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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.
- Workforce Innovation and Opportunity Act
The Department of Labor (DOL or the Department) issues this Final Rule to implement titles I and III of the (WIOA). Through these regulations, the Department reforms and modernizes our nation's workforce development system. This rule provides the framework for changes for statewide and local...
- Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements
This major final rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in...
- Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2016
Publication of the Unified Agenda of Regulatory and Deregulatory Actions and the Regulatory Plan represent key components of the regulatory planning mechanism prescribed in Executive Order 12866, ``Regulatory Planning and Review'' (58 FR 51735) and incorporated in Executive Order 13563, ``Improving ...
- Business Conduct Standards for Security-Based Swap Dealers and Major Security-Based Swap Participants
In accordance with Section 764 of Title VII (``Title VII'') of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the ``Dodd-Frank Act''), the Securities and Exchange Commission (``SEC'' or ``Commission'') is adopting new rules under the Securities Exchange Act of 1934 (``Exchange Act'')...
- Semiannual Regulatory Agenda
The Spring 2016 Unified Agenda of Federal Regulatory and Deregulatory Actions. Publication of the Spring 2016 Unified Agenda of Federal Regulatory and Deregulatory Actions represents a key component of the regulatory planning mechanism prescribed in Executive Order 12866 ``Regulatory Planning and...
- Announcement of the Award of Two Single-Source Program Expansion Supplement Grants To Support Legal Services to Refugees Under the Unaccompanied Alien Children's Program
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Continuing Education for Comparative Effectiveness Research Survey.'' In accordance with the...
- 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications
This final rule finalizes a new edition of certification criteria (the 2015 Edition health IT certification criteria or ``2015 Edition'') and a new 2015 Edition Base Electronic Health Record (EHR) definition, while also modifying the ONC Health IT Certification Program to make it open and...
- Home Mortgage Disclosure (Regulation C)
The Bureau of Consumer Financial Protection (Bureau) is publishing for public comment a proposed rule amending Regulation C to implement amendments to the Home Mortgage Disclosure Act (HMDA) made by section 1094 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act)....
The Securities and Exchange Commission is adopting new Regulation under the Securities Act of 1933 and the Securities Exchange Act of 1934 to implement the requirements of Title III of the Jumpstart Our Business Startups Act. Regulation prescribes rules governing the offer and sale of securities...
- Food Labeling: Revision of the Nutrition and Supplement Facts Labels
The Food and Drug Administration (FDA or we) is amending its labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The updated information is consistent with current...