Department of Health and Human Services February 15, 2019 – Federal Register Recent Federal Regulation Documents

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

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.

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.

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.