Framework for a Real-World Evidence Program; Availability; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the document entitled ``Framework for a Real-World Evidence Program; Availability'' that appeared in the Federal Register on December 7, 2018. The Agency is taking this action to allow interested persons additional time to submit comments.
Retail Pharmacy Interest in Utilization of Innovative Educational Technology To Increase Human Papillomavirus (HPV) Vaccination Rates in Rural Areas
This request for information (RFI) is issued for informational and planning purposes only. This RFI is not a solicitation; nor does it commit the Department of Health and Human Services (HHS) to issue a solicitation, make any award, or pay any costs associated with responding to this announcement. The RFI is being issued by the National Vaccine Program Office (NVPO) of the U.S. Department of Health and Human Services. The NVPO is located in the Office of the Assistant Secretary for Health (ASH), Office of the Secretary (OS), U.S. Department of Health and Human Services (HHS). The NVPO provides strategic leadership and management, policy scholarship and recommendations, and encourages collaboration and coordination among federal agencies and other stakeholders whose mission is to reduce the burden of preventable infectious disease through immunization. NVPO offers thorough reporting, unbiased advice and expertise to other agencies in identifying and responding to gaps in the vaccine system. Prevention of cancers associated with Human Papillomavirus (HPV) infections continues to be a public health challenge in the United States. Vaccination is an effective, primary medical intervention for prevention of infection from these viruses. Despite this, HPV vaccination series completion rates remain low nationwide, with adolescents living in rural communities (per census definition of
Blood Products Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee (BPAC). The general function of the committee is to provide advice and recommendations to the Agency on regulatory issues related to blood and products derived from blood. Matters considered at the meeting will include testing of the blood supply for Zika virus, topics relevant to blood donation by men who have sex with men, and an overview of research programs in the Laboratory of Biochemistry and Vascular Biology. At least one portion of the meeting will be closed to the public.
Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements
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 export notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, cosmetics, and tobacco that may not be marketed or sold in the United States.
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With New Animal Drug Applications and Veterinary Master Files
The Food and Drug Administration (FDA, Agency, 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 (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 collection of information associated with new animal drug applications.
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.
Prospective Grant of an Exclusive Patent License: “Treatment of Acute Lymphoblastic Leukemia, T-Cell Lymphoma, and Non-Small Cell Lung Cancer Using the 4A10 Antibody and Fragments Thereof”
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 Patent Applications listed in the Supplementary Information section of this notice to Fannin Partners L.L.C., (``Fannin'') of Houston, Texas.