80 FR 43782 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 141 (July 23, 2015)

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.

[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)]
[Notices]
[Pages 43782-43784]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18026]


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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.

DATES: Fax written comments on the collection of information by August 
24, 2015.

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 0910-0717. 
Also include the FDA 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: 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 
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

[[Page 43783]]

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 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).
    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.
    We estimate the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   No. of
          Activity                No. of      disclosures  per   Total annual    Average  burden    Total hours
                                respondents      respondent       disclosures    per  disclosure
----------------------------------------------------------------------------------------------------------------
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
 accordance with Sec.                                                           (30 min.).......
 201.327(a)(1) for new
 sunscreen SKUs.
    Total...................  ..............  ................  ..............  ................             966
----------------------------------------------------------------------------------------------------------------
\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 43784]]



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


    Dated:` July 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18026 Filed 7-22-15; 8:45 am]
 BILLING CODE 4164-01-P