Department of Health and Human Services January 2017 – Federal Register Recent Federal Regulation Documents

This final rule revises the procedures that the Department of Health and Human Services (HHS) follows at the Administrative Law Judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage (MA) and other Medicare competitive health plans, and enrollees in Medicare prescription drug plans, as well as appeals of Medicare beneficiary enrollment and entitlement determinations, and certain Medicare premium appeals. In addition, this final rule revises procedures that the Department of Health and Human Services follows at the Centers for Medicare & Medicaid Services (CMS) and the Medicare Appeals Council (Council) levels of appeal for certain matters affecting the ALJ level.

The National Institutes of Health (NIH) considered a proposal to conduct research involving the deliberate transfer of a chloramphenicol resistance trait to Rickettsia typhi, conorii, rickettsii, and felis. The acquisition of this antibiotic resistance trait could possibly compromise the use of a class of antibiotics for the treatment of Rickettsia infections in humans. Under the NIH Guidelines (https://www.osp.od.nih.gov/sites/default/files/ NIH_Guidelines.html), these experiments can proceed only after they are reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approved by the NIH Director as Major Actions. This proposal was discussed at the December 4, 2015, RAC meeting. The proposal was published in the Federal Register on December 29, 2015, (80 FR 81346) with a request for public comment; one comment was received. This notice announces the final NIH action regarding this proposal.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability of a draft guidance entitled ``Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition'' that appeared in the Federal Register of November 23, 2016. The draft guidance, when finalized, will describe our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects of isolated or synthetic non-digestible carbohydrates that are added to foods that are beneficial to human health. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' This revised draft guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy. This revised draft guidance for industry replaces the draft guidance for industry of the same title issued in February 2015.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Multiple Endpoints in Clinical Trials.'' This draft guidance provides sponsors and review staff with the Agency's thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. Most clinical trials performed in drug development contain multiple endpoints to assess the effects of the drug and to document the ability of the drug to favorably affect one or more disease characteristics. The purpose of this guidance is to describe various strategies for grouping and ordering endpoints for analysis and applying some well- recognized statistical methods for managing multiplicity within a study to control the chance of making erroneous conclusions about a drug's effects.

Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) and the National Treasury Employees Union (NTEU) have renewed the ACF Labor Management Committee Charter.

The Food and Drug Administration (FDA or Agency) 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 use of rapid response surveys to obtain data on safety information to support quick turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals, and other user facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers, when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``How to Prepare a Pre-Request for Designation (Pre-RFD).'' The purpose of this guidance is to explain the Pre-RFD process at the FDA Office of Combination Products (OCP), describe and help a sponsor understand the type of information that the sponsor should include in a Pre-RFD, and assist sponsors in obtaining a preliminary assessment from FDA through the Pre-RFD process. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, this informal process provides information about a non-combination or combination product's assignment to the appropriate Agency Center (Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), or Center for Biologics Evaluation and Research (CBER)) for premarket review and regulation. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions.'' The purpose of this guidance is to provide greater clarity for FDA staff and Investigational Device Exemptions (IDE) application sponsors and sponsor-investigators regarding the principal factors that the Agency considers when assessing the benefits and risks of IDE applications for human clinical study. The guidance also characterizes benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others.

This final rule revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our overall effort to achieve broad- based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers.

The Agency for Healthcare Research and Quality (AHRQ) is seeking information from healthcare delivery organizations about current challenges they are facing and solutions they are implementing as they seek to become learning healthcare systems. AHRQ is also seeking to identify opportunities such organizations see for the Agency to assist them in this workfor example by summarizing best practices, creating training materials, developing standardized metrics, and/or convening learning networks.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry and FDA staff entitled ``Current Good Manufacturing Practice Requirements for Combination Products.'' The guidance describes and explains the document on current good manufacturing practice (CGMP) requirements for combination products, which published in the Federal Register of January 22, 2013, and includes general considerations for CGMP compliance as well as analysis of hypothetical scenarios.