alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
§ 820.75 Process validation. ( a ) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.
( b ) Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met. ( 1 ) Each manufacturer shall ensure that validated processes are performed by qualified individual(s).
( 2 ) For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.
( c ) When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.
§ 74.2206 D&C Green No. 6. ( a ) *Identity and specifications.* The color additive D&C Green No. 6 shall conform in identity and specifications to the requirements of § 74.1206 (a) and (b).
( b ) *Uses and restrictions.* D&C Green No. 6 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.
( c ) *Labeling requirements.* The label of the color additive shall conform to the requirements of § 70.25 of this chapter.
( d ) *Certification.* All batches of D&C Green No. 6 shall be certified in accordance with regulations in part 80 of this chapter.
[47 FR 14146, Apr. 4, 1982, as amended at 51 FR 9784, Mar. 21, 1986]
# C_2018328EN.01003801.xml

| 17.9.2018 | EN | Official Journal of the European Union | C 328/38 |
| --- | --- | --- | --- |

17.9.2018

EN

Official Journal of the European Union

C 328/38

---

Judgment of the General Court of 12 July 2018 — Nexans France and Nexans v Commission

(Case T-449/14) (1)

((Competition - Agreements, decisions and concerted practices - European market for power cables - Decision finding an infringement of Article 101 TFEU - Single and continuous infringement - Illegal nature of the inspection decision - Reasonable time - Principle of sound administration - Principle of personal responsibility - Joint and several liability for payment of the fine - Sufficient proof of the infringement - Duration of the infringement - Fines - Proportionality - Equal treatment - Unlimited jurisdiction))

(2018/C 328/51)

Language of the case: English

Parties

Applicants: Nexans France SAS (Courbevoie, France) and Nexans SA (Courbevoie) (represented by: G. Forwood, lawyer, M. Powell, A. Rogers and A. Oh, Solicitors)

Defendant: European Commission (represented initially by: C. Giolito, H. van Vliet and A. Biolan, and subsequently by C. Giolito and H. van Vliet, acting as Agents, and by B. Doherty, Barrister)

Re:

Application under Article 263 TFEU for the annulment of Commission Decision C(2014) 2139 final of 2 April 2014 relating to a proceeding under Article 101 [TFEU] and Article 53 of the EEA Agreement (Case AT.39610 — Power cables) in so far as it concerns the applicants and, in the alternative, a reduction of the fine imposed on the applicants.

Operative part of the judgment

The Court:

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

1.

Dismisses the action;

| 2. | Orders Nexans France SAS and Nexans SA to pay the costs. |
| --- | --- |

2.

Orders Nexans France SAS and Nexans SA to pay the costs.

---

(1)  OJ C 282, 25.8.2014.

---
<TABLE> <S> <C>

<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE BALANCE
SHEET FOR DECEMBER 31, 1999 AND THE STATEMENT OF OPERATIONS FOR THE YEAR ENDED
DECEMBER 31, 1999 AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH
FINANCIAL STATEMENTS.
</LEGEND>

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<SECURITIES>                                 3,107,392
<RECEIVABLES>                               16,543,691
<ALLOWANCES>                                 5,510,998
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<TOTAL-COSTS>                               16,816,591
<OTHER-EXPENSES>                            29,213,615
<LOSS-PROVISION>                             6,751,951
<INTEREST-EXPENSE>                              28,862
<INCOME-PRETAX>                            (6,420,073)
<INCOME-TAX>                               (2,311,226)
<INCOME-CONTINUING>                        (4,108,847)
<DISCONTINUED>                                       0
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<CHANGES>                                            0
<NET-INCOME>                               (4,108,847)
<EPS-BASIC>                                      (.41)
<EPS-DILUTED>                                    (.41)


</TABLE>
This disposition is not appropriate for publication and is not precedent *

except as provided by 9th Cir. R. 36-3.

The panel unanimously concludes this case is suitable for decision **

without oral argument. See Fed. R. App. P. 34(a)(2).

EN/Research

NOT FOR PUBLICATION

UNITED STATES COURT OF APPEALS

 FOR THE NINTH CIRCUIT

VIRGINIA LEGASPI,

 Plaintiff - Appellant,

 v.

ST. JOSEPH’S MEDICAL CENTER OF

STOCKTON; et al.,

 Defendants - Appellees.

No. 08-17163

D.C. No. 2:07-cv-00291-FCDGGH

MEMORANDUM *

Appeal from the United States District Court

for the Eastern District of California

Frank C. Damrell, Jr., District Judge, Presiding

Submitted March 16, 2010** 

Before: SCHROEDER, PREGERSON, and RAWLINSON, Circuit Judges.

Virginia Legaspi appeals from the district court’s order dismissing her Labor

Management Relations Act action for failure to prosecute. We have jurisdiction

FILED

APR 01 2010

MOLLY C. DWYER, CLERK

U.S. COURT OF APPEALS
EN/Research 2 08-17163

under 28 U.S.C. § 1291. We review for an abuse of discretion, Ghazali v. Moran,

46 F.3d 52, 53 (9th Cir. 1995) (per curiam), and we affirm.

The district court did not abuse its discretion by dismissing the action 

where Legaspi’s conduct prejudiced defendants’ ability to defend the action and

the court had already warned Legaspi several times that failure to comply with the

court’s orders could result in dismissal of her action. See id. at 53-54 (outlining

factors to consider before dismissing an action for failure to follow a district

court’s local rules).

Similarly, the district court did not abuse its discretion by denying Legaspi’s

motion for leave to file an untimely opposition because her failure to prosecute was

neither negligent nor excusable. See Briones v. Riviera Hotel & Casino, 116 F.3d

379, 381-82 (9th Cir. 1997) (per curiam) (observing that as a general rule “pro se

litigants are not excused from following court rules”).

Legaspi’s remaining contentions are unpersuasive.

AFFIRMED.
---

EXHIBIT 13.A



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 Annual Report of Petaquilla Minerals Ltd. (the Company) on Form 20-F for the fiscal period ended May 31, 2009, as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Richard Fifer, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:



| |    |  |                                                                                                                                                      
| | -- |  | -----------------------------------------------------------------------------------------------------------------------------------------------------
| | 1. |  | The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and    
| |    |  |                                                                                                                                                      
| | 2. |  | The information contained in the Report fairly presents, in all materials respects, the financial condition and results of operations of the Company.





|                              | 
|----------------------------- | 
|/s/ Richard Fifer             | 
|Richard Fifer                 | 
|(principal executive officer) | 



Dated:  September 4, 2009





The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.





---
<TABLE> <S> <C>


<ARTICLE>                     5

<S>                             <C>
<PERIOD-TYPE>                   3-MOS
<FISCAL-YEAR-END>                              DEC-31-2000
<PERIOD-START>                                 JAN-01-2000
<PERIOD-END>                                   MAR-31-2000
<CASH>                                                   0
<SECURITIES>                                             0
<RECEIVABLES>                                    2,680,557
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<INVENTORY>                                      1,647,330
<CURRENT-ASSETS>                                 5,228,441
<PP&E>                                           2,590,228
<DEPRECIATION>                                     465,405
<TOTAL-ASSETS>                                   7,783,436
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<SALES>                                          4,486,369
<TOTAL-REVENUES>                                 4,486,369
<CGS>                                            3,287,106
<TOTAL-COSTS>                                    3,287,106
<OTHER-EXPENSES>                                   967,825
<LOSS-PROVISION>                                         0
<INTEREST-EXPENSE>                                 129,752
<INCOME-PRETAX>                                    107,746
<INCOME-TAX>                                             0
<INCOME-CONTINUING>                                107,746
<DISCONTINUED>                                           0
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<CHANGES>                                                0
<NET-INCOME>                                       107,746
<EPS-BASIC>                                              0
<EPS-DILUTED>                                            0



</TABLE>
§ 584.725 25-Hydroxyvitamin D3. ( a ) *Product.* 25-Hydroxyvitamin D3 (9,10-secocholesta-5,7,10(19)-triene-3β, 25-diol).
( b ) *Conditions of use.* This substance is generally recognized as safe as a source of vitamin D3 activity in feed or drinking water of broiler chickens when used in accordance with the limitations in paragraph (c) of this section.
( c ) *Limitations.* ( 1 ) Not to exceed 69 parts per billion (ppb) in feed or 34.5 ppb in drinking water. It shall be used in accordance with good manufacturing and feeding practices.
( 2 ) The product must comply with the following specifications: ( i ) Not less than 94.0 percent 25-hydroxyvitamin D3.
( ii ) Not more than 1 percent of any individual sterol.
( iii ) Not more than 5 percent water.
( iv ) Not more than 20 parts per million (ppm) lead.
( v ) Not more than 20 ppm aluminum.
( vi ) Not more than 1.0 percent solvents and non-detectable levels of 2′. 4′. 5′. 7′-tetraiodofluorescin.
( 3 ) Product labeling shall bear the following: ( i ) A statement to indicate that the maximum use level of 25-hydroxyvitamin D3 must not exceed 69 ppb in feed or 34.5 ppb in drinking water.
( ii ) Adequate use directions to ensure that 25-hydroxyvitamin D3 (and all premixes) is uniformly blended throughout the feed or drinking water.
( iii ) An expiration date on all premix labeling.
( iv ) A statement on all premix labeling (feed and drinking water forms) that 25-hydroxyvitamin D3 should not be used simultaneously in both feed and water.
[72 FR 12564, Mar. 16, 2007]
EXHIBIT 32.2





CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER 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 Annual Report of Ambassadors International, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2009 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Mark T. Detillion, hereby certifies in his capacity as Chief Financial Officer of the Company, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:





(1)
The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and





(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.





/s/ Mark T. Detillion


Mark T. Detillion


Chief Financial Officer


April 20, 2011





The foregoing certification is being furnished solely to accompany this Report pursuant to 18 U.S.C. §1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
# C_2015155EN.01003905.xml

| 11.5.2015 | EN | Official Journal of the European Union | C 155/39 |
| --- | --- | --- | --- |

11.5.2015

EN

Official Journal of the European Union

C 155/39

---

Order of the General Court of 16 March 2015 — Polymer-Chemie v Commission

(Case T-306/14) (1)

1

(2015/C 155/54)

Language of the case: German

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

---

(1)  OJ C 223, 14.7.2014.

1

---
# C_2015262EN.01004101.xml

| 10.8.2015 | EN | Official Journal of the European Union | C 262/41 |
| --- | --- | --- | --- |

10.8.2015

EN

Official Journal of the European Union

C 262/41

---

Judgment of the Civil Service Tribunal (Second Chamber) of 30 June 2015 — Dybman v EEAS

(Case F-129/14) (1)

1

((Civil Service - EEAS staff - Officials - Disciplinary procedure - Disciplinary penalty - Criminal proceedings in progress at the time of the adoption of the disciplinary penalty - Identical facts submitted to the Appointing Authority and to the criminal court - Breach of Article 25 of Annex IX to the Staff Regulations))

(2015/C 262/55)

Language of the case: French

Parties

Parties

Applicant: Pierre Dybman (Brussels, Belgium) (represented by: J.-N. Louis, R. Metz, D. Verbeke and N. de Montigny, lawyers)

Applicant:

Defendant: European External Action Service (represented by: S. Marquardt and M. Silva, acting as Agents)

Defendant:

Re:

Re:

Application for annulment of the decision of the EEAS to remove the applicant from his post without reducing his pension rights.

Operative part of the judgment

Operative part of the judgment

The Tribunal:

| 1. | Annuls the decision of the European External Action Service to remove Mr Dybman from his post without reducing his pension rights; |
| --- | --- |

1.

Annuls the decision of the European External Action Service to remove Mr Dybman from his post without reducing his pension rights;

| 2. | Orders the European External Action Service to bear its own costs and to pay the costs incurred by Mr Dybman. |
| --- | --- |

2.

Orders the European External Action Service to bear its own costs and to pay the costs incurred by Mr Dybman.

---

(1)  OJ C 7, 12.1.2015, p. 61.

1

---
#### International Shoe Company *v.*Lacy

[No. 17,174.

Filed May 21, 1945.]

For former opinion, see 114 Ind. App. 641.

*Owen S. Boling, Newberger, Simon & Davis,*and *Alex Asch,*all of Indianapolis, for appellant.

*Walter G. Todd*and *Milton E. Craig,*both of Indianapolis, for appellee.

Draper, C. J.

In an opinion filed on March 20, 1944, and reported in 114 Ind. App. 641, 53 N. E. (2d) 636, the judgment rendered in favor of the appellee Lacy on her cross-complaint was reversed by this Court, but *79without directions. It has now been made to appear that the trial court, though willing to proceed in accordance with the decision of this Court, has not done so because of its uncertainty as to the full import and effect of our mandate.

This Court retains jurisdiction of the original cause for the purpose of effectuating its mandate. *Union Trust Co., etc.*v. *Curtis*(1917), 186 Ind. 516, 116 N. E. 916.

The appellant in the appeal in this case, assigned as error the overruling of its motion for new trial. Being of the opinion that the trial court erred in not sustaining the motion and granting a new trial, the judgment was reversed. Thus the cause was in effect ordered remanded with instructions to sustain appellant’s motion for a new trial, and for further proceedings.

The trial court is therefore ordered to proceed accordingly.

Note. — Reported in 61 N. E. (2d) 85.
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.1660 Quality control material (assayed and unassayed). ( a ) *Identification.* A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
( b ) *Classification.* Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000, 84 FR 71796, Dec. 30, 2019]
§ 556.760 Zeranol. ( a ) *Acceptable daily intake (ADI).* The ADI for total residue of zeranol is 1.25 μg/kg of body weight per day.
( b ) *Tolerances.* The tolerances for zeranol are: ( 1 ) *Cattle.* Edible tissues (excluding milk): Not required.
( 2 ) *Sheep.* Edible tissues (excluding milk): 20 ppb.
( c ) *Related conditions of use.* See § 522.2680 of this chapter.
<TABLE> <S> <C>

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</TABLE>