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 Rules and Regulations D09002ee1c80f291e D09002ee1c80f2997 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 responding to two objections that it received on the final rule that amended the color additive regulations to provide for the safe use of mica-based pearlescent pigments as color additives in ingested drugs. After reviewing the objections, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. FDA is also establishing a new effective date for this color additive regulation, which was stayed by the filing of objections. 71 FR 41125 https://www.govinfo.gov/app/details/FR-2006-07-20/E6-11536 E6-11536 fr20jy06-10 4160-01-S Docket No. 1998C-0431 https://www.govinfo.gov/app/details/FR-2006-07-20/E6-11536 https://www.govinfo.gov/content/pkg/FR-2006-07-20/html/E6-11536.htm https://www.govinfo.gov/content/pkg/FR-2006-07-20/pdf/E6-11536.pdf 3 p. 41125 41127 71 FR 41125 Title 21 Part 73 21 CFR Part 73 Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments; Federal Register Vol. 71, Issue RULE E6-11536 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2005-08-23 Docket No. 1998C-0431 4160-01-S E6-11536 Final rule; response to objections; removal of stay.

The Food and Drug Administration (FDA) is responding to two objections that it received on the final rule that amended the color additive regulations to provide for the safe use of mica-based pearlescent pigments as color additives in ingested drugs. After reviewing the objections, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. FDA is also establishing a new effective date for this color additive regulation, which was stayed by the filing of objections.

The final rule that published in the Federal Register of July 22, 2005 (the July 2005 final rule) (70 FR 42271), with an effective date of August 23, 2005, was stayed by the filing of objections as provided for under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(e)(2)) as of August 22, 2005. This final rule is newly effective as of July 20, 2006. Aydin [Ouml]rstan, Center for Food Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1301. Color additives: Mica-based pearlescent pigments, Vol. 71, no. 139 Office of the Federal Register, National Archives and Records Administration 2006-07-20 continuing daily deposited born digital 265 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2006-07-20 P0b002ee18095815e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr20jy06 https://www.govinfo.gov/app/details/FR-2006-07-20 https://www.govinfo.gov/content/pkg/FR-2006-07-20/pdf/FR-2006-07-20.pdf https://www.govinfo.gov/content/pkg/FR-2006-07-20/xml/FR-2006-07-20.xml fdlp 41091 41344 DGPO 2010-09-22 2024-06-06 FR-2006-07-20 machine generated eng FR FR-2006-07-20 71 139