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

The Food and Drug Administration (FDA or we) is classifying the automated indirect immunofluorescence microscope and software- assisted system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the automated indirect immunofluorescence microscope and software-assisted system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish a 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 proposed semiannual performance measures for the ACL Traumatic Brain Injury State Partnership program as reauthorized under the Traumatic Brain Injury Reauthorization Act of 2014.

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 work and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Evaluation of the Cancer Survivorship Demonstration Project. This information collection aims to help CDC better understand strategies and best practices to identify and address current cancer survivorship needs and gaps.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Health Resources and Services Administration published a notice in the Federal Register, FR 2017-23562 (October 31, 2017), announcing the charter renewal of the National Advisory Committee on Rural Health and Human Services (NACRHHS).

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 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 ``Project NICE: Navigating Insurance Coverage Expansion''. Project NICE will evaluate the efficacy of an in-person health insurance enrollment assistance intervention among Black and Hispanic men who have sex with men (MSM) and Transgender persons living in the Chicago, Illinois metropolitan area.

The Food and Drug Administration (FDA, we, the Agency) is amending food additive regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of formic acid and ammonium formate. This action is in response to a food additive petition filed by BASF Corp for Feed Grade Sodium Formate (FAP 2286), which also proposed to amend the animal food additive regulations for formic acid and ammonium formate to limit formic acid and formate salts from all added sources.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended by expanding the permitted uses of synthetic iron oxide as a color additive to include use in dietary supplement tablets and capsules.

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) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee (the Committee). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues related to blood and products derived from blood. The meeting will be open to the public.

The National Toxicology Program (NTP) announces a meeting to peer review the Draft Report on Carcinogens (RoC) Monograph on Antimony Trioxide. The Office of the Report on Carcinogens, Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS) prepared the monograph. This peer-review meeting is by webcast only and is open to the public. Registration is requested for oral comment and is required to access the webcast. Information about the meeting and registration is available at https:// ntp.niehs.nih.gov/go/38853.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific 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.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. The purpose of this notice is to allow 60 days for public comment. The Fogarty International Center (FIC), National Institute of Environmental Health Sciences (NIEHS), including the Superfund Research Program (SRP) within NIEHS, National Institute of General Medical Science (NIGMS), and National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Menu Labeling: Supplemental Guidance for Industry.'' The draft guidance, when finalized, will address concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments. It includes expanded and new interpretations of policy, and identifies places where FDA intends to be more flexible in its approach. This draft guidance also includes many graphical depictions in order to convey our thinking on various topics and to provide examples of options for implementation. It addresses calorie disclosure signage for self-service foods, including buffets and grab-and-go foods; reasonable basis, and the criteria for considering the natural variation of foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer.

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 ``Healthy Homes and Lead Poisoning Surveillance System (HHLPSS)''. The overarching goal of the Healthy Homes and Lead Poisoning Surveillance System (HHLPSS) is to support healthy homes surveillance activities at the state and national levels.

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 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 assessment of cancer prevention services at selected community mental health centers. CDC seeks to request an Office of Management and Budget (OMB) clearance for a three-year data collection project.