[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Proposed Rules]
[Pages 35678-35681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14771]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201 and 310
[Docket No. FDA-2011-N-0449]
SPF Labeling and Testing Requirements and Drug Facts Labeling for
Over-the-Counter Sunscreen Drug Products; Agency Information Collection
Activities; Proposed Collection
AGENCY: Food and Drug Administration, HHS.
ACTION: Comment request.
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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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on 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 August 16, 2011.
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:
Elizabeth Berbakos, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-3792, [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
[[Page 35679]]
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 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 0910-New)
Elsewhere in this issue of the Federal Register, we (FDA) are
publishing a final rule establishing labeling and effectiveness testing
requirements for certain 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 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 a draft guidance published elsewhere in this issue of the
Federal Register, we state 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. 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
[[Page 35680]]
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 section of the document, there are currently approximately 1.53
SKUs marketed for every sunscreen 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 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).
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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Annual
Activity No. of frequency per Total annual Hours per Total hours
respondents response responses response
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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...........................
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Total burden in years one .............. .............. .............. .............. 30,066
and two....................
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Total burden in each .............. .............. .............. .............. 966
subsequent year............
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\1\ There are no capital, operating or 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 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 21 CFR 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 21 CFR 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 sunscreen final rule. We
estimate that these 3,600 SKUs are marketed by 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 21 CFR 201.66(e).
We estimate the burden of this collection of information as
follows:
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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Annual
Activity No. of frequency per Total annual Hours per Total hours
respondents response responses response
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Format labeling in accordance 100 36 3,600 12 43,200
with 201.66(c) and (d) for
existing sunscreen SKUs \2\....
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Format labeling in accordance 20 3 60 12 720
with 201.66(c) and (d) for new
sunscreen SKUs.................
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Total first year burden..... .............. .............. .............. .............. 43,920
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Total burden for each .............. .............. .............. .............. 720
subsequent year............
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\1\ We estimate 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.
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: June 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14771 Filed 6-14-11; 8:45 am]
BILLING CODE 4160-01-P