Unknown. Final order

4,529 words·~21 min read·/register/2014/02/18/2014-03388·

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--- schema: federal-register doc_type: fedreg source_file: FR-2014-02-18.xml --- 79 32 Tuesday, February 18, 2014 Contents Advisory Council on Historic Preservation See Historic Preservation, Advisory Council Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 9209-9214 2014-03482 2014-03484 2014-03487 Common Formats for Patient Safety Data Collection and Event Reporting, 9214-9215 2014-03492 Agriculture Agriculture Department See Forest Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 9157 2014-03372 Air Force Air Force Department NOTICES Meetings: Air Force Academy Board of Visitors, 9182-9183 2014-03394 Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: FFL Out-of-Business Records Request, 9279-9280 2014-03414 Army Army Department See Engineers Corps Coast Guard Coast Guard RULES Safety Zones: Eleventh Coast Guard District Annual Fireworks Events, 9088-9097 2014-03468 Maintenance Dredging 35-Foot Channel and Rock Removal;

Portland Harbor, ME, 9086-9088 2014-03464 Special Local Regulations: Southern California Annual Marine Events for the San Diego Captain of the Port Zone, 9085-9086 2014-03470 PROPOSED RULES Safety Zones: Sea Plane Landing; Bayou Grande; Pensacola, FL, 9118-9120 2014-03467 Commerce Commerce Department See Economic Analysis Bureau See Industry and Security Bureau See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Qualitative Feedback on Agency Service Delivery, 9159 2014-03378 Defense Department Defense Department See Air Force Department See Engineers Corps Drug Drug Enforcement Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Reports of Suspicious Orders or Theft/Loss of Listed Chemicals/Machines, 9280-9281 2014-03415 Economic Analysis Bureau Economic Analysis Bureau NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: BE-125; Quarterly Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons, 9159-9160 2014-03361 BE-37; Survey of U.S. Airline Operators' Foreign Revenues and Expenses, 9160-9161 2014-03363 Education Department Education Department NOTICES Applications for New Awards: Alaska Native Education Program, 9184-9189 2014-03475 Native Hawaiian Education Program, 9189-9194 2014-03477 Energy Department Energy Department See Federal Energy Regulatory Commission Engineers Engineers Corps NOTICES Draft Guidance for Industry and Staff:

Great Lakes and Mississippi River Interbasin Study, 9183 2014-03491 Meetings: Board on Coastal Engineering Research, 9183-9184 2014-03445 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: New Mexico; Transportation Conformity and General Conformity Requirements for Bernalillo County, 9097-9100 2014-03434 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Arizona;

Regional Haze and Interstate Visibility Transport Federal Implementation Plan, 9318-9378 2014-02714 New Mexico; Transportation Conformity and General Conformity Requirements for Bernalillo County, 9133-9134 2014-03439 Texas; Prevention of Significant Deterioration; Greenhouse Gas Tailoring Rule Revisions; Withdrawal, 9123-9133 2014-03429 Wisconsin; Redesignation of the Milwaukee-Racine 2006 24-Hour Fine Particle Nonattainment Area to Attainment, 9134-9152 2014-03314 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 9198-9199 2014-03335 Environmental Impact Statements; Weekly Receipts, 9199 2014-03317 Meetings: Mobile Sources Technical Review Subcommittee, 9199 2014-03449 Privacy Act; Systems of Records, 9199-9204 2014-03430 2014-03431 Proposed Consent Decrees, Clean Air Act Citizen Suit, 9204-9205 2014-03427 Executive Office of the President See Management and Budget Office See Science and Technology Policy Office Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 9205-9206 2014-03330 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Debt Collection Financial Statement, 9251-9252 2014-03504 Exemption of State-Owned Properties under Self-Insurance Plan, 9250-9251 2014-03359 How to Process Mission Assignments in Federal Disaster Operations, 9252 2014-03497 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 9194-9197 2014-03418 2014-03419 2014-03420 Complaints:

New York Association of Public Power v. Niagara Mohawk Power Corp., The New York Independent System Operator, Inc., 9197 2014-03435 Environmental Assessments; Availability, etc.: Tygart LLC, 9197-9198 2014-03437 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Verso Androscoggin Power, LLC, 9198 2014-03436 Federal Railroad Federal Railroad Administration NOTICES Environmental Impact Statements; Availability, etc.: Chicago to Joliet High-Speed Rail Project, Cook and Will Counties, IL, 9306-9309 2014-03325 High-Speed Rail Project From Granite City, IL to St.

Louis, MO, 9309-9311 2014-03324 Petitions for Waivers of Compliance, 9311-9312 2014-03472 2014-03473 Federal Transit Federal Transit Administration NOTICES Buy American Waivers: Cross-Cabinet Cabinet, 9312-9313 2014-03444 Variable Refrigerant Flow HVAC System, 9313-9314 2014-03448 Fiscal Fiscal Service NOTICES Surety Companies Acceptable on Federal Bonds; Terminations: Kansas Bankers Surety Co., 9315 2014-03237 Fish Fish and Wildlife Service PROPOSED RULES Migratory Bird Hunting and Permits:

Regulations for Managing Harvest of Light Goose Populations, 9152-9156 2014-03446 NOTICES Endangered and Threatened Wildlife and Plants; Initiation of 5-Year Status Reviews: Five Species in Oregon, Palau, Guam, and the Northern Mariana Islands, 9263-9264 2014-03451 Environmental Impact Statements; Availability, etc.: Riverwide Restoration Plan; Allied Paper, Inc./Portage Creek/Kalamazoo River Superfund Site, 9264-9266 2014-03332 Food and Drug Food and Drug Administration RULES Medical Devices;

Neurological Devices: Classification of the Neuropsychiatric Interpretive Electroencephalograph Assessment Aid, 9083-9085 2014-03388 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Animal Feed Regulatory Program Standards, 9223-9224 2014-03460 Animal Generic Drug User Fee Act Cover Sheet, 9224-9225 2014-03352 Establishing and Maintaining Lists of United States Milk Product Manufacturers/Processors With Interest in Exporting, 9221-9222 2014-03389 Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile, 9219-9220 2014-03382 Final Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes To Be Documented in Annual Reports, 9215 2014-03350 Focus Groups as Used by the Food and Drug Administration (All FDA-Regulated Products), 9222-9223 2014-03351 Medical Devices;

Third Party Review under the Food and Drug Administration Modernization Act, 9215 2014-03354 Over-the-Counter Human Drugs; Labeling Requirements, 9217 2014-03348 Potential Tobacco Product Violations Reporting Form, 9216-9217 2014-03381 Risks in Direct-to-Consumer Prescription Drug Television Advertisements, 9217-9219 2014-03390 Determinations That Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness: STAVZOR (Valproic Acid) Delayed-Release Capsules, 125 Milligrams, 250 Milligrams, and 500 Milligrams, 9225 2014-03455 GANITE (Gallium Nitrate) Injectable and Five Other Drug Products, 9225-9226 2014-03458 Guidance for Industry and Staff:

Requests for Feedback on Medical Device Submissions; Pre-Submission Program and Meetings with FDA Staff, 9226-9229 2014-03453 Meetings: 2014 Medical Countermeasures Initiative Regulatory Science Symposium, 9230 2014-03358 FDA/Xavier University PharmaLink Conference; Leadership in a Global Supply Chain, 9229 2014-03454 Report on Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments, 9230-9235 2014-03353 Forest Forest Service NOTICES Environmental Impact Statements;

Availability, etc.: McCollins Late Successional Reserve Habitat Restoration Project, Klamath National Forest, CA, 9157-9159 2014-03428 General Services General Services Administration NOTICES Travel Data Challenge Competition, 9206-9209 2014-03191 Health and Human Health and Human Services Department See Agency for Healthcare Research and Quality See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health RULES World Trade Center Health Program:

Amendments to List of World Trade Center Related Health Conditions; Cancer; Revision, 9100-9117 2014-03370 Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 9235 2014-03442 Meetings: Advisory Commission on Childhood Vaccines, 9235-9236 2014-03441 Healthcare Research and Quality Agency See Agency for Healthcare Research and Quality Historic Historic Preservation, Advisory Council NOTICES Meetings:

Advisory Council on Historic Preservation, 9249-9250 2014-03373 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See Transportation Security Administration See U.S. Citizenship and Immigration Services Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: HUD Multifamily Energy Assessment, 9257-9258 2014-03478 Mortgage Insurance for Cooperative and Condominium Housing, 9255-9256 2014-03463 Mortgage Record Change, 9256 2014-03346 Mortgagee's Application for Partial Settlement, 9254-9255 2014-03466 Multifamily Accelerated Processing, 9255 2014-03471 Public Housing Annual Contributions Contractor and Inventory Removal Application, 9258-9260 2014-03480 Rent Schedule—Low Rent Housing, 9257 2014-03344 Section 8 Housing Assistance Payments Program:

Annual Adjustment Factors; Fiscal Year 2014, 9260-9263 2014-03461 Industry Industry and Security Bureau NOTICES Meetings: Materials Processing Equipment Technical Advisory Committee, 9162 2014-03385 Regulations and Procedures Technical Advisory Committee, 9161-9162 2014-03384 Transportation and Related Equipment Technical Advisory Committee, 9161 2014-03393 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Surface Mining Reclamation and Enforcement Office International Trade Adm International Trade Administration NOTICES Countervailing Duty Investigations;

Results, Extensions, Amendments, etc.: Steel Threaded Rod From India, 9162-9164 2014-03490 Determinations of Sales at Less Than Fair Value: Steel Threaded Rod From India, 9164-9167 2014-03483 International Trade Com International Trade Commission NOTICES Full Five-Year Reviews; Determinations: Polyethylene Terephthalate Film, Sheet, and Strip From Brazil, China, and the United Arab Emirates, 9276-9277 2014-03481 Investigations; Terminations, Modifications, and Rulings, etc.: Certain 3G Mobile Handsets and Components Thereof, 9277-9279 2014-03412 Certain Electronic Devices, Including Wireless Communication Devices, Tablet Computers, Media Players, etc., 9279 2014-03438 Justice Department Justice Department See Alcohol, Tobacco, Firearms, and Explosives Bureau See Drug Enforcement Administration Labor Department Labor Department See Labor Statistics Bureau See Occupational Safety and Health Administration Labor Statistics Labor Statistics Bureau NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 9281-9282 2014-03488 Land Land Management Bureau NOTICES Fee Collections: Public Land in Grand County, UT, 9266-9267 2014-03392 Public Land in Water Canyon, Humboldt County, NV; Final Supplementary Rules, 9267-9269 2014-03386 Realty Actions: Classification for Lease and/or Subsequent Conveyance for Recreation and Public Purposes of Public Land for a Park in Moapa, Clark County, NV, 9269-9270 2014-03387 Management Management and Budget Office NOTICES Discount Rates for Cost-Effectiveness Analysis of Federal Programs, 9284-9285 2014-03161 Military Compensation Military Compensation and Retirement Modernization Commission NOTICES Meetings:

Military Compensation and Retirement Modernization Commission, 9285 2014-03369 National Institute National Institute of Standards and Technology NOTICES Cybersecurity Framework, 9167-9168 2014-03495 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 9236-9243 2014-03411 Meetings: Center for Scientific Review, 9243-9244 2014-03406 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 9246 2014-03408 National Cancer Institute, 9246-9248 2014-03397 2014-03398 2014-03399 2014-03407 National Center for Advancing Translational Sciences, 9245 2014-03402 National Human Genome Research Institute, 9244-9245 2014-03401 National Institute of Allergy and Infectious Diseases, 9247 2014-03400 National Institute of Arthritis and Musculoskeletal and Skin Diseases, 9246 2014-03404 National Institute of Mental Health, 9245 2014-03403 National Institute on Aging, 9245-9246 2014-03396 National Institute on Deafness and Other Communication Disorders, 9247 2014-03409 National Institute of Environmental Health Sciences, 9247 2014-03405 Office of the Director, 9243 2014-03395 Prospective Grants of Exclusive Licenses:

Pre-Clinical Evaluation and Commercial Development of Human Therapeutics for Liver Cancer and Ovarian Cancer Within the Scope of the Licensed Patent Rights, 9248-9249 2014-03410 National Oceanic National Oceanic and Atmospheric Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Department of Commerce National Environmental Policy Act Environmental Questionnaire and Checklist, 9168-9169 2014-03343 Meetings: Gulf of Mexico Fishery Management Council, 9169-9170 2014-03443 Takes of Marine Mammals Incidental to Specified Activities:

St. George Reef Light Station Restoration and Maintenance at Northwest Seal Rock, Del Norte County, CA, 9170-9182 2014-03379 National Park National Park Service NOTICES Concession Contracts; Extensions, 9270-9272 2014-03349 Privacy Act; Systems of Records, 9272-9276 2014-03433 National Transportation National Transportation Safety Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 9285-9288 2014-03479 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Standard on Powered Platforms for Building Maintenance, 9282-9284 2014-03462 Office of Management and Budget See Management and Budget Office Peace Peace Corps NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 9288 2014-03440 Postal Service Postal Service PROPOSED RULES Rules of Practice in Proceedings Under the Debt Collection Act, 9120-9123 2014-03368 Public Debt Public Debt Bureau See Fiscal Service Railroad Retirement Railroad Retirement Board NOTICES Meetings;

Sunshine Act, 9288 2014-03554 Science Technology Science and Technology Policy Office NOTICES Spectrum Policy, 9288-9290 2014-03413 Securities Securities and Exchange Commission NOTICES Applications: Acacia Asset Management LLC and Acacia Trust, 9290-9296 2014-03377 Self-Regulatory Organizations; Proposed Rule Changes: ICE Clear Europe Ltd., 9296-9298, 9304-9305 2014-03374 2014-03375 NASDAQ OMX PHLX LLC, 9302-9303 2014-03376 NASDAQ Stock Market, LLC, 9298-9302 2014-03383 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 9276 2014-03486 Surface Transportation Surface Transportation Board NOTICES Applications: TTX Company, et al., 9314-9315 2014-03456 Petitions for Declaratory Orders: Rail-Term Corp., 9315 2014-03417 Susquehanna Susquehanna River Basin Commission NOTICES Meetings: Susquehanna River Basin Commission, 9305 2014-02983 Transportation Department Transportation Department See Federal Railroad Administration See Federal Transit Administration See Surface Transportation Board See Transportation Security Administration NOTICES Applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier Permits, 9306 2014-03416 Security Transportation Security Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Department of Homeland Security Traveler Redress Inquiry Program, 9252-9253 2014-03355 Treasury Treasury Department See Fiscal Service U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: myE-Verify, 9253-9254 2014-03357 Separate Parts In This Issue Part II Environmental Protection Agency, 9318-9378 2014-02714 Reader Aids Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 79 32 Tuesday, February 18, 2014 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2013-M-0042] Medical Devices; Neurological Devices; Classification of the Neuropsychiatric Interpretive Electroencephalograph Assessment Aid AGENCY:

Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug Administration

(FDA)is classifying the neuropsychiatric interpretive electroencephalograph

(EEG)assessment aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective March 20, 2014. The classification was applicable beginning July 15, 2013. FOR FURTHER INFORMATION CONTACT: Peter Como, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2463, Silver Spring, MD 20993-0002, 301-796-6919. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144, July 9, 2012, 126 Statute 1054), provides two procedures by which a person may request that FDA classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the **Federal Register** announcing this classification. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on November 18, 2011, classifying the Neuropsychiatric EEG-Based Assessment Aid

(NEBA)System for attention-deficit/hyperactivity disorder into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On December 8, 2011, Lexicor Medical Technology, LLC, submitted a request for classification of the NEBA System under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the de novo request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on July 15, 2013, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.1140 (§ 882.1440). Following the effective date of this final classification administrative order, any firm submitting a 510(k) premarket notification for a neuropsychiatric interpretive EEG assessment aid will need to comply with the special controls named in the final administrative order. The device is assigned the generic name neuropsychiatric interpretive electroencephalograph assessment aid, and it is identified as a prescription device that uses a patient's EEG to provide an interpretation of the patient's neuropsychiatric condition. The neuropsychiatric interpretive EEG assessment aid is used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis. FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks: Table 1—Neuropsychiatric Interpretive EEG Assessment Aid Risks and Mitigation Measures Identified risks Mitigation measures Adverse tissue reaction Biocompatibility. Electromagnetic incompatibility Electromagnetic compatibility testing. Equipment malfunction leading to injury to user/patient (shock, burn, or mechanical failure) Electrical safety, thermal, and mechanical testing. Labeling. False result leading to delay in treatment or unnecessary treatment due to hardware failure Performance testing. Hardware and software verification, validation, and hazard analysis. Technical parameters. Labeling. False result due to incorrect artifact reduction Operator training. Software verification and validation. Labeling. False result due to incorrect placement of electrodes Operator training. Clinical performance testing. Labeling. False result when a neuropsychiatric interpretive EEG assessment aid is used for confirmatory support or support for further testing Clinical performance testing. Device design characteristics. Labeling. Use error Clinical performance testing. Labeling. FDA believes that the following special controls, in addition to the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness: 1. The technical parameters of the device, hardware and software, must be fully characterized and must demonstrate a reasonable assurance of safety and effectiveness. a. Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. b. Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification and software design specification. Appropriate software verification, validation, and hazard analysis must be performed. 2. The device parts that contact the patient must be demonstrated to be biocompatible. 3. The device must be designed and tested for electrical safety, electromagnetic compatibility, thermal, and mechanical safety. 4. Clinical performance testing must demonstrate the accuracy, precision, reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs). 5. Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value, and negative predictive value per the device intended use. Repeatability of measurements must be demonstrated using interclass correlation coefficients and illustrated by qualitative scatter plot(s). 6. The device design must include safeguards to prevent use of the device as a stand-alone diagnostic. 7. The labeling must include the following information: a. A warning that the device is not to be used as a stand-alone diagnostic. b. A detailed summary of the clinical performance testing, including any adverse events and complications. c. The qualifications and training requirements for device users including technicians and clinicians. d. The intended use population and the intended use environment. e. Any instructions technicians should convey to patients regarding the collection of EEG data. f. Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway. g. Where appropriate, validated methods and instructions for reprocessing of any reusable components. Neuropsychiatric interpretive EEG assessment aids are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device. (Proposed § 882.1440(a); see section 520(e) of the FD&C Act (21 U.S.C. 360j(e)) and § 801.109 (21 CFR 801.109) (Prescription devices).) Prescription-use restrictions are a type of general controls as defined in section 513(a)(1)(A)(i) of the FD&C Act. Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification prior to marketing the device, which contains information about the neuropsychiatric interpretive EEG assessment aid they intend to market. II. Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action 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. III. Paperwork Reduction Act of 1995 This final administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485. IV. Reference The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at *http://www.regulations.gov.* 1. K112711—De Novo Request per 513(f) pursuant to the Agency's NSE Determination, dated November 18, 2011, From Lexicor Medical Technology, LLC, dated December 7, 2011. List of Subjects in 21 CFR Part 882 Medical devices, Neurological devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows: PART 882—NEUROLOGICAL DEVICES 1. The authority citation for 21 CFR part 882 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Add § 882.1440 to subpart B to read as follows: § 882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid.

(a)*Identification.* The neuropsychiatric interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph

(EEG)to provide an interpretation of the patient's neuropsychiatric condition. The neuropsychiatric interpretive EEG assessment aid is used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.

(b)*Classification.* Class II (special controls). The special controls for this device are:

(1)The technical parameters of the device, hardware and software, must be fully characterized and must demonstrate a reasonable assurance of safety and effectiveness.

(i)Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.

(ii)Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification and software design specification. Appropriate software verification, validation, and hazard analysis must be performed.

(2)The device parts that contact the patient must be demonstrated to be biocompatible.

(3)The device must be designed and tested for electrical safety, electromagnetic compatibility, thermal, and mechanical safety.

(4)Clinical performance testing must demonstrate the accuracy, precision, reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs).

(5)Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value, and negative predictive value per the device intended use. Repeatability of measurements must be demonstrated using interclass correlation coefficients and illustrated by qualitative scatter plot(s).

(6)The device design must include safeguards to prevent use of the device as a stand-alone diagnostic.

(7)The labeling must include the following information:

(i)A warning that the device is not to be used as a stand-alone diagnostic.

(ii)A detailed summary of the clinical performance testing, including any adverse events and complications.

(iii)The qualifications and training requirements for device users including technicians and clinicians.

(iv)The intended use population and the intended use environment.

(v)Any instructions technicians should convey to patients regarding the collection of EEG data.

(vi)Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway.

(vii)Where appropriate, validated methods and instructions for reprocessing of any reusable components. Dated: February 12, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014-03388 Filed 2-14-14; 8:45 am]

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