[Federal Register Volume 61, Number 242 (Monday, December 16, 1996)]
[Rules and Regulations]
[Pages 65944-65946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31575]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 355
[Docket No. 80N-0042]
RIN 0910-AA01
Anticaries Drug Products for Over-the-Counter Human Use; Partial
Stay of Final Rule; Enforcement Policy
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; partial stay of regulation; enforcement policy.
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SUMMARY: The Food and Drug Administration (FDA) is staying part of a
final rule that established conditions under which over-the-counter
(OTC) anticaries drug products (products that aid in the prevention of
dental cavities) are generally recognized as safe and effective and not
misbranded (60 FR 52474, October 6, 1995). This final rule stays the
testing procedures for fluoride dentifrice drug products to provide
manufacturers an additional 12 months to comply with these testing
requirements. This action is being taken in response to a citizen
petition requesting this stay and is part of the
[[Page 65945]]
ongoing review of OTC drug products conducted by FDA.
DATES: This partial stay for Sec. 355.70 (21 CFR 355.70), added by 60
FR 52474 at 52510, is effective September 23, 1996, and stays
Sec. 355.70(a) until October 7, 1997.
FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug
Evaluation and Research (HFD-105), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2304.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 6, 1995 (60 FR 52474), FDA
issued a final monograph for OTC anticaries drug products (21 CFR part
355) establishing conditions under which the drug products that are
subject to that monograph will be generally recognized as safe and
effective and not misbranded. The final monograph established in
Sec. 355.70 testing procedures for fluoride dentifrice drug products.
The testing procedures require the product to meet the biological test
requirements for animal caries reduction and one of the following
tests: Enamel solubility reduction or fluoride enamel uptake. The
effective date of the monograph was October 7, 1996.
On April 17, 1996, the Joint Oral Task Group of the Nonprescription
Drug Manufacturers Association (NDMA) and the Cosmetic, Toiletry and
Fragrance Association (CTFA) (the Task Group) submitted a citizen
petition (Ref. 1) requesting that the agency stay the effective date
for the biological testing requirements for OTC fluoride dentifrice
drug products from October 7, 1996, to October 7, 1997. The petition
contended that manufacturers needed additional time to comply with the
required biological testing requirements and to further implement the
Industry/U.S. Pharmacopeia (USP) Reference Standard Program.
The petition stated that at least 34 fluoride-containing dentifrice
products would not be in compliance with the biological testing
requirements of the final monograph by the effective date of October 7,
1996. The petition explained that there are only four testing
laboratories considered fully experienced to perform the required
biological testing and that these laboratories can only conduct a total
of 32 tests per year. The petition estimated that it would take about 8
months to validate additional laboratories to do the animal caries
reduction test. The petition argued that additional time was needed
because the animal caries reduction test was an optional test in the
tentative final monograph but a required test in the final monograph,
and industry did not become aware of this change until the final
monograph was published and was not prepared to meet this requirement
at that time. The petition contended that, because at least 67 products
must be tested, there is insufficient time to complete the needed
testing by October 7, 1996, and that a 12-month extension until October
7, 1997, would allow manufacturers sufficient time to perform the
required tests.
The petition noted two other problems that precluded compliance
with the October 7, 1996, effective date: (1) Several current USP
reference standards have not been retested to confirm their quality
standards, and (2) a lack or limited number of available USP reference
standards to fulfill the unanticipated requirements in the final
monograph for animal caries reduction testing.
Following a meeting (Ref. 2) and correspondence (Ref. 3) from FDA,
the Task Group provided the agency industry's formalized procedures for
handling USP dentifrice reference standards (Ref. 4), entitled
``Protocol for Submission & Maintenance of USP Fluoride Dentifrice
Reference Standards.'' The Task Group indicated that resupply and
retesting of currently available USP fluoride dentifrice reference
standards would be completed by July 1996, and that the two new USP
fluoride dentifrice reference standards (i.e., 1,500 parts per million
sodium monofluorophosphate dentifrice and sodium fluoride dentifrice in
a powdered dosage form) would be available by the beginning of June
1996. The agency has verified that this retesting has been completed
and that the new reference standards are currently available (Ref. 5).
On September 5, 1996 (Ref. 6), the Task Group provided the results
of a biological testing implementation survey in support of its request
for a 1-year stay of the effective date of this part of the final
monograph. The Task Group pointed out that 37 dentifrice products
remain to be tested and it usually takes 3 to 4 months to complete the
test and receive a final report. The Task Group stated that all testing
was currently projected to begin by February 1997 but that less than a
1-year delay would not allow for unforeseen circumstances during
testing and during the administration of the Industry/USP Reference
Standard Program to supply the testing standards.
II. The Agency's Response to the Petition
The agency acknowledges that requiring the animal caries reduction
test was a new requirement of the final monograph. In a letter to NDMA
dated September 23, 1996 (Ref. 7), FDA agreed to stay the effective
date of the testing procedures for fluoride dentifrice drug products
for 12 months. FDA reviewed the biological testing implementation
survey (Ref. 6), which indicated that approximately 92 percent of the
dentifrice products that require testing should be tested by March 30,
1997, and that testing of the remaining products should be completed by
June 30, 1997. The agency believes that it would be reasonable to
provide an additional 3 months to allow for unforeseen circumstances
during the conduct of this testing. Therefore, based on the survey
data, the agency is staying the testing procedures for fluoride
dentifrice drug products in Sec. 355.70(a) of the final monograph for
OTC anticaries drug products for 12 months until October 7, 1997.
However, based on the survey and the petitioner's assurances, the
agency does not anticipate granting any additional time beyond October
7, 1997, for manufacturers to complete the required biological testing
for existing OTC anticaries drug products.
Publication of this document constitutes final action on this
change under the Administrative Procedure Act (5 U.S.C. 553). This
final rule institutes a change that is nonsubstantive in nature. FDA
finds that notice and comment procedures are unnecessary and not in the
public interest (5 U.S.C. 533(b) and (d)). The agency believes that
staying Sec. 355.70(a) for 12 months will provide sufficient time for
industry to comply with the testing procedures for fluoride dentifrice
drug products included in the final monograph.
III. References
The following references are on display in the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857, and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
(1) Comment No. CP6, Docket No. 80N-0042, Dockets Management
Branch.
(2) Comment No. MM7, Docket No. 80N-0042, Dockets Management
Branch.
(3) Comment No. LET29, Docket No. 80N-0042, Dockets Management
Branch.
(4) Comment No. PR1, Docket No. 80N-0042, Dockets Management
Branch.
(5) Comment No. C104, Docket No. 80N-0042, Dockets Management
Branch.
(6) Comment No. EXT9, Docket No. 80N-0042, Dockets Management
Branch.
[[Page 65946]]
(7) Comment No. LET36, Docket No. 80N-0042, Dockets Management
Branch.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
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). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
Under the Regulatory Flexibility Act, if a rule has a significant
impact on a substantial number of small entities, an agency must
analyze regulatory options that would minimize any significant impact
of a rule on small entities. This final rule stays the effective date
of testing requirements that became effective on October 7, 1996, but
which will not be required now until October 7, 1997. Thus, this final
rule will not impose a significant economic burden on affected
entities. Therefore, under the Regulatory Flexibility Act (5 U.S.C.
605(b)), the Commissioner of Food and Drugs certifies that this final
rule will not have a significant economic impact on a substantial
number of small entities. No further analysis is required.
V. Environmental Impact
The agency has determined under 21 CFR 25.24(c)(6) 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.
List of Subjects in 21 CFR Part 355
Labeling, Over-the-counter drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
355 is amended as follows:
PART 355--ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
1. The authority citation for 21 CFR part 355 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,
355, 360, 371).
Sec. 355.70 [Partial stay]
2. In Sec. 355.70 Testing procedures for fluoride dentifrice drug
products, paragraph (a) is stayed until October 7, 1997.
Dated: December 5, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31575 Filed 12-13-96; 8:45 am]
BILLING CODE 4160-01-F
