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 2001_register executive 2010-09-23 article Notices D09002ee1c81d5f87 D09002ee1c81d6012 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 two draft guidances for industry entitled "Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format--General Considerations" and "Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format for Food Additive and Color Additive Petitions." These documents are the first in a series of guidance documents intended to provide guidance for industry regarding the preparation of regulatory submissions in electronic format to the Office of Food Additive Safety (OFAS), Center for Food Safety and Applied Nutrition (CFSAN). OFAS is providing these draft guidances as part of its implementation of 21 CFR part 11 and the Food Additives Regulatory Management (FARM) Project. 66 FR 39517 https://www.govinfo.gov/app/details/FR-2001-07-31/01-18948 01-18948 fr31jy01-85 4160-01-S Docket Nos. 01D-0294 and 01D-0295 https://www.govinfo.gov/app/details/FR-2001-07-31/01-18948 https://www.govinfo.gov/content/pkg/FR-2001-07-31/html/01-18948.htm https://www.govinfo.gov/content/pkg/FR-2001-07-31/pdf/01-18948.pdf 5 p. 39517 39521 66 FR 39517 Draft Guidances for Industry on Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format: General Considerations and for Food Additive and Color Additive Petitions; Availability; Federal Register Vol. 66, Issue NOTICE 01-18948 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2001-10-01 Docket Nos. 01D-0294 and 01D-0295 4160-01-S 01-18948 Notice.

The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled "Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format--General Considerations" and "Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format for Food Additive and Color Additive Petitions." These documents are the first in a series of guidance documents intended to provide guidance for industry regarding the preparation of regulatory submissions in electronic format to the Office of Food Additive Safety (OFAS), Center for Food Safety and Applied Nutrition (CFSAN). OFAS is providing these draft guidances as part of its implementation of 21 CFR part 11 and the Food Additives Regulatory Management (FARM) Project.

Submit written or electronic comments concerning these draft guidances by October 1, 2001, to ensure adequate consideration in the preparation of revised guidances, if warranted. However, you may submit written or electronic comments at any time. Submit written comments concerning the collection of information by October 1, 2001. JoAnn Ziyad, Center for Food Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3116. Reports and guidance documents; availability, etc.: Food Additive Safety Office; regulatory submissions in electronic format; general considerations and for food and color additive petitions, http://www.cfsan.fda.gov/@dms/opa-toc.html http://www.fda.gov/dockets/ecomments Vol. 66, no. 147 Office of the Federal Register, National Archives and Records Administration 2001-07-31 continuing daily deposited born digital 220 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2001-07-31 P0b002ee18099da68 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr31jy01 https://www.govinfo.gov/app/details/FR-2001-07-31 https://www.govinfo.gov/content/pkg/FR-2001-07-31/pdf/FR-2001-07-31.pdf https://www.govinfo.gov/content/pkg/FR-2001-07-31/xml/FR-2001-07-31.xml fdlp 39405 39613 DGPO 2010-09-23 2024-06-08 FR-2001-07-31 machine generated eng FR FR-2001-07-31 66 147