Department of Health and Human Services October 30, 2018 – Federal Register Recent Federal Regulation Documents
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Performance Review Board Membership
5 U.S.C. 4314(c)(1) through (5) requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more Senior Executive Service (SES) Performance Review Boards. The PRB shall review and evaluate the initial summary rating of a senior executive's performance, the executive's response, and the higher-level official's comments on the initial summary rating. In addition, the PRB will review and recommend executive performance bonuses and pay increases. 5 U.S.C. 4314(c)(4) requires the appointment of board members to be published in the Federal Register. The following persons comprise a standing roster to serve as members of the SES PRB for the Centers for Medicare & Medicaid Services:
Denial of Hearing Request Regarding Proposal To Refuse To Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Abuse-Deterrent Formulation, Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Order Refusing Approval
The Chief Scientist is denying a request for a hearing regarding the proposal by the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA or Agency) to refuse to approve a new drug application submitted by Pharmaceutical Manufacturing Research Services, Inc. (PMRS) for oxycodone hydrochloride (HCl) immediate-release (IR) capsules, 5 milligrams (mg), 15 mg, and 30 mg in its present form. The Chief Scientist denies approval.
Medicare Program; International Pricing Index Model for Medicare Part B Drugs
We are issuing this advance notice of proposed rulemaking (ANPRM) to solicit public comments on potential options we may consider for testing changes to payment for certain separately payable Part B drugs and biologicals (hereafter called ``drugs''). Specifically, CMS intends to test whether phasing down the Medicare payment amount for selected Part B drugs to more closely align with international prices; allowing private-sector vendors to negotiate prices for drugs, take title to drugs, and compete for physician and hospital business; and changing the 4.3 percent (post-sequester) drug add-on payment in the model to reflect 6 percent of historical drug costs translated into a set payment amount, would lead to higher quality of care for beneficiaries and reduced expenditures to the Medicare program.
Meeting of the National Advisory Council on Nurse Education and Practice
The National Advisory Council on Nurse Education and Practice (NACNEP or the Council) has scheduled a public meeting. Information about NACNEP and the agenda for this meeting can be found on the NACNEP website at https://www.hrsa.gov/advisory-committees/nursing/.
Zinpro Corp.; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA or we) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as an anticaking agent for the use with zinc-L-selenomethionine as a feed component.
Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA or we) is announcing that Adisseo France S.A.S. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as a carrier for selenomethionine hydroxy analogue at a level not to exceed 95 percent of the selenomethionine hydroxy analogue in its packaged form.
21st Century Cures: Announcing the Establishment of a Surrogate Endpoint Table; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to receive suggestions and comments from interested parties (including academic institutions, regulated industry, and patient groups) on the Agency's publication of the surrogate endpoint table (SE table). FDA has developed a web page, available at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ DevelopmentResources/ucm613636.htm that displays the SE table, describes the purpose of the table, and provides additional background information. Comments received on the SE table will help FDA determine its utility and may assist FDA in developing future iterations of the SE table and identifying best methods for conveying information about SEs on the FDA's website.
Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry.'' This guidance is intended to assist manufacturers, sponsors, and applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma products in the United States. The draft guidance document provides considerations for the successful development and licensing of dried plasma products and for the approval of devices used to manufacture dried plasma. The guidance includes recommendations on optimal sources of input plasma; manufacturing and product quality, including product characterization; packaging and reconstitution; clinical studies; and device submissions.
Sesame as an Allergen in Foods
The Food and Drug Administration (FDA or we) invites data and other information on the prevalence and severity of sesame allergies in the United States and the prevalence of sesame-containing foods sold in the United States that are not required to disclose sesame as an ingredient. We are taking this action to inform possible regulatory action on sesame to protect and promote the public health.
Government-Owned Inventions; Availability for Licensing
The invention listed below is jointly owned by an agency of the U.S. Government with Pontificia Universidad Catolica de Chile 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.
Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Continued CMS-Approval of Its Outpatient Physical Therapy and Speech Language Pathology Services Accreditation Program
This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for continued recognition as a national accrediting organization (AO) for clinics, rehabilitation agencies, or public health agencies that furnish outpatient physical therapy and speech language pathology services that wish to participate in the Medicare or Medicaid programs.
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