[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Pages 27230-27234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-11067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Sun Protection Factor 
Labeling and Testing Requirements and Drug Facts Labeling for Over-the-
Counter Sunscreen Drug Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by June 8, 
2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910--New and 
title ``SPF Labeling and Testing Requirements and Drug Facts Labeling 
for Over-the-Counter Sunscreen Drug Products.'' Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and

[[Page 27231]]

Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 
301-796-7651, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

    In the Federal Register of June 17, 2011 (76 FR 35620), FDA 
published a final rule establishing labeling and effectiveness testing 
requirements for certain over-the-counter (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 sun 
protection factor (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 the Federal Register of June 17, 2011 (76 FR 35665), we 
announced the availability of a draft guidance and stated 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.  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 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 document, there are currently approximately 1.53 SKUs marketed for 
every sunscreen spray 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

[[Page 27232]]

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).
    The sunscreen 2011 final rule published on June 17, 2011. In 
accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for 
public comment in the Federal Register of June 17, 2011, concerning the 
collection of information imposed by the final rule and allowed 60 days 
for public comment on the notice (76 FR 35678-35681). FDA created a 
public docket for submission of these comments (i.e., FDA-2011-N-0449). 
FDA received three comments to this docket, but only two of them 
concerned the collection of information in the 2011 sunscreen final 
rule (i.e., FDA-2011-N-0449-0002, FDA-2011-N-0449-0003).
    These comments were submitted by: (1) Consumers Union (see 
Attachment 2 of the Consumers Union comments), which publishes Consumer 
Reports and (2) The Personal Care Products Council (PCPC) jointly with 
The Consumer Healthcare Products Association (CHPA) (see Attachment 3 
of the PCPC/CHPA comments), which are trade associations for the OTC 
personal care products industry and the cosmetics industry in the 
United States, respectively.
    The Consumers Union comment states that the collection of 
information in the 2011 sunscreen final rule is practical and necessary 
for FDA's functions. Although the comment disagrees with the 2011 
sunscreen final rule's removal of a proposed in vivo ultraviolet A 
(UVA) protection test, that test has no bearing upon FDA's estimate of 
the third-party disclosure burden. Therefore, FDA is not making any 
modifications to our estimates of burden based upon the Consumers Union 
comment.
    The PCPC/CHPA comment states that FDA underestimated the burden to 
industry, including the third-party disclosure burden. However, ``the 
burden to industry'' is not the same as ``the third-party disclosure 
burden.'' This document only addresses the third-party disclosure 
burden. Table 1 of this document compares PCPC/CHPA's estimates with 
FDA's estimates.

         Table 1--Comparison of PCPC/CHPA's and FDA's Estimates
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                                  PCPC/CHPA                FDA
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Sunscreen product              >364...........  100.
 manufacturers.
Existing sunscreen products    4,528; 2,943...  3,591; 2,350.
 (SKUs formulations).
New sunscreen products (SKUs;  1,262; 824 per   60; 39 per year.
 formulations).                 year.
Hours per response (SPF        170.5 per        24 per formulation.
 testing).                      formulation.
Hours per response (principal  70.5 per SKU...  0.5 per SKU.
 display panel label).
Hours per response (Drug       70.5 per SKU...  12 per SKU.
 Facts label).
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    PCPC/CHPA's estimates of the number of sunscreen products and 
sunscreen product manufacturers are taken from brief letters submitted 
to PCPC/CHPA from the three market research organizations (Symphony IRI 
Group, The NPD Group, and Mintel). These letters are included in PCPC/
CHPA's comment. PCPC/CHPA's estimated number of existing sunscreen 
products and sunscreen product manufacturers were calculated by adding 
the estimated numbers from the Symphony IRI Group letter (i.e., 3,289 
products, 197 manufacturers) and The NPD Group letter (i.e., 1,239 
products, 167 manufacturers). PCPC/CHPA's estimated number of new 
sunscreen products is taken from Mintel's letter (i.e., 1,262 
products). However, how the exact numbers were derived from their 
databases was not provided, nor were any potential references that may 
have been used for their calculations and estimates. PCPC/CHPA's 
estimate of the hours required to conduct SPF testing and create 
principal display panel labels are based upon PCPC/CHPA's survey of its 
members. FDA describes the bases for its estimates in the 60-day notice 
concerning the collection of information imposed by the 2011 sunscreen 
final rule (76 FR 35620 at 35678 through 35681).
    In conclusion, FDA does not consider the data submitted sufficient 
to merit revising its estimates of third-party disclosure burden as 
described in the following paragraphs. Details on how the survey was 
conducted and the number of hours required to conduct SPF testing and 
create principal display panel labels were not provided. In addition, 
no data was submitted to support their conclusions. The market research 
organizations letters provided little information about how they 
derived their data regarding number of products and manufacturers. 
Market research organizations also explicitly state that there is no 
guarantee of the accuracy of their numbers. Therefore, FDA cannot 
assess the quality of the data upon which PCPC/CHPA's estimates were 
based. FDA discusses its consideration of PCPC/CHPA's estimates in the 
following paragraphs.
    Estimates of sunscreen products and sunscreen product 
manufacturers. FDA notes that all of PCPC/CHPA's estimates of sunscreen 
products and sunscreen product manufacturers are higher than FDA's 
estimates. The disparity between PCPC/CHPA's estimates and FDA's 
estimates remain unclear due to the lack of information about how their 
numbers were derived. PCPC/CHPA's estimate of new sunscreen products 
(i.e., 1,262 products per year) is much higher than FDA's estimate 
(i.e., 60 products per year). PCPC/CHPA states that its estimate of 
1,262 new products includes ``new products,'' ``new variety/range 
extensions,'' ``new formulations,'' ``new packaging,'' and 
``relaunches.'' Many of these products may not be considered new 
products (i.e., new SKUs) by FDA. For example, FDA would consider a 
minor labeling change on a particular 8 fluid ounce size bottle of a 
brand-name product to be a replacement of the same SKU, whereas PCPC/
CHPA considers the relabeled product to be a ``new product'' due to 
``new packaging'' as stated in their submission. Because the submitted 
data do not allow for verification of PCPC/CHPA's higher estimates and 
the market research organizations themselves will not guarantee the 
accuracy of these estimates, FDA is not revising its estimates of 
sunscreen products and sunscreen product manufacturers.
    Estimate of time required for SPF testing. FDA also notes that 
PCPC/CHPA's estimate of the time required to conduct SPF testing is 
much higher than FDA's estimate. PCPC/CHPA explains that FDA's estimate 
failed to consider the time required by good clinical practices (e.g., 
quality assurance testing, revision control, internal release of 
samples, documentation release, and shipment authorization). However, 
PCPC/CHPA does not provide time estimates for these procedures. Also, 
compliance with good clinical practices is a standard regulatory 
requirement and

[[Page 27233]]

does not constitute an additional burden resulting from the 2011 
sunscreen final rule. Regulations controlling paperwork burdens on the 
public in 5 CFR 1320.3(b)(2) state that the ``time, effort, and 
financial resources necessary to comply with a collection of 
information that would be incurred by persons in the normal course of 
their activities will be excluded from the ``burden'' if the Agency 
demonstrates that the reporting, recordkeeping, or disclosure 
activities needed to comply are usual and customary.'' PCPC/CHPA also 
explains that conducting the SPF test for a water-resistant product 
requires 3 to 4 weeks, instead of FDA's estimate of 24 hours (i.e., 3 
days, 8 hours/day). However, PCPC/CHPA does not adequately describe the 
``testing timelines'' section for conducting the SPF test. Even 
consideration of extra time required for data analysis fails to account 
for the difference between PCPC/CHPA's and FDA's estimate. Therefore, 
FDA is not revising its estimate of the time required to conduct SPF 
testing.
    Estimate of the time required to create principal display labeling. 
FDA's estimate of the time required to create principal display panel 
labeling (e.g., 0.5 hours/SKU) differs from PCPC/CHPA's estimate (70.5 
hours/SKU) because the estimates are based upon different tasks. FDA's 
estimate refers to the time required to insert the SPF value on the 
principal display panel, whereas PCPC/CHPA's estimate appears to be the 
time required to create the entire principal display panel and the Drug 
Facts panel. Only the insertion of the SPF value constitutes a third-
party disclosure burden. The remainder of the principal display panel 
labeling constitutes ``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, is not 
considered a collection of information. Therefore, FDA is not revising 
its estimate.
    Estimate of the time required to comply with Drug Facts labeling 
requirements. FDA's estimate of the time required to comply with Drug 
Facts labeling requirements (12 hours/SKU) differs from PCPC/CHPA's 
estimate of (70.5 hours/SKU). FDA's estimate is based upon estimated 
times to comply with Drug Facts requirements that were submitted in 
public comments for various OTC drug products, including OTC sunscreen 
products. PCPC/CHPA breaks down its estimate for complying with Drug 
Facts requirements into 12 sequential steps and provides a one-sentence 
description of each step. Presumably, the time estimated for each step 
represents the average reported by PCPC/CHPA's members. Obtaining 
averages for data has the potential for changing the outcome due to 
outliers. In addition, the individual estimates from each of PCPC/
CHPA's members are not provided in the PCPC/CHPA's comment in order to 
validate calculations made. Therefore, FDA cannot determine how 
representative PCPC/CHPA's estimate is of its members or how variable 
the estimate is between its members. In summary, FDA does not have 
sufficient data to assess the validity of the estimated times for each 
of these steps. Therefore, FDA does not consider the currently 
available data adequate to revise its estimate.
    FDA estimates the burden of this collection of information as 
follows:

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of
                                     Number of      disclosures    Total annual       Average
            Activity                respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
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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...........................
                                 -------------------------------------------------------------------------------
    Total burden in years one     ..............  ..............  ..............  ..............          30,066
     and two....................
    Total burden in each          ..............  ..............  ..............  ..............             966
     subsequent year............
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\1\ There are no capital costs or operating and 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 sunscreen 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 Sec.  
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 Sec.  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 2011 sunscreen final rule. 
We estimate that these 3,600 SKUs are marketed by

[[Page 27234]]

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 in Sec.  201.66(e).
    FDA estimates the burden of this collection of information as 
follows:

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of
                                     Number of      disclosures    Total annual       Average
            Activity                respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
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Format labeling in accordance                100              36           3,600              12          43,200
 with Sec.   201.66(c) and (d)
 for existing sunscreen SKUs \2\
Format labeling in accordance                 20               3              60              12             720
 with Sec.   201.66(c) and (d)
 for new sunscreen SKUs \3\.....
                                 -------------------------------------------------------------------------------
    Total first year burden.....  ..............  ..............  ..............  ..............          43,920
    Total burden for each         ..............  ..............  ..............  ..............             720
     subsequent year............
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\1\ FDA estimates 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.
\3\ Burden for first and second years 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: May 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11067 Filed 5-8-12; 8:45 am]
BILLING CODE 4160-01-P