Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph; Reopening of Comment Period; Proposed Rule

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 352

[Docket No. 78N-0038]

RIN 0905-AA06

Sunscreen Drug Products for Over-the-Counter Human Use; Proposed

Amendment to the Tentative Final Monograph; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

the tentative final monograph for over-the-counter (OTC) sunscreen drug

products (58 FR 28194, May 12, 1993) to include only the 15 active

ingredients for which United States Pharmacopeia (U.S.P.) monographs

currently exist or for which interest in developing U.S.P. monographs

has been expressed. This proposal is part of the ongoing review of OTC

drug products conducted by FDA. FDA is reopening the comment period

until August 22, 1994 to give interested parties an opportunity to

comment on the proposed amendment to the tentative final monograph.

DATES: Written comments or objections by August 22, 1994; writen

comments on the agency's economic impact determination by August 22,

1994.

ADDRESSES: Written comments or objections to the Dockets Management

Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug

Evaluation and Research (HFD-810), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-5000.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 12, 1993 (58 FR 28194), FDA

published a notice of proposed rulemaking, in the form of a tentative

final monograph, for OTC sunscreen drug products. In proposed

Sec. 352.10 (21 CFR 352.10) of the May 12, 1993, tentative final

monograph (58 FR 28194 at 28295), the agency proposed the following

ingredients in Category I (i.e., generally recognized as safe and

effective):

(1) Aminobenzoic acid,

(2) Cinoxate,

(3) Diethanolamine methoxycinnamate,

(4) Digalloyl trioleate,

(5) Dioxybenzone,

(6) Ethyl 4-[bis(hydroxypropyl)] aminobenzoate,

(7) Glyceryl aminobenzoate,

(8) Homosalate,

(9) Lawsone with dihydroxyacetone,

(10) Menthyl anthranilate,

(11) Octocrylene,

(12) Octyl methoxycinnamate,

(13) Octyl salicylate,

(14) Oxybenzone,

(15) Padimate O,

(16) Phenylbenzimidazole sulfonic acid,

(17) Red petrolatum,

(18) Sulisobenzone,

(19) Titanium dioxide,

(20) Trolamine salicylate.

The agency also stated that, in order for a sunscreen ingredient to be

included in the final monograph, it would be necessary for the

ingredient to be adequately characterized and for these standards to be

published in an official compendium (58 FR 28194 at 28284). The agency

noted that only a few Category I sunscreen active ingredients are

standardized and characterized for quality and purity and are included

in official compendia (i.e., aminobenzoic acid, cinoxate, dioxybenzone,

oxybenzone, and titanium dioxide). The agency suggested that interested

parties should develop with the U.S.P. appropriate standards for the

quality and purity of sunscreen active ingredients that are not already

included in official compendia (i.e., diethanolamine methoxycinnamate,

digalloyl trioleate, ethyl 4-[bis(hydroxypropyl)] aminobenzoate,

glyceryl aminobenzoate, homosalate, lawsone with dihydroxyacetone,

menthyl anthranilate, octocrylene, octyl methoxycinnamate, octyl

salicylate, phenylbenzimidazole sulfonic acid, red petrolatum,

sulisobenzone, and trolamine salicylate). The agency pointed out that

if such standards are not established, ingredients without available

public standards would not be included in the final monograph.

In letters dated January 13, 1994 (Ref. 1), the agency reminded two

manufacturers associations (representing many OTC drug and cosmetic

manufacturers of sunscreen-containing drug products) that all

sunscreens ingredients must have a U.S.P. monograph before being

included in the final monograph for OTC sunscreen drug products. FDA

encouraged the associations to work with the U.S.P. in establishing the

necessary monographs. Stating that the agency believes that some of the

proposed Category I ingredients are no longer used for formulating

sunscreen drug products, the agency questioned whether manufacturers

would be working to establish U.S.P. standards for these ingredients.

The agency asked for comment regarding which ingredients companies

would be working to establish U.S.P. monographs.

The associations replied jointly in a letter dated February 15,

1994 (Ref. 2). The letter stated that, in addition to the five

ingredients FDA listed as having established U.S.P. monographs, a sixth

ingredient, padimate O, also has a U.S.P. monograph. The letter further

stated that industry members currently intend to work with U.S.P. to

develop compendial monographs for the following nine ingredients:

(1) Diethanolamine,

(2) Octocrylene,

(3) Octyl methoxycinnamate,

(4) Octyl salicylate,

(5) Homosalate,

(6) Menthyl anthranilate,

(7) Phenylbenzimidazole sulfonic acid,

(8) Sulisobenzone,

(9) Trolamine salicylate.

No interest was expressed in the remaining ingredients (i.e., digalloyl

trioleate, ethyl 4-[bis(hydroxypropyl)] aminobenzoate, glyceryl

aminobenzoate, lawsone with dihydroxyacetone, and red petrolatum).

References

(1) Letters from W. E. Gilbertson, FDA, to J. D. Cope,

Nonprescription Drug Manufacturers Association, and E. E. Kavanaugh,

Cosmetic, Toiletry and Fragrance Association, Comments No. LET110

and LET111, respectively, in Docket No. 78N-0038, Dockets Management

Branch.

(2) Letter from E. E. Kavanaugh, Cosmetic, Toiletry and

Fragrance Association, and J. D. Cope, Nonprescription Drug

Manufacturers Association, to W. E. Gilbertson, FDA, Comment No.

C301, in Docket No. 78N-0038, Dockets Management Branch.

II. The Agency's Tentative Conclusions

Based upon the apparent lack of interest in establishing U.S.P.

monographs for digalloyl trioleate, ethyl 4-[bis(hydroxypropyl)]

aminobenzoate, glyceryl aminobenzoate, lawsone with dihydroxyacetone,

and red petrolatum, the agency tentatively concludes that these

ingredients will not be included in the final monograph for OTC

sunscreen drug products and should be deleted from the tentative final

monograph. Therefore, the agency is amending the tentative final

monograph for OTC sunscreen drug products to remove these five

ingredients. The agency is also withdrawing the warnings and directions

proposed in Secs. 352.52(c)(2) and 352.52(d)(3) for lawsone with

dihydroxyacetone.

FDA has examined the impacts of the amendment of the tentative

final monograph under Executive Order 12866 and the Regulatory

Flexibility Act (Pub. L. 96-354). Executive Order 12866 directs

agencies to assess all costs and benefits of available regulatory

alternatives and, when regulation is necessary, to select regulatory

approaches that maximize net benefits (including potential economic,

environmental, public health and safety, and other advantages;

distributive impacts; and equity). The agency believes that this

amendment of the tentative final monograph is consistent with the

regulatory philosophy and principles identified in the Executive Order.

In addition, the amendment of the tentative final monograph is not a

significant regulatory action as defined by the Executive Order and,

thus, is not subject to review under the Executive Order. The

Regulatory Flexibility Act requires agencies to analyze regulatory

options that would minimize any significant impact of a rule on small

entities. The agency is not aware of any currently marketed sunscreen

drug products that contain any of the ingredients being withdrawn from

the monograph. Accordingly, the agency certifies that the proposed rule

will not have a significant economic impact on a substantial number of

small entities. Therefore, under the Regulatory Flexibility Act, no

further analysis is required.

The agency is reopening the comment period until August 22, 1994 to

allow interested persons the opportunity to comment specifically on the

proposal in this document to include only the 15 active ingredients

listed. The agency is also inviting public comment regarding any

substantial or significant economic impact that this rulemaking would

have on OTC sunscreen drug products. Types of impact may include, but

are not limited to, costs associated with reformulating, relabeling, or

repackaging. Comments regarding the impact of this rulemaking on OTC

sunscreen drug products should be accompanied by appropriate

documentation. The agency will evaluate any comments and supporting

data that are received and will reassess the economic impact of this

rulemaking in the preamble to the final rule.

The agency has determined under 21 CFR 25.24(c)(6) 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.

Interested persons may, on or before August 22, 1994, submit to the

Dockets Management Branch (address above) written comments or

objections regarding this proposal. Written comments on the agency's

economic impact determination may be submitted on or before August 22,

1994. Three copies of all comments or objections are to be submitted,

except that individuals may submit one copy. Comments and objections

are to be identified with the docket number found in brackets in the

heading of this document and may be accompanied by a supporting

memorandum or brief. Received comments and objections may be seen in

the office above between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 352

Labeling, Over-the-counter drugs.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 352 (as proposed in the Federal Register of

May 12, 1993 (58 FR 28194)), be amended as follows:

PART 352--SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

1. The authority citation for 21 CFR part 352 continues to read as

follows:

Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371).

Sec. 352.10 [Amended]

2. Section 352.10 Sunscreen active ingredients is amended by

removing paragraphs (d), (f), (g), (i), and (q) and reserving them.

Sec. 352.20 [Amended]

3. Section 352.20 Permitted combinations of active ingredients is

amended by removing paragraphs (a)(2)(iv), (a)(2)(vi), (a)(2)(vii),

(a)(2)(ix), and (a)(2)(xvii) and reserving them.

Sec. 352.52 [Amended]

4. Section 352.52 Labeling of sunscreen drug products is amended by

removing paragraphs (c)(2) and (d)(3) and reserving them.

Dated: May 18, 1994.

Michael R. Taylor,

Deputy Commissioner for Policy.

[FR Doc. 94-13933 Filed 6-7-94; 8:45 am]

BILLING CODE 4160-01-F