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

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Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests
Document Number: 2020-03515
Type: Proposed Rule
Date: 2020-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is proposing to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments class III devices with the product code MZF, into class II (special controls), subject to premarket notification. FDA is also proposing new device classification regulations along with special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these types of devices from class III (premarket approval) to class II (special controls) and reduce the regulatory burdens associated with these devices, as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a premarket notification (510(k)) and receive clearance before marketing their device.
Hospira, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications
Document Number: 2020-03512
Type: Notice
Date: 2020-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Definition of the Term “Biological Product”
Document Number: 2020-03505
Type: Rule
Date: 2020-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulation that defines ``biological product'' to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act), and to provide its interpretation of the statutory term ``protein.'' Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards
Document Number: 2020-03464
Type: Notice
Date: 2020-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA 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 (the 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 provisions of the Voluntary National Retail Food Regulatory Program Standards.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
Document Number: 2020-03463
Type: Notice
Date: 2020-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
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 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 recordkeeping requirements for Type A Medicated Articles.
Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting for Custom Device Exemption
Document Number: 2020-03459
Type: Notice
Date: 2020-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
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 of an existing 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 the annual reporting for custom devices.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Corrections and Removals
Document Number: 2020-03458
Type: Notice
Date: 2020-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
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 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 submission of reports of corrections and removals that are associated with medical and radiation emitting products regulated by FDA's Center for Devices and Radiological Health.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2020-03444
Type: Notice
Date: 2020-02-21
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2020-03443
Type: Notice
Date: 2020-02-21
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Food Standards; General Principles and Food Standards Modernization; Reopening of the Comment Period
Document Number: 2020-03437
Type: Proposed Rule
Date: 2020-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is reopening the comment period for the proposed rule, published in the Federal Register of May 20, 2005, entitled ``Food Standards; General Principles and Food Standards Modernization,'' to establish a set of general principles for food standards for FDA to use when considering whether to establish, revise, or eliminate a food standard. The proposed rule was issued jointly with the United States Department of Agriculture (USDA) and, while FDA will continue to engage with USDA regarding the proposed rule, we are reopening the comment period to receive new data, information, or further comments only on FDA-specific aspects of the proposed rule, including FDA's 13 general principles.
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics; Draft Guidance for Industry; Availability
Document Number: 2020-03426
Type: Notice
Date: 2020-02-20
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 draft guidance entitled ``Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.'' This guidance expands upon, consolidates, and supplements the recommendations on nonclinical immune system assessments provided across multiple guidance documents, most notably the International Conference on Harmonization (ICH) guidance for industry ``S8 Immunotoxicity Studies for Human Pharmaceuticals.'' The topics covered include various aspects of immune suppression, modulation, and stimulation. This guidance replaces the withdrawn guidance entitled ``Immunotoxicology Evaluation of Investigational New Drugs.''
Medical Imaging Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2020-03424
Type: Notice
Date: 2020-02-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Medical Imaging Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2020-03410
Type: Notice
Date: 2020-02-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pulmonary-Allergy Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Submission for OMB Review; Tribal Child Support Enforcement Direct Funding Request: 45 CFR 309-Plan (OMB #0970-0218)
Document Number: 2020-03354
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting a 3-year extension of the 45 CFR 309-Plan (OMB #0970-0218, expiration 3/21/2020). There are no changes requested to this form.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-03343
Type: Notice
Date: 2020-02-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-03342
Type: Notice
Date: 2020-02-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-03341
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-03336
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-03335
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-03334
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2020-03333
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-03332
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2020-03331
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-03330
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Reopening of Comment Period
Document Number: 2020-03312
Type: Notice
Date: 2020-02-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability that published in the Federal Register on November 20, 2019. In that notice, FDA requested comments on the draft guidance for industry (GFI) #256 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' FDA is reopening the comment period to update comments and to receive any new information.
HHS Notice of Committee Establishment, Notice of Intent To Convene, and Call for Nominations for the NIH Human Fetal Tissue Research Ethics Advisory Board for Fiscal Year 2020
Document Number: 2020-03302
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, Office of the Secretary
The U.S. Department of Health and Human Services (HHS) announces the establishment of, and intent to convene, the National Institutes of Health (NIH) Human Fetal Tissue Research Ethics Advisory BoardFY 2020 (Ethics Board or Board), as authorized by section 492A of the Public Health Service (PHS) Act, as amended. HHS is soliciting nominations of individuals for appointment to the Ethics Board for fiscal year 2020. Nominations for qualified individuals for appointment to the Ethics Board are currently being accepted.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-03293
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2020-03290
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-03289
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-03288
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Cancellation of Meeting
Document Number: 2020-03286
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-03285
Type: Notice
Date: 2020-02-20
Agency: Department of Health and Human Services, National Institutes of Health
Medicaid Program; Preadmission Screening and Resident Review
Document Number: 2020-03081
Type: Proposed Rule
Date: 2020-02-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would modernize the requirements for Preadmission Screening and Resident Review (PASRR), currently referred to in regulation as Preadmission Screening and Annual Resident Review, by incorporating statutory changes, reflecting updates to diagnostic criteria for mental illness and intellectual disability, reducing duplicative requirements and other administrative burdens on State PASRR programs, and making the process more streamlined and person- centered.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-03357
Type: Notice
Date: 2020-02-19
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.
Meeting of the Tick-Borne Disease Working Group
Document Number: 2020-03255
Type: Notice
Date: 2020-02-19
Agency: Department of Health and Human Services
As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a meeting. The meeting will be open to the public. For this meeting, the TBDWG will be discussing and voting on recommendations for the 2020 TBDWG Report to the HHS Secretary and Congress. Most of the recommendations the TBDWG will consider are from the reports of eight TBDWG subcommittees, which were created to examine critical topic areas related to tick-borne diseases. Additionally, the TBDWG created the Federal Inventory Subcommittee and Public Comment Subcommittee. The Federal Inventory Subcommittee will present an analysis of tick-borne disease research and funding within federal agencies. The Public Comment subcommittee will provide an update on key themes of the written comments to the TBDWG. The 2020 report will address ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases; advances made pursuant to such research; federal activities related to tick-borne diseases; and gaps in tick-borne disease research.
National Human Genome Research Institute; Notice of Proposed Reorganization
Document Number: 2020-03173
Type: Notice
Date: 2020-02-19
Agency: Department of Health and Human Services, National Institutes of Health
The National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH) will host a public hearing to enable discussion of the Institute's proposal to reorganize the Division of Policy, Communications and Education. The proposed reorganization aims to enhance synergies in the areas of bioethics, policy, education, engagement, and communications.
World Trade Center Health Program; Petition 025-Parkinson's Disease and Parkinsonism, Including Heavy Metal-Induced Parkinsonism; Finding of Insufficient Evidence
Document Number: 2020-02991
Type: Proposed Rule
Date: 2020-02-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On October 15, 2019, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 025) to add ``Parkinson's disease'' to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that there is insufficient evidence available to support taking further action at this time regarding Parkinson's disease and parkinsonism, including heavy metal-induced parkinsonism. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Request for Information on Vaping Products Associated With Lung Injuries
Document Number: 2020-03160
Type: Notice
Date: 2020-02-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is opening a docket to obtain data and information related to the use of vaping products that are associated with recent lung injuries. This request for information (RFI) responds to direction from Congress to gather information from the public that could help identify and evaluate additional steps the Agency could take to ``address the recent pulmonary illnesses reported to be associated with the use of e-cigarettes and vaping products.'' FDA is seeking information on product design and potential ways to prevent consumers from modifying or adding substances to these products that are not intended by the manufacturers. In particular, FDA is seeking data and information in the form of reports and manuscripts that are unpublished or not available through indexed bibliographic databases. FDA has searched the publicly available scientific literature and is now seeking to supplement that with information not included in the published scientific literature.
Patient-Focused Drug Development for Stimulant Use Disorder; Public Meeting; Request for Comments
Document Number: 2020-03159
Type: Notice
Date: 2020-02-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Patient-Focused Drug Development for Stimulant Use Disorder.'' The purpose of the public meeting is to allow FDA to obtain stakeholder perspectives on the impact of stimulant use disorder and views on treatment approaches for stimulant use disorder.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2020-03128
Type: Notice
Date: 2020-02-18
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; INTRAROSA
Document Number: 2020-03115
Type: Notice
Date: 2020-02-18
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 INTRAROSA 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.
Medicare and Medicaid Programs: Application From the Joint Commission for Continued Approval of Its Hospital Accreditation Program
Document Number: 2020-03082
Type: Notice
Date: 2020-02-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-03078
Type: Notice
Date: 2020-02-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2020-03077
Type: Notice
Date: 2020-02-18
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2020-03076
Type: Notice
Date: 2020-02-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-03075
Type: Notice
Date: 2020-02-18
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Medicare Secondary Payer and Certain Civil Money Penalties
Document Number: 2020-03069
Type: Proposed Rule
Date: 2020-02-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary
This proposed rule would specify how and when CMS must calculate and impose civil money penalties (CMPs) when group health plan (GHP) and non-group health plan (NGHP) responsible reporting entities (RREs) fail to meet their Medicare Secondary Payer (MSP) reporting obligations in any one or more of the following ways: When RREs fail to register and report as required by MSP reporting requirements; when RREs report as required, but report in a manner that exceeds error tolerances established by the Secretary of the Department of Health and Human Services (the Secretary); when RREs contradict the information the RREs have reported when CMS attempts to recover its payments from these RREs. This proposed rule would also establish CMP amounts and circumstances under which CMPs would and would not be imposed.
Privacy Act of 1974; Matching Program
Document Number: 2020-03051
Type: Notice
Date: 2020-02-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new matching program between CMS and the Department of the Treasury (Treasury), Internal Revenue Services (IRS), ``Verification of Household Income and Family Size for Insurance Affordability Programs and Exemptions.''
Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly
Document Number: 2020-02085
Type: Proposed Rule
Date: 2020-02-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would revise regulations for the Medicare Advantage (Part C) program, Medicare Prescription Drug Benefit (Part D) program, Medicaid program, Medicare Cost Plan program, and Programs of All-Inclusive Care for the Elderly to implement certain sections of the Bipartisan Budget Act of 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, and the 21st Century Cures Act. This proposed rule would also enhance the Part C and D programs, codify several existing CMS policies, and implement other technical changes.