21 CFR - Food and Drugs
Title 21 published on 2012-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28817 RIN Docket No. FDA-2000-N-0011 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective November 28, 2012. Submit electronic or written comments by January 28, 2013. 21 CFR Part 101 The Food and Drug Administration (FDA or we) is establishing January 1, 2016, as the uniform compliance date for food labeling regulations that are issued between January 1, 2013, and December 31, 2014. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 15, 2010, we established January 1, 2014, as the uniform compliance date for food labeling regulations issued between January 1, 2011, and December 31, 2012.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25989 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25989 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25989 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25989 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25989 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25510 RIN Docket No. DEA-357 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Final order. Effective Date: October 18, 2012. 21 CFR Part 1308 This Final Order is issued by the Administrator of the Drug Enforcement Administration (DEA) to extend the temporary scheduling of methylone (3,4-methylenedioxy-N-methylcathinone) including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule I of the Controlled Substances Act (CSA). The temporary scheduling of methylone is due to expire on October 20, 2012. This document will extend the temporary scheduling of methylone to April 20, 2013, or until rulemaking proceedings are completed, whichever occurs first.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24475 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 4, 2012. 21 CFR Parts 510, 520, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) during August 2012 and to reflect a change of sponsor's address for Baxter Healthcare Corp. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24475 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 4, 2012. 21 CFR Parts 510, 520, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) during August 2012 and to reflect a change of sponsor's address for Baxter Healthcare Corp. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24475 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 4, 2012. 21 CFR Parts 510, 520, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) during August 2012 and to reflect a change of sponsor's address for Baxter Healthcare Corp. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24331 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 15, 2012. 21 CFR Parts 510, 522, 524, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24331 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 15, 2012. 21 CFR Parts 510, 522, 524, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24331 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 15, 2012. 21 CFR Parts 510, 522, 524, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24331 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 15, 2012. 21 CFR Parts 510, 522, 524, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-23529 RIN DEPARTMENT OF JUSTICE, Drug Enforcement Administration 21 CFR Part 1300
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-23065 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective September 19, 2012. 21 CFR Parts 520 and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to remove a warning for growing cattle on pasture or in dry lot and to codify all monensin free-choice Type C medicated feeds in 21 CFR part 558. This action is being taken to improve the accuracy of the regulations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-23065 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective September 19, 2012. 21 CFR Parts 520 and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to remove a warning for growing cattle on pasture or in dry lot and to codify all monensin free-choice Type C medicated feeds in 21 CFR part 558. This action is being taken to improve the accuracy of the regulations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22646 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 14, 2012. 21 CFR Parts 510 and 520 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Phibro Animal Health Corp. FDA is also amending the regulations to reflect a change of sponsor's address for Phibro Animal Health Corp. and for Eka Chemicals, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22646 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 14, 2012. 21 CFR Parts 510 and 520 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Phibro Animal Health Corp. FDA is also amending the regulations to reflect a change of sponsor's address for Phibro Animal Health Corp. and for Eka Chemicals, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-21943 RIN 1105-AA74 Docket No. OAG 127 AG Order No. 3343-2012 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Final rule. Effective Date: This rule is effective October 12, 2012. 21 CFR Part 1316 Consistent with Executive Order 13563, by this rule the Department of Justice (the Department) revises, consolidates, and updates its regulations regarding the seizure, forfeiture, and remission of assets. The rule recognizes that as of 2002 the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) is now part of the Department, and consolidates the regulations governing the seizure and administrative forfeiture of property by ATF with those of the Drug Enforcement Administration (DEA) and the Federal Bureau of Investigation (FBI). The rule also conforms the seizure and forfeiture regulations of ATF, DEA, FBI, and the Department's Criminal Division to address procedural changes necessitated by the Civil Asset Forfeiture Reform Act (CAFRA) of 2000. The rule allows ATF, DEA, and FBI to publish administrative forfeiture notices on an official Internet government Web site instead of in newspapers. Lastly, the rule updates the regulations to reflect current forfeiture practice and clarifies the existing regulations pertaining to the return of assets to victims through the remission process.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22296 RIN Docket No. FDA-2011-C-0050 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; confirmation of effective date. Effective Date Confirmed: August 7, 2012. 21 CFR Part 74 The Food and Drug Administration (FDA) is confirming the effective date of August 7, 2012, for the final rule that published in the Federal Register of July 6, 2012 (77 FR 39921) and that revised the requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22196 RIN Docket No. FDA-2012-N-0902 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 20, 2012. 21 CFR Parts 510 and 522 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of four new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22196 RIN Docket No. FDA-2012-N-0902 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 20, 2012. 21 CFR Parts 510 and 522 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of four new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22194 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 10, 2012. 21 CFR Parts 520, 522, and 556 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22194 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 10, 2012. 21 CFR Parts 520, 522, and 556 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22194 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 10, 2012. 21 CFR Parts 520, 522, and 556 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-21353 RIN Docket No. FDA-2009-F-0570 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 29, 2012. Submit either electronic or written objections and requests for a hearing by September 28, 2012. See section VII of this document for information on filing objections. 21 CFR Part 172 The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D 2 bakers yeast as a source of vitamin D 2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D 2 per 100 grams (g) in the finished food. This action is in response to a petition filed by Lallemand, Inc. (Lallemand).
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20889 RIN Docket No. FDA-2011-N-0252 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary Direct final rule. This rule is effective January 10, 2013. Submit either electronic or written comments by November 13, 2012. If HHS/FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. 21 CFR Part 21 The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, “FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.” HHS/FDA is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations. HHS/FDA is issuing a direct final rule for this action because the Agency expects that there will be no significant adverse comment on this rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20610 RIN Docket No. FDA-2012-N-0205 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 22, 2012. 21 CFR Part 20 This final rule makes technical changes that will update a requirement that many of the written agreements and memoranda of understanding (MOUs) between the Food and Drug Administration (FDA) and other departments, Agencies, and organizations be published in the Federal Register . Because we already post and will continue to post our ongoing agreements and MOUs with other departments, Agencies, and organizations on our Web site upon their completion, this requirement is no longer necessary. This final rule, accordingly, eliminates it. We are making these technical changes to conserve Agency time and resources, reduce government paperwork, and eliminate unnecessary Federal Register printing costs while continuing to afford public access to these documents.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20609 RIN Docket No. FDA-2010-N-0612 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 21, 2012. 21 CFR Part 500 The Food and Drug Administration (FDA) is amending its regulations regarding compounds of carcinogenic concern used in food-producing animals. Specifically, the Agency is clarifying the definition of “S o ” and revising the definition of “S m ” so that it conforms to the clarified definition of S o . Other clarifying and conforming changes are also being made.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20383 RIN Docket No. FDA-2011-D-0398 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability. Submit either electronic or written comments on Agency guidances at any time. 21 CFR Parts 16 and 118 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” The guidance contains questions we have received on the final rule since its publication and responses to those questions, and is intended to assist egg producers and other persons who are covered by the final rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20383 RIN Docket No. FDA-2011-D-0398 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability. Submit either electronic or written comments on Agency guidances at any time. 21 CFR Parts 16 and 118 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” The guidance contains questions we have received on the final rule since its publication and responses to those questions, and is intended to assist egg producers and other persons who are covered by the final rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19498 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 9, 2012. 21 CFR Parts 510, 520, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19498 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 9, 2012. 21 CFR Parts 510, 520, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19498 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 9, 2012. 21 CFR Parts 510, 520, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19147 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 6, 2012. 21 CFR Parts 510, 522, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug regulations to reflect a change of sponsor's address for Veterinary Service, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19147 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 6, 2012. 21 CFR Parts 510, 522, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug regulations to reflect a change of sponsor's address for Veterinary Service, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19147 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 6, 2012. 21 CFR Parts 510, 522, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug regulations to reflect a change of sponsor's address for Veterinary Service, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-18764 RIN 0910-AF88 Docket No. FDA-2009-N-0114 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This final rule is effective October 1, 2012. 21 CFR Part 807 The Food and Drug Administration (FDA) is amending its regulations to reflect recent statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments Act of 2007 (FDAAA), enacted on September 27, 2007, amended the FD&C Act by requiring domestic and foreign device establishments to begin submitting their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the timeframes when establishments are required to submit such information. In addition, this final rule would facilitate FDA's collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The final rule will update certain provisions in the regulations to improve the quality of registration and listing information available to FDA. FDA relies on having complete and accurate registration and listing information in order to accomplish a number of important public health objectives.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-18495 RIN 1117-AB31 Docket No. DEA-341F DEPARTMENT OF JUSTICE, Drug Enforcement Administration Final rule. Effective Date: August 29, 2012. 21 CFR Part 1300 With the issuance of this Final Rule, the Administrator of the DEA classifies the following two steroids as “anabolic steroids” under the Controlled Substances Act (CSA): prostanozol (17β-hydroxy-5α-androstano[3,2-c]pyrazole) and methasterone (2α,17α-dimethyl-5α-androstan-17β-ol-3-one). These steroids and their salts, esters, and ethers are Schedule III controlled substances subject to the regulatory control provisions of the CSA.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-17366 RIN Docket No. FDA-2012-F-0031 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 17, 2012. Submit either electronic or written objections and requests for a hearing by August 16, 2012. See section VIII of this document for information on the filing of objections. 21 CFR Part 177 The Food and Drug Administration (FDA or the Agency) is amending the food additive regulations to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups) because these uses have been abandoned. The action is in response to a petition filed by the American Chemistry Council.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16581 RIN Docket No. FDA-2011-C-0050 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 7, 2012, except as to any provisions that may be stayed by the filing of proper objections. Submit either electronic or written objections and requests for a hearing by August 6, 2012. See section XI of this document for information on the filing of objections. 21 CFR Part 74 The Food and Drug Administration (FDA or the Agency) is revising its requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol. This action is in response to a petition filed by Sun Chemical Corp.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16486 RIN Docket No. FDA-2011-N-0505 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 4, 2012. 21 CFR Part 870 The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the cardiovascular permanent pacemaker electrode. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the device. This action implements certain statutory requirements.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16203 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 3, 2012. 21 CFR Parts 522 and 556 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16203 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 3, 2012. 21 CFR Parts 522 and 556 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-15713 RIN Docket No. FDA-2012-N-0205 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Direct final rule; withdrawal. The direct final rule published at 77 FR 16923, March 23, 2012, is withdrawn, effective June 27, 2012. 21 CFR Part 20 The Food and Drug Administration (FDA) published in the Federal Register of March 23, 2012 (77 FR 16923), a direct final rule making technical changes to update a requirement that many of its written agreements and memoranda of understanding with other departments, Agencies, and organizations be published in the Federal Register. The comment period closed June 6, 2012. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-15258 RIN Docket No. FDA-2011-N-0526 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 20, 2012. 21 CFR Part 870 The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for pacemaker programmers. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-15244 RIN Docket No. FDA-2011-N-0522 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 20, 2012. 21 CFR Part 870 The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for implantable pacemaker pulse generators. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-14635 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 15, 2012. 21 CFR Part 516 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a conditionally approved supplemental application for conditional approval of a new animal drug (CNADA) intended for a minor use filed by AB Science. The supplemental CNADA provides for a revised indication for masitinib mesylate tablets in dogs.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-14035 RIN Docket No. FDA-2007-F-0390 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 11, 2012. Submit either electronic or written objections and requests for a hearing by July 11, 2012. See section VIII of this document for information on the filing of objections. 21 CFR Part 179 The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a carbon dioxide laser for etching information on the surface of fresh, intact citrus fruit. This action is in response to a petition filed by Durand-Wayland, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13409 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 4, 2012. 21 CFR Part 510 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Novopharm Ltd. to Teva Canada Ltd.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13010 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 510, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for cattle and for melengestrol acetate liquid Type A medicated article and use in combination medicated feeds for heifers fed in confinement for slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc., to Elanco Animal Health, Division of Eli Lilly & Co.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13010 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 510, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for cattle and for melengestrol acetate liquid Type A medicated article and use in combination medicated feeds for heifers fed in confinement for slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc., to Elanco Animal Health, Division of Eli Lilly & Co.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13010 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 510, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for cattle and for melengestrol acetate liquid Type A medicated article and use in combination medicated feeds for heifers fed in confinement for slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc., to Elanco Animal Health, Division of Eli Lilly & Co.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12594 RIN 0910-AG16 Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, correction. Effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12594 RIN 0910-AG16 Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, correction. Effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12594 RIN 0910-AG16 Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, correction. Effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11937 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 17, 2012. 21 CFR Parts 510, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11937 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 17, 2012. 21 CFR Parts 510, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11937 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 17, 2012. 21 CFR Parts 510, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11937 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 17, 2012. 21 CFR Parts 510, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11382 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 14, 2012. 21 CFR Part 520 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five abbreviated new animal drug applications (ANADAs) for griseofulvin powder, levamisole hydrochloride soluble powder, and oxytetracycline hydrochloride soluble powder from Teva Animal Health, Inc., to Cross Vetpharm Group, Ltd.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11391 RIN Docket No. FDA-1999-F-0021 formerly 1999F-2673 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; denial of requests for a hearing and response to objections. 21 CFR Part 179 The Food and Drug Administration (FDA) is denying requests for a hearing on the final rule that amended the food additive regulations to provide for the safe use of ionizing radiation for the control of microbial pathogens in seeds for sprouting. After reviewing objections to the final rule and requests for a hearing, FDA has concluded that the objections do not justify a hearing or otherwise provide a basis for revoking the regulation.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11390 RIN 0910-AF43 Docket No. FDA-1978-N-0018 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; delay of compliance dates; request for comments. Effective Date: This final rule is effective June 18, 2012. The final rule published at 76 FR 35620 on June 17, 2011, remains effective June 18, 2012. Comment date: Submit written or electronic comments on the delay of compliance dates by May 21, 2012. Compliance Dates: The compliance dates for the final rule published at 76 FR 35620 on June 17, 2011, including the lifting of the delay of implementation date for 21 CFR 201.66 as published at 69 FR 53801, September 3, 2004, are delayed until December 17, 2013, for products with annual sales of less than $25,000, and until December 17, 2012 for all other products subject to the rule. 21 CFR Parts 201 and 310 The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11390 RIN 0910-AF43 Docket No. FDA-1978-N-0018 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; delay of compliance dates; request for comments. Effective Date: This final rule is effective June 18, 2012. The final rule published at 76 FR 35620 on June 17, 2011, remains effective June 18, 2012. Comment date: Submit written or electronic comments on the delay of compliance dates by May 21, 2012. Compliance Dates: The compliance dates for the final rule published at 76 FR 35620 on June 17, 2011, including the lifting of the delay of implementation date for 21 CFR 201.66 as published at 69 FR 53801, September 3, 2004, are delayed until December 17, 2013, for products with annual sales of less than $25,000, and until December 17, 2012 for all other products subject to the rule. 21 CFR Parts 201 and 310 The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10892 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 7, 2012. 21 CFR Parts 510 and 522 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor name from Bioniche Teoranta to Mylan Institutional, LLC; a change of sponsor for fomepizole injectable solution from Synerx Pharma, LLC, to Mylan Institutional, LLC; and a change of sponsor address for Modern Veterinary Therapeutics, LLC.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10892 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 7, 2012. 21 CFR Parts 510 and 522 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor name from Bioniche Teoranta to Mylan Institutional, LLC; a change of sponsor for fomepizole injectable solution from Synerx Pharma, LLC, to Mylan Institutional, LLC; and a change of sponsor address for Modern Veterinary Therapeutics, LLC.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10632 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 3, 2012. 21 CFR Parts 522 and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during February 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10632 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 3, 2012. 21 CFR Parts 522 and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during February 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10649 RIN Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10649 RIN Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10649 RIN Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10292 RIN 0910-AG49 Docket No. FDA-2011-N-0079 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 16, 312, 511, and 812 The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10292 RIN 0910-AG49 Docket No. FDA-2011-N-0079 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 16, 312, 511, and 812 The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10292 RIN 0910-AG49 Docket No. FDA-2011-N-0079 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 16, 312, 511, and 812 The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10292 RIN 0910-AG49 Docket No. FDA-2011-N-0079 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 16, 312, 511, and 812 The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-9708 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective April 23, 2012. 21 CFR Part 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for approval of a new concentration of a Type A medicated article.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-9196 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective April 17, 2012. 21 CFR Part 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a tiamulin Type A medicated article that pertain to the production indications for use of increased rate of weight gain and improved feed efficiency in swine.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-8322 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective April 9, 2012. 21 CFR Part 520 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) for lincomycin hydrochloride; penicillin G potassium, USP; and tetracycline hydrochloride soluble powders administered in drinking water from Teva Animal Health, Inc., to Quo Vademus, LLC.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-7757 RIN Docket No. FDA-2012-N-0165 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective April 9, 2012. 21 CFR Part 866 In the Federal Register of March 9, 2012 (76 FR 14272), the Food and Drug Administration (FDA) classified norovirus serological reagents into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices. The document published with inadvertent errors in the Analysis of Impacts section. This document corrects those errors.
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to Title 21 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28967 RIN Docket No. 1999F-5321) DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective November 30, 2012. Submit either electronic or written objections and requests for a hearing by December 31, 2012. See section VIII of this document for information on the filing of objections. 21 CFR Part 179 The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a 4.5 kilogray (kGy) maximum absorbed dose of ionizing radiation to treat unrefrigerated (as well as refrigerated) uncooked meat, meat byproducts, and certain meat food products to reduce levels of foodborne pathogens and extend shelf life. This action is in response to a petition filed by the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS).
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28968 RIN Docket No. 1999F-5322) DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective November 30, 2012. Submit either electronic or written objections and requests for a hearing by December 31, 2012. See section VIII of this document for information on the filing of objections. 21 CFR Part 179 The Food and Drug Administration (FDA) is amending the food additive regulations to increase the maximum dose of ionizing radiation permitted in the treatment of poultry products, to include specific language intended to clarify the poultry products covered by the regulations, and to remove the limitation that any packaging used during irradiation of poultry shall not exclude oxygen. This action is in response to a petition filed by the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS).
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28817 RIN Docket No. FDA-2000-N-0011 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective November 28, 2012. Submit electronic or written comments by January 28, 2013. 21 CFR Part 101 The Food and Drug Administration (FDA or we) is establishing January 1, 2016, as the uniform compliance date for food labeling regulations that are issued between January 1, 2013, and December 31, 2014. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 15, 2010, we established January 1, 2014, as the uniform compliance date for food labeling regulations issued between January 1, 2011, and December 31, 2012.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28835 RIN Docket No. FDA-2012-N-1148 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of public hearing; request for comments. The public hearing will be held on December 17, 2012, 8 a.m. to 5 p.m. Individuals who wish to present at the public hearing must register by December 6, 2012. Section III of this document provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until January 2, 2013. 21 CFR Part 15 The Food and Drug Administration (FDA) is announcing a 1-day public hearing to obtain input on certain questions related to the implementation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). This public hearing is being held to obtain comments from the public on FDA consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and to request input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28015 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; amendment. Submit either electronic or written comments on the amendment to the Proposed Rule by December 19, 2012. See section VII for the proposed effective dates of a final rule based on the amended proposed rule. 21 CFR Part 801 The Food and Drug Administration (FDA) is amending its July 10, 2012, proposed rule (77 FR 40736) to establish a unique device identification system as required by recent amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law; section 614 of FDASIA amends the FD&C Act in ways that require modification of the timeframe for implementation of the proposed rule's requirements as they apply to devices that are implantable, life-saving (life-supporting), or life-sustaining.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-26315 RIN Docket No. FDA-2009-F-0303 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition. Submit either electronic or written comments on the petitioner's environmental assessment by November 26, 2012. 21 CFR Part 172 The Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by Ajinomoto Co., Inc., to indicate that the petitioned additive, N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl-α-aspartyl]-L-phenylalanine 1-methyl ester, monohydrate (proposed additive name Advantame, CAS Reg. No. 714229-20-6), is for use as a non-nutritive sweetener and flavor enhancer in foods generally, except meat and poultry. The previous filing notice indicated that the proposed additive was for use as a non-nutritive sweetener in tabletop applications and powdered beverage mixes.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-26242 RIN Docket No. 2004C‐0078) DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of withdrawal. 21 CFR Part 73 The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a color additive petition (CAP 4C0276) proposing that the color additive regulations be amended to provide for the safe use of synthetic iron oxide as a color additive in or on cooked meat products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25989 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25989 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25989 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25989 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25989 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25510 RIN Docket No. DEA-357 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Final order. Effective Date: October 18, 2012. 21 CFR Part 1308 This Final Order is issued by the Administrator of the Drug Enforcement Administration (DEA) to extend the temporary scheduling of methylone (3,4-methylenedioxy-N-methylcathinone) including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule I of the Controlled Substances Act (CSA). The temporary scheduling of methylone is due to expire on October 20, 2012. This document will extend the temporary scheduling of methylone to April 20, 2013, or until rulemaking proceedings are completed, whichever occurs first.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25509 RIN Docket No. DEA-357 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Notice of proposed rulemaking. DEA will permit interested persons to file written comments on this proposal pursuant to 21 CFR 1308.43(g). Electronic comments must be submitted and written comments must be postmarked on or before December 17, 2012. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after midnight Eastern Time on the last day of the comment period. Interested persons, defined at 21 CFR 1300.01 as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811),” may file a request for hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45 and 1316.47. Requests for hearing, notices of appearance, and waivers of participation must be received on or before November 16, 2012. 21 CFR Part 1308 The Drug Enforcement Administration (DEA) proposes placing 3,4-methylenedioxy-N-methylcathinone (methylone) including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule I of the Controlled Substances Act (CSA). This proposed action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24475 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 4, 2012. 21 CFR Parts 510, 520, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) during August 2012 and to reflect a change of sponsor's address for Baxter Healthcare Corp. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24475 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 4, 2012. 21 CFR Parts 510, 520, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) during August 2012 and to reflect a change of sponsor's address for Baxter Healthcare Corp. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24475 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 4, 2012. 21 CFR Parts 510, 520, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) during August 2012 and to reflect a change of sponsor's address for Baxter Healthcare Corp. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24331 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 15, 2012. 21 CFR Parts 510, 522, 524, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24331 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 15, 2012. 21 CFR Parts 510, 522, 524, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24331 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 15, 2012. 21 CFR Parts 510, 522, 524, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24331 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 15, 2012. 21 CFR Parts 510, 522, 524, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-23740 RIN Docket No. FDA-2012-N-0447 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Advance notice of proposed rulemaking; extension of comment period. The comment period for the advance notice of proposed rulemaking that published July 27, 2012 (77 FR 44177) is extended. Submit written or electronic comments by November 26, 2012. 21 CFR Part 514 The Food and Drug Administration (FDA) is extending the comment period for the advance notice of proposed rulemaking that appeared in the Federal Register of July 27, 2012. In the advance notice of proposed rulemaking, FDA requested comments regarding potential changes to its regulations relating to records and reports for approved antimicrobial new animal drugs. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-23529 RIN DEPARTMENT OF JUSTICE, Drug Enforcement Administration 21 CFR Part 1300
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-23065 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective September 19, 2012. 21 CFR Parts 520 and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to remove a warning for growing cattle on pasture or in dry lot and to codify all monensin free-choice Type C medicated feeds in 21 CFR part 558. This action is being taken to improve the accuracy of the regulations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-23065 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective September 19, 2012. 21 CFR Parts 520 and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to remove a warning for growing cattle on pasture or in dry lot and to codify all monensin free-choice Type C medicated feeds in 21 CFR part 558. This action is being taken to improve the accuracy of the regulations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22821 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. Submit either electronic or written comments on the proposed collection of information by October 25, 2012. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22821 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. Submit either electronic or written comments on the proposed collection of information by October 25, 2012. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22821 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. Submit either electronic or written comments on the proposed collection of information by October 25, 2012. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22821 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. Submit either electronic or written comments on the proposed collection of information by October 25, 2012. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22821 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. Submit either electronic or written comments on the proposed collection of information by October 25, 2012. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22821 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. Submit either electronic or written comments on the proposed collection of information by October 25, 2012. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22821 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. Submit either electronic or written comments on the proposed collection of information by October 25, 2012. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22821 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. Submit either electronic or written comments on the proposed collection of information by October 25, 2012. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22821 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. Submit either electronic or written comments on the proposed collection of information by October 25, 2012. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22821 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. Submit either electronic or written comments on the proposed collection of information by October 25, 2012. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22646 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 14, 2012. 21 CFR Parts 510 and 520 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Phibro Animal Health Corp. FDA is also amending the regulations to reflect a change of sponsor's address for Phibro Animal Health Corp. and for Eka Chemicals, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22646 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 14, 2012. 21 CFR Parts 510 and 520 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Phibro Animal Health Corp. FDA is also amending the regulations to reflect a change of sponsor's address for Phibro Animal Health Corp. and for Eka Chemicals, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-21943 RIN 1105-AA74 Docket No. OAG 127 AG Order No. 3343-2012 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Final rule. Effective Date: This rule is effective October 12, 2012. 21 CFR Part 1316 Consistent with Executive Order 13563, by this rule the Department of Justice (the Department) revises, consolidates, and updates its regulations regarding the seizure, forfeiture, and remission of assets. The rule recognizes that as of 2002 the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) is now part of the Department, and consolidates the regulations governing the seizure and administrative forfeiture of property by ATF with those of the Drug Enforcement Administration (DEA) and the Federal Bureau of Investigation (FBI). The rule also conforms the seizure and forfeiture regulations of ATF, DEA, FBI, and the Department's Criminal Division to address procedural changes necessitated by the Civil Asset Forfeiture Reform Act (CAFRA) of 2000. The rule allows ATF, DEA, and FBI to publish administrative forfeiture notices on an official Internet government Web site instead of in newspapers. Lastly, the rule updates the regulations to reflect current forfeiture practice and clarifies the existing regulations pertaining to the return of assets to victims through the remission process.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22422 RIN Docket No. FDA-2012-F-0949 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition. Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by October 12, 2012. 21 CFR Part 573 The Food and Drug Administration (FDA) is announcing that Arcadia Biosciences, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use in dry dog food of oil from a variety of bioengineered safflower.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22296 RIN Docket No. FDA-2011-C-0050 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; confirmation of effective date. Effective Date Confirmed: August 7, 2012. 21 CFR Part 74 The Food and Drug Administration (FDA) is confirming the effective date of August 7, 2012, for the final rule that published in the Federal Register of July 6, 2012 (77 FR 39921) and that revised the requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22196 RIN Docket No. FDA-2012-N-0902 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 20, 2012. 21 CFR Parts 510 and 522 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of four new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22196 RIN Docket No. FDA-2012-N-0902 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 20, 2012. 21 CFR Parts 510 and 522 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of four new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22194 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 10, 2012. 21 CFR Parts 520, 522, and 556 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22194 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 10, 2012. 21 CFR Parts 520, 522, and 556 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-22194 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 10, 2012. 21 CFR Parts 520, 522, and 556 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-21917 RIN Docket No. FDA-2012-C-0900 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition. 21 CFR Part 73 The Food and Drug Administration (FDA) is announcing that GNT USA, Inc. (GNT) has filed a petition proposing that the color additive regulations be amended to provide for the safe use of spirulina concentrate, made from the edible blue-green cyanobacterium Arthrospira platensis (also known as Spirulina platensis ) as a color additive in food.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-21639 RIN Docket No. FDA-2011-F-0765 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition. Submit either electronic or written comments on the petitioner's environmental assessment by October 4, 2012. 21 CFR Part 172 The Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by Nexira proposing that the food additive regulations be amended to provide for the expanded safe use of acacia gum (gum arabic) in foods.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-21353 RIN Docket No. FDA-2009-F-0570 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 29, 2012. Submit either electronic or written objections and requests for a hearing by September 28, 2012. See section VII of this document for information on filing objections. 21 CFR Part 172 The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D 2 bakers yeast as a source of vitamin D 2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D 2 per 100 grams (g) in the finished food. This action is in response to a petition filed by Lallemand, Inc. (Lallemand).
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20889 RIN Docket No. FDA-2011-N-0252 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary Direct final rule. This rule is effective January 10, 2013. Submit either electronic or written comments by November 13, 2012. If HHS/FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. 21 CFR Part 21 The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, “FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.” HHS/FDA is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations. HHS/FDA is issuing a direct final rule for this action because the Agency expects that there will be no significant adverse comment on this rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20890 RIN Docket No. FDA-2011-N-0252 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary Proposed rule. Submit either electronic or written comments by November 13, 2012. If HHS/FDA receives any significant adverse comments, the Agency will publish a document withdrawing the direct final rule within 30 days after the comment period ends. HHS/FDA will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures. 21 CFR Part 21 The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, “FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.” HHS/FDA proposes to exempt this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20610 RIN Docket No. FDA-2012-N-0205 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 22, 2012. 21 CFR Part 20 This final rule makes technical changes that will update a requirement that many of the written agreements and memoranda of understanding (MOUs) between the Food and Drug Administration (FDA) and other departments, Agencies, and organizations be published in the Federal Register . Because we already post and will continue to post our ongoing agreements and MOUs with other departments, Agencies, and organizations on our Web site upon their completion, this requirement is no longer necessary. This final rule, accordingly, eliminates it. We are making these technical changes to conserve Agency time and resources, reduce government paperwork, and eliminate unnecessary Federal Register printing costs while continuing to afford public access to these documents.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20609 RIN Docket No. FDA-2010-N-0612 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 21, 2012. 21 CFR Part 500 The Food and Drug Administration (FDA) is amending its regulations regarding compounds of carcinogenic concern used in food-producing animals. Specifically, the Agency is clarifying the definition of “S o ” and revising the definition of “S m ” so that it conforms to the clarified definition of S o . Other clarifying and conforming changes are also being made.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20383 RIN Docket No. FDA-2011-D-0398 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability. Submit either electronic or written comments on Agency guidances at any time. 21 CFR Parts 16 and 118 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” The guidance contains questions we have received on the final rule since its publication and responses to those questions, and is intended to assist egg producers and other persons who are covered by the final rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20383 RIN Docket No. FDA-2011-D-0398 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability. Submit either electronic or written comments on Agency guidances at any time. 21 CFR Parts 16 and 118 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” The guidance contains questions we have received on the final rule since its publication and responses to those questions, and is intended to assist egg producers and other persons who are covered by the final rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19498 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 9, 2012. 21 CFR Parts 510, 520, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19498 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 9, 2012. 21 CFR Parts 510, 520, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19498 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 9, 2012. 21 CFR Parts 510, 520, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19147 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 6, 2012. 21 CFR Parts 510, 522, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug regulations to reflect a change of sponsor's address for Veterinary Service, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19147 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 6, 2012. 21 CFR Parts 510, 522, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug regulations to reflect a change of sponsor's address for Veterinary Service, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19147 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 6, 2012. 21 CFR Parts 510, 522, and 524 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug regulations to reflect a change of sponsor's address for Veterinary Service, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-18764 RIN 0910-AF88 Docket No. FDA-2009-N-0114 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This final rule is effective October 1, 2012. 21 CFR Part 807 The Food and Drug Administration (FDA) is amending its regulations to reflect recent statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments Act of 2007 (FDAAA), enacted on September 27, 2007, amended the FD&C Act by requiring domestic and foreign device establishments to begin submitting their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the timeframes when establishments are required to submit such information. In addition, this final rule would facilitate FDA's collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The final rule will update certain provisions in the regulations to improve the quality of registration and listing information available to FDA. FDA relies on having complete and accurate registration and listing information in order to accomplish a number of important public health objectives.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-18495 RIN 1117-AB31 Docket No. DEA-341F DEPARTMENT OF JUSTICE, Drug Enforcement Administration Final rule. Effective Date: August 29, 2012. 21 CFR Part 1300 With the issuance of this Final Rule, the Administrator of the DEA classifies the following two steroids as “anabolic steroids” under the Controlled Substances Act (CSA): prostanozol (17β-hydroxy-5α-androstano[3,2-c]pyrazole) and methasterone (2α,17α-dimethyl-5α-androstan-17β-ol-3-one). These steroids and their salts, esters, and ethers are Schedule III controlled substances subject to the regulatory control provisions of the CSA.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-18366 RIN Docket No. FDA-2012-N-0447 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Advance notice of proposed rulemaking. Submit electronic or written comments by September 25, 2012. 21 CFR Part 514 The Food and Drug Administration (FDA or Agency) is soliciting comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs. FDA is considering revisions to this regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). As part of that process, FDA is reviewing other reporting requirements applicable to antimicrobial new animal drug sponsors to determine whether additional information should be reported. Collecting data on antimicrobial drugs used in food-producing animals will assist FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-17432 RIN Docket No. FDA-2012-F-0480 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition; correction. 21 CFR Part 172 The Food and drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 13, 2012 (77 FR 35317). The document announced that Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza had jointly filed a petition proposing that the food additive regulations be amended to provide for the safe use of folic acid in corn masa flour. The document was published with an error in the title of the document signer's signature. This document corrects that error.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-17366 RIN Docket No. FDA-2012-F-0031 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 17, 2012. Submit either electronic or written objections and requests for a hearing by August 16, 2012. See section VIII of this document for information on the filing of objections. 21 CFR Part 177 The Food and Drug Administration (FDA or the Agency) is amending the food additive regulations to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups) because these uses have been abandoned. The action is in response to a petition filed by the American Chemistry Council.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-17367 RIN Docket No. FDA-2012-F-0728 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition. Submit either electronic or written comments by September 17, 2012. 21 CFR Part 175 The Food and Drug Administration (FDA) is announcing that Representative Edward J. Markey has filed a petition proposing that the food additive regulations be amended to no longer provide for the use of Bisphenol A (BPA)-based epoxy resins as coatings in packaging for infant formula because these uses have been abandoned. FDA expressly requests comments on the petitioner's request.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16621 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16621 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16621 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16621 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16621 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16621 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16621 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16621 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16621 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16621 RIN 0910-AG31 Docket No. FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16581 RIN Docket No. FDA-2011-C-0050 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 7, 2012, except as to any provisions that may be stayed by the filing of proper objections. Submit either electronic or written objections and requests for a hearing by August 6, 2012. See section XI of this document for information on the filing of objections. 21 CFR Part 74 The Food and Drug Administration (FDA or the Agency) is revising its requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol. This action is in response to a petition filed by Sun Chemical Corp.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16486 RIN Docket No. FDA-2011-N-0505 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 4, 2012. 21 CFR Part 870 The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the cardiovascular permanent pacemaker electrode. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the device. This action implements certain statutory requirements.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16487 RIN Docket No. FDA-2012-N-0378 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments by October 4, 2012. Submit requests for a change in classification by July 23, 2012. FDA intends that, if a final rule based on this proposed rule is issued, anyone who wishes to continue to market the device will need to submit a PMA or a notice of completion of a PDP within 90 days of the effective date of the final rule. Please see section XII of this document for the proposed effective date of any final rule that may publish based on this proposal. 21 CFR Part 890 The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendments device, shortwave diathermy (SWD) for all other uses. This device applies to the body electromagnetic energy in the radio frequency bands of 13 megahertz to 27.12 megahertz and is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues. It is not intended for treatment of malignancies. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. This action implements certain statutory requirements.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16203 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 3, 2012. 21 CFR Parts 522 and 556 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-16203 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 3, 2012. 21 CFR Parts 522 and 556 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-15713 RIN Docket No. FDA-2012-N-0205 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Direct final rule; withdrawal. The direct final rule published at 77 FR 16923, March 23, 2012, is withdrawn, effective June 27, 2012. 21 CFR Part 20 The Food and Drug Administration (FDA) published in the Federal Register of March 23, 2012 (77 FR 16923), a direct final rule making technical changes to update a requirement that many of its written agreements and memoranda of understanding with other departments, Agencies, and organizations be published in the Federal Register. The comment period closed June 6, 2012. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-15258 RIN Docket No. FDA-2011-N-0526 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 20, 2012. 21 CFR Part 870 The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for pacemaker programmers. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-15244 RIN Docket No. FDA-2011-N-0522 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 20, 2012. 21 CFR Part 870 The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for implantable pacemaker pulse generators. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-15024 RIN Docket No. FDA-2012-N-0303 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by September 18, 2012. Please see section XIII of this document for the effective date of any final rule that may publish based on this proposal. 21 CFR Part 876 The Food and Drug Administration (FDA) is proposing to reclassify the implanted blood access device preamendments class III device into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-14635 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 15, 2012. 21 CFR Part 516 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a conditionally approved supplemental application for conditional approval of a new animal drug (CNADA) intended for a minor use filed by AB Science. The supplemental CNADA provides for a revised indication for masitinib mesylate tablets in dogs.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-14263 RIN Docket No. FDA-2012-F-0480 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition. 21 CFR Part 172 The Food and Drug Administration (FDA) is announcing that Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza have jointly filed a petition proposing that the food additive regulations be amended to provide for the safe use of folic acid in corn masa flour.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-14035 RIN Docket No. FDA-2007-F-0390 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 11, 2012. Submit either electronic or written objections and requests for a hearing by July 11, 2012. See section VIII of this document for information on the filing of objections. 21 CFR Part 179 The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a carbon dioxide laser for etching information on the surface of fresh, intact citrus fruit. This action is in response to a petition filed by Durand-Wayland, Inc.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13409 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 4, 2012. 21 CFR Part 510 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Novopharm Ltd. to Teva Canada Ltd.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13010 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 510, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for cattle and for melengestrol acetate liquid Type A medicated article and use in combination medicated feeds for heifers fed in confinement for slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc., to Elanco Animal Health, Division of Eli Lilly & Co.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13010 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 510, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for cattle and for melengestrol acetate liquid Type A medicated article and use in combination medicated feeds for heifers fed in confinement for slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc., to Elanco Animal Health, Division of Eli Lilly & Co.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13010 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 510, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for cattle and for melengestrol acetate liquid Type A medicated article and use in combination medicated feeds for heifers fed in confinement for slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc., to Elanco Animal Health, Division of Eli Lilly & Co.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12594 RIN 0910-AG16 Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, correction. Effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12594 RIN 0910-AG16 Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, correction. Effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12594 RIN 0910-AG16 Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, correction. Effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11937 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 17, 2012. 21 CFR Parts 510, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11937 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 17, 2012. 21 CFR Parts 510, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11937 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 17, 2012. 21 CFR Parts 510, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11937 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 17, 2012. 21 CFR Parts 510, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11382 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 14, 2012. 21 CFR Part 520 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five abbreviated new animal drug applications (ANADAs) for griseofulvin powder, levamisole hydrochloride soluble powder, and oxytetracycline hydrochloride soluble powder from Teva Animal Health, Inc., to Cross Vetpharm Group, Ltd.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11391 RIN Docket No. FDA-1999-F-0021 formerly 1999F-2673 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; denial of requests for a hearing and response to objections. 21 CFR Part 179 The Food and Drug Administration (FDA) is denying requests for a hearing on the final rule that amended the food additive regulations to provide for the safe use of ionizing radiation for the control of microbial pathogens in seeds for sprouting. After reviewing objections to the final rule and requests for a hearing, FDA has concluded that the objections do not justify a hearing or otherwise provide a basis for revoking the regulation.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11390 RIN 0910-AF43 Docket No. FDA-1978-N-0018 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; delay of compliance dates; request for comments. Effective Date: This final rule is effective June 18, 2012. The final rule published at 76 FR 35620 on June 17, 2011, remains effective June 18, 2012. Comment date: Submit written or electronic comments on the delay of compliance dates by May 21, 2012. Compliance Dates: The compliance dates for the final rule published at 76 FR 35620 on June 17, 2011, including the lifting of the delay of implementation date for 21 CFR 201.66 as published at 69 FR 53801, September 3, 2004, are delayed until December 17, 2013, for products with annual sales of less than $25,000, and until December 17, 2012 for all other products subject to the rule. 21 CFR Parts 201 and 310 The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11390 RIN 0910-AF43 Docket No. FDA-1978-N-0018 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; delay of compliance dates; request for comments. Effective Date: This final rule is effective June 18, 2012. The final rule published at 76 FR 35620 on June 17, 2011, remains effective June 18, 2012. Comment date: Submit written or electronic comments on the delay of compliance dates by May 21, 2012. Compliance Dates: The compliance dates for the final rule published at 76 FR 35620 on June 17, 2011, including the lifting of the delay of implementation date for 21 CFR 201.66 as published at 69 FR 53801, September 3, 2004, are delayed until December 17, 2013, for products with annual sales of less than $25,000, and until December 17, 2012 for all other products subject to the rule. 21 CFR Parts 201 and 310 The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10892 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 7, 2012. 21 CFR Parts 510 and 522 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor name from Bioniche Teoranta to Mylan Institutional, LLC; a change of sponsor for fomepizole injectable solution from Synerx Pharma, LLC, to Mylan Institutional, LLC; and a change of sponsor address for Modern Veterinary Therapeutics, LLC.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10892 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 7, 2012. 21 CFR Parts 510 and 522 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor name from Bioniche Teoranta to Mylan Institutional, LLC; a change of sponsor for fomepizole injectable solution from Synerx Pharma, LLC, to Mylan Institutional, LLC; and a change of sponsor address for Modern Veterinary Therapeutics, LLC.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10632 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 3, 2012. 21 CFR Parts 522 and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during February 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10632 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 3, 2012. 21 CFR Parts 522 and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during February 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10649 RIN Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10649 RIN Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10649 RIN Docket No. FDA-2011-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 4, 2012. 21 CFR Parts 600, 610, and 680 The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10292 RIN 0910-AG49 Docket No. FDA-2011-N-0079 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 16, 312, 511, and 812 The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10292 RIN 0910-AG49 Docket No. FDA-2011-N-0079 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 16, 312, 511, and 812 The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10292 RIN 0910-AG49 Docket No. FDA-2011-N-0079 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 16, 312, 511, and 812 The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-10292 RIN 0910-AG49 Docket No. FDA-2011-N-0079 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 16, 312, 511, and 812 The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-9708 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective April 23, 2012. 21 CFR Part 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for approval of a new concentration of a Type A medicated article.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-9196 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective April 17, 2012. 21 CFR Part 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a tiamulin Type A medicated article that pertain to the production indications for use of increased rate of weight gain and improved feed efficiency in swine.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-8844 RIN Docket No. FDA-2010-N-0155 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; draft text for proposed regulation. Submit either electronic or written comments by July 12, 2012. 21 CFR Part 558 The Food and Drug Administration (FDA) is announcing the availability of draft text for a proposed regulation intended to improve the efficiency of FDA's Veterinary Feed Directive (VFD) program. The Agency is making this draft text for a proposal available because of the complex scientific and regulatory issues involved, and because of the potential impact that changes to the VFD regulations may have on stakeholders. The Agency invites the public to submit comments with questions and concerns about the draft text for a proposed regulation.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-8322 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective April 9, 2012. 21 CFR Part 520 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) for lincomycin hydrochloride; penicillin G potassium, USP; and tetracycline hydrochloride soluble powders administered in drinking water from Teva Animal Health, Inc., to Quo Vademus, LLC.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-7757 RIN Docket No. FDA-2012-N-0165 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective April 9, 2012. 21 CFR Part 866 In the Federal Register of March 9, 2012 (76 FR 14272), the Food and Drug Administration (FDA) classified norovirus serological reagents into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices. The document published with inadvertent errors in the Analysis of Impacts section. This document corrects those errors.