SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products; Agency Information Collection Activities; Proposed Collection, 35678-35681 [2011-14771]
Download as PDF
<![CDATA[
35678
Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Proposed Rules
title ‘‘SPF Labeling and Testing
Requirements for OTC Sunscreen
Products with SPF Values Greater Than
50.’’
V. Environmental Impact
We have determined under 21 CFR
25.31(a) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
VI. Federalism
We have analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. Section
4(a) of the Executive order requires
agencies to ‘‘construe * * * a Federal
statute to preempt State law only where
the statute contains an express
preemption provision or there is some
other clear evidence that the Congress
intended preemption of State law, or
where the exercise of State authority
conflicts with the exercise of Federal
authority under the Federal statute.’’
The sole statutory provision giving
preemptive effect to the proposed rule is
section 751 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379r).
We believe that the preemptive effect
of this proposed rule, if finalized, would
be consistent with Executive Order
13132. Through the publication of this
proposed rule, we are providing notice
and an opportunity for State and local
officials to comment on this rulemaking.
jlentini on DSK4TPTVN1PROD with PROPOSALS3
VII. Proposed Effective Date
Any final rule based on this proposal
would become effective 1 year after the
date of its publication in the Federal
Register.
VIII. References
The following references are on
display in the Division of Dockets
Management (see ADDRESSES), under
Docket No. FDA–1978–N–0018
(formerly Docket No. 1978N–0038)
unless otherwise noted, and may be
seen by interested persons between 9
a.m. and 4 p.m., Monday through
Friday. We have verified the Web site
addresses, but we are not responsible for
any subsequent changes to the Web sites
after this document publishes in the
Federal Register.
1. FDA List of Docket Submissions
Addressed in This Proposed Rule.
2. Comment C716 from Playtex
Products, Inc., Docket No. FDA–1978–
N–0018.
3. Russak, J. E. et al., ‘‘A Comparison
of Sunburn Protection of High-Sun
Protection Factor (SPF) Sunscreens: SPF
VerDate Mar<15>2010
18:52 Jun 16, 2011
Jkt 223001
85 Sunscreen Is Significantly More
Protective Than SPF 50,’’ Journal of the
American Academy of Dermatology,
62:348–9, 2010.
4. Eastern Research Group,
‘‘Sunscreen Drug Formulations for Overthe-Counter Human Use,’’ Task Order
No. 21, Contract No. 223–03–8500,
2010.
List of Subjects in 21 CFR Part 201
Drugs, Labeling, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, it is proposed that
21 CFR part 201, as amended June 17,
2011, effective June 18, 2012, be further
amended as follows:
PART 201—LABELING
1. The authority citation for 21 CFR
part 201 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 358, 360, 360b, 360gg-360ss, 371,
374, 379e; 42 U.S.C. 216, 241, 262, 264.
2. Section 201.327 is amended by
revising paragraph (a) introductory text
and paragraphs (a)(1)(i)(A) and (a)(1)(ii)
to read as follows:
§ 201.327 Over-the-counter sunscreen
drug products; required labeling based on
effectiveness testing.
*
*
*
*
*
(a) Principal display panel. In
addition to the statement of identity in
paragraph (b) of this section, the
following statements shall be
prominently placed on the principal
display panel:
(1) Effectiveness claim.—(i) For
products that pass the broad spectrum
test in paragraph (j) of this section. (A)
The labeling states ‘‘Broad Spectrum
SPF [insert numerical SPF value
resulting from testing under paragraph
(i) of this section. For values over 50,
insert ‘‘50+’’ or ‘‘50 plus’’].’’
*
*
*
*
*
(ii) For sunscreen products that do
not pass the broad spectrum test in
paragraph (j) of this section. The
labeling states ‘‘SPF [insert numerical
SPF value resulting from testing under
paragraph (i) of this section. For values
over 50, insert ‘‘50+’’ or ‘‘50 plus’’].’’
The entire text shall appear in the same
font style, size, and color with the same
background color.
*
*
*
*
*
Dated: June 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14769 Filed 6–14–11; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00010
Fmt 4701
Sfmt 4702
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.
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 https://
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,
Elizabeth.Berbakos@fda.hhs.gov.
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
SUMMARY:
E:\FR\FM\17JNP3.SGM
17JNP3
Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Proposed Rules
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.
jlentini on DSK4TPTVN1PROD with PROPOSALS3
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;
§ 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
§ 201.327(i). Therefore, this provision
VerDate Mar<15>2010
18:52 Jun 16, 2011
Jkt 223001
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 § 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 onetime 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 §§ 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
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
1 Document No. FDA–1978–N–0018–0693 in
Docket No. FDA–1978–N–0018.
PO 00000
Frm 00011
Fmt 4701
Sfmt 4702
35679
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 § 201.327(a)(1), manufacturers will
have to conduct SPF tests according to
§ 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 § 201.327(i) to provide
the SPF value required to be disclosed
to the public in labeling under
§ 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
§ 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
E:\FR\FM\17JNP3.SGM
17JNP3
35680
Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Proposed Rules
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
No. of
respondents
Activity
Conduct SPF testing in accordance with § 201.327(i) for
existing sunscreen formulations 2 .....................................
Conduct SPF testing in accordance with § 201.327(i) for
new sunscreen formulations ............................................
Create PDP labeling in accordance with § 201.327(a)(1)
for existing sunscreen SKUs 2 ..........................................
Create PDP labeling in accordance with § 201.327(a)(1)
for new sunscreen SKUs .................................................
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
100
11.75
1,175
24
28,200
20
1.95
39
24
936
100
180
1,800
0.5
900
20
3
60
0.5
30
Total burden in years one and two ..............................
........................
........................
........................
........................
30,066
Total burden in each subsequent year .........................
........................
........................
........................
........................
966
1 There
are no capital, operating or maintenance costs associated with this collection of information.
for each of first and second years for currently marketed OTC sunscreens.
2 Burden
jlentini on DSK4TPTVN1PROD with PROPOSALS3
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 § 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 § 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 § 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
No. of
respondents
Activity
Format labeling in accordance with 201.66(c) and (d) for
existing sunscreen SKUs 2 ...............................................
VerDate Mar<15>2010
18:52 Jun 16, 2011
Jkt 223001
PO 00000
Frm 00012
Annual
frequency per
response
100
Fmt 4701
Sfmt 4702
Total annual
responses
36
E:\FR\FM\17JNP3.SGM
3,600
17JNP3
Hours per
response
Total hours
12
43,200
35681
Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Proposed Rules
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
No. of
respondents
Activity
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
Format labeling in accordance with 201.66(c) and (d) for
new sunscreen SKUs .......................................................
20
3
60
12
720
Total first year burden ..................................................
........................
........................
........................
........................
43,920
Total burden for each subsequent year .......................
........................
........................
........................
........................
720
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 § 201.66. There are no operating or maintenance costs associated with this collection of information.
2 First-year burden for currently marketed OTC sunscreens.
jlentini on DSK4TPTVN1PROD with PROPOSALS3
With the exception of the PDP
statement of SPF value in
§ 201.327(a)(1), the labeling
requirements in § 201.327(a) through
(h), which provide other elements of the
PDP, as well as specific content for
indications, directions, and warnings,
VerDate Mar<15>2010
18:52 Jun 16, 2011
Jkt 223001
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
PO 00000
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
Frm 00013
Fmt 4701
Sfmt 9990
E:\FR\FM\17JNP3.SGM
17JNP3
]]>Agencies
[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Proposed Rules]
[Pages 35678-35681]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14771]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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, Elizabeth.Berbakos@fda.hhs.gov.
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\
---------------------------------------------------------------------------
\1\ Document No. FDA-1978-N-0018-0693 in Docket No. FDA-1978-N-
0018.
---------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Annual
Activity No. of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
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...........................
-------------------------------------------------------------------------------
Total burden in years one .............. .............. .............. .............. 30,066
and two....................
-------------------------------------------------------------------------------
Total burden in each .............. .............. .............. .............. 966
subsequent year............
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Annual
Activity No. of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
Format labeling in accordance 100 36 3,600 12 43,200
with 201.66(c) and (d) for
existing sunscreen SKUs \2\....
[[Page 35681]]
Format labeling in accordance 20 3 60 12 720
with 201.66(c) and (d) for new
sunscreen SKUs.................
-------------------------------------------------------------------------------
Total first year burden..... .............. .............. .............. .............. 43,920
-------------------------------------------------------------------------------
Total burden for each .............. .............. .............. .............. 720
subsequent year............
----------------------------------------------------------------------------------------------------------------
\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
