[Federal Register Volume 67, Number 38 (Tuesday, February 26, 2002)]
[Notices]
[Pages 8818-8819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4511]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0398]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
March 28, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

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: 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 (OTC) Drug 
Product Labeling (OMB Control No. 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 (21 CFR 201.66) of the labeling requirements 
requires all OTC drug manufacturers to format labeling as set forth in 
paragraphs (c) and (d) of that section. 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 stockkeeping 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 21 
CFR 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 April 16, 2001, compliance date by 1 year to April 16, 
2002 (with a corresponding extension of the April 16, 2002, compliance 
date for products with annual sales of less than $25,000 to April 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 FR 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

[[Page 8819]]

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 hours 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.
    In the Federal Register of September 27, 2001 (66 FR 49388), the 
agency requested comments on the proposed collections of information. 
No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                           Annual Frequency      Total Annual
                   21 CFR Section                     No. of Respondents     per 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
  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: February 1, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-4511 Filed 2-25-02; 8:45 am]
BILLING CODE 4160-01-S