Department of Health and Human Services June 2021 – Federal Register Recent Federal Regulation Documents

On December 14, 2020, the Department of Health and Human Services published in the Federal Register a final rule (``Rule'') establishing the 340B Drug Pricing Program (340B Program) Administrative Dispute Resolution (ADR) Board (hereafter, ``the Board''). See 85 FR 80632 (Dec. 14, 2020). According to the Rule, the purpose of the 340B Program's ADR process is to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit as authorized by section 340B(a)(5)(C) of the Public Health Service Act, that a covered entity has violated the prohibitions on diversion or duplicate discounts. The Rule states that Board members from the Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA) must have relevant expertise and experience in drug pricing or drug distribution. The Rule also states that Board members from the Office of the General Counsel (OGC) must have expertise and experience in handling complex litigation. From the 340B ADR Board, the HRSA Administrator will select three voting members, one from each of the three HHS operating/staff divisions involved (i.e., CMS, HRSA, OGC) to form 340B ADR Panels that will review claims and, pursuant to delegated authority from the Secretary, make certain final agency decisions. All previous appointments to the Board are revoked. Based on recommendations from OGC, CMS, and HRSA, I hereby appoint the following Board members, who shall serve a term of two years, to be extended for additional terms upon agreement by the member and the head of his or her operating/staff division. Sean R. Keveney, Deputy General Counsel, the Office of the General Counsel, Department of Health and Human Services; Andy J. Miller, National Complex Litigation and Investigations Division Attorney, the Office of the General Counsel, Department of Health and Human Services; Glenn Clark, Public Health Advisor, HIV/AIDS Bureau, Health Resources and Services Administration, Department of Health and Human Services; CAPT Christina Meade, Area Regional Pharmacy Consultant, Office of Regional Operations, Health Resources and Services Administration, Department of Health and Human Services; CDR Timothy Lape, Division of Medicare Health Plans Operations, Medicare Branch, Centers for Medicare & Medicaid Services, Department of Health and Human Services; Adele Pietrantoni, Office of Program Operations and Local Engagement, Division of Drug and Health Plan Operations, Centers for Medicare & Medicaid Services, Department of Health and Human Services; Chantelle Britton, Senior Advisor, Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services, as ex-officio, non-voting member; and Julie Zadecky, Pharmacist, Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services, as ex-officio, non-voting member.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZOLGENSMA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance document entitled ``Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products.'' The guidance is intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). The guidance describes general and administrative information on evaluating and reporting changes and recommendations for reporting categories based on a tiered-reporting system for specific changes. The guidance announced in this notice finalizes the draft guidance, ``Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products,'' dated December 2017 and supersedes the document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products,'' dated July 1997 (July 1997 guidance).

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Remanufacturing of Medical Devices.'' This draft guidance is intended to help clarify whether activities performed on devices are likely ``remanufacturing.'' This draft guidance also includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. This draft guidance is not final nor is it in effect at this time.

This document corrects technical errors that appeared in the final rule published in the May 3, 2021, Federal Register, titled ``Medicare Program: Comprehensive Care for Joint Replacement Model Three Year Extension and Changes to Episode Definition and Pricing; Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency.''

NIOSH requests information on the Needs and Challenges in Personal Protective Equipment (PPE) Use for Underserved User Populations.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Syncopation Life Sciences Inc., (``Syncopation''), located in Palo Alto, California.

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.

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 the Agency) has determined the regulatory review period for TURALIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for a drug for use during the COVID-19 pandemic. FDA issued the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by B. Braun Melsungen AG. The Authorization contains, among other things, conditions on the emergency use of the authorized drug. The Authorization follows the February 4, 2020, determination by the Secretary of HHS 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. The virus is now named SARS- CoV-2, which causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. FDA is also announcing the revocation of the Authorization issued to Eli Lilly and Company for bamlanivimab alone. FDA revoked this authorization on April 16, 2021. Reprinted in this document is the issuance of the Authorization and the revocation, which include an explanation of the reasons for issuance or revocation.