Document ID: FDA-2010-N-0248-0001
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: 2010-06-03T04:00Z

[Federal Register: June 3, 2010 (Volume 75, Number 106)]
[Notices]               
[Page 31448-31449]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn10-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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 reinstatement 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 August 2, 2010.

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:  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:  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 reinstatement 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; 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 (OMB 
Control Number 0910 0340)--Reinstatement

    In the Federal Register of March 17, 1999 (64 FR 13254), we amended 
our

[[Page 31449]]

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 1999 
labeling final rule). 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.
    The only burden to comply with the regulations in part 201 is a 
one-time burden for OTC sunscreen products and new OTC drug products 
introduced to the marketplace under new drug applications (NDAs) or 
abbreviated new drug applications (ANDAs). All OTC drug products except 
sunscreens and new OTC products marketed under NDAs or ANDAs are 
already required to be in compliance with these labeling regulations. 
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 on 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. Because the compliance date has passed for all OTC drug 
products except sunscreens and drug products introduced under new NDAs 
or ANDAs, we believe that the labeling burden associated with the 1999 
labeling final rule applies only to these products. We do not 
anticipate receiving any requests for exemptions or deferrals under 
Sec.  201.66(e) because we have only received one request in the past 8 
years.
    We estimate that there are 4,750 OTC sunscreen drug product stock 
keeping units (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 the 1999 sunscreen final 
rule when it is published in the Federal Register. We estimate that 
these 4,750 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 4,750 sunscreen SKUs, the total number of hours 
dedicated to the labeling of sunscreen products would be 9,500 hours 
(4,750 SKUs times 2 hours/SKU) (see table 1 of this document).
    Based on estimates provided by the Consumer Healthcare Products 
Association, we believe that approximately 500 new OTC drug product 
SKUs marketed under NDAs or ANDAs are introduced to the marketplace 
each year. We estimate that these SKUs are marketed by 300 
manufacturers. We estimate that the preparation of labeling for new 
NDAs and ANDAs will require 5 hours to prepare, complete, and review 
new labeling prior to submitting the new labeling to us. Based on this 
estimate, the annual reporting burden for this type of labeling is 
approximately 2,500 hours (see table 1 of this document).
    FDA estimates 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              4,750            2              9,500
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201.66(c) and (d)\3\                300                  1.67                500            5              2,500
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Total                                                                                                     12,000
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\1\ FDA estimates 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.
\2\ Burden for manufacturers of sunscreen drug product.
\3\ Burden for manufacturers of products marketed under new NDAs or ANDAs.

    Dated: May 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13279 Filed 6-2-10; 8:45 am]
BILLING CODE 4160-01-S