
[Federal Register Volume 84, Number 27 (Friday, February 8, 2019)]
[Notices]
[Pages 2878-2879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01529]



[[Page 2878]]

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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 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.

DATES: Fax written comments on the collection of information by March 
11, 2019.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0717. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

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 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, the 2011 sunscreen final rule lifted the delay of 
implementing the prior 1999 sunscreen final rule (published in the 
Federal Register of May 21, 1999 (64 FR 27666), and stayed in the 
Federal Register of December 31, 2001 (66 FR 67485), from complying 
with the 1999 Drug Facts labeling final rule (published in the Federal 
Register of 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 Drug Facts labeling final rule added new Sec.  201.66 (21 CFR 
201.66) to part 201. Section 201.66 establishes content and format 
requirements for the Drug Facts portion of OTC drug product labels. We 
specifically exempted OTC sunscreen products from complying with the 
1999 Drug Facts 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 in the Federal Register of May 11, 2012 (77 FR 27591) (2012 
extension date notice).

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 collection 
of information regarding SPF labeling and testing requirements for OTC 
sunscreen products containing specified ingredients and marketed 
without approved applications (2011 60-day notice). 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 sunscreen final rule 
to include the SPF value determined by conducting the SPF test outlined 
in Sec.  201.327(i). Therefore, that provision resulted in an 
information collection with a third-party disclosure burden for 
manufacturers of OTC sunscreens covered by the 2011 sunscreen rule. We 
determined that products need only complete the testing and labeling 
required by the 2011 sunscreen rule once and then continue to use 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 sunscreen 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 2011 sunscreen rule was 
based on: (1) An estimate 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) the conduct of SPF testing based on the estimated number of 
existing formulations; (3) an estimate of the time to relabel currently 
marketed OTC sunscreens containing specified ingredients and marketed 
without approved applications; and (4) testing and labeling of new 
products introduced each year. The estimate for this burden in the 2011 
60-day notice was a total of 30,066 hours in years one and two and a 
total of 966 in each subsequent year.
    All currently marketed OTC sunscreen drug products are already 
required to comply with the SPF labeling requirements specified by the 
2011 sunscreen final rule. However, our original estimate also 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 must 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.

Drug Facts Labeling for OTC Sunscreens

    Because the 2011 sunscreen final rule also lifted the delay of 
implementing the Drug Facts regulations (Sec.  201.66) for OTC 
sunscreens, the rule also modified the information collection 
associated with Sec.  201.66 (currently approved under OMB control 
number 0910-0340) and added a third-party disclosure burden resulting 
from requiring OTC sunscreen products to comply with Drug Facts 
regulations. In the 1999 Drug Facts labeling final rule, 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. This section 
establishes requirements for the Drug Facts portion of labels on OTC 
drug products requiring such labeling, to include uniform headings and 
subheadings,

[[Page 2879]]

presented in a standardized order with minimum standards for type size 
and other graphical features. Therefore, OTC sunscreen products already 
on the market at that time incurred a one-time burden to comply with 
the requirements in Sec.  201.66(c) and (d). In the 60-day notice, the 
burden was estimated as 43,200 hours for existing sunscreen SKUs and 
720 hours for new sunscreen SKUs.
    The compliance dates for the 2011 sunscreen final rule that lifted 
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 the 2012 extension date notice. All currently marketed 
sunscreen products are, therefore, already required to comply with the 
Drug Facts labeling requirements in Sec.  201.66 and will incur no 
further burden in the 1999 Drug Facts 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 notice, we estimated that as many as 60 new product SKUs 
marketed each year must comply with Drug Facts regulations. We 
estimated that these 60 SKUs would be marketed by 30 manufacturers, 
which will spend approximately 12 hours on each label 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. This is equal to 
720 hours annually (60 SKUs, 12 hours per 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 considered 
this 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 Drug Facts labeling 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.
    In the Federal Register of August 22, 2018 (83 FR 42509), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

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


                                                 Table 2--Estimated Annual Third-Party Disclosure Burden
                                                                [Drug facts labeling] \1\
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                                                                 Number of
                  Activity                       Number of      disclosures            Total annual disclosures           Average burden    Total hours
                                                respondents   per respondent                                              per disclosure
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Format labeling in accordance with Sec.                   20               3  60........................................              12             720
 201.66(c) and (d) for new sunscreen SKUs.
Request for Drug Facts exemption or deferral               1           0.125  0.125 (7 minutes).........................              24               3
 Sec.   201.66(e).
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    Total...................................  ..............  ..............  ..........................................  ..............             723
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We note that these estimates may be adjusted in the future as the 
result of a detailed analysis of sunscreen market data conducted by FDA 
as part of the development of an upcoming proposed rule on OTC 
sunscreen products (RIN 0910-AA01). FDA intends to either or both amend 
this information collection or seek approval of additional information 
collections, as appropriate, concurrent with publication of the 
proposed rule.

    Dated: February 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01529 Filed 2-7-19; 8:45 am]
 BILLING CODE 4164-01-P


