[Federal Register Volume 77, Number 92 (Friday, May 11, 2012)]
[Rules and Regulations]
[Pages 27591-27593]
From the Federal Register Online via the Government Publishing 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
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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
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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