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    Subject Term: "Information services"

    2 publications with a total of 2 open recommendations
    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

    1 open recommendations
    Recommendation: In light of the agency's declining revenue associated with its basic statutory function and the charging for information that is often freely available elsewhere, Congress should consider examining the appropriateness and viability of the fee-based model under which NTIS currently operates for disseminating technical information to determine whether the use of this model should be continued.

    Agency: Congress
    Status: Open

    Comments: Congress has not yet enacted legislation to re-examine the fee-based model under which NTIS operates, although it has begun taking actions that give it an opportunity to do so. Specifically, the Department of Commerce Appropriations Acts, 2015, 2016 and 2017, prohibited NTIS from charging customers for reports authored by legislative branch offices unless the agency tells the customer how an electronic copy of the report can be accessed or downloaded for free online. The Act further stated that, if a customer still requires such a report from NTIS, the agency should not charge more than what is needed to recover the cost of processing, reproducing, and delivering the document requested. Additionally, in the 114th Congress, three bills (H.R. 443, S.787, and S.1636) were introduced and referred to the House Committee on Science, Space, and Technology and the Senate Committee on Commerce, Science, and Transportation. However, none of these bills were passed. The 115th Congress has yet to consider legislation that would ensure the assessment of the appropriateness or viability of NTIS functions.