Department of Health and Human Services August 5, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Therapies To Treat IGF-1 Deficiency and Achondroplasia
The National Cancer Institute and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to PreciThera, Inc, located in Montreal, Canada.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products
The Food and Drug Administration (FDA) is 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.
Pilot Program for Request for Designation and Pre-Request for Designation Electronic Submissions
The Office of Combination Products (OCP) in the Food and Drug Administration (FDA) is soliciting applications from members of the public interested in participating in a voluntary pilot program to help OCP evaluate a potential new electronic submissions process for Requests for Designation (RFD) and Pre-RFD. This RFD and Pre-RFD electronic submission process is intended to improve efficiency and completeness of RFD and Pre-RFD submissions. OCP plans to accept up to nine participants for the pilot program. The pilot program is intended to provide OCP input to inform this evaluation.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Programmatic Information Collection for the AHRQ Initiative to Support Primary Care to Advance Cardiovascular Health in States with High Prevalence of Preventable CVD Events.''
Revised Procedures and Standards: Home Visiting Evidence of Effectiveness (HomVEE) Review
The Administration for Children and Families (ACF), within the U.S. Department of Health and Human Services (HHS), oversees the Home Visiting Evidence of Effectiveness (HomVEE) review, which is proposing to revise the procedures and standards that guide its work. The revised procedures and standards will be presented in two separate Federal Register notices. The current Federal Register notice seeks comments on proposed changes and clarifications to several procedural topics and on the standards for assessing the quality of impact study designs. Readers are referred to the full version of the HomVEE Draft Version 2 Handbook on the HomVEE website (https://homvee.acf.hhs.gov) for more details. Another Federal Register notice summarizes updated definitions, rules, and procedures related to handling home visiting model versions (commonly referred to in the home visiting research literature as adaptations) in the review.
Updated Defintions, Rules, and Procedures Related to Model Versions: Home Visiting Evidence of Effectiveness (HomVEE) Review
The Administration for Children and Families (ACF), within the U.S. Department of Health and Human Services (HHS), oversees the Home Visiting Evidence of Effectiveness (HomVEE) review, which is proposing to revise the procedures and standards that guide its work. The revised procedures and standards will be presented in two separate Federal Register notices. The current Federal Register notice seeks comments on proposed updated definitions, rules, and procedures related to handling home visiting model versions (commonly referred to in the home visiting research literature as adaptations) in the HomVEE review. Another Federal Register notice summarizes proposed changes and clarifications to HomVEE's procedures and standards for rating the quality of impact studies and determining which home visiting models meet HHS criteria for evidence of effectiveness. Readers are referred to the full text of the HomVEE Draft Version 2 Handbook on the HomVEE website (https:// homvee.acf.hhs.gov/) for more details on all proposed changes.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Value-Based Purchasing Program for Federal Fiscal Year 2021
This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2021. We are also making changes to the case-mix classification code mappings used under the SNF PPS and making two minor revisions in the regulation text. Additionally, we are adopting the recent revisions in Office of Management and Budget (OMB) statistical area delineations. This rule also updates the Skilled Nursing Facility Value-Based Purchasing (VBP) Program that affects Medicare payment to SNFs.
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