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    Subject Term: Animals

    3 publications with a total of 10 open recommendations
    Director: John Neumann
    Phone: (202) 512-3841

    6 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop a process, which may include time frames, to establish appropriate durations of use on labels of all medically important antibiotics used in food animals.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to establish steps to increase veterinary oversight of medically important antibiotics administered in routes other than feed and water, such as injections and tablets.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop performance measures and targets for actions to manage the use of antibiotics such as revising the veterinary feed directive and developing guidance documents on judicious use.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS to develop performance measures and targets for collecting farm-specific data on antibiotic use in food animals.

    Agency: Department of Agriculture
    Status: Open

    Comments: USDA agreed with this recommendation. In July 2017, the Animal and Plant Health Inspection Service stated that it will develop performance measures and targets for collecting farm-specific data on antibiotic use in farm animals and antibiotic resistant bacteria by September 30, 2017.
    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS to develop performance measures and targets for collecting farm-specific data on antibiotic-resistant bacteria in food animals.

    Agency: Department of Agriculture
    Status: Open

    Comments: USDA agreed with this recommendation. In July 2017, the Animal and Plant Health Inspection Service stated that it will develop performance measures and targets for laboratory monitoring for antibiotic resistance of pathogens by September 30, 2017.
    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS and the Administrator of the Food Safety and Inspection Service to work with the Director of CDC to develop a framework for deciding when on-farm investigations are warranted during outbreaks.

    Agency: Department of Agriculture
    Status: Open

    Comments: USDA agreed with this recommendation. In July 2017, USDA's Animal and Plant Health Inspection Service agreed to work with USDA's Food Safety and Inspection Service and HHS' Centers for Disease Control and Prevention to develop an additional decision matrix by December 31, 2017 for use to determine when on-farm antimicrobial resistance investigative activities are warranted.
    Director: Anne-Marie Fennell
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: As the Aquatic Nuisance Species Task Force considers how to measure progress toward accomplishing its strategic goals, the Task Force should develop and regularly use a tracking mechanism, to include elements envisioned for an operational plan and to largely meet requirements in the 1990 Act, including: (1) specifying the roles of member agencies related to its strategic plan, (2) tracking activities to be conducted by collecting information on those activities and associated funding, (3) measuring progress member agencies have made in achieving its strategic goals, and (4) reporting to Congress annually on the progress of its program.

    Agency: Aquatic Nuisance Species Task Force
    Status: Open

    Comments: As of August 2017, the Aquatic Nuisance Species Task Force (ANSTF) has issued its 2015 report to Congress and has a working draft of its 2016 report, according to agency officials. The ANSTF reported that it finalized and distributed a new activity tracking tool in October 2016 to collect accomplishments for fiscal years 2015-16, and that it plans to assess and update its tool in future years to align with the development of its next strategic plan.
    Director: Steve D. Morris
    Phone: (202) 512-3841

    3 open recommendations
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to modify the voluntary reporting form FDA uses to obtain information on adverse events to ask whether drugs involved in adverse events were compounded.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2017, FDA has drafted a notice for publication in the Federal Register that seeks comment on editorial revisions to Form FDA 1932a to clarify how to report adverse drug events associated with compounded products using that form. The publication of the notice was issued in July 2017. After a 60-day public comment period, the revisions to Form FDA 1932a will be submitted to OMB for review and approval under the Paperwork Reduction Act.
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to develop policy or guidance for agency staff that specifies circumstances under which FDA will or will not enforce compounding regulations for animals and clearly define key terms.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In July 2017, FDA notified us that they are still in the process of developing guidance for agency staff that specifies circumstances under which FDA will enforce compounding regulations for animals. According to FDA, the agency received more than 150 comments regarding the draft Guide For Industry #230 and 280 nominations of bulk drug substances for use in compounding office stock; information necessary for updating the guidance. In addition, FDA is reviewing the substances that were nominated for use in compounding office stock. Officials did not provide a specific timeline for completing this work, but stated that developing updated guidance on compounding for animals continues to be a high priority for FDA.
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to consistently document the bases for FDA's decisions about how or whether it followed up on warning letters, adverse event reports, and complaints about drug compounding for animals.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2017, FDA reported that it is still developing an enforcement strategy for compounded animal drugs that includes a process for documenting the Agency's actions with respect to follow-up on warning letters, adverse event reports, and complaints.