Request for Nominations on the Pediatric Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Pediatric Advisory Committee for the Office of the Commissioner notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Pediatric Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Assessment of Food and Drug Administration Hiring and Retention; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Assessment of FDA Hiring and Retention''. The purpose of the public meeting is to share high-level findings from a recently completed diagnostic assessment of FDA's hiring process conducted by a qualified, independent contractor with expertise in assessing human resources operations and transformation. The purpose also is to outline a set of near-term actions FDA will or can take to improve the hiring process, provide an update on FDA's progress toward Prescription Drug User Fee Act (PDUFA) and Biosimilar User Fee Act (BsUFA) user fee hiring and retention commitments, and solicit input on actions FDA is taking and any further recommendations or priorities FDA should pursue with regard to the hiring process.
Advisory Committee; Patient Engagement Advisory Committee, Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Patient Engagement Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Patient Engagement Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 6, 2019.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection in the regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2019
This proposed rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. It proposes changes that would enhance the role of States as related to essential health benefits (EHB) and qualified health plan (QHP) certification; and would provide States with additional flexibility in the operation and establishment of Exchanges, including the Small Business Health Options Program (SHOP) Exchanges. It includes proposed changes to standards related to Exchanges; the required functions of the SHOPs; actuarial value for stand-alone dental plans; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions; and other related topics.