alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
# C_2014212EN.01004201.xml

| 7.7.2014 | EN | Official Journal of the European Union | C 212/42 |
| --- | --- | --- | --- |

7.7.2014

EN

Official Journal of the European Union

C 212/42

---

Appeal brought on 19 May 2014 by CR against the judgment of the Civil Service Tribunal of 12 March 2014 in Case F-128/12, CR v Parliament

(Case T-342/14 P)

2014/C 212/54

Language of the case: French

Parties

Parties

Appellant: CR (Malling, France) (represented by A. Salerno, lawyer)

Appellant:

Other party to the proceedings: European Parliament and Council of the European Union

Other party to the proceedings:

Form of order sought by the appellant

Form of order sought by the appellant

The appellant claims that the Court should:

| — | set aside the judgment of the Civil Service Tribunal of 12 March 2014; |
| --- | --- |

—

set aside the judgment of the Civil Service Tribunal of 12 March 2014;

| — | itself settle the dispute between the appellant and the European Parliament, by annulling the decision which the appellant challenged before the Civil Service Tribunal, in so far as that decision requires him to reimburse all the sums which he unlawfully received in respect of family allowances; or |
| --- | --- |

—

itself settle the dispute between the appellant and the European Parliament, by annulling the decision which the appellant challenged before the Civil Service Tribunal, in so far as that decision requires him to reimburse all the sums which he unlawfully received in respect of family allowances; or

| — | in the alternative, refer the case back to the Civil Service Tribunal; |
| --- | --- |

—

in the alternative, refer the case back to the Civil Service Tribunal;

| — | order the European Parliament to pay all the costs of both sets of proceedings. |
| --- | --- |

—

order the European Parliament to pay all the costs of both sets of proceedings.

Pleas in law and main arguments

Pleas in law and main arguments

The appellant contests the rejection of the objection of illegality brought against the last sentence of the second paragraph of Article 85 of the Staff Regulations of Officials. In support of the appeal, the appellant relies on two pleas in law.

| 1. | First plea in law, alleging infringement of the principle of legal certainty. |
| --- | --- |

1.

First plea in law, alleging infringement of the principle of legal certainty.

| 2. | Second plea in law, alleging a failure to respond to the appellant’s arguments as regards the disproportionate nature of the absence of any limitation period should the appointing authority be able to establish that the person concerned deliberately misled the administration with a view to obtaining payment of the sum in question. |
| --- | --- |

2.

Second plea in law, alleging a failure to respond to the appellant’s arguments as regards the disproportionate nature of the absence of any limitation period should the appointing authority be able to establish that the person concerned deliberately misled the administration with a view to obtaining payment of the sum in question.

---
Editorial Note on Part 882
Editorial Note: Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008.

§ 882.5870 Implanted peripheral nerve stimulator for pain relief. ( a ) *Identification.* An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
( b ) *Classification.* Class II (performance standards).
[44 FR 51730, Sept. 4, 1979, as amended at 78 FR 18234, Mar. 26, 2013]
Editorial Note on Part 882
Editorial Note: Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008.

§ 882.1700 Percussor. ( a ) *Identification.* A percussor is a small hammerlike device used by a physician to provide light blows to a body part. A percussor is used as a diagnostic aid during physical examinations.
( 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 § 882.9. The 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.
[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]
#### § 82.101 FD&C Blue No. 1.

The color additive FD&C Blue No. 1 shall conform in identity and specifications to the requirements of § 74.101(a)(1) and (b) of this chapter.
Editorial Note on Part 886
Editorial Note: Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.

§ 886.5120 Low-power binocular loupe. ( a ) *Identification.* A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.
( 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 § 886.9. The 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.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001]
# C_2014253EN.01006302.xml

| 4.8.2014 | EN | Official Journal of the European Union | C 253/63 |
| --- | --- | --- | --- |

4.8.2014

EN

Official Journal of the European Union

C 253/63

---

Action brought on 24 June 2014 — Vego Supermercados v Commission

(Case T-465/14)

2014/C 253/86

Language of the case: Spanish

Parties

Parties

Applicant: Vego Supermercados, SA (La Coruña, 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_2016326EN.01002602.xml

| 5.9.2016 | EN | Official Journal of the European Union | C 326/26 |
| --- | --- | --- | --- |

5.9.2016

EN

Official Journal of the European Union

C 326/26

---

Order of the General Court of 27 June 2016 — Portugal v Commission

(Case T-810/14) (1)

1

((Failure to comply with a judgment of the Court establishing an infringement - Periodic penalty payment - Judgment quantifying the amount of the penalty payment - Repeal of the national legislation incompatible with EU law - Date when the infringement ceased - Annulment of an earlier decision quantifying a penalty payment imposed in compliance with the same judgment of the Court - Res judicata - Action manifestly lacking any foundation in law))

(2016/C 326/47)

Language of the case: Portuguese

Parties

Parties

Applicant: Portuguese Republic (represented by: L. Inez Fernandes, J. de Oliveira and S. Nunes de Almeida, acting as Agents)

Applicant:

Defendant: European Commission (represented by: G. Braga da Cruz and M. Heller, acting as Agents)

Defendant:

Re:

Re:

Application based on Article 263 TFEU asking for annulment of the Commission decision MARKT/A2/3523710 of 3 October 2014 quantifying the penalty payment due by the Portuguese Republic for the period between 20 and 29 January 2008, in compliance with the judgment of 10 January 2008 in Commission v Portugal (C-70/06, EU:C:2008:3).

Commission

Portugal

Operative part of the order

Operative part of the order

| 1. | The action is dismissed as manifestly lacking any foundation in law. |
| --- | --- |

1.

The action is dismissed as manifestly lacking any foundation in law.

| 2. | The Portuguese Republic shall pay the costs. |
| --- | --- |

2.

The Portuguese Republic shall pay the costs.

---

(1)  OJ C 65, 23.2.2015.

1

---
Editorial Note on Part 886
Editorial Note: Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.

§ 886.5919 Hydrophilic re-coating solution. ( a ) *Identification.* A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) Clinical performance testing must evaluate device safety as assessed by adverse events, slit lamp findings, and maintenance of visual acuity.
( 2 ) The patient contacting components of the device and packaging components must be demonstrated to be biocompatible.
( 3 ) Performance testing must demonstrate the sterility of the device.
( 4 ) Use-related risk analysis must be performed to determine if a self-selection study and human factors validation study must be conducted to demonstrate that users can correctly use the device based solely on reading the directions for use.
( 5 ) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
( 6 ) Performance testing must demonstrate compatibility with each lens and solution labeled for use with the device.
( 7 ) Performance testing must demonstrate the ability of the device to restore the coating of compatible lenses.
( 8 ) Labeling must include the following: ( i ) Instructions on how to correctly use the device, including instructions to use fresh components for each use;
( ii ) Descriptions of compatible contact lenses;
( iii ) Descriptions of compatible care solutions;
( iv ) A warning that if patients are not sure of their lens material, they should contact their health care provider prior to use; and
( v ) A precaution against use with lenses that have not been demonstrated to be compatible with the device.
[89 FR 72323, Sept. 5, 2024]
Presidential Documents

Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Presidential Documents 10161 

Proclamation 8480 of March 1, 2010 

Read Across America Day, 2010 

By the President of the United States of America 

A Proclamation 

As the foundation that makes all other learning possible, literacy is the 

key to unlocking every child’s full potential. From riding a bus to opening 

a bank account, our everyday tasks and decisions require comprehension 

of the written word. On Read Across America Day, we reaffirm our commitment to investing in our children and giving them an essential tool for 

success in school and in life: the ability to read. 

Today marks the birthday of the late Theodor Seuss Geisel, known to millions 

as Dr. Seuss. His imaginative tales have helped generations of children 

learn to read, and they hold a cherished place on bookshelves in homes 

across America. Authors like Dr. Seuss, whose stories introduce fantastical 

worlds and characters, fold joy into reading and help spark the curiosity 

that is central to learning. 

While government must ensure that all our children receive a world-class 

education, parents and caregivers play a crucial role in preparing them— 

especially during early childhood. We can promote a positive relationship 

with books and language through everyday activities to make reading fun 

and interactive. When reading to young children, I urge all parents and 

caregivers to talk about what is happening in a story, point out details 

that relate to real life, and encourage them to ask about words they do 

not understand. Making regular trips to the library, playing word games, 

and simply keeping books around the home can foster a love of reading 

that will last a lifetime. We can also set a good example by turning off 

the television and picking up a book to read with or alongside our children. 

On Read Across America Day, my Administration is partnering with the 

National Education Association to encourage families across our Nation to 

make reading a priority. Together, we can give our sons and daughters 

the knowledge and skills they need to compete in the global economy, 

and in doing so, secure a brighter future for America. 

NOW, THEREFORE, I, BARACK OBAMA, President of the United States 

of America, by virtue of the authority vested in me by the Constitution 

and the laws of the United States, do hereby proclaim March 2, 2010, 

as Read Across America Day. I call upon children, families, educators, 

librarians, public officials, and all the people of the United States to observe 

this day with appropriate programs, ceremonies, and activities. 

mstockstill on DSKH9S0YB1PROD with PRESDOCD1

10162 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Presidential Documents 

IN WITNESS WHEREOF, I have hereunto set my hand this first day of 

March, in the year of our Lord two thousand ten, and of the Independence 

of the United States of America the two hundred and thirty-fourth. 

[FR Doc. 2010–4881 

Filed 3–4–10; 8:45 am] 

Billing code 3195–W0–P 


mstockstill on DSKH9S0YB1PROD with PRESDOCD1OB#1.EPS</GPH>
§ 640.93 General requirements. ( a ) *Preservative.* The final product shall not contain a preservative.
( b ) *Storage of bulk solution.* After all processing steps have been completed, the sterile bulk solution shall be stored in a manner that will ensure the continued sterility of the product, and at a temperature that shall not exceed the recommended storage temperature of the final product prescribed in § 610.53 of this chapter.
§ 99.203 Request to extend the time for completing planned studies. ( a ) A manufacturer may request, prior to or at the time of making a submission to FDA under § 99.201, that FDA extend the 36-month time period for completing the studies and submitting a supplemental application for the new use that is the subject of the information to be disseminated. Such request must set forth the reasons that such studies cannot be completed and submitted in a supplemental application within 36 months.
( b ) A manufacturer who has certified that it will complete the studies necessary to submit a supplemental application for a new use within a specified period of time from the date that dissemination of information under this part can begin under § 99.201(a)(4)(ii), but later finds that it will be unable to complete such studies and submit a supplemental application within that time period may request an extension of time from FDA. The manufacturer, in its request for extension, shall identify the product, the new use, and shall: ( 1 ) Describe the study or studies that cannot be completed on time and explain why the study or studies cannot be completed on time;
( 2 ) Describe the current status of the incomplete study or studies and summarize the work conducted, including the dates on which principal events concerning the study or studies occurred; and
( 3 ) Estimate the additional time needed to complete the studies and submit a supplemental application. The requested extension shall not exceed an additional 24 months.
( c ) The manufacturer shall send three copies of the request for extension to the same FDA office that received the manufacturer's initial submission and certification statement. The outside of the envelope shall be marked as “Request for Time Extension—Dissemination of Information on an Unapproved Use.”
<PAGE>   1

                                                                    EXHIBIT 23.2

                        CONSENT OF INDEPENDENT AUDITORS

The Board of Directors
Vixel Corporation

     We consent to the use of our report included herein dated May 1, 1997
relating to the balance sheet of Arcxel Technologies, Inc. as of December 31,
1996 and the related statements of operations, stockholders' equity and cash
flows for the period from June 18, 1996 (inception) to December 31, 1996, and to
the reference to our firm under the heading "Experts" in the prospectus.

/s/ KPMG LLP
---------------------------------------------------------
Orange County, California
June 22, 1999
# C_2014194EN.01002601.xml

| 24.6.2014 | EN | Official Journal of the European Union | C 194/26 |
| --- | --- | --- | --- |

24.6.2014

EN

Official Journal of the European Union

C 194/26

---

Action brought on 23 January 2014 — USFSPEI v Parliament and Council

(Case T-75/14)

2014/C 194/34

Language of the case: French

Parties

Parties

Applicant: Union syndicale fédérale des services publics européens et internationaux (Brussels, Belgium) (represented by: J.-N. Louis and D. de Abreu Caldas, lawyers)

Applicant:

Defendants: Council of the European Union and European Parliament

Defendants:

Form of order sought

Form of order sought

The applicant claims that the Court should:

| — | declare the present action admissible and well founded; |
| --- | --- |

—

declare the present action admissible and well founded;

| — | accordingly, annul points 27, 32, 46, 64(b), 65(b) and 67(d) of Regulation (EU, Euratom) No 1023/2013 of the European Parliament and of the Council of 22 October 2013; |
| --- | --- |

—

accordingly, annul points 27, 32, 46, 64(b), 65(b) and 67(d) of Regulation (EU, Euratom) No 1023/2013 of the European Parliament and of the Council of 22 October 2013;

| — | order the defendants to pay to USF a symbolic sum of EUR 1 to compensate for the non-material harm suffered and to pay the costs. |
| --- | --- |

—

order the defendants to pay to USF a symbolic sum of EUR 1 to compensate for the non-material harm suffered and to pay the costs.

Pleas in law and main arguments

Pleas in law and main arguments

The applicant invokes the unlawfulness of points 27, 32, 46, 64(b), 65(b) and 67(d) of Regulation (EU, Euratom) No 1023/2013 (1) in so far as they amend, inter alia, Article 5 (creation of the SC function group), Article 6 (elimination of the guarantee of career equivalence), Article 40(2) (restriction of CCP to 12 years), the second paragraph of Article 43 (indication of potential to carry out an administrator’s function starting from grade AST 5 instead of AST), Article 44(1) (new conditions for advancement to a higher step), Article 51 (professional incompetence procedure), Article 52 (leave in the interests of the service), Article 77 (pension accrual rate of 1,8 %), and Annex VIII, Article 9(2) (early retirement without penalty) of the Staff Regulations.

1

In support of its action, it invokes the infringement of the agreement between the OSP and the legislator on the 2004 reform, in particular on the reform of careers, the principles of a linear career structure and equivalence of careers.

It also invokes breach of Article 27 of the Charter of Fundamental Rights and of Article 21 of the European Social Charter, infringement of the principle of acquired rights, the principle of proportionality and the principle of non-discrimination.

---

(1)  Regulation (EU, Euratom) No 1023/2013 of the European Parliament and of the Council of 22 October 2013 amending the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the European Union (OJ 2013 L 287, p. 15).

1

---
§ 895.102 Powdered surgeon's glove. ( a ) *Identification.* A powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A powdered surgeon's glove incorporates powder for purposes other than manufacturing.
( b ) [Reserved]
[81 FR 91731, Dec. 19, 2016]
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.3610 Methamphetamine test system. ( a ) *Identification.* A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
( b ) *Classification.* Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
[52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019]