Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Center Patient Survey, OMB No. 0915-0368-Reinstatement
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Request for Information on “Update on Selected Topics in Asthma Management 2020: A Report From the National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC) Expert Panel Report 4 (EPR-4) Working Group”
The Expert Panel Working Group of the NHLBI National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC) is soliciting comments and suggestions from the public on ``Update on Selected Topics in Asthma Management 2020: A Report from the Expert Panel Report-4 (EPR-4) Working Group.'' This Request for Information (RFI) invites the scientific community, health professionals, organizations, patient communities, and the general public to provide comments and suggestions, including particular emphasis on the feasibility, acceptability, and capacity for implementation, of the proposed recommendations and implementation guidance. Responses to this RFI will be used to update and revise the report as necessary.
Proposed Collection; 60-Day Comment Request NCI Genomic Data Commons (GDC) Data Submission Request Form (National Cancer Institute)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Submission for OMB Review: Evaluation of the Child Welfare Capacity Building Collaborative, Part Two (OMB Number: 0970-0494)
The Administration for Children and Families (ACF) is requesting a three-year extension of the previously approved forms that include satisfaction surveys; surveys to assess jurisdiction's foundational capacity; a workshop follow-up survey; webinar and online learning registration forms; and service-specific feedback forms and interview protocol (OMB Number: 0970-0494, expiration March 31, 2020). This request includes one new innovation survey, and requests minor changes to the webinar and online learning registration forms. Three instruments from the original approval are not included with this request. This requested extension relates to a second set of instruments, which are part of a larger data collection effort being conducted for the evaluation of the Child Welfare Capacity Building Collaborative. An extension request for the first group of evaluation instruments was submitted on April 24, 2019, (OMB Number: 0970-0484, FR, 84(79)).
Adaptive Designs for Clinical Trials of Drugs and Biologics; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Adaptive Designs for Clinical Trials of Drugs and Biologics.'' This guidance provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biological product. The guidance describes important principles for designing, conducting, and reporting the results from an adaptive clinical trial. This guidance finalizes the draft guidance entitled ``Adaptive Designs for Clinical Trials of Drugs and Biologics'' issued in October 2018. FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Information on Pediatric Uses of Medical Devices
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 associated with the requirement for submission of information on pediatric subpopulations that suffer from a disease or condition that a device is intended to treat, diagnose, or cure.
Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 21 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.