Department of Health and Human Services December 14, 2017 – Federal Register Recent Federal Regulation Documents

Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
Document Number: R1-2017-23932
Type: Rule
Date: 2017-12-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.
Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments
Document Number: 2017-26978
Type: Notice
Date: 2017-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.'' The purpose of the public workshop is to convene a discussion on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act). FDA plans to publish a background document approximately 2 weeks before the workshop date.
Submission for OMB Review; 30-Day Comment Request; Special Volunteer and Guest Researcher Assignment (Office of Intramural Research, Office of the Director)
Document Number: 2017-26966
Type: Notice
Date: 2017-12-14
Agency: Department of Health and Human Services, National Institutes of Health
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.
Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction
Document Number: 2017-26938
Type: Notice
Date: 2017-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop'' that appeared in the Federal Register of November 27, 2017. The document announced a public workshop to engage external stakeholders in discussions related to finalizing the draft guidance entitled ``Safety Assessment for IND Safety Reporting.'' The date of the meeting has changed.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-26937
Type: Notice
Date: 2017-12-14
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
Document Number: 2017-26933
Type: Notice
Date: 2017-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
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 the information collection in the regulations on the Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
Document Number: 2017-26932
Type: Notice
Date: 2017-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
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 the information collection for the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals.