providing Public Input: Public participation in this meeting of the Working Group is encouraged. Interested members of the public may attend the meeting in person. Pre-registration is highly encouraged and is available at the website: https://www.medicalcountermeasures.gov/​StrengtheningBiosecurity2009. Members of the public may also submit relevant written or oral information for the Working Group to consider. Oral and written information that is submitted may be made be available to the public; therefore, we request that statements do not include private or proprietary information. Oral Statements: Thirty minutes will be available each day of the meeting for public comment. In general, each speaker (or group of speakers) requesting an oral presentation will be limited to three minutes. To be placed on the public speaker list, interested parties should contact Dr. Laura Kwinn, in writing (preferably via e-mail to [e-mail]), by May 8, 2009. Written Statements: In general, individuals or groups may file written comments with the Working Group. All written comments must be received prior to May 18, 2009 and should be sent to Dr. Laura Kwinn (preferably by e-mail with “Working Group Public Comment” as the subject line). Individuals needing special assistance should notify Dr. Laura Kwinn by May 8, 2009.

Dated: April 27, 2009.

RADM W. Craig Vanderwagen,

Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services.