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

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Appointment of Administrative Dispute Resolution Board Members
Document Number: 2021-13461
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, Office of the Secretary
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-13437
Type: Notice
Date: 2021-06-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 ``School-Associated Violent Deaths Surveillance System (SAVD).''
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-13436
Type: Notice
Date: 2021-06-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-13435
Type: Notice
Date: 2021-06-24
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-13434
Type: Notice
Date: 2021-06-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Eligibility for the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Request for Comments
Document Number: 2021-13417
Type: Notice
Date: 2021-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or the Agency) is soliciting comments on our current policy on eligibility for indexing. Indexing is the process of adding an unapproved drug for a minor species to our index of legally marketed unapproved new animal drugs for minor species (the Index). Except for in some early non-food life stages, members of a food-producing minor species are not eligible for indexing, even if a subset of animals within a food-producing minor species is not intended to be consumed by humans or food-producing animals. Specifically, we are requesting comment on this policy.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZOLGENSMA
Document Number: 2021-13411
Type: Notice
Date: 2021-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
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.
COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention; Guidance for Industry; Availability
Document Number: 2021-13394
Type: Notice
Date: 2021-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.'' FDA is issuing this guidance to assist sponsors developing master protocols for trials evaluating drugs and biological products for the treatment or prevention of COVID-19. This guidance primarily focuses on the trial design and conduct as well as statistical considerations for master protocols intended to generate substantial evidence of effectiveness and adequate characterization of safety for COVID-19. Additionally, this guidance provides administrative and procedural recommendations to sponsors of master protocols for COVID-19. Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry; Availability
Document Number: 2021-13392
Type: Notice
Date: 2021-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
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).
Premenopausal Women With Breast Cancer: Developing Drugs for Treatment; Guidance for Industry; Availability
Document Number: 2021-13388
Type: Notice
Date: 2021-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Premenopausal Women with Breast Cancer: Developing Drugs for Treatment.'' This guidance provides recommendations regarding the inclusion of premenopausal women in breast cancer clinical trials. The guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials for breast cancer drugs. This guidance finalizes the draft guidance of the same title issued on October 8, 2020.
National Institute of General Medical Sciences; Amended Notice of Meeting
Document Number: 2021-13377
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs; Public Workshop; Request for Comments
Document Number: 2021-13371
Type: Notice
Date: 2021-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs.'' The purpose of the public workshop is to discuss the challenges and clinical trial design considerations for developing therapeutic products for the treatment of progressive multifocal leukoencephalopathy (PML).
National Library of Medicine; Notice of Closed Meeting
Document Number: 2021-13368
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2021-13362
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP, the full meeting agenda, and instructions for linking to public access will be posted on the SACHRP website at https://www.hhs.gov/ohrp/sachrp- committee/meetings/index.html.
Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2021-13360
Type: Notice
Date: 2021-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
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.
National Library of Medicine; Notice of Closed Meetings
Document Number: 2021-13356
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2021-13354
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2021-13353
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2021-13348
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2021-13347
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-13342
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-13340
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2021-13339
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2021-13338
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-13336
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Office of The Director, National Institutes of Health; Notice of Closed Meeting
Document Number: 2021-13335
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-13333
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-13330
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
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; Correction
Document Number: 2021-13324
Type: Rule
Date: 2021-06-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.''
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2021-13312
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2021-13289
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-13279
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-13276
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2021-13275
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Needs and Challenges in Personal Protective Equipment (PPE) Use for Underserved User Populations
Document Number: 2021-13263
Type: Notice
Date: 2021-06-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH requests information on the Needs and Challenges in Personal Protective Equipment (PPE) Use for Underserved User Populations.
Prospective Grant of an Exclusive Patent License: Delivery of a Corrective Glucose-6-Phosphatase-Alpha Gene to Treat Glycogen Storage Disease Type 1a (GSD-Ia) in Humans
Document Number: 2021-13261
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Child Health and Human Development, 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 U.S. and foreign Patents and Patent Applications listed in the Supplementary Information section of this notice to Panacea Opportunity, Ltd.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Monospecific CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies
Document Number: 2021-13260
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
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.
Notice To Announce Request for Information (RFI) Inviting Input on NIAAA's 2022-2026 Strategic Plan Outline
Document Number: 2021-13239
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is currently developing an updated strategic plan to highlight priorities and guide activities for advancing the Institute's mission over the next five years. Through this Request for Information, NIAAA seeks comments on the draft outline for its FY 2022-2026 Strategic Plan from diverse stakeholders, including scientific experts, health care providers, patients and family members, advocacy groups, other federal agencies, and non-governmental scientific, professional, and healthcare organizations.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2021-13224
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-13223
Type: Notice
Date: 2021-06-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-13222
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-13219
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2021-13211
Type: Notice
Date: 2021-06-24
Agency: Department of Health and Human Services
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-13194
Type: Notice
Date: 2021-06-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Determination of Regulatory Review Period for Purposes of Patent Extension; TURALIO
Document Number: 2021-13186
Type: Notice
Date: 2021-06-23
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-13184
Type: Notice
Date: 2021-06-23
Agency: Department of Health and Human Services, National Institutes of Health
Authorization and Revocation of Emergency Use of Drugs During the COVID-19 Pandemic; Availability
Document Number: 2021-13183
Type: Notice
Date: 2021-06-23
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; GIVLAARI
Document Number: 2021-13176
Type: Notice
Date: 2021-06-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for GIVLAARI 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 drug product.