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Federal Register/Vol. 78, No. 57/Monday, March 25, 2013 Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Proposed Rules 17895 22,109 hours due to this proposed 1. The panel transcript and other being placed in commercial regulatory change. meeting materials are available on distribution. FDA’s Web site at http://www.fda.gov/ IX. Proposed Effective Date Dated: March 19, 2013. AdvisoryCommittees/ Leslie Kux, FDA is proposing that any final order CommitteesMeetingMaterials/ Assistant Commissioner for Policy. based on this proposal become effective MedicalDevices/ on the date of its publication in the MedicalDevicesAdvisoryCommittee/ [FR Doc. 2013–06723 Filed 3–22–13; 8:45 am] Federal Register or at a later date if CirculatorySystemDevicesPanel/ BILLING CODE 4160–01–P stated in the final order. ucm240575.htm. X. Codification of Orders List of Subjects in 21 CFR Part 870 DEPARTMENT OF JUSTICE Prior to the amendments by FDASIA, Medical devices. section 515(b) of the FD&C Act provided Drug Enforcement Administration Therefore, under the Federal Food, for FDA to issue regulations to require Drug, and Cosmetic Act and under approval of an application for premarket 21 CFR Part 1308 authority delegated to the Commissioner approval for preamendments devices or of Food and Drugs, it is proposed that [Docket No. DEA–370] devices found substantially equivalent 21 CFR part 870 be amended as follows: to preamendments devices. Section Schedules of Controlled Substances: 515(b) of the FD&C Act, as amended by PART 870—CARDIOVASCULAR Placement of Alfaxalone into Schedule FDASIA, provides for FDA to require DEVICES IV approval of an application for premarket AGENCY: approval for such devices by issuing a ■ 1. The authority citation for 21 CFR Drug Enforcement final order, following the issuance of a part 870 continues to read as follows: Administration, Department of Justice. ACTION: Notice of proposed rulemaking. proposed order in the Federal Register. Authority: 21 U.S.C. 351, 360, 360c, 360e, FDA will continue to codify the 360j, 371. SUMMARY: The Drug Enforcement requirement for an application for ■ 2. Section 870.5310 is amended by Administration (DEA) proposes the premarket approval, resulting from placement of 5a-pregnan-3a-ol-11,20- changes issued in a final order, in the revising the section heading and paragraphs (a) and (c) to read as follows: dione (alfaxalone) including its salts, Code of Federal Regulations (CFR). isomers, and salts of isomers whenever Therefore, under section 515(b)(1)(A) of § 870.5310 Automated external defibrillator the existence of such salts, isomers, and the FD&C Act, as amended by FDASIA, system. salts of isomers is possible, into in this proposed order, we are proposing (a) Identification. An automated Schedule IV of the Controlled to require approval of an application for external defibrillator (AED) system Substances Act (CSA). This proposed premarket approval for AEDs and if this consists of an AED device and its action is pursuant to the CSA which proposed order is finalized, we will accessories, i.e., battery, pad electrode requires that such actions be made on make the language in 21 CFR 870.5310 and, if applicable, an adapter. An AED the record after opportunity for a consistent with the final version of this system analyzes the patient’s hearing through formal rulemaking. proposed order. electrocardiogram, interprets the cardiac DATES: DEA will permit interested XI. Comments rhythm, and automatically delivers an persons to file written comments on this Interested persons may submit either electrical shock (fully automated AED), proposal pursuant to 21 CFR 1308.43(g). electronic comments regarding this or advises the user to deliver the shock Electronic comments must be submitted document to http://www.regulations.gov (semi-automated or shock advisory and written comments must be or written comments to the Division of AED) to treat ventricular fibrillation or postmarked on or before April 24, 2013. Dockets Management (see ADDRESSES). It pulseless ventricular tachycardia. Commenters should be aware that the is only necessary to send one set of * * * * * electronic Federal Docket Management comments. Identify comments with the (c) Date PMA or notice of completion System will not accept comments after docket number found in brackets in the of PDP is required. A PMA is required midnight Eastern Time on the last day heading of this document. Received to be submitted to the Food and Drug of the comment period. comments may be seen in the Division Administration by [A DATE WILL BE Interested persons, defined at 21 CFR of Dockets Management between 9 a.m. ADDED 90 DAYS AFTER DATE OF 1300.01 as those ‘‘adversely affected or and 4 p.m., Monday through Friday, and PUBLICATION OF A FUTURE FINAL aggrieved by any rule or proposed rule will be posted to the docket at http:// ORDER IN THE FEDERAL REGISTER], issuable pursuant to section 201 of the www.regulations.gov. for any automated external defibrillator Act (21 U.S.C. 811),’’ may file a request that was in commercial distribution for hearing pursuant to 21 CFR 1308.44 XII. Reference before May 28, 1976, or that has, by [A and in accordance with 21 CFR 1316.45 The following reference has been DATE WILL BE ADDED 90 DAYS and 1316.47. Requests for hearing and placed on display in the Division of AFTER DATE OF PUBLICATION OF A waivers of participation must be Dockets Management (see ADDRESSES) FUTURE FINAL ORDER IN THE received on or before April 24, 2013. and may be seen by interested persons FEDERAL REGISTER], been found to be ADDRESSES: To ensure proper handling between 9 a.m. and 4 p.m., Monday substantially equivalent to any of comments, please reference ‘‘Docket through Friday, and is available automated external defibrillator that No. DEA 370’’ on all electronic and electronically at http:// was in commercial distribution before written correspondence. DEA www.regulations.gov. (FDA has verified May 28, 1976. Any other automated encourages all comments be submitted the Web site address in this reference external defibrillator and automated electronically through http:// section, but FDA is not responsible for external defibrillator accessories, i.e., www.regulations.gov using the any subsequent changes to the Web site pad electrodes, adaptors, and batteries electronic comment form provided on after this document publishes in the shall have an approved PMA or that site. An electronic copy of this Federal Register.) declared completed PDP in effect before document and supplemental VerDate Mar<15>2010 17:07 Mar 22, 2013 Jkt 229001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 E:\FR\FM\25MRP1.SGM 25MRP1 srobinson on DSK4SPTVN1PROD with PROPOSALS 17896 Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Proposed Rules information to this proposed rule are may not be posted online or made of 1970, often referred to as the also available at the http:// available in the public docket. Controlled Substances Act and the www.regulations.gov Web site for easy Personal identifying information and Controlled Substances Import and reference. Paper comments that confidential business information Export Act (21 U.S.C. 801–971), as duplicate the electronic submission are identified and located as set forth above amended (hereinafter, ‘‘CSA’’). The not necessary as all comments will be redacted, and the comment, in implementing regulations for these submitted to www.regulations.gov will redacted form, will be posted online and statutes are found in Title 21 of the be posted for public review and are part placed in the DEA’s public docket file. Code of Federal Regulations (CFR), parts of the official docket record. Should Please note that the Freedom of 1300 to 1321. Under the CSA, controlled you, however, wish to submit written Information Act applies to all comments substances are classified in one of five comments via regular or express mail, received. If you wish to inspect the schedules based upon their potential for they should be sent to the Drug agency’s public docket file in person by abuse, their currently accepted medical Enforcement Administration, Attention: appointment, please see the ‘‘For use, and the degree of dependence the DEA Federal Register Representative/ Further Information Contact’’ paragraph, substance may cause. 21 U.S.C. 812. The OD, 8701 Morrissette Drive, Springfield, above. initial schedules of controlled Virginia 22152. All requests for hearing Request for Hearing, Notice of substances by statute are found at 21 and waivers of participation must be Appearance at or Waiver of U.S.C. 812(c) and the current list of sent to Drug Enforcement Participation in Hearing scheduled substances are published at Administration, Attention: Hearing 21 CFR Part 1308. Clerk/LJ, 8701 Morrissette Drive, In accordance with the CSA, this The CSA permits these schedules to Springfield, Virginia 22152. action is a formal rulemaking ‘‘on the be modified by providing that record after opportunity for a hearing.’’ scheduling of any drug or other FOR FURTHER INFORMATION CONTACT: John 21 U.S.C. 811(a). Such proceedings are substance may be initiated by the W. Partridge, Executive Assistant, Office conducted pursuant to the provisions of Attorney General: (1) On his own of Diversion Control, Drug Enforcement the Administrative Procedure Act (5 motion; (2) at the request of the Administration; Mailing Address: 8701 U.S.C. 556 and 557) and 21 CFR Secretary of Health and Human Services Morrissette Drive, Springfield, Virginia 1308.41. Pursuant to 21 CFR 1308.44(a)– (HHS); or (3) on the petition of any 22152; Telephone:
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