alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.1445 Lactate dehydrogenase isoenzymes test system. ( a ) *Identification.* A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.
( 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 § 862.9.
[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]
#### Burroughs *v.*Bank of Ila.

No. 8531.

December 21, 1931.

*Clarence E. Adams,*for plaintiff in error.

*R. Howard Gordon*and *Erwin, Erwin & Nix,*contra.

Beck, P. J.

In the bill of exceptions error is assigned upon a judgment dismissing *&*motion for a new trial in a claim case wherein the jury had returned a verdict adverse to the claimant. The case was tried on March 3, 1931. The motion for new trial was filed in due course and was set for a hearing in vacation, with the right to file the brief of evidence on or before the date stated or at any time before the final hearing on the motion. The case was first set for a hearing on April 4, 1931. On that date, by proper order of court, the hearing was continued until April 25. Again it was continued from that time until May 23, on which date an order was passed setting a hearing of the motion for May 30, 1931. On this last date another motion was made for a continuance, which, after hearing, the judge overruled and refused to grant additional time for the filing of the brief of evidence. The brief of evidence not having been filed on that date, the judge dismissed the motion. *Held,*that the granting or refusing- of further time within which to perfect the motion and file the brief of evidence was a matter in the discretion of the judge; and from an examination of the facts in the record this court can not say that he abused his discretion in refusing further time and in dismissing the motion.

*Judgment affirmed.*

*All the Justices concur.*
<TABLE> <S> <C>


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</TABLE>
Exhibit 3.1

                            CERTIFICATE OF FORMATION

                                       OF

                                 PSEG POWER LLC

      This Certificate of Formation of PSEG Power LLC (the "LLC"), dated as of
June 16, 1999, is being duly executed and filed by Bernard J. Kelley, as an
authorized person, to form a limited liability company under the Delaware
Limited Liability Company Act (6 Del.C. subsection 18-101, et seq.).

      FIRST. The name of the limited liability company formed hereby is PSEG
Power LLC.

      SECOND. The address of the registered office of the LLC in the State of
Delaware is c/o The Corporation Trust Company, 1209 Orange Street, Wilmington,
New Castle County, Delaware 19801.

      THIRD. The name and address of the registered agent for service of process
on the LLC in the State of Delaware is The Corporation Trust Company, 1209
Orange Street, Wilmington, New Castle County, Delaware 19801.

      IN WITNESS WHEREOF, the undersigned has executed this Certificate of
Formation as of the date first above written.

                                                     /s/ Bernard J. Kelley
                                                     -----------------------
                                                     Name: Bernard J. Kelley
                                                     Authorized Person
§ 582.5049 Aminoacetic acid. ( a ) *Product.* Glycine (aminoacetic acid).
( b ) [Reserved]
( c ) *Limitations, restrictions, or explanation.* This substance is generally recognized as safe when used in animal feeds in accordance with good manufacturing or feeding practice.
**AD Economic Evaluation**



### Docket No . FAA - 20 15 - 1480 Directorate ID : 20 14 - SW - 071 - AD Helicopter Model: Airbus Helicopters Model EC120B Helicopters Number of Helicopters (U.S. Operators): 37 Helicopters in the US Registry . Rea son : The actions are intended to prevent an object from sliding between the canopy and the cabin floor, loss of yaw control, and subsequent loss of helicopter control. Costs : Parts per Helicopter $ 584 Labor per Helicopter ( 2 work- hour s x 

### $ 8 5 /work hour for the installation) $ 170 Other (Explain) Total Cost per Helicopter $ 754 Total US Fleet Cost $ 27,898 Executive Order 12866 : Could the AD be considered a “significant regulatory action?” Yes ( ) No (  ) DOT Regulatory Policies and Procedures : Is the AD significant? Yes ( ) Explain Below No (  ) Regulatory Flexibility Act : Will the AD have a significant economic impact on a substantial number of small entities? Yes ( ) No (  ) Project Engineer : Robert Grant
<TABLE> <S> <C>


<ARTICLE> 5

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<EPS-BASIC>                                          1.68
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</TABLE>
Editorial Note on Part 892
Editorial Note: Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.

§ 892.1620 Cine or spot fluorographic x-ray camera. ( a ) *Identification.* A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier.
( b ) *Classification.* Class II.
Exhibit 99.2

THE  FOLLOWING  CERTIFICATION  ACCOMPANIES  THE ISSUER'S  ANNUAL  REPORT ON FORM
10-KSB AND IS NOT FILED, AS PROVIDED IN SEC RELEASE NOS.  33-8212,  34-47551 AND
IC-25967, DATED MARCH 21, 2003.

                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  Annual  Report  of  BrandPartners  Group,  Inc.  (the
"Company") on Form 10-KSB for the year ended December 31, 2002 as filed with the
Securities  and  Exchange  Commission  on the date  hereof (the  "Report"),  the
undersigned, hereby certifies pursuant to 18 U.S.C. ss.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) of
the Securities Exchange Act of 1934; and

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

                                        By: /s/  Sharon Burd
                                            ----------------------------
                                                 Sharon Burd
                                                 Chief Financial Officer

                                                 March 31, 2003

A SIGNED  ORIGINAL OF THIS  WRITTEN  STATEMENT  REQUIRED BY SECTION 906 HAS BEEN
PROVIDED TO THE ISSUER AND WILL BE RETAINED BY THE ISSUER AND  FURNISHED  TO THE
SECURITIES AND EXCHANGE COMMISSION OR ITS STAFF UPON REQUEST.
# C_2014339EN.01001001.xml

| 29.9.2014 | EN | Official Journal of the European Union | C 339/10 |
| --- | --- | --- | --- |

29.9.2014

EN

Official Journal of the European Union

C 339/10

---

Request for a preliminary ruling from the Bundesfinanzhof (Germany) lodged on 17 July 2014 — Kyowa Hakko Europe GmbH v Hauptzollamt Hannover

(Case C-344/14)

2014/C 339/11

Language of the case: German

Referring court

Referring court

Bundesfinanzhof

Parties to the main proceedings

Parties to the main proceedings

Applicant: Kyowa Hakko Europe GmbH

Applicant:

Defendant: Hauptzollamt Hannover

Defendant:

Questions referred

Questions referred

| 1. | Do amino acid mixes such as those at issue in the present case (RM0630 and RM0789), from which (in combination with carbohydrates and fats) a foodstuff is manufactured by which a substance that is vital for health and present in normal diet but which can in individual cases trigger an allergic reaction is replaced and, as a result, allergy-induced health impairments can be avoided and existing complaints alleviated, if not cured, constitute medicaments consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses within the meaning of heading 3003 of the Combined Nomenclature (1)?
  If Question 1 is answered in the negative: |
| --- | --- |

1.

Do amino acid mixes such as those at issue in the present case (RM0630 and RM0789), from which (in combination with carbohydrates and fats) a foodstuff is manufactured by which a substance that is vital for health and present in normal diet but which can in individual cases trigger an allergic reaction is replaced and, as a result, allergy-induced health impairments can be avoided and existing complaints alleviated, if not cured, constitute medicaments consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses within the meaning of heading 3003 of the Combined Nomenclature (1)?

1

If Question 1 is answered in the negative:

| 2. | Do the amino acid mixes constitute food preparations under heading 2106 of the Combined Nomenclature which, pursuant to note 1(a) to Chapter 30 of the Combined Nomenclature, are excluded from Chapter 30 because they have no prophylactic or therapeutic effect beyond the supply of nutrition? |
| --- | --- |

2.

Do the amino acid mixes constitute food preparations under heading 2106 of the Combined Nomenclature which, pursuant to note 1(a) to Chapter 30 of the Combined Nomenclature, are excluded from Chapter 30 because they have no prophylactic or therapeutic effect beyond the supply of nutrition?

---

(1)  Commission Implementing Regulation (EU) No 1001/2013 of 4 October 2013 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ 2013 L 290, p. 1).

1

---
§ 884.5200 Hemorrhoid prevention pressure wedge. ( a ) *Identification.* A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor and delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth.
( 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 § 884.9. The special controls for this device are: ( 1 ) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.
( 2 ) The labeling must include specific instructions regarding the proper placement and use of the device.
( 3 ) The device must be demonstrated to be biocompatible.
( 4 ) Mechanical bench testing of material strength must demonstrate that the device will withstand forces encountered during use.
( 5 ) Safety and effectiveness data must demonstrate that the device prevents hemorrhoids in women undergoing spontaneous vaginal delivery, in addition to general controls.
[76 FR 21238, Apr. 15, 2011, as amended at 84 FR 71816, Dec. 30, 2019]
<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONSOLIDATED FINANCIAL STATEMENTS OF HARBINGER CORPORATION FOR THE YEAR ENDED
DECEMBER 31, 1995, AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH
CONSOLIDATED FINANCIAL STATEMENTS.
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</TABLE>
§ 814.126 Postapproval requirements and reports. ( a ) An HDE approved under this subpart H shall be subject to the postapproval requirements and reports set forth under subpart E of this part, as applicable, with the exception of § 814.82(a)(7). In addition, medical device reports submitted to FDA in compliance with the requirements of part 803 of this chapter shall also be submitted to the IRB of record.
( b ) In addition to the reports identified in paragraph (a) of this section, the holder of an approved HDE shall prepare and submit the following complete, accurate, and timely reports: ( 1 ) *Periodic reports.* An HDE applicant is required to submit reports in accordance with the approval order. Unless FDA specifies otherwise, any periodic report shall include: ( i ) An update of the information required under § 814.102(a) in a separately bound volume;
( ii ) An update of the information required under § 814.104(b)(2), (b)(3), and (b)(5);
( iii ) The number of devices that have been shipped or sold since initial marketing approval under this subpart H and, if the number shipped or sold exceeds 8,000, an explanation and estimate of the number of devices used per patient. If a single device is used on multiple patients, the applicant shall submit an estimate of the number of patients treated or diagnosed using the device together with an explanation of the basis for the estimate;
( iv ) Information describing the applicant's clinical experience with the device since the HDE was initially approved. This information shall include safety information that is known or reasonably should be known to the applicant, medical device reports made under part 803 of this chapter, any data generated from the postmarketing studies, and information (whether published or unpublished) that is known or reasonably expected to be known by the applicant that may affect an evaluation of the safety of the device or that may affect the statement of contraindications, warnings, precautions, and adverse reactions in the device's labeling; and
( v ) A summary of any changes made to the device in accordance with supplements submitted under § 814.108. If information provided in the periodic reports, or any other information in the possession of FDA, gives the agency reason to believe that a device raises public health concerns or that the criteria for exemption are no longer met, the agency may require the HDE holder to submit additional information to demonstrate continued compliance with the HDE requirements.
( 2 ) *Other.* An HDE holder shall maintain records of the names and addresses of the facilities to which the HUD has been shipped, correspondence with reviewing IRB's, as well as any other information requested by a reviewing IRB or FDA. Such records shall be maintained in accordance with the HDE approval order.
[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998; 71 FR 16228, Mar. 31, 2006; 82 FR 26349, June 7, 2017]
<TABLE> <S> <C>

<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONSOLIDATED FINANCIAL STATEMENTS AS OF AND FOR THE THREE MONTHS ENDED JUNE 30,
2000, AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL
STATEMENTS.
</LEGEND>
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</TABLE>
Editorial Note on Part 882
Editorial Note: Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008.

§ 882.4650 Neurosurgical suture needle. ( a ) *Identification.* A neurosurgical suture needle is a needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.
( 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 § 882.9.
[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000]
Editorial Note on Part 880
Editorial Note: Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.

§ 880.5410 Neonatal transport incubator. ( a ) *Identification.* A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.
( b ) *Classification.* Class II (performance standards).