alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 878
Editorial Note: Nomenclature changes to part 878 appear at 73 FR 35341, June 23, 2008.

§ 878.4825 General laparoscopic power morcellation containment system. ( a ) *Identification.* A general laparoscopic power morcellation containment system is a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign tissue that is not suspected to contain malignancy.
( 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 ) Performance testing must demonstrate the sterility of patient-contacting components of the device.
( 3 ) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
( 4 ) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: ( i ) Demonstration of the device impermeability to tissue, cells, and fluids;
( ii ) Demonstration that the device allows for the insertion/withdrawal of laparoscopic instruments while maintaining pneumoperitoneum;
( iii ) Demonstration that the containment system provides adequate space to perform morcellation and adequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera;
( iv ) Demonstration that compatible laparoscopic instruments and morcellators do not compromise the integrity of the containment system; and
( v ) Demonstration that users can adequately deploy the device, morcellate a specimen without compromising the integrity of the device, and remove the device without spillage of contents.
( 5 ) Training must be developed and validated to ensure users can follow the instructions for use.
( 6 ) Labeling must include: ( i ) A contraindication for use in gynecological procedures;
( ii ) A contraindication against use of tissue that is known or suspected to contain malignancy;
( iii ) The following boxed warning: “Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. The use of laparoscopic power morcellators may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk;”
( iv ) A statement limiting use of device to physicians who have completed the training program; and
( v ) A shelf life.
[86 FR 66458, Nov. 23, 2021]
Fourth Court of Appeals

San Antonio, Texas

MEMORANDUM OPINION

No. 04-18-00853-CV

IN RE C.D.M. and C.M.M., Children

Original Mandamus Proceeding1

PER CURIAM

Sitting: Rebeca C. Martinez, Justice

Luz Elena D. Chapa, Justice

Irene Rios, Justice

Delivered and Filed: February 6, 2019

PETITION FOR WRIT OF MANDAMUS DENIED

On November 13, 2018, relator filed a petition for writ of mandamus. Relator also filed a 

motion for stay of the underlying proceedings pending final resolution of the petition for writ of 

mandamus, which this court granted on November 13, 2018. After considering the petition, this 

court concludes relator is not entitled to the relief sought. Accordingly, the petition for writ of 

mandamus is DENIED. See TEX. R. APP. P. 52.8(a). The stay imposed on November 13, 2018 is 

LIFTED. 

PER CURIAM

 1 This proceeding arises out of Cause No. 2012-CI-13803, styled In the Interest of C.D.M. and C.M.M., Children, 

pending in the 166th Judicial District Court, Bexar County, Texas, the Honorable David A. Canales presiding.
Editorial Note on Part 878
Editorial Note: Nomenclature changes to part 878 appear at 73 FR 35341, June 23, 2008.

§ 878.4783 Negative pressure wound therapy device for reduction of wound complications. ( a ) *Identification.* A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under § 878.4780. This classification does not include devices intended for organ space wounds.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following: ( i ) Wound complication rates; and
( ii ) All adverse events.
( 2 ) The patient-contacting components of the device must be demonstrated to be biocompatible.
( 3 ) Performance data must demonstrate the sterility 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 labeled shelf life.
( 5 ) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the instructions for use.
( 6 ) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested in a worst-case scenario for the intended use life: ( i ) Ability to maintain pressure levels at the wound site under a worst-case scenario for the intended use life;
( ii ) Fluid removal rate consistent with the wound types specified in the indications for use; and
( iii ) Timely triggering of all alarms.
( 7 ) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device.
( 8 ) Software verification, validation, and hazard analysis must be performed.
( 9 ) Labeling must include the following: ( i ) Instructions for use;
( ii ) A summary of the device technical specifications, including pressure settings, modes (*e.g.,* continuous or intermittent), alarms, and safety features;
( iii ) Compatible components and devices;
( iv ) A summary of the clinical evidence for the indications for use;
( v ) A shelf life for sterile components; and
( vi ) Use life and intended use environments.
( 10 ) For devices intended for use outside of a healthcare facility, patient labeling must include the following: ( i ) Information on how to operate the device and its components and the typical course of treatment;
( ii ) Information on when to contact a healthcare professional; and
( iii ) Use life.
[86 FR 70734, Dec. 10, 2021]
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 2 290 BROADWAY NEWYORK, NY 10007-1866

Miles M. Croom Assistant Regional Administrator NOAA Fisheries, Southeast Regional Office Habitat Conservation Division 263 13th Avenue South St. Petersburg, FL 33701 Dear Mr. Croom: 

### AUG 2 3 2005

Thank you for your letter ofMay 13,2005 providing NOAA National Marine Fisheries Service's fmmal Essential Fish Habitat (EFH) recommendations on the modifications to the designations ofthe ocean dredged material disposal sites around Puerto Rico (at 40 CFR 228.16) that are being contemplated bythe U.S. Environmental Protection Agency. In your letter you recommend that EFH be mapped in areas where dredging is anticipated to facilitate future EFH consultations for individual projects. On July 11, 2005 our staffmet at your offices in Cabo Rojo to further discuss this recmmnendation. We agreed at that meeting that large scale mapping ofEFH at this time is impractical but that EPA should continue to compile information on benthic habitat that has become available through benthic surveys and other EFH mapping studies to identifypotential routes for transport ofsediment laden barges. Critical or potential areas ofEFH identified along those routes would then be evaluated as part ofEFH consultations for individual projects before a permit will be issued. Ifyou have any further questions about the proposed action, please do not hesitate to contact Mark Reiss at (212) 637-3799.

_,/·-?' Thank you·**~~~----~--;'** 

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.. ·· £ ' // L Douglas!Pjlbst Teamieider Dreefged Material Management Team Drvision ofEnvironmental Planning and Protection

Cc: Lisamarie Carrubba, PhD

Internet Address (URL) • http://www.epa.gov Recycled/Recyclable •Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper
N O T FO R PUB L ICAT IO N UNITED STATES C OUR T OF APPEALS FOR THE NINTH C IR C UIT M AR IO M ORENO-TOSC ANO, Pe titione r, v. LORETTA E. LYNC H, Attorne y Ge ne ra l, R

e sponde n t . No. 13-72134 Age n c y No. A075-570-882 M EM O R ANDUM *

On Pe tition for Re vie w of a n Orde r of the B oa rd of Im m igration Appe a ls Subm itte d Se pte m

be r 21, 2015 * * B e fore : REINHAR

DT, LEAVY, a

nd B E R ZON, C irc uit Judge s. M ario M o re no-Tosc ano, a native and c i tiz e n of M e xic o, pe titions for re vie w of the De pa

rtm e n t of Hom e l and Se c urity ’ s (“ D HS” ) June 14, 2013, order re insta ting his 1997 orde

r of re m ova l. W e hav e jurisdic tion unde r 8 U.S.C . § 1252. Our re vie w is “ lim ite d

to c onfirm ing the a ge nc y ’ s c om plia n c e with the 

# FIL ED

SEP 28 2015 M OLLY C. DW Y ER, CLERK U . S. CO URT O F APPEALS

* This disposition is not a ppropria te for public at ion a

nd is not pre c e de nt e xc e pt a s provide d

by 9th C ir. R . 36-3. ** The pa

ne l una nim ously c onc lude s this c a se is suita ble for de c ision without oral a

rgum e nt. Se e Fe d. R . App. P. 34(a)(2).re insta

te m e nt re gula

tions.” Garc ia de Rinc on v . DHS, 539 F.3d 1133, 1137 (9th C ir. 2008). W e de ny

the pe tition for re vie w. The DHS did not e rr in issuing M ore no-Tosc ano’ s re insta te m e nt orde r, whe re the re c ord shows, a nd M ore no-Tosc ano a dm itte d in a sworn sta te m e nt to a DHS offic e r, tha

t he w a s a n a lie n, he wa s subje c t to a prior orde r of re m ova l in 1997, a nd he ille ga lly

re e nte re d subse que nt to tha

t orde r. Se e Garc ia de

Rinc on , 539 F.3d a

t 1137 (our jurisdiction is lim i te d to re vie w ing “ t

hre e disc re te inquirie s an im m igration offic e r m

ust m ake in orde r to re insta te a re m ova l orde r: (1) whe the r the pe titione r is a n a l ie n; (2) whe the r the pe titione r wa s subje c t to a prior re m ova l orde r, and (3) whe t he r the pe titione r re -e nte re d ille ga lly ” ); 8 U.S.C . § 1231(a )(5) (if the DHS “ finds tha t a n a lie n ha s re e nte re d the Unite d State s ille g a lly a fte r having be e n re m ove d or ha ving depa rte d volunta rily , unde r an orde r of re m ova l, the prior orde r of re m ova l is re insta te d from its original da

t e ” ). Furthe rm ore , M ore no-Tosc a no doe s not c onte nd tha

t a ny m i sc arria ge of justic e oc c urre d in c onne c tion with his unde rly ing 1997 re m ova l orde r. Se e Garc ia deRinc on , 539 F.3d a

t 1138 (while

a pe t itione r is ge ne ra l ly

pre ve nte d from c olla te ra lly atta c king a

n unde rly ing de porta

tion orde r on c onstitutiona l or le ga l grounds, 8 U.S.C . § 1252(a)(2)(D) pe rm its som e m e a sure of re vie wif he c a n de m onstra

te a “ gross m isc arria g e of justic e ” in the unde rly ing proc e e dings). 1 3 - 7 2 1 3 4 2In light of this disposition, we do not re a c h M ore no-Tosc an o’ s re m a ining c onte ntions. PE T IT IO N FO R RE V IE WDE NIE D .

1 3 - 7 2 1 3 4 3
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# Gas Technology Institute – Fuel Switching Study

The American Gas Association (AGA) and the American Public Gas Association (APGA) commissioned the Gas Technology Institute (GTI) to conduct a study to evaluate the potential impact of fuel switching if new minimum efficiency standards for natural gas furnaces were to require condensing equipment in the replacement and new construction markets.

The objective of the research summarized in this report and accompanying spreadsheet was to develop and publish information on fuel switching behavior related to residential heating and water heating systems in new construction and replacement markets at national, regional, and state levels. The technical information is intended for use in evaluating the impact of fuel switching on the technical feasibility and economic justification for increasing federal minimum efficiency requirements from non-condensing furnace efficiency levels to condensing furnace efficiency levels.

Survey Observations Survey Instrument Survey Results

Contact: Rick Murphy, Managing Director of Sustainable Growth | 202-824-7301 | rmurphy@aga.org

Site Map | Privacy Policy | Terms and Conditions ©2014 American Gas Association 400 North Capitol Street, NW | Washington, DC 20001
**Exhibit21.1**

 

**SUBSIDIARIESOF MACKIE DESIGNS INC.**

**Asof December 31, 2001**

 
| **Subsidiary**                                                   |   | **State of Incorporation or Country in which Organized** |
|------------------------------------------------------------------|--------|----------------------------------------------------------|
| Mackie Sales Corporation                                         |   | Barbados                                                 |
| Mackie Designs  Manufacturing Inc.                               |   | Washington, U.S.A                                        |
| Mackie Designs (Netherlands)  B.V.                               |   | The Netherlands                                          |
| Mackie Designs (Italy)  S.p.A.                                   |   | Italy                                                    |
| AVM S.r.L.                                                       |   | Italy                                                    |
| Mackie Designs (France)  S.A.                                    |   | France                                                   |
| Mackie Designs PLC                                               |   | UK                                                       |
| Mackie Industrial, Inc.                                          |   | New Jersey, U.S.A.                                       |
| RCF China Limited                                                |   | China                                                    |
| Mackie Designs  (Deutschland) GmbH                               |   | Germany                                                  |
| EAW International Ltd.                                           |   | U.S. Virgin Islands                                      |
| Eastern Acoustic Works  International Ltd.                       |   | UK                                                       |
| SIA Software Company                                             |   | New York, U.S.A.                                         |
| Class A                                                          |   | Czech Republic                                           |
| Mackie Designs (Belgium)  BVBA                                   |   | Belgium                                                  |
| Mackie Designs Engineering  Services  BVBA (formerly Sydec N.V.) |   | Belgium                                                  |
| Acuma Labs Inc.                                                  |   | Canada                                                   |
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Exhibit 10.12.1  


 
 

Year 2002 Chief Executive Officer and Executive Vice Presidents
  Bonus Plan Overview    
  


	A.
	Purpose




The
Year 2002 Corporate Management Bonus Plan has been developed to provide financial incentives to those members of management that can make an important contribution to the success of Michaels
Stores & its subsidiaries. 



	1.
	Bonus Payout





Bonus
payout for the Chief Executive Officer [or Executive Vice President] can be up to ___% of base salary as of February 3, 2002 and will be based on the Company
profit performance for FY 2002 before income taxes. 




	B.
	Bonus Plan Eligibility



	1.
	The
profit performance period parallels Fiscal Year 2002. It begins on February 3, 2002 and concludes on February 1, 2003.



	2.
	If
an associate was not employed in a bonus eligible position during the entire fiscal year, he/she will be eligible to receive a prorated bonus based upon the number of full months
that he/she was in a bonus eligible position. An individual who assumes a bonus eligible position on or before the 15thof the month will receive credit for the entire month. An
individual who assumes a position after the 15th of the month will not receive credit for that month. Anyone hired after November 15th, 2002 will not be eligible to
participate in the Year 2002 Corporate Management Bonus Plan.



	3.
	Bonus
payout will be a percentage of your actual base salary as of February 3, 2002.



	4.
	An
associate must be employed by the Company in a bonus eligible position at the time of payout in order to be eligible for or receive a bonus payment.



	5.
	Associates
in bonus eligible positions may sometimes change positions or be promoted within a fiscal year. If a change results in a different bonus percentage payout level, bonus
earnings for each position will be calculated separately at year end. The number of full months (see #2, above) in each position, the respective base salaries and the applicable target bonus amount(s)
for each bonus eligible position will be calculated and then added together to provide the final bonus payment.



	6.
	Bonus
payments are typically made in April of the following fiscal year.



	7.
	An
associate will not be eligible to receive a bonus payment for FY 2002 if: 1) he/she receives an overall performance rating of "Unsatisfactory" for FY 2002 and/or 2) at
the time of bonus payout he/she is on a Performance Improvement Plan ("PIP") that was initiated during FY 2002. Associates who are on a Performance Improvement Plan that was initiated in FY 2003 will
be eligible for a bonus payment for FY 2002.



	8.
	The
Company anticipates that this bonus plan will be part of an ongoing bonus program, but the Company does not guarantee that the program will in fact continue for future periods or
that the terms of the program will not change. 
















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Year 2002 Chief Executive Officer and Executive Vice Presidents Bonus Plan Overview
### {In Archive} Fw: Monthly call Carl Young to: Dayana Medina 03/29/2011 12:21 PM
From: Carl Young/R6/USEPA/US To: Dayana Medina/R6/USEPA/US@EPA History: This message has been forwarded. Archive: This message is being viewed in an archive. Hi Dayana, Below are the attachments. Carl Carl Young EPA Region 6 Air Planning Section 214-665-6645 ----- Forwarded by Carl Young/R6/USEPA/US on 03/29/2011 12:21 PM -----

From: "Walker Williamson" <Walker.Williamson@tceq.texas.gov> To: Carl Young/R6/USEPA/US@EPA Cc: "Donna Huff" <Donna.Huff@tceq.texas.gov>, "Guy Hoffman" <Guy.Hoffman@tceq.texas.gov> Date: 03/25/2011 02:58 PM Subject: Re: Monthly call


### Hey, Carl: Sorry, but we have one more item for the agenda. I got this from Nina Castillo on our Mobile Source Programs Team: On Tuesday's conference call , we would like to discuss the TCEQ proposed idling rulemaking. We need some clarification with regards to the rulemaking proposal comments submitted by the EPA on March 10 , 2011. The EPA expressed concern that the proposal to retain the exemption for a motor vehicle when idling for heating or air conditioning while a driver is using the vehicle's sleeper berth for a government-mandated rest period will allow an emission increase over the approved State Implementation Plan (SIP )

. In the Dallas-Fort Worth (DFW ) A ttainment Demonstration SI P , the idling restrictions emission reductions are part of the Voluntary Mobile Source Emission Reduction Programs (VMEP ) commitments. The attached North Central Texas Council of Governments (NCTCOG ) Voluntary Mobile Source Emission Reduction Program and Other Local Program Achievements document indicates the DFW achieved an excess of NO X reduction through the VMEP commitments , indicating that VMEP commitments could be achieved without the vehicle idling reductions.



### >>> <Young.Carl@epamail.epa.gov> 3/25/2011 8:46 AM >>> Hi Walker, I'll add these topics. Also, I'll "185 Fees Update". Talk with you all Tuesday at 2.
Exhibit 10.9 (f)

                       ASSIGNMENT AND ASSUMPTION AGREEMENT

         THIS ASSIGNMENT AND ASSUMPTION AGREEMENT ("Agreement") is entered into
this 1st day of November 2002 by and between Ledger Technologies Pty.
Ltd.(A.C.N. 085 887 921), of 10 Bickhams Court, East St.Kilda, Victoria
Australia ("Assignor"), and Perfect Optical Corporation, of 110 East 23rd
Street, New York NY ("Assignee").

         Pursuant to the terms of this Agreement, in exchange for the
satisfaction of $260,000 (USD) of obligations owed by Assignor to Assignee in
connection with the loan arrangements reached in July 2000, Assignor hereby
assigns, conveys, transfers and delivers all of its right, title and interest in
and to $260,000 (USD) of that certain Promissory Note (Loan Agreement) dated
November 8, 2000 (the "Note") due from I. T. Technology, Inc.(the "Obligor") to
Assignor (the "Partial Note Assignment"). Assignee acknowledges and agrees that
the remaining principal balance and accrued and unpaid interest due on the Note
shall remain the property of the Assignor.

         In connection with and limited to the Partial Note Assignment, Assignee
hereby agrees to assume all of Assignor's obligations under that certain Loan
Agreement dated November 8, 2000 between the Assignor and the Obligor.

         IN WITNESS WHEREOF, Assignor, Assignee and the Obligor have duly
executed this Assignment and Assumption Agreement as of the date first above
written.


                                              LEDGER TECHNOLOGIES PTY. LTD


                                                       By:  /s/ Lisa Mochkin
                                                       Name:   Lisa Mochkin
                                                               Title: Director


                                              PERFECT OPTICAL CORPORATION


                                                       By:  /s/Israel Motchkin
                                                       Name:
                                                       Title: PRES
AGREED TO AND ACCEPTED
THIS 1 DAY OF NOVEMBER 2002

I. T. TECHNOLOGY, INC.

By: /s/ Yam-Hin Tan
Name: Yam-Hin Tan
Title:  Chief Financial Officer
April 11, 1980

427 A.2d 1212

#### Commonwealth v. Campbell, Appellant.

Submitted March 23, 1979.

Douglas M. Johnson, Assistant Public Defender, for *609appellant;

Eric J. Cox, Assistant District Attorney, for Commonwealth, appellee.

Before CERCONE, P. J., and WATKINS and HOFFMAN, JJ.

Order affirmed.