Document ID: FDA-2013-N-0823-0008
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-the- Counter Drug Product Labeling
Posted Date: 2019-06-19T04:00Z

[Federal Register Volume 84, Number 118 (Wednesday, June 19, 2019)]
[Notices]
[Pages 28555-28557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12996]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0823]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Format and Content Requirements for Over-the-Counter 
Drug Product Labeling

AGENCY: Food and Drug Administration, HHS.

[[Page 28556]]

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 the standardized format and 
content requirements for the labeling of over-the-counter (OTC) drug 
products.

DATES: Submit either electronic or written comments on the collection 
of information by August 19, 2019.

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 August 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 19, 2019. 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-2013-N-0823 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Format and Content Requirements 
for Over-the- Counter Drug Product Labeling.'' 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 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, 
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 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.

[[Page 28557]]

Format and Content Requirements for Over-the-Counter Drug Product 
Labeling--21 CFR Part 201

OMB Control Number 0910-0340--Extension

    This information collection supports FDA regulations at Sec.  
201.66 (21 CFR 201.66), which establish standardized content and format 
requirements for the labeling of all marketed OTC drug products. The 
regulations set forth the content and format requirements for the Drug 
Facts portion of labels on OTC drug products. These regulations require 
OTC drug product labeling to include uniform headings and subheadings, 
presented in a standardized order, with minimum standards for type size 
and other graphical features.
    Currently marketed OTC drug products are already required to comply 
with these labeling requirements and will incur no further burden to 
comply with Drug Facts labeling requirements in Sec.  201.66. Labeling 
modifications already required to be in Drug Facts format are ``usual 
and customary'' as part of routine redesign practice, thus they do not 
create additional burden within the meaning of the PRA.
    Therefore, burden for this information collection is that which is 
necessary to comply with the labeling requirements in Sec.  201.66, 
applicable to new OTC drug products and OTC sunscreen drug products 
introduced to the marketplace under new drug applications, abbreviated 
new drug applications, or an OTC drug monograph. New OTC drug products 
must comply with the labeling requirements in Sec.  201.66 as they are 
introduced to the marketplace.
    Based on our electronic drug registration and listing database, we 
estimate that approximately 10,463 new OTC drug product stock keeping 
units (SKUs) are introduced to the marketplace each year. We estimate 
that these SKUs are marketed by 1,416 manufacturers. We estimate that 
the preparation of labeling for new OTC drug products requires 12 hours 
to prepare, complete, and review prior to submitting the new labeling 
to us. Based on this estimate, the annual reporting burden for this 
type of labeling is 94,296 hours.
    All currently marketed sunscreen products are required to comply 
with the Drug Facts labeling requirements in Sec.  201.66, so they will 
incur no further burden under the information collection provisions in 
the regulation. However, a new OTC sunscreen drug product, like any new 
OTC drug product, will be subject to a one-time burden to comply with 
Drug Facts labeling requirements in Sec.  201.66. We estimate, based on 
our electronic drug registration and listing database, that 5,253 new 
SKUs of OTC sunscreen drug products will be marketed each year. We 
estimate that these 5,253 SKUs will be marketed by 294 manufacturers. 
We estimate that 12 hours will be spent on each label. This is 
reflected in table 1, row 1.
    When determining the burden for Sec.  201.66, it is also important 
to consider exemptions or deferrals of the regulation allowed products 
under Sec.  201.66(e). We receive very few requests for exemptions or 
deferrals. We also estimate that a request for deferral or exemption 
requires 24 hours to complete. This is reflected in table 1, row 2.
    We estimate the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of
         21 CFR section              Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosure    per disclosure
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Sec.   201.66(c) and (d) for new             855            9.19           7,858              12          94,296
 OTC drug products..............
Sec.   201.66(e)................               1               1               1              24              24
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    Total.......................  ..............  ..............  ..............  ..............          94,320
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an 
overall increase of 82,797 hours and a corresponding increase of 6,898 
disclosures. This increase corresponds with data obtained from our 
database.

    Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12996 Filed 6-18-19; 8:45 am]
BILLING CODE 4164-01-P