Department of Health and Human Services 2015 – Federal Register Recent Federal Regulation Documents

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 the information collection request entitled Airline and Maritime Conveyance Manifest Orders.

The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active ingredients) that can be used to compound drug products in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs (503A bulks list). The Agency previously solicited nominations for the list, but some of the nominated substances were not supported by sufficient information for FDA to evaluate them. FDA is establishing a public docket where these substances can be renominated with sufficient supporting information or to receive nominations of bulk drug substances that were not previously nominated for consideration for inclusion on the 503A bulks list. Interested parties can also submit comments on nominated substances via this docket.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance describes FDA's interim regulatory policy regarding the use of bulk drug substances by licensed pharmacists in State-licensed pharmacies or Federal facilities and by licensed physicians to compound human drug products while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act). When final, the guidance will reflect the Agency's current thinking on the issues addressed by the guidance.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with electronic submission of medical device registration and listing.

The Food and Drug Administration (FDA) has classified an autosomal recessive carrier screening gene mutation detection system into class II (special controls). The special controls that apply to this device are identified in this order and will be part of the codified language for the autosomal recessive carrier screening gene mutation detection system classification. The Agency has classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Department of Health and Human Services (HHS or the Department) is revising its regulations governing administrative appeals to reflect a change of address for the Interior Board of Indian Appeals (IBIA). The IBIA moved to a new address at 801 North Quincy St., Suite 300, Arlington, VA 22203 effective February 11, 2002.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device Recall Authority'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twenty third meeting on November 17, 2015. At this meeting, the Commission will continue to discuss the role of deliberation and deliberative methods to engage the public and inform consideration in bioethics, and how to integrate pubic dialogue into the bioethics conversation; bioethics education as a forum for fostering deliberative skills, and preparing students to participate in public dialogue in bioethics; goals and methods of bioethics education; and integrating bioethics education across a range of professional disciplines and educational levels.

This document provides the methodology and data sources necessary to determine federal payment amounts made in program years 2017 and 2018 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low- income individuals otherwise eligible to purchase coverage through Affordable Insurance Marketplaces.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.'' This guidance has been developed to provide industry with FDA's recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient- use containers. This guidance provides FDA's revised definitions for single-dose and multiple-dose containers, and introduces the definition of a new package type term, ``single-patient-use'' container. Marketing applications for such products include: New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), Premarket Approval Applications (PMAs), and Premarket Notifications under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).