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Project Bioshield: HHS Can Improve Agency Internal Controls for Its New Contracting Authorities

GAO-09-820 Published: Jul 21, 2009. Publicly Released: Jul 21, 2009.
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Highlights

The Project BioShield Act of 2004 (BioShield Act) increased the federal government's ability to procure needed countermeasures to address threats from chemical, biological, radiological, and nuclear agents. Under the BioShield Act, the Department of Health and Human Services (HHS) was provided with new contracting authorities (increased simplified acquisition and micropurchase thresholds, and expanded abilities to use procedures other than full and open competition and personal services contracts) and was authorized to use about $5.6 billion in a Special Reserve Fund to procure countermeasures. Based on the BioShield Act's mandate, GAO reviewed (1) how HHS has used its purchasing and contracting authorities, and (2) the extent to which HHS has internal controls in place to manage and help ensure the appropriate use of its new authorities. To do this work, GAO reviewed contract files and other HHS documents, including internal control guidance, which GAO compared with federal statutes and federal internal control standards.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services The Secretary of Health and Human Services should include comprehensive risk assessment statements in written guidance on the internal controls for the BioShield contracting authorities for which the agency was required to establish controls.
Closed – Implemented
In response to our recommendation, HHS' Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH), the two agencies in HHS with contracting responsibilities under the BioShield Act, issued policy documents that added comprehensive risk assessment statements to their internal controls. BARDA issued its policy document in September 2009 and NIH issued its policy document in September 2010.

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Topics

AccountabilityAnthraxBiological weaponsCombating terrorismContract administrationContract authorityCounterterrorismFederal procurementFederal procurement policyFederal regulationsGovernment contractsInternal controlsProcurement planningProcurement practicesProcurement regulationsProgram evaluationRegulatory agenciesRisk assessmentRisk factorsRisk managementStrategic national stockpilePolicies and procedures