Document ID: FDA-2010-N-0248-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Format and Content Requirements for Over-the-Counter Drug Product Labeling
Posted Date: 2010-08-13T04:00Z

[Federal Register: August 13, 2010 (Volume 75, Number 156)]
[Notices]               
[Page 49495-49497]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au10-58]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0248]

 
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) 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 
September 13, 2010.

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 e-mailed 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:  Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@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--OMB Control Number 0910-0340--Reinstatement

    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

[[Page 49496]]

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. Section 201.66 sets 
content and format requirements for the Drug Facts portion of labels on 
OTC drug products.
    The only burden to comply with the regulations in part 201 is a 
one-time burden for the following products:
     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\
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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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     OTC sunscreen products.
    The burden is limited to these products because, as explained in 
this document, most currently marketed OTC drug products are already 
required to be in compliance with these labeling regulations, and thus 
will incur no further burden in order to satisfy this regulation. We 
recognize that some manufacturers may choose to modify labeling already 
required to be in Drug Facts format. We believe that such changes are 
usual and customary as part of routine redesign practice, and thus do 
not create additional burden within the meaning of the PRA. With the 
exceptions described, new products must comply with the regulations as 
they are introduced to the marketplace. Also, as explained in this 
document, OTC sunscreen products have not been required to comply with 
these regulations but are anticipated to become subject to these 
requirements when a sunscreen final rule becomes effective.
    Specifically, on June 20, 2000 (65 FR 38191), we published a 
Federal Register document that required all OTC drug products marketed 
under the OTC monograph system except sunscreen products to comply with 
the regulations by May 16, 2005, or sooner (65 FR 38191 at 38193). 
Sunscreen products do not have to comply with the regulations until we 
lift the stay of the sunscreen final rule that was published in the 
Federal Register of May 21, 1999 (64 FR 27666) (the 1999 sunscreen 
final rule). In the Federal Register of December 31, 2001 (66 FR 
67485), we stayed the 1999 sunscreen final rule indefinitely. In the 
Federal Register of September 3, 2004 (69 FR 53801), we delayed the 
Sec.  201.66 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 anticipated that sunscreen products would 
become subject to Sec.  201.66 at the time any resultant final rule 
becomes effective.
    Based on a recent estimate provided by the Consumer Healthcare 
Products Association (CHPA),\2\ we believe that approximately 900 new 
OTC drug product stock keeping units (SKUs) are introduced to the 
marketplace each year. Further, we estimate that these SKUs are 
marketed by 300 manufacturers. We estimate that the preparation of 
labeling for new OTC drug products will require 5 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 4,500 hours. (See table 1 of this document.)
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    \2\ Letter submitted to FDA by CHPA on March 1, 2010 (available 
in Docket No. FDA-2010-N-0248).
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    We estimate that there are 4,752 OTC sunscreen drug product SKUs 
that have not yet complied with the 1999 labeling final rule. All of 
these SKUs will need to implement the new labeling format by the 
implementation date included in a sunscreen final rule when it is 
published in the Federal Register. We estimate that these 4,752 SKUs 
are marketed by 400 manufacturers and that approximately 2 hours will 
be spent on each submission. (See table 1 of this document.) The number 
of hours per submission (response) is based on our estimate in the 1999 
labeling final rule (64 FR 13254 at 13276). If an average of 2 hours is 
spent preparing, completing, and reviewing each of the estimated 4,752 
sunscreen SKUs, the total number of hours dedicated to the labeling of 
OTC sunscreen products would be 9,504 hours (4,752 SKUs times 2 hours/
SKU). (See table 1 of this document.)
    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 believe 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.
    In the Federal Register of June 3, 2010 (75 FR 31448), we published 
a 60-day notice requesting public comment on the proposed collection of 
information. We received no comments.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                      No. of          Annual Frequency  per       Total Annual         Hours per
                21 CFR Section                      Respondents             Response                Responses          Response          Total Hours
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201.66(c) and (d)\2\                                           400                    11.88                  4,752               2                 9,504
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201.66(c) and (d)\3\                                           300                     3                       900               5                 4,500
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201.66(e)                                                        1                     0.125                 0.125              24                     3
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Total                                                                                                                                             14,007
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\1\ We estimate that capital costs of 22 to 25 million dollars will result from preparing labeling content and format in accordance with Sec.   201.66.
  There are no operating or maintenance costs associated with this collection of information.

[[Page 49497]]

\2\ Burden for manufacturers of sunscreen drug products.
\3\ Burden for manufacturers of new OTC drug products.

    Dated: August 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19985 Filed 8-12-10; 8:45 am]
BILLING CODE 4160-01-S