alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
§ 56.103 Circumstances in which IRB review is required. ( a ) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part.
( b ) Except as provided in §§ 56.104 and 56.105, the Food and Drug Administration may decide not to consider in support of an application for a research or marketing permit any data or information that has been derived from a clinical investigation that has not been approved by, and that was not subject to initial and continuing review by, an IRB meeting the requirements of this part. The determination that a clinical investigation may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulations to submit the results of the investigation to the Food and Drug Administration.
( c ) Compliance with these regulations will in no way render inapplicable pertinent Federal, State, or local laws or regulations.
[46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981]
```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7615 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                                H. R. 7615

   To allow States to elect to observe daylight savings time for the 
             duration of the year, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 11, 2024

  Ms. Maloy introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
   To allow States to elect to observe daylight savings time for the 
             duration of the year, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Daylight Act''.

SEC. 2. OPTIONAL YEAR-LONG APPLICATION OF DAYLIGHT SAVINGS TIME.

    Section 3(a) of the Uniform Time Act of 1966 (15 U.S.C. 260a) is 
amended--
            (1) by inserting ``or may by law apply the advancement of 
        time described in this section for the duration of the year,'' 
        after ``may by law exempt itself from the provisions of this 
        subsection providing for the advancement of time,'';
            (2) by striking ``the standard time otherwise applicable 
        during that period'' and inserting ``the same standard time'';
            (3) by striking ``may by law exempt either the entire State 
        as provided in (1) or'' and inserting ``, by law, may apply 
        either standard time provided for in paragraph (1) to the 
        entire State,''; and
            (4) by inserting ``, or may apply the advancement of time 
        for the duration of the year to the entire area of the State 
        lying within any time zone'' before the period at the end.
                                 <all>
```
§ 522.2610 Trimethoprim and sulfadiazine. ( a ) *Specifications.* Each milliliter (mL) contains: ( 1 ) 40 milligrams (mg) trimethoprim suspended in a solution containing 200 mg sulfadiazine; or
( 2 ) 80 mg trimethoprim suspended in a solution containing 400 mg sulfadiazine (as the sodium salt).
( b ) *Sponsors.* See Nos. 000061 and 054771 in § 510.600(c) of this chapter.
( c ) *Conditions of use* — ( 1 ) *Dogs* — ( i ) *Amount.* 1 mL of the product described in paragraph (a)(1) of this section (40 mg trimethoprim and 200 mg sulfadiazine) per 20 pounds (9 kilograms) of body weight per day by subcutaneous injection.
( ii ) *Indications for use.* For the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, and acute septicemia due to Streptococcus zooepidemicus.
( iii ) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
( 2 ) *Horses* — ( i ) *Amount.* 2 mL of the product described in paragraph (a)(2) of this section (160 mg trimethoprim and 800 mg sulfadiazine) per 100 pounds (45 kilograms) of body weight per day by intravenous injection as single, daily dose for 5 to 7 days. The daily dose may also be halved and given morning and evening.
( ii ) *Indications for use.* For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory tract infections, acute urogenital infections, and wound infections and abscesses.
( iii ) *Limitations.* Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[71 FR 30803, May 31, 2006, as amended at 79 FR 16197, Mar. 25, 2014]
* Pursuant to 5TH CIR. R. 47.5, the court has determined

that this opinion should not be published and is not precedent

except under the limited circumstances set forth in 5TH CIR.

R. 47.5.4.

IN THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

 

No. 00-51012

Conference Calendar

 

UNITED STATES OF AMERICA,

Plaintiff-Appellee,

versus

BENITO RODRIGUEZ-ORTIZ,

Defendant-Appellant.

--------------------

Appeal from the United States District Court

for the Western District of Texas

USDC No. A-00-CR-72-ALL-JN

--------------------

April 12, 2001

Before JOLLY, HIGGINBOTHAM, and JONES, Circuit Judges.

PER CURIAM:*

Enrique Rodriguez-Ortiz appeals the 70-month sentence

imposed following his plea of guilty to a charge of being found

in the United States after deportation, a violation of 8 U.S.C.

§ 1326. For the first time on appeal, Rodriguez argues that the

aggravated-felony conviction that resulted in his increased

sentence under 8 U.S.C. § 1326(b)(2) was an element of the

offense that should have been charged in the information to which

he pleaded guilty.
No. 00-51012

-2-

Rodriguez acknowledges that his argument is foreclosed by

the Supreme Court’s decision in Almendarez-Torres v. United

States, 523 U.S. 224 (1998), but he seeks to preserve the issue

for Supreme Court review in light of the decision in Apprendi v.

New Jersey, 120 S. Ct. 2348 (2000). 

Apprendi did not overrule Almendarez-Torres. See Apprendi,

120 S. Ct. at 2362; United States v. Dabeit, 231 F.3d 979, 984

(5th Cir. 2000), cert. denied, 121 S. Ct. 1214 (2001). Rodriguez

has failed to demonstrate error, plain or otherwise. Dabeit, 231

F.3d at 983-84. The judgment of the district court is 

AFFIRMED.
<PAGE>

                                                                    EXHIBIT 23.1


                    CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS

     As independent public accountants, we hereby consent to the incorporation 
of our reports dated February 5, 1999, included on pages F-2 and S-1 of the 
1998 Annual Report to Shareholders on Form 10-K of UroCor, Inc., into the 
previously filed Registration Statements on Form S-8 (File Nos. 333-16075, 
333-58013, 333-58015 and 333-58017) of UroCor, Inc.



                                              ARTHUR ANDERSEN LLP

Oklahoma City, Oklahoma,
February 5, 1999













                                      -1-
§ 74.2710 D&C Yellow No. 10. ( a ) *Identity and specifications.* The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of § 74.1710(a)(1) and (b).
( b ) *Uses and restrictions.* The color additive D&C Yellow No. 10 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.
( c ) *Labeling.* The label of the color additive shall conform to the requirements of § 70.25 of this chapter.
( d ) *Certification.* All batches of D&C Yellow No. 10 shall be certified in accordance with regulations in part 80 of this chapter.
[48 FR 39220, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984]
RESUMEN DIAG SEROEPIDEMIOLOGICO 2008

MES 3 ABC EITB VIAA

ENERO 2135 112 471

FEBRERO 768 16

MARZO 1936 70 57

ABRIL 4928 275 310

MAYO 10818 387 72

JUNIO 9680 320

JULIO 7392 550 44

AGOSTO 4400 183 45

SEPTIEMBRE 3070 245 92

OCTUBRE 4048 159 85

NOVIEMBRE 3696 243 30

DICIEMBRE 2640 120 37

TOTAL 55511 2680 1243
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.1390 5-Hydroxyindole acetic acid/serotonin test system. ( a ) *Identification.* A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in urine. Measurements of 5-hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine 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 § 862.9.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]
<PAGE>   1
                                  


                         CONSENT OF INDEPENDENT AUDITORS



         We consent to the incorporation by reference in this Registration
Statement of Pan Environmental Corporation on Form S-8 of our report dated
January 6, 1998, incorporated by reference in the Annual Report on Form 10-K of
Pan Environmental Corporation for the year ended December 31, 1997.



                               /s/ WILLIAM L. BUTCHER, CPA P.S.
                               ------------------------------------
                               William L. Butcher, CPA P.S.
                               Everett, Washington
# C_2015381EN.01005901.xml

| 16.11.2015 | EN | Official Journal of the European Union | C 381/59 |
| --- | --- | --- | --- |

16.11.2015

EN

Official Journal of the European Union

C 381/59

---

Order of the General Court of 15 September 2015 — Makhlouf v Council

(Case T-592/14) (1)

1

(2015/C 381/75)

Language of the case: French

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

---

(1)  OJ C 361, 13.10.2014.

1

---
Exhibit 32.1

# SECTION 1350
CERTIFICATION

| | In
connection with the accompanying Quarterly Report on Form 10-Q/A of Penn Treaty
American Corporation (the Company) for the period ended September 30, 2004 as
filed with the Securities and Exchange Commission, I, William W. Hunt, President and
Chief Executive Officer of the Company, certify pursuant to 18 U.S.C. Section §1350,
as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002 that to the best of my
knowledge:
| | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | (1) | the
Quarterly Report on Form 10-Q/A for the period ended September 30, 2004
               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 Quarterly Report on Form 10-Q/A for the
               period ended September 30, 2004 fairly presents, in all material respects,
the                Companys financial condition and results of operations.
| | --- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

|                          |  |                                                       
|------------------------- |  | ------------------------------------------------------
|Date:  September 28, 2005 |  | /s/ William W. Hunt                                   
|                          |  | William W. Hunt
 President and Chief Executive Officer
p. 1


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# C_2016305EN.01002901.xml

| 22.8.2016 | EN | Official Journal of the European Union | C 305/29 |
| --- | --- | --- | --- |

22.8.2016

EN

Official Journal of the European Union

C 305/29

---

Order of the General Court of 29 June 2016 — Group v EUIPO — ILIEV (GROUP Company TOURISM & TRAVEL)

(Case T-567/14) (1)

1

((European Union trade mark - Opposition proceedings - Application for European Union figurative mark GROUP Company TOURISM & TRAVEL - Earlier, non-registered national figurative marks GROUP Company TOURISM & TRAVEL - Relative ground for refusal - Application of national law - Article 8(4) of Regulation (EC) No 207/2009 - Evidence establishing the content of the national right - Rule 19(2)(d) of Regulation (EC) No 2868/95 - Failure to take account of evidence adduced before the Board of Appeal - Discretion of the Board of Appeal - Article 76(2) of Regulation No 207/2009))

(2016/C 305/39)

Language of the case: Bulgarian

Parties

Parties

Applicant: Group OOD (Sofia, Bulgaria) (represented by: D. Dragiev and A. Andreev, lawyers)

Applicant:

Defendant: European Union Intellectual Property Office (represented by: A. Folliard-Monguiral, P. Ivanov and D. Botis, Agents)

Defendant:

Other party to the proceedings before the Board of Appeal of EUIPO, intervening before the General Court: Kosta Iliev (Sofia) (represented by: S. Ganeva, lawyer)

Other party to the proceedings before the Board of Appeal of EUIPO, intervening before the General Court:

Re:

Re:

Action brought against the decision of the Fourth Board of Appeal of EUIPO of 2 June 2014 (Case R 1587/2013-4) relating to opposition proceedings between Group OOD and Mr Iliev.

Operative part of the order

Operative part of the order

| 1. | Annuls the decision of the Fourth Board of Appeal of the European Union Intellectual Property Office (EUIPO) of 2 June 2014 (Case R 1587/2013-4). |
| --- | --- |

1.

Annuls the decision of the Fourth Board of Appeal of the European Union Intellectual Property Office (EUIPO) of 2 June 2014 (Case R 1587/2013-4).

| 2. | Orders EUIPO and Mr Kosta Iliev to bear their own costs and to pay those incurred by Group OOD. |
| --- | --- |

2.

Orders EUIPO and Mr Kosta Iliev to bear their own costs and to pay those incurred by Group OOD.

---

(1)  OJ C 372, 20.10.2014.

1

---
# C_2014448EN.01000802.xml

| 15.12.2014 | EN | Official Journal of the European Union | C 448/8 |
| --- | --- | --- | --- |

15.12.2014

EN

Official Journal of the European Union

C 448/8

---

Request for a preliminary ruling from the Consiglio di Stato (Italy) lodged on 29 September 2014 — Agenzia Italiana del Farmaco (AIFA), Ministry for Health v Doc Generici srl

(Case C-452/14)

(2014/C 448/11)

Language of the case: Italian

Referring court

Referring court

Consiglio di Stato

Parties to the main proceedings

Parties to the main proceedings

Applicants: Agenzia Italiana del Farmaco (AIFA), Ministry for Health

Applicants:

Defendant: Doc Generici srl

Defendant:

Questions referred

Questions referred

| 1. | Must Article 3(2)(a) of Council Regulation (EC) No 297/95 of 10 February 1995 (1), in the version currently in force, be interpreted as meaning that Type I marketing authorisation variations — and, in particular, in respect of the case in the main proceedings, Type IA variations — where an identical variation affecting several authorisations belonging to the same holder are concerned, are subject to a single fee, to the extent specified therein, or to as many fees as there are authorisations affected by the variation? |
| --- | --- |

1.

Must Article 3(2)(a) of Council Regulation (EC) No 297/95 of 10 February 1995 (1), in the version currently in force, be interpreted as meaning that Type I marketing authorisation variations — and, in particular, in respect of the case in the main proceedings, Type IA variations — where an identical variation affecting several authorisations belonging to the same holder are concerned, are subject to a single fee, to the extent specified therein, or to as many fees as there are authorisations affected by the variation?

1

| 2. | In the circumstances in the present proceedings, may or must, as held by this Chamber, the question be referred to the Court of Justice? |
| --- | --- |

2.

In the circumstances in the present proceedings, may or must, as held by this Chamber, the question be referred to the Court of Justice?

---

(1)  Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ 1995 L 35, 15.2.1995, p. 1).

1

---
# C_2016364EN.01005001.xml

| 3.10.2016 | EN | Official Journal of the European Union | C 364/50 |
| --- | --- | --- | --- |

3.10.2016

EN

Official Journal of the European Union

C 364/50

---

Order of the Civil Service Tribunal (3rd Chamber) of 20 July 2016 — Hoeve v Commission

(Case F-46/14) (1)

((Civil service - Officials - Pensions - Article 11(2) of Annex VIII to the Staff Regulations - Pension rights acquired, prior to entering the service of the EU, under a national pension scheme - Transfer to the EU pension scheme - Proposal concerning additional pensionable years - Objection of inadmissibility - Concept of an act having adverse effect - Article 83 of the Rules of Procedure))

(2016/C 364/64)

Language of the case: French

Parties

Applicant: Roelof-Jan Wino Hoeve (Brussels, Belgium) (represented initially by D. de Abreu Caldas, M. de Abreu Caldas and J.-N. Louis, lawyers, and subsequently by J.-N. Louis, lawyer)

Defendant: European Commission (represented initially by J. Currall and G. Gattinara, acting as Agents, and subsequently by G. Gattinara, acting as Agent, and lastly by G. Gattinara and F. Simonetti, acting as Agents)

Re:

Application for annulment of the decision relating to the transfer of the applicant’s pension rights to the European Union pension scheme which applies the new GIP relating to Articles 11 and 12 of Annex VIII to the Staff Regulations.

Operative part of the order

| 1. | The action is dismissed as inadmissible. |
| --- | --- |

1.

The action is dismissed as inadmissible.

| 2. | Mr Roelof-Jan Wino Hoeve shall bear his own costs and pay the costs incurred by the European Commission. |
| --- | --- |

2.

Mr Roelof-Jan Wino Hoeve shall bear his own costs and pay the costs incurred by the European Commission.

---

(1)  OJ C 212, 7/7/2014, p. 47.

---
§ 520.1193 Ivermectin tablets and chewables. ( a ) *Specifications.* ( 1 ) Each tablet or chewable contains 68, 136, or 272 micrograms (mcg) ivermectin.
( 2 ) Each chewable contains 55 or 165 mcg ivermectin.
( b ) *Sponsors.* See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. ( 1 ) No. 000010 for use of tablets or chewables described in paragraph (a)(1) as in paragraph (d)(1) and chewables described in paragraph (a)(2) as in paragraph (d)(2) of this section.
( 2 ) Nos. 051311 and 069043 for use of tablets described in paragraph (a)(1) as in paragraph (d)(1) of this section.
( c ) *Special considerations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
( d ) *Conditions of use* — ( 1 ) *Dogs.* For use in dogs 6 weeks of age and older as follows: ( i ) *Amount.* 6.0 mcg per kilogram (kg) of body weight (2.72 mcg per pound (lb)), minimum. Up to 25 lb, 68 mcg; 26 to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; over 100 lb, a combination of the appropriate tablets. Administer at monthly dosing intervals.
( ii ) *Indications for use.* To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (*Dirofilaria immitis*) for 1 month (30 days) after infection.
( 2 ) *Cats.* For use in cats 6 weeks of age and older as follows: ( i ) *Amount.* Up to 2.3 kilograms (up to 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to 15 lb), 165 mcg; over 6.8 kilograms (15 lb), a combination of the appropriate chewables (recommended minimum dose of 24 mcg/kg of body weight (10.9 mcg/lb)). Administer once a month.
( ii ) *Indications for use.* To prevent feline heartworm disease by eliminating the tissue stage of heartworm larvae *Dirofilaria immitis* for a month (30 days) after infection, and for removal and control of adult and immature (L4) hookworms *Ancylostoma tubaeforme* and *A. braziliense.*
[67 FR 11230, Mar. 13, 2002, as amended at 67 FR 21996, May 2, 2002; 69 FR 43735, July 22, 2004; 81 FR 17607, Mar. 30, 2016; 84 FR 39183, Aug. 9, 2019]