alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 882
Editorial Note: Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008.

§ 882.5955 Temporary coil embolization assist device. ( a ) *Identification.* A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) Clinical performance testing of the device must demonstrate the device performs as intended for temporary use as an endovascular device to assist in the coil embolization of intracranial aneurysms and must evaluate all adverse events, including tissue or vessel damage that could lead to dissection, perforation, hemorrhage, or vasospasm, thrombo-embolic events, and coil entanglement.
( 2 ) The patient-contacting components of the device must be demonstrated to be biocompatible.
( 3 ) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use, including: ( i ) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, compressive, and tip deflection forces;
( ii ) Mechanical testing to evaluate the radial forces exerted by the device;
( iii ) Simulated use testing to demonstrate the device can be delivered to the target location in the neurovasculature and is compatible with embolic coils;
( iv ) Dimensional verification testing;
( v ) Radiopacity testing; and
( vi ) Performance testing to evaluate the coating integrity and particulates under simulated use conditions.
( 4 ) Animal testing under anticipated use conditions must evaluate all adverse events, including damage to vessels or tissues.
( 5 ) Performance data must support the sterility and pyrogenicity of the device.
( 6 ) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
( 7 ) The labeling must include: ( i ) Instructions for use;
( ii ) A detailed summary of the device technical parameters, including compatible delivery catheter dimensions and device sizing information;
( iii ) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events; and
( iv ) A shelf life.
[86 FR 70733, Dec. 13, 2021]
<PAGE>

                                                                    EXHIBIT 32.1

                            CERTIFICATION PURSUANT TO
                             18 U.S.C. SECTION 1350,
                             AS ADOPTED PURSUANT TO
                  SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

      In connection with the quarterly report on Form 10-Q of Biopure
Corporation for the period ended July 31, 2005, I, Zafiris G. Zafirelis,
President and Chief Executive Officer, hereby certify, to the best of my
knowledge, pursuant to 18 U.S.C. 1350, as adopted pursuant to 906 of the
Sarbanes-Oxley Act of 2002, that:

      1.    the Form 10-Q for the period ended July 31, 2005, fully complies
            with the requirements of section 13(a) or 15(d) of the Securities
            Exchange Act of 1934; and

      2.    the information contained in the Form 10-Q for the period ended July
            31, 2005 fairly presents, in all material respects, the financial
            condition and results of operations of Biopure Corporation.

/s/ Zafiris G. Zafirelis
-------------------------------------
Zafiris G. Zafirelis
President and Chief Executive Officer

September 9, 2005
Editorial Note on Part 868
Editorial Note: Nomenclature changes to part 868 appear at 73 FR 35341, June 23, 2008.

§ 868.1750 Pressure plethysmograph. ( a ) *Identification.* A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.
( b ) *Classification.* Class II (performance standards).
[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Notices]
[Page 10791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5052]


=======================================================================
-----------------------------------------------------------------------

ELECTION ASSISTANCE COMMISSION


Sunshine Act Notice

AGENCY: U.S. Election Assistance Commission.

ACTION: Notice of Public Meeting Agenda.

Date and Time: Thursday, March 11, 2010, 10 a.m.-12 p.m. EST.

Place: U.S. Election Assistance Commission, 1225 New York Ave, NW., 
Suite 150, Washington, DC 20005 (Metro Stop: Metro Center).

Agenda

    The Commission will hold a public meeting to discuss identifying 
and mitigating risk in elections operations. Commissioners will receive 
an update on re-accrediting Wyle Laboratories, Inc. Commissioners will 
consider other administrative matters.
    Members of the public may observe but not participate in EAC 
meetings unless this notice provides otherwise. Members of the public 
may use small electronic audio recording devices to record the 
proceedings. The use of other recording equipment and cameras requires 
advance notice to and coordination with the Commission's Communications 
Office.*
    * View EAC Regulations Implementing Government in the Sunshine Act.
    This meeting and hearing will be open to the public.

Person to Contact for Information: Bryan Whitener, Telephone: (202) 
566-3100.

Thomas R. Wilkey,
Executive Director, U.S. Election Assistance Commission.
[FR Doc. 2010-5052 Filed 3-5-10; 11:15 am]
BILLING CODE 6820-KF-P
Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Federal Trade Commission

# FOR FURTHER INFORMATION CONTACT:

Sandra M. Peay, Contact Representative Or Renee Hallman, Contact Representative, Federal Trade Commission, Premerger Notification Office, Bureau of Competition, Room H-303, Washington, DC 20580, (202) 326-3100.

By Direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 2010-5172 Filed 3-10-10; 8:45 am]

BILLING CODE 6750-01-M
STEAM ELECTRIC CBI REPLACEMENT PAGE 

EPA-HQ-OW-2009-0819 

DCN: SE03544

THE FOLLOWING HAS BEEN REMOVED BECAUSE IT 

CONTAINS CONFIDENTIAL BUSINESS INFORMATION 

(CBI) PER 40 CFR PART 2, SUBPART B.
Editorial Note on Part 888
Editorial Note: Nomenclature changes to part 888 appear at 73 FR 35341, June 23, 2008.

§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis. ( a ) *Identification.* A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.
( b ) *Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
[66 FR 12737, Feb. 28, 2001]
Editorial Note on Part 860
Editorial Note: Nomenclature changes to part 860 appear at 73 FR 35341, June 23, 2008, and at 86 FR 54846, Oct. 5, 2021.

§ 860.90 Consultation with panels. ( a ) When the Commissioner is required to consult with a panel concerning a classification under § 860.84, the Commissioner will consult with the panel in one of the following ways: ( 1 ) Consultation by telephone with at least a majority of current voting panel members and, when possible, nonvoting panel members in a telephone or video conference call; or
( 2 ) Discussion at a panel meeting.
( b ) The method of consultation chosen by the Commissioner will depend upon the importance and complexity of the subject matter involved and the time available for action. When time and circumstances permit, the Commissioner will consult with a panel through discussion at a panel meeting.
[83 FR 64456, Dec. 17, 2018]
OFFICE OF THE ATTORNEY GENERAL OF TEXAS AUSTIN

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:- i..-
**Exhibit 34.1**

**REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM**

Board of Directors and Shareholders of California Republic Bank 

California Republic Bank 

Irvine, CA 92612 

We have examined management’s assertion, included in the accompanying Management’s Report on Assessment of Compliance with SEC Regulation ABServicing Criteria, that California Republic Bank (the Company) complied with the servicing criteria set forth in Item 1122(d) of the Securities and Exchange Commission’s Regulation AB for the asset-backed securities (“ABS”)transactions for which the Company acts as servicer of automotive retail installment sale contracts included in private and public securitization sponsored by the Company (the “Platform”) as of and for the year ended December 31,2015, excluding criteria 1122 (d)(2)(iv), 1122 (d)(2)(vi), 1122 (d)(3)(ii)-(iv), 1122 (d)(4)(ix)-(xiii), and 1122 (d)(4)(xv), which management has determined are not applicable to the activities performed by the Company with respect to the Platform.Appendix B to management’s assertion identifies the individual asset-backed transactions defined by management as constituting the Platform. Management is responsible for the Company’s compliance with the servicing criteria. Ourresponsibility is to express an opinion on management’s assertion about the Company’s compliance with the servicing criteria based on our examination. 

Our examination was conducted in accordance with attestation standards of Public Company Accounting Oversight Board (United States), and, accordingly,included examining, on a test basis, evidence about the Company’s compliance with the applicable servicing criteria, including tests on a sample basis of the servicing activities related to the Platform, determining whether the Companyperformed those selected activities in compliance with the servicing criteria during the specified period, and performing such other procedures as we considered necessary in the circumstances. Our procedures were limited to selected servicingactivities performed by the Company during the period covered by this report and, accordingly, such samples may not have included servicing activities related to each asset-backed transaction included in the Platform. Further, an examination is notdesigned to detect noncompliance arising from errors that may have occurred prior to the period specified above that may have affected the balances or amounts calculated or reported by the Company during the period covered by this report. We believethat our examination provides a reasonable basis for our opinion. Our examination does not provide a legal determination on the Company’s compliance with the servicing criteria. 

In our opinion, management’s assertion that the Company complied with the aforementioned applicable servicing criteria as of and for the year endedDecember 31, 2015 for the Platform is fairly stated, in all material respects. 

/s/ Deloitte & Touche LLP 

Los Angeles, California 

March 30, 2016
[Federal Register Volume 75, Number 47 (Thursday, March 11, 2010)]
[Notices]
[Page 11527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5208]


-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12715-002]


Fairlawn Hydroelectric Company, LLC; Notice of Preliminary Permit 
Application Accepted for Filing and Soliciting Comments, Motions To 
Intervene, and Competing Applications

March 4, 2010.
    On January 4, 2010, the Fairlawn Hydroelectric Company, LLC filed 
an application, pursuant to section 4(f) of the Federal Power Act, 
proposing to study the feasibility of the Jennings Randolph Project, to 
be located the U.S. Army Corps of Engineers Jennings Randolph Dam, on 
the North Branch Potomac River, Garrett County, Maryland, and Mineral 
County, West Virginia.
    The proposed project would utilize the existing U.S. Army Corps of 
Engineers' Jennings Randolph Dam and would consist of: (1) A proposed 
intake structure to be built on the upstream face of the dam; (2) a 
720-foot-long penstock through the dam; (3) a proposed powerhouse 
containing 2 generating units with a total generating capacity of 14.0 
MW; (4) a proposed 2/3-mile-long, 138 kV transmission line; (5) a 
tailrace, and (6) appurtenant facilities. The project would have an 
estimated average annual generation of 52.0 gigawatts-hours.
    Applicant Contact: Mr. M. Clifford Phillips, Advanced Hydro 
Solutions LLC, 150 North Miller Road, Suite 450 C, Fairlawn, OH 44333, 
phone (330) 869-8451.
    FERC Contact: Michael Spencer, (202) 502-6093.
    Deadline for filing comments, motions to intervene, competing 
applications (without notices of intent), or notices of intent to file 
competing applications: 60 days from the issuance of this notice. 
Comments, motions to intervene, notices of intent, and competing 
applications may be filed electronically via the Internet. See 18 CFR 
385.2001(a)(1)(iii) and the instructions on the Commission's Web site 
under the ``e-Filing'' link. If unable to be filed electronically, 
documents may be paper-filed. To paper-file, an original and eight 
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy 
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For 
more information on how to submit these types of filings please go to 
the Commission's Web site located at http://www.ferc.gov/filing-comments.asp. More information about this project can be viewed or 
printed on the ``eLibrary'' link of Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
    Enter the docket number (P-12715) in the docket number field to 
access the document. For assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-5208 Filed 3-10-10; 8:45 am]
BILLING CODE 6717-01-P
f;^ •y:^§J}^tiij OF 

Office of the Secretary 

J.S.De 

Transportation 

US. Department of '• 7^>T i'>^C''"Vr(r>''' 1200 New jersey Avenue, SE 

" ' ' '-'^^^nljQj\}2 Washington, DC 20590 

Of Transportation '"-'•• '^•'•^o I I p |.Q . 

August 11,2011 

Mr. John R. Mietus, Jr. 

Counsel for Orange Air, LLC 

6701 Democracy Boulevard, Suite 300 

Bethesda,MD 20817-7500 

Re: Dockets DOT-OST-2011-0073 and DOT-OST-2011-0074 

Applications of Orange Air, LLC for section 41102 Certificate Authority 

Dear Mr. Mietus: 

We have completed our review of the supplemental information filed on June 23, 2011, by 

Orange Air, LLC ("Orange Air"), in response to our letter requesting additional information for 

the determination of its fitness to conduct interstate and foreign charter air transportation of 

persons, property, and mail. 

This review has revealed the need for additional and/or clarifying information before we can 

complete processing Orange Air's applications. The attached Information Request lists the areas 

where further and/or clarification information is necessary. I ask that you respond fully to this 

request within 30 days of the date of this letter. The original plus 6 copies of your response 

should be mailed to U.S. Department of Transportation, Docket Operations, (M-30, Room 

W12-140), 1200 New Jersey Avenue, S.E., West Building Ground Floor, Washington, D.C. 

20590, or you may electronically file your response at www.regulations.gov. 

As is the Department's practice, further processing of Orange Air's application will be deferred 

pending receipt of this material. In addition, please remember that Orange Air should promptly 

provide the Department with any information regarding changes it may undergo in areas affecting 

its fitness {i.e., management, operating plans or financial condition, compliance disposition, or 

ownership) while its applications are under review by the Department. 

Thank you for your cooperation in this matter. If you have any questions regarding this letter or 

the requested information, please feel free to contact me at 202-366-9967. 

Sincerely, 

Scott A. Faulk 

Transportation Industry Analyst 

Air Carrier Fitness Division 
cc: Dockets DOT-OST-2011-0073 and DOT-OST-2011-0074 

Mr. Robert E. Talmadge 

FAA Miami CMO-29 

2895 S.W. 145*^ Avenue 

Miramar, FL 33027 
INFORMATION REQUEST 

Orange Air, LLC 

MANAGEMENT AND KEY TECHNICAL PERSONNEL 

1. Please submit revised updated resumes, which list Orange Air as the current place of 

employment, for Messrs. Karl Rothman, Paul W. J. Hook, Joseph Schoofs, Brooke 

Mayger, and Roger Carbon. 

FINANCIAL POSITION 

1. The depreciation expense in the projected income statement and the depreciation expense 

in the assumptions associated with them are inconstant. Please address this difference 

and submit revised financial statements. 

2. Also regarding the assumptions, please provide an explanation to why the Administrative 

Expenses and Other Operating Expenses are not broken down in a similar fashion when 

compared to the other listed expenses.
Editorial Note on Part 872
Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

§ 872.6660 Porcelain powder for clinical use. ( a ) *Identification.* Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.
( b ) *Classification.* Class II.
Editorial Note on Part 872
Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

§ 872.3165 Precision attachment. ( a ) *Identification.* A precision attachment or preformed bar is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture.
( b ) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001]