02-17771. Preliminary Guidance for Notification of Possession of Select Agents

AGENCY:

Centers for Disease Control and Prevention, Department of Health and Human Services.

ACTION:

General notice.

SUMMARY:

The purpose of this Notice is to announce preliminary guidance for notification of possession of select agents as mandated in Section 202(a) of Public Law 107-188 “Public Health Security and Bioterrorism Preparedness and Response Act of 2002.”

FOR FURTHER INFORMATION CONTACT:

John R. Moore, Centers for Disease Control and Prevention, Office of Program Planning and Evaluation, 1600 Clifton Road NE, Mailstop D-23, Atlanta, Georgia 30333. Telephone: [phone].

SUPPLEMENTARY INFORMATION:

On June 12, 2002, President George W. Bush signed Public Law 107-188 “Public Health Security and Bioterrorism Preparedness and Response Act of 2002.” Section 202(a) of the Act directs the Secretary of the Department of Health and Human Services, within 30 days of enactment, to provide written guidance on how persons in possession of biological agents or toxins shall notify the Secretary of such possession. To meet this requirement, the Centers for Disease Control and Prevention (CDC) has submitted a proposed data collection instrument (see draft form below) and guidance document to the Office for Management and Budget (OMB) for approval under the Paperwork Reduction Act. CDC published a notice in the Federal Register on July 2, 2002 inviting public comments on the proposed data collection. Public comments are due by July 16, 2002. Within two weeks of this date, and upon receipt of OMB approval, CDC will publish another notice in the Federal Register announcing approval and publication of the data collection instrument. The data collection instrument will contain the list of select agents currently contained in 42 CFR part 72, appendix A.

Each facility should designate a responsible facility official (RFO) to complete this form by September 10, 2002. It is the responsibility of the RFO to ensure management oversight of this notification requirement. The RFO should be either a safety officer, a senior management official of the facility, or both, who has been authorized by the facility to complete and submit the notification form. The RFO should not be an individual who actually possesses, uses, or transfers such agents or toxins. To complete the notification form, the RFO will need to inventory its facility and consult with others (e.g., principal investigators) as necessary to obtain the information required for the notification form. The RFO must review and sign the notification form and will be the point of contact if CDC has questions concerning the form or other matters related to the Act. Many facilities will receive the form via direct mailing, and the form will also be published in the Federal Register.

Further guidance, the approved data collection instrument, and location of submission will be announced at a later date.

Dated: July 10, 2002.

Nancy E. Cheal,

Acting Associate Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention.