alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
# C_2014142EN.01002002.xml

| 12.5.2014 | EN | Official Journal of the European Union | C 142/20 |
| --- | --- | --- | --- |

12.5.2014

EN

Official Journal of the European Union

C 142/20

---

Request for a preliminary ruling from the Corte Suprema di Cassazione (Italy) lodged on 21 February 2014 — A2A SpA v Agenzia delle Entrate

(Case C-89/14)

2014/C 142/28

Language of the case: Italian

Referring court

Referring court

Corte Suprema di Cassazione

Parties to the main proceedings

Parties to the main proceedings

Applicant: A2A SpA

Applicant:

Defendant: Agenzia delle Entrate

Defendant:

Question referred

Question referred

Must Article 14 of Council Regulation (EC) No 659/1999 of 22 March 1999 laying down detailed rules for the application of Article 93 of the EC Treaty (1) and Articles 9, 11 and 13 of Commission Regulation (EC) No 794/2004 (2) of 21 April 2004 implementing Regulation No 659/1999 be interpreted as precluding national legislation which, in relation to the recovery of State aid pursuant to a Commission decision notified on 7 June 2002, provides that the interest is to be determined on the basis of Chapter V of Regulation No 794/2004 (that is to say, on the basis of Articles 9 and 11 thereof, in particular) and, in consequence, that an interest rate based on the system of compound interest is to be applied?

1

2

---

(1)  OJ 1999 L 83, p. 1.

1

(2)  Commission Regulation (EC) No 794/2004 of 21 April 2004 implementing Council Regulation (EC) No 659/1999 laying down detailed rules for the application of Article 93 of the EC Treaty (OJ 2004 L 140, p. 1).

2

---
#### § 524.1484 Neomycin ophthalmic and topical dosage forms.
§ 582.3490 Methylparaben. ( a ) *Product.* Methylparaben (methyl *p*-hydroxybenzoate).
( b ) *Tolerance.* This substance is generally recognized as safe for use at a level not exceeding 0.1 percent in accordance with good manufacturing or feeding practice.
<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THERMO POWER
CORPORATION'S QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED JUNE 28, 1997
AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
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<PERIOD-END>                               JUN-28-1997
<CASH>                                          25,129
<SECURITIES>                                     9,168
<RECEIVABLES>                                   19,489
<ALLOWANCES>                                       679
<INVENTORY>                                     21,630
<CURRENT-ASSETS>                                85,669
<PP&E>                                          19,284
<DEPRECIATION>                                   8,756
<TOTAL-ASSETS>                                 115,119
<CURRENT-LIABILITIES>                           31,795
<BONDS>                                            263
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                         1,249
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<TOTAL-LIABILITY-AND-EQUITY>                   115,119
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<TOTAL-REVENUES>                                91,450
<CGS>                                           75,758
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<OTHER-EXPENSES>                                 1,778
<LOSS-PROVISION>                                   157
<INTEREST-EXPENSE>                                  14
<INCOME-PRETAX>                                  2,610
<INCOME-TAX>                                     1,281
<INCOME-CONTINUING>                              1,095
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                     1,095
<EPS-PRIMARY>                                      .09
<EPS-DILUTED>                                        0
        


</TABLE>
###### Editorial Note on Part 312

#### Editorial Note:

Nomenclature changes to part 312 appear at 69 FR 13717, Mar. 24, 2004.

#### § 312.68 Inspection of investigator's records and reports.

An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator pursuant to § 312.62. The investigator is not required to divulge subject names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained.
<TABLE> <S> <C>

<PAGE>

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<PERIOD-TYPE>                   12-MOS                   12-MOS
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<PERIOD-START>                             NOV-01-1998             NOV-01-1997
<PERIOD-END>                               OCT-31-1999             OCT-31-1998
<CASH>                                           1,081                   2,687
<SECURITIES>                                         0                       0
<RECEIVABLES>                                   77,431                  74,561
<ALLOWANCES>                                     (350)                   (350)
<INVENTORY>                                     84,589                  71,613
<CURRENT-ASSETS>                               169,945                 156,427
<PP&E>                                         107,261                 100,202
<DEPRECIATION>                                  63,403                  58,518
<TOTAL-ASSETS>                                 325,793                 314,765
<CURRENT-LIABILITIES>                          108,588                 100,363
<BONDS>                                         67,858                  74,301
<PREFERRED-MANDATORY>                                0                       0
<PREFERRED>                                      5,000                   5,000
<COMMON>                                             0                       0
<OTHER-SE>                                    (44,067)                (34,046)
<TOTAL-LIABILITY-AND-EQUITY>                   325,793                 314,765
<SALES>                                        348,187                 392,785
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<CGS>                                          310,774                 344,327
<TOTAL-COSTS>                                  350,194                 390,425
<OTHER-EXPENSES>                                     0                       0
<LOSS-PROVISION>                                     0                       0
<INTEREST-EXPENSE>                              11,119                  12,836
<INCOME-PRETAX>                               (13,126)                (10,476)
<INCOME-TAX>                                   (2,877)                 (2,161)
<INCOME-CONTINUING>                                  0                       0
<DISCONTINUED>                                       0                       0
<EXTRAORDINARY>                                      0                       0
<CHANGES>                                            0                       0
<NET-INCOME>                                  (10,249)                 (8,315)
<EPS-BASIC>                                          0                       0
<EPS-DILUTED>                                        0                       0


</TABLE>
§ 830.350 Correction of information submitted to the Global Unique Device Identification Database. ( a ) If FDA becomes aware that any information submitted to the Global Unique Device Identification Database (GUDID) appears to be incorrect or potentially misleading, we may notify the labeler of the specific information that appears to be incorrect, and request that the labeler provide corrected information or explain why the information is correct. The labeler must provide corrected information or provide a satisfactory explanation of why the information is correct within 30 days of receipt of FDA's notification.
( b ) If the labeler does not respond to FDA's notification within 30 days of receipt, or if FDA determines, at any time, that any information in the GUDID is incorrect or could be misleading, we may delete or correct the information. Any action taken by FDA under this paragraph does not relieve the labeler of its responsibility under paragraph (a) of this section to provide corrected information or an explanation of why the information previously submitted is correct.
---

EXHIBIT 13.B.


CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Transition Report of Petaquilla Minerals Ltd. (the “Company”) on Form 20-F for the fiscal period ended June 30, 2013, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Ezequiel Sirotinsky, Chief Financial 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: 3.

   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; and4.

   The information contained in the Report fairly presents, in all materials respects, the financial condition and results of operations of the Company. /s/ Ezequiel Sirotinsky Ezequiel Sirotinsky(Principal financial and accounting officer) Dated: October 31, 2013 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.


---
§ 510.455 Requirements for free-choice medicated feeds. ( a ) *What is free-choice medicated feed?* For the purpose of this part, free-choice medicated feed is medicated feed that is placed in feeding or grazing areas and is not intended to be consumed fully at a single feeding or to constitute the entire diet of the animal. Free-choice feeds include, but are not limited to, medicated blocks (agglomerated feed compressed or rendered into a solid mass and cohesive enough to hold its form), mineral mixes, and liquid feed tank supplements (“lick tank” supplements) containing one or more new animal drugs. The manufacture of medicated free-choice feeds is subject to the current good manufacturing practice regulations in part 225 of this chapter for medicated feeds.
( b ) *What is required for new animal drugs intended for use in free-choice feed?* Any new animal drug intended for use in free-choice feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)) or listed in the index under section 572 of the act (21 U.S.C. 360ccc-1). Such approvals under section 512 of the act must be: ( 1 ) An original new animal drug application (NADA),
( 2 ) A supplemental NADA, or
( 3 ) An abbreviated NADA.
( c ) *What are the approval requirements under section 512 of the act for new animal drugs intended for use in free-choice feed?* An approval under section 512 of the act for a Type A medicated article intended for use in free-choice feed must contain the following information: ( 1 ) Data, or reference to data in a master file (MF), showing that the target animal consumes the new animal drug in the Type C free-choice feed in an amount that is safe and effective (consumption/effectiveness data); and
( 2 ) Data, or reference to data in an MF, showing the relevant ranges of conditions under which the drug will be chemically and physically stable in the Type C free-choice feed under field conditions.
( d ) *How are consumption/effectiveness and/or stability data to be submitted?* The data must be submitted as follows: ( 1 ) Directly in the NADA, by a sponsor; and/or
( 2 ) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder.
( e ) *What will be stated in the published approval for a new animal drug intended for use in free-choice feed?* The approval of a new animal drug intended for use in free-choice feed, as published in this subchapter, will include: ( 1 ) The formula and/or specifications of the free-choice medicated feed, where the owner of this information requests such publication, or
( 2 ) A statement that the approval has been granted for a proprietary formula and/or specifications.
( f ) *When is a medicated feed mill license required for the manufacture of a free-choice medicated feed?* An approved medicated feed mill license is required for the manufacture of the following types of feeds: ( 1 ) All free-choice medicated feeds that contain a Category II drug, and
( 2 ) Free-choice medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications.
[69 FR 30197, May 27, 2004, as amended at 72 FR 69121, Dec. 6, 2007]
§ 524.1484f Neomycin, prednisolone, and tetracaine otic suspension. ( a ) *Specifications.* The product contains 5 milligrams of neomycin sulfate equivalent to 3.5 milligrams of neomycin base, 2.5 milligrams of prednisolone acetate, and 5 milligrams of tetracaine hydrochloride in each milliliter of sterile suspension.
( b ) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.
( c ) *Conditions of use in dogs and cats* — ( 1 ) *Amount.* Instill 2 to 6 drops in the external ear canal 2 or 3 times daily.
( 2 ) *Indications for use.* For the treatment of acute otitis externa and, to a lesser degree, chronic otitis externa; as treatment or adjunctive therapy of certain ear conditions caused by or associated with neomycin-susceptible organisms and/or allergy.
( 3 ) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10971, Feb. 27, 2014]
Exhibit
15.1




To the
Partners of


Icahn
Enterprises L.P.





We have
reviewed, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the unaudited consolidated interim financial
statements of Icahn Enterprises L.P. and Subsidiaries as of September 30, 2010,
and for the three-month and nine-month periods ended September 30, 2010 and
2009, as indicated in our report dated November 5, 2010; because we did not
perform an audit, we expressed no opinion on that information.





We are
aware that our report referred to above, which is included in your Quarterly
Report on Form 10-Q for the quarter ended September 30, 2010 is incorporated by
reference in Registration Statements on Forms S-3 (File No. 333-158705,
effective May 17, 2010 and File No. 333-143930, effective December 17, 2007) and
Form S-4 (File No. 333-166139, effective June 21, 2010).





We also
are aware that the aforementioned report, pursuant to Rule 436(c) under the
Securities Act of 1933, is not considered a part of the Registration Statement
prepared or certified by an accountant within the meaning of Sections 7 and 11
of that Act.








/s/ Grant
Thornton, LLP








New York,
New York


November
5, 2010
##### 



Exhibit 32.2 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 Ambassadors International, Inc. (the
Company) on Form 10-K/A for the period ended December 31, 2003 as filed with
the Securities and Exchange Commission on the date hereof (the Report), the
undersigned, Brian R. Schaefgen, Chief Financial Officer of the Company
certifies, 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 13a-14(b)
or 15d-14(b) 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. /s/ Brian R. Schaefgen
§ 807.22 Times for establishment registration and device listing. ( a ) *Initial registration and listing.* An owner or operator of an establishment who has not previously entered into an operation described in § 807.20(a) shall register within 30 days after entering into such an operation and submit device listing information at that time.
( b ) *Registration and listing updates.* Owners or operators shall review and update all of their establishment registration and device listing information that is on file at FDA, documenting any changes that were not previously reported as follows: ( 1 ) Annual registration for each fiscal year is required for all establishments. Annual registration shall take place during the period beginning on October 1 and ending on December 31 of each fiscal year;
( 2 ) Updates to the registration information as described in § 807.25(b) shall be made within 30 days of any change to such information;
( 3 ) Every fiscal year, during the period beginning on October 1 and ending on December 31, owners or operators shall review and update all of their device listing information that is on file at FDA, reporting any changes or deletions to listings and any new listings that were not previously reported. The accuracy of all information on file must be confirmed each year regardless of whether any changes were made to the owner or operator's list of devices; and
( 4 ) Changes to listing information may also be made at other times, such as when a device is introduced into commercial distribution, when a change is made to a previously-listed device, or when a previously-listed device is removed from commercial distribution.
( c ) *Failure to submit required information.* Failure to submit any of the required information on time, as specified in paragraphs (a) and (b) of this section, will put the establishment in a “failed to register” or “failed to list” status as applicable. The establishment will not be considered active and the establishment registration and device listing information may not appear on the FDA Web site until such time as the owner or operator submits and FDA processes the required information.
[77 FR 45942, Aug. 2, 2012]
§ 7.59 General industry guidance. A recall can be disruptive of a firm's operation and business, but there are several steps a prudent firm can take in advance to minimize this disruptive effect. Notwithstanding similar specific requirements for certain products in other parts of this chapter, the following is provided by the Food and Drug Administration as guidance for a firm's consideration: ( a ) Prepare and maintain a current written contingency plan for use in initiating and effecting a recall in accordance with §§ 7.40 through 7.49, 7.53, and 7.55.
( b ) Use sufficient coding of regulated products to make possible positive lot identification and to facilitate effective recall of all violative lots.
( c ) Maintain such product distribution records as are necessary to facilitate location of products that are being recalled. Such records should be maintained for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention.
#### Alfred Cross *v.*Warden, Connecticut State Prison

*Alfred Cross,*pro se, the plaintiff.

Submitted May 21

decided May 21, 1969

The request by the plaintiff dated May 14, 1969, that this court issue a writ of mandamus is dismissed.
#### § 82.102 FD&C Blue No. 2.

The color additive FD&C Blue No. 2 shall conform in identity and specifications to the requirements of § 74.102(a)(1) and (b) of this chapter.

[48 FR 5261, Feb. 4, 1983]
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<PERIOD-END>                               JUN-30-1998
<CASH>                                       1,602,516
<SECURITIES>                                53,426,910
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<BONDS>                                     11,971,974
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<FN>
<F1>FOR PURPOSES OF THIS EXHIBIT, PRIMARY MEANS BASIC.
</FN>
        

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§ 522.1185 Isoflupredone. ( a ) *Specifications.* Each milliliter of suspension contains 2 milligrams (mg) of isoflupredone acetate.
( b ) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.
( c ) *Conditions of use* — ( 1 ) *Cattle* — ( i ) *Amount.* Administer 10 to 20 mg by intramuscular injection.
( ii ) *Indications for use.* For use in the treatment of bovine ketosis. For alleviation of pain associated with generalized and acute localized arthritic conditions; for treating acute hypersensitivity reactions; and as an aid in correcting circulatory defects associated with severe toxicity and shock.
( iii ) *Limitations.* Animals intended for human consumption should not be slaughtered within 7 days of last treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
( 2 ) *Horses and swine* — ( i ) *Amount* — ( A ) *Horses.* Administer 5 to 20 mg by intramuscular injection for systemic effect or by intrasynovial injection into a joint cavity, tendon sheath, or bursa for local effect.
( B ) *Swine.* The usual dose for a 300-pound animal is 5 mg by intramuscular injection.
( ii ) *Indications for use.* For alleviation of pain associated with generalized and acute localized arthritic conditions; for treating acute hypersensitivity reactions; and as an aid in correcting circulatory defects associated with severe toxicity and shock.
( iii ) *Limitations.* Animals intended for human consumption should not be slaughtered within 7 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 16190, Mar. 25, 2014]