Department of Health and Human Services November 2019 – Federal Register Recent Federal Regulation Documents

The Administration for Children and Families (ACF) is requesting to renew approval of the ACF-196 Temporary Assistance for Needy Families (TANF) Financial Reporting Form. The ACF-196 is the form used by states to estimate funding needs and request grant awards under the TANF program. In addition, the form is used to report data in substantiation of state claims and to certify the availability of the legislatively mandated state match. ACF will use the financial data provided by states to estimate quarterly funding needs, calculate award amounts, and assess compliance with statutory and regulatory requirements relating to administrative costs and state matching requirements. No changes are proposed to the form.

This final notice announces our decision to approve the Accreditation Commission for Health Care (ACHC) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. A hospice that participates in Medicaid must also meet the Medicare conditions for participation.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) proposes to amend two provisions within its foreign quarantine regulations to provide additional clarity and safeguards to address the risk to public health from the importation of human remains into the United States.

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) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with certain Freedom of Information Act and Privacy Act requests.

This gives notice under (specific statutes and regulations citations and) the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR); (formerly known as the Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2021.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2021.

The Food and Drug Administration (FDA, the Agency, 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 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, including each proposed extension/revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the FDA and Sponsors or Applicants.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

This document corrects the information provided for [Document Identifier: CMS-10718] titled ``Model Medicare Advantage and Medicare Prescription Drug Plan Individual Enrollment Request Form.''

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 (PRA).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Transdermal and Topical Delivery SystemsProduct Development and Quality Considerations.'' This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS) regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Specifically, the guidance discusses FDA's current thinking on product design and pharmaceutical development, manufacturing process and control, and finished product control. It also addresses special considerations for areas where quality is closely tied to product performance and potential safety issues, such as adhesion failure and the impact of applied heat on drug delivery.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``2019 Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program.'' The purpose of the public meeting is to help ensure that as standard core sets of clinical outcome assessments (COAs) are developed as part of the FDA pilot grant program, the identified concepts, COAs, and endpoints reflect what is most important to patients and relevant to regulatory and potentially other stakeholder decision making. To facilitate this, stakeholders including patients, care partners, FDA reviewers, drug developers, other government and academic researchers, health care providers, health technology assessors and health payers are encouraged to attend the meeting.

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GFI) #256 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' The draft guidance, if finalized, will describe FDA's current thinking about compounding animal drugs from bulk drug substances. FDA has generally exercised enforcement discretion with regard to animal drug compounding from bulk drug substances under certain circumstances when no other medically appropriate treatment options exist. This draft guidance, a continuation of this practice, is intended to provide additional information and clarity to veterinarians and pharmacists about FDA's current thinking with respect to animal drug compounding from bulk drug substances. FDA previously published draft guidance on this issue for public comment in May 2015 (Draft GFI #230, ``Compounding Animal Drugs from Bulk Drug Substances''). We received over 150 comments on that draft guidance. Based on those comments, we decided to withdraw the May 2015 draft guidance and publish this draft guidance for public comment.

In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the National Institute of Neurological Disorders and Stroke (NINDS), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.