4998 Federal Register / Vol. 84, No. 34 / Wednesday, February 20, 2019 / Rules and Regulations 
Cleveland, OH, Cuyahoga County, ILS OR 
LOC RWY 24, Amdt 16A 
Columbus, OH, Rickenbacker Intl, NDB RWY 
5R, Amdt 2A, CANCELED 
Columbus, OH, Rickenbacker Intl, NDB RWY 
23L, Amdt 2A, CANCELED 
Youngstown-Warren, OH, Youngstown- 
Warren Rgnl, RADAR 1, Amdt 14 
Tulsa, OK, Tulsa Intl, ILS OR LOC RWY 18L, 
Amdt 16A 
Tulsa, OK, Tulsa Intl, RNAV (GPS) RWY 8, 
Amdt 2B 
Clarion, PA, Clarion County, VOR–A, Amdt 
3A, CANCELED 
Corry, PA, Corry-Lawrence, NDB RWY 14, 
Amdt 5, CANCELED 
Franklin, PA, Venango Rgnl, VOR RWY 3, 
Amdt 5B, CANCELED 
Harrisburg, PA, Harrisburg Intl, ILS OR LOC 
RWY 31, Amdt 1E 
Hazleton, PA, Hazleton Rgnl, Takeoff 
Minimums and Obstacle DP, Amdt 3 
West Chester, PA, Brandywine Rgnl, RNAV 
(GPS) RWY 9, Amdt 1A 
West Chester, PA, Brandywine Rgnl, RNAV 
(GPS) RWY 27, Amdt 1A 
West Chester, PA, Brandywine Rgnl, Takeoff 
Minimums and Obstacle DP, Amdt 1A 
West Chester, PA, Brandywine Rgnl, VOR–A, 
Amdt 4A 
York, PA, York, RNAV (GPS) RWY 17, Amdt 
2C 
York, PA, York, RNAV (GPS) RWY 35, Amdt 
1C 
Greenville, SC, Greenville Downtown, ILS Y 
OR LOC Y RWY 1, Orig-B 
Greenville, SC, Greenville Downtown, ILS Z 
OR LOC Z RWY 1, Amdt 30B 
Orangeburg, SC, Orangeburg Muni, Takeoff 
Minimums and Obstacle DP, Amdt 4 
Pierre, SD, Pierre Rgnl, ILS OR LOC RWY 31, 
Amdt 12D 
Albany, TX, Albany Muni, RNAV (GPS) RWY 
17, Amdt 1C 
Albany, TX, Albany Muni, RNAV (GPS) RWY 
35, Amdt 1C 
Baytown, TX, RWJ Airpark, Takeoff 
Minimums and Obstacle DP, Amdt 1A 
Borger, TX, Hutchinson County, VOR RWY 
17, Amdt 9, CANCELED 
Borger, TX, Hutchinson County, VOR/DME 
RWY 35, Amdt 4A, CANCELED 
Fredericksburg, TX, Gillespie County, 
Takeoff Minimums and Obstacle DP, Amdt 
2 
Galveston, TX, Scholes Intl at Galveston, ILS 
OR LOC RWY 14, Amdt 12C 
Galveston, TX, Scholes Intl at Galveston, 
VOR RWY 14, Amdt 4C 
Haskell, TX, Haskell Muni, RNAV (GPS)-A, 
Orig-A 
Houston, TX, Conroe-North Houston Rgnl, 
ILS OR LOC RWY 14, Amdt 3C 
Houston, TX, Conroe-North Houston Rgnl, 
NDB RWY 14, Amdt 3C 
Houston, TX, George Bush Intercontinental/ 
Houston, ILS OR LOC RWY 8L, ILS RWY 8L SA CAT I, ILS RWY 8L CAT II, ILS RWY 8L CAT III, Amdt 4D 
Houston, TX, George Bush Intercontinental/ 
Houston, ILS OR LOC RWY 9, ILS RWY 9 SA CAT I, ILS RWY 9 SA CAT II, Amdt 10B 
Houston, TX, George Bush Intercontinental/ 
Houston, ILS OR LOC RWY 26L, ILS RWY 26L SA CAT I, ILS RWY 26L CAT II, ILS RWY 26L CAT III, Amdt 21D Houston, TX, George Bush Intercontinental/ 
Houston, ILS OR LOC RWY 26R, ILS RWY 
26R SA CAT I, ILS RWY 26R CAT II, ILS RWY 26R CAT III, Amdt 4B 
Houston, TX, George Bush Intercontinental/ 
Houston, ILS OR LOC RWY 27, ILS RWY 27 SA CAT I, ILS RWY 27 CAT II, ILS RWY 27 CAT III, Amdt 11A 
Houston, TX, Pearland Rgnl, VOR–B, Amdt 
1A, CANCELED 
Houston, TX, William P Hobby, ILS OR LOC 
RWY 4, ILS RWY 4 SA CAT I, ILS RWY 4 CAT II, ILS RWY 4 CAT III, Amdt 43A 
Houston, TX, William P Hobby, ILS OR LOC 
RWY 13R, Amdt 12D 
Houston, TX, William P Hobby, ILS OR LOC 
RWY 31L, Amdt 6D 
La Porte, TX, La Porte Muni, VOR–A, Orig- 
B, CANCELED 
Olney, TX, Olney Muni, RNAV (GPS) RWY 
17, Amdt 1 
Olney, TX, Olney Muni, RNAV (GPS) RWY 
35, Amdt 1 
Brookneal, VA, Brookneal/Campbell County, 
RNAV (GPS) RWY 24, Amdt 1B 
Brookneal, VA, Brookneal/Campbell County, 
VOR–A, Amdt 2A 
Norfolk, VA, Chesapeake Rgnl, VOR/DME 
RWY 23, Amdt 1A, CANCELED 
Petersburg, VA, Dinwiddie County, Takeoff 
Minimums and Obstacle DP, Amdt 1 
Burlington, WI, Burlington Muni, RNAV 
(GPS) RWY 11, Orig-C 
Burlington, WI, Burlington Muni, RNAV 
(GPS) RWY 29, Amdt 1C 
Park Falls, WI, Park Falls Muni, NDB RWY 
36, Amdt 1A, CANCELED 
Platteville, WI, Platteville Muni, RNAV (GPS) 
RWY 7, Orig-C 
Platteville, WI, Platteville Muni, RNAV (GPS) 
RWY 25, Orig-A 
Bluefield, WV, Mercer County, ILS OR LOC 
RWY 23, Amdt 15D 
Rescinded: On February 7, 2019 (84 FR 
2441), the FAA published an Amendment in 
Docket No. 31229, Amdt No. 3831, to Part 97 of the Federal Aviation Regulations under section 97.33. The following entry for College Station, TX, effective February 28, 2019, is hereby rescinded in its entirety: 
College Station, TX, Easterwood Field, RNAV 
(GPS) RWY 29, Amdt 1B 
[FR Doc. 2019–02679 Filed 2–19–19; 8:45 am] 
BILLING CODE 4910–13–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 872 
[Docket No. FDA–2019–N–0142] 
Medical Devices; Dental Devices; 
Classification of the Auto Titration Device for Oral Appliances 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final order. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is classifying the auto titration device for oral appliances into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the auto titration device for oral appliances’ classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens. 
DATES : This order is effective February 
20, 2019. The classification was applicable on August 23, 2018. 
FOR FURTHER INFORMATION CONTACT : 
Anita Belani, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G314, Silver Spring, MD 20993–0002, 301–796–3944, Anita.Belani@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
I. Background 
Upon request, FDA has classified the 
auto titration device for oral appliances as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. 
The automatic assignment of class III 
occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as ‘‘postamendments devices’’ because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
FDA may take a variety of actions in 
appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate 
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by means of the procedures for 
premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). 
FDA may also classify a device 
through ‘‘De Novo’’ classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification. 
Under the first procedure, the person 
submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). 
Under the second procedure, rather 
than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. 
Under either procedure for De Novo 
classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device. 
We believe this De Novo classification 
will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining ‘‘substantial equivalence’’). Instead, sponsors can use the 510(k) process, when necessary, to market their device. 
II. De Novo Classification 
For this device, FDA issued an order 
on November 23, 2016, finding the 
MATRx plus not substantially equivalent to a predicate not subject to premarket approval application. Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order. 
On December 21, 2017, Zephyr Sleep 
Technologies submitted a request for De Novo classification of the MATRx plus. 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. We classify 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 that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. 
Therefore, on August 23, 2018, 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 872.5571. We have named the generic type of device auto titration device for oral appliances, and it is identified as a prescription home use device that determines a target position to be used for a final oral appliance for the reduction of snoring and mild to moderate obstructive sleep apnea. 
FDA has identified the following risks 
to health associated specifically with this type of device and the measures required to mitigate these risks in table 
1. 
TABLE 1—A UTOTITRATION DEVICE FOR ORALAPPLIANCES RISKS AND MITIGATION MEASURES  
Identified risks Mitigation measures 
Adverse tissue reaction ............................................................................ Biocompatibility evaluation. 
Infection .................................................................................................... Reprocessing validation and Labeling. 
Intraoral/temporomandibular joint injury, irritation, or pain due to: Clinical performance testing; Human factors assessment; Non-clinical 
performance testing; Software verification, validation, and hazard 
analysis; Electrical safety testing; Electromagnetic compatibility test-ing; and Wireless coexistence testing. 
•Use error 
•Algorithm-directed positioning 
•Interference with other devices 
•Device electrical failure 
Incorrect titration level due to use error ................................................... Human factors assessment and Labeling. 
Disruption of sleep .................................................................................... Labeling. 
Temporary change in bite or dentition ..................................................... Labeling. 
FDA has determined that special 
controls, in combination with the 
general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified by this 
order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act. 
At the time of classification, auto 
titration devices for oral appliances are 
for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 
352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)). 
III. Analysis of 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 
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the human environment. Therefore, 
neither an environmental assessment nor an environmental impact statement is required. 
IV. Paperwork Reduction Act of 1995 
This final order establishes special 
controls that refer to previously 
approved collections of information found in other FDA regulations and guidance. 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 the guidance document ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ have been approved under OMB control number 0910–0844; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910–0073; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910–0231; 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. 
List of Subjects in 21 CFR Part 872 
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 872 is amended as follows: 
PART 872—DENTAL DEVICES 
■1. The authority citation for part 872 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
■2. Add § 872.5571 to subpart F to read 
as follows: 
§ 872.5571 Auto titration device for oral 
appliances. 
(a) Identification. An auto-titration 
device for oral appliances is a 
prescription home use device that determines a target position to be used for a final oral appliance for the reduction of snoring and mild to moderate obstructive sleep apnea. 
(b) Classification. Class II (special 
controls). The special controls for this device are: (1) Clinical performance testing must 
evaluate the following: 
(i) Performance characteristics of the 
algorithm; and 
(ii) All adverse events. 
(2) Non-clinical performance testing 
must demonstrate that the device 
performs as intended under anticipated conditions for use, including the following: 
(i) Validation of the closed loop 
algorithm; 
(ii) Mechanical integrity over the 
expected use life; 
(iii) Characterization of maximum 
force, distance, and speed of device movement; and 
(iv) Movement accuracy of intraoral 
components. 
(3) Performance testing must 
demonstrate the wireless compatibility, electrical safety, and electromagnetic compatibility of the device in its intended use environment. 
(4) Software verification, validation, 
and hazard analysis must be performed. 
(5) The patient-contacting 
components of the device must be demonstrated to be biocompatible. 
(6) Performance data must validate 
the reprocessing instructions for any reusable components. 
(7) Patient labeling must include: (i) Information on device use, 
including placement of sensors and mouthpieces; 
(ii) A description of all alarms; and (iii) Instructions for reprocessing any 
reusable components. 
(8) A human factors assessment must 
evaluate simulated use of the device in a home use setting. 
Dated: February 14, 2019. 
Lowell J. Schiller, 
Acting Associate Commissioner for Policy. 
[FR Doc. 2019–02824 Filed 2–19–19; 8:45 am] 
BILLING CODE 4164–01–P 
ENVIRONMENTAL PROTECTION 
AGENCY 
40 CFR Part 52 
[EPA–R10–OAR–2018–0596; FRL–9989–56– 
Region 10] 
Air Plan Approval; OR: Lane County 
Outdoor Burning and Enforcement Procedure Rules 
AGENCY : Environmental Protection 
Agency (EPA). 
ACTION : Final rule. 
SUMMARY : The Environmental Protection 
Agency (EPA) is approving and incorporating by reference into the Oregon State Implementation Plan (SIP) the Lane Regional Air Protection Agency’s (LRAPA) revised outdoor burning rule submitted by the Oregon Department of Environmental Quality (ODEQ) on July 19, 2018. The revised rule, as it applies in Lane County, Oregon, clarifies terminology and provides additional controls of outdoor burning activities, reducing particulate emissions and strengthening the Oregon SIP. In addition, the EPA is approving but not incorporating by reference the enforcement procedures and civil penalties rule for LRAPA submitted by the ODEQ on September 25, 2018. The revised rule brings the enforcement procedures and civil penalties rule, as it applies in Lane County, into alignment with recent changes in Oregon State regulations. 
DATES : This final rule is effective March 
22, 2019. 
ADDRESSES : The EPA has established a 
docket for this action under Docket ID No. EPA–R10–OAR–2018–0596. All documents in the docket are listed on the https://www.regulations.gov 
website. Although listed in the index, some information is not publicly available, e.g., Confidential Business 
Information or other information the disclosure of which is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available at https://www.regulations.gov, or please contact 
the person listed in the 
FOR FURTHER  
INFORMATION CONTACT section for 
additional availability information. 
FOR FURTHER INFORMATION CONTACT : 
Christi Duboiski at (360) 753–9081, or duboiski.christi@epa.gov. 
SUPPLEMENTARY INFORMATION : 
Throughout this document, wherever ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, it is intended to refer to the EPA. 
Table of Contents 
I. Background 
II. Response to Comment III. Final Action IV. Incorporation by Reference V. Oregon Notice Provision VI. Statutory and Executive Order Reviews 
I. Background 
On July 19, 2018 and September 25, 
2018, the ODEQ and LRAPA submitted 
revisions to the Oregon SIP as they apply in Lane County. On November 18, 2018, the EPA proposed to approve the LRAPA Title 47 outdoor burning rule which provided clarification and additional controls of outdoor burning activities in Lane County (83 FR 60836). 
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