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    Subject Term: Pregnancy

    3 publications with a total of 7 open recommendations
    Director: Katherine M. Iritani
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: The Secretary of HHS should expeditiously develop a plan--that includes priorities, timeframes, clear roles and responsibilities, and methods for assessing progress--to effectively implement the NAS-related recommendations identified in the Protecting Our Infants Act: Final Strategy. (Recommendation 1)

    Agency: Department of Health and Human Services
    Status: Open

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

    5 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to consolidate information from individual diagnostic test labels and make this information available in a form that enables users to more readily compare information across tests.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration is working to consolidate and make available on its website information for Zika virus diagnostic tests that have emergency use authorization.
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to require manufacturers to list the identity of comparator assays on their diagnostic test labels.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration plans to recommend to sponsors of Zika virus diagnostic tests that they provide a description of the comparator assay.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to establish a transparent process to provide CDC diagnostic tests, upon request, to manufacturers that are in the final stages of diagnostic test authorization.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Centers for Disease Control and Prevention (CDC) Technology Transfer Office is working to establish a transparent process that ensures CDC diagnostic tests can be provided to manufacturers.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to include information on CDC-developed tests distributed to or shared with public health laboratories on CDC's website, including laboratory developed tests.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us the Centers for Disease Control and Prevention (CDC) provides information on CDC-developed diagnostic tests on the Food and Drug Administration?s (FDA) website. CDC stated that their website will feature a direct link to FDA information on CDC-developed tests. CDC will continue to explore additional outlets for publication of information on CDC-developed diagnostic tests.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to provide details such as collection records, dates, and data limitations on posted and disseminated mosquito distribution maps to better inform mosquito control experts and the general public.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In June 2016, the Centers for Disease Control and Prevention (CDC) published a report on the distribution of the mosquitos that can transmit Zika virus and other viruses in the United States. This report included new county collection records, collection dates, and summary maps for each species of mosquitos. In August 2017, officials from the Department of Health and Human Services told us the CDC is planning to update the mosquito distribution information on their website by the end of 2017, and it will include the underlying model predictions and country collection records.
    Director: Vijay A. D'Souza
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: In order to ensure that efforts to address prenatal opioid use and NAS are systematically and effectively planned and coordinated across the federal government, the Director of ONDCP should document the process, including discussions held and information considered, of developing action items on prenatal opioid use and NAS. This may include documenting gaps that were considered in developing action items.

    Agency: Executive Office of the President: Office of National Drug Control Policy
    Status: Open

    Comments: In May 2017 and July 2017, ONDCP officials described the process used to develop the action items related to prenatal opioid use and NAS for the 2015 National Drug Control Strategy report. Specifically, officials described working directly with federal agencies to identify proposals for action items and review proposals during an interagency working group meeting in March 2015. However, ONDCP officials could not provide us any formal documentation, such as meeting minutes, showing the process used or what gaps were considered in developing the action items. ONDCP officials also told us the action items related to prenatal opioid use and NAS for the 2015 Strategy have been generally completed. No action items related to prenatal opioid use and NAS were included in the 2016 Strategy and ONDCP officials said they did not know whether any related action items will be included for the 2017 Strategy. We will update the status of this recommendation after future Strategy reports are published.