The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey
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 the information collection requirements for a voluntary survey for the Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the Department of Homeland Security (DHS), which will inform the FDA Food Safety Modernization Act (FSMA), National Agriculture and Food Defense Strategy (NAFDS) Report to Congress. The proposed survey will be used to determine what food defense activities, if any, State, local, territorial, and/or tribal (SLTT) agencies have completed to date. The information will be compared to the initial baseline data previously collected by State(s).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled “Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).
ACLA President to Testify on Regulation of Diagnostic Tests
Washington, D.C. – American Clinical Laboratory Association (ACLA) President Susan Van Meter will testify before the House Energy and Commerce Committee’s Subcommittee on Health for a hearing … Read More
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ACLA Statement on LDT Proposed Rule Comments by FDA and CMS
Washington, D.C. – In response to a joint release from the U.S. Food & Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) … Read More
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ACLA Welcomes Mary Lee Watts and Elyse Oveson to Key Positions
Washington, D.C. – The American Clinical Laboratory Association (ACLA) has welcomed Mary Lee Watts as Vice President of Government Affairs and Policy and Elyse Oveson … Read More
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FDA Proposed Rule to Regulate LDTs as Medical Devices Would Slow Development of Critical Lab Tests and Should be Withdrawn, ACLA Urges
FDA Regulation of LDTs is Misguided; Requires Congressional Authorization Washington, D.C. – The American Clinical Laboratory Association (ACLA) today submitted comments urging the U.S. Food … Read More
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