FDA Amendment 21 CFR Part 1040 Effective Sept. 1986

The following references are on file in the Dockets Management Branch (HFA305), Food and Drug Administration, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Forbes, P.D., R.E. Davies, and C.A. Cole, "Photocarcinogenesis by UVA Alone," Abstract MAM-D6, Tenth Annual Meeting, American Society for Photobiology, Vancouver, BC, Canada. June 27-July 1, 1982.

2. Van Weelden, H., F.R. de Gruijl, and J.C. van der Leun, "Tumors induced by UVA in Mice," Abstract WAM-F4, Photochemistry and Photobiology, 7S:79, 1983.

3. Staberg B. et al. "The Carcinogenic Effect of UVA Irradiation," Journal of Investigative Dermatology, 81:6:517-519, 1983.

4. Sutherland. B.M., P. Runge, and J.C. Sutherland, "DNA Photoreactivating Enzyme from Placental Mammals. Origin and Characteristics," Biochemistry 23:4710-4715, 1974.

5. Mutzhas. M.F., et al., "A New Apparatus with High Radiation Between 328-480 nm: Physical Description and Dermatological Applications." Journal of Investigative Dermatology, 76:42-47, 1981.

6. Jeffry, Jr., T.E., "Danger of Tanning Booths Bared. New Release," American Academy of Dermatology. Evanston, IL, May 1, 1983.

7. Pathak, M.A., "Sunscreens: Topical and Systemic Approaches for Protection of Human Skin Against Harmful Effects of Solar Radiation." Journal of the American Academy of Dermatology, 7:285-311, 1982.

The FDA has evaluated the economic consequences of this action in accordance with Executive Order 12291 and the Regulatory Flexibility Act (Pub. L. 98-354). This action has been determined not to be a major rule as defined in Executive Order 12291. Further, the agency certifies that the final rule will not have a significant impact on a substantial number of small entities, as defined in the Regulatory Flexibility Act. A threshold assessment supporting this conclusion is on file with the Dockets Management Branch (address above).

Section 1040.20 (d) and (e) of this final rule contains information collection requirements that were submitted for review and approval to the Director of the Office of Management and Budget (OMB), as required by Section 3507 of the Paperwork Reduction Act of 1980. The requirements were approved and assigned OMB control number 09100195.