[Federal Register Volume 67, Number 119 (Thursday, June 20, 2002)]
[Rules and Regulations]
[Pages 41821-41823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 352

[Docket No. 78N-0038]
RIN 0910-AA01


Sunscreen Drug Products for Over-the-Counter Human Use; Final 
Monograph; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulation that established conditions under which over-the-counter 
(OTC) sunscreen drug products are generally recognized as safe and 
effective and not misbranded. This amendment updates the monograph to 
incorporate United States Pharmacopeia (U.S.P.) name changes for four 
active ingredients included in the monograph. This final rule is part 
of FDA's ongoing review of OTC drug products.

DATES: This final rule is effective September 1, 2002. Submit written 
or electronic comments by August 19, 2002.

ADDRESSES: Submit written or electronic comments to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: John D. Lipnicki, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 21, 1999 (64 FR 27666), FDA issued a 
final monograph for OTC sunscreen drug products (21 CFR part 352). 
Section 352.10 of that monograph included the active ingredients 
menthyl anthranilate, octyl methoxycinnamate, octyl salicylate, and 
phenylbenzimidazole sulfonic acid.
    In 2000 (Ref. 1), the U.S.P. proposed (for inclusion in the Third 
Supplement to U.S.P. 24) name changes for these four ingredients based 
on names adopted by the United States Adopted Names (USAN) Council. The 
new names are: Meradimate for menthyl anthranilate, octinoxate for 
octyl methoxycinnamate, octisalate for octyl salicylate, and ensulizole 
for phenylbenzimidazole sulfonic acid. These name changes became 
official on March 1, 2001, and were subsequently included in the U.S.P. 
with an effective date of September 1, 2002 (Ref. 2).

II. Naming Process

    The Federal Food, Drug, and Cosmetic Act (the act) requires the 
label of a drug to bear the established name of the drug to the 
exclusion of any other nonproprietary name (except the applicable 
systematic chemical name or the chemical formula) (21 U.S.C. 
352(e)(1)(A)(i)). The established name of the drug is defined as:
    (A) the applicable official name designated pursuant to section 
508 [of the Act], or (B) if there is no such name and such drug, or 
such ingredient, is an article recognized in an official compendium, 
then the official title thereof in such compendium, or (C) if 
neither clause (A) nor clause (B) of this subparagraph applies, then 
the common or usual name, if any, of such drug or of such ingredient 
* * *.
21 U.S.C. 352(e)(3)
    Section 508 of the act (21 U.S.C. 358) authorizes FDA to designate 
an official name for any drug if FDA determines ``that such action is 
necessary or desirable in the interest of usefulness and simplicity'' 
(21 U.S.C. 358(a)). FDA does not, however, routinely designate official 
names for drug products under section 508 of the act (Sec.  299.4(e) 
(21 CFR 299.4(e))). In the absence of designation by FDA of an official 
name, interested persons may rely on the current compendial name as the 
established name (Sec.  299.4(e)).

III. The Technical Amendment

    FDA has not designated official names for the following active 
ingredients: Menthyl anthranilate, octyl methoxycinnamate, octyl 
salicylate, and phenylbenzimidazole sulfonic acid. Thus, their 
established names are the current compendial names. The U.S.P. has now 
changed the compendial names to: Meradimate for menthyl anthranilate, 
octinoxate for octyl methoxycinnamate, octisalate for octyl salicylate, 
and ensulizole for phenylbenzimidazole sulfonic acid. To be consistent 
with the change in official compendial names, the agency is changing 
these names in Sec.  352.10 in the

[[Page 41822]]

ingredient listing and in Sec.  352.20 in the permitted combinations 
listing. Because the active ingredients are listed in alphabetical 
order in Sec.  352.10, the ingredients listed in paragraphs (f) through 
(n) are rearranged because of these name changes. These name changes 
will become effective on September 1, 2002, to coincide with the U.S.P. 
effective date.
    Because section 502(e)(1) and (e)(3) of the act (21 U.S.C. 
352(e)(1) and (e)(3)) require the established name of a drug to be 
used, any sunscreen drug product initially introduced or initially 
delivered for introduction into interstate commerce after September 1, 
2002, will need to bear the new established names ``meradimate,'' 
``octinoxate,'' ``octisalate,'' and ``ensulizole.''
    To the extent that 5 U.S.C. 553 applies to this action, it is 
exempt from notice and comment because it constitutes a rule of agency 
procedure under 5 U.S.C. 553(b)(3)(A). Alternatively, the agency's 
implementation of this action without opportunity for public comment 
comes within the good cause exceptions in 5 U.S.C. 553(b)(3)(B) in that 
obtaining public comment is impracticable, unnecessary, and contrary to 
public interest. This labeling revision represents a minor clarifying 
change that does not change the substance of the labeling requirements 
contained in the final regulations. As discussed above, manufacturers 
must relabel their products as a result of the U.S.P. name change to 
remain in compliance with the act. This amendment updates the names of 
four active ingredients in the final monograph for OTC sunscreen drug 
products to reflect this official name change that has already been 
implemented by the U.S.P. In accordance with 21 CFR 10.40(e)(1), FDA is 
providing an opportunity for comment on whether the regulation should 
be modified or revoked.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 104-4). 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). Under the Regulatory Flexibility Act, if a rule has a 
significant economic impact on a substantial number of small entities, 
an agency must analyze regulatory options that would minimize any 
significant impact of the rule on small entities. Section 202(a) of the 
Unfunded Mandates Reform Act of 1995 requires that agencies prepare a 
written statement of anticipated costs and benefits before proposing 
any rule that may result in an expenditure in any one year by State, 
local, and tribal governments, in the aggregate, or by the private 
sector, of $100 million (adjusted annually for inflation).
    The agency concludes that this final rule is consistent with the 
principles set out in Executive Order 12866 and in these two statutes. 
FDA has determined that the final rule is not a significant regulatory 
action as defined by the Executive order and so is not subject to 
review under the Executive order.
    The Unfunded Mandates Reform Act of 1995 does not require FDA to 
prepare a statement of costs and benefits for this final rule, because 
the final rule is not expected to result in any 1-year expenditure that 
would exceed $100 million adjusted for inflation. The current inflation 
adjusted statutory threshold is about $110 million.
    The purpose of this final rule is to update the final monograph for 
OTC sunscreen drug products to incorporate U.S.P. name changes for four 
active ingredients included in the monograph. As discussed in section 
II of this document, section 502(e)(1) and (e)(3) of the act require 
that the established name of a drug be used. Under Sec.  299.4(e), 
because FDA does not routinely designate official names under section 
508 of the act, the established name under section 502(e) of the act 
ordinarily is the compendial name of the drug. Therefore, because FDA 
has not designated an official name under section 508 of the act, 
manufacturers must relabel their products as a result of the U.S.P. 
name change to remain in compliance with the act. Updating the names of 
the active ingredients in the sunscreen monograph to reflect their 
current established names will eliminate possible confusion by the 
public. The U.S.P. allows manufacturers 18 months to comply with the 
name changes, and the agency's effective date coincides with that of 
the U.S.P.
    Because manufacturers must relabel their products as a result of 
the U.S.P. name change to remain in compliance with the act, this rule 
does not impose any additional costs on industry. Consequently, the 
agency certifies that this final rule will not have a significant 
economic impact on a substantial number of small entities. Therefore, 
no further analysis is required.

V. Paperwork Reduction Act of 1995

    The agency concludes that the labeling requirements in this 
document are not subject to review by the Office of Management and 
Budget because they do not constitute a ``collection of information'' 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 
Rather, the labeling statements are a ``public disclosure of 
information originally supplied by the Federal Government to the 
recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).

VI. Environmental Impact

    The agency has determined under 21 CFR 25.31(a) 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.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government Accordingly, the agency has concluded that 
the rule does not contain policies that have federalism implications as 
defined in the Executive order and, consequently, a federalism summary 
impact statement is not required.

VIII. Opportunity for Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments by August 19, 2002. Two 
copies of all written comments are to be submitted. Individuals 
submitting written comments or anyone submitting electronic comments 
may submit one copy. Comments 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 may 
be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

IX. References

    The following references have been placed on display in the Dockets

[[Page 41823]]

Management Branch (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. ``Pharmacopeial Forum,'' The United States Pharmacopeial 
Convention, Inc., Rockville, MD, pp. 693 to 694, 717 to 719, and 726 
to 729, May and June, 2000.
    2. ``Third Supplement,'' United States Pharmacopeia 24, National 
Formulary 19, The United States Pharmacopeial Convention, Inc., 
Rockville, MD, pp. 3025, 3053, 3061 to 3062, January 2, 2001.

List of Subjects in 21 CFR 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, 21 CFR part 
352 is 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: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
    2. Section 352.10 is amended by revising paragraphs (f) through (n) 
to read as follows:


Sec.  352.10  Sunscreen active ingredients.

* * * * *
    (f) Ensulizole up to 4 percent.
    (g) Homosalate up to 15 percent.
    (h) [Reserved].
    (i) Meradimate up to 5 percent.
    (j) Octinoxate up to 7.5 percent.
    (k) Octisalate up to 5 percent.
    (l) Octocrylene up to 10 percent.
    (m) Oxybenzone up to 6 percent.
    (n) Padimate O up to 8 percent.
* * * * *
    3. Section 352.20 is amended by revising paragraphs (a)(1) and 
(a)(2) as follows:


Sec.  352.20  Permitted combinations of active ingredients.

* * * * *
    (a) Combinations of sunscreen active ingredients. (1) Two or more 
sunscreen active ingredients identified in Sec.  352.10(a), (c), (e), 
(f), (g), and (i) through (r) may be combined with each other in a 
single product when used in the concentrations established for each 
ingredient in Sec.  352.10. The concentration of each active ingredient 
must be sufficient to contribute a minimum SPF of not less than 2 to 
the finished product. The finished product must have a minimum SPF of 
not less than the number of sunscreen active ingredients used in the 
combination multiplied by 2.
    (2) Two or more sunscreen active ingredients identified in Sec.  
352.10(b), (c), (e), (g), (j) through (m), (o), and (q) may be combined 
with each other in a single product when used in the concentrations 
established for each ingredient in Sec.  352.10. The concentration of 
each active ingredient must be sufficient to contribute a minimum SPF 
of not less than 2 to the finished product. The finished product must 
have a minimum SPF of not less than the number of sunscreen active 
ingredients used in the combination multiplied by 2.
* * * * *

    Dated: June 11, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-15632 Filed 6-19-01; 8:45 am]
BILLING CODE 4160-01-S