Department of Health and Human Services November 19, 2018 – Federal Register Recent Federal Regulation Documents
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Activities Deemed Not To Be Research: Public Health Surveillance, 2018 Requirements
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a draft guidance document entitled, ``Activities Deemed Not to Be Research: Public Health Surveillance, 2018 Requirements.''
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Chimeric Antigen Receptor (CAR) Therapies for the Treatment of FMS-Like Tyrosine Kinase 3 (FLT3) Expressing Cancers
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 ElevateBio. (``Elevate''), located in Cambridge, MA.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing.
Determination That REGITINE (Phentolamine Mesylate) Injection, 5 Milligrams/Vial, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR). This meeting is open to the public, limited only by available seating. The meeting room accommodates approximately 60 people. The public is also welcome to listen to the meeting by calling 800-619-8521, passcode 7019704, limited by 100 lines. The deadline for notification of attendance is December 3, 2018. The public comment period is scheduled on December 12, 2018 from 2:30 p.m. until 2:45 p.m., EST and December 13, 2018 from 10:10 a.m. until 10:25 a.m., EST. Individuals wishing to make a comment during Public Comment period, please email your name, organization, and phone number by November 30, 2018 to Amanda Malasky at amalasky@cdc.gov.
National Biodefense Science Board Public Teleconference
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will hold a public teleconference on December 13, 2018.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled ``Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.'' Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct is on the FDA's ``Postmarketing Requirements and Commitments: Reports'' web page (https://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Post- marketingPhaseIVCommitments/ucm064436.htm).
Meeting of the Advisory Committee on Infant Mortality
The Advisory Committee on Infant Mortality (ACIM) has scheduled a public meeting.
National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy
HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).
Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Continued Approval of Its Ambulatory Surgical Center Accreditation Program
This final notice announces our decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs.
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2019
This notice announces a $586.00 calendar year (CY) 2019 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, 2019 and on or before December 31, 2019.
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