CDC Cleared to Collect "Select
Agents" Information
August 9, 2002 -The Centers for Disease Control and
Prevention (CDC) published in the Aug. 6 Federal Register
[67 FR 51057-64] a notice
clearing the agency to begin collecting information on the
presence of biological "select agents" at private and public
organizations, including academic institutions. This information
collection is mandated by the Public Health Security and Bioterrorism
Preparedness Act, signed into law June 12. Under the law,
universities, clinics, and other organizations or individuals
must report their possession of specified biological agents,
including anthrax bacillus, ricin, and Yersinia pestis - the
agent of plague - to the federal government by Sept. 10, 2002.
The CDC's notice includes guidance and a final information
collection form that lists the select agents. The agency intends
to mail the form and guidance document to approximately 190,000
facilities immediately; organizations that do not receive
the documents are urged to contact CDC directly. The guidance
requires each facility to designate a responsible official,
or "RFO," to collect and provide the information. All facilities-even
those not possessing select agents-are required to reply.
The form also includes information to be collected by the
USDA's Animal and Plant Health Inspection Service (APHIS),
a partner in this effort.
The Office of Management and Budget, which approved the
data-collection, noted a number of concerns raised by public
comments on earlier draft guidance, although the CDC effectively
conceded to none of these objections. Among expressed concerns
are a perceived ambiguity in the definition of "facility,"
the requirement that institutions not possessing agents must
also respond (although not required by the statute), and that
the burden of effort for compliance will be much larger than
CDC has estimated.
Accordingly, the AAMC urges member institutions to examine
the notice in coordination, as appropriate, with university
administrators, and to contact CDC for more information as
necessary.
Information:
Stephen Heinig, Senior Research Fellow
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
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