[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)]
[Notices]
[Pages 42509-42512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18073]


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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 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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 comments 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 October 22, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 22, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0449 for ``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.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The

[[Page 42510]]

second copy, which will have the claimed confidential information 
redacted/blacked out, will be available for public viewing and posted 
on https://www.regulations.gov. Submit both copies to the Dockets 
Management Staff. If you do not wish your name and contact information 
to be made publicly available, you can provide this information on the 
cover sheet and not in the body of your comments and you must identify 
this information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
<a href="/cdn-cgi/l/email-protection#025250435176636464426466632c6a6a712c656d74"><span class="__cf_email__" data-cfemail="247476657750454242644240450a4c4c570a434b52">[email protected]</span></a>.

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--21 
CFR 201.327(a)(1) and (i), 21 CFR 201.66(c) and (d)

OMB Control Number 0910-0717--Extension

I. Background

    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 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).

II. 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 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 1 and 2, 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

[[Page 42511]]

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.
    We received only two comments on our estimated information 
collection burden (FDA-2011-N-0449-0002 and FDA-2011-N-0449-0003). 
These comments were already addressed in FDA's notice entitled ``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'' published in the Federal Register of May 9, 
2012 (77 FR 27230).
    In the Federal Register of April 16, 2015 (80 FR 20499), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                               Number of
                                              Number  of      disclosures    Total annual
                 Activity                     respondents         per         disclosures          Average burden  per disclosure           Total hours
                                                              respondent
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Conduct SPF testing in accordance with                  20            1.95              39  24..........................................             936
 Sec.   201.327(i) for new sunscreens.
Create PDP labeling in accordance with                  20               3              60  0.5 (30 minutes)............................              30
 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.

III. 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, 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 42512]]



                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                    Number  of      disclosures    Total annual       Average
            Activity                respondents         per         disclosures     burden per      Total hours
                                                    respondent                      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.

    We note that these estimates may be adjusted in the future 
development of an upcoming rulemaking on over-the-counter sunscreen 
products (RIN 0910-AA01). FDA intends to amend this information 
collection and/or seek approval of additional information collections, 
as appropriate, concurrent with this rulemaking.

    Dated: August 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18073 Filed 8-21-18; 8:45 am]
 BILLING CODE 4164-01-P


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