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.

§ 878.4456 Hemostatic device for intraluminal gastrointestinal use. ( a ) *Identification.* A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) The device must be demonstrated to be biocompatible.
( 2 ) Performance data must support the sterility and pyrogenicity 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 identified shelf life.
( 4 ) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following: ( i ) The ability to deliver the hemostatic material to the bleeding site;
( ii ) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and
( iii ) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation.
( 5 ) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: ( i ) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids.
( ii ) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems.
( 6 ) Labeling must include: ( i ) Information identifying and explaining how to use the device and its components; and
( ii ) A shelf life.
[83 FR 52971, Oct. 19, 2018]
EXHIBIT 10.77




 




 




Gary J. Skoien




Chairman, President,

and




Chief Executive

Officer




 




 




December 19, 2002




 




 




Mr. Thomas Rumptz




Horizon Group Properties, Inc.




5000 Hakes Drive




Muskegon,

MI   49441




 




Dear Tom:




 




This letter

amends your initial retention letter. 

“The Term of This Agreement” on Page 2, Section 4 shall be changed to

June 30, 2003.




 




Please feel

free to call me with any questions you may have.  Thank you for all of your hard work on behalf of Horizon Group

Properties, Inc.




 




	

   


  	

  Very truly yours,


  	

   


  
	

   


  	

   


  	

   


  
	

   


  	

   


  	

   


  
	

   


  	

  /s/ Gary J. Skoien
3200 Rio Grande

UNITED STATES OF AMERICA

ESTADOS UNIDOS MEXICANOS

Eagle

Mountains

SW OE S

Eagle

Mountains SE

Bramlett

Ranch

Indian Hot

Springs

Eagle

Mountains SW

FEET

FEET

760 000 FEET

DQ

DP

DQ

DP

105°07'30"

40'

30" 42'30"

40'

42'

15'

15' 30" 07'30"

45'

105° 105°

105°

30" 30°37'

12'30"

12'

37'

45'

10'

30° 30°

10'

30° 30"

10 260 000

790 000 FEET

10 230 000

E

33

4 4

4

33

33

4 4

4

33

33

33

4

33

4 4

34

33

33

000m

33

33

34

000m

33

4

33

33

4

34

33

33

4 4

33

4

4

000m

33

34

33

000m

4

33

33

4

4

33

86

N

94

78

92

87

87

90

92

83

96

95

81

95

78

00

90

91

99

98

82

93

77

00

81

97

82

N

E

79 86

89

93

97

94

01

89

85

96

85

98

77

01

83

99

91

79

U.S. DEPARTMENT OF THE INTERIOR

U. S. GEOLOGICAL SURVEY

TEXAS

ADJOINING 7.5' QUADRANGLES

QUADRANGLE LOCATION

TX 30105-413

EAGLE MOUNTAINS SW OE S, TX-CHH

2010

Interstate Route State Route

ROAD CLASSIFICATION

Interstate Route US Route State Route

Ramp 4WD

US Route Local Road

EAGLE MOUNTAINS SW OE S QUADRANGLE

TEXAS-CHIHUAHUA

7.5-MINUTE SERIES

Zone 13R

Imagery.............................................NAIP, September 2008

Roads.....................................US Census Bureau TIGER data

with limited USGS updates, 2008

Names...............................................................GNIS, 2008

Hydrography.................National Hydrography Dataset, 1995

Contours............................National Elevation Dataset, 2005

North American Datum of 1983 (NAD83)

World Geodetic System of 1984 (WGS84). Projection and

1 000-meter grid: Universal Transverse Mercator,

Produced by the United States Geological Survey

10 000-foot ticks: Texas Coordinate System of 1983

(central zone)

1000 500 0 METERS 1000 2000

1000 0 1000 2000 3000 4000 5000 6000 7000 8000 9000 10000

FEET

This map was produced to conform with version 0.5.10 of the

draft USGS Standards for 7.5-Minute Quadrangle Maps.

A metadata file associated with this product is also draft version 0.5.10

SCALE 1:24 000

1 0.5 0 1

MILES

MN

1 0.5 0 KILOMETERS 1 2

GN

UTM GRID AND 2010 MAGNETIC NORTH DECLINATION AT CENTER OF SHEET

0° 6 ́

2 MILS

8° 20 ́

148 MILS

U.S. National Grid

100,000-m Square ID

Grid Zone Designation

13R

DP

DQ 34 00

CONTOUR INTERVAL 20 FEET

NORTH AMERICAN VERTICAL DATUM OF 1988
**UN PUBLISHED**  UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

**No. 10**  **- 7029** 

UNITED STATES OF AMERICA , Plaintiff

- Appellee ,
v. KIM A. PRATER , Defendant

- Appellant
.
Appeal from the United States District Court for the Western Distr ict of Virginia , at Abingdon
. James P. Jones , District Judge. ( 1:03

- cr - 00075

- jpj

- mfu

— 1; 1:01

- cr - 00018

- jpj

- 1 )

Submitted : November 18, 2010 Decided: December 1, 2010

Before SHEDD and AGEE , Circuit Judges, and HAMILTON, Senior Circuit Judge.

A ffi rmed in part ; dismissed in part by un published per curiam opinion
. Kim A. Prater, Appellant Pro Se. Steven Randall Ramseyer, Assistant United States Attorney, Abingdon, Virginia, for Appellee.
Unpublished opinions are not binding precedent in this ci rcuit.2 PER CURIAM: Kim A. Prater appeals the district court ’ s order denying his 18 U.S.C. § 3582(c) (2006) motion for a sentence reduction. We have reviewed the record and find no reversible error. Accordingly, we affirm for the reasons stated by the d istrict court. United States v. Prater , Nos. 1:03

- cr - 00075

- jpj

- mfu

- 1; 1:01

- cr - 00018

- jpj

- 1 (W.D. Va. June 18, 2010)
. Prater also appeals the denial of his 28 U.S.C.A. § 2255 (West Supp. 2010) motion. The order is not appealable unless a circuit justice or judge issues a certificate of appealability. 28 U.S.C. § 2253(c)(1) (2006). A certificate of appealability will not issue absent “a substantial showing of the denial of a constitutional right.” 28 U.S.C. § 2253(c)(2) (2006). When the district court denies relief on the merits, a prisoner satisfies this standard by demonstrating that reasonable jurists would find that the district court’s assessment of the constitutional claims is debatable or wrong. Slack v. McDaniel , 529 U.S. 473, 484 (2000); see M iller

- El v. Cockrell , 537 U.S. 322, 336

- 38 (2003). When the district court denies relief on procedural grounds, the prisoner must demonstrate both that the dispositive procedural ruling is debatable, and that the motion states a debatable claim of the den ial of a constitutional right. Slack , 529 U.S. at 484

- 85.3 We have independently reviewed the record and conclude that Prater has not made the requisite showing. Accordingly, we deny a certificate of appealability and dismiss the appeal. We dispense wit h oral argument because the facts and legal contentions are adequately presented in the materials before the court and argument would not aid the decisional process.

AFFIRMED IN PART ; DISMISSED IN PART
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.                  

###### Department of Agriculture

###### Forest Service

# AGENCY:

Forest Service, USDA.

# ACTION:

Notice of meeting.

# SUMMARY:

The Yakutat Resource Advisory Committee will meet in Yakutat, Alaska. The purpose of the meeting is to  continue business of the Yakutat Resource Advisory Committee. The committee was formed to carry out the requirements of the Secure Rural Schools and Selt-Determination Act of 2000. The agenda for this meeting is to review submitted project proposals and consider recommending projects for funding. Project proposals were due by March 19, 2010 to be considered at this meeting.

# DATES:

The meeting will be held March 30, 2010 from 6-9 p.m.

# ADDRESSES:

                        The meeting will be held at the Kwaan Conference Room, 712 Ocean Cape Drive, Yakutat, Alaska. Send written comments to Lee A. Benson, c/o Forest Service, USDA, P.O. Box 327, Yakutat, AK 99689, (907) 784-3359 or electronically to                         *labenson@fs.fed.us.*

# FOR FURTHER INFORMATION CONTACT:

Lee A. Benson, District Ranger and Designated Federal Official, Yakutat Ranger District, (907) 784-3359.

# SUPPLEMENTARY INFORMATION:

The meeting is open to the public. Council discussion is limited to Forest Service staff and Council members. However, persons who wish to bring resource projects or other Resource Advisory Committee matters to the attention of the Council may file written statements with the Council staff before or after the meeting. Public input sessions will be provided and individuals who made written requests by March 30, 2010 will have the opportunity to address the Council at those sessions.

Dated: February 19, 2010.

Lee A. Benson,

District Ranger,  Yakutat Ranger District, Tongass National Forest.

[FR Doc. 2010-4691 Filed 3-5-10; 8:45 am]

BILLING CODE 3410-11-M
# C_2014253EN.01005502.xml

| 4.8.2014 | EN | Official Journal of the European Union | C 253/55 |
| --- | --- | --- | --- |

4.8.2014

EN

Official Journal of the European Union

C 253/55

---

Action brought on 12 June 2014 — Afar 4 v Commission

(Case T-417/14)

2014/C 253/73

Language of the case: Spanish

Parties

Parties

Applicant: Afar 4, SL (Madrid, Spain) (represented by: A. López Gómez, lawyer)

Applicant:

Defendant: European Commission

Defendant:

Form of order sought

Form of order sought

The applicant claims that the Court should:

| — | annul the contested decision; |
| --- | --- |

—

annul the contested decision;

| — | in the alternative, annul the decision categorising the measures which together constitute the ‘Spanish Tax Lease System’ (‘STLS’) as new State aid that is incompatible with the internal market; |
| --- | --- |

—

in the alternative, annul the decision categorising the measures which together constitute the ‘Spanish Tax Lease System’ (‘STLS’) as new State aid that is incompatible with the internal market;

| — | in the alternative, annul Articles 1 and 4 of the contested decision, which identify the investors in the Economic Interest Groupings (EIGs) as the only beneficiaries of the alleged aid and, consequently, as solely liable for its recovery; |
| --- | --- |

—

in the alternative, annul Articles 1 and 4 of the contested decision, which identify the investors in the Economic Interest Groupings (EIGs) as the only beneficiaries of the alleged aid and, consequently, as solely liable for its recovery;

| — | in the alternative, annul Article 4 of the contested decision, in so far as it orders recovery of the alleged aid in breach of general principles of EU law; |
| --- | --- |

—

in the alternative, annul Article 4 of the contested decision, in so far as it orders recovery of the alleged aid in breach of general principles of EU law;

| — | in the alternative, annul Article 4 of the contested decision, in so far as it makes a determination as to the lawfulness of private contracts between the investors and other entities, in full or in such a way as to limit the bar on passing on the burden of recovery to the profitability of the operations; and |
| --- | --- |

—

in the alternative, annul Article 4 of the contested decision, in so far as it makes a determination as to the lawfulness of private contracts between the investors and other entities, in full or in such a way as to limit the bar on passing on the burden of recovery to the profitability of the operations; and

| — | order the Commission to pay the costs of these proceedings. |
| --- | --- |

—

order the Commission to pay the costs of these proceedings.

Pleas in law and main arguments

Pleas in law and main arguments

The pleas in law and main arguments are those raised in Case T-401/14 Duro Felguera SA v Commission.

---
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.                  

###### Department of Transportation

###### Office of the Secretary

                    The following applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier Permits were filed under Subpart B (formerly Subpart Q) of the Department of Transportation's Procedural Regulations (                    *See*14 CFR 301.201*et seq.*).                

The due date for Answers, Conforming Applications, or Motions to Modify Scope are set forth below for each application. Following the Answer period DOT may process the application by expedited procedures. Such procedures may consist of the adoption of a show-cause order, a tentative order, or in appropriate cases a final order without further proceedings.

*Docket Number:*                     DOT-OST-2010-0029.                

*Date Filed:*                     February 2, 2010.                

*Due Date for Answers, Conforming Applications, or Motion to Modify Scope:*                     February 23, 2010.                

*Description:*                     Application of Perimeter Aviation LP as represented by its general partner Perimeter Aviation GP Inc. c/o/b Perimeter Aviation requesting an exemption and a foreign air carrier permit to engage in charter foreign air transportation of persons, property and mail: (1) Between any points in Canada and any point or points in the United States; (2) between any point or points in the United States and any point or points in a third country or countries, provided that, except with respect to cargo charters, such service constitutes part of a continuous operation, with or without a change of aircraft, that includes service to Canada for the purpose of carrying local traffic between                           ( print page 10341)                        Canada and the United States; and (3) other charter operations.                

Renee V. Wright, 

Program Manager, Docket Operations, Federal Register Liaison.

[FR Doc. 2010-4673 Filed 3-4-10; 8:45 am]

BILLING CODE 4910-9X-P
# ~MHARR Manufilctured llouslng ArnKla!lon forRegulatory R•lorm Mark Weiss President8 CEO mmarkweiss@aol.com 202-783-4087 fax 202-783-4075 MHARRDG@AOL.COM

1331 Pennsylvania Avenue, NW• Suite 512 •Washington, DC 20004

P.O. BOX507 RED BAY, ALABAMA 35582 jbostick@sunshinehomes-inc.com President (256) 356-4427 574.533.0431

- Phone 574.533.0438

- Fax 800.733.0431 E-MAIL: edward.hussey@ libertyhomesinc.com 

# LIBERTY HOMES, INC. Corporate Office

# 1:;~~;;fE~~;~;~~:::6) Edward Joseph Hussey "'&'ti ti#'!!* Vice President - Secretary General Counsel

# ~MHARR M•nut.ulun>d l/ou.lngAssodallon ror Regulalnq Refomi Danny D. Ghorbani President8 CEO dannyghorbani@aol.com 202-783-4087 fax 202-783-4075 MHARRDG@AOL.COM

1331 Pennsylvania Avenue, NW• Suite 512 •Washington, DC 20004

### /)~**~r** 

## . 

# s. 

# c;;? ;y**-~~'** r/)/-\

# 1 IECC EFFECT

# \A1J~.r7_ ,/" {?t

# 'v:,l'.~·.

# '~~**~'<'tf**

Insulation

R38-21-22 vs. R28-11-11 Exterior Doors Exterior Walls

2x6 vs. 2x4 Windows Rafters Energy Heel with Flat Ceiling Bill of Material Increases Selling Price lncrease:Wholesale 50% SOM Retail Markup 1.4 x DW 28X56 1568 sq. ft. 641.12 322.40 295.00 641.90 180.00 2080.42

4160.84 5825.17 SW 14X66 924 sq. ft. 499.82 322.40 264.00 449.33 108.00 1643.55

3287.10 4601.94>From the public testimony of Don Surrena, CBO >National Association ofHome Builders > ProgramManager, Energy Efficiency > > Begin forwarded message: >>> >>We estimate that in 2014 the average price ofnew manufactured homes (including the cost of lot development) is $53,230 for single homes and $100,259 for double homes. Increasing the price ofnew single manufactured homes by $1,000 will disqualify 347,901 households from being able to afford these homes. Similarly, ifthe price ofnew double manufactured home rises by $1,000, 315,385 households will be priced out ofthemarket. The effects are NOT cumulative, since they are based on the same income distribution ofall US households. These are NOT effects on sales, rather only on ability to qualify for a mortgage. >> >> >>Ournew manufactured home prices are based on the average sale prices for single and double new manufactured homes reported by The Manufactured Housing Institute (MHI). They are further adjusted for inflation and additional costs oflot development. The inflation factor is the increase in new manufactured home prices from 2012 to 2013 as reported by the MHI. The lot development cost adjustment is based on the NAHB survey ofconstruction costs. >> >>NATALIA SINIAVSKAIA, Ph.D. > > HousingPolicyEconomist > > Survey and HousingPolicyResearch >> >>National Association ofHome Builders >> 1201 15th Street, NW >>Washington, DC 20005
Editorial Note on Part 868
Editorial Note: Nomenclature changes to part 868 appear at 73 FR 35341, June 23, 2008.

§ 868.2380 Nitric oxide analyzer. ( a ) *Identification.* The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures during administration of nitric oxide.
( b ) *Classification.* Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
[65 FR 14465, Mar. 3, 2000]
# C_2014253EN.01006401.xml

| 4.8.2014 | EN | Official Journal of the European Union | C 253/64 |
| --- | --- | --- | --- |

4.8.2014

EN

Official Journal of the European Union

C 253/64

---

Action brought on 24 June 2014 — Fonditel Pensiones v Commission

(Case T-467/14)

2014/C 253/87

Language of the case: Spanish

Parties

Parties

Applicant: Fonditel Pensiones, Entidad Gestora de Fondos de Pensiones, SA (Madrid, Spain) (represented by: J.L. Buendía Sierra, E. Abad Valdenebro, R. Calvo Salinero and A. Lamadrid de Pablo, lawyers)

Applicant:

Defendant: European Commission

Defendant:

Form of order sought

Form of order sought

The applicant claims that the General Court should:

| — | annul the contested decision in so far as it categorises the measures which, according to that decision, together constitute the ‘Spanish Tax Lease System’ as new State aid that is incompatible with the internal market; |
| --- | --- |

—

annul the contested decision in so far as it categorises the measures which, according to that decision, together constitute the ‘Spanish Tax Lease System’ as new State aid that is incompatible with the internal market;

| — | in the alternative, annul Articles 1 and 4 of the contested decision, which identify the investors in the Economic Interest Groupings (EIGs) as the beneficiaries of the alleged aid and as the sole addressees of the order for recovery; |
| --- | --- |

—

in the alternative, annul Articles 1 and 4 of the contested decision, which identify the investors in the Economic Interest Groupings (EIGs) as the beneficiaries of the alleged aid and as the sole addressees of the order for recovery;

| — | in the alternative, annul Article 4 of the contested decision, in so far as it orders recovery of the alleged aid; |
| --- | --- |

—

in the alternative, annul Article 4 of the contested decision, in so far as it orders recovery of the alleged aid;

| — | annul Article 4 of the contested decision, in so far as it makes a determination as to the lawfulness of private contracts between the investors and other entities; and |
| --- | --- |

—

annul Article 4 of the contested decision, in so far as it makes a determination as to the lawfulness of private contracts between the investors and other entities; and

| — | order the Commission to pay the costs of these proceedings. |
| --- | --- |

—

order the Commission to pay the costs of these proceedings.

Pleas in law and main arguments

Pleas in law and main arguments

The pleas in law and main arguments are those raised in Case T-700/13 Bankia v Commission.

Bankia

Commission

---
# C_2016098EN.01004202.xml

| 14.3.2016 | EN | Official Journal of the European Union | C 98/42 |
| --- | --- | --- | --- |

14.3.2016

EN

Official Journal of the European Union

C 98/42

---

Judgment of the General Court of 27 January 2016 — Montagut Viladot v Commission

(Case T-696/14 P) (1)

1

((Appeal - Staff cases - Recruitment - Competition to constitute a reserve from which to recruit grade AD 5 administrators - Decision of the selection board not to place the applicant’s name on the reserve list - Diploma which does not satisfy the conditions in the notice of competition - Dismissal of the action at first instance))

(2016/C 098/55)

Language of the case: Spanish

Parties

Parties

Appellant: Bernat Montagut Viladot (Schaerbeek, Belgium) (represented by: F.A. Rodríguez-Gigirey Pérez and J.A. Simón Sánchez, lawyers)

Appellant:

Other party to the proceedings: European Commission (represented by: I. Galindo Martín and G. Gattinara, acting as Agents)

Other party to the proceedings:

Re:

Re:

Appeal brought against the judgment of the Civil Service Tribunal of the European Union (First Chamber) of 15 July 2014 in Montagut Viladot v Commission (F-160/12, ECR-SC, EU:F:2014:190), seeking to have that judgment set aside.

Montagut Viladot

Commission

Operative part of the judgment

Operative part of the judgment

The Court:

| 1. | Dismisses the appeal; |
| --- | --- |

1.

Dismisses the appeal;

| 2. | Orders Mr Bernat Montagut Viladot to pay the costs. |
| --- | --- |

2.

Orders Mr Bernat Montagut Viladot to pay the costs.

---

(1)  OJ C 409, 17.11.2014.

1

---