[Federal Register Volume 63, Number 156 (Thursday, August 13, 1998)]
[Rules and Regulations]
[Pages 43302-43303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 358

[Docket No. 81N-0201]
RIN 0910-AA01


Pediculicide Drug Products for Over-the-Counter Human Use; Final 
Monograph; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulation that established conditions under which over-the-counter 
(OTC) pediculicide drug products (products used for the treatment of 
head, pubic (crab), and body lice) are generally recognized as safe and 
effective and not misbranded. This final rule clarifies that the 
pediculicide active ingredient, pyrethrum extract, is to provide a 
specified concentration range of pyrethrins in a formulated product. 
This final rule is part of the ongoing review of OTC drug products 
conducted by FDA.

EFFECTIVE DATE: September 14, 1998.

FOR FURTHER INFORMATION CONTACT: Michael T. Benson, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2245.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of December 14, 1993 (58 FR 65452), FDA 
issued a final monograph for OTC pediculicide drug products (part 358 
(21 CFR part 358, subpart G)) 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 effective date 
of that monograph was December 14, 1994. The active ingredients under 
Sec. 358.610 of the monograph were described as the combination of 
pyrethrum extract (0.17 to 0.33 percent) with piperonyl butoxide (2 to 
4 percent) in a nonaerosol dosage formulation.
    On October 30, 1996, the Nonprescription Drug Manufacturers 
Association (NDMA) requested a technical amendment of the final 
monograph to clarify that pyrethrum extract in Sec. 358.610 provides a 
concentration of 0.17 to 0.33 percent pyrethrins in the final product 
formulation (Ref. 1). NDMA stated that proposed Sec. 358.610 of the 
tentative final monograph for OTC pediculicide drug products listed 
``pyrethrins (0.17 to 0.33 percent)'' as the active ingredient (54 FR 
13480 at 13487, April 3, 1989), and that there was no United States 
Pharmacopeia (USP) monograph for pyrethrins at that time. NDMA noted 
that a USP monograph entitled ``pyrethrum extract'' (Ref. 2) was in 
effect at the time of publication of the final monograph for OTC 
pediculicide drug products in 1993, and FDA used ``pyrethrum extract 
(0.17 to 0.33 percent)'' in Sec. 358.610. The USP monograph (Ref. 2) 
stated that pyrethrum extract contains approximately 50 percent of the 
sum of Pyrethrins I and II. NDMA added that, subsequently, USP changed 
the concentration of Pyrethrins I and II in pyrethrum extract from 50 
percent to 20 percent (Ref. 3). NDMA pointed out that a manufacturer 
following Sec. 358.610 of the final monograph and the latest USP 
monograph for pyrethrum extract could produce a product containing one-
fifth the desired concentration of pyrethrins. NDMA recommended that 
the agency publish a technical amendment to revise Sec. 358.610 to 
state ``* * * pyrethrum extract (providing a concentration of 
pyrethrins of 0.17 to 0.33 percent) * * *'' instead of ``* * * 
pyrethrum extract (0.17 to 0.33 percent) * * *.'' NDMA indicated that 
this amendment would allow manufacturers flexibility in using pyrethrum 
extract containing either 50 or 20 percent pyrethrins to produce a 
pediculicide product with the desired concentration of pyrethrins.

II. Description of the Technical Amendment

    The agency concurs that amendment of Sec. 358.610 is appropriate 
and is revising this section accordingly.
    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. The 
change does not alter the required range of pyrethrins for pediculicide 
active ingredients, but simply clarifies that the range was intended to 
apply to the pyrethrins in the active ingredients. Therefore, FDA finds 
that the notice and comment procedures are unnecessary and not in the 
public interest (5 U.S.C. 553(b) and (d)).

III. References

    The following references are on display in the Dockets Management 
Branch (HFA-305), Food and Drug

[[Page 43303]]

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. LET19, Docket No. 81N090201, Dockets Management 
Branch.
    2. United States Pharmacopeia 23--National Formulary 18, United 
States Pharmacopeial Convention, Inc., Rockville, MD, p. 1345, 1994.
    3. Second Supplement to USP 23 and to NF 18, United States 
Pharmacopeial Convention, Inc., Rockville, MD, p. 2671, 1995.

IV. Analysis of Impacts

    FDA has examined the impacts of this 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). 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 makes a minor clarification in the concentration of an 
active ingredient. It does not change the manner in which manufacturers 
make these pediculicide drug products and will not cause any burden on 
small entities. The agency certifies that this final rule will not have 
a significant economic impact on a substantial number of small 
entities. This economic analysis, together with other relevant sections 
of this document, serves as the agency's final regulatory flexibility 
analysis, as required under the Regulatory Flexibility Act.
    The Unfunded Mandates Act (2 U.S.C. 1501 et seq.) does not apply to 
this final rule because it would not 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.

V. 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.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that is categorically excluded from the preparation of an 
environmental assessment because these actions, as a class, will not 
result in the production or distribution of any substance and therefore 
will not result in the production of any substance into the 
environment.

List of Subjects in 21 CFR Part 358

    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 
358 is amended as follows:

PART 358--MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER 
HUMAN USE

    1. The authority citation for 21 CFR part 358 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

    2. Section 358.610 is revised to read as follows:

Sec. 358.610  Pediculicide active ingredients.

    The active ingredients of the product consist of the combination of 
pyrethrum extract (providing a concentration of pyrethrins of 0.17 to 
0.33 percent) with piperonyl butoxide (2 to 4 percent) in a nonaerosol 
dosage formulation.

    Dated: August 5, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-21794 Filed 8-12-98; 8:45 am]
BILLING CODE 4160-01-F