Department of Health and Human Services May 13, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Determination of Regulatory Review Period for Purposes of Patent Extension; GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for the GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; AUSTEDO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AUSTEDO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.'' The purpose of the public meeting is to meet performance commitments included in the Prescription Drug User Fee Act (PDUFA) VI, Biosimilar User Fee Act (BsUFA) II, and Generic Drug User Fee Amendments (GDUFA) II. The public meeting will include presentations from FDA on the 5- year plans for the PDUFA VI, BsUFA II, and GDUFA II; the Agency's progress in implementing resource capacity planning and modernized time reporting; and the results of the fiscal year (FY) 2018 evaluation of PDUFA, BsUFA, and GDUFA resource management. The Agency will also address the impact of the modernized fee structure changes on the PDUFA and BsUFA programs and report on the contribution of the BsUFA spending trigger to the BsUFA program.
Patient Safety Organizations: Voluntary Relinquishment From the AABB Center for Patient Safety
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the AABB Center for Patient Safety, PSO number P0032, of its status as a PSO, and has delisted the PSO accordingly.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Proposed Information Collection Activity; Procedural Justice-Informed Alternatives to Contempt Demonstration Project Data Collection (OMB #0970-0505)
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data as part of the rigorous evaluation of the Procedural Justice-Informed Alternatives to Contempt (PJAC) demonstration.
Testing Services and Scores for Foreign Health Care Workers To Demonstrate English Language Proficiency
HRSA announces a request for comments and notice of a public meeting to receive feedback on proposed updates to the list of testing services and scores for foreign health care workers to demonstrate English language proficiency pursuant to section 343 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA).
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
