Alcohol, Tobacco, Firearms, and Explosives Bureau – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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 certain labeling statements for nonprescription human drug products marketed without an approved application.
Testicular Toxicity: Evaluation During Drug Development; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Testicular Toxicity: Evaluation During Drug Development.'' The draft guidance addresses nonclinical findings that may raise concerns of a drug- related adverse effect on the testes, clinical monitoring of adverse testicular effects early in clinical development, and the design and conduct of a safety clinical trial assessing drug-related testicular toxicity. The draft guidance is intended to assist sponsors developing drugs to identify nonclinical signals of testicular toxicity and to evaluate the potential for such toxicity in humans.
Public Meeting on Patient-Focused Drug Development for Huntington's and Parkinson's Diseases
The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for Huntington's disease and Parkinson's disease. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of Huntington's disease and Parkinson's disease on daily life and patient views on treatment approaches. Although these are both neurological diseases, since they are quite distinct, FDA will structure this public meeting into two distinct sessions. The morning session, scheduled from 9 a.m. to 1 p.m., will be devoted to hearing patient perspectives on the impact of Huntington's disease on daily life and their views on currently available treatment approaches. The afternoon session, scheduled from 1 p.m. to 5 p.m., will be devoted to obtaining patient perspectives on the impact of Parkinson's disease on daily life and patient views on currently available treatment approaches.
Alzchem AG; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA) is announcing that Alzchem AG has filed a petition proposing that the food additive regulations be amended to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in diets for broiler chickens and turkeys.
Canned Pacific Salmon; Technical Amendment
The Food and Drug Administration (FDA or we) is amending a regulation pertaining to canned Pacific salmon. The amendment removes a paragraph that contains an obsolete cross-reference.
Commerce in Explosives; List of Explosive Materials (2011R-18T)
Pursuant to 18 U.S.C. 841(d) and 27 CFR 555.23, the Department must publish and revise at least annually in the Federal Register a list of explosives determined to be within the coverage of 18 U.S.C. 841 et seq. The list covers not only explosives, but also blasting agents and detonators, all of which are defined as explosive materials in 18 U.S.C. 841(c). This notice publishes the 2011 List of Explosive Materials.
Commerce in Explosives; List of Explosive Materials (2010R-27T)
Pursuant to 18 U.S.C. 841(d) and 27 CFR 555.23, the Department must publish and revise at least annually in the Federal Register a list of explosives determined to be within the coverage of 18 U.S.C. 841 et seq. The list covers not only explosives, but also blasting agents and detonators, all of which are defined as explosive materials in 18 U.S.C. 841(c). This notice publishes the 2010 List of Explosive Materials.
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