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

Under an Executive Order that directs federal agencies to address the economic emergency created by the COVID-19 pandemic by rescinding, modifying, waiving, or providing exemptions from regulations and other requirements that may inhibit economic recovery, consistent with applicable law and with protection of the public health and safety, with national and homeland security, and with budgetary priorities and operational feasibility. The Order directs agencies to ``identify regulatory standards that may inhibit economic recovery'' and to take appropriate action such as rescission or suspension of regulations, including by use of good cause or emergency authorities where appropriate. Agencies have likewise been called on to assess the various temporary deregulatory actions they have taken to fight COVID- 19 and its impact on our economy to determine which temporary regulatory actions should be made permanent. The Order directs agencies to assist businesses and other entities in complying with the law through prompt issuance of pre-enforcement rulings and to formulate policies of enforcement discretion that recognize such entities' efforts to comply with the law.

The CDC published a document in the Federal Register of September 30, 2020, concerning a closed meeting of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)DD21-001, Study to Explore Early Development (SEED) Follow up Studies. The document contained incorrect dates.

The Department of Health and Human Services (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH) announces the draft Vaccines National Strategic Plan 2021-2025 (Vaccine Plan) available for public comment. The draft Vaccine Plan may be reviewed at www.hhs.gov/oidp.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is requesting a 3-year extension of the Voluntary Acknowledgment of Paternity and Required Data Elements for Paternity Establishment Affidavits (OMB #0970-0171). There are no changes requested to the form, but burden estimates have been adjusted.

The Food and Drug Administration (FDA, Agency, or we) 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 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 information collection pertaining to FDA consultation procedures for foods derived from new plant varieties, including information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Clinical Drug Interaction Studies With Combined Oral Contraceptives.'' This guidance assists sponsors of investigational new drug applications and new drug applications in evaluating the need for and design drug-drug interaction (DDI) studies involving combined oral contraceptives (COCs) during drug development as well as determining how to communicate the results and recommendations from the DDI studies. Specifically, this guidance focuses on the conduct of clinical studies to evaluate the DDI potential of an investigational drug on a COC, including the need for and design of the clinical studies and the interpretation of the study results.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #255 entitled ``Elemental Impurities in Animal Drug ProductsQuestions and Answers.'' This guidance provides recommendations to sponsors regarding the control of elemental impurities in animal drug products, including all dosage forms and routes of administration.

This notice announces a $599.00 calendar year (CY) 2021 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2021 and on or before December 31, 2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Cross Labeling Oncology Drugs in Combination Drug Regimens.'' This guidance describes FDA's current recommendations on including relevant information in labeling for oncology drugs approved for use in combination drug regimens.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Social Services Block Grant (SSBG) Post-Expenditure Report (OMB #0970-0234, expiration 1/31/2021). Although ACF initially proposed changes (see 85 FR 57863), after reconsideration during the initial comment period, this request is for an extension with no changes.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.'' The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance document provides new Q&As. It does not replace the draft guidance document entitled ``New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),'' issued December 12, 2018.

The Food and Drug Administration (FDA) is announcing the issuance and reissuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued, and in some cases reissued, the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad, and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance and reissuance, are listed in this document, and are available on FDA's website at the links indicated.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Richard M. Simon from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Richard M. Simon was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Simon was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of August 6, 2020 (30 days after receipt of the notice), Mr. Simon had not responded. Mr. Simon's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.

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.