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 1997_register executive 2010-09-24 article Notices D09002ee1be01a5af D09002ee1be01a625 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 revised Form FDA 356h entitled ``Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use.'' This revised form is intended to be used by applicants for a wide range of products regulated by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) under the Public Health Service Act (the PHS Act) and the Federal Food, Drug, and Cosmetic Act (the act). The revised form is also intended to standardize the application form, to reduce the time required to prepare applications, and to expedite review by FDA staff. This action is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives, and is intended to reduce unnecessary burdens for industry without diminishing public health protection. 62 FR 36558 https://www.govinfo.gov/app/details/FR-1997-07-08/97-17717 97-17717 fr08jy97-68 4160-01-F Docket No. 96N-0192 https://www.govinfo.gov/app/details/FR-1997-07-08/97-17717 https://www.govinfo.gov/content/pkg/FR-1997-07-08/html/97-17717.htm https://www.govinfo.gov/content/pkg/FR-1997-07-08/pdf/97-17717.pdf 3 p. 36558 36560 62 FR 36558 Revised Form FDA 356h, Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use; Availability; Federal Register Vol. 62, Issue NOTICE 97-17717 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 1998-01-08 Docket No. 96N-0192 4160-01-F 97-17717 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a revised Form FDA 356h entitled ``Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use.'' This revised form is intended to be used by applicants for a wide range of products regulated by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) under the Public Health Service Act (the PHS Act) and the Federal Food, Drug, and Cosmetic Act (the act). The revised form is also intended to standardize the application form, to reduce the time required to prepare applications, and to expedite review by FDA staff. This action is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives, and is intended to reduce unnecessary burdens for industry without diminishing public health protection.

Written comments may be submitted at any time. Applicants submitting new drug applications (NDA's), abbreviated new drug applications (ANDA's), abbreviated antibiotic drug applications (AADA's), applications for products specified in Sec. 601.2(c) (21 CFR 601.2(c)), or for autologous somatic cell therapy products will be required to use revised Form 356h beginning January 8, 1998. CBER: Robert A. Yetter, Center for Biologics Evaluation and Research (HFM-10), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0381. Vol. 62, no. 130 Office of the Federal Register, National Archives and Records Administration 1997-07-08 continuing daily deposited born digital 208 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1997-07-08 P0b002ee180a393b5 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr08jy97 https://www.govinfo.gov/app/details/FR-1997-07-08 https://www.govinfo.gov/content/pkg/FR-1997-07-08/pdf/FR-1997-07-08.pdf fdlp 36447 36643 DGPO 2010-09-24 2023-05-06 FR-1997-07-08 machine generated eng FR FR-1997-07-08 62 130