[Federal Register Volume 63, Number 224 (Friday, November 20, 1998)]
[Notices]
[Pages 64512-64513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97C-0171]


Closure Medical Corp.; Withdrawal of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal, without prejudice to future filing, of a color additive 
petition (CAP 7C0250) proposing that the color additive regulations be 
amended to

[[Page 64513]]

provide for the safe use of D&C Violet No. 2 to color 2-octyl 
cyanoacrylate topical tissue adhesives.

FOR FURTHER INFORMATION CONTACT: Ellen M. Waldron, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3089.

SUPPLEMENTARY INFORMATION: 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withdrawn the petition without prejudice to a future filing (21 CFR 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