[Federal Register Volume 70, Number 2 (Tuesday, January 4, 2005)]
[Notices]
[Pages 362-364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-27]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0534]


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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[[Page 363]]

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 written or electronic comments on the collection of 
information by March 7, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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: Karen L. Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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; 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 Over-the-Counter (OTC) Drug Product 
Labeling--(OMB Control Number 0910-0340)

    In the Federal Register of March 17, 1999 (64 FR 13254), FDA 
amended its regulations governing requirements for human drug products 
to establish standardized format and content requirements for the 
labeling of all marketed OTC drug products. The rule requires 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. The rule is intended to enable consumers to better 
read and understand OTC drug product labeling and to apply this 
information to the safe and effective use of OTC drug products. FDA 
concludes that the labeling statements required under this rule are not 
subject to review by OMB because they are originally supplied by the 
Federal Government to the recipient for the purpose of disclosure to 
the public (5 CFR 1320.3(c)(2)) and therefore do not constitute a 
collection of information under the PRA (44 U.S.C. 3501 et seq.).
    Section 201.66 of the labeling requirements (21 CFR 201.66) 
requires all OTC drug manufacturers to format labeling as set forth in 
paragraphs (c) and (d). FDA has learned from the industry that OTC drug 
product manufacturers routinely redesign the labeling of their products 
as part of their usual and customary business practice. The rule 
provides varied timeframes for implementing the labeling requirements. 
Therefore, the majority of respondents will be able to format OTC drug 
product labeling in accordance with Sec.  201.66 as part of their 
routine redesign practice, creating no additional paperwork or economic 
burden.
    In discussing the collection of information under the PRA in the 
final rule (64 FR 13254 at 13274 to 13276), FDA stated that of the 
39,310 stock keeping units (SKUs) (individual products, packages, and 
sizes) currently marketed under a final monograph, approximately 32 
percent, or 12,573 products, may necessitate labeling changes sooner 
than provided under their usual and customary practice of label design. 
FDA estimated that of the 400 respondents who produce OTC drug 
products, including the 12,573 products described above, each may be 
required to respond approximately 31.4 times to this rule outside of 
their usual and customary practice. Each response was estimated to 
take, on the average of, 4 hours, for a total of 50,292 hours per year. 
The burden was expected to be a one-time burden.
    FDA stated that although the usual and customary practice of label 
redesign would minimize the burden for the remaining 68 percent of SKUs 
currently marketed, or 26,737 products, additional time may be 
necessary for each company to make the format changes under this rule. 
FDA estimated that of the 400 respondents who produce OTC drug 
products, each may be required to respond approximately 66.8 times to 
bring the 26,737 products into compliance with this rule. FDA estimated 
that each response for this group will take an average of 2.5 hours for 
a total of 66,842 hours. The burden was expected to be a one-time 
burden.
    Finally, FDA estimated that approximately 61 respondents hold new 
drug applications (NDAs) and abbreviated new drug applications (ANDAs) 
(41 NDA holders and 20 ANDA holders) for which supplements and 
amendments will be required. FDA expected that 522 submissions (350 to 
NDAs and 172 to ANDAs) will be required for labeling changes under 
Sec.  201.66(c) and (d), which averages to 8.5 submissions per 
respondent. FDA estimated that each submission will take an average of 
2 hours to prepare for a total of 1,040 hours annually. The burden was 
also expected to be a one-time burden.
    Because the final rule was issued on March 17, 1999, FDA extended 
the May 16, 2001, compliance date for products subject to drug 
marketing applications approved before May 16, 1999, and for products 
subject to an OTC drug monograph finalized before May 16, 1999, by 1 
year to May 16, 2002 (with a corresponding extension of the May 16, 
2002, compliance date for products with annual sales of less than 
$25,000 to May 16, 2003) (65 FR 38191, June 20, 2000). Products subject 
to an OTC drug monograph finalized on or after May 16, 1999, had to 
comply within the period specified in the final monograph. However, if 
a monograph had not been finalized as of May 16, 2002, then the 
products have to comply as of the first major labeling revision after 
May 16,

[[Page 364]]

2002, or by May 16, 2005, whichever occurs first.
    Since March 17, 1999, FDA has published six major final rules on 
OTC drug monographs and several minor amendments to existing final 
monographs. The following are the six major final rules and their date 
of publication:
     Sunscreen drug products (May 21, 1999),
     Cough-cold combination drug products (December 23, 2002),
     Antidiarrheal drug products (April 17, 2003),
     Ingrown toenail relief drug products (May 7, 2003),
     Skin protectant drug products (June 4, 2003), and
     Antiperspirant drug products (June 9, 2003).
    The effective date for the final monograph for OTC sunscreen drug 
products and for the implementation of the new labeling format for 
these products has been stayed indefinitely (65 FR 36319, June 8, 2000, 
and 69 FR 53801, September 3, 2004). The effective date for products 
subject to the final rules on the other OTC drug monographs to 
implement the new labeling format will occur by the end of 2004, except 
for a small number of products with annual sales less than $25,000. 
Those products will have until June 2005 to implement the new labeling 
format. These dates should enable manufacturers to coordinate the 
relabeling required by the final monographs with the relabeling 
required by the OTC drug product labeling final rule.
    FDA previously estimated that 12,573 out of 39,310 SKUs were 
affected by the March 17, 1999, OTC drug product labeling final rule. 
Based on information in the six final rules issued since that time, FDA 
estimates that 11,250 additional SKUs have already been affected by the 
OTC drug product labeling final rule. Thus, 15,487 SKUs remain to be 
affected by the OTC drug product labeling final rule. All of these will 
need to implement the new labeling format by May 16, 2005, except for 
the sunscreen drug products that are currently deferred.
    As the number of products remaining to be affected by the OTC drug 
product labeling final rule is close to the number of products affected 
at the time of the May 17, 1999, publication of that final rule, FDA is 
listing the same numbers of respondents, annual frequency per response, 
and total annual responses in this notice.
    FDA believes the hours per response and total hours may be less 
than the numbers stated in the final rule for several reasons. First, 
respondents have made a number of inquiries to FDA already since the 
final rule was issued in 1999. FDA's experience with these inquiries is 
that inquiries have been less than 2.5 or 4 hours per response, 
generally averaging 0.25 to 0.5 hour per inquiry. Second, respondents 
have gained significant experience with the final rule since 1999, 
reducing their need to make additional inquiries. Third, FDA issued a 
draft guidance for industry entitled ``Labeling Over-the-Counter Human 
Drug Products; Updating Labeling in ANDA's'' (66 FR 11174, February 22, 
2001), which included a number of labeling examples to assist holders 
of ANDAs for OTC drug products and manufacturers of reference listed 
drugs (RLDs) for the ANDAs to implement the new OTC drug product 
labeling regulation. FDA issued a final guidance for industry on 
October 18, 2002 (67 FR 64402). This guidance should have reduced some 
of the hours per response and total hours for some NDA and ANDA 
holders. However, FDA is not currently able to estimate how much time 
has been reduced. Accordingly, FDA is listing the same hours per 
response and total hours in this notice as appeared in the March 17, 
1999, final rule.
    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   Total Annual       Hours Per
     21 CFR Section        Respondents      per Response       Responses         Response         Total Hours
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201.66\2\                           400              31.43          12,573               4                50,292
201.66                              400              66.8           26,737               2.5              66,842
201.66(c) and (d)\2\                 61               8.5              522               2                 1,044
201.66(e)                            25               4                100              24                 2,400
Total                    ..............  .................  ..............  .................            120,578
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ One-time burden.


    Dated: December 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-27 Filed 1-3-05; 8:45 am]
BILLING CODE 4160-01-S