🏥HRSA Considers Duchenne Muscular Dystrophy for Newborn Screening Panel
HRSA is considering recommending to the Secretary the addition of Duchenne Muscular Dystrophy (DMD) to the Recommended Uniform Screening Panel (RUSP). HRSA is providing notice and requesting comments from the public on this potential recommendation. Conditions listed on the RUSP are part of the evidence-informed preventive health guidelines supported by HRSA for infants and children. Non- grandfathered health plans are required to cover screenings included in the HRSA-supported comprehensive guidelines without cost-sharing (e.g., co-payment, co-insurance, etc.). HRSA is particularly interested in comments that address the potential benefit of early screening of DMD within the newborn period, the ability of state newborn screening programs to screen for DMD, and the availability of effective treatments for DMD. In deciding whether to provide recommendations to the Secretary supporting the addition of DMD to the RUSP, HRSA will consider public comments, including evidence-based reports, obtained through this notice.
Learn More🩺HRSA Considers Adding MLD to Newborn Screening Panel
HRSA is considering recommending to the Secretary the addition of Metachromatic Leukodystrophy (MLD) to the Recommended Uniform Screening Panel (RUSP). HRSA is providing notice and requesting comments from the public on this potential recommendation. Conditions listed on the RUSP are part of the evidence-informed preventive health guidelines supported by HRSA for infants and children. Non- grandfathered health plans are required to cover screenings included in the HRSA-supported comprehensive guidelines without cost-sharing (e.g., co-payment, co-insurance, etc.). HRSA is particularly interested in comments that address the potential benefit of early screening of MLD within the newborn period, the ability of state newborn screening programs to screen for MLD, and the availability of effective treatments for MLD. In deciding whether to provide recommendations to the Secretary supporting the addition of MLD to the RUSP, HRSA will consider public comments, including evidence-based reports, obtained through this notice.
Learn More🍼CDC Proposes Data Collection for Newborn Disease Detection
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Enhancing Data-driven Disease Detection in Newborns (ED3N). This national newborn screening (NBS) data platform serves as a secure, central, and national data sharing resource for the U.S. state and territorial NBS community.
Learn More🧬FDA Classification of Muscular Dystrophy Newborn Screening Test
The Food and Drug Administration (FDA, the Agency, or we) is classifying the muscular dystrophy newborn screening test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the muscular dystrophy newborn screening test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🧬FDA Classifies Newborn Screening Test System Under Class II
The Food and Drug Administration (FDA, the Agency, or we) is classifying the lysosomal storage disorder newborn screening test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the lysosomal storage disorder newborn screening test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🩺ACHDNC Meeting on Heritable Disorders and Business Compliance Impacts
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting. Information about ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory- committees/heritable-disorders/index.html.
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