United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2013_register executive 2013-11-13 article Proposed Rules D09002ee1c7fac976 D09002ee1c7fac9ff United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a "changes being effected" (CBE-0) supplement. The proposed rule describes the process by which information regarding a CBE-0 labeling supplement submitted by a new drug application (NDA) holder, an ANDA holder, or a biologics license application (BLA) holder would be made publicly available during FDA's review of the labeling change and clarifies requirements for all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA or ANDA holder's CBE-0 labeling supplement. The proposed rule also would amend the regulations to allow submission of a CBE-0 labeling supplement for certain changes to the "Highlights of Prescribing Information" for drug products with labeling in the "Physician Labeling Rule" (PLR) format. 78 FR 67985 https://www.govinfo.gov/app/details/FR-2013-11-13/2013-26799 2013-26799 fr13no13-15 RIN 0910-AG94 4160-01-P Docket No. FDA-2013-N-0500 https://www.govinfo.gov/app/details/FR-2013-11-13/2013-26799 https://www.govinfo.gov/content/pkg/FR-2013-11-13/html/2013-26799.htm https://www.govinfo.gov/content/pkg/FR-2013-11-13/pdf/2013-26799.pdf Administrative Practice and Procedure Confidential Business Information Drugs Reporting and Recordkeeping Requirements Biologics 15 p. 67985 67999 78 FR 67985 Title 21 Part 314 21 CFR Part 314 Title 21 Part 601 21 CFR Part 601 RIN 0910-AG94 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Federal Register Vol. 78, Issue PRORULE 2013-26799 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-01-13 Docket No. FDA-2013-N-0500 4160-01-P 2013-26799 Proposed rule.

The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a "changes being effected" (CBE-0) supplement. The proposed rule describes the process by which information regarding a CBE-0 labeling supplement submitted by a new drug application (NDA) holder, an ANDA holder, or a biologics license application (BLA) holder would be made publicly available during FDA's review of the labeling change and clarifies requirements for all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA or ANDA holder's CBE-0 labeling supplement. The proposed rule also would amend the regulations to allow submission of a CBE-0 labeling supplement for certain changes to the "Highlights of Prescribing Information" for drug products with labeling in the "Physician Labeling Rule" (PLR) format.

Submit either electronic or written comments on the proposed rule by January 13, 2014. See section VII for the proposed effective date of a final rule based on this proposed rule. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by December 13, 2013, (see the "Paperwork Reduction Act of 1995" section of this document). Janice L. Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6304, Silver Spring, MD 20993-0002, 301- 796-3601. Administrative Practice and Procedure Confidential Business Information Drugs Reporting and Recordkeeping Requirements Biologics Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products , oira_submission@omb.eop.gov http://labels.fda.gov http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.imshealth.com/ims/Global/Content/Insights/IMS%20Institute%20for%20Healthcare%20Informatics/IHII_Medicines_in_U.S_Report_2011.pdf http://www.regulations.gov Vol. 78, no. 219 Office of the Federal Register, National Archives and Records Administration 2013-11-13 continuing daily deposited born digital 408 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-11-13 P0b002ee186543cf7 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13no13 https://www.govinfo.gov/app/details/FR-2013-11-13 https://www.govinfo.gov/content/pkg/FR-2013-11-13/pdf/FR-2013-11-13.pdf https://www.govinfo.gov/content/pkg/FR-2013-11-13/xml/FR-2013-11-13.xml fdlp 67925 68323 DGPO 2013-11-13 2024-06-03 FR-2013-11-13 machine generated eng FR FR-2013-11-13 78 219