Subject Matter Expertise
Legislative and Regulatory Drafting;- Federal Budget/Appropriations Process, including OMB Guidance;
- Appropriations Principles in Federal Contracts and Grants. For example, we have assisted clients in matters relating to: limitations on appropriations as to time or purpose: Anti-Deficiency Act, Bona Fide Needs Rule, and the issue of services contracts crossing fiscal years;
- FDA Guidance and Regulations (Food Drug and Cosmetic Act and regulations relating to diagnostic devices, molecular assays for human diagnostic use); FDA Guidance: Emergency Use Authorizations which permit the FDA Commissioner to “allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved and available alternatives.”
- The Pandemic All-Hazards Preparedness Act (PAHPA) (PAHPA), Public Law No. 109-417, provides authority for a number of programs, established BARDA, and includes the advanced development and acquisitions of medical countermeasures to defend against Public Health Emergencies;
- The Public Readiness and Emergency Preparedness Act (PREP Act) (Pub. L. 109-148), which is available to provide immunity from liability claims relating to the use of covered countermeasures during a declared public health emergency (such as the H1N1 Pandemic);
- The SAFETY Act and qualification of products or services as “Anti-Terrorism Technology” in order to obtain immunity from third party products liability claims.