[Federal Register: March 29, 2005 (Volume 70, Number 59)]
[Page 15864-15865]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0534]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Format and Content 
for Over-the-Counter Drug Product Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 (the PRA).

DATES: Fax written comments on the collection of information by April 
28, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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: 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 for Over-the-Counter (OTC) Drug Product Labeling--
(OMB Control Number 0910-0340)--Extension

    In the Federal Register of March 17, 1999 (64 FR 13254), FDA 
amended its regulations governing requirements for human drug products 
to establish a standardized format for the labeling of all over-the-
counter (OTC) drug products. The rule added new Sec.  201.66 (21 CFR 
201.66) and requires OTC drug product labeling to include uniform 
headings and subheadings, presented in a standardize order, with 
minimum standards for type size and other graphic 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 ``a public disclosure of information 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 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 OTC labeling requirements. 
Therefore, the majority of respondents have been 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 
    In discussing the collection of information under the PRA in the 
final rule (64 FR 13254 at 13274 to 13276), FDA estimated that, of the 
39,310 stock keeping units (SKUs) (individual products, packages, and 
sizes) marketed under a final monograph when the OTC labeling 
requirements were issued on March 17, 1999, approximately 32 percent, 
or 12,573 products, may necessitate labeling format 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, 4 hours, for a total of 50,292 hours per year. This 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, or 26,737 products, marketed at the time the OTC labeling 
requirements were issued on March 17, 1999, 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 the rule. FDA estimated 
that for this group, each response will take an average of 2.5 hours 
for a total of 66,842 hours. This burden was expected to be a one-time 
    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 would be required. FDA expected that 522 submissions (350 to 
NDAs and 172 to ANDAs) would 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 wouldtake an average of 
2 hours to prepare for a total of 1,040 hours annually. This burden was 
also expected to be a one-time burden.
    Since the final rule was issued on March 17, 1999, FDA 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). Since March 17, 1999, FDA has published 6 
additional major final rules on OTC drug monographs and several minor 
amendments to existing final monographs. The effective date for 
relabeling the OTC drug products affected by these final monographs in 
the new format occurred by the end of 2004, except for OTC sunscreen 
drug products (for which implementation of the new labeling 
requirements has been stayed indefinitely while FDA amends the 
monograph for these products) and a small number of other OTC drug 
products with annual sales less than $25,000. Based on information in 
the 6 final rules issued since 1999, FDA estimates that 11,250 
additional SKUs (out of the original 26,737 that needed to be relabeled 
in the new format) have

[[Page 15865]]

already been affected by the final rule. Thus, 15,487 SKUs remain to be 
affected by the OTC drug product labeling final rule, minus 
approximately 2,000 OTC sunscreen drug product SKUs. All of these 
except the sunscreen drug products will need to have the new labeling 
format by May 16, 2005, for products initially introduced or initially 
delivered for introduction into interstate commerce after that date. 
For these reasons, FDA considers the number of products remaining to be 
affected by the OTC drug products labeling final rule to be close to 
the number of products that were affected at the time the final rule 
published on March 17, 1999. FDA finds that the number of products 
remaining to be affected by the final rule is similar to the number of 
products that were estimated as initially affected in the collection of 
information in the final rule. Accordingly, in this notice FDA is using 
the same numbers of respondents, annual frequency per response, and 
total annual responses it estimated in 1999.
    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 already since the final 
rule was issued in 1999. FDA's experience 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, FDA has issued a guidance for industry 
entitled ``Labeling OTC Human Drug Products--Updating Labeling in RLDs 
and ANDAs'' (67 FR 64402, October 18, 2002), which included a number of 
labeling examples to assist holders of RLDs (reference listed drugs, 
i.e., the applicable innovator) and ANDAs for OTC drug products to 
implement the new OTC drug product labeling regulation. Third, FDA has 
issued two draft guidances for industry entitled ``Labeling OTC Drug 
Products (Small Entity Compliance Guide)'' (69 FR 71420, December 9, 
2004) and ``Labeling OTC Human Drug Products--Questions and Answers'' 
(70 FR 2415, January 13, 2005). These guidances provide extensive 
additional information and examples how to implement the new OTC drug 
product labeling requirements.
    The guidance documents should have reduced some of the hours per 
response and total hours for some NDA and ANDA holders and 
manufacturers who market products under the OTC drug monographs. 
However, FDA is not currently able to estimate how much the time has 
been reduced. Accordingly, in this notice FDA is listing the same hours 
per response and total hours as appeared in the final rule.
    In the Federal Register of January 4, 2005 (70 FR 362), FDA 
requested comments on the proposed collections of information. No 
comments were received.

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

    Dated: March 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6088 Filed 3-28-05; 8:45 am]