Federal Register/Vol. 67, No. 119/Thursday, June 20, 2002/Rules
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Federal Register / Vol. 67, No. 119 / Thursday, June 20, 2002 / Rules and Regulations 41821 was republished in FAA Order 7400.8J, Issued in Washington, DC, on June 14, In 2000 (Ref. 1), the U.S.P. proposed dated September 20, 2001. 2002. (for inclusion in the Third Supplement This regulation only involves an Reginald C. Matthews, to U.S.P. 24) name changes for these established body of technical Manager, Airspace and Rules Division. four ingredients based on names regulations for which frequent and [FR Doc. 02–15601 Filed 6–19–02; 8:45 am] adopted by the United States Adopted routine amendments are necessary to BILLING CODE 4910–13–P Names (USAN) Council. The new names keep them operationally current. It, are: Meradimate for menthyl therefore—(1) Is not a ‘‘significant anthranilate, octinoxate for octyl regulatory action’’ under Executive DEPARTMENT OF HEALTH AND methoxycinnamate, octisalate for octyl Order 12866; (2) is not a ‘‘significant HUMAN SERVICES salicylate, and ensulizole for rule’’ under DOT Regulatory Policies phenylbenzimidazole sulfonic acid. Food and Drug Administration and Procedures (44 FR 11034; February These name changes became official on 26, 1979); and (3) does not warrant March 1, 2001, and were subsequently 21 CFR Part 352 preparation of a regulatory evaluation as included in the U.S.P. with an effective the anticipated impact is so minimal. [Docket No. 78N–0038] date of September 1, 2002 (Ref. 2). Since it has been determined that this RIN 0910–AA01 II. Naming Process is a routine matter that will only affect The Federal Food, Drug, and Cosmetic air traffic procedures and air navigation, Sunscreen Drug Products for Over-the- Act (the act) requires the label of a drug it is certified that this rule will not have Counter Human Use; Final Monograph; to bear the established name of the drug a significant economic impact on a Technical Amendment to the exclusion of any other substantial number of small entities AGENCY: nonproprietary name (except the under the criteria of the Regulatory Food and Drug Administration, HHS. applicable systematic chemical name or Flexibility Act. the chemical formula) (21 U.S.C. ACTION: Final rule; technical Environmental Review amendment. 352(e)(1)(A)(i)). The established name of the drug is defined as: The FAA has determined that this SUMMARY: The Food and Drug (A) the applicable official name designated action qualifies for categorical exclusion Administration (FDA) is amending the pursuant to section 508 [of the Act], or (B) under the National Environmental regulation that established conditions if there is no such name and such drug, or such ingredient, is an article recognized in an Policy Act in accordance with FAA under which over-the-counter (OTC) official compendium, then the official title Order 1050.1D, Policies and Procedures sunscreen drug products are generally thereof in such compendium, or (C) if neither for Considering Environmental Impacts. recognized as safe and effective and not clause (A) nor clause (B) of this subparagraph This airspace action is not expected to misbranded. This amendment updates applies, then the common or usual name, if cause any potentially significant the monograph to incorporate United any, of such drug or of such ingredient * * environmental impacts, and no States Pharmacopeia (U.S.P.) name *. extraordinary circumstances exist that changes for four active ingredients 21 U.S.C. 352(e)(3) warrant preparation of an included in the monograph. This final environmental assessment. rule is part of FDA’s ongoing review of Section 508 of the act (21 U.S.C. 358) OTC drug products. authorizes FDA to designate an official List of Subjects in 14 CFR Part 73 name for any drug if FDA determines DATES: This final rule is effective ‘‘that such action is necessary or Airspace, Navigation (air). September 1, 2002. Submit written or electronic comments by August 19, desirable in the interest of usefulness Adoption of the Amendment 2002. and simplicity’’ (21 U.S.C. 358(a)). FDA does not, however, routinely designate ADDRESSES: Submit written or electronic In consideration of the foregoing, the official names for drug products under comments to the Dockets Management Federal Aviation Administration section 508 of the act (§ 299.4(e) (21 Branch (HFA–305), Food and Drug amends 14 CFR part 73 as follows: CFR 299.4(e))). In the absence of Administration, 5630 Fishers Lane, rm. designation by FDA of an official name, PART 73—SPECIAL USE AIRSPACE 1061, Rockville, MD 20852. Submit interested persons may rely on the electronic comments to http:// current compendial name as the 1. The authority citation for part 73 www.fda.gov/dockets/ecomments. established name (§ 299.4(e)). continues to read as follows: FOR FURTHER INFORMATION CONTACT: John D. Lipnicki, Center for Drug Evaluation III. The Technical Amendment Authority: 49 U.S.C. 106(g), 40103, 40113, and Research (HFD–560), Food and FDA has not designated official names 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– Drug Administration, 5600 Fishers for the following active ingredients: 1963 Comp., p. 389. Lane, Rockville, MD 20857, 301–827– Menthyl anthranilate, octyl § 73.43 [Amended] 2222. methoxycinnamate, octyl salicylate, and SUPPLEMENTARY INFORMATION: phenylbenzimidazole sulfonic acid. 2. Section 73.43 is amended as Thus, their established names are the follows: I. Background current compendial names. The U.S.P. * * * * * In the Federal Register of May 21, has now changed the compendial names 1999 (64 FR 27666), FDA issued a final to: Meradimate for menthyl R–4305 Lake Superior, MN [Amended] monograph for OTC sunscreen drug anthranilate, octinoxate for octyl By removing the words ‘‘Using Agency. products (21 CFR part 352). Section methoxycinnamate, octisalate for octyl USAF, Detachment 1, HQ Air Combat 352.10 of that monograph included the salicylate, and ensulizole for Command (DOSR), Offutt AFB, NE’’ and active ingredients menthyl anthranilate, phenylbenzimidazole sulfonic acid. To inserting the words ‘‘Using Agency. USAF, octyl methoxycinnamate, octyl be consistent with the change in official 55th Wing, Offutt AFB, NE.’’ salicylate, and phenylbenzimidazole compendial names, the agency is * * * * * sulfonic acid. changing these names in § 352.10 in the VerDate jun<06>2002 16:51 Jun 19, 2002 Jkt 197001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\20JNR1.SGM pfrm15 PsN: 20JNR1 41822 Federal Register / Vol. 67, No. 119 / Thursday, June 20, 2002 / Rules and Regulations ingredient listing and in § 352.20 in the has a significant economic impact on a number of small entities. Therefore, no permitted combinations listing. Because substantial number of small entities, an further analysis is required. the active ingredients are listed in agency must analyze regulatory options V. Paperwork Reduction Act of 1995 alphabetical order in § 352.10, the that would minimize any significant ingredients listed in paragraphs (f) impact of the rule on small entities. The agency concludes that the through (n) are rearranged because of Section 202(a) of the Unfunded labeling requirements in this document these name changes. These name Mandates Reform Act of 1995 requires are not subject to review by the Office changes will become effective on that agencies prepare a written of Management and Budget because September 1, 2002, to coincide with the statement of anticipated costs and they do not constitute a ‘‘collection of U.S.P. effective date. benefits before proposing any rule that information’’ under the Paperwork Because section 502(e)(1) and (e)(3) of may result in an expenditure in any one Reduction Act of 1995 (44 U.S.C. 3501 the act (21 U.S.C. 352(e)(1) and (e)(3)) year by State, local, and tribal et seq.). Rather, the labeling statements require the established name of a drug governments, in the aggregate, or by the are a ‘‘public disclosure of information to be used, any sunscreen drug product private sector, of $100 million (adjusted originally supplied by the Federal initially introduced or initially annually for inflation). Government to the recipient for the delivered for introduction into interstate The agency concludes that this final purpose of disclosure to the public’’ (5 commerce after September 1, 2002, will rule is consistent with the principles set CFR 1320.3(c)(2)). need to bear the new established names out in Executive Order 12866 and in VI. Environmental Impact ‘‘meradimate,’’ ‘‘octinoxate,’’ these two statutes. FDA has determined ‘‘octisalate,’’ and ‘‘ensulizole.’’ that the final rule is not a significant The agency has determined under 21 To the extent that 5 U.S.C. 553 applies regulatory action as defined by the CFR 25.31(a) that this action is of a type to this action, it is exempt from notice Executive order and so is not subject to that does not individually or and comment because it constitutes a review under the Executive order. cumulatively have a significant effect on rule of agency procedure under 5 U.S.C. The Unfunded Mandates Reform Act the human environment. Therefore, 553(b)(3)(A). Alternatively, the agency’s of 1995 does not require FDA to prepare neither an environmental assessment implementation of this action without a statement of costs and benefits for this nor an environmental impact statement opportunity for public comment comes final rule, because the final rule is not is required. within the good cause exceptions in 5 expected to result in any 1-year U.S.C. 553(b)(3)(B) in that obtaining VII. Federalism expenditure that would exceed $100 public comment is impracticable, FDA has analyzed this final rule in million adjusted for inflation. The unnecessary, and contrary to public accordance with the principles set forth current inflation adjusted statutory interest. This labeling revision in Executive Order 13132. FDA has represents a minor clarifying change threshold is about $110 million.