[Federal Register Volume 78, Number 234 (Thursday, December 5, 2013)]
[Notices]
[Pages 73197-73199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29079]


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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; Over-the-Counter 
Drugs; Labeling Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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.

DATES: Fax written comments on the collection of information by January 
6, 2014.

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 [email protected]. 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

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.

Over-the-Counter Drugs; Labeling Requirements--(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 over-the-counter (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 (21 CFR 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 Paperwork 
Reduction Act of 1995 (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, abbreviated new drug applications, or an 
OTC drug monograph, except for products in ``convenience size'' 
packages.\1\ New OTC drug products

[[Page 73198]]

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 
inSec.  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 hours per response (24) 
gives a total response time for requesting exemption or deferral equal 
to 3 hours.
    In the Federal Register of July 23, 2013 (78 FR 44124), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment in response to the 
notice. The comment was a complaint about the ``deceptively large'' 
containers in which some OTC drug products are packaged. These 
deceptively large containers mislead consumers into thinking that they 
were purchasing more product than the package actually contained.
    We do not consider this comment relevant to this proposed 
collection of information. This information collection concerns OTC 
drug product labeling format and content, specifically the labeling 
that appears within the Drug Facts panel. This comment is a complaint 
about OTC drug products packaged in ``deceptively large'' containers, 
which is a separate issue and is not the subject of this notice. The 
regulations for Drug Facts labeling in Sec.  201.66 do not establish, 
and were not intended to establish, container size requirements for OTC 
drug products. The Federal Food, Drug, and Cosmetic Act already 
prohibits the use of deceptively large containers. According to 21 
U.S.C. 352(i): ``A drug or device shall be deemed to be misbranded if 
it is a drug and its container is so made, formed, or filled as to be 
misleading.'' Therefore, the commenter's complaint is already addressed 
by statute.
    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 73199]]

    Dated: November 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29079 Filed 12-4-13; 8:45 am]
BILLING CODE 4160-01-P