Notices. Final rule

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BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 73 [Docket No. FAA-2017-0886; Airspace Docket No. 16-ASO-11] Amendment of Restricted Areas R-3004A and R-3004B and Establishment of R-3004C; Fort Gordon, GA Republication Editorial Note: Rule document 2017-20435 was originally published on pages 44513 through 44514 in the issue of Monday, September 25, 2017. In that publication, on page 44514, in the forty-ninth line of the first column and the thirty-fifth line of the second column, the number 1 was inadvertently deleted from the text.

The corrected document is published here in its entirety. AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action modifies the restricted areas at Fort Gordon, GA to further subdivide the vertical limits of the airspace. The designated altitudes for R-3004A and R-3004B are realigned and a new subarea, designated R-3004C, is established above R-3004B. The FAA is taking this action to allow for more efficient use of the airspace during periods when military activities only require restricted airspace below 3,500 feet MSL.

The modifications are fully contained within the existing lateral and vertical boundaries of the restricted airspace. DATES: Effective date: 0901 UTC, December 7, 2017. FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone:

(202)267-8783. SUPPLEMENTARY INFORMATION: Authority for This Rulemaking The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it vertically subdivides the restricted airspace at Fort Gordon, GA, into three sections to enable more efficient use of airspace. Background The restricted airspace at Fort Gordon, GA consists of R-3004A, extending from the surface to 7,000 feet MSL; and R-3004B, extending from 7,001 feet MSL to 16,000 feet MSL. The time of designation for both areas is as activated by NOTAM 24 hours in advance. A FAA review of the utilization of the airspace revealed that most activities being conducted only require restricted airspace below 3,500 feet MSL. However, when R-3004A was activated, restrictions were in effect up to 7,000 feet MSL. While lateral boundaries of the restricted airspace remain the same as currently charted and the overall vertical limits of the restricted airspace are unchanged, in order to provide for more efficient use of airspace, the FAA and the using agency agreed to further subdivide the restricted airspace vertically. The FAA is realigning the designated altitudes for R-3004A and R-3004B and establishing R-3004C as a third subdivision. The new configuration enables activation of restricted airspace to the lower altitude required for the majority of the using agency's training needs while maintaining the ability to activate additional restricted airspace for missions that require higher altitudes. The designated altitudes for R-3004A are amended to read “surface to but not including 3,500 feet MSL” (decreased from 7,000 feet MSL). The designated altitudes for R-3004B are amended to read “3,500 feet MSL to but not including 7,000 feet MSL,” instead of the current “7,001 feet MSL to 16,000 feet MSL.” This amendment also established a third subdivision, designated R-3004C, which extends from 7,000 feet MSL to 16,000 feet MSL. These changes accommodate the using agency's requirements while releasing unneeded restricted airspace for access by other users. In addition, the aircraft activity limitations on use of the areas are amended to clarify the limitations in effect during the annual Masters Golf Tournament. These changes enhance the efficient use of the National Airspace System by providing for activation of the minimum amount of restricted airspace needed for the specific mission being conducted resulting in the release of unneeded restricted airspace for access by other users. The Rule This rule amends Title 14 Code of Federal Regulations (14 CFR) part 73 by further dividing the current restricted airspace at Fort Gordon, GA, into three subareas instead of two. The designated altitudes for R-3004A are amended from the current “surface to 7,000 feet MSL,” to “surface to but not including 3,500 feet MSL.” The designated altitudes for R-3004B are amended from the current “7,001 feet MSL to 16,000 feet MSL” to “3,500 feet MSL to but not including 7,000 feet MSL.” A new third subdivision, designated R-3004C, is established and extends from 7,000 feet MSL to 16,000 feet MSL.” Additionally, the terms and conditions listed in the restricted area legal descriptions for aircraft activities in the restricted areas are revised, in part. Specifically, in order to clarify aircraft operations during the annual Masters Golf tournament, the text of item number 1 is changed from “1. Aircraft activities may not be conducted on weekends, National holidays, or the entire week of the Masters Golf Tournament” to: “1. Aircraft activities must not be conducted on weekends, national holidays, or from the Sunday prior to the Masters Golf Tournament through the Monday after (and subsequent weather days if required).” The terms and conditions in Items 2 and 3 remain unchanged. The above modifications enhance the efficient use of airspace and reduce the burden on the public by lessening the amount of restricted airspace at Fort Gordon, GA, that is activated on a routine basis. These modifications do not change the current lateral boundaries, overall designated altitudes, or activities conducted within the restricted areas; therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Regulatory Notices and Analyses The FAA has determined that this action only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore:

(1)Is not a “significant regulatory action” under Executive Order 12866;

(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and

(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. Environmental Review The FAA has determined that this action of vertically subdividing limits of existing restricted airspace within the current lateral and vertical limits qualifies for categorical exclusion under the National Environmental Policy Act and in accordance with FAA Order 1050.1F—Environmental Impacts: Policies and Procedures, Categorical Exclusions for Procedural Actions, paragraph 5-6.5d—Modification of the technical description of special use airspace (restricted areas) that does not alter the dimensions, altitudes, or times of designation of the airspace. Therefore, this airspace action is not expected to result in any significant environmental impacts. In accordance with FAAO 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, this action has been reviewed for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis, and it is determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment. List of Subjects in 14 CFR Part 73 Airspace, prohibited areas, restricted areas. Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73, as follows: PART 73—SPECIAL USE AIRSPACE 1. The authority citation for part 73 continues to read as follows: Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. § 73.30 [Amended] 2. § 73.30 is amended as follows: R-3004A Fort Gordon, GA [Amended] By removing the current designated altitudes and aircraft activity limitations and inserting the following in their places: *Designated Altitudes.* Surface to but not including 3,500 feet MSL. Aircraft activity is limited to the following terms and conditions: 1. Aircraft activities must not be conducted on weekends, national holidays, or from the Sunday prior to the Masters Golf Tournament through the Monday after (and subsequent weather days if required). 2. Aircraft activities may only be conducted from the surface to 12,000 feet AGL. 3. Weather conditions required for aircraft activities are 5 miles visibility and with prevailing clouds or obscuring phenomena no greater than five-tenths coverage of the sky and bases no lower than 3,000 feet AGL. R-3004B Fort Gordon, GA [Amended] By removing the current designated altitudes and aircraft activity limitations and inserting the following in their places: *Designated Altitudes.* 3,500 feet MSL to but not including 7,000 feet MSL. Aircraft activity is limited to the following terms and conditions: 1. Aircraft activities must not be conducted on weekends, national holidays, or from the Sunday prior to the Masters Golf Tournament through the Monday after (and subsequent weather days if required). 2. Aircraft activities may only be conducted from the surface to 12,000 feet AGL. 3. Weather conditions required for aircraft activities are 5 miles visibility and with prevailing clouds or obscuring phenomena no greater than five-tenths coverage of the sky and bases no lower than 3,000 feet AGL. R-3004C Fort Gordon, GA [New] *Boundaries.* Beginning at lat. 33°21′54″ N., long. 82°12′14″ W.; to lat. 33°19′44″ N., long. 82°12′14″ W.; to lat. 33°16′21″ N., long. 82°17′59″ W.; to lat. 33°17′30″ N., long. 82°22′59″ W.; to lat. 33°21′16″ N., long. 82°18′46″ W.; to lat. 33°22′16″ N., long. 82°16′59″ W.; to the point of beginning. *Designated Altitudes.* 7,000 feet MSL to 16,000 feet MSL. *Times of designation.* By NOTAM 24 hours in advance. *Controlling agency.* FAA, Atlanta ARTCC. *Using agency.* U.S. Army, Commanding Officer, Fort Gordon, GA. Aircraft activity is limited to the following terms and conditions: 1. Aircraft activities must not be conducted on weekends, national holidays, or from the Sunday prior to the Masters Golf Tournament through the Monday after (and subsequent weather days if required). 2. Aircraft activities may only be conducted from the surface to 12,000 feet AGL. 3. Weather conditions required for aircraft activities are 5 miles visibility and with prevailing clouds or obscuring phenomena no greater than five-tenths coverage of the sky and bases no lower than 3,000 feet AGL. Issued in Washington, DC, on September 19, 2017. Rodger A. Dean, Jr., Manager, Airspace Policy Group. [FR Doc. R1-2017-20435 Filed 10-13-17; 8:45 am] BILLING CODE 1301-00-D DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2017-N-5296] Medical Devices; Immunology and Microbiology Devices; Classification of the Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug Administration (FDA or we) is classifying the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens 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 nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens' 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 October 16, 2017. The classification was applicable on September 22, 2014. FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, *steven.tjoe@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens 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 (the 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 to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively). 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 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). 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 PMA in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device. II. De Novo Classification On May 27, 2014, T2 Biosystems, Inc., submitted a request for classification of the T2Candida Panel and T2Dx® Instrument. 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 general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on September 22, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.3960. We have named the generic type of device nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens, and it is identified as a qualitative in vitro device intended for the amplification, detection, and identification of microbial-associated nucleic acid sequences from patients with suspected bloodstream infections. This device is intended to aid in the diagnosis of bloodstream infection when used in conjunction with clinical signs and symptoms and other laboratory findings. 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—Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens Risks and Mitigation Measures Identified risks Mitigations measures Incorrect identification of a pathogenic microorganism by the device can lead to improper patient management Special Controls (1), (2), (3), (4), and (5). Failure to correctly interpret test results Special Control (6). Failure to correctly operate the instrument Special Controls

(7)and (8). 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. In order 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. 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 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. 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, the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073, and the collections of information in 21 CFR parts 801 and 809, regarding labeling have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 866 Biologics, Laboratories, 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 866 is amended as follows: PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES 1. The authority citation for part 866 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l,* 371. 2. Add § 866.3960 to subpart D to read as follows: § 866.3960 Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.

(a)*Identification.* A nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens is a qualitative in vitro device intended for the amplification, detection, and identification of microbial-associated nucleic acid sequences from patients with suspected bloodstream infections. This device is intended to aid in the diagnosis of bloodstream infection when used in conjunction with clinical signs and symptoms and other laboratory findings.

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

(1)Premarket notification submissions must include detailed device description documentation, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including primer/probe sequence, design, and rationale for sequence selection.

(2)Premarket notification submissions must include detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (limit of detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carryover, and cross contamination.

(3)Premarket notification submissions must include detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted reference methods.

(4)Premarket notification submissions must include detailed documentation for device software, including, but not limited to, software applications and hardware-based devices that incorporate software.

(5)The device labeling must include limitations regarding the need for culture confirmation of negative specimens, as appropriate.

(6)A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.

(7)Premarket notification submissions must include details on an end user device training program that will be offered while marketing the device, as appropriate.

(8)As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument. Dated: October 10, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-22287 Filed 10-13-17; 8:45 am]

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