Department of Health and Human Services December 2016 – 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 revision of the information collection entitled ``Colorectal Cancer Control Program (CRCCP) Monitoring Activities.'' The change to the collection will include a redesigned survey and a redesigned clinic-level data collection template.

The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Biomonitoring of Great Lakes Populations Program III.'' The purpose of the proposed study is to evaluate body burden levels of priority contaminants in Great Lakes residents, particularly those who are at high exposure risk, in the Milwaukee Bay Estuary Area of Concern (AOC) area that was not previously addressed in ATSDR's previous biomonitoring programs around the Great Lakes.

The Food and Drug Administration (FDA or we) is extending the comment period for a docket to receive information and comments on the use of the term ``healthy'' in the labeling of human food products. We established the docket through a notice that appeared in the Federal Register of September 28, 2016. In the notice, we requested comments on the term ``healthy'', generally, and as a nutrient content claim in the context of food labeling; we also requested comments on specific questions contained in the notice. 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) is announcing the availability of the guidance entitled ``Medical Device Accessories Describing Accessories and Classification Pathways for New Accessory Types.'' This document provides guidance to industry and FDA staff about the regulation of accessories to medical devices. The guidance explains what devices FDA generally considers an ``accessory'' and encourages use of the de novo classification process under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to allow manufacturers and other parties to request risk- and regulatory control-based classification of accessories of a new type (i.e., accessories of a type that has not been previously classified under the FD&C Act, cleared for marketing under a 510(k) submission, or approved in an application for premarket approval (PMA)).

The Food and Drug Administration (FDA or we) is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The final rule appeared in the Federal Register of December 1, 2014, and on May 5, 2016, we stated in the Federal Register that the enforcement of the final rule would begin on May 5, 2017. We are taking this action to clarify and confirm that the compliance date for the final rule is May 5, 2017.

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).

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.

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.

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.

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.

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.

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.

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).

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.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Postmarket Management of Cybersecurity in Medical Devices.'' FDA is issuing this guidance to inform industry and FDA staff of the Agency's recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. The guidance clarifies FDA's postmarket recommendations with regards to addressing cybersecurity vulnerabilities and emphasizes that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of the postmarket management of their medical devices.