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    Subject Term: "Conflict of interests"

    8 publications with a total of 38 open recommendations
    Director: Lawrance Evans, Jr.
    Phone: (202) 512-8678

    6 open recommendations
    Recommendation: As the Board of Governors implements plans to develop an ERM framework, it should include a component to identify and assess risks of regulatory capture across the LISCC program. (Recommendation 1)

    Agency: Federal Reserve System: Board of Governors
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Board of Governors should finalize and implement program-wide guidance for the LISCC Reserve Banks on implementing LISCC policies. (Recommendation 2)

    Agency: Federal Reserve System: Board of Governors
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Board of Governors should finalize and implement a mechanism to monitor and regularly assess Reserve Banks' implementation of LISCC policies and procedures. (Recommendation 3)

    Agency: Federal Reserve System: Board of Governors
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Board of Governors should streamline its conflict-of-interest disclosure review process for participants in the LISCC program, such as by storing disclosure information in compatible electronic systems. (Recommendation 4)

    Agency: Federal Reserve System: Board of Governors
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Board of Governors should systematically collect and maintain information on the institutions supervisory employees work for before they are hired by the Federal Reserve and their employment destination when they leave. (Recommendation 5)

    Agency: Federal Reserve System: Board of Governors
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Board of Governors should conduct a periodic self-assessment of ethics programs, policies, and procedures that apply to LISCC program participants. (Recommendation 6)

    Agency: Federal Reserve System: Board of Governors
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Timothy M. Persons
    Phone: (202) 512-6412

    11 open recommendations
    Recommendation: To improve independence, the Administrator of APHIS should formally document the reporting structure for the APHIS component of the Select Agent Program from the APHIS director of the program to the Administrator of APHIS. (Recommendation 1)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: USDA agreed with this recommendation and stated in its agency comments on the report, dated September 21, 2017, that APHIS plans to develop a document that outlines the communication, reporting structure, and oversight activities of the APHIS Administrator and the director of APHIS's component of the Select Agent Program.
    Recommendation: To improve independence, the CDC director of the Select Agent Program should work with APHIS to establish control activities to help ensure that each component of the program carries out its inspection responsibilities as outlined in the program's memorandum of understanding. (Recommendation 2)

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
    Status: Open

    Comments: HHS agreed with this recommendation. In December 2017, the Select Agent Program finalized a joint standard operating procedure that states that APHIS will lead inspections for all CDC-owned laboratories and CDC will lead inspections for APHIS-owned entities, consistent with the program's memorandum of understanding. This is a positive step towards implementation of this recommendation. However, the procedure does not describe any control activities that will help ensure that the procedure is followed. Once GAO has information on any control activities that the program is implementing to ensure the procedure is followed, GAO will determine if the program has met the intent of the recommendation.
    Recommendation: To improve independence, the APHIS director of the Select Agent Program should work with CDC to establish control activities to help ensure that each component of the program carries out its inspection responsibilities as outlined in the program's memorandum of understanding. (Recommendation 3)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: USDA agreed with this recommendation. In December 2017, the Select Agent Program finalized a joint standard operating procedure that states that APHIS will lead inspections for all CDC-owned laboratories and CDC will lead inspections for APHIS-owned entities, consistent with the program's memorandum of understanding. This is a positive step towards implementation of this recommendation. However, the procedure does not describe any control activities that will help ensure that the procedure is followed. Once GAO has information on any control activities that the program is implementing to ensure the procedure is followed, GAO will determine if the program has met the intent of the recommendation.
    Recommendation: To improve independence, the CDC director of the Select Agent Program should regularly assess the potential risks posed by the program's structure and the effectiveness of its mechanisms to address those risks, such as by commissioning external reviews, and take actions as necessary to ensure that any identified risks are addressed so that impairments to independence do not affect its ability to achieve its objectives. (Recommendation 4)

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
    Status: Open

    Comments: HHS agreed with this recommendation and stated in December 2017 that the Select Agent Program was in the process of developing a plan to solicit an external review to assess the potential risks posed by the program's structures within CDC and APHIS.
    Recommendation: To improve independence, the APHIS director of the Select Agent Program should regularly assess the potential risks posed by the program's structure and the effectiveness of its mechanisms to address those risks, such as by commissioning external reviews, and take actions as necessary to ensure any identified risks are addressed so that impairments to independence do not affect its ability to achieve its objectives. (Recommendation 5)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: USDA agreed with this recommendation and stated in its agency comments on the report, dated September 21, 2017, that the Select Agent Program plans to explore options, including re-examining previous reviews, and assess the need for additional review to ensure potential risks posed by the program's structure are adequately addressed.
    Recommendation: To improve the ability to perform reviews, the CDC director of the Select Agent Program should work with APHIS to develop and implement a plan to identify which laboratory activities carry the highest biological safety and security risks and to respond to those risks by aligning inspections and other oversight efforts to target those activities. (Recommendation 6)

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
    Status: Open

    Comments: HHS agreed with this recommendation and stated in December 2017 that the Select Agent Program was developing procedures to analyze data in its new information system. In addition, the program plans to provide training to align inspections and other oversight activities to the highest risks. HHS stated that the program expects to complete these activities by June 2018.
    Recommendation: To improve the ability to perform reviews, the APHIS director of the Select Agent Program should work with CDC to develop and implement a plan to identify which laboratory activities carry the highest biological safety and security risks and to respond to those risks by aligning inspections and other oversight efforts to target those activities. (Recommendation 7)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: USDA agreed with this recommendation and stated in its agency comments on the report, dated September 21, 2017, that the Select Agent Program plans to develop procedures to analyze data in its new information system to improve the inspection process.
    Recommendation: To improve transparency, the CDC director of the Select Agent Program should work with APHIS to determine what additional information about laboratories' use of select agents, incidents, and violations of the select agent regulations is appropriate for the program to share with registered laboratories. (Recommendation 8)

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
    Status: Open

    Comments: HHS agreed with this recommendation and stated in December 2017 that the Select Agent Program was developing a plan for disseminating information to registered laboratories. HHS stated that the program expects to complete this plan by March 2018.
    Recommendation: To improve transparency, the APHIS director of the Select Agent Program should work with CDC to determine what additional information about laboratories' use of select agents, incidents, and violations of the select agent regulations is appropriate for the program to share with registered laboratories. (Recommendation 9)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: USDA agreed with this recommendation and stated in its agency comments on the report, dated September 21, 2017, that the Select Agent Program is exploring ways to disseminate information on common deficiencies identified during inspections to laboratories registered with the program. In addition, USDA stated that the program plans to analyze data on potential occupational exposures to identify common causes and provide recommendations to prevent future exposures.
    Recommendation: To improve technical expertise and overcome fragmentation, the CDC director of the Select Agent Program should work with APHIS to develop a joint workforce plan that assesses workforce and training needs for the program as a whole. This assessment should be done in conjunction with the development of the strategic plan. (Recommendation 10)

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
    Status: Open

    Comments: HHS agreed with this recommendation and stated in December 2017 that the Select Agent Program planned to complete development of a joint strategic plan and workforce assessment by March 2018.
    Recommendation: To improve technical expertise and overcome fragmentation, the APHIS director of the Select Agent Program should work with CDC to develop a joint workforce plan that assesses workforce and training needs for the program as a whole. This assessment should be done in conjunction with the development of the strategic plan. (Recommendation 11)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: USDA agreed with this recommendation and stated in its agency comments on the report, dated September 21, 2017, that the Select Agent Program has initiated contract support to guide the program through development of a joint strategic plan that will include an assessment of workforce and training needs.
    Director: Diana Maurer
    Phone: (202) 512-8777

    3 open recommendations
    Recommendation: The Director of the USMS should develop specific documented guidance--both for the current and new processes--to enhance raters' ability to consistently interpret and apply experience-based benchmarks for GS-14 and GS-15 positions and competency-based benchmarks for GS-13 positions when evaluating candidate qualifications. (Recommendation 1)

    Agency: Department of Justice: United States Marshals Service
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Director of the USMS should develop and implement a mechanism to provide specific feedback to employees on the results of the promotion process, including their readiness for promotion. (Recommendation 2)

    Agency: Department of Justice: United States Marshals Service
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Director of the USMS should develop and implement an agency-wide action plan to more fully understand and address areas where employees express negative perceptions of the merit promotion process. Consistent with Office of Personnel Management guidance in this area, the plan should specify (1) time frames for accomplishing the actions, (2) who will be responsible for implementing the actions, (3) who will be affected by the actions, (4) the resources required, and (5) a plan to communicate these actions to managers and employees. (Recommendation 3)

    Agency: Department of Justice: United States Marshals Service
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Lawrance Evans
    Phone: (202) 512-8678

    2 open recommendations
    Recommendation: To provide greater assurance that the Federal Reserve is complying with the Monetary Control Act's requirement to establish fees on the basis of costs actually incurred and an allocation of imputed private-sector costs, the Chair of the Federal Reserve Board of Governors of the Federal Reserve System should consider ways to incorporate the costs related to integrated planning for recovery and wind down and compliance with antimoney-laundering requirements, to the extent practicable, in its imputed private-sector cost methodology.

    Agency: Federal Reserve System: Board of Governors
    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 greater assurance that the Federal Reserve is complying with the Monetary Control Act's requirement to establish fees on the basis of costs actually incurred and an allocation of imputed private-sector costs, the Chair of the Federal Reserve Board of Governors of the Federal Reserve System should periodically obtain independent testing of the methods the Federal Reserve uses to capture its actual costs and simulate those of the private sector.

    Agency: Federal Reserve System: Board of Governors
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Yvonne D. Jones
    Phone: (202) 512-6806

    2 open recommendations
    Recommendation: To help ensure HHS has reliable data on SGEs not serving on federal boards, the Secretary of HHS should take steps to improve the reliability of data on SGEs not serving on boards. For example, the agency could reconcile human capital data with general counsel and ethics office data, or issue clarifying guidance to human capital staff on appropriately identifying SGEs in human capital databases.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In October 2016, HHS submitted its action plan to address GAO's recommendations. HHS stated the agency is currently reviewing its internal policies and procedures related to the hiring of special government employees not serving on boards to identify policy options that might improve data reliability. In January 2017, the Office of Government Ethics issued its Ethics Program Review of HHS and commented on ongoing and planned efforts by HHS to address challenges associated with identifying Special Government Employees who do not serve on federal advisory committees. Ongoing efforts include internal coordination between the Office of General Counsel-Ethics Division and human resource officials to implement new requirements based on 5 CFR part 2638. We are following up with HHS to determine the status of actions on the new requirements.
    Recommendation: To help ensure that agencies report consistent and reliable data, the Director of OGE should determine (e.g., through a survey of Designated Agency Ethics Officials and/or by analyzing agency data) whether other executive branch agencies are experiencing data challenges similar to HHS, State, and NRC. If they are, the Director should take steps to help the agencies strengthen their data.

    Agency: Office of Government Ethics
    Status: Open

    Comments: In 2016 and 2017, OGE reported on action taken to address coordination and data challenges agencies face in fulfilling ethics program requirements for Special Government Employees. In 2016, OGE published a final rule amending its regulations that govern executive branch ethics programs found at 5 CFR Part 2638. OGE reported that this regulation will help agencies strengthen their data and address concerns raised by agencies with regard to human resource coordination. In February 2017, OGE reported on results of a survey of executive branch ethics officials and concluded that based on agency responses, OGE does not believe executive branch agencies are experiencing systematic challenges in connection with data regarding Expert/Consultant SGEs. OGE reported the survey results show that information regarding the hiring and designation of SGEs is primarily within the control of human resource officials and described steps taken by OGE to strengthen the relationship between human resources and agency ethics officials. We are following up with OGE actions taken to improve internal coordination between ethics and human resource officials at executive branch agencies as required by the amended regulations.
    Director: Anne-Marie Fennell
    Phone: (202) 512-3841

    8 open recommendations
    Recommendation: To better leverage the commissioners' expertise in the development of the annual work plan, Congress should consider amending the Denali Commission Act, potentially with one of the identified options.

    Agency: Congress
    Status: Open

    Comments: On December 10, 2016, Congress passed the Water Infrastructure Improvements for the Nation Act, or WIIN Act. As of December 14, 2016, the legislation had not yet been signed by the President. Section 5002 of the legislation included provisions related to the Denali Commission. If the legislation becomes law we will review it in more detail to see if it addresses this matter for congressional consideration.
    Recommendation: To address barriers to the operation of the Commission, Congress should consider amending the Denali Commission Act to include either a holdover or delegation of authority provision when the Federal Cochair position is vacant.

    Agency: Congress
    Status: Open

    Comments: On December 10, 2016, Congress passed the Water Infrastructure Improvements for the Nation Act, or WIIN Act. As of December 14, 2016, the legislation had not yet been signed by the President. Section 5002 of the legislation included provisions related to the Denali Commission. If the legislation becomes law we will review it in more detail to see if it addresses this matter for congressional consideration.
    Recommendation: To enhance the Commission's operations, the Commission's Federal Cochair should direct the Commission to consider options for fulfilling the Commission's statutory purpose and finalize that new approach in a new strategic plan.

    Agency: Denali Commission
    Status: Open

    Comments: As of December 2016, GAO is reviewing actions by the agency to implement this recommendation.
    Recommendation: To improve the Commission's grants management, the Commission's Federal Cochair should direct the Commission to issue Commission-specific policies for awarding and managing grants.

    Agency: Denali Commission
    Status: Open

    Comments: As of December 2016, GAO is reviewing actions by the agency to implement this recommendation.
    Recommendation: To improve the Commission's grants management, the Commission's Federal Cochair should direct the Commission to establish a documented process for ensuring that the findings of single audits of grantees are promptly resolved and take action to resolve any recent single audits that showed evidence of a potential problem.

    Agency: Denali Commission
    Status: Open

    Comments: As of December 2016, GAO is reviewing actions by the agency to implement this recommendation.
    Recommendation: To improve the Commission's grants management, the Commission's Federal Cochair should direct the Commission to continue efforts to close out grants and projects, including deobligating unspent grant funds in a timely manner.

    Agency: Denali Commission
    Status: Open

    Comments: As of December 2016, GAO is reviewing actions by the agency to implement this recommendation.
    Recommendation: To improve the Commission's grants management, the Commission's Federal Cochair should direct the Commission to take steps to consistently manage and retain Commission records, including implementing its record retention policy once it is approved.

    Agency: Denali Commission
    Status: Open

    Comments: As of December 2016, GAO is reviewing actions by the agency to implement this recommendation.
    Recommendation: To allow for greater flexibility in the Commission's operations, Congress should consider amending the Denali Commission Act to modify or end the 5 percent cap on administrative expenditures.

    Agency: Congress
    Status: Open

    Comments: As of December 14, 2016, no legislation had been enacted to address this issue.
    Director: Brown, Orice Williams
    Phone: (202)512-5837

    4 open recommendations
    Recommendation: While creating control systems at the same time that the emergency programs were being designed and implemented posed unique challenges, the recent crisis provided invaluable experience that the Federal Reserve System can apply in the future should the use of these authorities again become warranted. Going forward, to further strengthen policies for selecting vendors, ensuring the transparency and consistency of decision making involving the implementation of any future emergency programs, and managing risks related to these programs, the Chairman of the Federal Reserve Board should direct Federal Reserve Board and Reserve Bank staff to strengthen procedures in place to guide Reserve Banks' efforts to manage emergency program access for higher-risk borrowers by providing more specific guidance on how Reserve Bank staff should exercise discretion and document decisions to restrict or deny program access for depository institutions and primary dealers that would otherwise be eligible for emergency assistance.

    Agency: Federal Reserve System: Board of Governors
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: While creating control systems at the same time that the emergency programs were being designed and implemented posed unique challenges, the recent crisis provided invaluable experience that the Federal Reserve System can apply in the future should the use of these authorities again become warranted. Going forward, to further strengthen policies for selecting vendors, ensuring the transparency and consistency of decision making involving the implementation of any future emergency programs, and managing risks related to these programs, the Chairman of the Federal Reserve Board should direct Federal Reserve Board and Reserve Bank staff to document a plan for estimating and tracking losses that could occur under more adverse economic conditions within and across all emergency lending activities and for using this information to inform policy decisions, such as decisions to limit risk exposures through program design or restrictions applied to eligible borrowing institutions.

    Agency: Federal Reserve System: Board of Governors
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: While creating control systems at the same time that the emergency programs were being designed and implemented posed unique challenges, the recent crisis provided invaluable experience that the Federal Reserve System can apply in the future should the use of these authorities again become warranted. Going forward, to further strengthen policies for selecting vendors, ensuring the transparency and consistency of decision making involving the implementation of any future emergency programs, and managing risks related to these programs, the Chairman of the Federal Reserve Board should direct Federal Reserve Board and Reserve Bank staff, in drafting regulations to establish the policies and procedures governing emergency lending under section 13(3) of the Federal Reserve Act, to set forth the Federal Reserve Board's process for documenting, to the extent not otherwise required by law, its justification for each use of this authority.

    Agency: Federal Reserve System: Board of Governors
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: While creating control systems at the same time that the emergency programs were being designed and implemented posed unique challenges, the recent crisis provided invaluable experience that the Federal Reserve System can apply in the future should the use of these authorities again become warranted. Going forward, to further strengthen policies for selecting vendors, ensuring the transparency and consistency of decision making involving the implementation of any future emergency programs, and managing risks related to these programs, the Chairman of the Federal Reserve Board should direct Federal Reserve Board and Reserve Bank staff to document the Federal Reserve Board's guidance to Reserve Banks on types of emergency program decisions and risk events that require approval by or consultation with the Board of Governors, the Federal Open Market Committee, or other designated groups or officials at the Federal Reserve Board.

    Agency: Federal Reserve System: Board of Governors
    Status: Open

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