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    Federal Agency: "Department of Health and Human Services: Food and Drug Administration"

    12 publications with a total of 20 open recommendations including 2 priority recommendations
    Director: Steve Morris
    Phone: (202) 512-3841

    2 open recommendations
    Recommendation: The Commissioner of FDA should pursue formal agreements with countries exporting seafood to the United States that commit these countries to test for drugs of concern to FDA and the corresponding maximum residue levels (MRLs) that FDA established for these drugs. (Recommendation 1)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Commissioner of FDA should coordinate and communicate with FSIS in developing drug residue testing methods and corresponding maximum residue levels for imported seafood that may also be applicable to imported catfish. (Recommendation 4)

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

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

    1 open recommendations
    Recommendation: To ensure efficient use of generic drug user fees, facilitate oversight and transparency, and plan for risks, the Commissioner of FDA should develop a plan for administering user fee carryover that includes analyses of program costs and risks and reflects actual operational needs and contingencies.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    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development and take full advantage of the QIDP designation, FDA should clarify how drug sponsors should utilize draft guidance documents that were released in accordance with GAIN.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: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its Office of International Programs (OIP) strategic workforce plan, the Commissioner of FDA should assess the effectiveness of the foreign offices' contributions by systematically tracking information to measure whether the offices' activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and warning letters.

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

    Comments: HHS concurred with this recommendation and stated that FDA plans to conduct internal annual reviews of its foreign offices' performances and track their contributions by type of commodity. We will assess these actions once they have been completed.
    Recommendation: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its OIP strategic workforce plan, the Commissioner of FDA should establish goals to achieve the appropriate staffing level for its foreign offices, which would include separating foreign office vacancies from the OIP-wide vacancy rate, and setting goals by position type.

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

    Comments: HHS concurred with this recommendation. HHS said that the strategic workforce plan for FDA's foreign offices will be updated to reflect the disaggregation of performance measures that track foreign office vacancy rates and targets by position type. We will assess these actions once they have been completed.
    Director: Elizabeth H. Curda
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: In order to ensure that the agency is adequately protecting the White Oak campus as a designated high-risk facility and strategically planning for the White Oak campus's future, as FDA moves forward with its proposed planning efforts, the Commissioner of FDA, in consultation with the Administrator of GSA, should implement vehicular access control measures on the White Oak campus to meet the requirements of the high-risk facility level designation assigned in the 2014 risk assessment report, or fully document the rationale for any deviations from these requirements.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: In order to ensure that the agency is adequately protecting the White Oak campus as a designated high-risk facility and strategically planning for the White Oak campus's future, as FDA moves forward with its proposed planning efforts, the Commissioner of FDA, in consultation with the Administrator of GSA, should further incorporate leading strategic facilities planning practices into FDA's proposed planning efforts by ensuring that FDA establish strategic linkage between its strategic priorities and its facilities plans.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: In order to ensure that the agency is adequately protecting the White Oak campus as a designated high-risk facility and strategically planning for the White Oak campus's future, as FDA moves forward with its proposed planning efforts, the Commissioner of FDA, in consultation with the Administrator of GSA, should document the key information related to daily operational activities and ongoing benefits and challenges that are needed to inform FDA's proposed planning efforts in the areas of needs assessment, gap identification, and alternatives analysis, and incorporate into proposed planning efforts a detailed strategy for collecting and analyzing this information.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    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

    1 open recommendations
    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.
    Director: J. Alfredo Gómez
    Phone: (202) 512-3841

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure the safety of food imported into the United States, the Commissioner of Food and Drugs should complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. If the inspection numbers from that evaluation are different from the inspection targets mandated in FSMA, FDA should report the results to Congress and recommend appropriate legislative changes.

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

    Comments: In January 2015, we recommended that the Commissioner of FDA complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. Additionally, if the inspection numbers from that analysis are different from the inspection targets mandated in the FDA Food Safety Modernization Act (FSMA), FDA should report the results to Congress and recommend appropriate legislative changes. At the time of our report, FDA was not keeping pace with FSMA's mandate to increase inspections each year from 2011 through 2016. In April 2017, FDA indicated that that it does not anticipate going significantly beyond 1,200 foreign food facilities inspections per year, based on the amount of additional funding needed to meet the foreign inspection requirement of FSMA. However, FDA has not conducted an analysis to determine whether the increased number of inspections mandated by FSMA or the lower number of inspections it is currently conducting is sufficient to ensure comparable safety of imported and domestic food. FDA noted that, in January 2017, it began an analysis to define and describe the global inventory of human and animal food firms and examine the application of regulatory oversight tools across the inventory. According to FDA, the analysis will help it assess the annual number of foreign food facility inspections as part of an overall risk-based allocation of resources for ensuring that imported foods are produced in a manner the meets applicable U.S. safety standards. We continue to believe that FDA should complete such an analysis and report the results to Congress.
    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: Melvin, Valerie C
    Phone: (202) 512-6304

    2 open recommendations
    Recommendation: To help ensure the success of FDA's modernization efforts, the Commissioner of FDA should direct the CIO to, in completing the assessment of Mission Accomplishments and Regulatory Compliance Services (MARCS), develop an integrated master schedule (IMS) that (1) identifies which legacy systems will be replaced and when; (2) identifies all current and future tasks to be performed by contractors and FDA; and (3) defines and incorporates information reflecting resources and critical dependencies.

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

    Comments: In commenting on our report, the Department of Health and Human Services neither agreed nor disagreed with our recommendations. However, in response to this recommendation, FDA officials developed an integrated master schedule (IMS) for the Mission Accomplishment and Regulatory Compliance System, along with corresponding sub-project schedules. The officials also provided explanations of their approach for updating the schedules and estimating resources that are reflected in the schedules, and evidence that the agency is updating the schedule regularly. However, the IMS did not identify all legacy systems to be replaced, did not trace all tasks and contractor subproject schedules, and did not include information reflecting the use of government resources. In 2016, we requested that FDA provide an update on their efforts to address these limitations. As of September 2017, the agency restructured MARCS into two projects and notified us that it was working to establish an IMS for each. FDA officials expect to complete the schedules by the end of calendar year 2017. Until FDA takes steps to address the noted deficiencies, it will lack key information needed for determining what work remains and for identifying and addressing potential problems, thus increasing risks to the success of the agency's modernization efforts. We will continue to work with the Department to address this recommendation.
    Recommendation: To help ensure the success of FDA's modernization efforts, the Commissioner of FDA should direct the CIO to monitor progress of MARCS against the integrated master schedule IMS.

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

    Comments: In commenting on the report, the Department of Health and Human Services neither agreed nor disagreed with our recommendations. However, in response to this recommendation, FDA officials provided a baseline schedule, integrated master schedule (IMS), and sub-project schedules intended to be used to monitor progress of the agency's efforts to implement changes to the Mission Accomplishment and Regulatory Compliance System (MARCS). Nonetheless, while the IMS is updated regularly, it contains data anomalies, and FDA has not documented reasons for changes to the schedule. Consequently, the schedule does not include complete and reliable information needed for monitoring progress of the system investment. As of September 2017, the agency restructured MARCS into two projects and notified us that it was working to establish an IMS for each. FDA officials expect to complete the schedules by the end of calendar year 2017, and to use the schedules to continually monitor the status of the projects. Until FDA takes steps to address deficiencies noted in the IMS for MARCS, it will continue to lack key data needed to monitor progress of the implementation of the system, and increase the risks of this key component of the agency's modernization efforts. We will continue to work with the Department to address this recommendation.
    Director: Crosse, Marcia G
    Phone: (202)512-3407

    1 open recommendations
    Recommendation: To help ensure that FDA's overseas offices are able to fully meet their mission of helping to ensure the safety of imported products, the Commissioner of FDA should ensure, as it completes its strategic planning process for the overseas offices, that it develops a set of performance goals and measures that can be used to demonstrate overseas office contributions to long-term outcomes related to the regulation of imported products and that overseas office activities are coordinated with the centers and Office of Regulatory Affairs (ORA).

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

    Comments: In August 2017, FDA reported that it remains committed to strengthening its efforts and systematically monitoring and evaluating the overseas offices' contributions to the agency's mission and objectives. FDA also stated that it is making significant progress in several areas by enhancing strategic planning and analysis, refining the Office of International Program's (OIP) performance metrics, and designing a monitoring and evaluation plan. For example, FDA stated it has developed a framework with refined performance metrics to distinguish and assess the distinct contribution of OIP and its foreign offices towards program objectives and broader agency goals. FDA said that the performance metrics will track and monitor the quantity, quality, and timeliness of activity outputs and intermediate outcomes resulting from OIP's work. The measures have been standardized and defined, and will be further disaggregated to enable various levels of analyses, including distinguishing the unique efforts by foreign offices and product type. According to FDA, it plans to roll out its performance framework, related metrics, and monitoring and evaluation processes in fiscal year 2018. FDA said it anticipates that its performance measures, enhanced monitoring, and increased sharing of best practices across foreign offices and FDA headquarters will facilitate tracking of performance, allow greater accountability, and provide a foundation for continuous improvement. GAO will continue to monitor FDA's progress.
    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.