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New Animal Drug Applications; Beta-Aminopropionitrile Fumarate; n
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications (NADAs) for lack of compliance with the reporting requirements in an FDA regulation.
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Hazard Communication Standard
OSHA is proposing through this notice of proposed rulemaking (NPRM) to modify the Hazard Communication Standard (HCS) to conform to the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revision 7 (GHS, Rev. 7), to address issues that arose during the implementation of the 2012 update to the HCS, and...
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Hazardous Materials: Editorial Corrections and Clarifications
This final rule corrects editorial errors and improves the clarity of certain provisions in the Hazardous Materials Regulations and PHMSA program and procedural regulations. The intended effect of this rulemaking is to enhance the accuracy and reduce misunderstandings of the regulations. The amendments contained in this final rule are...
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Hazardous Materials: Adoption of Miscellaneous Petitions To Reduce Regulatory Burdens
The Pipeline and Hazardous Materials Safety Administration (PHMSA) is amending the Hazardous Materials Regulations in response to 24 petitions for rulemaking submitted by the regulated community between February 2015 and March 2018. This final rule updates, clarifies, or provides relief from various regulatory requirements without adversely...
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Regulatory Clean Up Initiative
The U.S Department of Health and Human Services (HHS) is amending its regulations to make miscellaneous corrections, including correcting references to other regulations, misspellings and other typographical errors. This document is necessary to inform the public of these non-substantive changes to HHS's regulations.
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Standard for the Flammability of Mattresses and Mattress Pads; Proposed Amendment
The Consumer Product Safety Commission (Commission, or CPSC) is proposing to amend its Standard for the Flammability of Mattresses and Mattress Pads. The ignition source cigarette specified in the standard for use in the mattress standard's performance tests, Standard Reference Material cigarette SRM 1196, is no longer available for purchase....
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Safety Standard for Crib Mattresses
The Danny Keysar Child Product Safety Notification Act, section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires the United States Consumer Product Safety Commission (CPSC) to promulgate consumer product safety standards for durable infant or toddler products. These standards are to be ``substantially the same as''...
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Importation of Prescription Drugs
The Secretary of Health and Human Services (Secretary) is issuing a final rule to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada. Under this final rule, States and Indian Tribes, and in certain future circumstances pharmacists and wholesalers, may submit...
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Regulations Regarding “Intended Uses”
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its medical product ``intended use'' regulations. This action, if finalized, will amend FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act...
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Requirements for Additional Traceability Records for Certain Foods
The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule would require these entities to establish and maintain records...
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Revocation of the Test for Mycoplasma
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to remove the specified test for the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. The rule is being finalized because the existing test for Mycoplasma is overly restrictive in that it...
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Office of Regulatory Affairs Division Director; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is revising its regulations to reflect changes to the Agency's organizational structure, including the reorganization of the Office of Regulatory Affairs (ORA). The revisions update addresses and replace references to the district officials with references to division officials. The rule...
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Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices
The Food and Drug Administration (FDA, the Agency, or we), with the Department of the Treasury's concurrence, is proposing to amend its regulations to require that certain data elements be submitted for veterinary devices that are being imported or offered for import in the Automated Commercial Environment (ACE) or any other electronic data...
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New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2020. FDA is informing the public of the availability of summaries of the basis of approval...
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Hazardous Materials: Liquefied Natural Gas by Rail
PHMSA, in coordination with the Federal Railroad Administration (FRA), is amending the Hazardous Materials Regulations (HMR) to allow for the bulk transport of ``Methane, refrigerated liquid,'' commonly known as liquefied natural gas (LNG), in rail tank cars. This rulemaking authorizes the transportation of LNG by rail in DOT-113C120W...
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Safety Standard for Gates and Enclosures
Pursuant to the Consumer Product Safety Improvement Act of 2008 (CPSIA), the U.S. Consumer Product Safety Commission (CPSC) is issuing this final rule establishing a safety standard for gates and enclosures that are intended to confine a child. The CPSC is also amending its regulations regarding third party conformity assessment bodies to...