Recommendation: The Commissioner of FDA should establish a process for the agency to communicate directly with all U.S.-based commercial airlines, including regional airlines, to encourage them to request construction inspections to ensure compliance with the agency's standards for the sanitary construction of aircraft galleys and lavatories. (Recommendation 1)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: HHS concurs with GAO's recommendation. FDA agrees that enhancing communication with U.S.-based commercial airlines, including major national and regional commuter airlines, to encourage them to request construction inspections can have a positive impact on efforts to gain compliance with the Agency's standards for aircraft galley and lavatory sanitation and potable water system installation. FDA has a long history of working collaboratively with interstate travel conveyance stakeholders to provide public health oversight to the industry. As part of this collaboration, FDA and the airline industry connect through a variety of mechanisms to provide access to diverse industry partners. To effectively engage all relevant stakeholders, FDA will consider ways to enhance current mechanisms and coordinate with airlines on better communication. FDA will review its existing outreach channels to allow airline stakeholders to actively and directly engage with the Agency on construction inspections. FDA will review its Interstate Travel Program website to determine if updates can be made to emphasize airline construction and reconstruction information. FDA maintains open dialog with airline organizations, including the Airlines for America (A4A), the Regional Airline Association (RAA), and the International Flight Services Association (IFSA). Members of A4A are comprised of major national airlines, whereas those of RAA are comprised of regional commuter airlines and those in IFSA include airlines and airline food suppliers. These industry associations are valuable partners in developing solutions to problems that concern the airlines and airline construction. FDA will continue to engage with these organizations in written correspondence and at relevant national industry meetings (such as the Environmental Protection Agency biennial meeting on aircraft drinking water safety) and will include the topic of construction inspections. FDA will also continue to use these existing mechanisms to develop a better communication process with the airline industry on its efforts to improve industry practice and government oversight.

Recommendation: The Secretary of Health and Human Services should develop a mechanism to routinely monitor, evaluate, and report on coordination efforts for infectious disease modeling across multiple agencies. (Recommendation 1)

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation and stated that it is developing a process whereby it will coordinate its efforts in infectious disease modeling across its components, including efforts to monitor, evaluate and report on its coordination. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The Secretary of Health and Human Services should direct CDC to establish guidelines that ensure full reproducibility of CDC's research by sharing with the public all permissible and appropriate information needed to reproduce research results, including, but not limited to, model code. (Recommendation 2)

Agency: Department of Health and Human Services
Status: Open

Comments: The Centers for Disease Control and Prevention concurred with this recommendation. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The Director of CDC should take steps to determine participation rates and distribution needed in the AR Option of the National Healthcare Safety Network for conducting regional and national assessments of antibiotic resistance of public health importance. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should ensure that CDC's evaluation of its surveillance system for antibiotic-resistant gonorrhea includes measures of its representativeness, such as comparison of the trends in the sample population with those in the overall U.S. population, using specially designed studies if needed. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services and the Centers for Disease Control and Prevention concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should provide information on uncertainties for antibiotic resistance estimates in its consolidated Threats Reports, including standard errors or confidence intervals, as appropriate. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services generally concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should develop a plan for timely, consolidated reports of antibiotic resistance in priority pathogens at regular intervals. (Recommendation 4)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human services concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should identify leadership and clarify roles and responsibilities among HHS agencies to assess the clinical outcomes of diagnostic testing for identifying antibiotic-resistant bacteria. (Recommendation 5)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services concurred with GAO's recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should direct the Center for Devices and Radiological Health to conduct additional monitoring and evaluation of the status of FDA-authorized tests that rely on breakpoints, on a regular basis, to determine whether test manufacturers are updating breakpoints, seeking additional resources as needed. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Food and Drug Administration: Office of the Commissioner
Status: Open

Comments: The Department of Health and Human Services and the Food and Drug Administration concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should develop a strategic framework to further incentivize the development of new treatments for antibiotic-resistant infections, including through the use of postmarket financial incentives, and, if appropriate, make recommendations to Congress for necessary authority. (Recommendation 7)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services did not concur with GAO's recommendation. In commenting on our report, the department noted that it has convened a workgroup to develop a strategic framework that includes proposals to address a variety of challenges facing antibiotic product developers and agreed that additional incentives are needed. However, the department stated it is still analyzing whether postmarket financial incentives should be included in this framework. We believe our recommendation is still warranted, given the importance of antibiotic resistance to public health and the importance of sustaining the antibiotic pipeline, including after antibiotics are brought to market. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should direct the CARB Task Force to include in its annual updates to the President plans for addressing any barriers preventing full implementation of the National Action Plan and, as appropriate, make recommendations for new or modified actions. Specifically, the CARB Task Force should identify plans to address barriers, such as those related to expanding (1) a CDC program designed to strengthen the U.S. response to resistant gonorrhea; (2) antibiotic stewardship programs across health care settings; and (3) antibiotic use data collection across health care settings, to the extent feasible. (Recommendation 8)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation, and stated that beginning in 2020 and continuing annually thereafter, the CARB Task Force's progress reports will include discussion of any barriers preventing full implementation of the National Action Plan, including, as appropriate, barriers that GAO has identified. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of Homeland Security should identify the information about family members apprehended together that its components collectively need to process those family members and communicate that information to its components. (Recommendation 1)

Agency: Department of Homeland Security
Status: Open

Comments: According to DHS, in June 2020, DHS's Office of Immigration Statistics launched a Family Status Data Standards Community of Interest (COI) under the purview of the DHS Immigration Data Integration Initiative. In August 2020, DHS reported that the Family Status COI includes subject matter experts and data system managers from DHS components, the Department of Health and Human Services, and the Executive Office for Immigration Review. The COI's mandate includes drafting common DHS-wide and interagency data standards (common codes, common definitions, common formats) for all topics related to family status, including codes to identify the reasons for family separation, members apprehended together, and unaccompanied children. DHS expects to complete these actions by September 30, 2020. Identifying and communicating department-wide information needs with respect to family members who have been apprehended together should help provide DHS with greater assurance that its components are identifying all individuals who may be eligible for relief from removal from the United States based on their family relationships.

Recommendation: The Secretary of Homeland Security should ensure that, at the time of apprehension, CBP collects the information that DHS components collectively need to process family members apprehended together. (Recommendation 2)

Agency: Department of Homeland Security
Status: Open

Comments: In commenting on a draft of our report, DHS reported that its Office of Immigration Statistics (OIS) will work with relevant components and offices to ensure all required information is collected at the time of apprehension on the Form I-213 when processing family members apprehended together. As of August 2020, DHS reported that DHS OIS continues to work with relevant components and offices to ensure all required information is collected at the time of apprehension on Form I-213 when processing family members apprehended together. DHS expects to complete these actions by September 30, 2020. Collecting information about the relationships between family members apprehended together and documenting that information on the Form I-213 could help address fragmentation among DHS components and improve the information available to other agencies.

Recommendation: The Secretary of Homeland Security should ensure that CBP documents the information that DHS components collectively need to process family members apprehended together on the Form I-213. (Recommendation 3)

Agency: Department of Homeland Security
Status: Open

Comments: In commenting on a draft of our report, DHS reported that, upon implementation of the steps the department plans to take in response to our second recommendation, CBP will issue guidance to the field to ensure that CBP agents and officers document the information that DHS components collectively need to process family members. In August 2020, DHS reported that component agencies continue to collaborate to define the process of family members apprehended together, as will be reflected on CBP Form I-213. DHS estimates issuing this guidance by March 31, 2021. Collecting information about the relationships between family members apprehended together and documenting that information on the Form I-213 could help address fragmentation among DHS components and improve the information available to other agencies.immigration or other proceedings.

Recommendation: The Secretary of Homeland Security should evaluate options for developing a unique identifier shared across DHS components' data systems to link family members apprehended together. (Recommendation 4)

Agency: Department of Homeland Security
Status: Open

Comments: In commenting on a draft of our report, DHS reported that its Office of Immigration Statistics (OIS) plans to work with relevant components to develop a unique shared identifier linking family members apprehended together. According to DHS, DHS OIS launched the Family Status Community of Interest (COI) in June 2020, and the COI has since established a bi-weekly meeting schedule. The COI's initial focus is on standard codes describing the reasons for family separations. Upon completing the family separation reason standard, DHS reported that the COI will prioritize developing common codes to identify family members apprehended together. DHS estimates completing these actions by March 31, 2021. Evaluating options for developing a shared unique family member identifier across components that would allow each component access to certain information about family members apprehended together would help bridge the information gaps about family relationships between components caused by DHS's fragmented data systems.

Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to require manufacturers to list the identity of comparator assays on their diagnostic test labels.

Agency: Department of Health and Human Services
Status: Open

Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration plans to recommend to sponsors of Zika virus diagnostic tests that they provide a description of the comparator assay. When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: In order for drug sponsors to benefit from FDA's revised guidance on antibiotic development and take full advantage of the QIDP designation, FDA should develop and make available written guidance on the QIDP designation that includes information about the process a drug sponsor must undertake to request the fast track designation and how the agency is applying the market exclusivity incentive.

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: According to HHS, FDA issued draft guidance (a document of frequently asked questions) in January of 2018 that describes the QIDP designation. However, this document is in draft form and has not yet been finalized. As of August 2020, FDA reported it is working to finalize this guidance this year. GAO will revisit this recommendation when the final guidance is issued.

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 April 2020, 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 June 2020, according to a CDC official.

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 April 2020, 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 June 2020, according to a CDC official.

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. HHS plans to release the updated manual in June 2020, according to a CDC official.

Recommendation: To help improve the U.S. aviation sector's preparedness for future communicable disease threats from abroad, the Secretary of Transportation should work with relevant stakeholders, such as the Department of Health and Human Services, to develop a national aviation-preparedness plan for communicable disease outbreaks. Such a plan could establish a mechanism for coordination between the aviation and public health sectors and provides clear and transparent planning assumptions for a variety of types and levels of communicable disease threats.

Agency: Department of Transportation
Status: Open
Priority recommendation

Comments: The Department of Transportation (DOT) has not developed a national aviation-preparedness plan to respond to communicable disease threats from abroad. In June 2020, we urged Congress to take legislative action to require the Secretary of Transportation to work with relevant agencies and stakeholders to develop a national aviation-preparedness plan to limit the spread of communicable disease threats, and minimize travel and trade impacts (see GAO-20-625). GAO's periodic updates on the CARES Act of 2020 provide information about actions taken by Congress to address this matter. DOT partially concurs with our recommendation and agrees that an aviation preparedness plan is needed, but continues to suggest that the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) have responsibility for communicable disease response and preparedness planning, respectively, and that these departments should lead any efforts to address planning for communicable disease outbreaks, including for transportation. In the absence of a national aviation-preparedness plan, DOT officials point to ongoing efforts to engage with interagency partners at DHS and HHS, as well as industry stakeholders, to better collaborate on communicable disease response and preparedness as they relate to civil aviation. For example, in July 2020, DOT, HHS, and DHS issued guidance to airports and airlines for implementing measures to mitigate public health risks associated with COVID-19. While this guidance is a positive step, DOT has not yet taken action to develop an aviation preparedness plan for future communicable disease threats that incorporate such things as protocols for responding to the threat and coordination among stakeholders.