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Federal Register/Vol. 66, No. 103/Tuesday, May 29, 2001/Proposed Rules

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Federal Register/Vol. 66, No. 103/Tuesday, May 29, 2001/Proposed Rules Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Proposed Rules 29059 notice number of this NPRM. Persons § 71.1 [Amended] Administration, 5630 Fishers Lane, rm. interested in being placed on a mailing 2. The incorporation by reference in 1061, Rockville, MD 20852. list for future NPRMs should also 14 CFR 71.1 of Federal Aviation FOR FURTHER INFORMATION CONTACT: request a copy of Advisory Circular No. Administration Order 7400.9H dated Gerald M. Rachanow, Center for Drug 11–2A, which describes the application September 1, 2000, and effective Evaluation and Research (HFD–560), procedure. September 16, 2000, is proposed to be Food and Drug Administration, 5600 The Proposal amended as follows: Fishers Lane, Rockville, MD 20857, 301–827–2307. The FAA is considering an Paragraph 6005 Class E airspace areas extending upward from 700 feet or more SUPPLEMENTARY INFORMATION: amendment to Part 71 of the Federal above the surface of the earth. Aviaiton Regulations (14 CFR part 71) to I. Background * * * * * establish Class E airspace area at In the Federal Register of September Couldersport, PA. An RNAV Approach, AEA PA E5 Couldersport, PA (New) 23, 1993 (58 FR 49890), FDA published Helicopter RNAV 343, has been Charles Cole Memorial Hospital Heliport a final monograph for OTC topical developed for Charles Cole Memorial Lat. 41°46′16.14″ N/long. 77°58′28″ W) antifungal drug products in part 333 (21 Hospital Heliport, Couldersport, PA. That airspace extending upward from 700 CFR part 333), subpart C. That Controlled airspace extending upward feet above the surface within a 6 mile radius monograph includes six antifungal from 700 feet AGL is needed to of the Charles Cole Memorial Hospital active ingredients used for the treatment accommodate the SIAP. Class E airspace Heliport. of athlete’s foot, jock itch, and ringworm designations for airspace areas * * * * * and one ingredient used for the extending upward from 700 feet from or Issued in Jamaica, New York, on May 15, prevention of athlete’s foot. The above the surface are published in 2001. monograph provides that two Paragraph 6005 of FAA Order 7400.9H, F.D. Hatfield, ingredients may contain professional dated September 1, 2000, and effective Manager, Air Traffic Division, Eastern Region. labeling (may be provided to health September 16, 2000, which is professionals but not to the general [FR Doc. 01–13311 Filed 5–25–01; 8:45 am] incorporated by reference in 14 CFR public) for the treatment of superficial 71.1. The Class E airspace designation BILLING CODE 4910–13–M infections caused by yeast (Candida listed in this document would be albicans). A manufacturer submitted a published subsequently in the Order. citizen petition (Refs. 1 through 4) to The FAA has determined that this DEPARTMENT OF HEALTH AND include the antifungal ingredient proposed regulation only involves an HUMAN SERVICES clotrimazole in the monograph for both established body of technical Food and Drug Administration the OTC and professional labeling regulations for which frequent and treatment claims. Subsequently, the routine amendments are necessary to 21 CFR Part 333 manufacturer withdrew its request to keep them operationally current. include clotrimazole in the monograph Therefore, this proposed regulation—(1) [Docket No. 96P–0460] for the professional labeling treatment is not a ‘‘significant regulatory action’’ claim (Ref. 5). under Executive Order 12866; (2) is not RIN 0910–AA01 a ‘‘significant rule’’ under DOT II. The Agency’s Evaluation of the Topical Antifungal Drug Products for Citizen Petition Regulatory Policies and Procedures (44 Over-the-Counter Human Use; FR 11034; February 26, 1979); and (3) Proposed Amendment of Final A. General Background does not warrant preparation of a Monograph Clotrimazole is a member of the regulatory evaluation as the anticipated imidazole class of antifungal drugs and impact is so minimal. Since this is a AGENCY: Food and Drug Administration, is recognized in the U.S. Pharmacopeia routine matter that would only affect air HHS. (Ref. 6). Clotrimazole has been marketed traffic procedures and air navigation, it ACTION: Proposed rule. as a topical antifungal at a 1-percent is certified that this proposed rule concentration in the United States as a would not have significant economic SUMMARY: The Food and Drug prescription product since 1975 and as impact on a substantial number of small Administration (FDA) is issuing a an OTC product since 1989 under new entities under the criteria of the proposed rule that would amend the drug applications (NDAs) in cream, Regulatory Flexibility Act. final monograph for over-the-counter (OTC) topical antifungal drug products lotion, and solution dosage forms. The List of Subjects in 14 CFR Part 71 to add the ingredient clotrimazole as agency notes that clotrimazole has also Airspace, Incorporation by reference, generally recognized as safe and been marketed OTC in a number of Navigation (air). effective for the treatment of athlete’s other countries, the first marketing foot, jock itch, and ringworm. This occurring in 1980. Distribution figures The Proposed Amendment proposal is part of FDA’s ongoing (Ref. 1) indicate a significant amount of In consideration of the foregoing, the review of OTC drug products. the drug has been marketed OTC in the Federal Aviation Administration United States and other countries since DATES: Submit written comments by 1990. Miconazole nitrate, a related proposes to amend 14 CFR part 71 as August 27, 2001. Submit written follows: member of the imidazole class of comments on the agency’s economic antifungal drugs, is currently included impact determination by August 27, PART 71—[AMENDED] as an active ingredient in § 333.210(c) of 2001. See section IX of this document the final monograph for OTC topical 1. The authority citation for 14 CFR for the effective date of any final rule antifungal drug products. part 71 continues to read as follows: that may publish based on this proposal. B. Safety Authority: 49 U.S.C. 106(g), 40103, 40113, ADDRESSES: Submit written comments 40120; E.O. 10854, 24 FR 9565, 3 CFR , 1959– to the Docket Management Branch The toxicity of clotrimazole has been 1963 Comp., p. 389. (HFA–305), Food and Drug well-studied (Refs. 1 and 2). Acute VerDate 11<MAY>2000 14:47 May 25, 2001 Jkt 194001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\FR\FM\29MYP1.SGM pfrm01 PsN: 29MYP1 29060 Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Proposed Rules toxicity has been studied in a variety of States. The manufacturer has reported (potassium hydroxide) preparation and/ animal species. When administered 555 adverse drug events (ADEs) from or culture. Subjects applied the assigned intraperitoneally, the LD50 was March 1975 through March 1996. Of products (double-blind, randomized, approximately 500 milligrams/kilogram these, 240 (43 percent) are reports of parallel study) twice a day for 28 days (mg/kg) for mice and 1,200 mg/kg for ‘‘therapeutic response decrease’’ (lack of and were evaluated clinically weekly for rats. Subacute dermal toxicity studies in effectiveness) with topical antifungal 5 weeks, with samples taken each week rabbits (comparing clotrimazole cream treatment. The majority of the ADEs for KOH preparation and culture. Of the or solution to its vehicle) did not reveal were topical and nonserious in nature. 61 cases (27 on active and 34 on any significant dermal or systemic Pruritis (itching), rashes, erythema vehicle) evaluated, mycological changes. Other dermal tolerance studies (abnormal redness of the skin), and conversion rates (a change from positive showed minimal irritation from paresthesia (abnormal sensation of the to negative of both KOH preparation and clotrimazole, and they showed that skin skin, such as burning, stinging, or culture) for tinea corporis/cruris were reactions on rabbits were essentially the tingling) were the most common events 76 percent (13/17) for active and 5 same for the drug and the vehicle cream, reported and are common to all topical percent (1/21) for vehicle (P<0.001) and solution, or lotion. Ocular tolerance antifungal drugs. Rarely, individuals for tinea pedis 60 percent (6/10) for studies in rabbits showed slight experienced a systemic allergic reaction. active and 0 (0/13) for vehicle (P=0.002). conjunctival reddening and mild The number and nature of reported The fungus most frequently detected irritation for both clotrimazole cream or ADEs is similar before and after was T. rubrum. Eight of 12 subjects (67 solution and its vehicle, which subsided clotrimazole OTC marketing in the percent) in the clotrimazole group who 48 to 72 hours after instillation. United States began in 1989. had severe clinical signs and symptoms Studies have shown clotrimazole is The contact sensitization potential of were clinically cured compared to 0 of very poorly absorbed following dermal 1-percent clotrimazole cream was 14 in the vehicle group (P=0.0003). application. Duhm et al. (Ref. 7) determined using the Maximization Test Clayton and Connor (Refs. 2, 3, 4, and reported that topical administration of (26 subjects) and the Draize Repeat 8, Delbay 007) compared 1-percent radiolabeled 1-percent clotrimazole Insult Test (207 subjects) (Ref. 2). No clotrimazole cream (50 subjects) to cream or solution to normal skin sensitization occurred in either test. Whitfield’s Ointment (3-percent resulted in less than 0.5 percent of the There are no known drug interactions, salicylic acid and 6-percent benzoic activity excreted in the urine up to 5 abuse potential, or overdose potential acid) (52 subjects) and to nystatin days after application of the cream and associated with clotrimazole when less than 0.05 percent up to 4 days after applied topically to the skin for ointment (14 subjects) in treating several application of the solution. When the antifungal use. There have been fungal infections in a randomized, solution was applied to acutely infrequent reports of consumers double-blind trial based on the subject’s inflamed skin, 0.15 percent of the mistaking the solution (10 mL condition.
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