Document ID: FDA-2013-N-0823-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling
Posted Date: 2019-11-12T05:00Z

[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Pages 61064-61065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24509]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Format and Content 
Requirements for Over-the-Counter Drug Product Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 
December 12, 2019.

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

[[Page 61065]]

OMB control number 0910-0340. Also include the FDA docket number found 
in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 over-the-counter (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.
    In the Federal Register of June 19, 2019 (84 FR 28555), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received from a trade 
organization representing nurse practitioners. The comment advocated 
revising FDA regulations to provide for provider-neutral language in 
Agency regulations but acknowledged its use in current Agency guidance. 
We appreciate this comment, but we decline to adopt the suggestion at 
this time.
    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
                                     Number of      disclosures    Total annual   Average burden
         21 CFR section             respondents         per         disclosures   per disclosure    Total hours
                                                    respondent
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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: October 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24509 Filed 11-8-19; 8:45 am]
 BILLING CODE 4164-01-P