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Federal Register/Vol. 64, No. 98/Friday, May 21, 1999/Rules And 27666 Federal Register / Vol. 64, No. 98 / Friday, May 21, 1999 / Rules and Regulations * * * EFFECTIVE UPON PUBLICATION FDC date State City Airport FDC No. SIAP 04/29/99 ....... PA STATE COLLEGE ........... UNIVERSITY PARK ............................. 9/2846 VOR/DME RNAV or GPS RWY 6 AMDT 6 04/29/99 ....... PA STATE COLLEGE ........... UNIVERSITY PARK ............................. 9/2847 VOR or GPS±B AMDT 9 04/29/99 ....... WI APPLETON ..................... OUTAGAMIE COUNTY REGIONAL ... 9/2851 ILS RWY 3, AMDT 16C 04/30/99 ....... MO BUTLER .......................... BUTLER MEMORIAL ........................... 9/2875 GPS RWY 18, ORIG 04/30/99 ....... TX AUSTIN ........................... AUSTIN-BERGSTROM INTL ............... 9/2879 ILS RWY 35L, AMDT 1 04/30/99 ....... TX AUSTIN ........................... AUSTIN-BERGSTROM INTL ............... 9/2880 GPS RWY 35L, AMDT 1 04/30/99 ....... TX AUSTIN ........................... AUSTIN-BERGSTROM INTL ............... 9/2881 GPS RWY 17R, AMDT 1 04/30/99 ....... TX AUSTIN ........................... AUSTIN-BERGSTROM INTL ............... 9/2882 ILS RWY 17R, AMDT 1 05/1/99 ......... NH MANCHESTER ............... MANCHESTER .................................... 9/3102 ILS RWY 2, AMDT 2 05/1/99 ......... NH MANCHESTER ............... MANCHESTER .................................... 9/3103 ILS RWY 35, AMDT 19 05/04/99 ....... IL CHICAGO/AURORA ....... AURORA MUNI ................................... 9/2970 VOR or GPS±A AMDT 1A 05/05/99 ....... IL CHICAGO/AURORA ....... AURORA MUNI ................................... 9/2983 ILS RWY 9, AMDT 1A 05/06/99 ....... OH MIDDLETOWN ................ HOOK FIELD MUNI ............................. 9/3009 LOC RWY 23, AMDT 7B 05/06/99 ....... OH MIDDLETOWN ................ HOOK FIELD MUNI ............................. 9/3010 NDB or GPS RWY 23, AMDT 8A 05/06/99 ....... OH MIDDLETOWN ................ HOOK FIELD MUNI ............................. 9/3011 NDB or GPS±A, AMDT 2A 05/10/99 ....... MN WORTHINGTON ............. WORTHINGTON MUNI ....................... 9/3086 NDB or GPS RWY 29, ORIG 05/10/99 ....... MN WORTHINGTON ............. WORTHINGTON MUNI ....................... 9/3088 ILS RWY 29, ORIG 05/10/99 ....... VA RICHMOND ..................... CHESTERFIELD COUNTY ................. 9/3074 NDB or GPS RWY 33, AMDT 7A 05/10/99 ....... VA RICHMOND ..................... CHESTERFIELD COUNTY ................. 9/3075 VOR/DME or GPS RWY 15, ORIG 05/10/99 ....... VA RICHMOND ..................... CHESTERFIELD COUNTY ................. 9/3082 ILS RWY 33, ORIG [FR Doc. 99±12949 Filed 5±20±99; 8:45 am] EFFECTIVE DATES: This regulation is glyceryl aminobenzoate, lawsone with BILLING CODE 4910±13±M effective May 21, 2001 for parts 310, dihydroxyacetone (interest was 352, and 700 and is effective May 22, subsequently shown in developing a 2000 for part 740. monograph for lawsone and dihydroxyacetone), and red petrolatum. DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: John The agency also reiterated that all HUMAN SERVICES D. Lipnicki, Center for Drug Evaluation and Research (HFD±560), Food and sunscreen ingredients must have a USP Food and Drug Administration Drug Administration, 5600 Fishers monograph before being included in the Lane, Rockville, MD 20857, 301±827± final monograph for OTC sunscreen 21 CFR Parts 310, 352, 700, and 740 2222. drug products. This final rule includes SUPPLEMENTARY INFORMATION: those sunscreen ingredients that have [Docket No. 78N±0038] USP monographs. I. Introduction In the Federal Register of September RIN 0910±AA01 In the Federal Register of August 25, 16, 1996 (61 FR 48645), the agency Sunscreen Drug Products For Over- 1978 (43 FR 38206), FDA published, amended the proposed rule to include The-Counter Human Use; Final under § 330.10(a)(6) (21 CFR avobenzone as a single ingredient and in Monograph 330.10(a)(6)), an advance notice of combination with certain other proposed rulemaking (ANPRM) to sunscreen ingredients (interim AGENCY: Food and Drug Administration, establish a monograph for OTC marketing was allowed in the Federal HHS. sunscreen drug products, together with Register of April 30, 1997 (62 FR ACTION: Final rule. the recommendations of the Advisory 23350)). In the Federal Register of Review Panel on OTC Topical October 22, 1998 (63 FR 56584), the SUMMARY: The Food and Drug Analgesic, Antirheumatic, Otic, Burn, agency proposed to amend the tentative Administration (FDA) is issuing a final and Sunburn Prevention Drug Products final monograph to include zinc oxide rule in the form of a final monograph (the Panel), which was the advisory as a single ingredient and in establishing conditions under which review panel that evaluated data on the combination with any proposed over-the-counter (OTC) sunscreen drug active ingredients in this drug class. The Category I sunscreen active ingredient products are generally recognized as agency's proposed regulation for OTC except avobenzone. safe and effective and not misbranded as sunscreen drug products, in the form of In the Federal Register of April 5, part of FDA's ongoing review of OTC a tentative final monograph, was 1994 (59 FR 16042), the agency drug products. FDA is issuing this final published in the Federal Register of reopened the administrative record and rule after considering public comments May 12, 1993 (58 FR 28194). announced a public meeting to discuss on the agency's proposed regulation, In the Federal Register of June 8, 1994 ultraviolet A (UVA) radiation claims which was issued in the form of a (59 FR 29706), the agency proposed to and testing procedures. In the Federal tentative final monograph, and new data amend the tentative final monograph Register of August 15, 1996 (61 FR and information on sunscreen drug (and reopened the comment period until 42398), the agency reopened the products that have come to the agency's August 22, 1994) to remove five administrative record and announced a attention. FDA is also issuing final rules sunscreen ingredients because of a lack public meeting to discuss the regarding the labeling of certain of interest in establishing United States photochemistry and photobiology of cosmetic products to inform consumers Pharmacopeia (USP) monographs: sunscreens. that these products do not provide Digalloyl trioleate, ethyl 4- This final monograph completes the protection from the sun. [bis(hydroxypropyl)] aminobenzoate, tentative final monograph except for VerDate 06-MAY-99 15:32 May 20, 1999 Jkt 183247 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\21MYR1.XXX pfrm07 PsN: 21MYR1 Federal Register / Vol. 64, No. 98 / Friday, May 21, 1999 / Rules and Regulations 27667 certain testing issues and UVA labeling, submission of a formal petition by an specified when the final rule for testing which the agency will discuss in future interested party. procedures publishes. issues of the Federal Register. Until The agency has included these data 2. Several comments recommended then, UVA labeling may continue in and information in the administrative modifications to the definition of accord with the tentative final record and addressed them in this minimal erythema dose (MED) in monograph and its amendments. The document. The agency has considered proposed § 352.3(a). Some comments agency advises that on or after May 21, the request for an oral hearing in its objected to the presumption that 2001, no OTC drug product that is response to the comment and believes it erythema is a ``diffusing'' reaction that subject to the monograph and that has adequately responded to the starts from within the exposed site and contains a nonmonograph condition manufacturer and that a hearing is not moves outward in a dose dependent may be initially introduced or initially needed. As discussed in section II.G, manner, i.e., ``redness reaching the delivered for introduction into interstate comment 29 of this document, the borders of the exposure site.'' Other commerce unless it is the subject of an agency is allowing the marketing of OTC comments asserted that the definition is approved new drug application or sunscreen drug products with SPF too limiting because it may not be abbreviated new drug application. values above 30 under one collective appropriate for all solar simulator Further, any OTC drug product subject term (i.e., ``30 plus'' or ``30 +''). The configurations (e.g., no template). Many to this monograph that is repackaged or agency will also consider including comments recommended the definition relabeled after the effective date of the labeling in the monograph with actual of MED used by the European Trade monograph must be in compliance with label SPF values on products with SPF Association COLIPA (Ref. 5): ``The the monograph regardless of the date the values over 30 when adequate data are quantity of radiant energy required to product was initially introduced or submitted to substantiate a testing produce the first perceptible, initially delivered for introduction into procedure applicable to SPF values over unambiguous redness reaction with interstate commerce. Manufacturers are 30. clearly defined borders.'' Another encouraged to comply voluntarily as comment recommended ``erythema- soon as possible. II. The Agency's Conclusions on the Comments effective ultraviolet radiation'' in place In response to the proposed rule on of ``radiant energy.'' OTC sunscreen drug products and A. General Comments on OTC The agency agrees that the proposed subsequent reopenings of the Sunscreen Drug Products definition of MED should be modified administrative
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