Closure Medical Corp.; Withdrawal of Color Additive Petition

In a notice published in the Federal Register of May 1, 1997 (62 FR 23781), FDA announced that a color additive petition (CAP 7C0250) had been filed by Closure Medical Corp., 5265 Capital Blvd., Raleigh, NC 27616 (currently 5250 Greens Dairy Rd., Raleigh, NC 27616). The petition proposed to amend the color additive regulations in Sec. 74.3602 D&C Violet No. 2 (21 CFR 74.3602) to provide for the safe use of D&C Violet No. 2 to color 2-octyl cyanoacrylate topical tissue adhesives. With the passage of the Medical Device Amendments of 1976 (Pub. L. 94-295), Congress mandated the listing of color additives for use in medical devices when the color additive in the device comes into direct contact with the body for a significant period of time (21 U.S.C. 379e(a)). Since the filing of this petition, the agency has determined that the proposed use of the subject topical tissue adhesives, and therefore, any color additive used in these adhesives, would not contact the body for a significant period of time (Ref. 1). Consequently, the petitioned use of D&C Violet No. 2 is exempt from the statutory listing requirement. Therefore, Closure Medical Corp. has now withdrawn the petition without prejudice to a future filing (21 CFR 71.6(c)(2)) (Ref. 2). The agency received two comments on the safety of D&C Violet No. 2 in response to the notice of filing for this petition. Arts, Crafts & Theater Safety, Inc. (ACTS) commented that D&C Violet No. 2 could possibly be a carcinogen, based on studies of other anthraquinone dyes and structurally related compounds that concluded those substances were reasonably anticipated to be human carcinogens. They stated that the petition should be denied unless D&C Violet No. 2 is studied for cancer effects and found to show no evidence of carcinogenicity. In response to ACTS'' comment, Flamm Associates commented that in addition to a consideration of the general chemical class of a substance, other structural features need to be evaluated in determining the carcinogenic potential of a substance. They further stated that D&C Violet No. 2 has been tested for carcinogenicity and found to be noncarcinogenic. The agency concludes that, although the subject petition is being withdrawn, the safety of the currently approved uses of D&C Violet No. 2 (21 CFR 74.1602, 74.2602 and 74.3602) is supported by an extensive body of toxicity testing data and that the comments provide no basis for a safety concern.

References

The following references have been placed on display in the Dockets Management Branch (HFA-305), 5630 Fishers Lane, Rockville, MD 20852 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Memorandum from Office of Device Evaluation, Program Operations Staff (Center for Devices and Radiological Health, FDA), to Division of Petition Control (Center for Food Safety and Applied Nutrition, FDA), concerning ``CAP 7C0250'', dated October 23, 1998. 2. Letter from Hyman, Phelps & McNamara, P.C., to Office of Premarket Approval (FDA), dated August 25, 1998.

Dated: November 3, 1998. Laura M. Tarantino, Acting Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition. [FR Doc. 98-31030 Filed 11-19-98; 8:45 am] BILLING CODE 4160-01-F