Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Availability, 35665-35668 [2011-14767]
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Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
AGENCY:
5. Section 310.545 is amended by
revising paragraphs (a)(29) and (d)(31)
and by adding new paragraph (d)(40) to
read as follows:
§ 310.545 Drug products containing
certain active ingredients offered over-thecounter (OTC) for certain uses.
(a) * * *
(29) Sunscreen drug products.
(i) Ingredients.
Where n ≥ 5
(5) Calculation of mean absorbance
values. (i) Mean transmittance values,
Diethanolamine methoxycinnamate
Digalloyl trioleate
Ethyl 4-[bis(hydroxypropyl)]
aminobenzoate
Glyceryl aminobenzoate
Lawsone with dihydroxyacetone
Red petrolatum
are converted into mean absorbance
values,
emcdonald on DSK2BSOYB1PROD with RULES3
at each wavelength by taking the
negative logarithm of the mean
transmittance value as follows:
(ii) The calculation yields 111
monochromatic absorbance values in 1
nanometer increments from 290 to 400
nanometers.
(6) Number of plates. For each
sunscreen product, mean absorbance
values should be determined from at
least three individual PMMA plates.
Because paragraph (d) of this section
requires at least 5 measurements per
plate, there should be a total of at least
15 measurements.
(7) Calculation of the critical
wavelength. The critical wavelength is
identified as the wavelength at which
the integral of the spectral absorbance
curve reaches 90 percent of the integral
over the UV spectrum from 290 to 400
nm. The following equation defines the
critical wavelength:
VerDate Mar<15>2010
18:47 Jun 16, 2011
Jkt 223001
(ii) Any ingredients labeled with any
of the following or similar claims.
Instant protection or protection
immediately upon application.
Claims for ‘‘all-day’’ protection or
extended wear claims citing a specific
number of hours of protection that is
inconsistent with the directions for
application in 21 CFR 201.327.
*
*
*
*
*
(d) * * *
(31) December 31, 2002, for products
subject to paragraph (a)(29)(i) of this
section.
*
*
*
*
*
(40) June 18, 2012, for products
subject to paragraph (a)(29)(ii) of this
section. June 17, 2013, for products with
annual sales less than $25,000.
Dated: June 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14766 Filed 6–14–11; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
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ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Enforcement Policy—
OTC Sunscreen Drug Products Marketed
Without an Approved Application.’’
The draft guidance is intended to inform
manufacturers of over-the-counter
(OTC) sunscreen products about our
enforcement policy for certain OTC
sunscreen products marketed without
an approved new drug application. The
draft guidance describes our intended
approach to enforcement for certain
OTC sunscreen products prior to an
effective final monograph.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers all comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 16,
2011. Submit written comments on the
proposed collection of information by
August 16, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Reynold Tan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
SUMMARY:
E:\FR\FM\17JNR3.SGM
17JNR3
ER17JN11.007</GPH>
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360b–360f, 360j, 361(a), 371, 374,
375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b–263n.
Food and Drug Administration,
HHS.
ER17JN11.008</GPH>
4. The authority citation for 21 CFR
part 310 continues to read as follows:
■
■
is the ratio of the mean of the C(λ)
values to the mean of the P(λ) values, as
follows:
Draft Guidance for Industry on
Enforcement Policy for Over-theCounter Sunscreen Drug Products
Marketed Without an Approved
Application; Availability
ER17JN11.011</GPH>
PART 310—NEW DRUGS
[Docket No. FDA–2010–D–0509]
ER17JN11.010</GPH>
A mean critical wavelength of 370 nm
or greater is classified as broad spectrum
protection.
21 CFR Parts 201 and 310
ER17JN11.006</GPH>
Where λc = critical wavelength
A(λ) = mean absorbance at each wavelength
dλ = wavelength interval between
measurements
ER17JN11.010</GPH>
determined for each wavelength λ over
the full UV spectrum (290 to 400
nanometers). The transmittance values
should be measured at 1 nanometer
intervals. Measurements of spectral
irradiance transmitted for each
wavelength λ through control PMMA
plates coated with 15 microliters of
glycerin (no sunscreen product) should
be obtained from at least 5 different
locations on the PMMA plate [C1(λ),
C2(λ), C3(λ), C4(λ), and C5(λ)]. In
addition, a minimum of 5 measurements
of spectral irradiance transmitted for
each wavelength λ through the PMMA
plate covered with the sunscreen
product will be similarly obtained after
pre-irradiation of the sunscreen product
[P1(λ), P2(λ), P3(λ), P4(λ), and P5(λ)].
The mean transmittance for each
wavelength,
35665
35666
Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Rules and Regulations
Hampshire Ave., Bldg. 22, rm. 5411,
Silver Spring, MD 20993–0002, 301–
796–2090.
SUPPLEMENTARY INFORMATION:
emcdonald on DSK2BSOYB1PROD with RULES3
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Enforcement Policy—OTC Sunscreen
Drug Products Marketed Without an
Approved Application.’’ Certain OTC
sunscreen products without an
approved new drug application 1 have
been marketed under our enforcement
discretion while we work to establish a
final monograph for OTC sunscreen
products. These products are not yet the
subject of an effective final monograph.
We continue to evaluate information
to determine appropriate conditions for
OTC sunscreen products to be generally
recognized as safe and effective
(GRASE) and not misbranded. In a final
rule published elsewhere in this issue of
the Federal Register, we establish in
§ 201.327 (21 CFR 201.327) and
§ 310.545 (21 CFR 310.545) labeling and
testing requirements for OTC sunscreen
products that contain certain active
ingredients and are marketed without
approved applications. We are also
publishing a proposed rule elsewhere in
this issue of the Federal Register that
would, if finalized, limit the maximum
labeled sun protection factor (SPF)
value for OTC sunscreen products to
‘‘50 +’’or ‘‘50 plus.’’ In addition to both
rules mentioned previously, we are
publishing an ANPRM where we are
asking sunscreen manufacturers and
other interested parties to submit data
on OTC sunscreen drug products
marketed without approved
applications that are formulated in
certain dosage forms. For spray dosage
forms, we are requesting data to resolve
specific questions about both
effectiveness and safety. We are also
inviting comment on possible labeling
and testing requirements for spray
dosage forms.
Because of this complex regulatory
backdrop, we are developing a guidance
to clarify our enforcement policy
towards certain OTC sunscreen
products before a final monograph
becomes effective. The draft guidance
applies only to OTC sunscreen products
marketed without an approved
application that contain only active
ingredients or combinations of active
ingredients identified as GRASE in a
1999 sunscreen final rule published in
1 See section 505 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 355). Approved
applications under section 505 include both new
drug applications (NDAs) and abbreviated new drug
applications (ANDAs).
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the Federal Register of May 21, 1999 (64
FR 27666) (the 1999 final rule) that was
stayed before becoming effective (69 FR
53801, September 3, 2004);
The draft guidance states our
intention to continue to exercise
enforcement discretion for these types
of products under certain
circumstances. The draft guidance
addresses OTC sunscreen products
subject to the final rule codified in
§ 201.327 (i.e., products with Broad
Spectrum SPF values of 15 or higher,
products that do not provide broad
spectrum protection, and products with
Broad Spectrum SPF values between 2
and 14). The draft guidance also
indicates the Agency’s enforcement
approach for sunscreen products labeled
with specific SPF values higher than 50,
sunscreens formulated in various dosage
forms, and products that contain an
insect repellent active ingredient
registered with the Environmental
Protection Agency. In addition, the draft
guidance addresses enforcement policy
with regard to the continued labeling of
certain OTC sunscreens with SPF values
determined using the SPF test methods
contained in either the Agency’s 1999
final rule (64 FR 27666 at 27689 through
27693) or a proposed rule that
published in the Federal Register of
August 27, 2007 (the 2007 proposed
rule) (72 FR 49070 at 49114 through
49119).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on ‘‘Enforcement Policy—OTC
Sunscreen Drug Products Marketed
Without an Approved Application.’’ It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance discusses our
intended enforcement policy for OTC
sunscreen products marketed without
approved applications, including
recommendations for labeling and
testing of these products. Certain of
these provisions are subject to review
and approval by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501 et seq.). These
provisions are discussed further in the
following paragraphs.
The draft guidance also references
submissions under 21 CFR 330.14. The
information collections provisions of
PO 00000
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that regulation have been submitted to
OMB for approval, in accordance with
the PRA (76 FR 6801, February 8, 2011).
Under the PRA, Federal Agencies
must obtain approval from OMB for
each collection of information that 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 for each proposed
collection of information before
submitting the collection to OMB for
approval.
This draft guidance refers to labeling
and testing requirements applicable to
certain OTC sunscreen products under
§ 201.327. Elsewhere in this issue of the
Federal Register, in accordance with
section 3506(c)(2)(A) of the PRA, we are
publishing a 60-day notice soliciting
public comment on the collections of
information in that regulation and will
then submit these information
collection provisions to OMB for
approval. These requirements will not
be effective until we obtain OMB
approval.
This draft guidance also contains
additional information collection
provisions that are not addressed by the
notice regarding the provisions of
§ 201.327. To comply with the
requirements of the PRA, we are
publishing this notice of the additional
proposed collection of information set
forth in this guidance document and
inviting comments on the following
topics: (1) Whether the proposed
information collected is necessary for
the proper performance of FDA’s
functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimated
burden of the proposed information
collected, including the validity of the
methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information collected;
and (4) ways to minimize the burden of
information collected on the
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Information Collections Applicable to
Sunscreens That Choose To Defer
Retesting of SPF Values and Continue
Labeling With a Previously-Calculated
SPF Value
As already noted, the information
collection provisions resulting from
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Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Rules and Regulations
emcdonald on DSK2BSOYB1PROD with RULES3
§ 201.327 addressed in this draft
guidance are the subject of a 60-day
PRA notice published elsewhere in this
issue of the Federal Register. This draft
guidance proposes to temporarily
modify that information collection by
stating 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 2011 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 1999 final rule
(64 FR 27666 at 27689 through 27693)
or the SPF test method described in the
2007 proposed rule (72 FR 49070 at
49114 through 49119). We believe that
the majority of currently-marketed
sunscreen formulations will meet this
standard and, therefore, may defer their
conduct of new SPF testing. However,
this one-time testing will need to be
conducted within 2 years after
publication of the 2011 final rule
(§ 201.327), which is within the period
addressed in the PRA notice for that
regulation. We, therefore, do not expect
this draft guidance will alter the burden
calculated for SPF testing under
201.327(i) or calculated for developing
the PDP (principal display panel) label
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in compliance with 201.327(a)(1), as
indicated in that document.
Under the draft guidance,
manufacturers who do choose to delay
SPF testing in accordance with
201.327(i) would nonetheless be
expected to include on their product’s
PDP the effectiveness statement
required by 201.327(a)(1)—either
‘‘Broad Spectrum SPF’’ or ‘‘SPF’’, as
applicable—followed by the numerical
SPF value resulting from prior testing.
This creates a burden for third-party
disclosure. With respect to the 2011
final rule, we estimated that there are
approximately 100 manufacturers of
sunscreens (respondents) and we
anticipated that it would require no
more than 0.5 hours per stock keeping
units (SKU) for these manufacturers to
prepare and review labeling that inserts
the SPF value into the effectiveness
statement provided by 201.327(a)(1).2
We anticipate that manufacturers will
choose to avail themselves of the delay
of SPF testing provided for under the
guidance for as many as half (1,175) of
the 2,350 formulations estimated in the
2011 final rule. Based on the estimate
that there are about 1.53 SKUs for every
2 By the terms of our enforcement policy, such
manufacturers would be employing an existing test
value, and thus would not incur any additional
burden of testing associated with this information
collection provision.
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35667
formulation, we estimate that as many
as 1,798 SKUs may have to be relabeled. For these 1,798 SKUs, we
estimate that it will take no more than
0.5 hours per SKU to prepare and
review labeling that inserts a previously
derived SPF value into the effectiveness
(SPF) statement required under
201.327(a)(1). Therefore, the total
burden is estimated be 899 hours (1,798
SKUs times 0.5 hours per SKU).
The final rule becomes effective 1
year after its date of publication, so that
firms that seek to fall within the
enforcement policy described in the
guidance will need to begin labeling
products with their previously-derived
SPF value within the first year after
publication of the rule. (Under the
enforcement policy guidance, labeling
bearing a previously derived SPF value
will have to be discontinued and
replaced by the labeling required by
201.327(a)(1) no later than 2 years after
the date of publication of the final rule.)
We therefore assume that the entire
burden of labeling products with
previously derived SPF values will be
incurred in the first year, with no
recurrence. This burden estimate is
presented in table 1 of this document.
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Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Rules and Regulations
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1
Number of
respondents
Activity
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
Create PDP labeling statement ‘‘Broad Spectrum SPF [fill
in value]’’ based on existing SPF test results 2 ................
100
17.98
1,798
0.5
899
Total first-year burden ..................................................
........................
........................
........................
........................
899
1
2
There are no capital costs or operating and maintenance costs associated with this collection of information.
First-year burden.
emcdonald on DSK2BSOYB1PROD with RULES3
We conclude that other labeling
recommendations of the draft guidance
are not subject to review by OMB under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.). The labeling
statements for additional directions and
warnings recommended in the guidance
for sunscreens formulated as sprays 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.
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III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
PO 00000
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IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance document
at either https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: June 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14767 Filed 6–14–11; 8:45 am]
BILLING CODE 4160–01–P
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]]>Agencies
[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Rules and Regulations]
[Pages 35665-35668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14767]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201 and 310
[Docket No. FDA-2010-D-0509]
Draft Guidance for Industry on Enforcement Policy for Over-the-
Counter Sunscreen Drug Products Marketed Without an Approved
Application; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Enforcement
Policy--OTC Sunscreen Drug Products Marketed Without an Approved
Application.'' The draft guidance is intended to inform manufacturers
of over-the-counter (OTC) sunscreen products about our enforcement
policy for certain OTC sunscreen products marketed without an approved
new drug application. The draft guidance describes our intended
approach to enforcement for certain OTC sunscreen products prior to an
effective final monograph.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers all comments on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 16, 2011. Submit written comments on the proposed
collection of information by August 16, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Reynold Tan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
[[Page 35666]]
Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993-0002, 301-
796-2090.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Enforcement Policy--OTC Sunscreen Drug Products Marketed
Without an Approved Application.'' Certain OTC sunscreen products
without an approved new drug application \1\ have been marketed under
our enforcement discretion while we work to establish a final monograph
for OTC sunscreen products. These products are not yet the subject of
an effective final monograph.
---------------------------------------------------------------------------
\1\ See section 505 of the Federal Food, Drug and Cosmetic Act
(21 U.S.C. 355). Approved applications under section 505 include
both new drug applications (NDAs) and abbreviated new drug
applications (ANDAs).
---------------------------------------------------------------------------
We continue to evaluate information to determine appropriate
conditions for OTC sunscreen products to be generally recognized as
safe and effective (GRASE) and not misbranded. In a final rule
published elsewhere in this issue of the Federal Register, we establish
in Sec. 201.327 (21 CFR 201.327) and Sec. 310.545 (21 CFR 310.545)
labeling and testing requirements for OTC sunscreen products that
contain certain active ingredients and are marketed without approved
applications. We are also publishing a proposed rule elsewhere in this
issue of the Federal Register that would, if finalized, limit the
maximum labeled sun protection factor (SPF) value for OTC sunscreen
products to ``50 +''or ``50 plus.'' In addition to both rules mentioned
previously, we are publishing an ANPRM where we are asking sunscreen
manufacturers and other interested parties to submit data on OTC
sunscreen drug products marketed without approved applications that are
formulated in certain dosage forms. For spray dosage forms, we are
requesting data to resolve specific questions about both effectiveness
and safety. We are also inviting comment on possible labeling and
testing requirements for spray dosage forms.
Because of this complex regulatory backdrop, we are developing a
guidance to clarify our enforcement policy towards certain OTC
sunscreen products before a final monograph becomes effective. The
draft guidance applies only to OTC sunscreen products marketed without
an approved application that contain only active ingredients or
combinations of active ingredients identified as GRASE in a 1999
sunscreen final rule published in the Federal Register of May 21, 1999
(64 FR 27666) (the 1999 final rule) that was stayed before becoming
effective (69 FR 53801, September 3, 2004);
The draft guidance states our intention to continue to exercise
enforcement discretion for these types of products under certain
circumstances. The draft guidance addresses OTC sunscreen products
subject to the final rule codified in Sec. 201.327 (i.e., products
with Broad Spectrum SPF values of 15 or higher, products that do not
provide broad spectrum protection, and products with Broad Spectrum SPF
values between 2 and 14). The draft guidance also indicates the
Agency's enforcement approach for sunscreen products labeled with
specific SPF values higher than 50, sunscreens formulated in various
dosage forms, and products that contain an insect repellent active
ingredient registered with the Environmental Protection Agency. In
addition, the draft guidance addresses enforcement policy with regard
to the continued labeling of certain OTC sunscreens with SPF values
determined using the SPF test methods contained in either the Agency's
1999 final rule (64 FR 27666 at 27689 through 27693) or a proposed rule
that published in the Federal Register of August 27, 2007 (the 2007
proposed rule) (72 FR 49070 at 49114 through 49119).
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on
``Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an
Approved Application.'' It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance discusses our intended enforcement policy for
OTC sunscreen products marketed without approved applications,
including recommendations for labeling and testing of these products.
Certain of these provisions are subject to review and approval by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501 et seq.). These provisions are discussed
further in the following paragraphs.
The draft guidance also references submissions under 21 CFR 330.14.
The information collections provisions of that regulation have been
submitted to OMB for approval, in accordance with the PRA (76 FR 6801,
February 8, 2011).
Under the PRA, Federal Agencies must obtain approval from OMB for
each collection of information that 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 for each proposed collection of information before
submitting the collection to OMB for approval.
This draft guidance refers to labeling and testing requirements
applicable to certain OTC sunscreen products under Sec. 201.327.
Elsewhere in this issue of the Federal Register, in accordance with
section 3506(c)(2)(A) of the PRA, we are publishing a 60-day notice
soliciting public comment on the collections of information in that
regulation and will then submit these information collection provisions
to OMB for approval. These requirements will not be effective until we
obtain OMB approval.
This draft guidance also contains additional information collection
provisions that are not addressed by the notice regarding the
provisions of Sec. 201.327. To comply with the requirements of the
PRA, we are publishing this notice of the additional proposed
collection of information set forth in this guidance document and
inviting comments on the following topics: (1) Whether the proposed
information collected is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimated burden of the proposed
information collected, including the validity of the methodology and
assumptions used; (3) ways to enhance the quality, utility, and clarity
of the information collected; and (4) ways to minimize the burden of
information collected on the respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Information Collections Applicable to Sunscreens That Choose To Defer
Retesting of SPF Values and Continue Labeling With a Previously-
Calculated SPF Value
As already noted, the information collection provisions resulting
from
[[Page 35667]]
Sec. 201.327 addressed in this draft guidance are the subject of a 60-
day PRA notice published elsewhere in this issue of the Federal
Register. This draft guidance proposes to temporarily modify that
information collection by stating 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 2011 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 1999 final rule (64 FR
27666 at 27689 through 27693) or the SPF test method described in the
2007 proposed rule (72 FR 49070 at 49114 through 49119). We believe
that the majority of currently-marketed sunscreen formulations will
meet this standard and, therefore, may defer their conduct of new SPF
testing. However, this one-time testing will need to be conducted
within 2 years after publication of the 2011 final rule (Sec.
201.327), which is within the period addressed in the PRA notice for
that regulation. We, therefore, do not expect this draft guidance will
alter the burden calculated for SPF testing under 201.327(i) or
calculated for developing the PDP (principal display panel) label in
compliance with 201.327(a)(1), as indicated in that document.
Under the draft guidance, manufacturers who do choose to delay SPF
testing in accordance with 201.327(i) would nonetheless be expected to
include on their product's PDP the effectiveness statement required by
201.327(a)(1)--either ``Broad Spectrum SPF'' or ``SPF'', as
applicable--followed by the numerical SPF value resulting from prior
testing. This creates a burden for third-party disclosure. With respect
to the 2011 final rule, we estimated that there are approximately 100
manufacturers of sunscreens (respondents) and we anticipated that it
would require no more than 0.5 hours per stock keeping units (SKU) for
these manufacturers to prepare and review labeling that inserts the SPF
value into the effectiveness statement provided by 201.327(a)(1).\2\ We
anticipate that manufacturers will choose to avail themselves of the
delay of SPF testing provided for under the guidance for as many as
half (1,175) of the 2,350 formulations estimated in the 2011 final
rule. Based on the estimate that there are about 1.53 SKUs for every
formulation, we estimate that as many as 1,798 SKUs may have to be re-
labeled. For these 1,798 SKUs, we estimate that it will take no more
than 0.5 hours per SKU to prepare and review labeling that inserts a
previously derived SPF value into the effectiveness (SPF) statement
required under 201.327(a)(1). Therefore, the total burden is estimated
be 899 hours (1,798 SKUs times 0.5 hours per SKU).
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\2\ By the terms of our enforcement policy, such manufacturers
would be employing an existing test value, and thus would not incur
any additional burden of testing associated with this information
collection provision.
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The final rule becomes effective 1 year after its date of
publication, so that firms that seek to fall within the enforcement
policy described in the guidance will need to begin labeling products
with their previously-derived SPF value within the first year after
publication of the rule. (Under the enforcement policy guidance,
labeling bearing a previously derived SPF value will have to be
discontinued and replaced by the labeling required by 201.327(a)(1) no
later than 2 years after the date of publication of the final rule.) We
therefore assume that the entire burden of labeling products with
previously derived SPF values will be incurred in the first year, with
no recurrence. This burden estimate is presented in table 1 of this
document.
[[Page 35668]]
Table 1--Estimated Annual Third-Party Disclosure Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
Activity Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
Create PDP labeling statement 100 17.98 1,798 0.5 899
``Broad Spectrum SPF [fill in
value]'' based on existing SPF
test results \2\...............
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Total first-year burden..... .............. .............. .............. .............. 899
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ First-year burden.
We conclude that other labeling recommendations of the draft
guidance are not subject to review by OMB under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.). The labeling statements for
additional directions and warnings recommended in the guidance for
sunscreens formulated as sprays 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.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
document at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: June 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14767 Filed 6-14-11; 8:45 am]
BILLING CODE 4160-01-P
