
[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18861-18863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07369]


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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.

ACTION: Notice.

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SUMMARY: 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 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 May 31, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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,

[[Page 18862]]

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.

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 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 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, March 17, 1999). 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 hour per response (24) gives a total response time for requesting 
exemption of deferral equal to 3 hours.
    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
         21 CFR Section             Number of    disclosures per   Total annual   Average burden    Total hours
                                   respondents      respondent      disclosures   per 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           0.125              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.



[[Page 18863]]

    Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07369 Filed 3-31-16; 8:45 am]
 BILLING CODE 4164-01-P


