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 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, 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– , octyl § 73.43 [Amended] 2222. methoxycinnamate, , 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 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

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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. determined that the rule does not that does not change the substance of The purpose of this final rule is to contain policies that have substantial the labeling requirements contained in update the final monograph for OTC direct effects on the States, on the the final regulations. As discussed sunscreen drug products to incorporate relationship between the National above, manufacturers must relabel their U.S.P. name changes for four active Government and the States, or on the products as a result of the U.S.P. name ingredients included in the monograph. distribution of power and change to remain in compliance with As discussed in section II of this responsibilities among the various the act. This amendment updates the document, section 502(e)(1) and (e)(3) of levels of government Accordingly, the names of four active ingredients in the the act require that the established name agency has concluded that the rule does final monograph for OTC sunscreen of a drug be used. Under § 299.4(e), not contain policies that have drug products to reflect this official because FDA does not routinely federalism implications as defined in name change that has already been designate official names under section the Executive order and, consequently, implemented by the U.S.P. In 508 of the act, the established name a federalism summary impact statement accordance with 21 CFR 10.40(e)(1), under section 502(e) of the act is not required. FDA is providing an opportunity for ordinarily is the compendial name of comment on whether the regulation the drug. Therefore, because FDA has VIII. Opportunity for Comments should be modified or revoked. not designated an official name under Interested persons may submit to the section 508 of the act, manufacturers Dockets Management Branch (see IV. Analysis of Impacts must relabel their products as a result of ADDRESSES) written or electronic FDA has examined the impacts of the the U.S.P. name change to remain in comments by August 19, 2002. Two final rule under Executive Order 12866 compliance with the act. Updating the copies of all written comments are to be and the Regulatory Flexibility Act (5 names of the active ingredients in the submitted. Individuals submitting U.S.C. 601–612) (as amended by subtitle sunscreen monograph to reflect their written comments or anyone submitting D of the Small Business Regulatory current established names will electronic comments may submit one Fairness Act of 1996 (Public Law 104– eliminate possible confusion by the copy. Comments are to be identified 121)), and the Unfunded Mandates public. The U.S.P. allows manufacturers with the docket number found in Reform Act of 1995 (Public Law 104–4). 18 months to comply with the name brackets in the heading of this Executive Order 12866 directs agencies changes, and the agency’s effective date document and may be accompanied by to assess all costs and benefits of coincides with that of the U.S.P. a supporting memorandum or brief. available regulatory alternatives and, Because manufacturers must relabel Received comments may be seen in the when regulation is necessary, to select their products as a result of the U.S.P. Dockets Management Branch between 9 regulatory approaches that maximize name change to remain in compliance a.m. and 4 p.m., Monday through net benefits (including potential with the act, this rule does not impose Friday. economic, environmental, public health any additional costs on industry. and safety, and other advantages; Consequently, the agency certifies that IX. References distributive impacts; and equity). Under this final rule will not have a significant The following references have been the Regulatory Flexibility Act, if a rule economic impact on a substantial placed on display in the Dockets

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Management Branch (see ADDRESSES) (e), (g), (j) through (m), (o), and (q) may reflect the approval. The regulation in and may be seen by interested persons be combined with each other in a single 21 CFR 522.690 is being amended to between 9 a.m. and 4 p.m., Monday product when used in the add a cross-reference for the concurrent through Friday. concentrations established for each use of dinoprost solution by 1. ‘‘Pharmacopeial Forum,’’ The United ingredient in § 352.10. The intramuscular injection and is being States Pharmacopeial Convention, Inc., concentration of each active ingredient revised to reflect a current format. The Rockville, MD, pp. 693 to 694, 717 to 719, must be sufficient to contribute a basis of approval is discussed in the and 726 to 729, May and June, 2000. minimum SPF of not less than 2 to the freedom of information summary. 2. ‘‘Third Supplement,’’ United States Pharmacopeia 24, National Formulary 19, finished product. The finished product In addition, DEC International, Inc., The United States Pharmacopeial must have a minimum SPF of not less has not been previously listed in the Convention, Inc., Rockville, MD, pp. 3025, than the number of sunscreen active animal drug regulations as a sponsor of 3053, 3061 to 3062, January 2, 2001. ingredients used in the combination an approved application. At this time, multiplied by 2. 21 CFR 510.600(c) is being amended to List of Subjects in 21 CFR 352 * * * * * add entries for the firm. Labeling, Over-the-counter drugs. In accordance with the freedom of Dated: June 11, 2002. Therefore, under the Federal Food, information provisions of 21 CFR part Margaret M. Dotzel, Drug, and Cosmetic Act and under 20 and 514.11(e)(2)(ii), a summary of authority delegated to the Commissioner Associate Commissioner for Policy. safety and effectiveness data and of Food and Drugs, 21 CFR part 352 is [FR Doc. 01–15632 Filed 6–19–01; 8:45 am] information submitted to support amended as follows: BILLING CODE 4160–01–S approval of this application may be seen in the Dockets Management Branch PART 352—SUNSCREEN DRUG (HFA–305), Food and Drug PRODUCTS FOR OVER-THE- DEPARTMENT OF HEALTH AND Administration, 5630 Fishers Lane, rm. COUNTER HUMAN USE HUMAN SERVICES 1061, Rockville, MD 20852, between 9 1. The authority citation for 21 CFR Food and Drug Administration a.m. and 4 p.m., Monday through part 352 continues to read as follows: Friday. 21 CFR Parts 510, 522, and 529 Under section 512(c)(2)(F)(ii) of the Authority: 21 U.S.C. 321, 351, 352, 353, Federal Food, Drug, and Cosmetic Act 355, 360, 371. Certain Other Dosage Form New (21 U.S.C. 360b(c)(2)(F)(ii)), this 2. Section 352.10 is amended by approval qualifies for 3 years of revising paragraphs (f) through (n) to Animal Drugs; Progesterone Intravaginal Inserts marketing exclusivity beginning May 2, read as follows: 2002. § 352.10 Sunscreen active ingredients. AGENCY: Food and Drug Administration, The agency has carefully considered HHS. * * * * * the potential environmental effects of (f) Ensulizole up to 4 percent. ACTION: Final rule. this action. FDA has concluded that the (g) up to 15 percent. action will not have a significant impact SUMMARY: The Food and Drug on the human environment, and that an (h) [Reserved]. Administration (FDA) is amending the (i) Meradimate up to 5 percent. environmental impact statement is not (j) Octinoxate up to 7.5 percent. animal drug regulations to reflect required. The agency’s finding of no (k) Octisalate up to 5 percent. approval of a new animal drug significant impact and the evidence (l) up to 10 percent. application (NADA) filed by DEC supporting that finding, contained in an (m) up to 6 percent. International, Inc. The NADA provides environmental assessment, may be seen (n) up to 8 percent. for use of progesterone intravaginal in the Dockets Management Branch (see * * * * * inserts for manipulation of estrus in ADDRESSES) between 9 a.m. and 4 p.m., 3. Section 352.20 is amended by cattle. Monday through Friday. revising paragraphs (a)(1) and (a)(2) as DATES: This rule is effective June 20, This rule does not meet the definition follows: 2002. of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because § 352.20 Permitted combinations of active FOR FURTHER INFORMATION CONTACT: it is a rule of ‘‘particular applicability.’’ ingredients. Harlan J. Howard, Center for Veterinary Therefore, it is not subject to the Medicine (HFV–126), Food and Drug congressional review requirements in 5 * * * * * U.S.C. 801–808. (a) Combinations of sunscreen active Administration, 7500 Standish Pl., ingredients. (1) Two or more sunscreen Rockville, MD 20855, 301–827–0231, e- List of Subjects active ingredients identified in § mail: [email protected]. 21 CFR Part 510 352.10(a), (c), (e), (f), (g), and (i) through SUPPLEMENTARY INFORMATION: DEC (r) may be combined with each other in International, Inc., 1919 South Administrative practice and a single product when used in the Stoughton Rd., P.O. Box 8050, Madison procedure, Animal drugs, Labeling, concentrations established for each WI 53708–8050, filed NADA 141–200 Reporting and recordkeeping ingredient in § 352.10. The that provides for use of EAZI–BREED requirements. CIDR Progesterone Intravaginal Inserts concentration of each active ingredient 21 CFR Parts 522 and 529 must be sufficient to contribute a for synchronization of estrus in suckled minimum SPF of not less than 2 to the beef cows and replacement beef and Animal drugs. finished product. The finished product dairy heifers, for advancement of first Therefore, under the Federal Food, must have a minimum SPF of not less postpartum estrus in suckled beef cows, Drug, and Cosmetic Act and under than the number of sunscreen active and for advancement of first pubertal authority delegated to the Commissioner ingredients used in the combination estrus in replacement beef heifers. The of Food and Drugs and redelegated to multiplied by 2. NADA is approved as of May 2, 2002, the Center for Veterinary Medicine, 21 (2) Two or more sunscreen active and the regulations in 21 CFR part 529 CFR parts 510, 522, and 529 are ingredients identified in § 352.10(b), (c), are amended by adding § 529.1940 to amended as follows:

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