Department of Health and Human Services June 2018 – Federal Register Recent Federal Regulation Documents

The U.S. Department of Health and Human Services (HHS) is hereby giving notice that the charter for the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) has been renewed.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, FDA staff, and other stakeholders entitled ``Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.'' This guidance (Guidance 1) is the first of a series of four methodological guidance documents that FDA committed to develop to address in a stepwise manner how to collect and submit information from patients and caregivers for medical product development and regulatory decision making.

As required by the 21st Century Cures Act (Cures Act), the Food and Drug Administration (FDA or Agency) is proposing a list of alternative or streamlined mechanisms for complying with the current good manufacturing practice (CGMP) requirements for combination products. Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar EntitiesQuestions and Answers.'' This guidance provides answers to common questions regarding the communication of health care economic information (d) about approved prescription drugs and approved or cleared medical devices by medical product manufacturers, packers, distributers, and their representatives (firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (collectively referred to as payors). This guidance also provides answers to common questions about both firms' dissemination of information to payors about medical products that are not yet approved or cleared for any use and firms' dissemination of information to payors about unapproved uses of approved or cleared medical products. The Agency is issuing this guidance to explain FDA's current thinking on frequently asked questions regarding these topics in order to provide clarity for firms and payors. FDA is also 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.

The Food and Drug Administration (FDA or we) 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #3 entitled ``General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals.'' This guidance describes the type of information that the FDA's Center for Veterinary Medicine (CVM) recommends sponsors provide to address the human food safety of new animal drugs used in food-producing animals. The human food safety evaluation of new animal drugs used in food-producing animals helps ensure that food derived from treated animals is safe for human consumption. CVM developed this guidance to inform sponsors of the scientific data and/or information that may provide an acceptable basis to determine that the residue of a new animal drug in or on food, when consumed, presents a reasonable certainty of no harm to humans.

In accordance with the Federal Advisory Committee Act, this notice announces a public meeting of the Council on Graduate Medical Education (COGME). This notice is being published less than 15 days prior to the meeting date due to unforeseen administrative delays.

The National Institutes of Health (NIH) is informing the research community and other interested parties that it received from the NIH Council of Councils the report of its Working Group on Assessing the Safety of Relocating At-Risk Chimpanzees, and the agency will consider recommendations contained in the report (see https:// dpcpsi.nih.gov/sites/ default/files/CoC_May_2018_WG_Report_508.pdf). The NIH invites public comment in response to this Request for Information (RFI).

The Food and Drug Administration (FDA) is announcing the renewal of the Peripheral and Central Nervous System Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Peripheral and Central Nervous System Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 4, 2020.

The Food and Drug Administration (FDA or Agency) has determined that MUTAMYCIN (mitomycin) injectable, 5 milligrams (mg)/ vial and 20 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, if all other legal and regulatory requirements are met.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.

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.

This final rule finalizes a policy that provides flexibility in the determination of episode spending for Comprehensive Care for Joint Replacement Payment Model (CJR) participant hospitals located in areas impacted by extreme and uncontrollable circumstances for performance years 3 through 5.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Undetermined cause of Serratia marcescens infectionsMultiple States, 2018. The goal of this investigation is to identify potential risk factors leading to an outbreak of Serratia marcescens infections among U.S. healthcare patients. Data will be used to identify a cause of the infections and prevent additional events from occurring.