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    Subject Term: "Manufacturing industry"

    10 publications with a total of 18 open recommendations
    Director: John Neumann
    Phone: (202) 512-3841

    1 open recommendations
    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: The Department of Commerce responded to the recommendation with three actions. (1) Labor, DHS, and HHS were invited to participate in the Manufacturing USA program resulting in Labor, Biomedical Advanced Research and Development Authority, and FDA agreeing to participate and naming representatives to the Manufacturing USA Interagency Working Team.(2) Labor was invited to present at and participate in the Spring 2017 Manufacturing USA Network meeting resulting in Labor participating in the meeting, presenting its apprenticeship programs, and continuing participation in the Manufacturing Education and Workforce Development team regular meetings. (3) The Manufacturing USA Interagency Working Team has begun discussions on expanding the Manufacturing USA network governance document to include activities, roles, and responsibilities of non-institute sponsoring agencies. Final program policy decisions will be made once the new Administration's agency leadership is in place. Completion is expected by Fall 2017.
    Director: Andrew Sherrill
    Phone: (202) 512-7215

    1 open recommendations
    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: OSTP did not state whether it agreed or disagreed with this recommendation. They provided some comments on the draft recommendation. For example, OSTP commented that the recommendation could focus on the extent to which the objectives of the Advanced Manufacturing Partnership (AMP) recommendations are being achieved in periodic updates to the implementation of the National Strategic Plan for Advanced Manufacturing. However, these recommendations were not covered in the scope of our report: we focused on reporting on the progress in achieving the objectives of the strategic plan.
    Director: John Neumann
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To better ensure that the activities carried out under the ITM program do not duplicate the efforts of other federal loan guarantee programs, such as SBA's 7(a) program, the Secretary of Commerce should direct EDA to work with SBA and NIST to further identify any gaps in capital access that may be present that the program could fill, and then develop marketing materials and conduct outreach to help target those gaps.

    Agency: Department of Commerce
    Status: Open

    Comments: Partially addressed. As of November 2016 the Economic Development Administration (EDA) had begun taking action on GAO's February 2016 recommendation to work with SBA and NIST to identify gaps in capital access and develop marketing materials and conduct outreach based on any gaps identified for the Federal Loan Guarantees for Innovative Technologies in Manufacturing program (ITM). Due to delays in establishing the program, however, these efforts are still in progress. According to EDA officials, as of November 28, 2016 EDA contractors working on the ITM program had held a preliminary discussion with SBA to discuss program marketing, outreach and potential gaps in capital access that the ITM program may be able to fill, among other topics, but had not yet initiated additional coordination with NIST. We continue to believe that coordination with SBA and NIST to identify gaps in capital access, and then marketing the program to target those gaps could help EDA ensure that ITM program activities do not duplicate the efforts of other federal loan guarantee programs.
    Director: Johana Ayers
    Phone: (202) 512-5741

    4 open recommendations
    Recommendation: To help DOD ensure that it appropriately considers the manufacturing arsenals as a source of manufacture and is strategically positioned to sustain the manufacturing arsenals' critical capabilities, the Secretary of Defense should direct the Secretary of the Army to issue clear, step-by-step implementing guidance, such as an instruction or guidebook, on the process for conducting make-or-buy analyses in a consistent manner.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with our recommendation related to issuing implementing guidance on make-or-buy analyses but provided no details on how or when it would issue such guidance. As of September 2016 DOD had not taken any action and this recommendation will remain open.
    Recommendation: To help DOD ensure that it appropriately considers the manufacturing arsenals as a source of manufacture and is strategically positioned to sustain the manufacturing arsenals' critical capabilities, the Secretary of Defense should direct the Secretary of the Army to identify and document fundamental elements--such as steps, interim milestones, time frames, and resources--for implementing the Army's Organic Industrial Base Strategic Plan 2012-2022.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with our recommendation related to implementing its 2012 strategic plan but provided no details on how or when it would implement the recommendation. As of September 2016 DOD had not taken any action and this recommendation will remain open.
    Recommendation: To help DOD ensure that it appropriately considers the manufacturing arsenals as a source of manufacture and is strategically positioned to sustain the manufacturing arsenals' critical capabilities, the Secretary of Defense should direct the Office of the Deputy Assistant Secretary of Defense for Maintenance Policy and Programs--in coordination with the military services, as appropriate, to complete DOD's ongoing effort to establish a process for identifying the manufacturing arsenals' critical capabilities and a method for determining the minimum workload needed to sustain these capabilities.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with our recommendation related to developing a process to identify the arsenals? critical capabilities and a method to determine the minimum workload needed to sustain those capabilities. DOD stated that its effort to address this recommendation were on going. As of September 2016 DOD had not taken any action and this recommendation will remain open.
    Recommendation: To help DOD ensure that it appropriately considers the manufacturing arsenals as a source of manufacture and is strategically positioned to sustain the manufacturing arsenals' critical capabilities, the Secretary of Defense should direct the Office of the Deputy Assistant Secretary of Defense for Maintenance Policy and Programs--in coordination with the military services, as appropriate, to develop and issue guidance, such as a DOD instruction, to implement the process for identifying the manufacturing arsenals' critical capabilities and the method for determining the minimum workload needed to sustain these capabilities.

    Agency: Department of Defense
    Status: Open

    Comments: Although DOD did not specifically comment on our recommendation related to issuing guidance to implement a process for identifying the arsenals critical capabilities and a method for determining the minimum workload needed to sustain these capabilities, it commented that it expects to issue an instruction incorporating such a process by the end of fiscal year 2016. However, as of September 2016 DOD had not taken any action and this recommendation will remain open.
    Director: David J. Wise
    Phone: (202) 512-2834

    2 open recommendations
    Recommendation: To ensure that transit agencies have appropriate and current guidance to assist them when procuring transit buses, the Administrator of FTA should update its Best Practices Procurement Manual and assess its other related guidance identified in this report and update that guidance as needed.

    Agency: Department of Transportation: Federal Transit Administration
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To provide a more efficient and cost-effective way for transit agencies to procure transit buses while complying with federal procurement requirements, the Administrator of FTA, in conjunction with the Administrator of the General Services Administration, should submit a legislative proposal to Congress that would authorize transit agencies that are recipients of FTA grants to access GSA sources of supply for the purchase of transit buses.

    Agency: Department of Transportation: Federal Transit Administration
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To ensure that DEA is best positioned to administer the quota process to ensure an adequate and uninterrupted supply of controlled substances for legitimate medical use and respond to shortages of drugs containing controlled substances, the Administrator of DEA should expeditiously establish formal policies and procedures to facilitate coordination with FDA as directed by the Food and Drug Administration Safety and Innovation Act, including a specific time frame in which DEA will be expected to respond to FDA requests to expedite shortage-related quota applications.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In June 2016, DEA stated that the agency had met with FDA to determine the specific procedures by which information regarding drug shortages will be exchanged pursuant to the Food and Drug Administration Safety and Innovation Act. DEA stated it will include these procedures in the work plan being created in response to the updated memorandum of understanding signed by FDA and DEA in March 2015. DEA officials also said that they plan to include in the work plan time frames for which DEA will be expected to respond to FDA requests to expedite shortage-related quota applications. GAO is continuing to monitor the status of this recommendation.
    Recommendation: To strengthen DEA's and FDA's ability to respond to shortages of drugs containing controlled substances, the Administrator of DEA and the Commissioner of FDA should, either in the MOU or in a separate agreement, specifically outline what information the agencies will share, and time frames for sharing such information, in response to a potential or existing drug shortage.

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

    Comments: In March 2015, DEA and FDA updated the MOU to establish procedures regarding the exchange of proprietary and other sensitive information between the two agencies. The MOU calls for the development of separate plans to specify what information is to be shared and who it is to be shared with. Since establishing the MOU, DEA said that it had met with FDA to determine the specific procedures for sharing information about drug shortages and a draft work plan has been circulated between the two agencies for comment. As of July 2016, FDA officials said that it has completed its section of the work plan related to sharing information about drug shortages. Although GAO has been advised by DEA that the workplan has not been finalized, in August 2017, FDA stated that it and DEA are actively sharing information and have successfully completed numerous exchanges. GAO is continuing to monitor the status of this recommendation.
    Recommendation: To strengthen DEA's and FDA's ability to respond to shortages of drugs containing controlled substances, the Administrator of DEA and the Commissioner of FDA should, either in the MOU or in a separate agreement, specifically outline what information the agencies will share, and time frames for sharing such information, in response to a potential or existing drug shortage.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In March 2015, DEA and FDA updated the MOU to establish procedures regarding the exchange of proprietary and other sensitive information between the two agencies. The MOU calls for the development of separate plans to specify what information is to be shared and who it is to be shared with. Since establishing the MOU, DEA said that it had met with FDA to determine the specific procedures for sharing information about drug shortages and a draft work plan has been circulated between the two agencies for comment. GAO is continuing to monitor the status of this recommendation.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    1 open recommendations
    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 August 2017, FDA reported that it had not conducted any rigorous analysis of predictors of drug shortages nor have new drug risk factors been identified. Although FDA adopted a new, commercially developed data system, the "Shortage Tracker" to track drug shortages in March 2016, it is used to help the Drug Shortage Staff manage their workload. FDA reported that this system has now been fully operational for over a year. However, no trend analysis relating to drug shortages has been conducted and the agency has no plans to conduct such analyses at this time.
    Director: Crosse, Marcia G
    Phone: (202) 512-7114

    2 open recommendations
    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 establish performance measures that include time frames for making final decisions on SE submissions and Exemption from SE submissions.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has established performance measures that include time frames for reviewing and acting on some of its new tobacco product submissions, including regular Substantial Equivalence (SE) submissions and Exemption from SE submissions, received in fiscal years 2015 through 2018. However, as of September, 2017, FDA has not developed performance measures for provisional SE submissions, the type of SE submissions that represent new tobacco products that may continue to be marketed unless and until FDA's Center for Tobacco Products finds that they are not substantially equivalent. We are keeping this recommendation open until the agency establishes performance measures, including time frames for making final decisions, for provisional SE submissions.
    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 monitors 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, because the agency has not yet reported establishing and monitoring performance measures for provisional SE submissions, we are leaving this recommendation open as of August 2017.
    Director: Scire, Mathew J
    Phone: (202) 512-8678

    1 open recommendations
    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. 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.
    Director: Shames, Lisa R
    Phone: (202) 512-2649

    2 open recommendations
    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: In September 2014, FDA indicated that guidance on potential conflicts of interest for experts participating on GRAS panels is a priority for the agency. In its Final Rule on Substances Generally Recognized as Safe (81 FR 54959), issued Aug. 17, 2016, FDA stated that it had decided to issue guidance regarding conflicts of interest and that it would announce the availability of a draft guidance document through a notice in the Federal Register. As of December 2016, FDA had not yet issued this draft guidance.
    Recommendation: To better ensure FDA's oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to monitor the appropriateness of companies' GRAS determinations through random audits or some other means, including issuing guidance on how to document GRAS determinations.

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

    Comments: On Aug. 17, 2016, FDA published a final rule on Substances Generally Recognized as Safe (GRAS) (81 FR 54959). This final rule includes a section titled "Guidance on Documenting Conclusions of GRAS Status," which states that FDA is "issuing a guidance" for companies on how to document their GRAS determinations. It is not clear from the rule the time frame for issuing this guidance, whether it will be issued in draft first for comment, and whether it will part of the guidance on conflicts of interest that FDA also plans to issue at a later date, as noted elsewhere in the rule. As of December 2016, FDA had not issued this guidance.