
[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Proposed Rules]
[Pages 35678-35681]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14771]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 310

[Docket No. FDA-2011-N-0449]


SPF Labeling and Testing Requirements and Drug Facts Labeling for 
Over-the-Counter Sunscreen Drug Products; Agency Information Collection 
Activities; Proposed Collection

AGENCY: Food and Drug Administration, HHS.

ACTION: Comment request.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on SPF labeling and testing requirements for 
over-the-counter (OTC) sunscreen products containing specified 
ingredients and marketed without approved applications, and on 
compliance with Drug Facts labeling requirements for all OTC sunscreen 
products.

DATES: Submit either electronic or written comments on the collection 
of information by August 16, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of Information Management, Food and Drug 
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-3792, Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined

[[Page 35679]]

in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests 
or requirements that members of the public submit reports, keep 
records, or provide information to a third party. Section 3506(c)(2)(A) 
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to 
provide a 60-day notice in the Federal Register concerning each 
proposed collection of information before submitting the collection to 
OMB for approval. To comply with this requirement, FDA is publishing 
notice of the proposed collection of information set forth in this 
document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

SPF Labeling and Testing Requirements for OTC Sunscreen Products 
Containing Specified Active Ingredients and Marketed Without Approved 
Applications, and Drug Facts Labeling for All OTC Sunscreen Products--
21 CFR 201.327(a)(1) and (i), 21 CFR 201.66(c) and (d)--(OMB 0910-New)

    Elsewhere in this issue of the Federal Register, we (FDA) are 
publishing a final rule establishing labeling and effectiveness testing 
requirements for certain OTC sunscreen products containing specified 
active ingredients and marketed without approved applications (2011 
sunscreen final rule; Sec.  201.327 (21 CFR 201.327)). The rule also 
lifts the delay of implementation date of the Drugs Facts regulation 
(21 CFR 201.66) for all OTC sunscreens. This rule is not yet in effect. 
It is intended to be effective June 18, 2012.

SPF Labeling and Testing for OTC Sunscreens Containing Specified Active 
Ingredients and Marketed Without Approved Applications

    Section 201.327(a)(1) requires the principal display panel (PDP) 
labeling of a sunscreen covered by the rule to include the SPF value 
determined by conducting the SPF test outlined in Sec.  201.327(i). 
Therefore, this provision will result in an information collection with 
a third-party disclosure burden for manufacturers of OTC sunscreens 
covered by the rule. Products need only complete the testing and 
labeling required by the rule one time, and then continue to utilize 
the resultant labeling (third-party disclosure) going forward, without 
additional burden.
    In a draft guidance published elsewhere in this issue of the 
Federal Register, we state that we do not intend to initiate 
enforcement action before June 17, 2013 if an OTC sunscreen subject to 
Sec.  201.327 that was initially marketed prior to June 17, 2011, the 
date of publication of the final rule, continues to include an SPF 
value in its labeling that was determined prior to that date according 
to either the SPF test method described in the May 21, 1999, final rule 
(64 FR 27666 at 27689 through 27693) or the SPF test method described 
in the August 27, 2007, proposed rule (72 FR 49070 at 49114 through 
49119). We believe that the majority of currently-marketed OTC 
sunscreen formulations will meet this standard and, therefore, may 
defer their conduct of new SPF testing. However, this one-time testing 
will nonetheless need to be conducted within the first 3 years after 
publication of the 2011 final rule for all OTC sunscreens covered by 
that rule. We therefore do not anticipate that the draft guidance will 
alter the annualized burden associated with Sec. Sec.  201.327(a)(1) 
and (i) as estimated here. We provide a separate PRA analysis in the 
notice of availability for the draft guidance to address the 
information collections provisions that result from it.
    Our estimate of third-party disclosure burden includes the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information. We have estimated that there are 
approximately 100 manufacturers of OTC sunscreen drug products. We 
estimate that these 100 manufacturers are currently producing as many 
as 2,350 OTC sunscreen formulations and that these formulations are 
available in approximately 3,600 stock keeping units (SKUs) (see 2010 
sunscreen final rule--indicating recent data supports estimate of up to 
2,348 formulations and 3,591 SKUs).\1\
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    \1\ Document No. FDA-1978-N-0018-0693 in Docket No. FDA-1978-N-
0018.
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    Our estimates on the conduct of SPF testing are based on the 
estimated number of formulations because, if the same formulation is 
sold under different SKUs, the formulation will only have to be 
retested one time in order to develop the labeling for multiple 
marketed SKUs. However, our estimates on labeling are based on the 
number of SKUs because, although each SKU will not need to be tested to 
establish its SPF value, the labeling of each SKU has to be considered.
    To determine the SPF value required in Sec.  201.327(a)(1), 
manufacturers will have to conduct SPF tests according to Sec.  
201.327(i). We estimate that all 100 manufacturers will have to retest 
currently marketed sunscreen formulations. We estimate that there are 
approximately 2,350 existing sunscreen formulations that will require 
retesting. We further estimate that it will take 24 hours (i.e., three 
8-hour days) to complete SPF testing for each of the formulations. This 
estimate assumes SPF testing of a high SPF sunscreen that includes 80 
minutes of water resistance testing, which reflects products requiring 
the most time to test. Therefore, a total of 56,400 hours will be 
required as the one-time burden to retest existing sunscreen products 
in accordance with Sec.  201.327(i) to provide the SPF value required 
to be disclosed to the public in labeling under Sec.  201.327(a)(1). In 
accordance with FDA's enforcement policy guidance, retesting of 
currently marketed sunscreen products should be completed within 2 
years after the date of publication of the final rule, so if this one-
time burden is annualized across that time period, the result is a 
burden of 28,200 hours in each of the first 2 years to complete 
retesting of existing sunscreen products.
    Once manufacturers have tested their products to determine the SPF 
value to comply with the third-party disclosure (labeling) requirements 
in Sec.  201.327(a)(1), the manufacturers will need to insert the SPF 
value after the term ``SPF'' in either the statement ``SPF'' or ``Broad 
Spectrum SPF,'' as applicable. We estimate that each of the 100 
manufacturers will spend no more than 0.5 hours per SKU to prepare, 
complete, and review the labeling for each of 3,600 currently marketed 
SKUs. Therefore, we estimate that a total of no more than 1,800 hours 
will be required as a one time burden to relabel currently marketed OTC 
sunscreens containing specified ingredients and marketed without 
approved applications (3,600 SKUs times 0.5 hours per SKU). In 
accordance with FDA's enforcement policy guidance, relabeling of 
currently marketed sunscreen products should be completed within 2 
years after the date of publication of the final rule, so if this one-
time burden is annualized across that time period, the result is a 
burden

[[Page 35680]]

of 900 hours in each of the first 2 years to complete relabeling of 
existing sunscreen products.
    In addition, new products may also be introduced each year, and 
these products will have to be tested and labeled with the SPF value 
determined in the test. We estimate that as many as 60 new OTC 
sunscreen products (SKUs) may be introduced each year. As discussed in 
this section of the document, there are currently approximately 1.53 
SKUs marketed for every sunscreen formulation (3,600 SKUs divided by 
2,350 formulations). Therefore, we estimate that the 60 new sunscreen 
SKUs will represent 39 new formulations annually. We expect the burden 
of testing the 39 new formulations marketed each year will require 936 
hours per year (39 formulations times 24 hours testing per 
formulation). We estimate that labeling of the 60 new SKUs marketed 
each year will require 30 hours per year (60 SKUs times 0.5 hours per 
SKU).
    We estimate the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                      Annual
            Activity                  No. of       frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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Conduct SPF testing in                       100           11.75           1,175              24          28,200
 accordance with Sec.
 201.327(i) for existing
 sunscreen formulations \2\.....
Conduct SPF testing in                        20            1.95              39              24             936
 accordance with Sec.
 201.327(i) for new sunscreen
 formulations...................
Create PDP labeling in                       100             180           1,800             0.5             900
 accordance with Sec.
 201.327(a)(1) for existing
 sunscreen SKUs \2\.............
Create PDP labeling in                        20               3              60             0.5              30
 accordance with Sec.
 201.327(a)(1) for new sunscreen
 SKUs...........................
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    Total burden in years one     ..............  ..............  ..............  ..............          30,066
     and two....................
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    Total burden in each          ..............  ..............  ..............  ..............             966
     subsequent year............
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\1\ There are no capital, operating or maintenance costs associated with this collection of information.
\2\ Burden for each of first and second years for currently marketed OTC sunscreens.

Drug Facts Labeling for OTC Sunscreens

    Because the 2011 final rule also lifts the delay of implementation 
date for Drug Facts regulations (21 CFR 201.66) for OTC sunscreens, the 
rule will also modify the information collection associated with Sec.  
201.66 (currently approved under OMB control number 0910-0340) and 
result in additional third-party disclosure burden resulting from 
requiring OTC sunscreen products to comply with Drug Facts regulations. 
In the Federal Register of March 17, 1999 (64 FR 13254), we amended our 
regulations governing requirements for human drug products to establish 
standardized format and content requirements for the labeling of all 
marketed OTC drug products, codified in 21 CFR 201.66 (the 1999 Drug 
Facts labeling final rule). Section 201.66 sets requirements for the 
Drug Facts portion of labels on OTC drug products, requiring such 
labeling to include uniform headings and subheadings, presented in a 
standardized order, with minimum standards for type size and other 
graphical features. In the Federal Register of September 3, 2004 (69 FR 
53801), we delayed the Sec.  201.66 implementation date for OTC 
sunscreen products indefinitely, pending future rulemaking to amend the 
substance of labeling for these products. The 2011 sunscreen final rule 
lifts this stay for OTC sunscreens. Therefore, currently marketed OTC 
sunscreen products will incur a one-time burden to comply with the 
requirements in 21 CFR 201.66 (c) and (d).
    We estimate that there are 3,600 currently marketed OTC sunscreen 
drug product SKUs, and we assume for purposes of this estimate that 
none of them have yet complied with the 1999 Drug Facts labeling final 
rule. These 3,600 SKUs will need to implement the new labeling format 
by the implementation date included in the sunscreen final rule. We 
estimate that these 3,600 SKUs are marketed by 100 manufacturers and 
that approximately 12 hours will be spent on each label. The number of 
hours per label (response) is based on the most recent estimate used 
for other OTC drug products to comply with the 1999 Drug Facts labeling 
final rule, including public comments received on this estimate in 2010 
that addressed sunscreens. If an average of 12 hours is spent 
preparing, completing, and reviewing each of the estimated 3,600 
sunscreen SKUs, the total number of hours dedicated to the one-time 
relabeling of currently marketed OTC sunscreen products, as necessary 
to comply with Sec.  201.66 would be 43,200 (3,600 SKUs times 12 hours/
SKU).
    In addition to this one-time burden, we estimate that 60 new 
sunscreen SKUs marketed each year will have a third-party disclosure 
burden to comply with Drug Facts regulations equal to 720 hours 
annually (60 SKUs times 12 hours/SKU). We estimate that these new SKUs 
will be marketed by 20 manufacturers. We do not expect any OTC 
sunscreens to apply for exemptions or deferrals of the Drug Facts 
regulations 21 CFR 201.66(e).
    We estimate the burden of this collection of information as 
follows:

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                      Annual
            Activity                  No. of       frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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Format labeling in accordance                100              36           3,600              12          43,200
 with 201.66(c) and (d) for
 existing sunscreen SKUs \2\....

[[Page 35681]]

 
Format labeling in accordance                 20               3              60              12             720
 with 201.66(c) and (d) for new
 sunscreen SKUs.................
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    Total first year burden.....  ..............  ..............  ..............  ..............          43,920
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    Total burden for each         ..............  ..............  ..............  ..............             720
     subsequent year............
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\1\ We estimate a one-time medium capital cost of $6.1 million dollars will result from preparing labeling
  content and format for OTC sunscreens in accordance with Sec.   201.66. There are no operating or maintenance
  costs associated with this collection of information.
\2\ First-year burden for currently marketed OTC sunscreens.

    With the exception of the PDP statement of SPF value in Sec.  
201.327(a)(1), the labeling requirements in Sec.  201.327(a) through 
(h), which provide other elements of the PDP, as well as specific 
content for indications, directions, and warnings, 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)) and, therefore, are not collections of information. These 
provisions are thus not subject to OMB review under the PRA.

    Dated: June 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14771 Filed 6-14-11; 8:45 am]
BILLING CODE 4160-01-P


