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 1999_register executive 2010-09-24 article Notices D09002ee1bdfe2742 D09002ee1bdfe27e6 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 guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--General Considerations.'' This guidance discusses issues common to all submissions in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). A notice of availability for a related guidance entitled ``Providing Regulatory Submissions in Electronic Format--NDA's'' is being published elsewhere in this issue of the Federal Register. Both guidances are part of a series of guidances being developed by the agency to assist applicants who wish to make regulatory submissions in electronic format. Guidances addressing other submission types, such as biologics license applications, abbreviated new drug applications (ANDA's), and investigational new drug applications (IND's), are being developed and will be issued in the future. Although submissions in electronic format are voluntary, the agency encourages them as a way to improve the efficiency of handling and reviewing documents and data. 64 FR 4433 https://www.govinfo.gov/app/details/FR-1999-01-28/99-2059 99-2059 fr28ja99-86 4160-01-F Docket No. 98D-0075 https://www.govinfo.gov/app/details/FR-1999-01-28/99-2059 https://www.govinfo.gov/content/pkg/FR-1999-01-28/html/99-2059.htm https://www.govinfo.gov/content/pkg/FR-1999-01-28/pdf/99-2059.pdf 2 p. 4433 4434 64 FR 4433 Guidance for Industry on General Considerations for Providing Regulatory Submissions in Electronic Format; Availability; Federal Register Vol. 64, Issue NOTICE 99-2059 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 98D-0075 4160-01-F 99-2059 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--General Considerations.'' This guidance discusses issues common to all submissions in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). A notice of availability for a related guidance entitled ``Providing Regulatory Submissions in Electronic Format--NDA's'' is being published elsewhere in this issue of the Federal Register. Both guidances are part of a series of guidances being developed by the agency to assist applicants who wish to make regulatory submissions in electronic format. Guidances addressing other submission types, such as biologics license applications, abbreviated new drug applications (ANDA's), and investigational new drug applications (IND's), are being developed and will be issued in the future. Although submissions in electronic format are voluntary, the agency encourages them as a way to improve the efficiency of handling and reviewing documents and data.

Written comments may be submitted at any time. Kenneth Edmunds, Center for Drug Evaluation and Research (HFD-73), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3276, e-mail: ESUB@CDER.fda.gov; or Michael B. Fauntleroy, Center for Biologics Evaluation and Research, Office of the Director, (HFM-99), Food and Drug Administration, rm. 200N, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-5101, e-mail: Esubprep@cber.fda.gov. Vol. 64, no. 18 Office of the Federal Register, National Archives and Records Administration 1999-01-28 continuing daily deposited born digital 244 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1999-01-28 P0b002ee180a734c3 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28ja99 https://www.govinfo.gov/app/details/FR-1999-01-28 https://www.govinfo.gov/content/pkg/FR-1999-01-28/pdf/FR-1999-01-28.pdf fdlp 4285 4516 DGPO 2010-09-24 2023-05-05 FR-1999-01-28 machine generated eng FR FR-1999-01-28 64 18