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 2006_register executive 2010-09-22 article Notices D09002ee1c80f310e D09002ee1c80f3183 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 announcing the availability of a document entitled "Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format--Lot Release Protocols" dated July 2006. The guidance is intended to provide manufacturers of biological products regulated by CBER with recommendations for submitting lot release protocols in electronic format to CBER Product Release Branch. This guidance document finalizes the draft guidance entitled "Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research" dated May 1998. 71 FR 39684 https://www.govinfo.gov/app/details/FR-2006-07-13/E6-11040 E6-11040 fr13jy06-77 4160-01-S Docket No. 1998D-0315 https://www.govinfo.gov/app/details/FR-2006-07-13/E6-11040 https://www.govinfo.gov/content/pkg/FR-2006-07-13/html/E6-11040.htm https://www.govinfo.gov/content/pkg/FR-2006-07-13/pdf/E6-11040.pdf 2 p. 39684 39685 71 FR 39684 Guidance for Industry on Providing Regulatory Submissions to the Center for Biologics Evaluation and Research in Electronic Format-Lot Release Protocols; Availability; Federal Register Vol. 71, Issue NOTICE E6-11040 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 1998D-0315 4160-01-S E6-11040 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format--Lot Release Protocols" dated July 2006. The guidance is intended to provide manufacturers of biological products regulated by CBER with recommendations for submitting lot release protocols in electronic format to CBER Product Release Branch. This guidance document finalizes the draft guidance entitled "Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research" dated May 1998.

Submit written or electronic comments on agency guidances at any time. Astrid Szeto, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N,Rockville, MD 20852-1448, 301-827-6210. Reports and guidance documents; availability, etc.: Center for Biologics Evaluation and Research; electronic regulatory submissions, http://www.fda.gov/cber/guidelines.htm http://www.fda.gov/dockets/ecomments http://www.fda.gov/ohrms/dockets/default.htm Vol. 71, no. 134 Office of the Federal Register, National Archives and Records Administration 2006-07-13 continuing daily deposited born digital 500 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2006-07-13 P0b002ee18094dda6 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13jy06 https://www.govinfo.gov/app/details/FR-2006-07-13 https://www.govinfo.gov/content/pkg/FR-2006-07-13/pdf/FR-2006-07-13.pdf https://www.govinfo.gov/content/pkg/FR-2006-07-13/xml/FR-2006-07-13.xml fdlp 39511 40001 DGPO 2010-09-22 2024-06-06 FR-2006-07-13 machine generated eng FR FR-2006-07-13 71 134