[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Notices]
[Pages 44124-44126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17548]


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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 September 23, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, [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; (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--(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

[[Page 44125]]

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 (67 FR 16304), 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 (d)(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), 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.
    OTC sunscreen products were previously not included in our 
consideration of the burden to comply with the Drug Facts labeling 
requirements in Sec.  201.66. We specifically exempted OTC sunscreen 
products from complying with the 1999 labeling final rule until we 
lifted the stay of the sunscreen final rule published in the Federal 
Register of May 21,1999 (64 FR 27666). In the Federal Register of 
December 31, 2001 (66 FR 67485), we stayed the 1999 sunscreen final 
rule indefinitely. Additionally, in the Federal Register of September 
3, 2004 (69 FR 53801), we delayed the Sec.  201.66 labeling 
implementation date for OTC sunscreen products indefinitely, pending 
future rulemaking to amend the substance of labeling for these 
products. In the Federal Register of August 27, 2007 (72 FR 49070), we 
proposed changes to labeling and related testing requirements for 
sunscreen products to address both ultraviolet A and ultraviolet B 
radiation, and we anticipated that sunscreen products would become 
subject to Sec.  201.66 at the time any resultant final rule becomes 
effective. In the Federal Register of June 17, 2011 (76 FR 35620), we 
published a final rule that established testing and labeling 
requirements for OTC sunscreen products. This 2011 final rule lifted 
the delay of the Sec.  201.66 labeling implementation date for OTC 
sunscreen product. The compliance dates for the 2011 final rule were 
June 18, 2012, for sunscreen products with annual sales of $25,000 or 
more and June 17, 2013, for sunscreen products with annual sales of 
less than $25,000, but we later delayed these compliance dates to 
December 17, 2012, and December 17, 2013, respectively, when we 
published an extension date notice on May 11, 2012 (77 FR 27591).
    All currently marketed sunscreen products are, therefore, already 
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 estimated that 60 new SKUs of 
OTC sunscreen drug products would be marketed each year (77 FR 27234). 
We estimated that these 60 SKUs would be marketed by 30 manufacturers. 
We estimated 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 an 8-year period equates to an annual frequency of 
response equal to 0.125. 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 (0.125) by the number of hour per response (24) 
gives a total response time for requesting exemption or deferral equal 
to 3 hours.
    FDA estimates the current 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
         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           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 44126]]

    Dated: July 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17548 Filed 7-22-13; 8:45 am]
BILLING CODE 4160-01-P