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  • Current Good Manufacturing Practice Requirements for Food for Animals; Guidance for Industry; Availability

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry #235 entitled ``Current Good Manufacturing Practice Requirements for Food for Animals.'' This guidance helps domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) determine whether and how they need to comply with the current good manufacturing practice requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule.

  • Notice of Public Meeting, Pecos District Resource Advisory Council, New Mexico

    In accordance with the Federal Land Policy and Management Act (FLPMA) of 1976, the Federal Advisory Committee Act (FACA) of 1972, and the Federal Lands Recreation Enhancement Act of 2004, the U.S. Department of the Interior, Bureau of Land Management (BLM) Pecos District Resource Advisory Council (RAC) will meet as indicated below.

  • Extension of the Timetable Requirement To Submit Study Data in Logical Observation Identifiers Names and Codes

    The Food and Drug Administration (FDA or the Agency) is announcing the extension of the deadline to provide Logical Observation Identifiers Names and Codes (LOINC) for clinical laboratory test results in investigational study data provided in regulatory submissions submitted to the Center for Drug Evaluation and Research and to the Center for Biologics Evaluation and Research. FDA has determined, in response to industry comments and internal review, that it is appropriate to extend the date required to submit LOINC codes in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), and for certain investigational new drugs (INDs). LOINC codes will be required in NDAs, ANDAs, and BLAs for studies that start after March 15, 2020 (Ma...

  • Notice and Request for Comments

    EIA, pursuant to the Paperwork Reduction Act of 1995, intends to extend with changes for three years with the Office of Management and Budget (OMB) Form EIA-63C Densified Biomass Fuel Report. Form EIA- 63C collects data on pellet fuel and other densified biomass fuel production, sales, and inventory levels from operators of U.S. pellet fuel manufacturing facilities. The data collected is used for the purpose of estimating densified biomass fuel consumption in the United States, as well as production, sales, and inventory at state, regional, and national levels.

  • Notice of Proposed Information Collection for Public Comment: 2018 Rental Housing Finance Survey

    The Department of Housing and Urban Development (HUD) is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

  • Air Plan Approval; Wisconsin; Regional Haze Progress Report

    The Environmental Protection Agency (EPA) is proposing to approve the regional haze progress report under the Clean Air Act as a revision to the Wisconsin State Implementation Plan (SIP). Wisconsin has satisfied the progress report requirements of the Regional Haze Rule. Wisconsin has also met the requirements for a determination of the adequacy of its regional haze plan with its negative declaration submitted with the progress report.

  • Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0082

    In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, without change, of the following collection of information: 1625-0082, Navigation Safety Information and Emergency Instructions for Certain Towing Vessels. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.

  • Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on generic tiotropium bromide inhalation powder entitled ``Draft Guidance on Tiotropium Bromide.'' The draft guidance, when finalized, will provide product- specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for tiotropium bromide inhalation powder.

  • Sunshine Act Meeting
  • Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing

    This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.

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