alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Subpart A of Part 876
Editorial Note: Nomenclature changes to part 876 appear at 73 FR 35341, June 23, 2008.

§ 876.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: ( a ) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;
( b ) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or
( c ) The device is an in vitro device that is intended: ( 1 ) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;
( 2 ) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;
( 3 ) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;
( 4 ) For assessing the risk of cardiovascular diseases;
( 5 ) For use in diabetes management;
( 6 ) For identifying or inferring the identity of a microorganism directly from clinical material;
( 7 ) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;
( 8 ) For noninvasive testing as defined in § 812.3(k) of this chapter; and
( 9 ) For near patient testing (point of care).
[65 FR 2316, Jan. 14, 2000]
Exhibit 35.1



AMERICAN HONDA FINANCE CORPORATION

ANNUAL COMPLIANCE CERTIFICATE

PURSUANT TO SECTION 3.11(a) OF THE

SALE AND SERVICING AGREEMENT AND

ITEM 1123 OF REGULATION AB



I, Paul C. Honda, do hereby
certify that I am the Vice President and Assistant Secretary of American Honda Finance Corporation, a California corporation (the
“Company”), and further certify on behalf of the Company in its capacity as servicer (the “Servicer” and
“Sponsor”) under the Sale and Servicing Agreement (the “Agreement”) dated as of August 19, 2015 among the
Servicer and Sponsor, American Honda Receivables LLC, as Seller, and Honda Auto Receivables 2015-3 Owner Trust, as follows:



| | (i) | A review of the activities of the Servicer during the reporting period ended March 31, 2017, and of its performance under the
Agreement has been made under my supervision.
| | --- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | (ii) | To the best of my knowledge, based on such review, the Servicer has fulfilled all of its obligations
under the Agreement throughout such period in all material respects.
| | ---- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------



IN WITNESS WHEREOF, I have hereunto set my hand
this 22nd day of May, 2017.



| | /s/ Paul C. Honda                                   
| | ----------------------------------------------------
| | Paul C. Honda                                       
| | Vice President and Assistant Secretary              
| | (senior officer in charge of the servicing function)
Editorial Note on Part 880
Editorial Note: Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.

§ 880.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: ( a ) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;
( b ) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or
( c ) The device is an in vitro device that is intended: ( 1 ) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;
( 2 ) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;
( 3 ) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;
( 4 ) For assessing the risk of cardiovascular diseases;
( 5 ) For use in diabetes management;
( 6 ) For identifying or inferring the identity of a microorganism directly from clinical material;
( 7 ) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;
( 8 ) For noninvasive testing as defined in § 812.3(k) of this chapter; and
( 9 ) For near patient testing (point of care).
[65 FR 2318, Jan. 14, 2000]
Editorial Note on Part 872
Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

§ 872.1730 Electrode gel for pulp testers. ( a ) *Identification.* An electrode gel for pulp testers is a device intended to be applied to the surface of a tooth before use of a pulp tester to aid conduction of electrical current.
( 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 the limitations in § 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001]
Editorial Note on Part 866
Editorial Note: Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.

§ 866.5060 Prealbumin immunological test system. ( a ) *Identification.* A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.
( 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 § 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]
# C_2015026EN.01004701.xml

| 26.1.2015 | EN | Official Journal of the European Union | C 26/47 |
| --- | --- | --- | --- |

26.1.2015

EN

Official Journal of the European Union

C 26/47

---

Action brought on 17 October 2014 — ZZ and Others v Commission

(Case F-112/14)

(2015/C 026/62)

Language of the case: French

Parties

Parties

Applicants: ZZ and Others (represented by: S. Orlandi, lawyer)

Applicants:

Defendant: European Commission

Defendant:

Subject-matter and description of the proceedings

Subject-matter and description of the proceedings

Annulment of the decisions of the appointing authority to classify the applicants, in accordance with the new rules on career and promotion applicable after the reform of the Staff Regulations of 1 January 2014, in the type of post ‘Senior Administrator in transition’, depriving them, in their opinion, of the opportunity of promotion to grade AD 14, and a declaration that Article 30(3) of Annex XIII to the Staff Regulations is unlawful.

Form of order sought

Form of order sought

The applicants claim that the Tribunal should:

| — | annul the decisions classifying the applicants in the type of post ‘Senior Administrator in transition’; |
| --- | --- |

—

annul the decisions classifying the applicants in the type of post ‘Senior Administrator in transition’;

| — | declare that Article 30(3) of Annex XIII to the Staff Regulations is unlawful; |
| --- | --- |

—

declare that Article 30(3) of Annex XIII to the Staff Regulations is unlawful;

| — | order the European Commission to pay the costs. |
| --- | --- |

—

order the European Commission to pay the costs.

---
**Exhibit 31.2**

 

**CERTIFICATION**

 

I, Richard J. Baum, certifythat:

 

1. I have reviewed thisquarterly report on Form 10-Q, as amended, of Ebix, Inc.;

 

2. Based on my knowledge, thisreport does not contain any untrue statement of a material fact or omit to statea material fact necessary to make the statements made, in light of thecircumstances under which such statements were made, not misleading withrespect to the period covered by this report;

 

3. Based on my knowledge, thefinancial statements, and other financial information included in this report,fairly present in all material respects the financial condition, results ofoperations and cash flows of the registrant as of, and for, the periodspresented in this report;

 

4. The registrant’s othercertifying officer and I are responsible for establishing and maintainingdisclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)and 15d-15(e)) for the registrant and have:

 

(a) Designed such disclosurecontrols and procedures, or caused such disclosure controls and procedures tobe designed under our supervision, to ensure that material information relatingto the registrant, including its consolidated subsidiaries, is made known to usby others within those entities, particularly during the period in which thisreport is being prepared;

 

(b) Evaluated the effectivenessof the registrant’s disclosure controls and procedures and presented in thisreport our conclusions about the effectiveness of the disclosure controls andprocedures, as of the end of the period covered by this report based on suchevaluation; and

 

(c) Disclosed in this reportany change in the registrant’s internal control over financial reporting thatoccurred during the registrant’s most recent fiscal quarter (the registrant’sfourth fiscal quarter in the case of an annual report) that has materiallyaffected, or is reasonably likely to materially affect, the registrant’sinternal control over financial reporting; and

 

5. The registrant’s othercertifying officer and I have disclosed, based on our most recent evaluation ofinternal control over financial reporting, to the registrant’s auditors and theaudit committee of the registrant’s board of directors (or persons performingthe equivalent functions):

 

(a) All significant deficienciesand material weaknesses in the design or operation of internal control overfinancial reporting which are reasonably likely to adversely affect theregistrant’s ability to record, process, summarize and report financialinformation; and

 

(b) Any fraud, whether or notmaterial, that involves management or other employees who have a significantrole in the registrant’s internal control over financial reporting.

 

 
| Date:  | May 20, 2005            | /s/ Richard J. Baum |   |
|--------|-------------------------|---------------------|--------|
|   | Richard J. Baum         |
|   | Chief Financial Officer |

 

1

----
# C_2014235EN.01001902.xml

| 21.7.2014 | EN | Official Journal of the European Union | C 235/19 |
| --- | --- | --- | --- |

21.7.2014

EN

Official Journal of the European Union

C 235/19

---

Action brought on 26 March 2014 — The Body Shop International v OHIM — Spa Monopole (SPA WISDOM)

(Case T-201/14)

2014/C 235/26

Language in which the application was lodged: English

Parties

Parties

Applicant: The Body Shop International plc (Littlehampton, United Kingdom) (represented by: I. Vernimme, H. Viaene, S. Vandewynckel and D. Gillet, lawyers)

Applicant:

Defendant: Office for Harmonisation in the Internal Market (Trade Marks and Designs)

Defendant:

Other party to the proceedings before the Board of Appeal: Spa Monopole, compagnie fermière de Spa SA/NV (Spa, Belgium)

Other party to the proceedings before the Board of Appeal:

Form of order sought

Form of order sought

The applicant claims that the Court should:

| — | Annul the decision of the Fourth Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 16 January 2014 given in Case R 1516/2012-4; |
| --- | --- |

—

Annul the decision of the Fourth Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 16 January 2014 given in Case R 1516/2012-4;

| — | Order the defendant, and, if necessary, the intervener, to pay the costs of proceedings. |
| --- | --- |

—

Order the defendant, and, if necessary, the intervener, to pay the costs of proceedings.

Pleas in law and main arguments

Pleas in law and main arguments

Applicant for a Community trade mark: The applicant

Applicant for a Community trade mark:

Community trade mark concerned: The wordmark ‘SPA WISDOM’ for goods in Class 3 — Community trade mark application No 8 9 00  748

Community trade mark concerned:

Proprietor of the mark or sign cited in the opposition proceedings: The other party to the proceedings before the Board of Appeal

Proprietor of the mark or sign cited in the opposition proceedings:

Mark or sign cited in opposition: The Benelux trademarks Nos 3 89  230, 4 99  046, 3 72  307 for the word mark ‘SPA’ and the Benelux trademark No 6 93  395 for the word mark ‘LES THERMES DE SPA’

Mark or sign cited in opposition:

Decision of the Opposition Division: Upheld the opposition

Decision of the Opposition Division:

Decision of the Board of Appeal: Dismissed the appeal

Decision of the Board of Appeal:

Pleas in law: Infringement of Articles 8(1)(b) and 8(5) CTMR

Pleas in law:

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

§ 862.2140 Centrifugal chemistry analyzer for clinical use. ( a ) *Identification.* A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and spectrophotometrically measure concentrations of the sample constituents. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
( 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 2308, Jan. 14, 2000]
WARNING: THE EDGAR SYSTEM ENCOUNTERED ERROR(S) WHILE PROCESSING THIS SCHEDULE.

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<S>                             <C>
<PERIOD-TYPE>                   3-MOS
<FISCAL-YEAR-END>                              DEC-31-2000
<PERIOD-START>                                 JAN-01-2000
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</TABLE>
§ 340.50 Labeling of stimulant drug products. ( a ) *Statement of identity.* The labeling of the product contains the established name of the drug, if any, and identifies the product as an “altertness aid” or a “stimulant.”
( b ) *Indications.* The labeling of the product states, under the heading “Indications,” the following: “Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the Act relating to misbranding and the prohibition in section 301(d) of the Act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the Act.
( c ) *Warnings.* The labeling of the product contains the following warnings under the heading “Warnings”: ( 1 ) “The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.”
( 2 ) “For occasional use only. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a” (select one of the following: “physician” or “doctor”).
( 3 ) “Do not give to children under 12 years of age.”
( d ) *Directions.* The labeling of the product contains the following information under the heading “Directions”: Adults and children 12 years of age and over: Oral dosage is 100 to 200 milligrams not more often than every 3 to 4 hours.
§ 524.1240 Levamisole. ( a ) *Specifications.* The drug contains 200 milligrams of levamisole per milliliter of diethylene glycol monobutyl ether (DGME) solution.
( b ) *Sponsors.* See Nos. 000061 and 054771 in § 510.600(c) of this chapter.
( c ) *Related tolerances.* See § 556.350 of this chapter.
( d ) *Conditions of use. Cattle* — ( 1 ) *Amount.* 2.5 milliliters per 110 pounds (10 milligrams of levamisole per kilogram) of body weight as a single dose topically to the back of the animal.
( 2 ) *Indications for use.* Anthelmintic effective against stomach worms (*Haemonchus, Trichostrongylus, Ostertagia*), intestinal worms (*Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia*), and lungworms (*Dictyocaulus*).
( 3 ) *Limitations.* Conditions of constant helminth exposure may require retreatment within 2 to 4 weeks after the first treatment. Cattle must not be slaughtered within 9 days following last treatment. Do not administer to dairy animals of breeding age. Do not treat animals before dipping or prior to exposure to heavy rain. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism, and before using in severely debilitated animals.
[52 FR 10887, Apr. 6, 1987, as amended at 53 FR 7504, Mar. 9, 1988; 62 FR 61626, Nov. 19, 1997; 67 FR 78355, Dec. 24, 2002; 79 FR 10970, Feb. 27, 2014]
§ 182.8013 Ascorbic acid. ( a ) *Product.* Ascorbic acid.
( b ) *Conditions of use.* This substance is generally recognized as safe when used in accordance with good manufacturing practice.
Editorial Note on Part 868
Editorial Note: Nomenclature changes to part 868 appear at 73 FR 35341, June 23, 2008.

§ 868.2340 Compensated thorpe tube flowmeter. ( a ) *Identification.* A compensated thorpe tube flowmeter is a device intended for medical purposes that is used to control and measure gas flow rate accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure.
( 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 the limitations in § 868.9.
[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001]
Editorial Note on Part 886
Editorial Note: Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.

§ 886.5915 Optical vision aid. ( a ) *Identification.* An optical vision aid is a device that consists of a magnifying lens with an accompanying AC-powered or battery-powered light source intended for use by a patient who has impaired vision to increase the apparent size of object detail.
( b ) *Classification.* Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]