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 2015_register executive 2015-08-28 article Proposed Rules D09002ee1c7f73067 D09002ee1c7f730e7 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) is proposing a regulation to designate official names and proper names for certain biological products. These products are filgrastim-sndz (Biologics License Application (BLA) 125553), filgrastim (BLA 103353), tbo- filgrastim (BLA 125294), pegfilgrastim (BLA 125031), epoetin alfa (BLA 103234), and infliximab (BLA 103772). The official names and proper names of these products would include distinguishing suffixes composed of four lowercase letters and would be designated as filgrastim-bflm (BLA 125553), filgrastim-jcwp (BLA 103353), filgrastim-vkzt (BLA 125294), pegfilgrastim-ljfd (BLA 125031), epoetin alfa-cgkn (BLA 103234), and infliximab-hjmt (BLA 103772). Although FDA is continuing to consider the appropriate naming convention for biological products, including how such a convention would be applied retrospectively to currently licensed products, FDA is proposing to take action with respect to these six products because of the need to encourage routine usage of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices for the biological products subject to this rulemaking, and to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway. 80 FR 52224 https://www.govinfo.gov/app/details/FR-2015-08-28/2015-21382 2015-21382 fr28au15-21 RIN 0910-AH25 4164-01-P Docket No. FDA-2015-N-0648 https://www.govinfo.gov/app/details/FR-2015-08-28/2015-21382 https://www.govinfo.gov/content/pkg/FR-2015-08-28/html/2015-21382.htm https://www.govinfo.gov/content/pkg/FR-2015-08-28/pdf/2015-21382.pdf Drugs 8 p. 52224 52231 80 FR 52224 Title 21 Part 299 21 CFR Part 299 RIN 0910-AH25 Designation of Official Names and Proper Names for Certain Biological Products; Federal Register Vol. 80, Issue PRORULE 2015-21382 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2015-11-12 Docket No. FDA-2015-N-0648 4164-01-P 2015-21382 Proposed rule.

The Food and Drug Administration (FDA) is proposing a regulation to designate official names and proper names for certain biological products. These products are filgrastim-sndz (Biologics License Application (BLA) 125553), filgrastim (BLA 103353), tbo- filgrastim (BLA 125294), pegfilgrastim (BLA 125031), epoetin alfa (BLA 103234), and infliximab (BLA 103772). The official names and proper names of these products would include distinguishing suffixes composed of four lowercase letters and would be designated as filgrastim-bflm (BLA 125553), filgrastim-jcwp (BLA 103353), filgrastim-vkzt (BLA 125294), pegfilgrastim-ljfd (BLA 125031), epoetin alfa-cgkn (BLA 103234), and infliximab-hjmt (BLA 103772). Although FDA is continuing to consider the appropriate naming convention for biological products, including how such a convention would be applied retrospectively to currently licensed products, FDA is proposing to take action with respect to these six products because of the need to encourage routine usage of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices for the biological products subject to this rulemaking, and to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.

Submit either electronic or written comments on the proposed rule by November 12, 2015. See section IV of this document for the proposed effective date of any final rule that may publish based on this proposal. Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-2500. Drugs Designation of Official Names and Proper Names for Certain Biological Products , http://info.cvscaremark.com/insights2014/Singh06-Medical-Specialty-Utilization-and-Management-Opportunities.pdf http://ismp.org/tools/guidelines/StandardOrderSets.asp http://www.apotex.com/global/about/press/20141217.asp http://www.ashp.org/DocLibrary/BestPractices/MedMisGdlAntineo.aspx http://www.celltrion.com/en/COMPANY/notice_view.asp?idx=456&code=ennews&intNowPage=1&menu_num=&align_year=all http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm338856.pdf http://www.prnewswire.com/news-releases/hospira-submits-new-biologics-license-application-to-us-fda-for-proposed-epoetin-alfa-biosimilar-300018991.html http://www.regulations.gov Vol. 80, no. 167 Office of the Federal Register, National Archives and Records Administration 2015-08-28 continuing daily deposited born digital 212 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-08-28 P0b002ee18d687b05 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28au15 https://www.govinfo.gov/app/details/FR-2015-08-28 https://www.govinfo.gov/content/pkg/FR-2015-08-28/pdf/FR-2015-08-28.pdf https://www.govinfo.gov/content/pkg/FR-2015-08-28/xml/FR-2015-08-28.xml fdlp 52173 52373 DGPO 2015-08-28 2024-06-02 FR-2015-08-28 machine generated eng FR FR-2015-08-28 80 167