94251 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Rules and Regulations 
the case of a subcontract for the 
construction of any public facility, or in excess of $700,000 in the case of all other subcontracts, and which offer further subcontracting possibilities, to adopt a subcontracting plan of their own consistent with this section, and must ensure at a minimum that all subcontractors required to maintain subcontracting plans pursuant to this paragraph will review and approve subcontracting plans submitted by their subcontractors; monitor their subcontractors’ compliance with their approved subcontracting plans; ensure that subcontracting reports are submitted by their subcontractors when required; acknowledge receipt of their subcontractors’ reports; compare the performance of their subcontractors to their subcontracting plans and goals; and discuss performance with their subcontractors when necessary to ensure their subcontractors make a good-faith effort to comply with their subcontracting plans; and 
(xi) The prime contractor must 
provide a written statement of the types of records it will maintain to demonstrate procedures which have been adopted to ensure subcontractors at all tiers comply with the requirements and goals set forth in the subcontracting plan established in accordance with paragraph (c)(1)(x) of this section, including the establishment of source lists of small business concerns, small business concerns owned and controlled by veterans, small business concerns owned and controlled by service-disabled veterans, qualified HUBZone small business concerns, small business concerns owned and controlled by socially and economically disadvantaged individuals, and small business concerns owned and controlled by women; the efforts to identify and award subcontracts to such small business concerns; and size or socioeconomic certifications or representations received in connection with each subcontract. 
* * * * * 
Dated: December 14, 2016. 
Maria Contreras-Sweet, 
Administrator. 
[FR Doc. 2016–30874 Filed 12–22–16; 8:45 am] 
BILLING CODE 8025–01–P SECURITES AND EXCHANGE 
COMMISSION 
17 CFR Part 242 
[Release No. 34–79237A] 
RIN 3235–AL99 
Consolidated Audit Trail 
ACTION : Notification regarding expired 
temporary rule. 
SUMMARY : The Commission is providing 
notice regarding temporary Rule 608T 
under the Securities Exchange Act of 1934. The Commission designated 12:01 a.m. on November 16, 2016, as the expiration time for Rule 608T, because after that time the rule would no longer be necessary. 
DATES : December 23, 2016. 
FOR FURTHER INFORMATION CONTACT : 
Rebekah Liu, Special Counsel, at (202) 551–5665; Jennifer Colihan, Special Counsel, at (202) 551–5642; Leigh Duffy, Special Counsel, at (202) 551–5928; John Lee, Special Counsel, at (202) 551– 5689; or Ted Uliassi, Special Counsel, at (202) 551–6905, or Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–7010. 
SUPPLEMENTARY INFORMATION : On 
November 3, 2016, the Securities and Exchange Commission adopted a temporary rule, Rule 608T, under the Securities Exchange Act of 1934 to extend to November 15, 2016, the date by which the Commission was required to act on the proposed National Market System Plan Governing the Consolidated Audit Trail (the ‘‘CAT NMS Plan’’). Rule 608T solely governed the timeframe for action on the proposed CAT NMS Plan. The Commission adopted the temporary rule as an interim final temporary rule in light of the impending November 10, 2016 date designated by the Commission under Rule 608 as the date by which the Commission would take action on the proposed CAT NMS Plan. The Commission designated 12:01 a.m. on November 16, 2016, as the expiration time for Rule 608T because after that time the temporary rule would no longer be necessary. 
On November 3, 2016, the 
Commission published the temporary rule on its Web site. Due to a subsequent clerical error, the temporary rule was not published in the Federal Register. On November 8, 2016, the Commission provided public notice of its scheduled open meeting to consider the CAT NMS Plan, posting the notice on its Web site, and on November 15, 2016, the Commission approved the CAT NMS Plan at its open meeting. The expiration time of 12:01 a.m. on November 16, 2016 for the temporary rule has now passed. 
Dated: December 19, 2016. 
Brent J. Fields, 
Secretary. 
[FR Doc. 2016–30883 Filed 12–22–16; 8:45 am] 
BILLING CODE 8011–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 882 
[Docket No. FDA–2016–N–4165] 
Medical Devices; Neurological 
Devices; Classification of the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final order. 
SUMMARY : The Food and Drug 
Administration (FDA) is classifying the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment’s classification. 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 December 
23, 2016. The classification was applicable on September 2, 2016. 
FOR FURTHER INFORMATION CONTACT : 
Leigh Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993–0002, 301–796–5613, leigh.anderson@fda.hhs.gov. 
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 
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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), provides two procedures by which a person may request FDA to 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) of the FD&C Act 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device. 
On October 26, 2015, Concentric 
Medical, Inc., submitted a request for classification of the Trevo ProVue and XP ProVue Retrievers (Trevo Retrievers) under section 513(f)(2) of the FD&C Act. 
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). 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 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 September 2, 2016, 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 882.5600. 
Following the effective date of this 
final classification order, any firm submitting a premarket notification (510(k)) for a neurovascular mechanical thrombectomy device for acute ischemic stroke treatment will need to comply with the special controls named in this final order. 
The device is assigned the generic 
name neurovascular mechanical thrombectomy device for acute ischemic stroke treatment, and it is identified as a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature. 
FDA has identified the following risks 
to health associated specifically with this type of device, as well as the measures required to mitigate these risks in table 1. 
TABLE 1—N EUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT RISKS AND  
MITIGATION MEASURES  
Identified risk Mitigation measure 
Adverse Tissue Reaction ............................................................... Biocompatibility Evaluation. 
Infection .......................................................................................... Sterility Testing, Shelf-Life Testing, Labeling. 
Tissue or Vessel Damage: 
•Dissection ............................................................................ Non-clinical Performance Testing. 
•Perforation ........................................................................... Clinical Performance Testing. 
•Hemorrhage ......................................................................... Labeling. 
Stroke Progression ......................................................................... Non-clinical Performance Testing, Clinical Performance Testing, Labeling. 
Emboli ............................................................................................ Non-clinical Performance Testing, Clinical Performance Testing, Labeling. 
FDA believes that the special controls, 
in combination with the general 
controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. 
Neurovascular mechanical 
thrombectomy device for acute ischemic stroke treatment devices are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 
21 CFR 801.109 Prescription devices). 
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) 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 neurovascular mechanical thrombectomy device for acute ischemic stroke treatment they intend to market. 
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II. 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. 
III. 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, 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 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 part 882 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
■2. Add § 882.5600 to subpart F to read 
as follows: 
§ 882.5600 Neurovascular mechanical 
thrombectomy device for acute ischemic stroke treatment. 
(a) Identification. A neurovascular 
mechanical thrombectomy device for 
acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature. 
(b) Classification. Class II (special 
controls). The special controls for this device are: 
(1) The patient contacting 
components of the device must be demonstrated to be biocompatible. 
(2) Non-clinical performance testing 
must demonstrate that the device performs as intended under anticipated conditions of use, including: 
(i) Mechanical testing to demonstrate 
the device can withstand anticipated tensile, torsional, and compressive forces. 
(ii) Mechanical testing to evaluate the 
radial forces exerted by the device. 
(iii) Non-clinical testing to verify the 
dimensions of the device. 
(iv) Non-clinical testing must 
demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions. 
(v) Non-clinical testing must 
demonstrate the device is radiopaque and can be visualized. 
(vi) Non-clinical testing must evaluate 
the coating integrity and particulates under simulated use conditions. 
(vii) Animal testing must evaluate the 
safety of the device, including damage to the vessels or tissue under anticipated use conditions. 
(3) Performance data must support the 
sterility and pyrogenicity of the patient contacting components of the device. 
(4) Performance data must support the 
shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life. 
(5) Clinical performance testing of the 
device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure. 
(6) The labeling must include: 
(i) Information on the specific patient 
population for which the device is 
intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size. 
(ii) Detailed instructions on proper 
device preparation and use for thrombus retrieval from the neurovasculature. 
(iii) A summary of the clinical testing 
results, including a detailed summary of the device- and procedure-related complications and adverse events. 
(iv) A shelf life. 
Dated: December 19, 2016. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2016–31007 Filed 12–22–16; 8:45 am] 
BILLING CODE 4164–01–P DEPARTMENT OF JUSTICE 
Bureau of Prisons 
28 CFR Parts 500 and 553 
[Docket No. BOP–1163] 
RIN 1120–AB63 
Contraband and Inmate Personal 
Property: Technical Change 
AGENCY : Bureau of Prisons, Justice. 
ACTION : Final rule. 
SUMMARY : In this document, the Bureau 
of Prisons makes a minor technical change to its regulations on contraband and inmate personal property to maintain consistency in language which describes the purpose of the regulations as ensuring the safety, security, or good order of the facility or protection of the public. 
DATES : This rule will be effective on 
January 23, 2017. 
FOR FURTHER INFORMATION CONTACT : 
Sarah Qureshi, Office of General Counsel, Bureau of Prisons, phone (202) 307–2105. 
SUPPLEMENTARY INFORMATION : 
In this document, the Bureau of 
Prisons (Bureau) finalizes a minor technical change to its regulations on contraband and inmate personal property to maintain consistency in language which describes the purpose of the regulations as ensuring the ‘‘safety, security, or good order of the facility or protection of the public.’’ 
Variations on this phrase appear 
throughout the Bureau’s regulations in 28 CFR Chapter V. See 28 CFR 500.1(h), 
501.2(b), 501.3(b), 511.10(a), 511.11(a), 511.12(a), 511.15(b), 511.17(b), 540.12(a), 540.14(c) and (d), 540.15(d), 540.40, 540.44(c), 540.51(h), 540.70, 540.71(b) and (d), 540.100(a), 540.101(a), 541.12, 541.43(b), 541.63(c), 543.11(f), 543.14(a) and (c), 543.15(c), 543.16(b), 544.20, 544.21(b), 548.10, 548.16–548.18, 549.13(b), 549.50, 549.51(b), 551.1, 551.10, 551.12(d), 551.16(a), 551.31(b), 551.34(b), 551.35, 551.71(d), 551.110(a), 551.112(b), 551.113(a), 551.115(a), 552.13(b), 552.20, 552.21(a) and (d), 553.11(h), 553.12(b). 
The Bureau has conformed the phrase 
in all revised regulations since approximately 2005. This rule likewise conforms this phrase in the Bureau’s regulations on contraband. An interim rule on this subject was published on August 3, 2015 (80 FR 45883), and became effective on September 2, 2015, although public comments were accepted until October 2, 2015. 
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