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
Document Number: 2015-17558
Type: Notice
Date: 2015-07-17
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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Testicular Toxicity: Evaluation During Drug Development; Draft Guidance for Industry; Availability
Document Number: 2015-17557
Type: Notice
Date: 2015-07-17
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Testicular Toxicity: Evaluation During Drug Development.'' The draft guidance addresses nonclinical findings that may raise concerns of a drug- related adverse effect on the testes, clinical monitoring of adverse testicular effects early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 The draft guidance is intended to assist sponsors developing drugs to identify nonclinical signals of testicular toxicity and to evaluate the potential for such toxicity in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
Document Number: 2015-17556
Type: Notice
Date: 2015-07-17
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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)
Document Number: 2015-17379
Type: Proposed Rule
Date: 2015-07-16
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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
Document Number: 2015-17249
Type: Rule
Date: 2015-07-15
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
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.
Preparation for International Cooperation on Cosmetics Regulation
Document Number: 2015-17248
Type: Notice
Date: 2015-07-15
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities; Proposed Collection, Comments Requested: Annual Firearms Manufacturing and Exportation Report
Document Number: 2011-27494
Type: Notice
Date: 2011-10-25
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Commerce in Explosives; List of Explosive Materials (2011R-18T)
Document Number: 2011-26963
Type: Notice
Date: 2011-10-19
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
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.
Agency Information Collection Activities: Proposed Collection; Comments Requested; Supplemental Information on Water Quality Consideration
Document Number: 2011-26843
Type: Notice
Date: 2011-10-18
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested; eForm 6 Access Request
Document Number: 2011-26842
Type: Notice
Date: 2011-10-18
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed collection; Comments Requested; Application for Registration of Firearms Acquired by Certain Governmental Entities
Document Number: 2011-23730
Type: Notice
Date: 2011-09-16
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Application for Registration of Firearms Acquired by Certain Governmental Entities
Document Number: 2011-23247
Type: Notice
Date: 2011-09-12
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities; Proposed Collection; Comments Requested
Document Number: 2011-22902
Type: Notice
Date: 2011-09-08
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested: Federal Explosives License/Permit (FEL) Renewal Application
Document Number: 2011-22181
Type: Notice
Date: 2011-08-31
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested: Federal Firearms License (FFL) RENEWAL Application
Document Number: 2011-22180
Type: Notice
Date: 2011-08-31
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested; Supplemental Information on Water Quality Considerations
Document Number: 2011-20629
Type: Notice
Date: 2011-08-15
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2011-20628
Type: Notice
Date: 2011-08-15
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested; Annual Firearms Manufacturing and Exportation Report
Document Number: 2011-20627
Type: Notice
Date: 2011-08-15
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities; Proposed Collection; Comments Requested: Firearms Transaction Record, Part 1, Over-the-Counter; Extension Without Change of a Currently Approved Information Collection
Document Number: 2011-19370
Type: Notice
Date: 2011-08-01
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities; Proposed Collection; Comments Requested: Investigator Integrity Questionnaire
Document Number: 2011-14726
Type: Notice
Date: 2011-06-15
Agency: Department of Justice, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2011-388
Type: Notice
Date: 2011-01-11
Agency: Department of Justice, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32693
Type: Notice
Date: 2010-12-28
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32687
Type: Notice
Date: 2010-12-28
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32685
Type: Notice
Date: 2010-12-28
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32682
Type: Notice
Date: 2010-12-28
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32679
Type: Notice
Date: 2010-12-28
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32676
Type: Notice
Date: 2010-12-28
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32673
Type: Notice
Date: 2010-12-28
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities:
Document Number: 2010-32670
Type: Notice
Date: 2010-12-28
Agency: Department of Justice, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32324
Type: Notice
Date: 2010-12-27
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32326
Type: Notice
Date: 2010-12-23
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32322
Type: Notice
Date: 2010-12-23
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32309
Type: Notice
Date: 2010-12-23
Agency: Department of Justice, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32307
Type: Notice
Date: 2010-12-23
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32306
Type: Notice
Date: 2010-12-23
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-32300
Type: Notice
Date: 2010-12-23
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-31764
Type: Notice
Date: 2010-12-17
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-31761
Type: Notice
Date: 2010-12-17
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-31758
Type: Notice
Date: 2010-12-17
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-31755
Type: Notice
Date: 2010-12-17
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-31752
Type: Notice
Date: 2010-12-17
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-31401
Type: Notice
Date: 2010-12-15
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-31281
Type: Notice
Date: 2010-12-14
Agency: Department of Justice, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-30002
Type: Notice
Date: 2010-11-30
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Commerce in Explosives; List of Explosive Materials (2010R-27T)
Document Number: 2010-28874
Type: Notice
Date: 2010-11-17
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
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.
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-28234
Type: Notice
Date: 2010-11-09
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-27531
Type: Notice
Date: 2010-11-01
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-27530
Type: Notice
Date: 2010-11-01
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 2010-27529
Type: Notice
Date: 2010-11-01
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau