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Report File
Date Issued
Submitting OIG
Department of Health & Human Services OIG
Other Participating OIGs
Department of Health & Human Services OIG
Agencies Reviewed/Investigated
Department of Health & Human Services
Components
Food and Drug Administration
Report Number
A-03-16-00354
Report Description

The Food and Drug Administration (FDA) is one of several Federal agencies that ship and receive select agents. Select agents are biological agents or toxins that HHS and the Department of Agriculture have determined pose a threat to humans, animals, plants, or the environment. In 2015, another Federal agency found that one of its facilities had inadvertently shipped live Bacillus anthracis, a select agent which causes the deadly disease anthrax, to 194 laboratories in the United States and other countries. In response to these events, we initiated a review of the policies, procedures, and protocols FDA implemented to ensure the safe shipment of select agents to and from its laboratories.

Report Type
Audit
Agency Wide
Yes
Number of Recommendations
6
Additional Details
https://oig.hhs.gov/oas/reports/region3/31600354.asp

Open Recommendations

This report has 6 open recommendations.
Recommendation Number Significant Recommendation Recommended Questioned Costs Recommended Funds for Better Use Additional Details
267084 No $0 $0

We recommend that FDA ensure that its registered entities verify and maintain documentation to assure that employees who are required to have select agent training understand the training received.

267081 No $0 $0

We recommend that FDA update its registered entities' security plans to include procedures for notifying FSAP if a select agent package is received damaged to the extent that a release of the select agent may have occurred.

267083 No $0 $0

We recommend that FDA update its registered entities' security plans to include procedures for notifying FSAP if a select agent transfer authorization becomes void because the facts supporting the authorization changed.

267085 No $0 $0

We recommend that FDA Update its policies for shipping inactivated select agents to require that its registered entities record a description of the viability testing protocol used, the names of the personnel who inactivated the select agent, and the location of the inactivation.

267080 No $0 $0

We recommend that FDA update its registered entities' security plans to include procedures for notifying FSAP if a select agent shipment is not received within 48 hours after the expected time of delivery.

267082 No $0 $0

We recommend that FDA update its registered entities' security plans to include procedures for notifying FSAP if a select agent shipment will not be completed within 30 calendar days after transfer authorization issuance.

Department of Health & Human Services OIG

United States