[Federal Register Volume 66, Number 250 (Monday, December 31, 2001)]
[Rules and Regulations]
[Pages 67485-67487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-32086]


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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; Partial Stay; Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; partial stay.

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SUMMARY: The Food and Drug Administration (FDA) is staying the final 
monograph for over-the-counter (OTC) sunscreen drug products that 
published in the Federal Register of May 21, 1999 (64 FR 27666). The 
final monograph established conditions under which OTC sunscreen drug 
products are generally recognized as safe and effective and not 
misbranded. This stay of effective date applies to all OTC sunscreen 
drug products that would be regulated under part 352 (21 CFR part 352). 
This action does not stay the effective date for products that would be 
regulated under parts 310 and 700 (21 CFR parts 310 and 700). This 
action is being taken because the agency will be amending part 352 to 
address formulation, labeling, and testing requirements for both 
ultraviolet A (UVA) radiation protection and ultraviolet B (UVB) 
radiation protection. This action is part of FDA's ongoing review of 
OTC drug products.

DATES: This rule is effective January 30, 2002. Part 352, added at 64 
FR 27666 at 27687, is stayed until further notice. Written or 
electronic comments by April 1, 2002.

ADDRESSES: Submit written 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: Gerald M. Rachanow, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2307.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 21, 1999, FDA published a final rule 
in the form of a final monograph for OTC sunscreen drug products in 
part 352. The monograph included 16 active ingredients, required 
labeling for products that contain one or more of these active 
ingredients, a standardized test for measuring sun protection factor 
(SPF) values, and standard methods for measuring the water resistant 
properties of sunscreens. The labeling and test methods covered 
products intended to provide UVB radiation protection. The monograph 
did not, however, address active ingredients, labeling, and test 
methods for products intended to provide UVA protection. The final rule 
also included related nonmonograph conditions in Sec.  310.545(a)(29) 
(21 CFR 310.545(a)(29)) and new Sec.  700.35 (21 CFR 700.35), which 
addressed labeling for cosmetic products that contain sunscreen active 
ingredients for nontherapeutic, nonphysiologic uses (e.g., as a color 
additive or to protect the color of the product). The agency set a 2-
year effective date (May 21, 2001) for part 352 and for 
Secs. 310.545(a)(29) and 700.35.
    In the Federal Register of June 8, 2000 (65 FR 36319), the agency 
extended the effective date for all OTC sunscreen drug and cosmetic 
products that would be regulated under parts 310, 352, and 700 to 
December 31, 2002. The agency stated that this extension would be in 
the public interest as the agency developed a comprehensive sunscreen 
final monograph that addresses formulation, labeling, and testing 
requirements for both UVB and UVA radiation protection under part 352. 
The agency stated in this notice that it intended to move forward and 
publish a proposed rule for a comprehensive final monograph, receive 
comments on that proposal, and issue a final rule by December 31, 2001. 
That final rule would then have a 1-year effective date of December 31, 
2002.

II. Stay of Part 352

    The June 8, 2000, extension of effective date also included a 
reopening of the administrative record to allow for comment on specific 
information the agency requested in that document. The comment period 
closed on September 6, 2000. Since that time, the agency has been 
developing a proposed amendment to part 352 that addresses both UVB and 
UVA radiation protection.
    The agency expects to publish the proposal to amend part 352 next 
year. Following that publication, there will be a comment period and 
then the agency will prepare an amended final monograph for publication 
in a future issue of the Federal Register. Because the agency has not 
yet published the proposed amendment to part 352, it is not possible 
for manufacturers of OTC sunscreen drug products to relabel and

[[Page 67486]]

test their products in accord with an amended final monograph by the 
current effective date of December 31, 2002.
    Accordingly, the agency is staying part 352 until further notice is 
provided in a future issue of the Federal Register. The agency will 
propose a new effective date for part 352 within the proposed 
amendment. The agency anticipates that this new effective date will not 
be before January 1, 2005.
    This stay of effective date does not apply to parts 310 or 700, 
because the amendment of the monograph in part 352 has no effect on the 
requirements in these parts. The agency has already extended the 
effective dates for parts 310 and 700 to December 31, 2002, and finds 
there is no reason to further extend that date.
    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 
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) and 
(d)(3) in that obtaining public comment is impracticable, unnecessary, 
and contrary to the public interest. The agency is staying part 352 
because the agency has determined that it is not possible for 
manufacturers of OTC sunscreen drug products to relabel and test their 
products in accord with an amended final monograph by the current 
effective date of December 31, 2002. The agency intends to publish a 
proposal to amend part 352 next year in order to develop a 
comprehensive sunscreen monograph that addresses formulation, labeling, 
and testing requirements for both UVB and UVA radiation protection. 
This amendment will propose a new effective date for part 352. Thus, 
there will be an opportunity for public comment on the new effective 
date within the proposed amendment to part 352. In accordance with 21 
CFR 10.40(e)(1), FDA is providing an opportunity for comment on whether 
this partial stay should be modified or revoked.

III. Analysis of Impacts

    The economic impact of the final monograph was discussed in the 
final rule (64 FR 27666 at 27683). The economic impact of the extension 
of the effective date of the monograph until December 31, 2002, was 
discussed in the final rule extending that date (65 FR 36319 at 36323). 
This stay of the effective date provides additional time for companies 
to relabel and retest products, eliminates a second relabeling of 
sunscreen drug products when UVA labeling is included in the monograph, 
and reduces label obsolescence, as there will be additional time to use 
up more existing labeling. Thus, staying the effective date will 
significantly reduce the economic impact on industry.
    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 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 
regulatory philosophy and principles set out in the Executive order and 
in these two statutes. 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. FDA has determined that the final 
rule does not have a significant economic impact on a substantial 
number of small entities. The Unfunded Mandates Reform Act does not 
require FDA to prepare a statement of costs and benefits for the 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 purpose of this final rule is to stay the effective date of the 
final monograph for OTC sunscreen drug products in part 352. This will 
provide additional time for manufacturers to relabel and retest 
products and to use up existing product labeling. The agency encourages 
manufacturers who use up their existing product labeling before the 
amended final monograph is issued to prepare new labeling in accord 
with the existing final monograph in part 352 in the format set forth 
in Sec.  201.66 (21 CFR 201.66). Accordingly, the agency certifies that 
this final 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.

IV. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

V. 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.

VI. 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.

VII. Request for Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this rule by 
April 1, 2002. Three 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 office above between 9 a.m. and 4 
p.m., Monday through Friday.
    This final rule (partial stay) is issued under sections 201, 501, 
502, 503, 505, 510, and 701 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321, 351, 352, 353, 355, 360, and 371) and under

[[Page 67487]]

authority delegated to the Commissioner of Food and Drugs.

    Dated: December 21, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-32086 Filed 12-28-01; 8:45 am]
BILLING CODE 4160-01-S