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Open Recommendations

Animal Drugs: Strengthening Federal Incentives Could Help Address Unmet Animal Health Needs

GAO-26-107896
Mar 03, 2026
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3 Open Recommendations
Agency Affected Sort descending Recommendation Status
Congress Congress should consider whether the statutory 5-year limit on conditional approval for animal drugs should be expanded to appropriately balance the goals of increasing drug availability to address unmet animal health needs, protecting animal and human health, and maintaining incentives for sponsors to develop drugs for markets with limited profitability, and should amend the statute as appropriate.
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Food and Drug Administration The Commissioner of FDA should incorporate a benefit-risk assessment into its process for evaluating whether animal drugs that use alternative study designs have demonstrated substantial evidence of effectiveness. (Recommendation 1)
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When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Food and Drug Administration The Commissioner of FDA should develop guidance for industry on its use of benefit-risk assessments in its regulatory decisions for animal drugs that demonstrate substantial evidence of effectiveness using alternative study designs. (Recommendation 2)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Sexual Health Education: HHS Could Improve Efforts to Assess Grantee Performance

GAO-26-107617
Mar 02, 2026
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1 Open Recommendations
Agency Affected Sort descending Recommendation Status
Administration for Children and Families The Administrator of ACF should identify and implement appropriate near-term goals with specific targets and time frames for the performance measures related to youth outcomes and program experiences for the SRAE programs. (Recommendation 1)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Public Health Preparedness: Improved Coordination Needed for HHS’s Emergency Preparedness Programs

GAO-26-107507
Feb 23, 2026
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5 Open Recommendations
Agency Affected Sort descending Recommendation Status
Department of Health and Human Services The Assistant Secretary for Preparedness and Response and the Director of CDC should develop a mechanism, or mechanisms, to coordinate PHEP and HPP by, for example, taking into consideration GAO's Leading Practices to Enhance Interagency Collaboration and Address Crosscutting Challenges. (Recommendation 1)
Open
We will update the status of this recommendation when HHS provides its 180-day letter (expected in summer 2026)
Department of Health and Human Services The Director of CDC should provide information to jurisdictions on how the required PHEP activities support the development of the public health preparedness capabilities. (Recommendation 2)
Open
We will update the status of this recommendation when HHS provides its 180-day letter (expected in summer 2026)
Department of Health and Human Services The Assistant Secretary for Preparedness and Response should provide information to jurisdictions on how the required HPP activities support the development of the health care preparedness capabilities. (Recommendation 3)
Open
We will update the status of this recommendation when HHS provides its 180-day letter (expected in summer 2026)
Department of Health and Human Services The Director of CDC should collect and analyze information on jurisdictions' ability meet the public health preparedness capabilities and identify any related gaps in partnership with jurisdictions. (Recommendation 4)
Open
We will update the status of this recommendation when HHS provides its 180-day letter (expected in summer 2026)
Department of Health and Human Services The Assistant Secretary for Preparedness and Response should collect and analyze information on jurisdictions' ability to meet health care preparedness capabilities and identify any related gaps in partnership with jurisdictions. (Recommendation 5)
Open
We will update the status of this recommendation when HHS provides its 180-day letter (expected in summer 2026)

High Risk Research: HHS Should Publicly Share More Information on How Risk Is Assessed and Mitigated

GAO-26-107348
Feb 19, 2026
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1 Open Recommendations
Agency Affected Sort descending Recommendation Status
Department of Health and Human Services The Secretary of Health and Human Services should work with HHS funding agencies to ensure that key information on the agencies' risk reviews of extramural research and intramural projects involving pathogens are publicly shared with researchers, Congress, and the public, as appropriate. Such information should be regularly updated and include the outcomes of risk reviews, steps HHS funding agencies and researchers took to mitigate risk, and the total number of research projects involving higher-risk pathogen research that agencies support. (Recommendation 1)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

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