[Federal Register: August 13, 1998 (Volume 63, Number 156)] [Rules and Regulations] [Page 43302-43303] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr13au98-9] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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