In 2016, the U.S. Department of Health and Human Services finalized its Guidelines for Regulatory Impact Analysis under the leadership of its Assistant Secretary for Planning Evaluation and Analytics Team. The Guidelines discuss strategies for characterizing the uncertainty in quantified effects as well as the potential impacts of non-quantified effects.
Division of Science and Public Health Policy
The Division of Science and Public Health Policy is the ASPE lead on public health and biomedical science issues and initiatives, including programmatic and policy areas that involve complex or rapidly evolving science and technology. The Division provides technical assistance on regulatory impact analysis development to HHS agencies and offices. The Division is responsible for policy coordination; long-range planning; legislative development; economic, program, and regulatory analysis; and evaluation focused on the HHS science and public health agencies – the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH), and Office of the Assistant Secretary for Preparedness and Response (ASPR). Examples of issue areas include:
- Biomedical innovation
- Biomedical research policy
- Medical product regulation
- Drug development, safety, availability, and pricing
- Public health and emergency preparedness, response, and recovery
- Opioid epidemic response
- Emerging infectious diseases
- Prevention of chronic diseases
- Food safety
Reports
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Prescription Drug Supply Chains: An Overview of Stakeholders and Relationships
Many stakeholders and steps are involved in the life cycle of a prescription drug as it moves from chemical synthesis and formulation through dispensing or administration to patients. The specific steps involved in prescription drug supply chains often differ depending on the type of drug, the channel of distribution, and the patient’s source of prescription drug coverage.
Research Brief
Drug Checking Programs in the United States and Internationally: Environmental Scan Summary
This environmental scan presents a review and synthesis of approaches and strategies adopted by drug checking programs and existing evidence on their effectiveness in changing drug use attitudes, behavior, and health outcomes. It includes studies of drug checking programs across a variety of settings in the United States and internationally.
Report
Guidelines for Regulatory Impact Analysis Supplement: Addressing International Effects
This report extends the brief discussion of addressing international effects contained in the Department of Health and Human Service Guidelines for Regulatory Impact Analysis (2016). The purpose of this supplement is to expand that discussion and provide more detailed information on conducting such assessments.
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ASPE Issue Brief
Parents' Intentions to Vaccinate Children Ages 12-17 for COVID-19: Demographic Factors, Geographic Patterns, and Reasons for Hesitancy
As of September 13, 2021, three vaccines to prevent infection with SARS-CoV-2, the virus that causes COVID-19, are available in the United States. The Pfizer vaccine was granted full approval for use in individuals over the age of 16 by the U.S.
Report
Valuing COVID-19 Mortality and Morbidity Risk Reductions in U.S. Department of Health and Human Services Regulatory Impact Analyses
This report develops an approach for valuing COVID-19 mortality and morbidity risk reductions based on the U.S. Department of Health and Human Services (HHS) Guidelines for Regulatory Impact Analysis. Valuing risk reductions associated with regulations or other policies that address the novel coronavirus disease 2019 (COVID-19) presents major challenges.
ASPE Issue Brief
Unvaccinated for COVID-19 but Willing: Demographic Factors, Geographic Patterns, and Changes Over Time
As of August 4, 2021, 70.1 percent of U.S. adults have received at least one dose of a COVID-19 vaccine. However, vaccine coverage varies dramatically across the country, with vaccine coverage being less than 40 percent in a third of U.S. counties. Despite a sufficient supply of COVID-19 vaccines, daily vaccinations have dwindled in recent months.