Document ID: FDA-1978-N-0018-0746
Agency: fda
Document Type: Rule
Title: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates
Posted Date: 2012-05-11T04:00Z

[Federal Register Volume 77, Number 92 (Friday, May 11, 2012)]
[Rules and Regulations]
[Pages 27591-27593]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11390]

[[Page 27591]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 310

[Docket No. FDA-1978-N-0018] (Formerly Docket No. 1978N-0038)
RIN 0910-AF43

Labeling and Effectiveness Testing; Sunscreen Drug Products for 
Over-the-Counter Human Use; Delay of Compliance Dates

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; delay of compliance dates; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is delaying the 
compliance dates for the final rule for over-the-counter (OTC) 
sunscreen drug products that published in the Federal Register of June 
17, 2011 (76 FR 35620). The final rule establishes labeling and 
effectiveness testing for certain OTC sunscreen products containing 
specified active ingredients and marketed without approved 
applications. It also amends labeling claims that are not currently 
supported by data and lifts the previously-published delay of 
implementation of the Drug Facts labeling requirements for OTC 
sunscreens. The 2011 final rule's compliance dates are being delayed 
because information received after publication of the 2011 final rule 
indicates that full implementation of the 2011 final rule's 
requirements for all affected products will require an additional 6 
months. This final rule is part of FDA's ongoing review of OTC drug 
products.

DATES: Effective Date: This final rule is effective June 18, 2012. The 
final rule published at 76 FR 35620 on June 17, 2011, remains effective 
June 18, 2012.
    Comment date: Submit written or electronic comments on the delay of 
compliance dates by May 21, 2012.
    Compliance Dates: The compliance dates for the final rule published 
at 76 FR 35620 on June 17, 2011, including the lifting of the delay of 
implementation date for 21 CFR 201.66 as published at 69 FR 53801, 
September 3, 2004, are delayed until December 17, 2013, for products 
with annual sales of less than $25,000, and until December 17, 2012 for 
all other products subject to the rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-1978-
N-0018 (formerly Docket No. 1978N-0038) and RIN number 0910-AF43, by 
any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency 
name, Docket No. FDA-1978-N-0018 (formerly Docket No. 1978N-0038), and 
RIN 0910-AF43 for this rulemaking. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov, insert the docket 
numbers, found in brackets in the heading of this document, into the 
``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Reynold Tan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993, 301-796-
2090.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 17, 2011, a final rule was 
published for OTC sunscreen products (hereafter referred to as ``2011 
final rule''). The 2011 final rule established labeling and 
effectiveness testing requirements for certain OTC sunscreen products 
containing specified active ingredients and marketed without approved 
applications, to be codified in the Code of Federal Regulations (CFR) 
at Sec.  201.327 (21 CFR 201.327) (which is effective June 18, 2012). 
It also amended Sec.  310.545 (21 CFR 310.545) to classify as new 
drugs, requiring premarket approval, sunscreens labeled with certain 
claims (claims for ``instant protection'' or protection immediately 
upon application, or claims for ``all-day'' protection or extended wear 
claims citing a specific number of hours of protection that is 
inconsistent with the directions for application in Sec.  201.327). 
Finally, it lifted the delay of implementation of the Drug Facts 
regulation, Sec.  201.66 (21 CFR 201.66), published at 69 FR 53801, 
September 3, 2004, requiring those products to comply with Sec.  201.66 
on the same date as they would be required to comply with Sec.  201.327 
(76 FR 35620 at 35629). The 2011 final rule had an effective date of 
June 18, 2012, which was 1 year following publication of the final 
rule. For OTC sunscreen products with annual sales of $25,000 or more, 
the 2011 final rule had a compliance date of June 18, 2012. For OTC 
sunscreen products with annual sales of less than $25,000, the 2011 
final rule had a compliance date of June 17, 2013.
    The 2011 final rule explains why these effective and compliance 
dates were chosen (76 FR 35620 at 35623 through 35624). The primary 
reason for a 1-year effective date and compliance date for the majority 
of products was that FDA chose a simpler and less expensive testing 
method to demonstrate broad spectrum activity than had been originally 
proposed. Because a simpler testing method was chosen, it was projected 
that most OTC sunscreen drug products could be brought into compliance 
with the new testing and labeling requirements within 1 year.
    Following publication of the 2011 final rule, a request to extend 
the period for implementation of the 2011 final rule by 6 months was 
submitted to FDA by The Personal Care Products Council (PCPC) and The 
Consumer Healthcare Products Association (CHPA), which are trade 
associations for the cosmetic and personal care products industry and 
the OTC drug products industry, respectively, in the United States 
(Ref. 1). PCPC and CHPA consolidated comments from its member companies 
in this submission. The submission provided several reasons, and 
supporting information, for requesting the additional time for 
implementation. Based on this submission, FDA is extending the 
compliance dates for the 2011 final rule, as explained in the 
paragraphs that follow.

II. Discussion of Rationale for Delay

    FDA is delaying the compliance dates of the 2011 final rule by 6 
months, to December 17, 2012, for products with sales of $25,000 or 
more, and until

[[Page 27592]]

December 17, 2013, for products with annual sales of less than $25,000. 
The 2011 final rule requirements are intended to ensure that OTC 
sunscreen products are used safely and effectively. Therefore, allowing 
adequate time for the 2011 final rule requirements to be fully 
implemented is in the interest of public health. Our reassessment of 
the time needed for full implementation of the 2011 final rule 
requirements supports delaying the compliance dates by 6 months.
    FDA finds that the information provided by the PCPC/CHPA 
submission, describing the process for testing and relabeling sunscreen 
products, supports the requested extension of the time for compliance 
with the 2011 final rule. The submission included an operational 
timeline that detailed the numerous steps involved in implementation of 
the new labeling requirements for a given product, and included 
specific time estimates for the different stages of implementation 
(Ref. 1). The operational timeline's time estimates were calculated by 
taking the average of time estimates calculated by PCPC's and CHPA's 
member companies. The submission stated that complete implementation of 
new labeling could not be achieved by June 18, 2012, particularly for 
sunscreen products that: (1) Had complex label redesign issues and (2) 
required broad spectrum testing. Complex label redesign issues included 
contending with special production techniques to implement relabeling 
(e.g., glass or plastic bottles that require embossing), incorporating 
complete Drug Facts panel labeling, and coordinating relabeling of 
product lines with many variants. The submission also estimated that 
because of the substantial number of existing or new formulations that 
would need to undergo broad spectrum testing and the limited capacity 
of testing facilities, it would require approximately 10 months for 
industry to complete the broad spectrum testing for all products. The 
overall operational timeline provided in the submission indicates that 
testing and other necessary label redesign issues could not be 
completed for all products in time for labeling consistent with those 
test results to be applied to products by June, 2012, the original 
compliance date for sunscreens with annual sales of $25,000 or more.
    FDA concurs that the operational timeline included in the 
submission supports extending the implementation period by an 
additional 6 months. One of our primary objectives in the 2011 final 
rule is to provide labeling that will enable consumers to identify and 
select sunscreen products that provide broad spectrum protection as 
well as a minimum sun protection factor (SPF) of 15. These sunscreens 
are particularly important for the public health because, in addition 
to helping prevent sunburn, sunscreens with a broad spectrum SPF value 
of 15 or higher, if used as directed with other sun protection 
measures, decrease the risk of skin cancer and early skin aging caused 
by the sun. If the timeline for implementation discourages 
manufacturers from conducting broad spectrum testing, and instead 
prompts them to apply the labeling that the final rule establishes for 
products that have not been established to offer broad spectrum 
protection, a major public health goal of the rule will be undermined. 
For this reason, granting manufacturers additional time to complete 
testing and relabeling is in the public interest. Also, implementation 
of Sec.  201.66, the general Drug Facts labeling requirements, has been 
intended to be coordinated with the implementation of the substantive 
labeling changes necessitated by Sec.  201.327, which provide the 
specific content for the Drug Facts panel for sunscreens. We therefore 
conclude that the implementation periods for these rules should remain 
coordinated.
    We also conclude that extension of the compliance dates for Sec.  
310.545(a)(29)(ii) should likewise be extended because it is claims in 
labeling, and not formulation, that defines what sunscreens are subject 
to this provision of the 2011 final rule. The claims that would 
necessitate submission of a new drug application (NDA), as defined by 
that provision of the rule, are claims that would be in conflict with 
the labeling required by Sec.  201.327. We believe that in many cases 
the relabeling of products to comply with Sec.  201.327 will remove 
claims that would otherwise bring the sunscreen within Sec.  
310.545(a)(29)(ii). We therefore intend to revise the compliance dates 
to be codified in Sec.  310.545(d)(40), so as to avoid requiring 
sunscreens that bear the indicated claims to be removed from the market 
before their relabeled replacements are ready.
    We note that the PCPC/CHPA submission also stated that instituting 
a 6-month extension in the implementation period would be consistent 
with actions taken on previous FDA sunscreen rulemakings. The 
submission cited the 2007 sunscreen proposed rule (72 FR 49070 at 
49073, August 27, 2007) and the 1999 sunscreen final rule (64 FR 27666 
at 27686, May 21, 1999), where it was stated that complying with 
requirements in a sunscreen final monograph may require an 
implementation period of more than 1 year. The submission stated that 
FDA has delayed implementation of rules in the past when a delay is 
justified.
    We acknowledge that implementation periods of more than 1 year were 
allowed for previous OTC sunscreen rulemakings and concur with the 
requested delay of implementation in light of the specific information 
submitted after the publication of the final rule, detailing specific 
reasons why additional time is required for all sunscreen drug products 
to achieve compliance. Because we cannot determine which particular 
products would be unable to comply, we are extending the compliance 
dates generally, but we nonetheless encourage manufacturers to act with 
diligence to bring products into compliance as soon as possible, so as 
to provide the public with the benefits of the new labeling. We have 
not altered the effective date of the regulation, and encourage 
manufacturers to introduce individual products bearing the new labeling 
as it becomes available, even in advance of the revised compliance 
date.
    We find that there is adequate rationale to delay the compliance 
dates for the 2011 final rule. We are issuing this rule directly, 
without issuing a notice of proposed rulemaking or taking comments on 
this action, for good cause. Because manufacturers' plans depend on the 
date by which compliance is expected, and the original compliance date 
for most products is now imminent, we find that issuing notice and 
taking comments are impracticable, unnecessary, and contrary to the 
public interest with respect to this action. As already noted, without 
this extension of the time for implementation, manufacturers who do not 
anticipate being able to comply by the original compliance dates 
expressed in the final rule would be faced either with discontinuing 
distribution, or potentially confining themselves to the labeling for 
products that have not been established to be broad spectrum. This 
means that consumers would be deprived of the additional information to 
make informed choices regarding their sun protection options. With 
regard to Sec.  310.545, in particular, we also find it is in the 
public interest to extend the compliance date prior to the effective 
date, to avoid the confusion that would likely ensue if the codified 
had already been incorporated into the CFR with the earlier compliance 
dates. Accordingly, 5 U.S.C. 553(b) and Sec.  10.40(e)(1) (21 CFR 
10.40(e)(1)) provide a statutory and regulatory basis for not issuing 
notice or taking comment

[[Page 27593]]

prior to implementing the delay of the compliance dates for the 2011 
final rule. In accordance with Sec.  10.40(e)(1), however, interested 
parties may submit comments on whether the extension of compliance 
dates set forth in this document should subsequently be modified or 
revoked.

III. Submission of Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Analysis of Impacts

    The 2011 final rule includes a comprehensive examination of the 
economic impact of the 2011 final rule (76 FR 35620 at 35654 through 
35657). A 6-month delay of the compliance dates for the 2011 final rule 
is unlikely to significantly affect the time or cost estimates made in 
that economic impact analysis. The 6-month delay allows additional time 
for testing and relabeling. However, the economic impact analysis in 
the 2011 final rule presumed that testing and relabeling could be fully 
implemented without the additional 6 months. Therefore, delaying the 
compliance dates by 6 months should not increase the time and cost 
estimates in the 2011 final rule.
    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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). We have determined that this final rule is not a significant 
regulatory action under Executive Order 12866. Consistent with 
Executive Order 13563, the approach taken here maintains ``flexibility 
and freedom of choice for the public,'' above all by providing 
``information for the public in a form that is clear and 
intelligible.''
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. We concluded that the 2011 final rule would have a 
significant economic impact on a substantial number of small entities. 
Our analysis of this economic impact is discussed at 76 FR 35620 at 
35657. However, delaying the compliance dates of the 2011 final rule 
does not affect any of the numerical estimates made in our analysis.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $139 million, using the most current (2011) Implicit 
Price Deflator for the Gross Domestic Product. It is not expected that 
this final rule will result in any 1-year expenditure that would meet 
or exceed this amount.
    The purpose of this final rule is to delay the compliance dates for 
the 2011 final rule by 6 months. The delay of the compliance dates is 
based upon information received after publication of the 2011 final 
rule that indicates that full implementation of the 2011 final rule's 
requirements for all affected products will require an additional 6 
months.

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. References

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES), and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has 
verified the Web site address, but we are not responsible for any 
subsequent changes to the Web site after this document publishes in the 
Federal Register.)
    1. ``Personal Care Products Council--Comment, FDA-2011-N-0449-0003, 
10/06/2011,'' http://www.regulations.gov.

List of Subjects in 21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical 
devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR part 310 is amended as follows:

PART 310--NEW DRUGS

0
1. The authority citation for 21 CFR part 310 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 
263b-263n.

0
2. Section 310.545 is amended by revising paragraph (d)(40) to read as 
follows:

Sec.  310.545  Drug products containing certain active ingredients 
offered over-the-counter (OTC) for certain uses.

* * * * *
    (d) * * *
    (40) December 17, 2012, for products subject to paragraph 
(a)(29)(ii) of this section. December 17, 2013, for products with 
annual sales less than $25,000.

    Dated: May 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11390 Filed 5-10-12; 8:45 am]
BILLING CODE 4160-01-P