Department of Health and Human Services February 2020 – Federal Register Recent Federal Regulation Documents

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2019, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Patient-Focused Drug Development for Vitiligo.'' The purpose of the public meeting is to allow FDA to obtain patient perspectives on the impact of vitiligo on daily life, patient views on treatment approaches, and decision factors considered when selecting a treatment.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA or we) is announcing that LANXESS Corporation has filed a petition proposing that the food additive regulations be amended to provide for the safe use of calcium formate as a feed acidifying agent, to lower the pH, in complete feeds for swine or poultry.

The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on November 26, 2019, seeking nominations of individuals to serve as non- federal public members on the Interagency Autism Coordinating Committee (IACC). The purpose of this Notice is to provide an extension to allow additional time for the acceptance of nominations to the IACC.

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 the Environmental Public Health Tracking Network, an information system which collects data from other CDC programs such as the National Center for Health Statistics, other federal agencies such as the Environmental Protection Agency, publicly accessible systems such as the Census Bureau, and funded and unfunded state and local health departments (SLHD).

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 Validated Follow-up Interview of Clinicians on Outpatient Antibiotic Stewardship Interventions. This collection aims to perform an interview of outpatient clinicians regarding the acceptability and perceived clinician-level barriers associated with our year-long implementation of interventions designed around the Core Elements of Outpatient Antibiotic Stewardship.

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 an opportunity for public 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 notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the creation of a new collection of information entitled ``Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed.''

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the 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 the Proposed New Survey, and solicits comments on the information collection requirements related to the Evaluation of participants of an Annual SMP/SHIP National Training Conference.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On February 4, 2020, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of this novel coronavirus (2019-nCoV) pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

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.