Department of Health and Human Services December 29, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 37 of 37
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements; Corrections
This document corrects technical and typographical errors that appeared in the final rule published in the November 15, 2016 Federal Register (81 FR 80170). That rule is entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements.''
Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products.'' The purpose of the public workshop is to have a scientific discussion of the current methods available for identifying and characterizing infectious disease risks associated with human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Botanical Drug Development; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Botanical Drug Development.'' This guidance describes FDA's current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations for submitting investigational new drug applications (INDs) to support future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. This guidance replaces the guidance for industry entitled ``Botanical Drug Products'' issued in June 2004 and finalizes the August 2015 draft guidance entitled ``Botanical Drug Development.''
Providing Regulatory Submissions in Electronic Format-Submission of Manufacturing Establishment Information; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatSubmission of Manufacturing Establishment Information.'' This guidance discusses the requirements for a valid electronic submission of manufacturing establishment information (MEI) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action will streamline the review of all manufacturing establishments involved in the preparation of a drug or biological product by consolidating information in one location and eliminating the inclusion of erroneous and/or outdated information from other Agency files.
Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug Applications and Two Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of four new drug applications (NDAs) and two abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Test Predictability of Falls Screening Tools.'' CDC will use the information collected to evaluate current screening tools and potentially design a new screening tool for health care practitioners to identify community-dwelling adults 65 and older at risk for falls.
Listing of Ingredients in Tobacco Products; Revised Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ``Listing of Ingredients in Tobacco Products.'' The revised guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). We received several comments to the draft guidance, and those comments were considered as the guidance was finalized.
Submission of Warning Plans for Cigars; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Submission of Warning Plans for Cigars.'' The guidance will help those involved in the manufacture, distribution, and sale of cigars in the United States understand the new cigar warning plan requirements under FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance reiterates the health warning statements and display and distribution requirements that should be provided in cigar warning plans and will help persons determine who should submit a warning plan, when a plan must be submitted, and what information should be included when submitting a plan.
Proposed Collection; 60-Day Comment Request; Continuation of Use of the Early Career Reviewer Program Online Application and Vetting System-Center for Scientific Review (CSR)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, Center for Scientific Review, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public; public comment sessions will be held during the meeting.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Alzheimer's and Dementia Program Data Reporting Tool (ADP-DRT) (Previously Entitled: Alzheimer's Disease Supportive Services Program Data Reporting Tool (ADSSP-DRT) and Alzheimer's disease Initiative- Specialized Supportive Services (ADI- SSS) project))
In compliance with 44 U.S.C. 3507, the Administration on Aging (AoA), Administration for Community Living (ACL), is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This notice collects comments on the information collection requirements relating to the continuation of an existing data collection for the Alzheimer's and Dementia Program Data Reporting Tool (ADP-PDR) and expansion of this collection to incorporate ACL grantees of the Alzheimer's Disease Initiative Specialized Supportive Services (ADI-SSS) project.
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities.'' This guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by State-licensed nuclear pharmacies and Federal facilities that are not registered as outsourcing facilities. Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) related to the production of drugs, FDA is issuing this guidance to describe the conditions under which it does not intend to take action for violations of certain provisions of the FD&C Act when a State-licensed nuclear pharmacy or Federal facility compounds or repackages radiopharmaceuticals.
Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.'' Specifically, this guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by entities that are registered with FDA as outsourcing facilities. This guidance describes how FDA intends to apply section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to radiopharmaceuticals compounded by outsourcing facilities, and it describes the conditions under which FDA does not intend to take action for violations of certain provisions of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals.
Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.'' This guidance is to assist the pharmaceutical industry and other investigators engaged in biosimilar product development in determining the clinical pharmacology data necessary for evaluation of a proposed biosimilar product. This guidance finalizes the draft guidance with the same name issued in May 2014. This guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Meeting of the Community Preventive Services Task Force (Task Force)
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars, and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research and practice-based evidence and issues recommendations. Task Force recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and stakeholders can consider when they are determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the evidence on which they are based, are compiled in the Guide to Community Preventive Services (The Community Guide).
Interagency Coordinating Committee on the Validation of Alternative Methods Communities of Practice Webinar on Incorporating Chemical Information: Resources, Limitations, and Characterizing the Domain of Applicability for 21st Century Toxicity Testing; Notice of Public Webinar; Registration Information
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces a public webinar ``Incorporating Chemical Information: Resources, Limitations, and Characterizing the Domain of Applicability for 21st Century Toxicity Testing.'' The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), National Institute of Environmental Health Sciences, and hosted by the U.S. Environmental Protection Agency's National Center for Computational Toxicology. Interested persons may participate via Adobe Connect. Time will be allotted for questions from the audience.
Using Informatics To Improve Data Analysis of Chemical Screening Assays Conducted in Zebrafish; Notice of Webinars; Registration Information
The National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences announces the webinar series, ``Using Informatics to Improve Data Analysis of Chemical Screening Assays Conducted in Zebrafish.'' The webinars will provide an overview of current issues that need to be addressed to facilitate the broader use of zebrafish for chemical safety screening studies and how data science can be applied to address some of those issues.
Prospective Grant of Exclusive Patent License: Development and Commercialization of Nitrite Salts for the Treatment, Amelioration, and Prevention by Any Route of Administration of Pulmonary Hypertension, Including All WHO Classifications of Pulmonary Hypertension, e.g., Groups 1-5
The National Heart, Lung, and Blood Institute (``NHLBI''), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an exclusive patent license to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to United Therapeutics Corporation (``United'') located in Silver Spring, MD and incorporated under the laws of Delaware.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery 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.
Refuse To Accept Procedures for Premarket Tobacco Product Submissions
The Food and Drug Administration (FDA) is issuing a final rule describing when FDA will refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the rule, FDA will refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the proposed rule, FDA will be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions.
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