Department of Health and Human Services January 12, 2015 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
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 current burden hours on regulated industry of complying with the guidance underlying this collection of information.
Study Data Technical Conformance Guide and Data Standards Catalog; Availability
The Food and Drug Administration (FDA) is announcing the availability of a Study Data Technical Conformance Guide, Version 2.0 (Guide), and an update to the Data Standards Catalog (Catalog). The Guide supplements the final guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data'' (eStudy Data guidance) and provides specifications and recommendations for, as well as general considerations on, submitting standardized study data using FDA-supported data standards specified in the Catalog. The Guide is intended to complement and promote interactions between sponsors and FDA review divisions.
Draft Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Notice for Public Meeting on Draft Environmental Impact Statement
The Food and Drug Administration (FDA or we) has made available for public review and comment the Draft Environmental Impact Statement (EIS) for the proposed rule establishing standards for the growing, harvesting, packing, and holding of produce for human consumption. The document is available in Docket No. FDA-2014-N-2244. FDA is also announcing a public meeting to discuss the Draft EIS. The purpose of the public meeting is to inform the public of the findings in the Draft EIS, to provide information about the EIS process (including how to submit comments, data, and other information to the docket), to solicit oral stakeholder and public comments on the Draft EIS, and to provide clarification, as needed, about the contents of the Draft EIS.
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) 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.
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