alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
§ 601.42 Approval with restrictions to assure safe use. ( a ) If FDA concludes that a biological product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the biological product, such as: ( 1 ) Distribution restricted to certain facilities or physicians with special training or experience; or
( 2 ) Distribution conditioned on the performance of specified medical procedures.
( b ) The limitations imposed will be commensurate with the specific safety concerns presented by the biological product.
COURT OF APPEALS

EIGHTH DISTRICT OF TEXAS

EL PASO, TEXAS

CHRISTOPER DAVID RYAN,

Appellant,

v.

THE STATE OF TEXAS,

Appellee. §

§

§

§

§

§ No. 08

- 14

- 00167

- CR

Appeal from the

112th District Court

of Upton County, Texas

(TC# 05

- 05

- U790

- DPO)

J U D G M E N T

The Court has considered this cause on the record and concludes there was no error in the

judgment. We therefore affirm the judgment of the court below . This decision shall be certified

below for observance.

IT IS SO ORDERED THIS 12TH DAY OF AUGUST, 2015.

YVONNE T. RODRIGUEZ, Justice

Before McClure, C.J., Rodriguez, and Hughes, JJ.
Editorial Note on Part 872
Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

§ 872.4200 Dental handpiece and accessories. ( a ) *Identification.* A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
( b ) *Classification.* Class I.
[55 FR 48439, Nov. 20, 1990]
§ 522.1260 Lincomycin. ( a ) *Specifications.* Each milliliter of solution contains lincomycin hydrochloride monohydrate equivalent to: ( 1 ) 25, 50, 100, or 300 milligrams (mg) lincomycin.
( 2 ) 25, 100, or 300 mg lincomycin.
( 3 ) 300 mg lincomycin.
( 4 ) 100 or 300 mg lincomycin.
( b ) *Sponsors.* See sponsors in § 510.600(c) of this chapter for uses as in paragraph (e) of this section. ( 1 ) No. 054771 for use of concentrations in paragraph (a)(1) of this section as in paragraph (e) of this section.
( 2 ) Nos. 016592 and 058005 for use of concentrations in paragraph (a)(2) of this section as in paragraph (e)(2) of this section.
( 3 ) No. 054771 for use of concentration in paragraph (a)(3) of this section as in paragraph (e)(2) of this section.
( 4 ) No. 061133 for use of concentrations in paragraph (a)(4) of this section as in paragraph (e)(2) of this section.
( c ) *Special considerations.* When common labeling for use of the drug in dogs, cats, and swine is included with the drug, all such uses are subject to the labeling requirements of § 201.105 of this chapter.
( d ) *Related tolerances.* See § 556.360 of this chapter.
( e ) *Conditions of use.* It is used for animals as follows: ( 1 ) *Dogs and cats* — ( i ) *Amount.* 5 mg per pound (/lb) of body weight twice daily or 10 mg/lb body weight once daily by intramuscular injection; 5 to 10 mg/lb body weight one or two times daily by slow intravenous injection.
( ii ) *Indications for use.* Infections caused by Gram-positive organisms, particularly streptococci and staphylococci.
( iii ) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
( 2 ) *Swine* — ( i ) *Amount.* 5 mg/lb body weight once daily by intramuscular injection for 3 to 7 days.
( ii ) *Indications for use.* Treatment of infectious arthritis and mycoplasma pneumonia.
( iii ) *Limitations.* Do not treat within 48 hours of slaughter. For No 054771: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 50 FR 31351, Aug. 2, 1985; 67 FR 34388, May 14, 2002; 68 FR 51705, Aug. 28, 2003; 69 FR 11507, Mar. 11, 2004; 69 FR 47361, Aug. 5, 2004; 71 FR 51996, Sept. 1, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 16191, Mar. 25, 2014; 81 FR 59134, Aug. 29, 2016; 84 FR 8974, Mar. 13, 2019; 88 FR 16548, Mar. 20, 2023]
Editorial Note on Part 866
Editorial Note: Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.

§ 866.3370 *Mycobacterium tuberculosis* immunofluorescent reagents. ( a ) *Identification. Mycobacterium tuberculosis* immunofluorescent reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify *Mycobacterium tuberculosis* directly from clinical specimens. The identification aids in the diagnosis of tuberculosis and provides epidemiological information on this disease. *Mycobacterium tuberculosis* is the common causative organism in human tuberculosis, a chronic infectious disease characterized by formation of tubercles (small rounded nodules) and tissue necrosis (destruction), usually occurring in the lung.
( b ) *Classification.* Class I (general controls).
**Exhibit32.2**

 

**CERTIFICATIONPURSUANT TO**

 

**18U.S.C. SECTION 1350,**

 

**ASADOPTED PURSUANT TO**

 

**SECTION906 OF THE SARBANES-OXLEY ACT OF 2002**

 

In connectionwith the Quarterly Report of ebix.com, Inc. (the “Company”) on Form 10-Q forthe period that ended September 30, 2003, as filed with the Securities andExchange Commission on the date hereof (the “Report”), I, Richard J. Baum,Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C.  1350, as adopted pursuant to 906 of theSarbanes-Oxley Act of 2002, that:

 

1.  The Report fully complies with therequirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934;and

 

2.  The information contained in the Reportfairly presents, in all material respects, the financial condition and resultof operations of the Company.

 

 
| Date:  | November 10, 2003 | /s/ Richard J. Baum     |   |
|--------|-------------------|-------------------------|--------|
|   |              | Richard J. Baum         |
|   |              | Chief Financial Officer |

 

1

----
#### § 660.26 Specificity tests and avidity tests.

Specificity and avidity tests shall be performed using test procedures approved by the Director, Center for Biologics Evaluation and Research.

[53 FR 12764, Apr. 19, 1988, as amended at 67 FR 9587, Mar. 4, 2002; 70 FR 14985, Mar. 24, 2005]
# C_2015056EN.01003103.xml

| 16.2.2015 | EN | Official Journal of the European Union | C 56/31 |
| --- | --- | --- | --- |

16.2.2015

EN

Official Journal of the European Union

C 56/31

---

Order of the General Court of 3 December 2014 — ENISA v Psarras

(Case T-689/14 P) (1)

1

(2015/C 056/45)

Language of the case: Greek

The President of the Appeal Chamber has ordered that the case be removed from the register.

---

(1)  OJ C 431, 1.12.2014.

1

---
MEMORANDUM 

DATE: November 10, 2014

TO: Clean Power Plan for Existing Power Plants; Docket Id: OAR–2013-0602

FROM: Howard J. Hoffman, EPA - OGC

SUBJECT: November 10, 2014 Phone Call with M.J. Bradley Regarding Proposed Clean 

Power Plan for Existing Power Plants

SUMMARY

On November 10, 2014, Kevin Culligan (EPA-OAQPS) and I spoke by telephone with Chris 

Van Atten of M.J. Bradley & Associates to discuss legal issues concerning the proposed Clean 

Power Plan for existing power plants.
```

[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Notices]
[Page 28001]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11887]

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

CONSUMER PRODUCT SAFETY COMMISSION

Sunshine Act Meeting Notice

TIME AND DATE: Wednesday, May 18, 2011; 10 a.m.-11 a.m.

PLACE: Hearing Room 420, Bethesda Towers, 4330 East West Highway, 
Bethesda, Maryland.

STATUS: Closed to the Public.

Matter To Be Considered

Compliance Status Report

    The Commission staff will brief the Commission on the status of 
compliance matters.
    For a recorded message containing the latest agenda information, 
call (301) 504-7948.

CONTACT PERSON FOR MORE INFORMATION: Todd A. Stevenson, Office of the 
Secretary, U.S. Consumer Product Safety Commission, 4330 East West 
Highway, Bethesda, MD 20814, (301) 504-7923.

    Dated: May 10, 2011.
Todd A Stevenson,
Secretary.
[FR Doc. 2011-11887 Filed 5-11-11; 11:15 am]
BILLING CODE 6355-01-P
```
Exhibit 23.1

The Board of Directors
GE Global Insurance Holding Corporation

We consent to incorporation by reference in the registration statement
(No. 33-80193) on Form S-3 of GE Global Insurance Holding Corporation of
our report dated January 17, 1997, relating to the consolidated
statements of financial position of GE Global Insurance Holding
Corporation and subsidiaries as of December 31, 1996 and 1995, and the
related consolidated statements of earnings, stockholder's equity and
cash flows for the years then ended, and all related schedules, which
report appears in the December 31, 1996, annual report on form 10-K of
GE Global Insurance Holding Corporation.

Also, we consent to incorporation by reference in the registration
statement (No. 33-80193) on Form S-3 of GE Global Insurance Holding
Corporation of our report dated January 21, 1995, with respect to the
combined statements of earnings, stockholder's equity and cash flows of
Employers Reassurance Corporation, Westport Insurance Corporation and
Puritan Excess and Surplus Lines Insurance Company for the year ended
December 31, 1994, which report appears in the December 31, 1996, annual
report on Form 10-K of GE Global Insurance Holding Corporation.  Our
report states that the combined financial statements have been prepared
to facilitate the preparation of the consolidated financial statements
of GE Global Insurance Holding Corporation.


                                         KPMG Peat Marwick LLP

Kansas City, Missouri
March 27, 1997
<TABLE> <S> <C>

<ARTICLE> 5

<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1999
<PERIOD-END>                               SEP-30-1999
<CASH>                                             387
<SECURITIES>                                     7,850
<RECEIVABLES>                                        0
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                                 8,237
<PP&E>                                          43,408
<DEPRECIATION>                                  15,804
<TOTAL-ASSETS>                                  35,841
<CURRENT-LIABILITIES>                          672,604
<BONDS>                                              0
<PREFERRED-MANDATORY>                           28,923
<PREFERRED>                                    739,696
<COMMON>                                    21,297,570
<OTHER-SE>                                   (636,763)
<TOTAL-LIABILITY-AND-EQUITY>                    35,841
<SALES>                                              0
<TOTAL-REVENUES>                                     0
<CGS>                                                0
<TOTAL-COSTS>                                        0
<OTHER-EXPENSES>                                36,698
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                               (36,398)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                           (36,398)
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                 72,055
<CHANGES>                                            0
<NET-INCOME>                                    35,357
<EPS-BASIC>                                          0
<EPS-DILUTED>                                        0


</TABLE>
<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE BALANCE
SHEET AND THE STATEMENTS OF REVENUE AND EXPENSES AND IS QUALIFIED IN ITS
ENTIRETY BY REFERENCE TO SUCH REPORT ON FORM 10-Q.
</LEGEND>

<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1999
<PERIOD-START>                             JAN-01-1999
<PERIOD-END>                               SEP-30-1999
<CASH>                                       2,419,878
<SECURITIES>                                         0
<RECEIVABLES>                                        0
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                                     0
<PP&E>                                               0
<DEPRECIATION>                                       0
<TOTAL-ASSETS>                               3,365,263
<CURRENT-LIABILITIES>                                0
<BONDS>                                              0
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                             0
<OTHER-SE>                                   3,349,571
<TOTAL-LIABILITY-AND-EQUITY>                 3,365,263
<SALES>                                              0
<TOTAL-REVENUES>                                85,578
<CGS>                                                0
<TOTAL-COSTS>                                        0
<OTHER-EXPENSES>                               174,956
<LOSS-PROVISION>                             (135,496)
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                                      0
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                                  0
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                 (358,735)
<EPS-BASIC>                                          0
<EPS-DILUTED>                                        0


</TABLE>
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.1030 Alanine amino transferase (ALT/SGPT) test system. ( a ) *Identification.* An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
( 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 § 862.9.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]
# C_2016106EN.01003202.xml

| 21.3.2016 | EN | Official Journal of the European Union | C 106/32 |
| --- | --- | --- | --- |

21.3.2016

EN

Official Journal of the European Union

C 106/32

---

Judgment of the General Court of 4 February 2016 — Italy v Commission

(Case T-686/14) (1)

1

((EAGGF - Guarantee Section - EAGGF and EAFRD - Expenditure excluded from financing - Fruit and vegetables - Tomato processing sector - Aid to producer organisations - Expenditure incurred by Italy - Proportionality - Res judicata))

(2016/C 106/36)

Language of the case: Italian

Parties

Parties

Applicant: Italian Republic (represented by: G. Palmieri, acting as Agent, and G. Galluzzo, avvocato dello Stato)

Applicant:

Defendant: European Commission (represented by: D. Bianchi and K. Skelly, acting as Agents)

Defendant:

Re:

Re:

Application for annulment in part of Commission Implementing Decision 2014/458 of 9 July 2014 excluding from European Union financing certain expenditure incurred by the Member States under the Guarantee Section of the European Agricultural Guidance and Guarantee Fund (EAGGF), under the European Agricultural Guarantee Fund (EAGF) and under the European Agricultural Fund for Rural Development (EAFRD) (OJ 2014 L 205, p. 62), in so far as it concerns the Italian Republic.

Operative part of the judgment

Operative part of the judgment

The Court:

| 1. | Dismisses the action; |
| --- | --- |

1.

Dismisses the action;

| 2. | Orders the Italian Republic to pay the costs. |
| --- | --- |

2.

Orders the Italian Republic to pay the costs.

---

(1)  OJ C 395, 10.11.2014.

1

---
**Exhibit 32.1**

SECTION 1350CERTIFICATION 

        Inconnection with the accompanying Quarterly Report on Form 10-Q of Penn TreatyAmerican Corporation (the “Company”) for the period ended March 31, 2005 asfiled with the Securities and Exchange Commission, I, William W. Hunt, President and ChiefExecutive Officer of the Company, certify pursuant to 18 U.S.C. Section §1350,as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002 that to the best of myknowledge:
# C_2014421EN.01001802.xml

| 24.11.2014 | EN | Official Journal of the European Union | C 421/18 |
| --- | --- | --- | --- |

24.11.2014

EN

Official Journal of the European Union

C 421/18

---

Request for a preliminary ruling from the Amtsgericht Rüsselsheim (Germany) lodged on 8 August 2014 — Dorothea Eckert and Karl-Heinz Dallner v Condor Flugdienst GmbH

(Case C-380/14)

2014/C 421/26

Language of the case: German

Referring court

Referring court

Amtsgericht Rüsselsheim

Parties to the main proceedings

Parties to the main proceedings

Applicants: Dorothea Eckert, Karl-Heinz Dallner

Applicants:

Defendant: Condor Flugdienst GmbH

Defendant:

By order of the Court of Justice of 9 September 2014, the present case was removed from the Court’s Register.

---
```

[115th Congress Public Law 315]
[From the U.S. Government Publishing Office]

[[Page 132 STAT. 4432]]

Public Law 115-315
115th Congress

                                 An Act

 
 To name the Department of Veterans Affairs community-based outpatient 
 clinic in Statesboro, Georgia, the Ray Hendrix Department of Veterans 
         Affairs Clinic. <<NOTE: Dec. 14, 2018 -  [H.R. 3946]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
SECTION 1. NAME OF DEPARTMENT OF VETERANS AFFAIRS COMMUNITY-BASED 
                              OUTPATIENT CLINIC, STATESBORO, 
                              GEORGIA.

    The Department of Veterans Affairs community-based outpatient clinic 
in Statesboro, Georgia, shall after the date of the enactment of this 
Act be known and designated as the ``Ray Hendrix Department of Veterans 
Affairs Clinic'' or the ``Ray Hendrix VA Clinic''. Any reference to such 
clinic in any law, regulation, map, document, record, or other paper of 
the United States shall be considered to be a reference to the Ray 
Hendrix Department of Veterans Affairs Clinic.

    Approved December 14, 2018.

LEGISLATIVE HISTORY--H.R. 3946:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 164 (2018):
            May 21, considered and passed House.
            Nov. 27, considered and passed Senate, amended.
            Dec. 10, House concurred in Senate amendments.

                                  <all>
```
# C_2015262EN.01002501.xml

| 10.8.2015 | EN | Official Journal of the European Union | C 262/25 |
| --- | --- | --- | --- |

10.8.2015

EN

Official Journal of the European Union

C 262/25

---

Judgment of the General Court of 16 June 2015 — Best-Lock (Europe) v OHIM — Lego Juris (Shape of a toy figure)

(Case T-395/14) (1)

1

((Community trade mark - Invalidity proceedings - Three-dimensional Community trade mark - Shape of a toy figure - Absolute grounds for refusal - Sign consisting exclusively of the shape which results from the nature of the goods themselves - Sign consisting exclusively of the shape of goods which is necessary to obtain a technical result - Article 7(1)(e)(i) and (ii) of Regulation (EC) No 207/2009 - Bad faith - Article 52(1)(b) of Regulation No 207/2009))

(2015/C 262/33)

Language of the case: English

Parties

Parties

Applicant: Best-Lock (Europe) Ltd (Colne, United Kingdom) (represented by: J. Becker, lawyer)

Applicant:

Defendant: Office for Harmonisation in the Internal Market (Trade Marks and Designs) (represented by: D. Hanf and A. Folliard-Monguiral, acting as Agents)

Defendant:

Other party to the proceedings before the Board of Appeal of OHIM, intervener before the General Court: Lego Juris A/S (Billund, Denmark) (represented by: V. von Bomhard, lawyer)

Other party to the proceedings before the Board of Appeal of OHIM, intervener before the General Court:

Re:

Re:

Action brought against the decision of the Fourth Board of Appeal of OHIM of 26 March 2014 (Case R 1695/2013-4), concerning invalidity proceedings between Best-Lock (Europe) Ltd and Lego Juris A/S.

Operative part of the judgment

Operative part of the judgment

The Court:

| 1) | Dismisses the action; |
| --- | --- |

1)

Dismisses the action;

| 2) | Orders Best-Lock (Europe) Ltd to pay the costs. |
| --- | --- |

2)

Orders Best-Lock (Europe) Ltd to pay the costs.

---

(1)  OJ C 315, 15.9.2014.

1

---
EPA-420-F-15-030

June 2015

Independent Commercial Importers 

The following is a list of Independent Commercial Importers (ICIs) who currently hold a valid Certificate of 

Conformity from EPA. This certificate allows the ICI to import certain nonconforming vehicles into the 

U. S., THE MAKES OR MODELS THAT AN ICI CAN IMPORT ARE LIMITED. You should contact the 

ICI to determine if it is qualified to import your particular vehicle and if it currently has a valid Certificate of 

Conformity.

DRPC, LLC. Falcon Lab, LLC G & K Automotive

4257 Page Avenue 4005 Mathews Road Conversion, Inc.

Michigan Center, MI 49254 Spring Arbor, MI 49283 2530 S. Birch Street 

Rep: Dan Machnik Rep: Jeff Kinney Santa Ana, CA 92707 

Phone: (517) 789-1974 Phone (517) 917-3499 Rep: George Gemayel

Fax: (517) 750-3392 Fax: (517) 750-3392 Phone (714) 545-9503 

Email: dmachnik@gmail.com Email: kinney@westernschools.org Fax: (714) 545-7667 

 Email: george@gnkauto.com

J.K. Technologies, LLC Redmer Strategic Products Wallace Environmental 

3500 Sweet Air Street and Services, Inc. Testing Laboratories

Baltimore, MD 21211 1340 S. Waverly Road 2140 Wirtcrest

Rep: Jonathan Weisheit Lansing, MI 48917 Houston, TX 77055 

Phone: (410) 366-6332 Rep: Julie Redmer Rep: Les Weaver

Fax: (410) 366-7655 Phone: (517) 646-5444 Phone: (713) 956-7705 

Email: convert2us@aol.com Fax: (517) 727-6006 Fax: (713) 956-0104 

 Email: Email: sales@wallacelab.co

 jredmer@redmerstrategicproducts.com

 EPA DOES NOT ENDORSE OR RECOMMEND ANY PARTICULAR ICI ON THIS LIST. Test 

documentation for an individual vehicle and other information concerning the quality of modifications will 

be carefully scrutinized to determine whether such vehicle meets all applicable EPA requirements under the 

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

§ 868.2500 Cutaneous oxygen (PcO2) monitor. ( a ) *Identification.* A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension.
( b ) *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.
[67 FR 76681, Dec. 13, 2002, as amended at 84 FR 71811, Dec. 30, 2019]