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 Secretary of Labor, in conducting any assessment of its staff training designed to improve clarity of communication with claimants, should ensure that the assessment considers claimants' challenges with understanding DOL's written communications on the evidence needed to successfully reopen or otherwise support a claim.

Agency: Department of Labor
Status: Open

Comments: DOL neither agreed nor disagreed with this recommendation. However, DOL acknowledged that it plans to focus its staff training efforts on a variety of needed training topics, including improving the quality of written communications. DOL further noted that its recently hired training analyst will be responsible for, among other things, designing assessment measures to gauge the quality of training and the effect it has improving the overall quality of claim outcomes. We encourage DOL to continue designing its assessment so that it considers claimants' challenges in understanding the evidence needed. As of July 2019, DOL said it will soon contract with a training vendor to help update training materials and expects training to be rolled out in fiscal year 2020. In addition, DOL said it has conducted hands-on staff training that includes providing claimants with a clear understanding as to why a claim is accepted or denied. We will consider closing this recommendation pending implementation of the updated training and efforts to assess it.

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: 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.

Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should report on this summary data and the results of this analysis in NIH's regular biennial report to Congress on the inclusion of women in research.

Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health
Status: Open

Comments: In August 2020, NIH reported that summary data as described in our Recommendation 4--that is, data and analysis on awardees' plans to conduct valid analysis by sex/gender--will be included in the 2019-2020 version of this publication, which the agency expects will be published in October 2021. We will continue to monitor NIH's actions on this matter.