Department of Health and Human Services June 30, 2020 – Federal Register Recent Federal Regulation Documents
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Development of Anti-Infective Drug Products for the Pediatric Population; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Development of Anti-Infective Drug Products for the Pediatric Population.'' The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for pediatric patients. The guidance addresses initiation of pediatric clinical studies, enrollment strategies, extrapolation of efficacy, and other considerations to help facilitate pediatric anti-infective drug product development.
Submission for OMB Review; 30 Day Comment Request Application Process for Clinical Research Training and Medical Education at the Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness (Clinical Center)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157-Extension
In compliance with of 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 Letters of Interest (LOI) for NCI-MATCH Laboratories
The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence. Due to the coronavirus pandemic the NCI is providing an extension of the previously published notice in the Federal Register on March 11, 2020 to allow candidate more time to submit LOIs. NCI-ComboMATCH trial leadership invites applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from patients utilizing Next-Generation Sequencing (NGS) assays to participate in the NCI-ComboMATCH trial. In order to support this trial, the designated laboratories participating in NCI-ComboMATCH will identify patients for the specific variants needed for trial eligibility. Laboratories will be required to contact any of the NCTN sites that have activated NCI-ComboMATCH if a specimen sent from one of these sites has a variant(s) that would potentially make the patient eligible for one of the treatment arms.
Request for Letters of Interest (LOI) for Pediatric Focused NCI-MATCH Laboratories
The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence. Due to the coronavirus pandemic the NCI is providing an extension of the previously published notice in the Federal Register on March 11, 2020, to allow candidate more time to submit LOIs.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Home Infusion Therapy Services Requirements
This proposed rule would update the home health prospective payment system (HH PPS) payment rates and wage index for calendar year (CY) 2021. This proposed rule also proposes to make permanent the changes to the home health regulations regarding the use of technology in providing services under the Medicare home health benefit as described in the Medicare and Medicaid Programs; Revisions in Response to the COVID-19 Public Health Emergency interim final rule with comment period. This proposed rule also proposes to remove provisions related to test transmission of OASIS data by a new HHA, because the provision is now obsolete due to changes in our data submission system. This proposed rule discusses policies finalized in the CY 2020 HH PPS final rule with comment period regarding the permanent home infusion therapy services benefit for CY 2021, and proposes conforming regulations text changes excluding home infusion therapy services from coverage under the Medicare home health benefit. Additionally, this proposed rule discusses Medicare enrollment policies for qualified home infusion therapy suppliers.
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