Document ID: FDA-2013-N-0823-0005
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: 2016-10-26T04:00Z

[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Pages 74452-74453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25854]

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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 (the PRA).

DATES: Fax written comments on the collection of information by 
November 25, 2016.

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

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 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 OTC Drug Product Labeling--21 CFR 
Part 201--OMB Control Number 0910-0340--Extension

    In the Federal Register of March 17, 1999 (64 FR 13254) (the 1999 
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 in part 
201 (21 CFR part 201). The regulations in part 201 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. Specifically, the 1999 labeling final rule added 
new Sec.  201.66 to part 201. Section 201.66 sets content and format 
requirements for the Drug Facts portion of labels on OTC drug products.
    On June 20, 2000 (65 FR 38191), we published a Federal Register 
final rule that required all OTC drug products marketed under the OTC 
monograph system to comply with the labeling requirements in Sec.  
201.66 by May 16, 2005, or sooner (65 FR 38191 at 38193). Currently 
marketed OTC drug products are already required to be in compliance 
with these labeling requirements, and thus will incur no further burden 
to comply with Drug Facts labeling requirements in Sec.  201.66. 
Modifications of labeling already required to be in Drug Facts format 
are usual and customary as part of routine redesign practice, and thus 
do not create additional burden within the meaning of the PRA. 
Therefore, the burden to comply with the labeling requirements in Sec.  
201.66 is a one-time burden applicable only to new OTC drug products 
introduced to the marketplace under new drug applications (NDAs), 
abbreviated new drug applications (ANDAs), or an OTC drug monograph, 
except for products in ``convenience size'' packages.\1\ New OTC drug 
products must comply with the labeling requirements in Sec.  201.66 as 
they are introduced to the marketplace.
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    \1\ In a final rule published in the Federal Register of April 
5, 2002, the Agency delayed the compliance dates for the 1999 
labeling final rule for all OTC drug products that: (1) Contain no 
more than two doses of an OTC drug and (2) because of their limited 
available labeling space, would require more than 60 percent of the 
total surface area available to bear labeling to meet the 
requirements set forth in Sec.  201.66(d)(1) and (9) and, therefore, 
qualify for the labeling modifications currently set forth in Sec.  
201.66(d)(10) (67 FR 16304 at 16306). The Agency issued this delay 
in order to develop additional rulemaking for these ``convenience 
size'' products (December 12, 2006; 71 FR 74474). These products are 
not currently subject to the requirements of Sec.  201.66. PRA 
approval for any requirements to which they may be subject in the 
future will be handled in a separate rulemaking.
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    Based on a March 1, 2010, estimate provided by the Consumer 
Healthcare Products Association (75 FR 49495 at 49496, August 13, 
2010), we estimated that approximately 900 new OTC drug product stock-
keeping units (SKUs) are introduced to the marketplace each

[[Page 74453]]

year. We estimated that these SKUs are marketed by 300 manufacturers. 
We estimated that the preparation of labeling for new OTC drug products 
would require 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 approximately 10,800 
hours.
    All currently marketed sunscreen products are required to be in 
compliance with the Drug Facts labeling requirements in Sec.  201.66, 
and thus will incur no further burden under the information collection 
provisions in the 1999 labeling final rule. 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 that 60 new SKUs of OTC sunscreen drug 
products would be marketed each year (77 FR 27230 at 27234). We 
estimate that these 60 SKUs would be marketed by 20 manufacturers. We 
estimate that approximately 12 hours would be spent 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.
    In 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). Since publication of the 1999 labeling final 
rule, we have received only one request for exemption or deferral. One 
response over a 10-year period equates to an annual frequency of 
response equal to 0.1. In the 1999 labeling final rule, we estimated 
that a request for deferral or exemption would require 24 hours to 
complete (64 FR 13254 at 13276). We continue to estimate that this type 
of response will require approximately 24 hours. Multiplying the annual 
frequency of response (0.1) by the number of hours per response (24) 
gives a total response time for requesting exemption of deferral equal 
to 3 hours.
    In the Federal Register of April 1, 2016 (81 FR 18861), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                              Table 1--Estimated Third-Party Disclosure Burden \1\
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                                                     Number of
                                     Number of      disclosures    Total annual       Average
         21 CFR section             respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
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201.66(c) and (d) for new OTC                300               3             900              12          10,800
 drug products..................
201.66(c) and (d) for new OTC                 20               3              60              12             720
 sunscreen products.............
201.66(e).......................               1           0.125            .125              24               3
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    Total.......................  ..............  ..............  ..............  ..............          11,523
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25854 Filed 10-25-16; 8:45 am]
 BILLING CODE 4164-01-P