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    Results:

    Subject Term: "Product evaluation"

    15 publications with a total of 33 open recommendations
    Director: Brian J. Lepore
    Phone: (202) 512-4523

    2 open recommendations
    Recommendation: To improve operational efficiencies and reduce costs related to product management and services that support commissary operations, the Secretary of Defense should direct the Chief Executive Officer of DeCA to develop a plan with objectives, goals, and time frames on how it will improve efficiency in product management, such as offering products based on store sales or customer demand.

    Agency: Department of Defense
    Status: Open

    Comments: As of August 2017, the Defense Commissary Agency (DeCA) started to implement the Category Performance Improvement process which could help improve efficiencies by offering products based on store sales and customer demand. In addition, DeCA is also offering commissary brand items which have improved efficiencies in inventory and stocking products. By making these improvements, DeCA could improve operational efficiencies. However, DeCA is in the early stages of implementing these actions and it is unclear to what extent these efficiencies have helped reduce costs related to product management.
    Recommendation: To improve operational efficiencies and reduce costs related to product management and services that support commissary operations, the Secretary of Defense should direct the Chief Executive Officer of DeCA to conduct comprehensive cost-benefit analyses to guide decisions on implementing the most cost-effective option as stocking and custodial services contracts are renewed, and on choosing product distribution options.

    Agency: Department of Defense
    Status: Open

    Comments: As of August 2017, the Defense Commissary Agency has not taken action that addresses GAO's March 2017 recommendation to conduct comprehensive cost-benefit analyses to guide decisions on implementing the most cost-effective option as stocking and custodial services contracts are renewed, and on choosing product distribution options.
    Director: John E. Dicken
    Phone: (202) 512-7114

    2 open recommendations
    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development and take full advantage of the QIDP designation, FDA should clarify how drug sponsors should utilize draft guidance documents that were released in accordance with GAIN.

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

    Comments: HHS gave GAO information on its Good Guidance Practices, which provide that guidance documents are not binding on FDA or the public and that sponsors can use alternative approaches consistent with applicable statutes. HHS also noted that FDA issues guidance in draft form to solicit public comment before finalizing its current thinking and recommendations. This practice, as reflected by language on applicable QIDP draft guidance documents indicating that the guidance will represent FDA's current thinking "when finalized," created uncertainty for sponsors in planning their antibiotic drug development programs. Without clarifying the role of draft guidance in the QIDP designation and process, this uncertainty will continue to persist. GAO considers this recommendation open.
    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 intends to begin developing guidance on the QIDP designation and will eventually make this guidance publicly available.
    Director: Carol C. Harris
    Phone: (202) 512-4456

    9 open recommendations
    Recommendation: To provide reasonable assurance that the program executes Agile software development for USCIS ELIS consistent with its own policies and guidance and follows applicable leading practices, the Secretary of the Department of Homeland Security (DHS) should direct the Director of USCIS to direct the USCIS Chief Information Officer (CIO), in coordination with the DHS CIO and the Chief of the Office of Transformation Coordination (OTC), to review and update, as needed, existing policies and guidance and consider additional controls to complete planning for software releases prior to initiating development and ensure software meets business expectations prior to deployment.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of July 2017, the U.S. Citizenship and Immigration Services (USCIS) within the Department of Homeland Security (DHS) had taken steps to address this recommendation. In particular, in June 2017, USCIS provided an updated policy, dated April 2017, governing planning and deploying software releases. USCIS also demonstrated partial compliance with that policy. For example, it provided some release planning review documentation for recent releases that are required by the updated policy, including readiness review memos for releases 7.2 and 8.1. However, USCIS did not demonstrate that the program responsible for developing the USCIS Electronic Immigration System (USCIS ELIS) was consistently following its updated policy. For example, USCIS did not demonstrate that the program was completing all planning activities prior to initiating development, as called for in its updated policy. Moreover, the agency did not demonstrate compliance with its previous policy for all software releases planned and deployed since our July 2016 report. We will continue to work with USCIS to monitor actions the agency is taking to address this recommendation.
    Recommendation: To provide reasonable assurance that the program executes Agile software development for USCIS ELIS consistent with its own policies and guidance and follows applicable leading practices, the Secretary of DHS should direct the Director of USCIS to direct the USCIS CIO, in coordination with the DHS CIO and the Chief of OTC, to review and update, as needed, existing policies and guidance and consider additional controls to consistently implement the principles of the framework adopted for Agile software development.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of July 2017, USCIS had taken steps to address this recommendation. For example, in May 2017, USCIS provided updated policy governing the development of software releases, dated April 2017, along with release planning artifacts specific to USCIS ELIS. The updated policy included an appendix devoted to generally accepted agency practices and applying Agile principles in the agency. However, USCIS had not clearly indicated if USCIS ELIS was to implement the practices described in the policy. For example, the updated policy did not require program compliance with the generally accepted agency practices. Moreover, supporting artifacts from the release planning process did not always define a commitment to a particular development methodology or set of development practices. For example, the team process agreements, which describe how members of individual teams will work with each other, did not indicate if developers were to adhere to the practices described in updated USCIS policy. We will continue to work with USCIS to obtain additional documentation about actions it is taking to address this recommendation.
    Recommendation: To provide reasonable assurance that the program executes Agile software development for USCIS ELIS consistent with its own policies and guidance and follows applicable leading practices, the Secretary of DHS should direct the Director of USCIS to direct the USCIS CIO, in coordination with the DHS CIO and the Chief of OTC, to review and update, as needed, existing policies and guidance and consider additional controls to define and consistently execute appropriate roles and responsibilities for individuals responsible for development activities consistent with its selected development framework.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of July 2017, USCIS had taken steps to address this recommendation. For example, in June 2017, USCIS provided updated policy, dated April 2017, governing the development of software releases and release planning artifacts. The updated policy and release documentation defined some roles and responsibilities that were previously only described by USCIS in its informal November 2014 management model, such as the authority and responsibility of a product owner. However, program documentation and policy did not define all of the roles and responsibilities. For example, program documentation and policy did not define the roles and responsibilities of a facilitator, or Scrum Master, which is a position identified in leading practices for software development using Scrum, the development methodology previously identified by the program. In addition, USCIS did not demonstrate that it had defined and committed to an updated development methodology for software releases. Such a defined methodology will impact expectations for the roles and responsibilities in software development. Without such a defined methodology or approach to Agile software development, it is not clear if roles and responsibilities defined by previously documented approach to Agile software development are still applicable for the current development approach. Moreover, documentation associated with program releases and updated policy did not define all of the roles and responsibilities for positions described by USCIS in its May 2017 written response to GAO. We will continue to work with USCIS to obtain additional documentation about actions it is taking to address this recommendation.
    Recommendation: To provide reasonable assurance that the program executes Agile software development for USCIS ELIS consistent with its own policies and guidance and follows applicable leading practices, the Secretary of DHS should direct the Director of USCIS to direct the USCIS CIO, in coordination with the DHS CIO and the Chief of OTC, to review and update, as needed, existing policies and guidance and consider additional controls to identify all system users and involve them in release planning activities.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of July 2017, DHS and USCIS had not provided information demonstrating that the department has addressed this recommendation. In October 2016, DHS provided a written response stating that the USCIS Office of Information Technology and Office of Transformation Coordination were working closely with the various USCIS directorates to obtain and integrate feedback through regular review sessions with the end users and through additional end user testing. However, as of July 2017, DHS and USCIS have not provided new information about the status of this recommendation.
    Recommendation: To provide reasonable assurance that the program executes Agile software development for USCIS ELIS consistent with its own policies and guidance and follows applicable leading practices, the Secretary of DHS should direct the Director of USCIS to direct the USCIS CIO, in coordination with the DHS CIO and the Chief of OTC, to review and update, as needed, existing policies and guidance and consider additional controls to write user stories that identify user roles, include estimates of complexity, take no longer than one sprint to complete, and describe business value.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of July 2017, USCIS had provided GAO with documentation intended to demonstrate that the agency had taken steps to address this recommendation. For example, in May 2017, USCIS provided updated policy governing the development of software releases along with release planning artifacts specific to USCIS ELIS and an Independent Verification and Validation assessment. The agency also provided a series of backlogs that captured user stories for some software releases. In addition, the Independent Verification and Validation assessment indicated that the program was tracking user story quality as part of assessing whether value was continuously discovered and aligned to the mission. However, the assessment report provided to GAO indicated a negative trend for this outcome. Moreover, USCIS policy no longer set expectations regarding user story development. In addition, supporting artifacts from the release planning process did not always define a commitment to a particular development methodology, which is turn impacts the expectations for writing user stories. Finally, backlogs provided by USCIS did not cover all releases in development since our July 2016 report and did not include enough detail to assess all aspects of the user story process (e.g., story size and user involvement). We will continue to work with USCIS to obtain additional documentation about actions it is taking to address this recommendation.
    Recommendation: To provide reasonable assurance that the program executes Agile software development for USCIS ELIS consistent with its own policies and guidance and follows applicable leading practices, the Secretary of DHS should direct the Director of USCIS to direct the USCIS CIO, in coordination with the DHS CIO and the Chief of OTC, to review and update, as needed, existing policies and guidance and consider additional controls to establish outcomes for Agile software development.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of July 2017, USCIS had taken steps to address this recommendation. For example, in April 2017, USCIS issued updated policy governing software development at the agency. The updated policy included an appendix devoted to generally accepted agency practices and applying Agile principles in the agency. This appendix also included a set of ten outcomes associated with using Agile practices at USCIS. For example, outcomes included that value is continuously discovered and aligned to the mission. However, the updated policy did not require program compliance with the practices and principles described in the appendix. Moreover, the agency did not demonstrate that USCIS ELIS had committed to achieving a specific set of outcomes for Agile software development, such as the outcomes described in the USCIS policy. We will continue to work with USCIS to obtain additional documentation about actions it is taking to address this recommendation.
    Recommendation: To provide reasonable assurance that the program executes Agile software development for USCIS ELIS consistent with its own policies and guidance and follows applicable leading practices, the Secretary of DHS should direct the Director of USCIS to direct the USCIS CIO, in coordination with the DHS CIO and the Chief of OTC, to review and update, as needed, existing policies and guidance and consider additional controls to monitor program performance and report to appropriate entities through the collection of reliable metrics.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of July 2017, USCIS had taken steps to address this recommendation. For example, in May 2017, USCIS provided updated policy governing the development of software that called for teams to prepare an Operations Monitoring Plan or dashboard showing the practices, tools, and measures that will monitor applications in production. The agency also provided a series of documents from internal systems and processes intended to monitor performance, such as a product dashboard for analyzing code quality (i.e., SonarQube) and a report from its Independent Verification and Validation team. However, the program was undergoing a re-baseline and had yet to document updated cost, schedule, and performance expectations against which to monitor. Moreover, the agency did not demonstrate that other metrics, such as customer satisfaction and team velocity, were being reliably collected. We will continue to work with USCIS to obtain additional documentation about actions it is taking to address this recommendation.
    Recommendation: To help manage the USCIS ELIS system, the Secretary of DHS should direct the Director of USCIS to direct the USCIS CIO, in coordination with the DHS CIO and the Chief of OTC, to review and update existing policies and guidance and consider additional controls to conduct unit and integration, and functional acceptance tests, and code inspection consistent with stated program goals.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of July 2017, USCIS had taken steps to address this recommendation. For example, in May 2017, USCIS provided artifacts from internal systems in place to monitor software development performance. These metrics monitored aspects of testing, such as code quality and code coverage. However, the program did not provide an updated Test and Evaluation Master Plan, which is a document it will produce as part of its ongoing effort to re-baseline. A Test and Evaluation Master Plan sets the testing expectations for the program as agreed upon with its stakeholders in DHS and USCIS. The updated plan will provide a basis for further evaluation of the steps DHS and USCIS have taken to address this recommendation. Moreover, the agency did not demonstrate that functional acceptance tests were being conducted in accordance with stated program goals. For example, the agency did not provide acceptance criteria or the associated tests demonstrating that user stories passed the defined acceptance criteria. We will continue to work with USCIS to obtain additional documentation about actions it is taking to address this recommendation.
    Recommendation: To help manage the USCIS ELIS system, the Secretary of DHS should direct the Director of USCIS to direct the USCIS CIO, in coordination with the DHS CIO and the Chief of OTC, to review and update existing policies and guidance and consider additional controls to develop complete test plans and cases for interoperability and end user testing, as defined in the USCIS Transformation Program Test and Evaluation Master Plan, and document the results.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of July 2017, DHS and USCIS had not provided information demonstrating that they had addressed this recommendation. In October 2016, DHS provided a written response indicating that an internal process for revisiting the USCIS ELIS Test and Evaluation Master Plan had been initiated, with participation from all relevant stakeholder groups. A Test and Evaluation Master Plan sets the testing expectations for the program as agreed upon with its stakeholders in DHS and USCIS. The updated plan will provide a basis for further evaluation of the steps DHS and USCIS have taken to address this recommendation. The letter also stated that USCIS had begun to work on a policy for new interoperability test procedures. Moreover, the letter added that end user testing is a continuing activity, including providing feedback of observed issues into the development queue, with the slow launch of the naturalization capabilities in USCIS ELIS being a model. However, as of July 2017, DHS and USCIS had not provided new information about the status of this recommendation. We will continue to work with DHS and USCIS to obtain additional documentation about actions they are taking to address this recommendation.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    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: On 9/6/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it plans to identify opportunities for setting measurable goals related to regulatory science. The agency indicated that it would provide an update by 3/6/17.
    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: On 9/6/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it is identifying mechanisms to improve its tracking of funding across the priority areas. The agency indicated that it would provide an update by 3/6/17.
    Director: Marie A. Mak
    Phone: (202) 512-4841

    3 open recommendations
    Recommendation: To provide greater compliance with the GIDEP reporting requirement among the DOD components and their defense supplier-base, the Undersecretary of Defense for Acquisition, Technology and Logistics should establish mechanisms for department-wide oversight of defense agencies' compliance with the GIDEP reporting requirement.

    Agency: Department of Defense: Office of the Secretary of Defense: Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics
    Status: Open

    Comments: In providing comments to this report DOD concurred with this recommendation but has not completed actions to implement it. DOD stated that it will issue new DOD Instruction covering the use of GIDEP, as well as a companion DOD manual, to include identification of roles and responsibilities for submission of reports and oversight of such submission. Both documents are expected to be completed by the end of the second quarter fiscal year 2018.
    Recommendation: To provide greater compliance with the GIDEP reporting requirement among the DOD components and their defense supplier-base, the Undersecretary of Defense for Acquisition, Technology and Logistics should develop a standardized process for determining the level of evidence needed to report a part as suspect counterfeit in GIDEP, such as a tiered reporting structure in GIDEP that provides an indication of where the suspect part is in the process of being assessed.

    Agency: Department of Defense: Office of the Secretary of Defense: Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics
    Status: Open

    Comments: In providing comments to this report DOD concurred with this recommendation but has not completed actions to implement it. DOD stated that it will issue new DOD Instruction covering the use of GIDEP, as well as a companion DOD manual, to include identification of roles and responsibilities for submission of reports and oversight of such submission. Both documents are expected to be completed by the end of the second quarter of fiscal year 2018.
    Recommendation: To provide greater compliance with the GIDEP reporting requirement among the DOD components and their defense supplier-base, the Undersecretary of Defense for Acquisition, Technology and Logistics should develop guidance for when access to GIDEP reports should be limited to only government users or made available to industry.

    Agency: Department of Defense: Office of the Secretary of Defense: Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics
    Status: Open

    Comments: In providing comments to this report DOD concurred with this recommendation but has not completed actions to implement it. DOD stated that it will issue new DOD Instruction covering the use of GIDEP, as well as a companion DOD manual, to include identification of roles and responsibilities for submission of reports and oversight of such submission. Both documents are expected to be completed by the end of the second quarter of fiscal year 2018.
    Director: Jennifer Grover
    Phone: (202) 512-7141

    2 open recommendations
    Recommendation: The Attorney General should direct ODAG to document a plan specifying DOJ's process for monitoring the effects of marijuana legalization under state law, in accordance with DOJ's 2013 marijuana enforcement policy guidance, to include the identification of the various data ODAG will use and their potential limitations for monitoring the effects of state marijuana legalization, and how ODAG will use the information sources in its monitoring efforts to help inform decisions on whether state systems are effectively protecting federal marijuana enforcement priorities.

    Agency: Department of Justice
    Status: Open

    Comments: The Department of Justice (DOJ) concurred with the recommendation and reported plans to implement it. In October 2016, officials reported that several DOJ components have met and taken steps to compile sources of relevant data, and that the Attorney General's Advisory Committee Marijuana Working Group continues to conduct regular discussions about marijuana. In November 2017, officials reported that the marijuana subcommittee of the Attorney General's Task Force on Crime Reduction and Public Safety is reviewing DOJ's marijuana policy, which includes a review of relevant data sources, as well as outreach to relevant stakeholders, including state and local officials. DOJ officials reported that they will provide additional details about the departments monitoring plan once its review of marijuana policy is complete.
    Recommendation: The Attorney General should direct ODAG to use existing mechanisms to share DOJ's monitoring plan with appropriate officials from DOJ components responsible for providing information DOJ reports using regarding the effects of state legalization to ODAG, obtain feedback, and incorporate the feedback into its plan.

    Agency: Department of Justice
    Status: Open

    Comments: DOJ concurred with the recommendation and reported plans to implement it. In October 2016, officials reported that several DOJ components have met and taken steps to compile sources of relevant data, and that the Attorney General's Advisory Committee Marijuana Working Group continues to conduct regular discussions about marijuana. In November 2017, officials reported that the marijuana subcommittee of the Attorney General's Task Force on Crime Reduction and Public Safety is reviewing DOJ's marijuana policy, which includes a review of relevant data sources, as well as outreach to relevant stakeholders, including state and local officials. DOJ officials reported that they will provide additional details about the department's monitoring plan once its review of marijuana policy is complete.
    Director: Valerie Melvin
    Phone: (202) 512-6304

    2 open recommendations
    Recommendation: To help ensure that FDA's IT strategic planning activities are successful in supporting the agency's mission, goals, and objectives, the Commissioner of FDA should require the CIO to establish schedules and milestones for completing a version of an IT strategic plan that incorporates elements to align the plan's strategies with agency-wide priorities; includes results-oriented goals and performance measures that support the agency's mission, along with targets for measuring the extent to which outcomes of IT initiatives support FDA's ability to achieve agency-wide goals and objectives; identifies key IT initiatives that support the agency's goals; and describes interdependencies among the initiatives.

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

    Comments: FDA concurred with the recommendation and stated that the agency plans to implement it. We contacted the agency in March 2017 and have requested documents regarding FDA's actions to address the recommendation. We are waiting to receive the documents. We will update the status of the agency's actions after we receive and evaluate their response.
    Recommendation: To help ensure that FDA's IT strategic planning activities are successful in supporting the agency's mission, goals, and objectives, the Commissioner of FDA should require the CIO to implement the plan to ensure that expected outcomes of the agency's key IT initiatives are achieved.

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

    Comments: FDA concurred with the recommendation and stated that the agency plans to implement it. We contacted the agency in March 2017 and have requested documents regarding FDA's actions to address the recommendation. We are waiting to receive the documents. We will update the status of the agency's actions after we receive and evaluate their response.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To improve the data on tracked safety issues and postmarket studies that are needed for required reporting and for systematic oversight of postmarket drug safety, the Secretary of HHS should direct the Commissioner of FDA to develop comprehensive plans, with goals and time frames, to help ensure that identified problems with the completeness, timeliness, and accuracy of information in its database on tracked safety issues and postmarket studies are corrected.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has started taking steps to help ensure that identified problems with its data on tracked safety issues and postmarket studies are corrected. For example, FDA plans to conduct an assessment of tracked safety data by 2022 and is developing a quality measurement plan that will include periodic audits of postmarket study data. However, as of August 2017, FDA has not provided specifics regarding what types of actions it will take once these assessments and audits are completed, including goals and time frames for when these actions will be completed. GAO is keeping this recommendation open until FDA provides information on how it will address issues identified in its assessments and audits and the time frames for doing so.
    Recommendation: To improve the data on tracked safety issues and postmarket studies that are needed for required reporting and for systematic oversight of postmarket drug safety, the Secretary of HHS should direct the Commissioner of FDA to work with stakeholders within FDA to identify additional improvements that could be made to FDA's current database or future information technology investments to capture information in a form that can be easily and systematically used by staff for oversight purposes.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has identified actions that could potentially improve FDA's process for overseeing tracked safety issues, but as of August 2017, FDA has not indicated that stakeholder input has been solicited specifically regarding improvements to FDA's IT systems that would facilitate systematic oversight of these issues. FDA may address this as part of a planned assessment of its data system that is not scheduled to be completed until FY 2022. For postmarket studies, FDA has indicated that it intends to formally assess the IT needs of users once it has transferred postmarket data to its new informatics platform, which will not occur until 2018 at the earliest. GAO is keeping this recommendation open until FDA has worked with stakeholders to identify improvements to FDA's IT systems to capture information in a form that can be used by staff for oversight purposes.
    Director: David C. Trimble
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To improve NNSA's ability to choose the best alternative that satisfies the mission need for lithium production, the Secretary of Energy should request that NNSA's Deputy Administrator for Defense Programs take steps to ensure that NNSA objectively consider all alternatives, without preference for a particular solution, as it proceeds with the analysis of alternatives process. Such steps could include clarifying the statement of mission need for lithium production so that it is independent of a particular solution.

    Agency: Department of Energy
    Status: Open

    Comments: As of December 2016, NNSA has not finalized its analysis of alternatives. However, documents provided and statements made by agency officials indicate that NNSA plans to construct a Lithium Production Facility. NNSA's preference for constructing a lithium production facility prior to finalizing its analysis of alternatives is not consistent with our recommendation.
    Director: Dave Powner
    Phone: (202) 512-9286

    1 open recommendations
    Recommendation: To address risks in the GOES-R program development and to help ensure that the satellite is launched on time, the Secretary of Commerce should direct the NOAA Administrator to address shortfalls in defect management identified in this report, including the lack of clear guidance on defect definitions, what defect metrics should be collected and reported, and how to establish a defect's priority or severity.

    Agency: Department of Commerce
    Status: Open

    Comments: NOAA agreed with this recommendation. The agency subsequently reported that contractors are required to report defects and that the agency can place a hold or put liens against contractors if defects are not addressed. NOAA also provided documentation to support its recurring meetings at which defects are addressed. Additionally, NOAA provided documentation on its defect reporting requirements and definitions. However, NOAA did not provide documentation showing what defect metrics should be collected and reported, and how to establish a defect's priority or severity. We will continue to monitor the agency's actions on this recommendation.
    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: Cackley, Alicia P
    Phone: (202) 512-8678

    2 open recommendations
    Recommendation: To improve the awareness, use, and usefulness of SaferProducts.gov, the CPSC should establish and incorporate metrics to assess efforts to increase awareness and use of SaferProducts.gov.

    Agency: Consumer Product Safety Commission
    Status: Open

    Comments: The Commission states that it measures overall awareness of SaferProducts.gov in a manner similar to the manner in which it measures the awareness of CPSC.gov: by the number of visits to the website. The Commission states that website visits is a reasonable proxy measure of overall awareness that is cost-effective to collect. According to the Commission, in fiscal year 2014, SaferProducts.gov had 2.4 million visits and 863,000 visitors, where visits are the number of sessions the site was hit and visitors are the count of unique IP addresses who came to the site. The Commission had previously indicated that it planned to include three questions on SaferProducts.gov in a National Awareness Survey designed to determine overall awareness of CPSC on a national level. While the Commission administered the survey, it did not include questions related to SaferProducts.gov. As of March 2017, the Commission has not taken specific steps to measure the overall awareness of SaferProducts.gov.
    Recommendation: To improve the awareness, use, and usefulness of SaferProducts.gov, the CPSC should implement cost-effective usability improvements to SaferProducts.gov, taking into account the results of any existing usability testing or any new testing CPSC may choose to conduct.

    Agency: Consumer Product Safety Commission
    Status: Open

    Comments: The Commission had begun making usability improvements to SaferProducts.gov by improving the search functionality and improving the user experience of submitting incident reports. The Commission planned to include a tagline to its website to increase users' understanding of the site's purpose--either "Report. Search. Protect." or "Report. Search. Be Empowered." by March 2017. However, as of April 2017, SaferProducts.gov does not include a tagline. The Commission also has not made any other website improvements in this regard, nor have staff undertaken user experience studies to assess users' understanding of the site.
    Director: Fleming, Susan A
    Phone: (202)512-4431

    1 open recommendations
    Recommendation: In order to encourage vehicle owners to comply with safety recalls, provide vehicle owners with specific information about whether their vehicle is involved in a recall, and identify factors that affect recall completion rates, among other things, the Secretary of Transportation should direct the Administrator of NHTSA to develop a plan to use the data it collects on recall campaigns to analyze particular patterns or trends that may characterize successful recalls and determine whether these represent best practices that could be used in other recall campaigns.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions NHTSA has taken in response to this recommendation will provide updated information.
    Director: Gomez, Jose A
    Phone: (202)512-2649

    1 open recommendations
    Recommendation: To enhance FDA's oversight of dietary supplements and foods with added dietary ingredients, and to better enable FDA to meet its responsibility to regulate dietary supplements that contain new dietary ingredients, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In July 2011, FDA published draft guidance for industry on new dietary ingredient notifications and related issues. This draft guidance includes information on when a dietary ingredient is considered new, evidence of safety, and methods for ingredient identity. We are waiting for the draft guidance to become final to close the recommendation.
    Director: Crosse, Marcia G
    Phone: (202)512-3407

    1 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the FDA Commissioner to expeditiously take steps to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process. These steps should include issuing regulations to (1) reclassify each device type into class I or class II, or requiring it to remain in class III, and (2) for those device types remaining in class III, require approval for marketing through the PMA process.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has taken steps to respond to this recommendation; however we are leaving the recommendation open because the agency has not yet taken final steps to reclassify or require premarket approval (PMA) for two class III device types allowed to enter the market through the less stringent 510(k) process. In 2009, FDA began a 5-step process to reclassify or to require PMAs for 26 class III device types. This process was modified by the Food and Drug Administration Safety and Innovation Act (FDASIA)--instead of issuing regulations as the final step, FDA issues an administrative order to reclassify or require PMAs for the device types. In 2014, the agency reported it had set a goal to have all remaining devices finalized by the second quarter of 2015; however, as of August 2017, FDA had not finished the process of reclassifying or requiring PMAs for 2 of 26 devices types. The agency reported completing the process for 24 device types, and provided new planned milestones to complete the process for the remaining device types by the middle of 2018. We will leave this recommendation open until FDA makes progress in reclassifying or requiring PMAs for the remaining device types.