[Federal Register Volume 59, Number 109 (Wednesday, June 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13933]


[[Page Unknown]]

[Federal Register: June 8, 1994]


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Part VI





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Part 352




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