[Federal Register Volume 67, Number 66 (Friday, April 5, 2002)]
[Rules and Regulations]
[Pages 16304-16308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8193]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 330, 331, 341, 346, 355, 358, 369, and 701

[Docket Nos. 98N-0337, 96N-0420, 95N-0259, and 90P-0201]
RIN 0910-AA79


Over-the-Counter Human Drugs; Labeling Requirements; Partial 
Delay of Compliance Dates

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; partial delay of compliance dates.

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SUMMARY: The Food and Drug Administration (FDA) is providing a partial 
delay of the compliance dates for certain products subject to its final 
rule that established standardized format and content requirements for 
the labeling of over-the-counter (OTC) drug products (Drug Facts Rule). 
That final rule requires all OTC drug products to comply with new 
format and labeling requirements within prescribed implementation 
periods. The agency intends in a future issue of the Federal Register 
to propose an amendment to the Drug Facts Rule to modify the labeling 
requirements for ``convenience-size'' OTC drug products. This final 
rule

[[Page 16305]]

postpones the compliance dates under the Drug Facts Rule for certain 
convenience-size OTC drug products pending the outcome of the future 
rulemaking.

DATES:   
    Effective Date: This rule is effective May 6, 2002.
    Compliance Dates: For compliance dates, see section II of the 
SUPPLEMENTARY INFORMATION section of this document. Submit written 
comments by July 5, 2002.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow or Cazemiro R. 
Martin, Center for Drug Evaluation and Research (HFD-560), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2307.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 17, 1999 (64 FR 13254), FDA 
published a final rule establishing standardized format and 
standardized content requirements for the labeling of OTC drug products 
(Drug Facts Rule). Those requirements are codified in Sec. 201.66 (21 
CFR 201.66).
    Section 201.66(a) states that the content and format requirements 
in Sec. 201.66 apply to the labeling of all OTC drug products. This 
includes products marketed under a final OTC drug monograph, products 
marketed under an approved new drug application (NDA) or abbreviated 
new drug application (ANDA) under section 505 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 355), and products for 
which there is no final OTC drug monograph or approved NDA/ANDA.
    In the Drug Facts Rule and in subsequent notices, the agency 
provided different dates by which OTC drug products had to comply with 
the new requirements. These dates varied according to the regulatory 
status of the products (64 FR 13254 at 13273 and 13274).

A. The Original Compliance Dates in the Drug Facts Rule

1. Products in the OTC Drug Review
    When the Drug Facts Rule was issued on March 17, 1999, products 
marketed under final OTC drug monographs were required to comply with 
the final rule by April 16, 2001. Products for which a final monograph 
became effective on or after April 16, 1999, had to comply as of: (1) 
The applicable implementation date for that final monograph; (2) the 
next major revision to any part of the label or labeling after April 
16, 2001; or (3) April 18, 2005, whichever occurred first.
    Combination drug products in which all of the active ingredients 
were the subject of a final monograph or monographs had to comply with 
the Drug Facts Rule as of April 16, 2001. Combination products in which 
one or more active ingredients were the subject of a final monograph, 
and one or more ingredients were still under review as of the effective 
date of the final rule, had to comply as of the implementation date for 
the last applicable final monograph for the combination, or as of April 
16, 2001, whichever occurred first. Combination products in which none 
of the active ingredients was the subject of a final monograph or 
monographs as of the effective date of the Drug Facts Rule had to 
comply as of: (1) The implementation date of the last applicable final 
monograph for the combination; (2) the next major revision to any part 
of the label or labeling after April 16, 2001; or (3) April 18, 2005, 
whichever occurred first.
2. Products Marketed Under NDAs and ANDAs
    Products that were the subject of an approved drug application (NDA 
or ANDA) that was approved before April 16, 1999, had to comply with 
the Drug Facts Rule as of April 16, 2001. Products that became the 
subject of an approved NDA or ANDA on or after April 16, 1999, were 
required to comply with the Drug Facts Rule at the time of approval (64 
FR 13254 at 13273).
3. Additional Provisions
    In addition, any OTC drug product not described in sections I.A.1 
and I.A.2 of this document had to comply with the final rule as of: (1) 
The next major revision to any part of the label or labeling after 
April 16, 2001; or (2) April 18, 2005, whichever occurred first.
    Products (including combinations) marketed under a final OTC drug 
monograph or monographs, or under an NDA or ANDA, with annual sales of 
less than $25,000 had to comply with the Drug Facts Rule as of April 
16, 2002. This extra time was intended to provide marketed products 
with a low level of distribution 1 additional year to comply with the 
Drug Facts Rule.
    The agency provided a chart that summarized the time periods within 
which the various categories of marketed OTC drug products were 
required to comply with the Drug Facts Rule (64 FR 13254 at 13274). 
Unless otherwise stated, all time periods in the chart began on the 
effective date of the Drug Facts Rule.

B. Correction Notice

    In the Federal Register of April 15, 1999 (64 FR 18571), the agency 
published a correction to the Drug Facts Rule and changed its effective 
date from April 16, 1999, to May 16, 1999. While the agency did not 
explicitly discuss the implementation plan and compliance dates for the 
final rule (or the chart at 64 FR 13274), the correction had the effect 
of changing the compliance dates for the final rule as follows: (1) The 
April 16, 1999, compliance date became May 16, 1999; (2) the April 16, 
2001, compliance date became May 16, 2001; (3) the April 16, 2002, 
compliance date became May 16, 2002; and (4) the April 18, 2005, 
compliance date became May 16, 2005.

C. Extension of Compliance Dates

1. Citizen Petitions Requesting Additional Implementation Time
    Following publication of the Drug Facts Rule and the April 15, 
1999, correction, the Consumer Healthcare Products Association (CHPA) 
and the Cosmetic, Toiletry, and Fragrance Association (CTFA) submitted 
citizen petitions (Refs. 1 and 2) requesting a 2-year extension of time 
for compliance with the Drug Facts Rule. Both associations requested an 
extension of the May 16, 2001, compliance date to May 16, 2003, and the 
May 16, 2002, compliance date to May 16, 2004. They also urged FDA to 
modify the labeling requirements of the Drug Facts Rule for single-use 
and convenience-size packages, and the petitions requested a 
categorical exemption for small packages. Neither requested a change to 
the May 16, 2005, compliance date. CHPA also requested that FDA stay 
the final rule for those products that had to comply with the Drug 
Facts Rule immediately.
    The agency answered these citizen petitions on February 4, 2000 
(Refs. 3 and 4) and denied the petitioner's request for a 2-year 
extension of the final rule. However, the agency concluded that a 1-
year delay of the May 16, 2001, compliance date to May 16, 2002 (and a 
corresponding delay of the May 16, 2002, compliance date for products 
with annual sales of less than $25,000 to May 16, 2003) was justified.

[[Page 16306]]

2. Notice of Delay of Compliance
    In the Federal Register of June 20, 2000 (65 FR 38191), the agency 
published a final rule providing a partial extension of the compliance 
dates for the Drug Facts Rule, per the February 4, 2000, responses to 
the citizen petitions. In this final rule, the agency also restated the 
implementation chart that appeared in the Drug Facts Rule (64 FR 13254 
at 13274), and updated it to show the new compliance dates (65 FR 38191 
at 38193). In addition, the agency amended language in the chart to 
clarify the applicable compliance dates when relabeling was required by 
another rule in addition to the Drug Facts Rule. Finally, the Drug 
Facts Rule also required labeling revisions in 21 CFR parts 201, 330, 
331, 341, 346, 355, 358, 369, and 701 (64 FR 13254 at 13291, 13292, and 
13294 to 13297). The June 20, 2000, final rule delayed the May 16, 
2001, and May 16, 2002, compliance dates for those revisions for 1 
additional year, respectively.

II. Single-Use and Convenience-Size Packages

    After FDA published its delay of compliance dates, CHPA requested a 
meeting to discuss class exemptions for OTC drug convenience-sizes in 
selected OTC categories, and it proposed several definitions of 
``convenience-size'' (Ref. 5). The agency responded in a subsequent 
letter (Ref. 6) that CHPA's proposed definitions of ``convenience-
size'' were so broad as to preclude a meaningful discussion. The agency 
explained that CHPA's proposed definitions of ``convenience-size'' 
could include many widely-used products that generally have not been 
(and are not) regarded as ``convenience-sizes'' (for example, packages 
containing 12 tablets or 4 ounces of cough/cold products, and 1-ounce 
tubes of topical antifungal drug products). The agency noted that 
adoption of an overly broad definition for ``convenience-size,'' with 
allowance for significant deviations from the general requirements of 
the rule, could circumvent the intent of the Drug Facts Rule and 
potentially undermine the interest of the public health and safety. The 
agency added that, under Sec. 201.66(d)(10), the Drug Facts Rule 
already provides some flexibility in the labeling of small packages.
    Thereafter, Lil' Drug Store Products, Inc., (Lil') submitted a 
citizen petition (Ref. 7) asking FDA to define ``convenience-size'' OTC 
drug products and to modify the labeling and content requirements of 
the Drug Facts Rule with respect to such products. Lil' proposed that 
``convenience-size'' OTC drug products be defined as packages sold to 
the public that contain one or two doses of an OTC drug product. Lil' 
also proposed that ``dose'' be defined as a manufacturer's recommended 
serving. In addition, Lil' requested that FDA modify the requirements 
of Sec. 201.66 for ``convenience-size'' OTC drug products by permitting 
a reduced version of OTC Drug Facts labeling to appear on the external 
packaging of such products, while requiring fully compliant Drug Facts 
labeling on the inside of the package through the use of package 
inserts or inner-package printing. Lil' stated that the labeling on the 
external packaging would: (1) Still include medically relevant 
information, (2) remain consistent with the retail environment in which 
``convenience-size'' OTC drug products are sold, and (3) still 
adequately enable consumers to make the unique purchasing decision 
associated with their use. Lil' described its ``convenience-size'' 
products as recognized, brand-name, quality OTC drug products packaged 
in small doses and made available to the consumer at his or her point 
of need. Lil' also stated that these products are a low cost (they 
typically retail for less than $.99) alternative to traditional 
multidose OTC drug packages, and they are mostly marketed in 
convenience stores that primarily sell products with efficient-size 
packaging and significant brand loyalty and awareness.
    In its response (Ref. 8) to the Lil' citizen petition, FDA stated 
that it had carefully reviewed the data and information in the petition 
and agreed that some accommodation for these ``convenience-size'' 
packages might be appropriate. However, FDA determined that additional 
comments from other interested persons should be considered before 
making a final decision, because a number of other manufacturers, 
repackers, and distributors would be affected by a change to the Drug 
Facts Rule and would likely want to comment on any proposed FDA course 
of action.
    FDA therefore stated that it intended to prepare, for publication 
in a future issue of the Federal Register, a proposed rule that would, 
if finalized, amend the Drug Facts Rule by defining ``convenience-
size'' OTC drug packages and addressing Drug Facts labeling 
requirements for such products. The proposed rule would also provide 
all interested parties an opportunity to comment on the viability, 
desirability, and impact of the proposed rule, and to respond to 
specific questions posed by the agency.
    Accordingly, at this time, FDA is announcing a partial delay of the 
compliance dates for the Drug Facts Rule in Sec. 201.66 for all OTC 
drug products that: (1) Contain no more than two doses of an OTC drug; 
and (2) because of their limited available labeling space, would 
require more than 60 percent of the total surface area available to 
bear labeling to meet the requirements set forth in Sec. 201.66(d)(1) 
to (d)(9) and therefore qualify for the labeling modifications 
currently set forth in Sec. 201.66(d)(10). For purposes of this notice, 
``dose'' is defined as the maximum single serving for an adult (or a 
child for products marketed only for children) as specified in the 
product's directions for use. FDA is aware that the scope of this delay 
may extend to some products that are also currently marketed as 
``sample'' or ``trial'' sizes. FDA is amending the June 20, 2000, 
implementation chart to add a footnote number ``1'' next to the header 
``Time Periods,'' which reads as follows:

                 Table 1.--Restated Implementation Chart
------------------------------------------------------------------------
              Products                         Time Periods\1\
------------------------------------------------------------------------
Single entity and combination        By May 16, 2002 (or by May 16,
 products subject to drug marketing   2003, if annual sales of the
 applications approved before May     product are less than $25,000).
 16, 1999.
Single entity and combination        Immediately upon approval of the
 products subject to drug marketing   application.
 applications approved on or after
 May 16, 1999.
Single entity products subject to    By May 16, 2002 (or by May 16,
 an OTC drug monograph finalized      2003, if annual sales of the
 before May 16, 1999.                 product are less than $25,000).
Single entity products subject to    Within the period specified in the
 an OTC drug monograph finalized on   final monograph. However, if a
 or after May 16, 1999.               monograph has not been finalized
                                      as of May 16, 2002, then the
                                      product must comply as of the
                                      first major labeling revision
                                      after May 16, 2002, or by May 16,
                                      2005, whichever occurs first.

[[Page 16307]]

 
Combination products subject to an   By May 16, 2002 (or by May 16,
 OTC drug monograph or monographs     2003, if annual sales of the
 in which all applicable monographs   product are less than $25,000).
 were finalized before May 16,
 1999.
Combination products subject to an   Within the period specified in the
 OTC drug monograph or monographs     last applicable monograph to be
 in which at least one applicable     finalized, or by May 16, 2002 (or
 monograph was finalized before May   by May 16, 2003, if annual sales
 16, 1999, and at least one           of the product are less than
 applicable monograph is finalized    $25,000), whichever occurs first,
 on or after May 16, 1999.            unless the last applicable
                                      monograph to be finalized
                                      specifies a later date.
Combination products subject to an   Within the period specified in the
 OTC drug monograph or monographs     last applicable monograph to be
 in which all applicable monographs   finalized. However, if the last
 are finalized on or after May 16,    monograph is not finalized as of
 1999.                                May 16, 2002, then the product
                                      must comply as of the first major
                                      labeling revision after May 16,
                                      2002, or by May 16, 2005,
                                      whichever occurs first.
All other single entity and          If a monograph has not been
 combination OTC drug products        finalized as of May 16, 2002, then
 (e.g., products in the OTC drug      the product must comply as of the
 review that are not yet the          first major labeling revision
 subject of proposed OTC drug         after May 16, 2002, or by May 16,
 monographs).                         2005, whichever occurs first.
------------------------------------------------------------------------
\1\ Time delayed until further notice for OTC drug products that contain
  no more than two doses of an OTC drug product and, because of their
  limited total surface area available to bear labeling, qualify for the
  labeling modifications set forth in Sec.  201.66(d)(10).

    FDA based the scope of this delay on Lil's petition, which defined 
``convenience-size'' as a product containing one or two doses of an OTC 
drug. Since the petition did not explicitly address the issue of 
package size, FDA decided to adopt the threshold set forth in 
Sec. 201.66(d)(10), because it is the one section of the current Drug 
Facts Rule that differentiates OTC drug packages based on size. The 
agency believes that the scope of this delay reflects the current 
marketplace in that the delay includes most, if not all, OTC drug 
products that are currently sold as ``convenience-size.''
    The delay in the compliance dates for the OTC drug packages 
described in this notice will remain in effect until a final rule 
issues with respect to the labeling of such OTC drug products or until 
such time as the agency issues further notice. In either case, the 
delay enables manufacturers of the packages described in this notice to 
continue marketing those products in their present labeling formats 
pending resolution of this issue. The labeling of such packages still 
needs to comply with the act and all other applicable regulatory 
requirements. Notwithstanding this delay in compliance dates, 
manufacturers who wish to do so may still relabel the affected products 
in the Drug Facts format, particularly when existing labeling is 
exhausted and relabeling would occur in the normal course of business, 
using any of the alternative design techniques described in the final 
rule (64 FR 13254 at 13268).
    To the extent that 5 U.S.C. 553 applies to this action, it is 
exempt from notice and comment because it constitutes a rule of 
procedure under 5 U.S.C 553(b)(3)(A). Alternatively, the agency's 
implementation of this action without opportunity for public comment 
comes within the good cause exceptions in 5 U.S.C. 553(b)(3)(B) in that 
obtaining public comment is impracticable, unnecessary, and contrary to 
the public interest. The agency is delaying the compliance date of 
Sec. 201.66 for products that meet the specific criteria described in 
this notice because the agency intends to publish a proposal to amend 
Sec. 201.66 by defining ``convenience-size'' drug packages and 
addressing Drug Facts labeling requirements for such packages. There 
will be an opportunity to comment on the new compliance date for such 
products within the proposed amendment to Sec. 201.66. In addition, 
given the imminence of the current compliance dates, seeking prior 
public comment on this delay is contrary to the public interest in the 
orderly issuance and implementation of regulations. Notice and comment 
procedures in this instance would create uncertainty, confusion, and 
undue financial hardship because, during the time that the agency would 
be proposing to extend the compliance date for Sec. 201.66, those 
companies affected would have to be preparing to relabel to comply with 
the May 16, 2002, compliance date. In accordance with 21 CFR 
10.40(e)(1), FDA is also providing an opportunity for comment on 
whether this delay should be modified or revoked.

III. Analysis of Impacts

    The economic impact of the Drug Facts Rule was discussed in the 
final rule (64 FR 13254 at 13276 to 13285). This partial delay of the 
compliance dates provides additional time for companies to relabel 
certain products to comply with the final rule. CHPA, in its request 
for a meeting (Ref. 5), stated that ``convenience-sizes'' represent 
less than 1 percent of the retail market. The partial delay for the 
products described in this notice will also reduce label obsolescence 
as companies will have additional time to use up more existing 
labeling. Thus, delaying the compliance dates for implementation for 
these specific products will significantly reduce the economic impact 
of the final rule on manufacturers of these products.
    FDA has examined the impacts of this final rule (partial delay of 
the compliance dates) under Executive Order 12866, the Regulatory 
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform 
Act of 1995 (2 U.S.C. 1501 et seq.). Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety, and other advantages; 
distributive impacts; and equity). Under the Regulatory Flexibility 
Act, if a rule has a significant economic impact on a substantial 
number of small entities, an agency must analyze regulatory options 
that would minimize any significant impact of the rule on small 
entities. Section 202(a) of the Unfunded Mandates Reform Act requires 
that agencies prepare a written statement of anticipated costs and 
benefits before proposing any rule that may result in an expenditure in 
any one year by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100 million (adjusted annually for 
inflation).
    The agency concludes that this final rule is consistent with the 
principles set out in the Executive order and in these two statutes. 
This final rule is not a significant regulatory action as defined

[[Page 16308]]

by the Executive order and so is not subject to review under the 
Executive order. As discussed in this section, FDA has determined that 
this final rule will not have a significant economic impact on a 
substantial number of small entities. The Unfunded Mandates Reform Act 
does not require FDA to prepare a statement of costs and benefits for 
this final rule because the final rule is not expected to result in any 
1-year expenditure that would exceed $100 million adjusted for 
inflation. The current inflation adjusted statutory threshold is about 
$110 million.
    The purpose of this final rule is to provide a partial delay of the 
compliance dates by which manufacturers need to relabel their 
``convenience-size'' products, as defined in this final rule. 
Accordingly, under the Regulatory Flexibility Act, the agency certifies 
that this final rule will not have a significant economic impact on a 
substantial number of small entities. No further analysis is required.

IV. The Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

V. Environmental Impact

    The agency has determined under 21 CFR 25.31(a) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VII. References

    The following references are on display in the Dockets Management 
Branch (address above) and may be seen by interested persons between 9 
a.m. and 4 p.m., Monday through Friday.
    1. Comment No. CP2, Docket No. 98N-0337.
    2. Comment No. CP1, Docket No. 99P-4617.
    3. Letter from W. K. Hubbard, FDA, to B. N. Kuhlik and M. S. 
Labson, Covington & Burling, coded PAV2, Docket No. 98N-0337.
    4. Letter from W. K. Hubbard, FDA, to E. E. Kavanaugh, CTFA, 
coded PAV1, Docket No. 99P-4617.
    5. Letter from R. W. Soller, CHPA, to C. Ganley, FDA, dated 
October 3, 2000, Docket No. 98N-0337.
    6. Letter from C. Ganley, FDA, to R. W. Soller, CHPA, dated 
December 22, 2000, Docket No. 98N-0337.
    7. Comment No. CP1, Docket No. 01P-0207.
    8. Letter from S. Galson, FDA, to J. M. Nikrant, Lil' Drug Store 
Products, Inc., coded LET 1, Docket No. 01P-0207.

VIII. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this final rule by July 5, 
2002. Three copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket numbers found in brackets in the heading of this document. 
Received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.
    This final rule (partial delay of compliance dates) is issued under 
sections 201, 501, 502, 503, 505, 510, and 701 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 355, 360, and 
371) and under authority of the Commissioner of Food and Drugs.

    Dated: March 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-8193 Filed 4-4-02; 8:45 am]
BILLING CODE 4160-01-S