FDA Amendment 21 CFR Part 352

Establishment of a Monograph; Notice of Proposed Rulemaking

AGENCY: Food and Drug Administration.
ACTION: Proposed rule.

SUMMARY: This proposed rule would establish conditions for the safety, effectiveness and labeling of over-the-counter (OTC) sunscreen drug products. The proposed rule, based on the recommendations of the Panel on Review of Topical Analgesic including antirheumatic, otic, burn, and sunburn treatment and prevention drugs is part of the Food and Drug Administration’s ongoing review of OTC drug products.

SUPPLEMENTARY INFORMATION: Pursuant to part 330 (21 CFR Part 330), the Commissioner of Food and Drugs received on Dec. 14, 1977, a report of the Advisory Review Panel on Over-The-Counter (OTC) Topical Analgesic, Antirheumatic, Otic, Burn and Sunburn Prevention and Treatment Products. In accordance with 330.10(a)(6). (21 CFR 330.10(a)(6), the Commissioner is issuing (1) a proposed regulation containing the monograph recommended by the Panel, which establishes conditions under which OTC sunscreen drugs are generally recognized as safe and effective and not misbranded; (2) a statement of the conditions excluded from the monograph on the basis of a determination by the Panel that they would result in the drugs generally not being recognized as safe and effective or would result in misbranding: (3) a statement of the conditions excluded from the monograph on the basis of a determination by the Panel that the available data are insufficient to classify such conditions under either (1) or (2) above; and (4) the conclusions and recommendations of the Panel to the Commissioner. The minutes of the Panel meetings are on public display in the office of the hearing Clerk (HFA-305), Food and Drug Administration (address given above).

The purpose of issuing the Panel’s unaltered conclusions and recommendations is to stimulate discussion, evaluation, and comment on the full sweep of the Panel’s deliberations. The Commissioner has not yet fully evaluated the report; the Panel’s findings are being issued as a formal proposal to obtain public comment before the agency reaches any decision on the Panel’s recommendations. The report has been prepared independently of the Food and Drug Administration (FDA). It represents the best scientific judgment of the Panel members but does not necessarily reflect the agency position on any particular matter contained in it.