Recommendation: As the Centers for Disease Control and Prevention (CDC) implements its COVID-19 Response Health Equity Strategy, the Director of the Centers for Disease Control and Prevention should determine whether having the authority to require states and jurisdictions to report race and ethnicity information for COVID-19 cases, hospitalizations, and deaths is necessary for ensuring more complete data, and if so, seek such authority from Congress. (Recommendation 6)

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

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

Recommendation: As CDC implements its COVID-19 Response Health Equity Strategy, the Director of the Centers for Disease Control and Prevention should involve key stakeholders to help ensure the complete and consistent collection of demographic data. (Recommendation 7)

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

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

Recommendation: As CDC implements its COVID-19 Response Health Equity Strategy, the Director of the Centers for Disease Control and Prevention should take steps to help ensure CDC's ability to comprehensively assess the long-term health outcomes of persons with COVID-19, including by race and ethnicity. (Recommendation 8)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
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 Centers for Disease Control and Prevention should ensure that, as it makes updates to its federal guidance related to reassessing schools' operating status, the guidance is cogent, clear, and internally consistent. (Recommendation 12)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
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 NIH should establish and implement a policy requiring all FACA committees under NIH's jurisdiction to post meeting minutes online. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health
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 IHS should document approved hardware inventory information by associating FISMA systems with the hardware on its network in a format that can be readily integrated into its CDM tools. (Recommendation 10)

Agency: Department of Health and Human Services: Public Health Service: Indian Health 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 IHS should document agency-specific variations from federal core configuration benchmarks for each operating system on its network. (Recommendation 11)

Agency: Department of Health and Human Services: Public Health Service: Indian Health 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 IHS should configure its CDM tools to compare configuration settings against federal core benchmarks applicable to its environment. (Recommendation 12)

Agency: Department of Health and Human Services: Public Health Service: Indian Health 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 CDC should take steps to determine participation rates and distribution needed in the AR Option of the National Healthcare Safety Network for conducting regional and national assessments of antibiotic resistance of public health importance. (Recommendation 1)

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

Comments: The Department of Health and Human Services concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should ensure that CDC's evaluation of its surveillance system for antibiotic-resistant gonorrhea includes measures of its representativeness, such as comparison of the trends in the sample population with those in the overall U.S. population, using specially designed studies if needed. (Recommendation 2)

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

Comments: The Department of Health and Human Services and the Centers for Disease Control and Prevention concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should provide information on uncertainties for antibiotic resistance estimates in its consolidated Threats Reports, including standard errors or confidence intervals, as appropriate. (Recommendation 3)

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

Comments: The Department of Health and Human Services generally concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should develop a plan for timely, consolidated reports of antibiotic resistance in priority pathogens at regular intervals. (Recommendation 4)

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

Comments: The Department of Health and Human services concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should direct the Center for Devices and Radiological Health to conduct additional monitoring and evaluation of the status of FDA-authorized tests that rely on breakpoints, on a regular basis, to determine whether test manufacturers are updating breakpoints, seeking additional resources as needed. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Food and Drug Administration: Office of the Commissioner
Status: Open

Comments: The Department of Health and Human Services and the Food and Drug Administration concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Administrator of HRSA should incorporate assessments of covered entities' compliance with state Medicaid programs' policies and procedures regarding the use and identification of 340B drugs into its audit process, working with CMS as needed to obtain states' policies and procedures. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS did not concur with this recommendation and, as of August 2020, did not plan to take any actions to implement the recommendation. As noted in our report, covered entities' compliance with state Medicaid programs' policies and procedures is fundamental to preventing duplicate discounts. Thus, we continue to believe that HRSA's audit process should include an assessment of covered entities' compliance with state Medicaid programs' policies and procedures related to 340B drugs as it is necessary to identify potential duplicate discounts and to ensure covered entities' compliance with 340B Program requirements.

Recommendation: The Administrator of HRSA should require covered entities to work with affected drug manufacturers regarding repayment of identified duplicate discounts in Medicaid managed care. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS did not concur with this recommendation and, as of August 2020, did not plan to take any actions to implement the recommendation. As noted in our report, HRSA officials told us that covered entities' obligations for preventing duplicate discounts are the same for Medicaid fee-for-service and managed care. Thus, we continue to believe that when duplicate discounts related to Medicaid managed care have been identified, the agency should require covered entities to work with manufacturers to remedy them as they do for duplicate discounts related to Medicaid fee-for-service to help ensure compliance with 340B Program requirements.

Recommendation: The Administrator of HRSA should ensure that the information it uses to verify nonprofit status for all nongovernmental hospitals that participate in the 340B Program is reliable—for example, by requiring and reviewing the submission of official documentation hospitals must already maintain or by ensuring the reliability of the data the agency uses. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation and in June 2020, reiterated that HRSA believes that the information it uses to determine nonprofit status is reliable, because hospital administrators attest to its accuracy. However, as discussed in our report, neither HRSA nor the agency that collects the data has evaluated the reliability of the data for verifying nonprofit status. Without ensuring it is using reliable information, HRSA cannot effectively determine if nongovernmental hospitals participating, or seeking to participate, in the 340B Program meet the statutory eligibility requirements.

Recommendation: The Administrator of HRSA should implement a process to verify that every nongovernmental hospital that participates in the 340B Program has a contract with a state or local government as required by statute. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS did not concur with this recommendation and, as of June 2, 2020, did not plan to take any actions to implement the recommendation. HHS noted that requiring all covered entities to submit a state or local government contract would create a significant burden for covered entities. However, as we noted in our report, HRSA already requires hospitals to maintain copies of their state or local government contracts. Therefore, it is unclear how implementing a process to verify the existence of those contracts would represent a significant burden. Without this information, HRSA does not have reasonable assurance that nongovernmental hospitals have the statutorily required contracts to participate in the 340B Program.

Recommendation: The Administrator of HRSA should provide more specific guidance for 340B Program auditors on how to determine if nongovernmental hospitals' contracts with state and local governments require the provision of health care services to low-income individuals not eligible for Medicaid or Medicare. (Recommendation 4)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation and in June 2020, indicated that HRSA had updated its audit guidance and procedures to more clearly specify that contracts must contain requirements for the provision of health care services to low-income individuals. However, these documents do not contain any specific guidance on how auditors are to evaluate whether contracts require these services. Without more specific guidance for auditors' review of contracts, HRSA lacks reasonable assurance that the audits are appropriately identifying deficiencies in nongovernmental hospitals' contracts with state or local governments.

Recommendation: The Administrator of HRSA should require nongovernmental hospitals participating in the 340B Program to demonstrate that they have contracts with state or local governments in effect prior to the beginning of their audits' periods of review and should apply consistent and appropriate consequences for hospitals that are unable to do so. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation. As noted in our report, HRSA updated its draft audit procedures for fiscal year 2020 audits in September 2019 to specify that auditors should look for effective dates that cover the entire audit period. While this is an important step, HRSA must also show that it has ceased accepting retroactive contract documentation, and has applied consistent and appropriate consequences when auditors find that nongovernmental hospitals did not have contracts in effect prior to the beginning of their audit periods. As of June 2020, HHS indicated that HRSA had not taken these actions. Allowing hospitals that are unable to demonstrate that they have contracts in place that cover their audits' periods of review to continue to participate without consequences undermines the effectiveness of HRSA's audit process and increases the risk that ineligible hospitals will receive discounts under the program.

Recommendation: The Director of the Agency for Healthcare Research and Quality should take steps to ensure appropriate agency-funded research data are readily findable and accessible to the public. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Agency for Healthcare Research and Quality
Status: Open

Comments: The Agency for Healthcare Research and Quality concurred with this recommendation. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The Director of the Agency for Healthcare Research and Quality should complete development of data management plan requirements. (Recommendation 9)

Agency: Department of Health and Human Services: Public Health Service: Agency for Healthcare Research and Quality
Status: Open

Comments: The Agency for Healthcare Research and Quality concurred with this recommendation. When we confirm what actions the agency has taken to implement the recommendation we will provide updated information.

Recommendation: The Director of the Agency for Healthcare Research and Quality should evaluate training needs for agency officials or others involved in reviewing the merits of researchers' data management plans and, if additional training is found to be warranted, develop and provide such training. (Recommendation 17)

Agency: Department of Health and Human Services: Public Health Service: Agency for Healthcare Research and Quality
Status: Open

Comments: The Agency for Healthcare Research and Quality concurred with this recommendation stating that it would assess training needs for agency officials and others involved in reviewing the merits of researchers' data management plans and would develop and provide additional training if warranted. When we confirm what actions the agency has taken to implement the recommendation we will provide updated information.

Recommendation: The Director of the Agency for Healthcare Research and Quality should develop and implement a mechanism to ensure researcher compliance with the public access plan and associated requirements.(Recommendation 23)

Agency: Department of Health and Human Services: Public Health Service: Agency for Healthcare Research and Quality
Status: Open

Comments: The Agency for Healthcare Research and Quality concurred with this recommendation. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The Director of the National Institutes of Health should fully develop and implement a mechanism to ensure researcher compliance with the public access plan and associated requirements. (Recommendation 25)

Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health
Status: Open

Comments: The National Institutes of Health concurred with this recommendation but stated that the agency already had mechanisms in place to ensure compliance with public access plan and associated requirements for publications and data. As discussed in the report, we believe our recommendation, as worded, appropriately reflected the extent to which the agency had implemented researcher compliance mechanisms at the time of issuance of our report. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: As the Subcommittee on Open Science moves forward, the National Institutes of Health co-chair, in coordination with other co-chairs and participating agencies, should take steps to fully implement leading practices that enhance and sustain collaboration. (Recommendation 35)

Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health
Status: Open

Comments: NIH concurred with GAO's November 2019 recommendation. NIH stated that the subcommittee and its working groups are actively coordinating and building consensus on issues and processes to implement leading practices that enhance and sustain collaboration across federal agencies. In March 2020, the Office of Science and Technology Policy provided information on steps the subcommittee has taken to address issues associated with public access to federally funded research results, including certain areas GAO identified as presenting challenges to public access plan implementation in the November 2019 report. GAO will collect and evaluate additional information to determine the extent to which these steps incorporate leading practices for interagency collaboration GAO has identified. By taking steps to fully implement the relevant leading practices we have identified, the subcommittee and its member agencies could better marshal their collective efforts to address common public access plan implementation challenges that agency officials and stakeholders identified.

Recommendation: As VA and IHS revise the MOU and related performance measures, the Director of IHS should ensure these measures are consistent with the key attributes of successful performance measures, including having measurable targets. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Indian Health 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 Administrator of HRSA should require covered entities to register contract pharmacies for each site of the entity for which a contract exists. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. As noted in our report, without complete information on contract pharmacy arrangements--including information on with sites of a covered entity have contracts with a contract pharmacy--HRSA cannot ensure that it is optimally targeting the limited number of audits done each year. Additionally, manufacturers lack important information to help ensure that 340B discounted drugs are only provided to pharmacies with a valid 340B contract with the covered entity site for which the drug is being dispensed.

Recommendation: The Administrator of HRSA should issue guidance to covered entities on the prevention of duplicate discounts under Medicaid managed care, working with CMS as HRSA deems necessary to coordinate with guidance provided to state Medicaid programs.(Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open
Priority recommendation

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should incorporate an assessment of covered entities' compliance with the prohibition on duplicate discounts, as it relates to Medicaid managed care claims, into its audit process after guidance has been issued and ensure that identified violations are rectified by the entities. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open
Priority recommendation

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should issue guidance on the length of time covered entities must look back following an audit to identify the full scope of noncompliance identified during the audit.(Recommendation 4)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should require all covered entities to specify their methodology for identifying the full scope of noncompliance identified during the audit as part of their corrective action plans, and incorporate reviews of the methodology into their audit process to ensure that entities are adequately assessing the full scope of noncompliance. (Recommendation 5)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. HHS noted that requiring all covered entities subject to an audit to specify their methodology for identifying the full scope of noncompliance identified during the audit would create a significant burden for covered entities. However, as noted in our report, HRSA already requires covered entities with audit findings to determine the full scope of noncompliance and requires entities subject to a targeted audit to provide their methodology for such assessments to HRSA. Thus, it is unclear how requiring covered entities subject to risk-based, as opposed to targeted, audits to provide HRSA with a written description of methodologies that they are already required to formulate and implement would create a significant additional burden. Without this information, HRSA does not have reasonable assurance that the majority of covered entities have adequately identified all instances of noncompliance.

Recommendation: The Administrator of HRSA should require all covered entities to provide evidence that their corrective action plans have been successfully implemented prior to closing audits, including documentation of the results of the entities' assessments of the full scope of noncompliance identified during each audit.(Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. HHS stated that requiring all covered entities with audit findings to provide evidence that their corrective action plans have been successfully implemented would create an undue burden for covered entities. However, HRSA already requires such evidence from covered entities subject to targeted audits, and it is unclear how providing evidence of implementation of corrective actions that entities developed and are required to implement would create significant additional burden for these entities. Additionally, without such evidence HRSA does not have a reasonable assurance that the majority of covered entities audited have corrected the issues identified in the audit, and are not continuing practices that could lead to noncompliance.

Recommendation: The Administrator of HRSA should provide more specific guidance to covered entities regarding contract pharmacy oversight, including the scope and frequency of such oversight. (Recommendation 7)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Assistant Secretary for Mental Health and Substance Use should establish procedures to better ensure that mid-performance changes to program priority goals, objectives, and targets are examined across multiple years. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Substance Abuse and Mental Health Services Administration
Status: Open

Comments: As of October 2019, HHS reported that the Substance Abuse and Mental Health Services Administration (SAMHSA) would add new additional features to its web-based system for overseeing the mental health protection and advocacy programs, with an implementation target date of October 2020. The agency described one new feature as a tracking tool to monitor program requests to revise priority goals, objectives, and targets over multiple years. In the meantime, SAMHSA has developed a manual tracking tool for its project officers to use until the electronic tool is in place. Another new feature is a workflow that will allow project officers, team leaders, and branch chiefs to review and approve changes made by the programs. However, SAMHSA has not yet provided documentation of the latter feature to demonstrate that it has developed procedures for project officers to review the changes over multiple years. Therefore, the agency lacks assurances that its project officers will consistently examine whether a particular program is regularly making changes to benchmarks that may be indicative of a potential performance problem. We will review the web-based tracking tool when available and continue to monitor SAMHSA's efforts to develop procedures for examining changes to benchmarks over multiple years.

Recommendation: The Director of IHS should implement a targeted, resource-efficient method to identify additional eligible Indian homes that may have existing deficiencies to include in IHS's Home Inventory Tracking System (HITS). (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Indian Health Service
Status: Open

Comments: In August 2018, IHS's Division of Sanitation Facilities Construction issued a memo to its Area Directors directing them to identify additional eligible Indian homes that may have existing deficiencies to include in HITS. The memo directed Area Offices to use existing staffing resources to leverage their annual efforts to gather sanitation needs data, in collaboration with tribes, to identify any additional homes. In December 2019, IHS officials stated that, as a result of implementing the 2018 memo, Area Directors had increased the number of eligible homes that they identified in 2019. We will continue to monitor the results of IHS's actions.

Recommendation: The Director of IHS should implement a mechanism to indicate in HITS whether each home with a deficiency level of 0 has been assessed. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Indian Health Service
Status: Open

Comments: As of December 2019, IHS had developed a mechanism in HITS to indicate whether a home currently classified as deficiency level (DL) 0 had been assessed. IHS stated that it has eliminated the category of DL 0 from HITS; in its place, it created a new category of "Pending Assessment" for those homes that are in HITS but that have not been assessed. IHS also came up with a way to prioritize the homes in the Pending Assessment category based on their eligibility to receive assistance from IHS. Homes currently in HITS that have a DL 0 and received service through the Sanitation Facilities Construction Program from 2015 through today will be reassigned a DL 1 to indicate the deficiencies are only associated with routine operations and maintenance. IHS stated that the changes to HITS have been implemented and shared a proposal of how it will distribute the former DL 0 homes across the new categories. We will evaluate IHS's actions after they are complete.

Recommendation: The Director of IHS should reassess the point distribution across the Sanitation Deficiency System scoring factors as part of its program guidelines update, in light of trade-offs between funding projects that address the most severe sanitation deficiencies and projects that meet other needs. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Indian Health Service
Status: Open

Comments: As part of its reassessment of the point distribution across the scoring factors, in 2018 and 2019 IHS consulted with tribes and analyzed various options for changing the point distribution. We have asked IHS to provide additional information about its reassessment efforts. We will evaluate IHS's actions after we receive the additional information.

Recommendation: The Director of IHS, in cooperation with other members of the tribal infrastructure task force, should review the 2011 task force report and identify and implement additional actions to help increase the task force's collaboration at the national level. (Recommendation 7)

Agency: Department of Health and Human Services: Public Health Service: Indian Health Service
Status: Open

Comments: As of December 2019, IHS had reviewed the 2011 task force report and summarized actions taken and challenges associated with implementing the remaining recommendations. IHS stated that it anticipated discussing its summary with the other members at a future tribal infrastructure task force meeting. We will evaluate IHS's actions when they are complete.

Recommendation: The Director of IHS, in cooperation with other members of the tribal infrastructure task force, should direct IHS area offices to identify and pursue additional mechanisms to increase their collaboration. (Recommendation 12)

Agency: Department of Health and Human Services: Public Health Service: Indian Health Service
Status: Open

Comments: As of December 2019, IHS headquarters hosted a meeting that included staff from IHS Areas, EPA headquarters, and EPA regions to discuss additional mechanisms to increase collaboration, including best practices for identifying projects for joint funding collaborations. In addition, IHS and the other tribal infrastructure task force members agreed to jointly draft a memo for distribution to their field offices that would include contact information for other member agencies and encourage interagency coordination. We will evaluate IHS's remaining actions to satisfy this recommendation when they are complete.

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: CDC agreed with this October 2017 recommendation and, as of January 2020, CDC and APHIS were in the process of finalizing a joint workforce assessment focusing primarily on inspections, according to officials from the Select Agent Program. However, this joint assessment does not account for other aspects of the program, such as training, which was part of GAO's recommendation. According to Select Agent Program officials, the program is developing a new information system and officials plan to conduct a follow-up workload assessment once this new system is fully implemented, as they anticipate that the program will gain efficiencies once this new system is in place. Officials from the Select Agent Program said they did not have a definitive timeframe as to when the new system would be in place and a new workload assessment could be completed but, as of December 2019, they said it would be several years. Once the updated workforce assessment is completed, GAO will review it to determine if it fulfills the recommendation. Developing a joint workforce plan as recommended would help the program to better manage fragmentation by improving how it leverages resources, which in turn would help to ensure that all workforce and training needs are met.

Recommendation: As NIH-DFAS begins formalizing its internal guidance, the Director of NIH-DFAS should establish a mechanism for tracking key milestones in the indirect cost rate-setting process, such as when indirect cost rate proposals are due.

Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health: Office of Management: Office of Acquisition and Logistics Management: Office of Acquisition Management and Policy: Division of Financial Advisory Services
Status: Open

Comments: HHS concurred with this recommendations. In response, HHS stated that National Institute of Health's Division of Financial Advisory Services (DFAS) will establish a mechanism for tracking key milestones in the indirect cost rate-setting process. NIH-DFAS has initiatives underway that include moving from paper to electronic submissions of indirect cost proposals and developing a replacement to its Commercial Rate Agreement Distribution Services website. DFAS is looking into the feasibility of incorporating key milestones into these two major initiatives. NIH-DFAS is currently working with a contractor to develop a web based system that will establish a tracking system to account for when indirect cost proposal are due from organizations. The original initiative to enable the electronic submission of indirect cost proposals was modified to incorporate this new requirement. NIH-DFAS anticipates the planned date for implementation of this system to be October 1, 2017. As of February 4, 2020, this recommendation is still open because DFAS does not have the "proposal due date" and "extension due date" data fields activated in eFLow. DFAS is looking into adding those enhancements and hope to have these updates implemented by June 30, 2020. On July 8th, 2020, NIH-DFAS notified us that they plan to update us with the status of this recommendation by October 2020. We will continue to monitor the status of this recommendation.

Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should report on this summary data and the results of this analysis in NIH's regular biennial report to Congress on the inclusion of women in research.

Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health
Status: Open

Comments: In August 2020, NIH reported that summary data as described in our Recommendation 4--that is, data and analysis on awardees' plans to conduct valid analysis by sex/gender--will be included in the 2019-2020 version of this publication, which the agency expects will be published in October 2021. We will continue to monitor NIH's actions on this matter.

Recommendation: To help address the uncertainty NIH faces, related to the potential impact of increasing indirect costs on its funding of future research, the Director of NIH should assess the impact of growth in indirect costs on its research mission, including, as necessary, planning for how to deal with potential future increases in indirect costs that could limit the amount of funding available for total research, including the direct costs of research projects.

Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health
Status: Open

Comments: As of July 7, 2015, NIH provided some information indicating that it had taken action to address our recommendation by tracking the size of indirect costs as a proportion of NIH's overall budget as part of the agency's annual budget planning process and risk assessment program. However, we determined that the actions did not fully address the recommendation because they focus on the agency's overall budget and do not assess the potential ongoing impact of indirect costs for universities on its mission. As of September 2018, NIH officials have not informed us of any additional actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.