Department of Health and Human Services 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Food Advisory Committee (the Committee), Office of Regulations, Policy, and Social Sciences, Center for Food Safety and Applied Nutrition. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 information collection requirements of the Animal Drug User Fee cover sheet.

The invention Mutant IHD1 Inhibitors Useful for Treating Cancer is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S.

This notice announces the meeting dates for the Technical Advisory Panel on Medicare Trustee Reports on Monday, October 31, 2016 and Tuesday, November 1, 2016 in Washington, DC.

The Office of Disease Prevention and Health Promotion (ODPHP), on behalf of the U.S. Department of Health and Human Services (HHS) Federal Interagency Steering Committee for Adverse Drug Events, proposes new measures and targets for adverse drug events (ADEs) from anticoagulants, diabetes agents, and opioid analgesics for the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan). Based on input from the Federal Interagency Workgroups for Adverse Drug Events, six national measures and targets for the reduction of ADEs are being proposed. Each drug class highlighted in the ADE Action Plan (anticoagulants, diabetes agents, and opioid analgesics) includes a proposed inpatient and outpatient measure to track national progress in reduction of ADEs from these drug classes. The proposed targets will reflect improvement efforts over a four to six year period since the release of the ADE Action Plan in August 2014. As such, HHS is proposing a baseline year of 2014 for five of the measures and 2016 for one measure. All targets are to be achieved by 2020. HHS invites interested public and private professionals, organizations, and consumer representatives to submit written comments on the proposed 2020 ADE targets, found at https://health.gov/hcq/ade-measures.asp.

The Administration for Community Living (formerly the Administration on Aging (AoA)) is announcing that the continuation of collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements for premarket approval of medical devices.

The Food and Drug Administration (FDA) is establishing a public docket to receive input on emerging issues and cross-cutting scientific advances that may impact FDA preparedness and inter-Agency activities. Interested parties are invited to submit comments regarding emerging technologies and cross-cutting scientific advances of importance to FDA. The focus is on areas that may impact FDA in 5 or more years.

The Food and Drug Administration (FDA) has determined the regulatory review period for REPATHA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for MMR (measles, mumps, and rubella) and MMRV (measles, mumps, rubella, and varicella) vaccines.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for methylphenidate hydrochloride (HCl) extended-release (ER) tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal.