[Federal Register Volume 66, Number 188 (Thursday, September 27, 2001)]
[Notices]
[Pages 49388-49389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0398]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Format and Content Requirements for Over-the-Counter 
(OTC) 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 OTC drug products.

DATES: Submit written or electronic comments on the collection of 
information by November 26, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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 Information 
Resources Management (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: (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

    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 the 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), the agency 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.
    The agency 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 for this group, each response 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, the agency 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

[[Page 49389]]

Sec. 201.66(c) and (d), which averages to 8.5 submissions per 
respondent. The agency 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.
    Since the final rule was issued on March 17, 1999, the agency has 
extended the May 16, 2001, compliance date 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). During this time, the agency has 
published only one major final rule (which has had its effective date 
extended from May 21, 2001, to December 31, 2002) (65 36319, June 8, 
2000) and several minor amendments to existing final rules. These 
monograph amendments have an effective date of May 16, 2002, so that 
the relabeling required by the amendments may be coordinated with the 
relabeling required by the OTC drug product labeling final rule. For 
these reasons, the agency believes that the numbers of affected 
products in the different categories discussed in the collection of 
information in the final rule are little changed. Accordingly, the 
agency is listing the same number of respondents, annual frequency per 
response, and total annual responses in this notice.
    The agency 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 already since the 
final rule was issued in 1999. The agency's experience with these 
inquires made to the agency 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, the agency 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 for the ANDAs to 
implement the new OTC drug product labeling regulation. This guidance 
should have reduced some of the hours per response and total hours for 
some NDA and ANDA holders. However, the agency is not currently able to 
estimate how much the time has been reduced. Accordingly, the agency is 
listing the same hours per response and total hours in this notice as 
appeared in the final rule.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                  Annual Frequency per        Total Annual
               21 CFR Section                No. of Respondents         Response               Responses        Hours per Response       Total Hours
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201.66                                             400                    31.43               12,573                    4               50,292
201.66                                             400                    66.8                26,737                    2.5             66,842
201.66(c) and (d)                                   61                     8.5                   522                    2                1,044
201.66(e)                                           25                     4                     100                   24                2,400
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  Total                                                                                                                                120,578
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 21, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-24160 Filed 9-26-01; 8:45 am]
BILLING CODE 4160-01-S