[Federal Register: April 5, 2002 (Volume 67, Number 66)]
[Rules and Regulations]
[Page 16304-16308]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ap02-4]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
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Products Time Periods\1\
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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