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    Subject Term: Animals

    4 publications with a total of 19 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: Persons, Timothy M
    Phone: (202) 512-6412

    9 open recommendations
    Recommendation: To understand the extent to which incomplete inactivation occurs and whether incidents are being properly identified, analyzed, and addressed, the Secretary of Health and Human Services should direct the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to develop clear definitions of inactivation for use within their respective guidance documents that are consistent across the Select Agent Program, NIH's oversight of recombinant pathogens, and the Biosafety in Microbiological and Biomedical Laboratories manual.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2017, the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) within the Department of Health and Human Service (HHS) are taking steps to address this recommendation. Specifically, in January and March 2017, HHS, in collaboration with the United States Department of Agriculture (USDA), issued updated select agent regulations and guidance that included clear definitions of inactivation and a validated inactivation procedure that are consistent across the Federal Select Agent Program. Additionally, HHS stated in December 2016 that NIH will consider providing clear and consistent definitions of inactivation in future guidance that is harmonized with the select agent regulations. Moreover, NIH and CDC told us they plan to include a new appendix in the revised Biosafety in Microbiological and Biomedical Laboratories manual that specifically addresses the development, validation, and implementation of inactivation protocols, which they anticipate releasing in 2 to 3 years.
    Recommendation: To understand the extent to which incomplete inactivation occurs and whether incidents are being properly identified, analyzed, and addressed, the Secretary of Agriculture should direct APHIS to revise reporting forms to help identify when incidents involving incomplete inactivation occur and analyze the information reported to help identify the causes of incomplete inactivation to mitigate the risk of future incidents.

    Agency: Department of Agriculture
    Status: Open

    Comments: In March 2017, officials from the Federal Select Agent Program told us that they are in the process of modifying the program's incident reporting form to include reporting of inactivation failures, with completion anticipated by summer 2017.
    Recommendation: To understand the extent to which incomplete inactivation occurs and whether incidents are being properly identified, analyzed, and addressed, the Secretary of Health and Human Services should direct CDC and NIH to revise reporting forms within their respective areas of oversight to help identify when incidents involving incomplete inactivation occur and analyze the information reported to help identify the causes of incomplete inactivation to mitigate the risk of future incidents.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In March 2017, officials from the Federal Select Agent Program told us that they are in the process of modifying the program's incident reporting form to include reporting of inactivation failures, with completion anticipated by summer 2017. In addition, in August 2016, the National Institutes of Health (NIH) revised its template for reporting incidents subject to the NIH Guidelines to include a specific checkbox for entities to identify incidents that involve incomplete inactivation.
    Recommendation: To increase scientific information on inactivation and viability testing, the Secretaries of Health and Human Services and Agriculture should coordinate research efforts and take actions to help close gaps in the science of inactivation and viability testing across high-containment laboratories.

    Agency: Department of Agriculture
    Status: Open

    Comments: In March 2017, United States Department of Agriculture (USDA) officials stated that the department, in coordination with the Department of Health and Human Services (HHS), has examined current gaps related to inactivation and are in the process of taking steps to increase research on applied biosafety, in part to improve scientific understanding of processes for inactivation in high-containment laboratories. We are waiting for documentation and timeframes for implementation.
    Recommendation: To increase scientific information on inactivation and viability testing, the Secretaries of Health and Human Services and Agriculture should coordinate research efforts and take actions to help close gaps in the science of inactivation and viability testing across high-containment laboratories.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In March 2017, Department of Health and Human Services (HHS) officials stated that the department, in coordination with the United States Department of Agriculture (USDA), has examined current gaps related to inactivation and are in the process of taking steps to increase research on applied biosafety, in part to improve scientific understanding of processes for inactivation in high-containment laboratories. We are waiting for documentation and timeframes for implementation.
    Recommendation: To help ensure that inactivation protocols are scientifically sound and are effectively implemented, the Secretary of Health and Human Services should direct CDC and NIH to create comprehensive and consistent guidance for the development, validation, and implementation of inactivation protocols--to include the application of safeguards--across the Select Agent Program, NIH's oversight of recombinant pathogens, and the Biosafety in Microbiological and Biomedical Laboratories manual.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In March 2017, the Department of Health and Human Services (HHS), in collaboration with the United States Department of Agriculture (USDA), issued Federal Select Agent Program guidance on the inactivation of select agents and toxins. According to HHS, this guidance is intended to provide additional information to regulated entities to assist them in meeting new requirements for rendering samples with select agents as non-viable. HHS also stated that the Federal Select Agent Program will continue to work with other federal agencies to ensure that the federal government is addressing inactivation in a consistent manner. In addition, according to HHS, the National Institutes of Health (NIH) will consider providing clear and consistent guidance related to inactivation that is harmonized with the Federal Select Agent Program as appropriate. As of March 2017, NIH and the Centers for Disease Control and Prevention (CDC) were in the process of revising the Biosafety in Microbiological and Biomedical Laboratories manual to include a new appendix that addresses the development, validation, and implementation of inactivation protocols. HHS plans to release the updated manual in 2 to 3 years.
    Recommendation: To help ensure that dangerous pathogens can be located in the event there is an incident involving incomplete inactivation, the Secretary of Health and Human Services should direct the Directors of CDC and NIH, when updating the Biosafety in Microbiological and Biomedical Laboratories manual, to include guidance on documenting the shipment of inactivated material.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS) stated in March 2017 that the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) are in the process of revising the Biosafety in Microbiological and Biomedical Laboratories manual to include a new appendix that addresses inactivation methods, including guidance on documenting the shipment of inactivated material by 2020. HHS plans to release the updated manual in 2 to 3 years.
    Recommendation: To help ensure more consistent enforcement for violations involving incomplete inactivation of select agents, the Secretary of Agriculture should direct APHIS to develop and implement consistent criteria and documentation requirements for referring violations to investigative entities and enforcing regulations related to incidents involving incomplete inactivation.

    Agency: Department of Agriculture
    Status: Open

    Comments: In September 2017, the Federal Select Agent Program finalized a document that provides criteria on when to refer violations and options for enforcement. The document categorizes regulatory departures, grouped by level of risk, along a spectrum of severity with associated enforcement options. The program continues to develop associated documentation requirements for referring violations to investigative entities and enforcing regulations.
    Recommendation: To help ensure more consistent enforcement for violations involving incomplete inactivation of select agents, the Secretary of Health and Human Services should direct CDC to develop and implement consistent criteria and documentation requirements for referring violations to investigative entities and enforcing regulations related to incidents involving incomplete inactivation.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In September 2017, the Federal Select Agent Program finalized a document that provides criteria on when to refer violations and options for enforcement. The document categorizes regulatory departures, grouped by level of risk, along a spectrum of severity with associated enforcement options. In addition, the Centers for Disease Control and Prevention worked with the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to develop a policy document that outlines criteria for referring violations to the HHS OIG. One of the criterion for referral is any departure from the select agent regulations that creates a danger to public health and safety. This policy document was finalized in June 2017. The program continues to develop associated documentation requirements for referring violations to investigative entities and enforcing regulations.
    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.