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Federal Register/Vol. 63, No. 113/Friday, June 12, 1998/Proposed Rules

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Federal Register/Vol. 63, No. 113/Friday, June 12, 1998/Proposed Rules Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Proposed Rules 32159 No. 11±2A which describes the Authority: 49 U.S.C. 106(g), 40103, 40113, yeast derived form of the sucrase application procedure. 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959± enzyme, used for the treatment of 1963 Comp., p. 389. congenital sucrase-isomaltase The Proposal § 71.1 [Amended] deficiency. The Commission proposes The FAA proposes to amend 14 CFR 2. The incorporation by reference in this exemption because human part 71 by revising the Class E airspace 14 CFR 71.1 of Federal Aviation experience has shown no evidence of at Unalakleet, AK, due the Administration Order 7400.9E, Airspace serious toxicity. establishment of a GPS instrument Designations and Reporting Points, DATES: Comments on the proposal approach to RWY 14. The intended dated September 10, 1997, and effective should be submitted no later than effect of this proposal is to provide September 16, 1997, is to be amended August 26, 1998. adequate controlled airspace for as follows: ADDRESSES: Comments should be Instrument Flight Rules (IFR) operations mailed to the Office of the Secretary, at Unalakleet, AK. Paragraph 6005 Class E airspace extending upward from 700 feet or more above the Consumer Product Safety Commission, The area would be depicted on Washington, D.C. 20207, or delivered to aeronautical charts for pilot reference. surface of the earth. * * * * * the Office of the Secretary, Consumer The coordinates for this airspace docket Product Safety Commission, Room 502, are based on North American Datum 83. AAL AK E5 Unalakleet, AK 4330 East-West Highway, Bethesda, The Class E airspace areas designated as Unalakleet Airport, AK Maryland 20814±4408, telephone (301) an 700/1200 foot transition area are (Lat. 63°53′18′′N., long. 160°47′56′′W.) 504±0800. Comments may also be filed published in paragraph 6005 in FAA Unalakleet VORTAC by telefacsimile to (301) 504±0127 or by ° ′ ′′ ° ′ ′′ Order 7400.9E, Airspace Designations (Lat. 63 53 31 N., long. 160 41 04 W.) email to [email protected]. and Reporting Points, dated September Unalakleet Localizer 10, 1997, and effective September 16, (Lat. 63°52′52′′N., long. 160°47′42′′W.) FOR FURTHER INFORMATION CONTACT: 1997, which is incorporated by That airspace extending upward from 700 Jacqueline Ferrante, Ph.D., Division of reference in 14 CFR 71.1 (62 FR 52491; feet above the surface within a 6.7-mile Health Sciences, Directorate for radius of the Unalakleet Airport and within Epidemiology and Health Sciences, October 8, 1997). The Class E airspace ° listed in this document would be 2 miles each side of the 289 radial of the Consumer Product Safety Commission, Unalakleet VORTAC extending from the 6.7- revised and published in the Order. Washington, D.C. 20207; telephone mile radius to 14.1 miles west of the (301) 504±0477 ext. 1199. The FAA has determined that these VORTAC and within 3 miles east and 3 miles SUPPLEMENTARY INFORMATION: proposed regulations only involve an west of the Unalakleet Localizer front course established body of technical extending from the 6.7-mile radius to 12.9 A. Background regulations for which frequent and miles north of the airport; and that airspace routine amendments are necessary to extending upward from 1,200 feet above the The Poison Prevention Packaging Act keep them operationally current. It, surface within a 22-mile radius of the of 1970 (``PPPA''), 15 U.S.C. 1471±1476, Unalakleet VORTAC extending clockwise provides the Commission with authority thereforeÐ(1) is not a ``significant ° ° regulatory action'' under Executive from the 165 radial to the 322 radial and to establish standards for the ``special within 4 miles east and 8 miles west of the packaging'' of household substances, Order 12866; (2) is not a ``significant Unalakleet Localizer front course extending rule'' under DOT Regulatory Policies such as drugs, when child resistant from the Localizer to 22 miles north of the packaging is necessary to protect and Procedures (44 FR 11034; February airport and within 4 miles north and 8 miles 26, 1979); and (3) does not warrant south of the Unalakleet VORTAC 289° radial children from serious personal injury or preparation of a regulatory evaluation as extending from the VORTAC to 27 miles west illness due to the substance and the the anticipated impact is so minimal. of the VORTAC. special packaging is technically feasible, Since this is a routine matter that will * * * * * practicable, and appropriate for such only affect air traffic procedures and air Issued in Anchorage, AK, on June 4, 1998. substance. Accordingly, the navigation, it is certified that this rule, Willis C. Nelson, Commission requires that oral prescription drugs be in child resistant when promulgated, will not have a Manager, Air Traffic Division, Alaskan significant economic impact on a Region. (``CR'') packaging. 16 CFR 1700.14(a)(10). substantial number of small entities [FR Doc. 98±15714 Filed 6±11±98; 8:45 am] The Commission's regulations allow under the criteria of the Regulatory BILLING CODE 4910±13±U Flexibility Act. companies to petition the Commission for exemption from CR requirements. 16 List of Subjects in 14 CFR Part 71 CFR Part 1702. Possible grounds for CONSUMER PRODUCT SAFETY granting the exemption are that: Airspace, Incorporation by reference, COMMISSION Navigation (air). (a) The degree or nature of the hazard to 16 CFR Part 1700 children in the availability of the substance, The Proposed Amendment by reason of its packaging, is such that In consideration of the foregoing, the Poison Prevention Packaging special packaging is not required to protect Federal Aviation Administration Requirements; Proposed Exemption of children from serious personal injury or proposes to amend 14 CFR part 71 as Sucraid serious illness resulting from handling, using or ingesting the substance, or follows: AGENCY: Consumer Product Safety (b) Special packaging is not technically PART 71ÐDESIGNATION OF CLASS A, Commission. feasible, practicable, or appropriate for the subject substance, or CLASS B, CLASS C, CLASS D, AND ACTION: Proposed rule. (c) Special packaging is incompatible with CLASS E AIRSPACE AREAS; the particular substance.16 CFR 1702.17. AIRWAYS; ROUTES; AND REPORTING SUMMARY: The Commission is proposing POINTS to exempt from its child-resistant On July 10, 1997, Orphan Medical, packaging requirements the oral Inc. (``Orphan Medical'') petitioned the 1. The authority citation for 14 CFR prescription drug Sucraid. Sucraid is a Commission to exempt its product, part 71 continues to read as follows: new liquid formulation of sacrosidase, a Sucraid, from the special packaging 32160 Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Proposed Rules requirements for oral prescription drugs. indicates that glycerol is only mildly illness resulting from handling, using, The petitioner stated that the exemption toxic by ingestion. In addition, the or ingesting the substance. Therefore, is justified because of lack of toxicity Handbook of Common Poisonings in the Commission voted to grant the and lack of adverse human experience Children characterizes glycerol as a petition and begin a rulemaking with the drug. The petitioner also stated laxative, stating that ``acute exposure to proceeding to exempt Sucraid from the that CR packaging is not technically most laxatives produces nausea, special packaging requirements for oral feasible, practicable and appropriate for vomiting, and diarrhea, which are prescription drugs. Sucraid. Because, as explained below, usually mild and self-limiting.'' the Commission concludes that Sucraid The CPSC staff found three cases in E. Regulatory Flexibility Act lacks sufficient toxicity to justify special the National Electronic Injury Certification packaging, the Commission did not Surveillance System (``NEISS'') of Under the Regulatory Flexibility Act, consider the technical feasibility, children under five years old ingesting 5 U.S.C. 601 et seq., an agency that practicability, and appropriateness of products containing glycerol. The engages in rulemaking generally must special packaging for Sucraid. products involved were a glycerol prepare proposed and final regulatory Sucraid is a liquid formulation of suppository, a baby enema preparation, flexibility analyses describing the sacrosidase, a yeast derived form of the and an ear solution. In all three cases impact of the rule on small businesses sucrase enzyme. It is used to treat the child was treated and released or and other small entities. Section 605 of patients with congenital sucrase- examined and released without the Act provides that an agency is not isomaltase deficiency (``CSID''). The treatment. required to prepare a regulatory petitioner estimates that there are Thus, based on the information flexibility analysis if the head of an approximately 3000 to 10,000 cases of discussed above, the glycerol agency certifies that the rule will not CSID in the United States. CSID is a component of Sucraid is not likely to have a significant economic impact on condition characterized by absent or cause significant toxicity to children. a substantial number of small entities. low levels of sucrase and isomaltase, C. Human Experience Data The Commission's Directorate for two enzymes in the small intestine. Economic Analysis prepared a According to the petitioner, there Sucrase breaks down sucrose (table preliminary assessment of the impact of have been three clinical trials of sugar) so that it can be absorbed. a rule to exempt Sucraid from special Sucraid, two of which are complete. The Persons with CSID have such symptoms packaging requirements. The staff clinical investigators conducting the as diarrhea, abdominal pain, bloating, reports that because of the small number trials did not rate any of the adverse and gas. Patients with severe CSID may of cases of CSID (3,000 to 10,000 in the effects encountered as probably or require hospitalization for diarrhea, U.S.), the market for Sucraid is expected definitely related to the drug.
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