Recommendation: To enhance interagency collaboration in the Manufacturing USA program, the Secretary of Commerce should direct the Director of the National Institute of Standards and Technology to work with all non-sponsoring agencies whose missions contribute to or are affected by advanced manufacturing to revise the Manufacturing USA governance system to ensure the roles and responsibilities for how these agencies could contribute to the Manufacturing USA program are fully identified.

Agency: Department of Commerce
Status: Open

Comments: In October 2019, the National Institute of Standards and Technology (NIST) reported that, working through the Manufacturing USA interagency team and the National Science and Technology Subcommittee on Advanced Manufacturing, it had revised the Manufacturing USA governance document to include a section defining roles related to facilitating information sharing for agencies who are not sponsoring Manufacturing USA institutes. We are seeking clarification from NIST on which non-sponsoring agencies are covered by the new section. We will revisit the status of this recommendation once we receive clarification.

Recommendation: To enhance the ability of the Executive Office of the President to implement the Revitalize American Manufacturing and Innovation Act of 2014 requirements related to reporting on advanced manufacturing, the Director of the Office of Science and Technology Policy, working through the National Science and Technology Council and agency leadership, as appropriate, should identify the information they will collect from federal agencies to determine the extent to which the objectives outlined in the National Strategic Plan for Advanced Manufacturing are being achieved.

Agency: Executive Office of the President: Office of Science and Technology Policy
Status: Open

Comments: In October, 2018, the Subcommittee on Advanced Manufacturing, Committee on Technology of the National Science Technology Council released a Strategy for American Leadership in Advanced Manufacturing. This strategy provided some information on progress toward achieving the objectives of the prior National Strategic Plan for Advanced Manufacturing; however, it is unclear what information is to be collected from agencies and likewise how progress toward achieving the goals of the current strategy will be measured. We will update the status of this recommendation when the Office of Science and Technology Policy identifies the information to be collected from federal agencies and how this information will be used to assess progress in achieving the current goals, objectives, and priorities.

Recommendation: To enhance its oversight of drug shortages, particularly as the agency fine-tunes the manner in which it gathers data on shortages and transitions from its database to a more robust system, the Commissioner of FDA should conduct periodic analyses using the existing drug shortages database (and, eventually, the new drug shortages information system) to routinely and systematically assess drug shortage information, and use this information proactively to identify risk factors for potential drug shortages early, thereby potentially helping FDA to recognize trends, clarify causes, and resolve problems before drugs go into short supply.

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

Comments: In September 2018, FDA told us that it was using its drug shortage data system, the "Shortage Tracker," to summarize information reported by manufacturers as the reasons for existing shortages. The agency indicated that it was developing a model that would factor in drug shortage data, warning signs identified through social media, and other factors to help identify early indicators that may predict future shortages. In July 2019, the agency indicated it could conduct periodic analyses of the causes of drug shortages. However, FDA had not yet proactively conducted any rigorous analyses of predictors of drug shortages to help recognize trends, clarify causes, and resolve problems before drugs go into short supply. In an August 2020 written response, FDA reported that it was undertaking modeling efforts to explore the feasibility of predicting future drug shortages using machine learning approaches. FDA planned to complete the initial modeling by fall 2020, at which time it would identify next steps. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: To improve CTP's ability to operate efficiently, achieve effective results, and plan appropriately, the Secretary of Health and Human Services should direct the Commissioner of FDA to monitor FDA's performance relative to those time frames, such as evaluating whether staff are performing reviews of these submissions efficiently and effectively.

Agency: Department of Health and Human Services
Status: Open

Comments: FDA has established and monitored performance measures that include time frames for reviewing and acting on regular SE submissions, Exemption from SE requests, and Modified Risk Tobacco Product applications for fiscal years 2015 through 2018. However, we are leaving this recommendation open until FDA begins monitoring its performance relative to timeframes for provisional SE submissions, which the agency plans to do at the end of fiscal year 2019.

Recommendation: To better ensure that air ventilation systems in manufactured homes perform as specified and meet the HUD Code, HUD should develop an appropriate method to test and validate the performance of the ventilation system as part of the HUD certification process.

Agency: Department of Housing and Urban Development
Status: Open

Comments: In March 2017, HUD stated that it has not developed a test to validate the performance of the whole-house ventilation specification. HUD reported that the Manufactured Housing Consensus Committee (MHCC) did not agree with the testing validation recommendations. As of March 2018, HUD continues to move forward in updating its standards, including a test for whole house ventilation. However, as part of the overall HUD effort to review regulations, HUD officials stated they are currently conducting a review of current and planned federal regulations for manufactured housing with the goal to facilitate the affordability of manufactured housing and to promote durable, safe, and cost effective construction techniques for manufactured homes. As a result, HUD does not anticipate moving forward with any manufactured housing regulations until it completes its review. We continue to believe that developing such a test will better ensure that air ventilation systems in manufactured homes perform as specified and meet the HUD Code and will continue to monitor HUD's progress in implementing our recommendation.

Recommendation: To better ensure FDA's oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to minimize the potential for conflicts of interest in companies' GRAS determinations, including taking steps such as issuing guidance for companies on conflict of interest and requiring information in GRAS notices regarding expert panelists' independence.

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

Comments: On November 16, 2017, FDA published a notification of availability for the draft guidance "Best Practices for Convening a GRAS Panel: Guidance for Industry," with a request for comments on the draft guidance by May 15, 2018. FDA indicated that the draft guidance represents FDA's current thinking on strategies to minimize the potential for conflicts of interest in companies' GRAS determinations, including assessing potential GRAS panel members for conflicts of interest. As of July 2020, FDA had not yet finalized the guidance, so we are leaving the recommendation open.