[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