Unknown. Final rule; technical amendment

4,417 words·~20 min read·/register/2001/05/22/01-12769·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2001-05-22.xml --- 66 99 Tuesday, May 22, 2001 Contents Agriculture Agriculture Department See Economic Research Service See Forest Service See Natural Resources Conservation Service See Rural Housing Service Air Force Air Force Department NOTICES Agency information collection activities: Proposed collection; comment request, 28155 01-12853 Alcohol Alcohol, Tobacco and Firearms Bureau PROPOSED RULES Alcoholic beverages:

Health warning statement; placement, legibility, and noticeability, 28135-28137 01-12802 Antitrust Antitrust Division NOTICES National cooperative research notifications: Asymmetrical Digital Subscriber Line Forum, 28200-28201 01-12857 Financial Services Technology Consortium, Inc., 28201 01-12858 Centers Centers for Disease Control and Prevention NOTICES Agency information collection activities: Submission for OMB review; comment request, 28166-28168 01-12773 01-12774 Grants and cooperative agreements; availability, etc.:

American Indian/Alaska Native Core Capacity Building Programs, 28168-28173 01-12810 Environmental health programs improvement, 28173-28174 01-12813 Professional Education on Prostate Cancer; Primary Health Care Providers Program, 28174-28177 01-12812 Redesigning Cities and Suburbs for Public Health Program, 28177-28179 01-12811 United Nations Foundation; Measles Control and Related Childhood Morbidity Reduction Program, 28179-28180 01-12814 Meetings: Disease, Disability, and Injury Prevention and Control Special Emphasis Panels, 28180-28181 01-12816 01-12817 01-12818 Public Health Service Activities and Research at DOE Sites Citizens Advisory Committee, 28181 01-12815 Coast Guard Coast Guard NOTICES Grants and cooperative agreements; availability, etc.:

Ballast water treatment systems; approval for experimental shipboard installation; comment request, 28213-28216 01-12719 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office Defense Defense Department See Air Force Department NOTICES Agency information collection activities: Submission for OMB review; comment request, 28154-28155 01-12828 Economic Economic Research Service NOTICES Agency information collection activities:

Proposed collection; comment request, 28144-28145 01-12845 Education Education Department NOTICES Agency information collection activities: Proposed collection; comment request, 28155-28156 01-12797 Submission for OMB review; comment request, 28156-28157 01-12798 Grants and cooperative agreements; availability, etc.: Dropout Prevention Demonstration Program, 28319-28339 01-12761 Employment Employment and Training Administration NOTICES Trade Act of 1974; implementation: Trade adjustment assistance program; designation of certifying officers, 28203 01-12820 Employment Employment Standards Administration NOTICES Agency information collection activities:

Proposed collection; comment request, 28203-28204 01-12821 Energy Energy Department See Federal Energy Regulatory Commission EPA Environmental Protection Agency RULES Air quality implementation plans; approval and promulgation; various States: California, 28056-28058 01-12716 Maryland, 28054-28056, 28058-28059 01-12712 01-12714 New Jersey, 28063-28066 01-12699 New York, 28059-28063 01-12700 Hazardous waste: Project XL program; site-specific projects— US Filter Recovery Services Facility, Roseville, MN, et al., 28066-28093 01-11671 Superfund program:

National oil and hazardous substances contingency plan— National priorities list update, 28093-28110 01-12703 01-12705 01-12707 01-12709 01-12710 Water supply: National primary and secondary drinking water regulations— Arsenic; maximum contaminant level goal, etc.; effective date delay, 28341-28350 01-12878 PROPOSED RULES Air quality implementation plans; approval and promulgation; various States: Maryland, 28137-28138 01-12713 01-12715 Hazardous waste management system: Hazardous waste manifest system modification, 28239-28318 01-11909 Superfund program:

National oil and hazardous substances contingency plan— National priorities list update, 28138-28141 01-12702 01-12704 01-12706 01-12708 01-12711 NOTICES Meetings: National Drinking Water Advisory Council, 28161-28162 01-12879 Pesticide Program Dialogue Committee, 28162-28163 01-12881 Executive Executive Office of the President See Presidential Documents FAA Federal Aviation Administration PROPOSED RULES Airworthiness directives: Eurocopter France, 28133-28134 01-12775 NOTICES Airport noise compatibility program:

Camarillo Airport, CA, 28216-28217 01-12835 Passenger facility charges; applications, etc.: Yellowstone Regional Airport, WY, 28217-28218 01-12836 FCC Federal Communications Commission RULES Common carrier services: Telecommunications Act of 1996; implementation— Unauthorized changes of consumers’ long distance carriers (slamming); 2000 biennial review of policies and rules, 28117-28125 01-12757 Federal Energy Federal Energy Regulatory Commission NOTICES Electric rate and corporate regulation filings:

PPL Electric Utilities Corp., 28159 01-12783 Southwest Power Pool, Inc., 28160 01-12784 Environmental statements; notice of intent: North Baja Pipeline, LLC, 28160-28161 01-12788 Hydroelectric applications, 28161 01-12785 *Applications, hearings, determinations, etc.:* Central Maine Power Co., 28157 01-12787 El Paso Natural Gas Co., 28157 01-12781 Idaho Power Co., 28157-28158 01-12786 Mississippi River Transmission Corp., 28158 01-12777 Northwest Pipeline Corp., 28158 01-12782 NSTAR Electric & Gas Corp., 28158-28159 01-12778 Texas Gas Transmission Corp., 28159 01-12780 Williston Basin Interstate Pipeline Co., 28159 01-12779 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies:

Change in bank control, 28163 01-12807 Formations, acquisitions, and mergers, 28163-28164 01-12806 Formations, acquisitions, and mergers; correction, 28163 01-12805 Permissible nonbanking activities, 28164 01-12804 Meetings; Sunshine Act, 28164 01-13074 FTC Federal Trade Commission NOTICES Agency information collection activities: Proposed collection; comment request, 28164-28165 01-12826 Federal Transit Federal Transit Administration NOTICES Buy America waivers: New Flyer of America, 28218 01-12863 Fish Fish and Wildlife Service RULES Endangered and threatened species:

Preble's meadow jumping mouse, 28125-28131 01-12792 NOTICES Endangered and threatened species permit applications, 28195-28196 01-12831 Marine mammal permit applications, 28196 01-12830 Food Food and Drug Administration RULES Medical devices: Orthopedic devices— Pedicle screw spinal systems; classification and reclassification; correction, 28051-28053 01-12769 NOTICES Reports and guidance documents; availability, etc.: Foodborne listeria monocytogenes among selected categories of ready-to-eat foods, relative risk to public health; risk assessment document, etc.

Comment period extension, 28181-28182 01-13055 Veterinary Medicinal Products, International Cooperation on Harmonisation of Technical Requirements for Registration— Impurities; residual solvents in new veterinary medicinal products, active substances and excipients, 28182-28183 01-12770 Forest Forest Service NOTICES Meetings: Southwest Washington Provincial Advisory Committee, 28145 01-12772 Health Health and Human Services Department See Centers for Disease Control and Prevention See Food and Drug Administration See Health Care Financing Administration See Health Resources and Services Administration NOTICES Agency information collection activities:

Proposed collection; comment request, 28165-28166 01-12776 National Vaccine Injury Compensation Program: Pneumococcal conjugate vaccines; addition to vaccine injury table, 28166 01-12808 Health Health Care Financing Administration RULES Medicaid: Psychiatric residential treatment facilities providing psychiatric services to individuals under age 21; use of restraint and seclusion, 28110-28117 01-13041 NOTICES Grants and cooperative agreements; availability, etc.: Medicaid— Long term services and supports permitting people of any age with disabilities or long-term illnesses to live in community; design and delivery, 28183-28187 01-12882 Privacy Act:

Computer matching programs, 28188-28189 01-12763 Health Health Resources and Services Administration NOTICES Grants and cooperative agreements; availability, etc.: Health Workforce Studies Regional Centers, 28189-28191 01-12771 Meetings: Interdisciplinary, Community-Based Linkages Advisory Committee, 28191-28192 01-12809 Housing Housing and Urban Development Department NOTICES Agency information collection activities: Proposed collection; comment request, 28192 01-12795 Grant and cooperative agreement awards:

Lead-Based Paint Hazard Control— Tides Foundation, 28192 01-12796 Privacy Act: Systems of records, 28192-28194 01-12839 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau International International Trade Administration NOTICES Antidumping: Solid agricultural grade ammonium nitrate from— Ukraine, 28147 01-12860 Stainless steel sheet and strip in coils from— Taiwan, 28147 01-12859 Justice Justice Department See Antitrust Division NOTICES Pollution control; consent judgments:

Applied Science Laboratories, Inc., et al., 28199 01-12856 Black Mesa Pipeline, Inc., 28199 01-12854 General Ceramics, Inc., 28200 01-12793 Marathon Ashland Petroleum LLC, 28200 01-12855 Labor Labor Department See Employment and Training Administration See Employment Standards Administration NOTICES Agency information collection activities: Submission for OMB review; comment request, 28201-28203 01-12843 01-12844 Land Land Management Bureau NOTICES Environmental statements; availability, etc.:

Zion National Park, UT, 28196-28197 01-12801 Motor vehicle use restrictions: Colorado, 28198 01-12800 Withdrawal and reservation of lands: Oregon, 28198-28199 01-12768 Maritime Maritime Administration NOTICES Fishery endorsements; vessel ownership and control requirements applicability: DEFENDER, 28219-28220 01-12837 PACIFIC PRINCE, 28220-28221 01-12838 National Capital National Capital Planning Commission NOTICES Reports and guidance documents; availability, etc.: National Capital Region; antennas on Federal property; guidelines and submission requirements, 28204 01-12877 National Credit National Credit Union Administration NOTICES Meetings;

Sunshine Act, 28205 01-13015 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management: Alaska; fisheries of Exclusive Economic Zone— Pacific cod, 28132 01-12870 Magnuson-Stevens Act provisions— Foreign fishing vessels; fee schedule, 28131-28132 01-12872 PROPOSED RULES Endangered and threatened species: Critical habitat designations— Bowhead whales; Western Arctic stock, 28141-28142 01-12876 Fishery conservation and management: Magnuson-Stevens Act provisions— Domestic fisheries; exempted fishing permits, 28142-28143 01-12871 NOTICES Agency information collection activities:

Proposed collection; comment request, 28147-28150 01-12865 01-12867 01-12868 01-12869 01-12875 Grants and cooperative agreements; availability, etc.: Dr. Nancy Foster Scholarship Program; financial assistance for graduate students, 28150-28153 01-12822 Meetings: New England Fishery Management Council, 28153 01-12873 North Pacific Fishery Management Council, 28154 01-12874 National Science National Science Foundation NOTICES Meetings: Social, Behavioral, and Economic Sciences Special Emphasis Panel, 28205 01-12829 NRCS Natural Resources Conservation Service NOTICES Environmental statements; availability, etc.:

Lower Tillamook Bay Watershed, OR, 28145-28146 01-12862 Nuclear Nuclear Regulatory Commission NOTICES Committees; establishment, renewal, termination, etc.: Reactor Safeguards Advisory Committee, 28206 01-12833 *Applications, hearings, determinations, etc.:* Babcock & Wilcox Co., 28205-28206 01-12834 Patent Patent and Trademark Office RULES Patent cases: Patent Cooperation Treaty application procedures; revision Correction, 28053-28054 01-12764 Presidential Presidential Documents PROCLAMATIONS *Special observances:* Safe Boating Week, National (Proc. 7440), 28049-28050 01-13056 World Trade Week (Proc. 7441), 28351-28354 01-13115 EXECUTIVE ORDERS Government agencies and employees:

Energy effects of Federal regulations; preparation of statements (EO 13211), 28355-28356 01-13116 Energy-related projects, actions to expedite Federal (EO 13212), 28357-28358 01-13117 Public Public Debt Bureau NOTICES Privacy Act: Systems of records, 28222-28236 01-12823 Public Public Health Service See Centers for Disease Control and Prevention See Food and Drug Administration See Health Resources and Services Administration Rural Rural Housing Service NOTICES Agency information collection activities:

Proposed collection; comment request, 28146-28147 01-12789 SEC Securities and Exchange Commission NOTICES Agency information collection activities: Submission for OMB review; comment request, 28206-28207 01-12790 Self-regulatory organizations; proposed rule changes: Government Securities Clearing Corp., 28207-28209 01-12824 National Association of Securities Dealers, Inc., 28209-28210 01-12825 New York Stock Exchange, Inc., 28210-28212 01-12791 SBA Small Business Administration NOTICES Agency information collection activities:

Proposed collection; comment request, 28212 01-12827 State State Department NOTICES Meetings: International Communications and Information Policy Advisory Committee, 28212 01-12851 Public Diplomacy, U.S. Advisory Commission, 28212 01-12849 Shipping Coordinating Committee, 28212-28213 01-12850 01-12852 Surface Surface Transportation Board NOTICES Rail carriers: Waybill data; release for use, 28222 01-12799 Transportation Transportation Department See Coast Guard See Federal Aviation Administration See Federal Transit Administration See Maritime Administration See Surface Transportation Board Treasury Treasury Department See Alcohol, Tobacco and Firearms Bureau See Public Debt Bureau Veterans Veterans Affairs Department NOTICES Privacy Act:

Computer matching programs, 28236-28237 01-12762 Separate Parts In This Issue Part II Environmental Protection Agency, 28239-28318 01-11909 Part III Department of Education, 28319-28339 01-12761 Part IV Environmental Protection Agency, 28341-28350 01-12878 Part V The President, 28351-28358 01-13115 01-13116 01-13117 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. 66 99 Tuesday, May 22, 2001 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 888 [Docket No. 95N-0176] Orthopedic Devices:

Classification and Reclassification of Pedicle Screw Spinal Systems; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration

(FDA)is correcting a final rule that classified certain previously unclassified preamendments pedicle screw spinal systems and reclassified certain postamendments pedicle screw spinal systems. The agency is correcting the rule to include an intended use that was inadvertently omitted from the codified language in the rule. In addition, the agency is correcting the rule to clarify that, when intended for certain uses, the device is a preamendments, not a postamendments, device. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). DATES: This rule is effective June 21, 2001. FOR FURTHER INFORMATION CONTACT: Aric D. Kaiser, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2036. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of July 27, 1998 (63 FR 40025), FDA published a final rule classifying certain previously unclassified preamendments pedicle screw spinal systems and reclassifying certain postamendments pedicle screw spinal systems. Following publication of the rule, the agency discovered that the rule contained several errors. II. Corrections to the Rule A. Severe Spondylolisthesis (Grades 3 and 4) at L5-S1 in Skeletally Mature Patients FDA inadvertently omitted one intended use from the codified language in the rule. This use, for which the device was being classified into class II, is treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having the implants attached to the lumbar and sacral spine with removal of the implants after attainment of a solid fusion. This omission from the codification was a typographical error. As described in the preamble to the rule, the Orthopedics and Rehabilitation Devices Advisory Panel (the Panel) recommended classifying the device into class II when intended for this use, and the agency had determined that class II was the appropriate class. In fact, the summary of the final rule included this intended use in the list of intended uses for which the device was being classified into class II. The agency is correcting the rule, therefore, to include treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having the implants attached to the lumbar and sacral spine with removal of the implants after attainment of solid fusion in the list of class II intended uses for the device. B. In Skeletally Mature Patients: Degenerative Spondylolisthesis With Objective Evidence of Neurologic Impairment; Fracture; Dislocation; Failed Previous Fusion (Pseudarthrosis); Degenerative Disc Disease; and Spondylolisthesis Other Than Either Severe Spondylolisthesis (Grades 3 and 4) at L5-S1 or Degenerative Spondylolisthesis with Objective Evidence of Neurologic Impairment In the final rule, FDA described the intended uses listed above as postamendments intended uses. However, on March 20, 1998, prior to publication of the final rule, FDA cleared a premarket notification submission (510(k)) that included preamendments documentation showing that spondylolisthesis (all types and grades), spondylolysis, trauma, failed previous fusions (pseudarthrosis), degenerative disc disease, and degeneration of the facets accompanied by instability in the cervical, thoracic, lumbar and sacral spine (C2-S1) are preamendments intended uses (Ref. 1). The 510(k) submission included affidavits establishing preamendments use from the original device marketer, the device inventor, credible users, and the sponsor of the 510(k). CDRH’s Office of Compliance found these documents adequate to establish the preamendments status of this device as a pedicle screw spinal system for specific indications. Consequently, the rule should have stated that for these intended uses, the device was being classified, not reclassified. FDA acknowledges that the additional preamendments intended uses should have been incorporated into the final rule prior to its publication. If this had been done, the codified language would be as it is below. The agency regrets any inconveniences that this delay in incorporating the additional preamendments intended uses may have caused. 1. In Skeletally Mature Patients: Degenerative Spondylolisthesis With Objective Evidence of Neurologic Impairment; Fracture; Dislocation; and Failed Previous Fusion (Pseudarthrosis) FDA’s error in referring to the device when intended to treat degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, or failed previous fusion (pseudarthrosis), as a postamendments, rather than a preamendments, device did not affect the classification into class II under the final rule. The agency intended to classify the device when intended for these uses into class II. In addition, the requirement that the agency obtain a recommendation from an advisory panel regarding the classification of a preamendments device was met because the Panel considered these intended uses when making its recommendation (Ref. 2). The fact that these are preamendments devices, rather than postamendments devices, intended uses has no impact on either the classification of the device or the premarket submissions required for pedicle screw spinal systems intended for these uses. In addition, no change in the codified language of the rule is necessary to reflect this fact. 2. Degenerative Disc Disease and Spondylolisthesis Other Than Either Severe Spondylolisthesis (Grades 3 and 4) at L5-S1 or Degenerative Spondylolisthesis With Objective Evidence of Neurologic Impairment FDA also described the device when intended to treat degenerative disc disease and spondylolisthesis other than severe spondylolisthesis (grades 3 and 4) at L5-S1 as a postamendments, rather than as a preamendments, device. This error did not affect the classification of the device, when intended for these uses, into class III under the final rule. The agency intended to classify the device when intended for these uses into class III. In addition, the requirement that the agency obtain from an advisory panel a recommendation regarding the classification of a preamendments device was satisfied because the Panel considered these intended uses when making its recommendation (Ref. 2). However, the agency’s error does affect the type of premarket submission required for the device when intended for these uses. Because these are preamendments intended uses, premarket approval applications are not required until the agency issues a final rule under section 515(b) of the act (21 U.S.C. 360e(b)) requiring submission of premarket approval applications. FDA intends to initiate the call for premarket approval applications for the device when intended for these uses in a future document in the **Federal Register** . Until that time, the devices may enter the market after clearance of a premarket notification (510(k)) submission. The agency is correcting the rule accordingly. C. Spondylolysis and Degeneration of the Facets Accompanied by Instability in the Thoracic, Lumbar and Sacral Spine; Severe Spondylolisthesis (Grades 3 and 4) at L5-S1 in the Nonskeletally Mature Population; Treatment of Cervical Spondylolisthesis (All Grades and Types); Cervical Spondylolysis; Cervical Degenerative Disc Disease; Degeneration of the Cervical Facets Accompanied by Instability; Cervical Trauma (Fracture and Dislocation); and Revision of Failed Previous Fusion Surgery (Pseudarthrosis) of the Cervical Spine On January 20, 1995, the agency cleared a 510(k) that included documentation that use of pedicle screw spinal systems to treat severe spondylolisthesis (grades 3 and 4) at L5-S1 in patients receiving fusion by autogenous bone graft having the implants attached to the lumbar and sacral spine with removal of the implants after attainment of a solid fusion is a preamendments intended use. While the preamendments indication originally described by the agency in the final rule was limited to skeletally mature patients, the preamendments documentation also supports the use of this pedicle screw spinal system for the same intended use in patients who are not skeletally mature (Ref. 3). In addition, the March 20, 1998, 510(k) clearance described above in section II.B of this document identified a number of intended uses that were not included as part of the final rule, specifically:

(1)Spondylolysis in the thoracic, lumbar and sacral spine;

(2)Degeneration of the facets accompanied by instability in the thoracic, lumbar and sacral spine;

(3)Cervical spondylolisthesis (all grades and types);

(4)Cervical spondylolysis;

(5)Cervical degenerative disc disease;

(6)Degeneration of the cervical facets accompanied by instability;

(7)Cervical trauma (fracture and dislocation); and

(8)Revision of failed previous fusion surgery (pseudarthrosis) of the cervical spine. Neither the use in nonskeletally mature patients nor the eight intended uses listed above were discussed by the Panel at either its August 20, 1993, or July 23, 1994, meetings or as part of the information they subsequently reviewed. Because they are preamendments intended uses, a panel recommendation is required before they may be classified (21 U.S.C. 360c(c)). FDA intends to seek the recommendation of an advisory panel with respect to classification of the device when intended for these uses at a future Panel meeting. For these intended uses, the device currently is considered an unclassified preamendments device and may enter the market after clearance of a 510(k) submission. D. Summary of the Revisions to § 888.3070 In light of the above, FDA has made the following changes to § 888.3070:

(1)FDA has reorganized the section to simplify the presentation.

(2)FDA has added “severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra” to the intended uses for the class II pedicle screw spinal systems (§ 888.3070(b)(1)). FDA has also added this intended use to the labeling for the special controls.

(3)FDA has changed the intended uses for which pedicle screw spinal systems are in class III from “all other uses” to “when intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment” (§ 888.3070(b)(2)).

(4)FDA has amended § 888.3070(c) to state that, for the devices described in paragraph § 888.3070(b)(2), no effective date has been established for submission of a premarket approval application

(PMA)or a notice of completion of a product development protocol (PDP). FDA will issue a rule to require PMA’s or PDP’s for these devices in the future. Until that time, pedicle screws for these intended uses may be marketed through the premarket notification process.

(5)At a future time, and after obtaining a Panel recommendation, FDA will propose a rule to classify the device for the unclassified uses described in section II.C of this document III. References The following references have been placed on display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. These references may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. K970599, Sofamor Danek Townley Pedicle Screw Plating System. 2. Food and Drug Administration Orthopedic and Rehabilitation Devices Advisory Panel Meeting transcripts, Gaithersburg, MD, July 22, 1994. 3. K932029, Sofamor Danek TSRH Spinal System. IV. Environmental Impact The agency had determined under 21 CFR 25.30(i) that this final rule is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. V. Analysis of Impacts FDA has examined the impact of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C 601-612) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, this rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The only effect of this correction is to delay the requirement for manufacturers of pedicle screw spinal systems intended for certain uses to submit PMA’s for these devices until FDA issues a regulation requiring such submissions. Therefore, the agency certifies that this final rule will not have a significant economic impact on a substantial number of small entities. This rule also does not trigger the requirement for a written statement under section 202(a) of the Unfunded Mandates Reform Act because it does not impose a mandate that results in an expenditure of $100 million or more by State, local, or tribal governments in the aggregate, or by the private sector, in any one year. List of Subjects in 21 CFR Part 888 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 888 is amended as follows: PART 888—ORTHOPEDIC DEVICES 1. The authority citation for 21 CFR part 888 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Section 888.3070 is revised to read as follows: § 888.3070 Pedicle screw spinal system.

(a)*Identification* . Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.

(b)*Classification* .

(1)Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:

(i)Compliance with material standards;

(ii)Compliance with mechanical testing standards;

(iii)Compliance with biocompatibility standards; and

(iv)Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”

(2)Class III (premarket approval), when intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

(c)*Date PMA or notice of completion of a PDP is required* . No effective date has been established of the requirement for premarket approval for the devices described in paragraph (b)(2) of this section. See § 888.3. Dated: May 11, 2001. Margaret M. Dotzel, Associate Commissioner for Policy. [FR Doc. 01-12769 Filed 5-21-01; 8:45 am]

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