This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is amending the filing notice for a color additive petition filed by Wesley Jessen, Corp. (now Ciba Vision Corp.), to indicate that the petitioned additive is more appropriately identified as mica coated with iron oxides or mica coated with titanium dioxide for use in contact lenses. The previous filing notice ( printed page 35552) indicated that the proposed additive was mica for use in contact lenses.
Aydin Örstan, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 202-418-3076.
In a notice published in the Federal Register of June 7, 2000 (65 FR 36148), FDA announced that a color additive petition (CAP 0C0271) had been filed by Wesley Jessen, Corp., 333 East Howard Ave., Des Plaines, IL 60018 (now Ciba Vision Corp., 11460 Johns Creek Pkwy., Duluth, GA 30097-1556). The petition proposed to amend the color additive regulations to provide for the safe use of mica to color contact lenses.
During its review of the petition, the agency determined that the subject color additives are composite pigments, commonly known as pearlescent pigments, composed of mica coated with iron oxides or mica coated with titanium dioxide. Therefore, FDA is amending the filing notice of June 7, 2000, to state that the petition proposes that the color additive regulations in 21 CFR part 73 subpart D—Medical Devices be amended to provide for the safe use of mica coated with iron oxides or mica coated with titanium dioxide, collectively identified as mica-based pearlescent pigments, in contact lenses.
The agency has determined under 21 CFR 25.32(l) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
Dated: May 6, 2002.
Alan M. Rulis,
Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.
[FR Doc. 02-12546 Filed 5-17-02; 8:45 am]
BILLING CODE 4160-01-S