Recommendation: The Under Secretary for Health should ensure VA's key offices, such as OAA and ORD, provide VA medical centers with examples of successful practices for strengthening research relationships with academic affiliates and that such information reflects the lessons learned from VA medical centers that have successfully cultivated these relationships. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with this recommendation. VA stated that they will establish a working group with representatives from both VA's Central Office and the field to identify and share best practices by December 31, 2020.

Recommendation: The Under Secretary for Health should ensure ORD, in consultation with the field, develops tools, such as a decision tree and successful practices, to help local VA medical center officials decide which entity—NPCs or academic affiliates—should administer extramural funding based on providing optimal support for the research. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with this recommendation. VA stated that the working group established to address GAO's first recommendation, which will include representatives from both VA's Central Office and the field, will develop and share tools to assist VA medical centers and their academic affiliates in determining how federal awards should be administered by December 31, 2020.

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 to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop and document measurable goals, such as targets and time frames, for its regulatory science efforts so it can consistently assess and report on the agency's progress in regulatory science efforts.

Agency: Department of Health and Human Services
Status: Open

Comments: In September 2018, the agency described the actions of committees developed by each of the centers to oversee their regulatory science activities. In July 2019, the agency indicated that it was revisiting its strategic regulatory science priorities as part of its cyclical strategic planning process, and the centers and various offices have taken steps to address the recommendation. In an August 2020 written response, the agency reported that a committee had undertaken a review its 2011 regulatory science strategic plan that will result in the issuance of an accountability framework--an internal document outlining the type of information that FDA centers and offices will provide to the agency's Chief Scientist to demonstrate progress made in addressing relevant focus areas of regulatory science. FDA reported that its goal was to complete this work by the end of December 2020. However, FDA still needs to document steps taken by these centers to develop measurable goals, and the agency indicated that the recommendation should remain open. GAO will continue to monitor the implementation of this recommendation.

Recommendation: In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to systematically track funding of regulatory science projects across each of its priority areas.

Agency: Department of Health and Human Services
Status: Open

Comments: In September 2018 and July 2019, the agency described actions taken by each center to better track its regulatory science funding. However, FDA still needed to complete these activities and document that funds are systematically tracked across each of the priority areas. In an August 2020 written response, the agency reported that there continue to be efforts to improve tracking of funds for regulatory science projects in priority areas. Specifically, it described the development of an accountability framework-an internal document outlining the type of information that FDA centers and offices will provide to the agency's Chief Scientist to demonstrate progress made in addressing relevant focus areas of regulatory science. According to FDA, as part of the internal accountability framework, it will track regulatory science projects. FDA reported that its goal was to complete this work by the end of December 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

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.

Recommendation: To ensure that nonmedical DOD research organizations coordinate with the Assistant Secretary of Defense for Health Affairs early in the research process to understand medical research requirements and avoid inefficiencies that may lead to duplicative work, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to communicate to DOD's nonmedical research organizations the importance of coordination with the Joint Program Committee for Combat Casualty Care chair on combat casualty care issues, and require this coordination early in the research process when these organizations conduct research with implications for combat casualty care.

Agency: Department of Defense
Status: Open

Comments: DOD took several actions in 2014 to communicate to DOD's nonmedical research organizations the importance of coordination with the Joint Program Committee for Combat Casualty Care. Specifically, DOD chartered the Armed Services Biomedical Research Evaluation and Management Community of Interest to include both medical and non-medical researchers and to improve coordination, collaboration, and cooperation. DOD also appointed senior leaders to work in both this community of interest and in other DOD research communities of interest, to improve coordination. Furthermore, DOD conducted joint research meetings to share research data across the medical and non-medical communities. However, DOD had not indicated a requirement for this coordination to occur early in the research process, as included in GAO's recommendation. As of September 2019, DOD has not provided additional information or documentation to address this recommendation.