Department of Health and Human Services July 12, 2019 – Federal Register Recent Federal Regulation Documents
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Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients; Public Workshop; Cancellation
The Food and Drug Administration is announcing the cancellation of a public workshop entitled ``Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients'' that was previously scheduled for August 8, 2019, from 8:30 a.m. to 4:30 p.m. This public workshop was announced in the Federal Register of May 2, 2019. The meeting has been cancelled due to unforeseen changes in the adenovirus drug development landscape.
All of Us Research Program, Tribal Consultation Meetings and Listening Sessions; Correction
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on June 3, 2019. That Notice requires a correction in the DATES and SUPPLEMENTARY INFORMATION sections.
Population Pharmacokinetics; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Population Pharmacokinetics.'' This revised draft guidance assists sponsors in the application of population pharmacokinetics (population PK) during the drug development process to inform drug use and includes FDA's current thinking on the data and model requirements for population PK analyses submitted as part of new drug applications (NDAs) and biologic license applications (BLAs). The revised draft guidance also provides expectations regarding the format and content of the population PK report as well as any labeling recommendations resulting from such analyses.
Establishing Effectiveness and Safety for Hormonal Drug Products Intended To Prevent Pregnancy; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.'' This draft guidance describes FDA's current thinking on key design considerations for these trials to help facilitate development of new and improved hormonal drug products for contraception. This draft guidance does not address development of contraceptive devices for this indication.
Submission for OMB Review; National Medical Support Notice-Part A
The Administration for Children and Families (ACF) is requesting a three year extension of the form National Medical Support Notice (NMSN) Part A (OMB #0970-0222 expiration 8/31/2019). Changes were made to the form based on comments received during the 60 day Notice.
Prospective Grant of an Exclusive Patent License: Autologus Therapy Using Bicistronic Chimeric Antigen Receptors Targeting CD19 and CD20
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 Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA.
Prospective Grant of an Exclusive Patent License: Allogeneic Therapy Using Bicistronic Chimeric Antigen Receptors Targeting CD19 and CD20
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 Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA.
Proposed Collection; 60-Day Comment Request Application and Impact of Clinical Research Training on Healthcare Professionals in Academia and Clinical Research (Office of the Director)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Clinical Research (OCR), Office of the Director (OD), National Institutes of Health, will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Idaho National Laboratory in Scoville, Idaho, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
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