Agency Information Collection Activities; Proposed Collection; Comment Request; Sun Protection Factor Labeling and Testing Requirements for Over-the-Counter Sunscreen Drug Products, 42509-42512 [2018-18073]
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Center’s website following the meeting:
https://healthpolicy.duke.edu/events/
expanding-access-to-treatment-for-OUD.
Webcast participants will be able to
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IV. References
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The following references are on
display in the Dockets Management
Staff (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also
available electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. Hedegaard, H., M. Warner, and A.M.
Minin˜o, ‘‘Drug Overdose Deaths in the
United States, 1999–2016,’’ NCHS Data
Brief, no. 294, Hyattsville, MD: National
Center for Health Statistics. 2017
(available at https://www.cdc.gov/nchs/
products/databriefs/db294.htm),
accessed June 27, 2018.
2. Substance Abuse and Mental Health
Services Administration, Center for
Behavioral Health Statistics and Quality,
‘‘Results from the 2016 National Survey
on Drug Use and Health: Detailed
Tables.’’ September 8, 2016 (available at
https://www.samhsa.gov/data/sites/
default/files/NSDUH-DetTabs-2016/
NSDUH-DetTabs-2016.htm), accessed
June 27, 2018.
Dated: August 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–18071 Filed 8–21–18; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0449]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Sun Protection
Factor Labeling and Testing
Requirements for Over-the-Counter
Sunscreen Drug Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 sun protection
factor (SPF) labeling and testing
requirements for over-the-counter (OTC)
sunscreen products containing specified
ingredients and marketed without
approved applications, and comments
on compliance with Drug Facts labeling
requirements for all OTC sunscreen
products.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by October 22, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 22,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 22, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
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the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0449 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Sun
Protection Factor Labeling and Testing
Requirements and Drug Facts Labeling
for Over-the-Counter Sunscreen Drug
Products.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
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second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
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
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is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SPF Labeling and Testing Requirements
for OTC Sunscreen Products—21 CFR
201.327(a)(1) and (i), 21 CFR 201.66(c)
and (d)
OMB Control Number 0910–0717—
Extension
I. Background
In the Federal Register of June 17,
2011 (76 FR 35620), we published a
final rule establishing labeling and
effectiveness testing requirements for
certain OTC sunscreen products
containing specified active ingredients
without approved applications (2011
sunscreen final rule; § 201.327 (21 CFR
201.327)). In addition to establishing
testing requirements, the 2011
sunscreen final rule lifted the delay of
implementing the prior 1999 sunscreen
final rule (published in the Federal
Register of May 21, 1999 (64 FR 27666)
and stayed in the Federal Register of
December 31, 2001 (66 FR 67485) from
complying with the 1999 Drug Facts
labeling final rule (published in the
Federal Register of March 17, 1999 (64
FR 13254)), in which we amended our
regulations governing requirements for
human drug products to establish
standardized format and content
requirements for the labeling of all
marketed OTC drug products in part 201
(21 CFR part 201). Specifically, the 1999
Drug Facts labeling final rule added new
§ 201.66 to part 201. Section 201.66
establishes content and format
requirements for the Drug Facts portion
of OTC drug product labels. We
specifically exempted OTC sunscreen
products from complying with the 1999
Drug Facts labeling final rule until we
lifted the stay of the 1999 sunscreen
final rule. The 2011 sunscreen final rule
became effective December 17, 2012, for
sunscreen products with annual sales of
$25,000 or more and December 17,
2013, for sunscreen products with
annual sales of less than $25,000 when
we published an extension date notice
in the Federal Register of May 11, 2012
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(77 FR 27591) (2012 extension date
notice).
II. SPF Labeling and Testing for OTC
Sunscreens Containing Specified Active
Ingredients and Marketed Without
Approved Applications
In the Federal Register of June 17,
2011 (76 FR 35678), we published a 60day notice requesting public comment
on the proposed collection of
information regarding SPF labeling and
testing requirements for OTC sunscreen
products containing specified
ingredients and marketed without
approved applications (2011 60-day
notice). In that notice, we stated that
§ 201.327(a)(1) requires the principal
display panel (PDP) labeling of a
sunscreen covered by the 2011
sunscreen final rule to include the SPF
value determined by conducting the
SPF test outlined in § 201.327(i).
Therefore, that provision resulted in an
information collection with a thirdparty disclosure burden for
manufacturers of OTC sunscreens
covered by the 2011 sunscreen rule. We
determined that products need only
complete the testing and labeling
required by the 2011 sunscreen rule
once and then continue to use the
resultant labeling (third-party
disclosure) going forward without
additional burden. This one-time testing
would need to be conducted within the
first 3 years after publication of the 2011
sunscreen final rule for all OTC
sunscreens covered by that rule.
We determined that the third-party
disclosure burden by manufacturers of
OTC sunscreens covered by the 2011
sunscreen rule was based on: (1) An
estimate of the time for reviewing
instructions, searching existing data
sources, gathering and maintaining the
data needed, and completing and
reviewing each collection of
information; (2) the conduct of SPF
testing based on the estimated number
of existing formulations; (3) an estimate
of the time to relabel currently marketed
OTC sunscreens containing specified
ingredients and marketed without
approved applications; and (4) testing
and labeling of new products
introduced each year. The estimate for
this burden in the 2011 60-day notice
was a total of 30,066 hours in years 1
and 2, and a total of 966 in each
subsequent year.
All currently marketed OTC
sunscreen drug products are already
required to comply with the SPF
labeling requirements specified by the
2011 sunscreen final rule. However, our
original estimate also included the
burden of new products introduced
each year. We estimated that as many as
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60 new OTC sunscreen products stock
keeping units (SKUs) may be introduced
each year, which must be tested and
labeled with the SPF value determined
in the test. We estimated that the 60
new sunscreen SKUs represent 39 new
formulations. The burden for testing and
labeling these formulations was
estimated at 30 hours per year.
We received only two comments on
our estimated information collection
burden (FDA–2011–N–0449–0002 and
FDA–2011–N–0449–0003). These
comments were already addressed in
FDA’s notice entitled ‘‘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’’ published in
42511
the Federal Register of May 9, 2012 (77
FR 27230).
In the Federal Register of April 16,
2015 (80 FR 20499), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number
of respondents
Activity
Total annual
disclosures
Average burden
per disclosure
Total hours
Conduct SPF testing in accordance with
§ 201.327(i) for new sunscreens.
Create PDP labeling in accordance with
§ 201.327(a)(1) for new sunscreen SKUs.
20
1.95
39
24 ...................................
936
20
3
60
0.5 (30 minutes) .............
30
Total .............................................................
........................
........................
........................
........................................
966
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Drug Facts Labeling for OTC
Sunscreens
Because the 2011 sunscreen final rule
also lifted the delay of implementing the
Drug Facts regulations (§ 201.66) for
OTC sunscreens, the rule also modified
the information collection associated
with § 201.66 (currently approved under
OMB control number 0910–0340) and
added a third-party disclosure burden
resulting from requiring OTC sunscreen
products to comply with Drug Facts
regulations. In the 1999 Drug Facts
labeling final rule, 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 § 201.66. This section establishes
requirements for the Drug Facts portion
of labels on OTC drug products
requiring such labeling, to include
uniform headings and subheadings,
presented in a standardized order with
minimum standards for type size and
other graphical features. Therefore, OTC
sunscreen products already on the
market at that time incurred a one-time
burden to comply with the requirements
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in § 201.66(c) and (d). In the 60-day
notice, the burden was estimated as
43,200 hours for existing sunscreen
SKUs and 720 hours for new sunscreen
SKUs.
The compliance dates for the 2011
sunscreen final rule that lifted the delay
of the § 201.66 labeling implementation
data for OTC sunscreen products were
December 17, 2012, for sunscreen
products with annual sales of $25,000 or
more and December 17, 2013, for
sunscreen products with annual sales of
less than $25,000, respectively, when
we published the 2012 extension date
notice. All currently marketed
sunscreen products are, therefore,
already required to comply with the
Drug Facts labeling requirements in
§ 201.66 and will incur no further
burden in the 1999 Drug Facts labeling
final rule. However, new OTC sunscreen
drug products will be subject to a onetime burden to comply with Drug Facts
labeling requirements in § 201.66. In the
2011 60-day notice, we estimated that as
many as 60 new product SKUs marketed
each year must comply with Drug Facts
regulations. We estimated that these 60
SKUs would be marketed by 30
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manufacturers, which will spend
approximately 12 hours on each label
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. This is equal to
720 hours annually (60 SKUs, 12 hours
per SKU). We stated that we do not
expect any OTC sunscreens to apply for
exemptions or deferrals of the Drug
Facts regulations in § 201.66(e).
However, we considered this in 2013
and estimated the burden for an
exemption or deferral by considering
the number of exemptions or deferrals
we have received since publication of
the 1999 Drug Facts labeling final rule
(one response) and estimating that a
request for deferral or exemption would
require 24 hours to complete.
Multiplying the annual frequency of
response (0.125) by the number of hours
per response (24) gives a total response
time for requesting an exemption or
deferral equal to 3 hours.
FDA estimates the burden of this
collection of information as follows:
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TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number
of respondents
Activity
Total annual
disclosures
Average
burden per
disclosure
Total hours
Format labeling in accordance with § 201.66(c) and (d) for
new sunscreen SKUs .......................................................
Request for Drug Facts exemption or deferral § 201.66(e)
20
1
3
0.125
60
0.125
12
24
720
3
Total ..............................................................................
........................
........................
........................
........................
723
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We note that these estimates may be
adjusted in the future development of
an upcoming rulemaking on over-thecounter sunscreen products (RIN 0910–
AA01). FDA intends to amend this
information collection and/or seek
approval of additional information
collections, as appropriate, concurrent
with this rulemaking.
Dated: August 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–18073 Filed 8–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–P–1335 and FDA–
2018–P–1361]
Determination That DITROPAN XL
(Oxybutynin Chloride) Extended
Release Tablets, 15 Milligrams, Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that DITROPAN XL
(oxybutynin chloride) Extended Release
Tablets, 15 milligrams (mg), were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for DITROPAN
XL (oxybutynin chloride) Extended
Release Tablets, 15 mg, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Glen
Cheng, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6210, Silver Spring,
MD 20993–0002, 301–796–1494.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
SUMMARY:
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per
respondent
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Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
DITROPAN XL (oxybutynin chloride)
Extended Release Tablets, 5 mg, 10 mg,
and 15 mg, are the subject of NDA
020897, held by Janssen
Pharmaceuticals Inc., and initially
approved on December 16, 1998.
DITROPAN XL is indicated for the
treatment of overactive bladder with
symptoms of urge urinary incontinence,
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urgency, and frequency, and for the
treatment of pediatric patients aged 6
years and older with symptoms of
detrusor overactivity associated with a
neurological condition (e.g., spina
bifida).
In a letter dated December 14, 2017,
Janssen Pharmaceuticals Inc. notified
FDA that DITROPAN XL (oxybutynin
chloride) Extended Release Tablets, 15
mg, were being discontinued, and FDA
moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. Although
DITROPAN XL (oxybutynin chloride)
Extended Release Tablets, 5 mg and 10
mg, were also previously listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book, they are
now listed in the ‘‘Prescription Drug
Product List’’ section of the Orange
Book.
Hyman, Phelps & McNamara, P.C.,
submitted a citizen petition dated
March 30, 2018 (Docket No. FDA–2018–
P–1335), and Ajanta Pharma Limited
submitted a citizen petition dated April
2, 2018 (Docket No. FDA–2018–P–
1361), under 21 CFR 10.30, requesting
that the Agency determine whether
DITROPAN XL (oxybutynin chloride)
Extended Release Tablets, 5 mg, 10 mg,
and 15 mg, were withdrawn from sale
for reasons of safety or effectiveness.
As noted, DITROPAN XL (oxybutynin
chloride) Extended Release Tablets, 5
mg and 10 mg, are no longer listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book, and
therefore we need not determine
whether they were withdrawn from sale
for reasons of safety or effectiveness.
With regard to DITROPAN XL
(oxybutynin chloride) Extended Release
Tablets, 15 mg, after considering the
citizen petition and reviewing Agency
records, and based on the information
we have at this time, FDA has
determined under § 314.161 that
DITROPAN XL (oxybutynin chloride)
Extended Release Tablets, 15 mg, were
not withdrawn from sale for reasons of
safety or effectiveness. The petitioners
have identified no data or other
information suggesting that this drug
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]]>Agencies
[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)]
[Notices]
[Pages 42509-42512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18073]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0449]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Sun Protection Factor Labeling and Testing
Requirements for Over-the-Counter Sunscreen Drug Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 sun protection factor (SPF) labeling and
testing requirements for over-the-counter (OTC) sunscreen products
containing specified ingredients and marketed without approved
applications, and comments on compliance with Drug Facts labeling
requirements for all OTC sunscreen products.
DATES: Submit either electronic or written comments on the collection
of information by October 22, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 22, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0449 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Sun Protection Factor Labeling
and Testing Requirements and Drug Facts Labeling for Over-the-Counter
Sunscreen Drug Products.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The
[[Page 42510]]
second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined 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) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
SPF Labeling and Testing Requirements for OTC Sunscreen Products--21
CFR 201.327(a)(1) and (i), 21 CFR 201.66(c) and (d)
OMB Control Number 0910-0717--Extension
I. Background
In the Federal Register of June 17, 2011 (76 FR 35620), we
published a final rule establishing labeling and effectiveness testing
requirements for certain OTC sunscreen products containing specified
active ingredients without approved applications (2011 sunscreen final
rule; Sec. 201.327 (21 CFR 201.327)). In addition to establishing
testing requirements, the 2011 sunscreen final rule lifted the delay of
implementing the prior 1999 sunscreen final rule (published in the
Federal Register of May 21, 1999 (64 FR 27666) and stayed in the
Federal Register of December 31, 2001 (66 FR 67485) from complying with
the 1999 Drug Facts labeling final rule (published in the Federal
Register of March 17, 1999 (64 FR 13254)), in which we amended our
regulations governing requirements for human drug products to establish
standardized format and content requirements for the labeling of all
marketed OTC drug products in part 201 (21 CFR part 201). Specifically,
the 1999 Drug Facts labeling final rule added new Sec. 201.66 to part
201. Section 201.66 establishes content and format requirements for the
Drug Facts portion of OTC drug product labels. We specifically exempted
OTC sunscreen products from complying with the 1999 Drug Facts labeling
final rule until we lifted the stay of the 1999 sunscreen final rule.
The 2011 sunscreen final rule became effective December 17, 2012, for
sunscreen products with annual sales of $25,000 or more and December
17, 2013, for sunscreen products with annual sales of less than $25,000
when we published an extension date notice in the Federal Register of
May 11, 2012 (77 FR 27591) (2012 extension date notice).
II. SPF Labeling and Testing for OTC Sunscreens Containing Specified
Active Ingredients and Marketed Without Approved Applications
In the Federal Register of June 17, 2011 (76 FR 35678), we
published a 60-day notice requesting public comment on the proposed
collection of information regarding SPF labeling and testing
requirements for OTC sunscreen products containing specified
ingredients and marketed without approved applications (2011 60-day
notice). In that notice, we stated that Sec. 201.327(a)(1) requires
the principal display panel (PDP) labeling of a sunscreen covered by
the 2011 sunscreen final rule to include the SPF value determined by
conducting the SPF test outlined in Sec. 201.327(i). Therefore, that
provision resulted in an information collection with a third-party
disclosure burden for manufacturers of OTC sunscreens covered by the
2011 sunscreen rule. We determined that products need only complete the
testing and labeling required by the 2011 sunscreen rule once and then
continue to use the resultant labeling (third-party disclosure) going
forward without additional burden. This one-time testing would need to
be conducted within the first 3 years after publication of the 2011
sunscreen final rule for all OTC sunscreens covered by that rule.
We determined that the third-party disclosure burden by
manufacturers of OTC sunscreens covered by the 2011 sunscreen rule was
based on: (1) An estimate of the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing each collection of information;
(2) the conduct of SPF testing based on the estimated number of
existing formulations; (3) an estimate of the time to relabel currently
marketed OTC sunscreens containing specified ingredients and marketed
without approved applications; and (4) testing and labeling of new
products introduced each year. The estimate for this burden in the 2011
60-day notice was a total of 30,066 hours in years 1 and 2, and a total
of 966 in each subsequent year.
All currently marketed OTC sunscreen drug products are already
required to comply with the SPF labeling requirements specified by the
2011 sunscreen final rule. However, our original estimate also included
the burden of new products introduced each year. We estimated that as
many as
[[Page 42511]]
60 new OTC sunscreen products stock keeping units (SKUs) may be
introduced each year, which must be tested and labeled with the SPF
value determined in the test. We estimated that the 60 new sunscreen
SKUs represent 39 new formulations. The burden for testing and labeling
these formulations was estimated at 30 hours per year.
We received only two comments on our estimated information
collection burden (FDA-2011-N-0449-0002 and FDA-2011-N-0449-0003).
These comments were already addressed in FDA's notice entitled ``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'' published in the Federal Register of May 9,
2012 (77 FR 27230).
In the Federal Register of April 16, 2015 (80 FR 20499), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual
Activity respondents per disclosures Average burden per disclosure Total hours
respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conduct SPF testing in accordance with 20 1.95 39 24.......................................... 936
Sec. 201.327(i) for new sunscreens.
Create PDP labeling in accordance with 20 3 60 0.5 (30 minutes)............................ 30
Sec. 201.327(a)(1) for new sunscreen
SKUs.
-------------------------------------------------------------------------------------------------------------
Total................................. .............. .............. .............. ............................................ 966
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Drug Facts Labeling for OTC Sunscreens
Because the 2011 sunscreen final rule also lifted the delay of
implementing the Drug Facts regulations (Sec. 201.66) for OTC
sunscreens, the rule also modified the information collection
associated with Sec. 201.66 (currently approved under OMB control
number 0910-0340) and added a third-party disclosure burden resulting
from requiring OTC sunscreen products to comply with Drug Facts
regulations. In the 1999 Drug Facts labeling final rule, 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. This section
establishes requirements for the Drug Facts portion of labels on OTC
drug products requiring such labeling, to include uniform headings and
subheadings, presented in a standardized order with minimum standards
for type size and other graphical features. Therefore, OTC sunscreen
products already on the market at that time incurred a one-time burden
to comply with the requirements in Sec. 201.66(c) and (d). In the 60-
day notice, the burden was estimated as 43,200 hours for existing
sunscreen SKUs and 720 hours for new sunscreen SKUs.
The compliance dates for the 2011 sunscreen final rule that lifted
the delay of the Sec. 201.66 labeling implementation data for OTC
sunscreen products were December 17, 2012, for sunscreen products with
annual sales of $25,000 or more and December 17, 2013, for sunscreen
products with annual sales of less than $25,000, respectively, when we
published the 2012 extension date notice. All currently marketed
sunscreen products are, therefore, already required to comply with the
Drug Facts labeling requirements in Sec. 201.66 and will incur no
further burden in the 1999 Drug Facts labeling final rule. However, new
OTC sunscreen drug products will be subject to a one-time burden to
comply with Drug Facts labeling requirements in Sec. 201.66. In the
2011 60-day notice, we estimated that as many as 60 new product SKUs
marketed each year must comply with Drug Facts regulations. We
estimated that these 60 SKUs would be marketed by 30 manufacturers,
which will spend approximately 12 hours on each label 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. This is equal to
720 hours annually (60 SKUs, 12 hours per SKU). We stated that we do
not expect any OTC sunscreens to apply for exemptions or deferrals of
the Drug Facts regulations in Sec. 201.66(e). However, we considered
this in 2013 and estimated the burden for an exemption or deferral by
considering the number of exemptions or deferrals we have received
since publication of the 1999 Drug Facts labeling final rule (one
response) and estimating that a request for deferral or exemption would
require 24 hours to complete. Multiplying the annual frequency of
response (0.125) by the number of hours per response (24) gives a total
response time for requesting an exemption or deferral equal to 3 hours.
FDA estimates the burden of this collection of information as
follows:
[[Page 42512]]
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
----------------------------------------------------------------------------------------------------------------
Format labeling in accordance 20 3 60 12 720
with Sec. 201.66(c) and (d)
for new sunscreen SKUs.........
Request for Drug Facts exemption 1 0.125 0.125 24 3
or deferral Sec. 201.66(e)...
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 723
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We note that these estimates may be adjusted in the future
development of an upcoming rulemaking on over-the-counter sunscreen
products (RIN 0910-AA01). FDA intends to amend this information
collection and/or seek approval of additional information collections,
as appropriate, concurrent with this rulemaking.
Dated: August 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18073 Filed 8-21-18; 8:45 am]
BILLING CODE 4164-01-P
