[Federal Register Volume 80, Number 73 (Thursday, April 16, 2015)]
[Notices]
[Pages 20499-20501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on Sun Protection Factor (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 June 15, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 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, including 
each proposed extension of an existing 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 Control 
Number 0910-0717)--Extension

    In the Federal Register of June 17, 2011 (76 FR 35620) we published 
a final rule establishing labeling and effectiveness testing 
requirements for certain OTC sunscreen products containing specified 
active ingredients without approved applications (2011 sunscreen final 
rule; Sec.  201.327 (21 CFR 201.327)). In addition to establishing 
testing requirements, this sunscreen final rule lifts the delay of 
implementation of the prior 1999 sunscreen final rule (published May 
21, 1999, at 64 FR 27666 and stayed December 31, 2001, 66 FR 67485) 
from complying with the 1999 labeling final rule (published March 17, 
1999, 64 FR 13254) in which 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 in part 201 (21 CFR part 201). Specifically, the 1999 labeling 
final rule added new Sec.  201.66 to part 201. Section 201.66 sets 
content and format requirements for the Drug Facts portion of labels on 
OTC drug products. We specifically exempted OTC sunscreen products from 
complying with the 1999 labeling final rule until we lifted the stay of 
the 1999 sunscreen final rule. The 2011 sunscreen final rule became 
effective December 17, 2012, for sunscreen products with annual sales 
of $25,000 or more and December 17, 2013, for sunscreen products with 
annual sales of less than $25,000 when we published an extension date 
notice on May 11, 2012 (77 FR 27591).

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

    In the Federal Register of June 17, 2011 (76 FR 35678), we 
published a 60-day notice requesting public comment on the proposed 
collection of information in regard to SPF labeling and testing 
requirements for OTC sunscreen products containing specified 
ingredients and marketed without approved applications. In that notice, 
we stated that Sec.  201.327 (a)(1) requires the principal display 
panel (PDP) labeling of a sunscreen covered by the 2011 final rule to 
include the SPF value determined by conducting the SPF test outlined in 
Sec.  201.327(i). Therefore, this provision results in information 
collection with a third-party disclosure burden for manufacturers of 
OTC sunscreens covered by the rule. We determined that 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. This one-time 
testing would 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 determined that the third-party disclosure burden by 
manufacturers of OTC sunscreens covered by the rule was based on an 
estimate: (1) Of the time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing each collection of information; (2) on the

[[Page 20500]]

conduct of SPF testing based on the estimated number of existing 
formulations; (3) of the time to relabel currently marketed OTC 
sunscreens containing specified ingredients and marketed without 
approved applications; and (4) on testing and labeling of new products 
introduced each year. The estimate for this burden in the 2011 60-day 
PRA notice was a total of 30,066 hours in years one and two and a total 
burden of 966 in each subsequent year.
    All currently marketed OTC sunscreen drug products are required at 
this time to be in compliance with the SPF labeling requirements 
specified by the 2011 final rule. However, our original estimate 
included the burden of new products introduced each year. We estimated 
that as many as 60 new OTC sunscreen products stock keeping units 
(SKUs) may be introduced each year which will have to be tested and 
labeled with the SPF value determined in the test. We estimated that 
the 60 new sunscreen SKUs represent 39 new formulations. The burden for 
testing and labeling these formulations was estimated at 30 hours per 
year.
    We have received no further comments on our estimate of burden for 
the collection of this information other than two comments (FDA-2011-N-
0449-0002 and FDA-2011-N-0449-0003). These comments were already 
addressed in FDA's notice of ``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'' published on 
May 9, 2012 (77 FR 27230).
    We estimate the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                 Number of
           Activity              Number of   disclosures  per   Total annual   Average  burden per   Total hours
                                respondents     respondent       disclosures        disclosure
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Conduct SPF testing in                   20              1.95              39  24.................           936
 accordance with Sec.
 201.327(i) for new
 sunscreens.
Create PDP labeling in                   20                 3              60  0.5 (30 min.)......            30
 accordance with Sec.
 201.327(a)(1) for new
 sunscreen SKUs.
                              ----------------------------------------------------------------------------------
    Total....................  ............  ................  ..............  ...................           966
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Drug Facts Labeling for OTC Sunscreens

    Because the 2011 final rule also lifts the delay of implementation 
of the Drug Facts regulations (Sec.  201.66) for OTC sunscreens, the 
rule also modifies the information collection associated with Sec.  
201.66 (currently approved under OMB control number 0910-0340) and adds 
an 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. Therefore, currently marketed OTC sunscreen 
products will incur a one-time burden to comply with the requirements 
in Sec.  201.66(c) and (d). The burden was estimated in the 60-day PRA 
notice published in the Federal Register of June 17, 2011 (76 FR 35678) 
as 43,200 hours for existing sunscreen SKUs and 720 hours for new 
sunscreen SKUs.
    The compliance dates for the 2011 final rule lifting the delay of 
the Sec.  201.66 labeling implementation data for OTC sunscreen 
products were December 17, 2012, for sunscreen products with annual 
sales of $25,000 or more and December 17, 2013, for sunscreen products 
with annual sales of less than $25,000, respectively, when we published 
an extension date notice on May 11, 2012 (77 FR 27591). All currently 
marketed sunscreen products are, therefore, already required to be in 
compliance with the Drug Facts labeling requirements in Sec.  201.66 
and will incur no further burden in the 1999 labeling final rule. 
However, new OTC sunscreen drug products will be subject to a one-time 
burden to comply with Drug Facts labeling requirements in Sec.  201.66. 
In the 2011 60-day PRA, we estimated that as many as 60 new product 
SKUs marketed each year will have to comply with Drug Facts 
regulations. We estimated that these 60 SKUs would be marketed by 30 
manufacturers. We estimated that approximately 12 hours would be spent 
on each label, based on the most recent estimate used for other OTC 
drug products to comply with the Drug Facts labeling final rule, 
including public comments received on this estimate in 2010 that 
addressed sunscreens. This is equal to 720 hours annually (60 SKUs x 12 
hours/SKU). We stated that we do not expect any OTC sunscreens to apply 
for exemptions or deferrals of the Drug Facts regulations in Sec.  
201.66(e). However, we took this into consideration in 2013 and 
estimated the burden for an exemption or deferral by considering the 
number of exemptions or deferrals we have received since publication of 
the 1999 final rule (one response) and estimating that a request for 
deferral or exemption would require 24 hours to complete. Multiplying 
the annual frequency of response (0.125) by the number of hours per 
response (24) gives a total response time for requesting an exemption 
or deferral equal to 3 hours.
    We estimate the burden of this collection of information as 
follows:

[[Page 20501]]



                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                    Number of
            Activity                Number of   disclosures  per   Total annual    Average  burden   Total hours
                                   respondents     respondent       disclosures    per  disclosure
----------------------------------------------------------------------------------------------------------------
Format labeling in accordance               20                 3              60                12           720
 with Sec.   201.66(c) and (d)
 for new sunscreen SKUs.........
Request for Drug Facts exemption             1             0.125           0.125                24             3
 or deferral Sec.   201.66(e)...
                                 -------------------------------------------------------------------------------
    Total.......................  ............  ................  ..............  ................           723
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: April 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08750 Filed 4-15-15; 8:45 am]
 BILLING CODE 4164-01-P