Department of Health and Human Services September 30, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured From Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry (GFI) #171 entitled ``Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.'' This draft guidance describes how the Agency intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media.
Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2020
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the sponsors of material threat MCM applications that meet all the requirements of this program and upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2020 and outlines the payment procedures for such fees.
Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2020
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug and biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to sponsors of rare pediatric disease product applications that meet all the requirements of this program and are submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2020 and outlines the payment procedures for such fees.
Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2020
The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for review of drug and biological products when those applications use a tropical disease priority review voucher. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2020.
National Institute of Neurological Disorders & Stroke (NINDS); Notice of Organizational Change
The National Institute of Neurological Disorders and Stroke (NINDS) will launch a public information website and host a webinar to enable public discussion regarding NINDS proposal to reorganize the Office of Communications and Public Liaison and Office of Scientific Liaison.
Healthcare Infection Control Practices Advisory Committee (HICPAC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, is limited only by room seating available (120). The public is also welcome to listen to the meeting via teleconference at 888-769- 9417, passcode: 4538315; 100 teleconference lines are available. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Meeting of the National Advisory Council on Nurse Education and Practice
In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP or Council) has scheduled a public meeting. Information about NACNEP, the agenda, and materials for this meeting can be found on the NACNEP website at https://www.hrsa.gov/advisory- committees/nursing/.
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington
This notice announces that laboratories located in and licensed by the State of Washington that possess a valid license under the Medical Test Site law, Chapter 70.42 of the Revised Code of Washington, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 4 years.
Agency Information Collection Request. 30-Day Public Comment Request
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.
Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #261 entitled ``Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.'' This draft guidance is intended for persons interested in pursuing conditional approval of new animal drugs for certain major uses in major species. Eligibility for conditional approval has been expanded beyond minor uses in major species and minor species to include certain major uses. The Center for Veterinary Medicine (CVM) refers to the process for conditionally approving new animal drugs that are not minor use and minor species (MUMS) drugs as ``expanded conditional approval.'' The purpose of expanded conditional approval is to incentivize development of new animal drugs for serious or life- threatening conditions or unmet animal or human health needs under circumstances where a demonstration of effectiveness would require a complex or particularly difficult study or studies. This draft guidance defines certain terms, clarifies the eligibility criteria for expanded conditional approval, and describes the criteria CVM intends to consider when determining expanded conditional approval eligibility.
Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care
This final rule reforms Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This final rule also increases the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care. Additionally, this rule updates fire safety standards for Medicare and Medicaid participating End-Stage Renal Disease (ESRD) facilities by adopting the 2012 edition of the Life Safety Code and the 2012 edition of the Health Care Facilities Code. Finally, this final rule updates the requirements that hospitals and Critical Access Hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These requirements are intended to conform to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns.
Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care
This final rule empowers patients to be active participants in the discharge planning process and complements efforts around interoperability that focus on the seamless exchange of patient information between health care settings by revising the discharge planning requirements that Hospitals (including Short-Term Acute-Care Hospitals, Long-Term Care Hospitals (LTCHs), Rehabilitation Hospitals, Psychiatric Hospitals, Children's Hospitals, and Cancer Hospitals), Critical Access Hospitals (CAHs), and Home Health Agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. This final rule also implements discharge planning requirements which will give patients and their families access to information that will help them to make informed decisions about their post-acute care, while addressing their goals of care and treatment preferences, which may ultimately reduce their chances of being re-hospitalized. It also updates one provision regarding patient rights in hospitals, intended to promote innovation and flexibility and to improve patient care.
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