Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products, 27230-27234 [2012-11067]
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EARLY TERMINATIONS GRANTED—Continued
April 1, 2012 thru April 30, 2012
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WP Prism Inc.; ISTA Pharmaceuticals, Inc.; WP Prism Inc.
Monitise plc; Clairmail, Inc.; Monitise plc.
Wabash National Corporation; Walker Group Resources LLC; Wabash National Corporation.
Oclaro, Inc.; Opnext, Inc.; Oclaro, Inc.
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Covidien plc; Yasuhiko Sata; Covidien plc.
Lear Corporation; GMI Holding Corporation; Lear Corporation.
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Marathon Petroleum Corporation; Stephanie E. White; Marathon Petroleum Corporation.
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South Jersey Health System, Inc.; Underwood-Memorial Health Systems, Inc.; South Jersey Health System, Inc.
Tyco Flow Control International Ltd.; Pentair, Inc.; Tyco Flow Control International Ltd.
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Temple University Health System, Inc.; The American Oncologic Hospital; Temple University Health System, Inc.
Blackbaud, Inc.; Convio, Inc.; Blackbaud, Inc.
DaVita Inc.; Brenda Spira; DaVita Inc.
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University of Rochester; F.F. Thompson Health System, Inc.; University of Rochester.
Galaxie Corporation; Prospect Capital Corporation; Galaxie Corporation.
Prospect Capital Corporation; Galaxie Corporation; Prospect Capital Corporation.
Welsh, Carson, Anderson & Stowe XI. L.P.; NEW Asurion Corporation; Welsh, Carson, Anderson & Stowe XI, L.P.
John D. Grier; Royal Dutch Shell plc; John D. Grier.
SAP AG; Richard W. Padula; SAP AG.
Merck & Co., Inc.; Endocyte, Inc.; Merck & Co., Inc.
Gores Capital Partners III, L.P.; TE Connectivity Ltd.; Gores Capital Partners III, L.P.
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FOR FURTHER INFORMATION CONTACT:
Renee Chapman, Contact
Representative,
Or
Theresa Kingsberry, Legal Assistant,
Federal Trade Commission, Premerger
Notification Office, Bureau of
Competition, Room H–303,
Washington, DC 20580, (202) 326–
3100.
By Direction of the Commission.
Donald S. Clark,
Secretary.
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[FR Doc. 2012–11037 Filed 5–8–12; 8:45 am]
BILLING CODE 6750–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0449]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Sun Protection
Factor Labeling and Testing
Requirements and Drug Facts Labeling
for Over-the-Counter Sunscreen Drug
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
SUMMARY:
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the Paperwork Reduction Act of 1995
(PRA).
Fax written comments on the
collection of information by June 8,
2012.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—New and
title ‘‘SPF Labeling and Testing
Requirements and Drug Facts Labeling
for Over-the-Counter Sunscreen Drug
Products.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
ADDRESSES:
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Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,
301–796–7651,
juanmanuel.vilela@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
SPF Labeling and Testing Requirements
for Over-the-Counter Sunscreen
Products Containing Specified Active
Ingredients and Marketed Without
Approved Applications, and Drug Facts
Labeling for All Over-the-Counter
Sunscreen Products—21 CFR
201.327(a)(1) and (i), 21 CFR 201.66(c)
and (d)
In the Federal Register of June 17,
2011 (76 FR 35620), FDA published a
final rule establishing labeling and
effectiveness testing requirements for
certain over-the-counter (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.
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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 sun protection factor (SPF)
value determined by conducting the
SPF test outlined in § 201.327(i).
Therefore, this provision will result in
an information collection with a thirdparty 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 the Federal Register of June 17,
2011 (76 FR 35665), we announced the
availability of a draft guidance and
stated 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
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(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 § 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
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
1 Document No. FDA–1978–N–0018–0693 in
Docket No. FDA–1978–N–0018.
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27231
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
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 document, there are
currently approximately 1.53 SKUs
marketed for every sunscreen spray
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
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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).
The sunscreen 2011 final rule
published on June 17, 2011. In
accordance with 5 CFR 1320.8(d), FDA
published a 60-day notice for public
comment in the Federal Register of June
17, 2011, concerning the collection of
information imposed by the final rule
and allowed 60 days for public
comment on the notice (76 FR 35678–
35681). FDA created a public docket for
submission of these comments (i.e.,
FDA–2011–N–0449). FDA received
three comments to this docket, but only
two of them concerned the collection of
information in the 2011 sunscreen final
rule (i.e., FDA–2011–N–0449–0002,
FDA–2011–N–0449–0003).
These comments were submitted by:
(1) Consumers Union (see Attachment 2
of the Consumers Union comments),
which publishes Consumer Reports and
(2) The Personal Care Products Council
(PCPC) jointly with The Consumer
Healthcare Products Association
(CHPA) (see Attachment 3 of the PCPC/
CHPA comments), which are trade
associations for the OTC personal care
products industry and the cosmetics
industry in the United States,
respectively.
The Consumers Union comment
states that the collection of information
in the 2011 sunscreen final rule is
practical and necessary for FDA’s
functions. Although the comment
disagrees with the 2011 sunscreen final
rule’s removal of a proposed in vivo
ultraviolet A (UVA) protection test, that
test has no bearing upon FDA’s estimate
of the third-party disclosure burden.
Therefore, FDA is not making any
modifications to our estimates of burden
based upon the Consumers Union
comment.
The PCPC/CHPA comment states that
FDA underestimated the burden to
industry, including the third-party
disclosure burden. However, ‘‘the
burden to industry’’ is not the same as
‘‘the third-party disclosure burden.’’
This document only addresses the thirdparty disclosure burden. Table 1 of this
document compares PCPC/CHPA’s
estimates with FDA’s estimates.
TABLE 1—COMPARISON OF PCPC/CHPA’S AND FDA’S ESTIMATES
PCPC/CHPA
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Sunscreen product manufacturers ..........................................................................
Existing sunscreen products (SKUs formulations) .................................................
New sunscreen products (SKUs; formulations) ......................................................
Hours per response (SPF testing) ..........................................................................
Hours per response (principal display panel label) ................................................
Hours per response (Drug Facts label) ..................................................................
PCPC/CHPA’s estimates of the
number of sunscreen products and
sunscreen product manufacturers are
taken from brief letters submitted to
PCPC/CHPA from the three market
research organizations (Symphony IRI
Group, The NPD Group, and Mintel).
These letters are included in PCPC/
CHPA’s comment. PCPC/CHPA’s
estimated number of existing sunscreen
products and sunscreen product
manufacturers were calculated by
adding the estimated numbers from the
Symphony IRI Group letter (i.e., 3,289
products, 197 manufacturers) and The
NPD Group letter (i.e., 1,239 products,
167 manufacturers). PCPC/CHPA’s
estimated number of new sunscreen
products is taken from Mintel’s letter
(i.e., 1,262 products). However, how the
exact numbers were derived from their
databases was not provided, nor were
any potential references that may have
been used for their calculations and
estimates. PCPC/CHPA’s estimate of the
hours required to conduct SPF testing
and create principal display panel labels
are based upon PCPC/CHPA’s survey of
its members. FDA describes the bases
for its estimates in the 60-day notice
concerning the collection of information
imposed by the 2011 sunscreen final
rule (76 FR 35620 at 35678 through
35681).
In conclusion, FDA does not consider
the data submitted sufficient to merit
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FDA
>364 .......................................................
4,528; 2,943 ...........................................
1,262; 824 per year ...............................
170.5 per formulation ............................
70.5 per SKU .........................................
70.5 per SKU .........................................
100.
3,591; 2,350.
60; 39 per year.
24 per formulation.
0.5 per SKU.
12 per SKU.
revising its estimates of third-party
disclosure burden as described in the
following paragraphs. Details on how
the survey was conducted and the
number of hours required to conduct
SPF testing and create principal display
panel labels were not provided. In
addition, no data was submitted to
support their conclusions. The market
research organizations letters provided
little information about how they
derived their data regarding number of
products and manufacturers. Market
research organizations also explicitly
state that there is no guarantee of the
accuracy of their numbers. Therefore,
FDA cannot assess the quality of the
data upon which PCPC/CHPA’s
estimates were based. FDA discusses its
consideration of PCPC/CHPA’s
estimates in the following paragraphs.
Estimates of sunscreen products and
sunscreen product manufacturers. FDA
notes that all of PCPC/CHPA’s estimates
of sunscreen products and sunscreen
product manufacturers are higher than
FDA’s estimates. The disparity between
PCPC/CHPA’s estimates and FDA’s
estimates remain unclear due to the lack
of information about how their numbers
were derived. PCPC/CHPA’s estimate of
new sunscreen products (i.e., 1,262
products per year) is much higher than
FDA’s estimate (i.e., 60 products per
year). PCPC/CHPA states that its
estimate of 1,262 new products includes
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‘‘new products,’’ ‘‘new variety/range
extensions,’’ ‘‘new formulations,’’ ‘‘new
packaging,’’ and ‘‘relaunches.’’ Many of
these products may not be considered
new products (i.e., new SKUs) by FDA.
For example, FDA would consider a
minor labeling change on a particular 8
fluid ounce size bottle of a brand-name
product to be a replacement of the same
SKU, whereas PCPC/CHPA considers
the relabeled product to be a ‘‘new
product’’ due to ‘‘new packaging’’ as
stated in their submission. Because the
submitted data do not allow for
verification of PCPC/CHPA’s higher
estimates and the market research
organizations themselves will not
guarantee the accuracy of these
estimates, FDA is not revising its
estimates of sunscreen products and
sunscreen product manufacturers.
Estimate of time required for SPF
testing. FDA also notes that PCPC/
CHPA’s estimate of the time required to
conduct SPF testing is much higher than
FDA’s estimate. PCPC/CHPA explains
that FDA’s estimate failed to consider
the time required by good clinical
practices (e.g., quality assurance testing,
revision control, internal release of
samples, documentation release, and
shipment authorization). However,
PCPC/CHPA does not provide time
estimates for these procedures. Also,
compliance with good clinical practices
is a standard regulatory requirement and
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does not constitute an additional burden
resulting from the 2011 sunscreen final
rule. Regulations controlling paperwork
burdens on the public in 5 CFR
1320.3(b)(2) state that the ‘‘time, effort,
and financial resources necessary to
comply with a collection of information
that would be incurred by persons in
the normal course of their activities will
be excluded from the ‘‘burden’’ if the
Agency demonstrates that the reporting,
recordkeeping, or disclosure activities
needed to comply are usual and
customary.’’ PCPC/CHPA also explains
that conducting the SPF test for a waterresistant product requires 3 to 4 weeks,
instead of FDA’s estimate of 24 hours
(i.e., 3 days, 8 hours/day). However,
PCPC/CHPA does not adequately
describe the ‘‘testing timelines’’ section
for conducting the SPF test. Even
consideration of extra time required for
data analysis fails to account for the
difference between PCPC/CHPA’s and
FDA’s estimate. Therefore, FDA is not
revising its estimate of the time required
to conduct SPF testing.
Estimate of the time required to create
principal display labeling. FDA’s
estimate of the time required to create
principal display panel labeling (e.g.,
0.5 hours/SKU) differs from PCPC/
CHPA’s estimate (70.5 hours/SKU)
because the estimates are based upon
different tasks. FDA’s estimate refers to
the time required to insert the SPF value
on the principal display panel, whereas
PCPC/CHPA’s estimate appears to be the
time required to create the entire
principal display panel and the Drug
Facts panel. Only the insertion of the
SPF value constitutes a third-party
disclosure burden. The remainder of the
principal display panel labeling
constitutes ‘‘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, is
not considered a collection of
information. Therefore, FDA is not
revising its estimate.
Estimate of the time required to
comply with Drug Facts labeling
requirements. FDA’s estimate of the
time required to comply with Drug Facts
labeling requirements (12 hours/SKU)
differs from PCPC/CHPA’s estimate of
(70.5 hours/SKU). FDA’s estimate is
based upon estimated times to comply
with Drug Facts requirements that were
submitted in public comments for
various OTC drug products, including
OTC sunscreen products. PCPC/CHPA
breaks down its estimate for complying
with Drug Facts requirements into 12
sequential steps and provides a onesentence description of each step.
Presumably, the time estimated for each
step represents the average reported by
PCPC/CHPA’s members. Obtaining
averages for data has the potential for
changing the outcome due to outliers. In
addition, the individual estimates from
each of PCPC/CHPA’s members are not
provided in the PCPC/CHPA’s comment
in order to validate calculations made.
Therefore, FDA cannot determine how
representative PCPC/CHPA’s estimate is
of its members or how variable the
estimate is between its members. In
summary, FDA does not have sufficient
data to assess the validity of the
estimated times for each of these steps.
Therefore, FDA does not consider the
currently available data adequate to
revise its estimate.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number 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 .................................................
Total burden in years one and two ..............................
Total burden in each subsequent year .........................
1 There
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total annual
disclosures
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
........................
........................
........................
........................
........................
........................
........................
........................
30,066
966
are no capital costs or operating and maintenance costs associated with this collection of information.
for each of first and second years for currently marketed OTC sunscreens.
2 Burden
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Drug Facts Labeling for OTC
Sunscreens
Because the 2011 sunscreen 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
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to establish standardized format and
content requirements for the labeling of
all marketed OTC drug products,
codified in § 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
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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 § 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
2011 sunscreen final rule. We estimate
that these 3,600 SKUs are marketed by
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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
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
in § 201.66(e).
FDA estimates the burden of this
collection of information as follows:
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
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
Format labeling in accordance with § 201.66(c) and (d) for
existing sunscreen SKUs 2 ...............................................
Format labeling in accordance with § 201.66(c) and (d) for
new sunscreen SKUs 3 .....................................................
100
36
3,600
12
43,200
20
3
60
12
720
Total first year burden ..................................................
Total burden for each subsequent year .......................
........................
........................
........................
........................
........................
........................
........................
........................
43,920
720
1 FDA estimates 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.
3 Burden for first and second years for currently marketed OTC sunscreens.
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,
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: May 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–11067 Filed 5–8–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2012–N–0427]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Inspection by Accredited Persons
Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
15:44 May 08, 2012
Jkt 226001
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the Inspection by Accredited Persons
Program Under the Medical Device User
Fee and Modernization Act of 2002.
DATES: Submit either electronic or
written comments on the collection of
information by July 9, 2012.
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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
SUPPLEMENTARY INFORMATION:
E:\FR\FM\09MYN1.SGM
09MYN1
]]>Agencies
[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Pages 27230-27234]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11067]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0449]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Sun Protection Factor
Labeling and Testing Requirements and Drug Facts Labeling for Over-the-
Counter Sunscreen Drug Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA).
DATES: Fax written comments on the collection of information by June 8,
2012.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910--New and
title ``SPF Labeling and Testing Requirements and Drug Facts Labeling
for Over-the-Counter Sunscreen Drug Products.'' Also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and
[[Page 27231]]
Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,
301-796-7651, juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
SPF Labeling and Testing Requirements for Over-the-Counter Sunscreen
Products Containing Specified Active Ingredients and Marketed Without
Approved Applications, and Drug Facts Labeling for All Over-the-Counter
Sunscreen Products--21 CFR 201.327(a)(1) and (i), 21 CFR 201.66(c) and
(d)
In the Federal Register of June 17, 2011 (76 FR 35620), FDA
published a final rule establishing labeling and effectiveness testing
requirements for certain over-the-counter (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 sun
protection factor (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 the Federal Register of June 17, 2011 (76 FR 35665), we
announced the availability of a draft guidance and stated 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. 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 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 document, there are currently approximately 1.53 SKUs marketed for
every sunscreen spray 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
[[Page 27232]]
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).
The sunscreen 2011 final rule published on June 17, 2011. In
accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for
public comment in the Federal Register of June 17, 2011, concerning the
collection of information imposed by the final rule and allowed 60 days
for public comment on the notice (76 FR 35678-35681). FDA created a
public docket for submission of these comments (i.e., FDA-2011-N-0449).
FDA received three comments to this docket, but only two of them
concerned the collection of information in the 2011 sunscreen final
rule (i.e., FDA-2011-N-0449-0002, FDA-2011-N-0449-0003).
These comments were submitted by: (1) Consumers Union (see
Attachment 2 of the Consumers Union comments), which publishes Consumer
Reports and (2) The Personal Care Products Council (PCPC) jointly with
The Consumer Healthcare Products Association (CHPA) (see Attachment 3
of the PCPC/CHPA comments), which are trade associations for the OTC
personal care products industry and the cosmetics industry in the
United States, respectively.
The Consumers Union comment states that the collection of
information in the 2011 sunscreen final rule is practical and necessary
for FDA's functions. Although the comment disagrees with the 2011
sunscreen final rule's removal of a proposed in vivo ultraviolet A
(UVA) protection test, that test has no bearing upon FDA's estimate of
the third-party disclosure burden. Therefore, FDA is not making any
modifications to our estimates of burden based upon the Consumers Union
comment.
The PCPC/CHPA comment states that FDA underestimated the burden to
industry, including the third-party disclosure burden. However, ``the
burden to industry'' is not the same as ``the third-party disclosure
burden.'' This document only addresses the third-party disclosure
burden. Table 1 of this document compares PCPC/CHPA's estimates with
FDA's estimates.
Table 1--Comparison of PCPC/CHPA's and FDA's Estimates
------------------------------------------------------------------------
PCPC/CHPA FDA
------------------------------------------------------------------------
Sunscreen product >364........... 100.
manufacturers.
Existing sunscreen products 4,528; 2,943... 3,591; 2,350.
(SKUs formulations).
New sunscreen products (SKUs; 1,262; 824 per 60; 39 per year.
formulations). year.
Hours per response (SPF 170.5 per 24 per formulation.
testing). formulation.
Hours per response (principal 70.5 per SKU... 0.5 per SKU.
display panel label).
Hours per response (Drug 70.5 per SKU... 12 per SKU.
Facts label).
------------------------------------------------------------------------
PCPC/CHPA's estimates of the number of sunscreen products and
sunscreen product manufacturers are taken from brief letters submitted
to PCPC/CHPA from the three market research organizations (Symphony IRI
Group, The NPD Group, and Mintel). These letters are included in PCPC/
CHPA's comment. PCPC/CHPA's estimated number of existing sunscreen
products and sunscreen product manufacturers were calculated by adding
the estimated numbers from the Symphony IRI Group letter (i.e., 3,289
products, 197 manufacturers) and The NPD Group letter (i.e., 1,239
products, 167 manufacturers). PCPC/CHPA's estimated number of new
sunscreen products is taken from Mintel's letter (i.e., 1,262
products). However, how the exact numbers were derived from their
databases was not provided, nor were any potential references that may
have been used for their calculations and estimates. PCPC/CHPA's
estimate of the hours required to conduct SPF testing and create
principal display panel labels are based upon PCPC/CHPA's survey of its
members. FDA describes the bases for its estimates in the 60-day notice
concerning the collection of information imposed by the 2011 sunscreen
final rule (76 FR 35620 at 35678 through 35681).
In conclusion, FDA does not consider the data submitted sufficient
to merit revising its estimates of third-party disclosure burden as
described in the following paragraphs. Details on how the survey was
conducted and the number of hours required to conduct SPF testing and
create principal display panel labels were not provided. In addition,
no data was submitted to support their conclusions. The market research
organizations letters provided little information about how they
derived their data regarding number of products and manufacturers.
Market research organizations also explicitly state that there is no
guarantee of the accuracy of their numbers. Therefore, FDA cannot
assess the quality of the data upon which PCPC/CHPA's estimates were
based. FDA discusses its consideration of PCPC/CHPA's estimates in the
following paragraphs.
Estimates of sunscreen products and sunscreen product
manufacturers. FDA notes that all of PCPC/CHPA's estimates of sunscreen
products and sunscreen product manufacturers are higher than FDA's
estimates. The disparity between PCPC/CHPA's estimates and FDA's
estimates remain unclear due to the lack of information about how their
numbers were derived. PCPC/CHPA's estimate of new sunscreen products
(i.e., 1,262 products per year) is much higher than FDA's estimate
(i.e., 60 products per year). PCPC/CHPA states that its estimate of
1,262 new products includes ``new products,'' ``new variety/range
extensions,'' ``new formulations,'' ``new packaging,'' and
``relaunches.'' Many of these products may not be considered new
products (i.e., new SKUs) by FDA. For example, FDA would consider a
minor labeling change on a particular 8 fluid ounce size bottle of a
brand-name product to be a replacement of the same SKU, whereas PCPC/
CHPA considers the relabeled product to be a ``new product'' due to
``new packaging'' as stated in their submission. Because the submitted
data do not allow for verification of PCPC/CHPA's higher estimates and
the market research organizations themselves will not guarantee the
accuracy of these estimates, FDA is not revising its estimates of
sunscreen products and sunscreen product manufacturers.
Estimate of time required for SPF testing. FDA also notes that
PCPC/CHPA's estimate of the time required to conduct SPF testing is
much higher than FDA's estimate. PCPC/CHPA explains that FDA's estimate
failed to consider the time required by good clinical practices (e.g.,
quality assurance testing, revision control, internal release of
samples, documentation release, and shipment authorization). However,
PCPC/CHPA does not provide time estimates for these procedures. Also,
compliance with good clinical practices is a standard regulatory
requirement and
[[Page 27233]]
does not constitute an additional burden resulting from the 2011
sunscreen final rule. Regulations controlling paperwork burdens on the
public in 5 CFR 1320.3(b)(2) state that the ``time, effort, and
financial resources necessary to comply with a collection of
information that would be incurred by persons in the normal course of
their activities will be excluded from the ``burden'' if the Agency
demonstrates that the reporting, recordkeeping, or disclosure
activities needed to comply are usual and customary.'' PCPC/CHPA also
explains that conducting the SPF test for a water-resistant product
requires 3 to 4 weeks, instead of FDA's estimate of 24 hours (i.e., 3
days, 8 hours/day). However, PCPC/CHPA does not adequately describe the
``testing timelines'' section for conducting the SPF test. Even
consideration of extra time required for data analysis fails to account
for the difference between PCPC/CHPA's and FDA's estimate. Therefore,
FDA is not revising its estimate of the time required to conduct SPF
testing.
Estimate of the time required to create principal display labeling.
FDA's estimate of the time required to create principal display panel
labeling (e.g., 0.5 hours/SKU) differs from PCPC/CHPA's estimate (70.5
hours/SKU) because the estimates are based upon different tasks. FDA's
estimate refers to the time required to insert the SPF value on the
principal display panel, whereas PCPC/CHPA's estimate appears to be the
time required to create the entire principal display panel and the Drug
Facts panel. Only the insertion of the SPF value constitutes a third-
party disclosure burden. The remainder of the principal display panel
labeling constitutes ``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, is not
considered a collection of information. Therefore, FDA is not revising
its estimate.
Estimate of the time required to comply with Drug Facts labeling
requirements. FDA's estimate of the time required to comply with Drug
Facts labeling requirements (12 hours/SKU) differs from PCPC/CHPA's
estimate of (70.5 hours/SKU). FDA's estimate is based upon estimated
times to comply with Drug Facts requirements that were submitted in
public comments for various OTC drug products, including OTC sunscreen
products. PCPC/CHPA breaks down its estimate for complying with Drug
Facts requirements into 12 sequential steps and provides a one-sentence
description of each step. Presumably, the time estimated for each step
represents the average reported by PCPC/CHPA's members. Obtaining
averages for data has the potential for changing the outcome due to
outliers. In addition, the individual estimates from each of PCPC/
CHPA's members are not provided in the PCPC/CHPA's comment in order to
validate calculations made. Therefore, FDA cannot determine how
representative PCPC/CHPA's estimate is of its members or how variable
the estimate is between its members. In summary, FDA does not have
sufficient data to assess the validity of the estimated times for each
of these steps. Therefore, FDA does not consider the currently
available data adequate to revise its estimate.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
Activity respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
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 costs or operating and 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 sunscreen 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 Sec.
201.66 (the 1999 Drug Facts labeling final rule). Section 201.66 sets
requirements for the Drug Facts portion of labels on OTC drug products,
requiring such labeling to include uniform headings and subheadings,
presented in a standardized order, with minimum standards for type size
and other graphical features. 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 Sec. 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 2011 sunscreen final rule.
We estimate that these 3,600 SKUs are marketed by
[[Page 27234]]
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 in Sec. 201.66(e).
FDA estimates the burden of this collection of information as
follows:
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
Activity respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
Format labeling in accordance 100 36 3,600 12 43,200
with Sec. 201.66(c) and (d)
for existing sunscreen SKUs \2\
Format labeling in accordance 20 3 60 12 720
with Sec. 201.66(c) and (d)
for new sunscreen SKUs \3\.....
-------------------------------------------------------------------------------
Total first year burden..... .............. .............. .............. .............. 43,920
Total burden for each .............. .............. .............. .............. 720
subsequent year............
----------------------------------------------------------------------------------------------------------------
\1\ FDA estimates 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.
\3\ Burden for first and second years 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: May 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11067 Filed 5-8-12; 8:45 am]
BILLING CODE 4160-01-P
