Agency Information Collection Activities; Submission for OMB Review; Comment Request; Semi-Annual and Final Reporting Requirements for the Older Americans Act Title IV Discretionary Grants Program
The Administration for Community Living (ACL) 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.
Navigating the Center for Drug Evaluation and Research: What You Should Know for Effective Engagement; Public Workshop
The Food and Drug Administrations (FDA) Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled ``Navigating CDER: What You Should Know for Effective Engagement.'' The purpose of this public workshop is to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER.
Agency Information Collection Activities; Proposed Collection; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
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 information to accompany humanitarian device exemption (HDE) applications and the collection of information regarding the annual distribution number (ADN).
How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?
The Food and Drug Administration (FDA) is announcing a public conference entitled ``How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?'' This conference will be cosponsored with the Critical Path Institute (C- Path). The purpose of the conference is to discuss, debate, and share views among stakeholders in academia, patient groups, regulatory bodies, and the health care and pharmaceutical industries on how best to measure, evaluate, and act upon liver injury and dysfunction caused by drugs used during clinical trials.
Advisory Committee: Vaccines and Related Biological Products Advisory Committee, Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Vaccines and Related Biological Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Vaccines and Related Biological Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until December 31, 2017.
Temporary Assistance for Needy Families (TANF) Program, State Reporting On Policies and Practices To Prevent Use of TANF Funds in Electronic Benefit Transfer Transactions in Specified Locations
This final rule makes regulatory changes to the Temporary Assistance for Needy Families (TANF) regulations to require states, subject to penalty, to maintain policies and practices that prevent TANF funded assistance from being used in any electronic benefit transfer transaction in any liquor store; any casino, gambling casino, or gaming establishment; or any retail establishment that provides adult-oriented entertainment in which performers disrobe or perform in an unclothed state for entertainment. This rule implements provisions of Section 4004 of the Middle Class Tax Relief and Job Creation Act of 2012.