alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Page 4307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01164]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]


Notice of Approval of Product Under Voucher: Rare Pediatric 
Disease Priority Review Voucher

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of approval of a product redeeming a priority review voucher. 
The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to 
award priority review vouchers to sponsors of approved rare pediatric 
disease product applications that meet certain criteria. FDA is 
required to publish notice of the issuance of priority review vouchers 
as well as the approval of products redeeming a priority review 
voucher. FDA has determined that the supplemental application 
(Supplement-35) for COSENTYX (secukinumab), approved June 16, 2020, 
meets the criteria for redeeming a priority review voucher.

FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1394, email: 
<a href="/cdn-cgi/l/email-protection#a8ebc9dcc0dad1c686e4cdcde8ceccc986c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="c98aa8bda1bbb0a7e785acac89afada8e7a1a1bae7aea6bf">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: FDA is announcing the approval of a product 
redeeming a rare pediatric disease priority review voucher. Under 
section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will report the 
issuance of rare pediatric disease priority review vouchers and the 
approval of products for which a voucher was redeemed. FDA has 
determined that the supplemental application (Supplement-35) for 
COSENTYX (secukinumab) meets the redemption criteria.
    For further information about the Rare Pediatric Disease Priority 
Review Voucher Program and for a link to the full text of section 529 
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further 
information about COSENTYX (secukinumab), go to the ``Drugs@FDA'' 
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01164 Filed 1-22-24; 8:45 am]
BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>
**EXHIBIT 31.1**

**CERTIFICATION PURSUANT TORULE 13a-14 AND 15d-14UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED**

I, William Santo, Chief Executive Officer ofFP Technology, Inc., certify that:

1.I havereviewed this Annual Report on Form 10-KSB of FP Technology, Inc.;

2. Based on myknowledge, this report does not contain any untrue statement of a material factor omit to state a material fact necessary to make the statements made, inlight of the circumstances under which such statements were made, notmisleading with respect to the period covered by this report;

3.Based on myknowledge, the financial statements, and other financial information includedin this report, fairly present in all material respects the financialcondition, results of operations and cash flows of the Registrant as of, andfor, the periods presented in this report;

4.Theregistrant’s other certifying officer and I are responsible for establishingand maintaining disclosure controls and procedures (as defined in Exchange ActRules 13a-15(e) and 15d-15(e)) for the Registrant and have:

(a)          designed suchdisclosure controls and procedures 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 thisannual report is being prepared;

(b)         evaluated theeffectiveness of the registrant’s disclosure controls and procedures andpresented in this report our conclusions about the effectiveness of the disclosurecontrols and procedures, as of the end of the period covered by this reportbased on such evaluation; and

(c)          disclosed inthis report any change in the Registrant’s internal control over financialreporting that occurred during the Registrant’s most recent fiscal quarter (theRegistrant’s fourth fiscal quarter in the case of an annual report) that hasmaterially affected, or is reasonably likely to materially affect, theregistrant’s internal control over financial reporting; and

5.Theregistrant’s other certifying officer and I have disclosed, based on our mostrecent evaluation of internal control over financial reporting, to theRegistrant’s auditors and the audit committee of the Registrant’s Board ofDirectors (or persons performing the equivalent function):

(a)          allsignificant deficiencies and material weaknesses in the design or operation ofinternal control over financial reporting which are reasonably likely toadversely affect the registrant’s ability to record, process, summarize and reportfinancial information; and

(b)         any fraud,whether or not material, that involves management or other employees who have asignificant role in the Registrant’s internal controls over financialreporting.
| Dated:  September 28, 2006 | By:    | /s/    | William Santo            |   |
|----------------------------|--------|--------|--------------------------|--------|
|                       |   |   | William Santo            |
|                       |   |   | Chief Executive  Officer |
|                            |        |        |                          |        |  |

 

----
UNPUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

No. 16-6138

JOSEPH COPPOLA,

Petitioner - Appellant,

v.

TERRY O’BRIEN, Warden,

Respondent - Appellee.

Appeal from the United States District Court for the Northern 

District of West Virginia, at Martinsburg. Robert W. Trumble, 

Magistrate Judge. (3:15-cv-00096-GMG-RWT)

Submitted: June 21, 2016 Decided: June 23, 2016

Before DUNCAN, KEENAN, and THACKER, Circuit Judges.

Dismissed by unpublished per curiam opinion.

Joseph Coppola, Appellant Pro Se. Helen Campbell Altmeyer, 

Assistant United States Attorney, Wheeling, West Virginia; Erin K. 

Reisenweber, Assistant United States Attorney, Martinsburg, West 

Virginia, for Appellee.

Unpublished opinions are not binding precedent in this circuit.
2

PER CURIAM:

Joseph Coppola seeks to appeal the magistrate judge’s order 

denying his motion for entry of default on his 28 U.S.C. § 2241 

(2012) petition. This court may exercise jurisdiction only over 

final orders, 28 U.S.C. § 1291 (2012), and certain interlocutory 

and collateral orders, 28 U.S.C. § 1292 (2012); Fed. R. Civ. P. 

54(b); Cohen v. Beneficial Indus. Loan Corp., 337 U.S. 541, 545-

46 (1949). The order Coppola seeks to appeal is neither a final 

order nor an appealable interlocutory or collateral order. 

Accordingly, we deny leave to proceed in forma pauperis and dismiss 

the appeal for lack of jurisdiction. We dispense with oral 

argument because the facts and legal contentions are adequately 

presented in the materials before this court and argument would 

not aid the decisional process.

DISMISSED
#### Thomas HARLEY, Petitioner-Appellant, v. Charles CONDON, Attorney General of the State of South Carolina; State Of South Carolina, Respondents-Appellees.

No. 02-7848.

United States Court of Appeals, Fourth Circuit.

Submitted Jan. 30, 2003.

Decided Feb. 5, 2003.

Thomas Harley, Appellant Pro Se.

Before WIDENER, NIEMEYER, and TRAXLER, Circuit Judges.

Dismissed by unpublished PER CURIAM opinion.

PER CURIAM.

Thomas Harley seeks to appeal the district court’s order dismissing his petition filed under 28 U.S.C. § 2254 (2000). The district court referred this case to a magistrate judge pursuant to 28 U.S.C. § 636(b)(1)(B) (2000). The magistrate judge recommended that relief be denied and advised Harley that failure to file timely objections to this recommendation could waive appellate review of a district court order based upon the recommendation. Despite this warning, Harley failed to object to the magistrate judge’s recommendation.

*221The timely filing of specific objections to a magistrate judge’s recommendation is necessary to preserve appellate review of the substance of that recommendation when the parties have been warned that failure to object will waive appellate review. *See Wright v. Collins,*766 F.2d 841, 845-46 (4th Cir.1985); *see also Thomas v. Arn,*474 U.S. 140, 106 S.Ct. 466, 88 L.Ed.2d 435 (1985). Harley has waived appellate review by failing to file objections after receiving proper notice. Accordingly, we deny a certificate of appealability and dismiss the appeal. We also deny Harley’s motion asking the court to consider documents as an amended complaint.

We dispense with oral argument because the facts and legal contentions are adequately presented in the materials before the court and argument would not aid the decisional process.

*DISMISSED.*
<PAGE>

                                                                    EXHIBIT 23.2

            Consent of Independent Registered Public Accounting Firm

To the Board of Directors and Shareholder of
CITGO Petroleum Corporation:

We consent to the incorporation by reference in the registration statement (No.
333-65454) on Form F-3 of PDVSA Finance Ltd. and Petroleos de Venezuela, S.A. of
our report dated March 3, 2005, except as to Note 17, which is as of March 30,
2005, with respect to the consolidated balance sheets of CITGO Petroleum
Corporation as of December 31, 2004 and 2003, and the related consolidated
statements of income and comprehensive income, shareholder's equity, and cash
flows for the years then ended, which report appears in the December 31, 2004,
annual report on Form 10-K of CITGO Petroleum Corporation.

                                                  KPMG LLP

Tulsa, Oklahoma
March 30, 2005
----

            COMMISSION REGULATION (EC) No 1805/2006

of 7 December 2006         

amending Annex I to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards thiamphenicol, fenvalerate and meloxicam

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (1), and in particular Article 2 thereof,

Having regard to the opinions of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,

Whereas:

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EEC) No 2377/90 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.

It shall apply from 8 February 2007.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 7 December 2006.

For the Commission

Günter VERHEUGEN            

Vice-President

----

(1)OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1729/2006 (OJ L 325, 24.11.2006, p. 6).

(2)OJ L 311, 28.11.2001, p. 1. Directive as amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).

----

ANNEX

The following substance is inserted in Annex I to Regulation (EEC) No 2377/90 (List of pharmacologically active substances for which maximum residue limits have been fixed):

1.   Anti-infectious agents

1.2.   Antibiotics

1.2.5.   Florfenicol and related compounds

2.   Anti-parasitic agents

2.2.   Agents acting against ectoparasites

2.2.3.   Pyrethroids

4.   Anti-inflammatory agents

4.1.   Non-steroidal anti-inflammatory agents

4.1.4.   Oxicam derivatives

----

(1)  Not for use in animals from which eggs are produced for human consumption, MRLs for fat, liver and kidney do not apply to fin fish.

(2)  For fin fish muscle relates to “muscle and skin in natural proportions”.

(3)  For porcine and poultry species this MRL relates to “skin and fat in natural proportions”.’         

----
<PAGE>   1

                  AURORA ELECTRONICS, INC. AND SUBSIDIARIES           Exhibit 11
                      COMPUTATION OF PER SHARE EARNINGS
                    (In thousands, except per share data)

<TABLE>
<CAPTION>
                                           Year Ended                 Year Ended
                                       September 30, 1995         September 30, 1994
                                    ------------------------   ------------------------
                                    Primary    Fully Diluted   Primary    Fully Diluted
                                    -------    -------------   -------    -------------
<S>                                <C>           <C>           <C>          <C>
Net income (loss)                  $(15,030)     $(15,030)     $(6,518)     $(6,518)

Add: Interest expense, net of
income tax, on debenture due
2001 and Promissory Notes
due 1997                                --            --           --           --
                                   --------      --------      -------      -------
Adjusted net earnings (loss)       $(15,030)     $(15,030)     $(6,518)     $(6,518)
                                   ========      ========      =======      =======

Adjusted Number of Common Shares

Weighted average shares 
outstanding                           7,445         7,445        7,110         7,110

Incremental shares for exercise
of stock options and warrants
and common stock issuable               934           934          381           381

Weighted average shares issuable
upon conversion of Debenture due
2001 and Promissory Notes due
1997                                     --            --           --            --
                                   --------        ------      -------      --------

Adjusted number of common
shares                                8,379         8,379        7,491         7,491
                                   ========       =======      =======      ========

Net earnings (loss) per common
shares                             $  (1.79)     $  (1.79)      $(0.87)     $  (0.87)
                                   ========      ========        ======      ========
</TABLE>
COURT OF APPEALS

EIGHTH DISTRICT OF TEXAS

EL PASO, TEXAS

§

IN RE No. 08-18-00214-CV

§

DISH NETWORK, LLC AND 

ECHOSPHERE, LLC,

RELATORS

§

§

AN ORIGINAL PROCEEDING

IN MANDAMUS

MEMORANDUM OPINION

Relators, DISH Network, LLC and Echosphere, LLC (referred to collectively as DISH) 

have filed a mandamus petition against the Honorable Selena Solis, Judge of the 243rd District 

Court of El Paso County, Texas, to challenge an order compelling pre-arbitration discovery and 

failing to rule on DISH’s motion to compel arbitration. The petition for writ of mandamus is

denied.

Generally, mandamus relief is appropriate only to correct a clear abuse of discretion or to 

compel the performance of a ministerial duty, and where the relator has no adequate remedy by 

appeal. In re Reece, 341 S.W.3d 360, 364 (Tex. 2011)(orig. proceeding); In re Prudential 

Insurance Company of America, 148 S.W.3d 124, 135-36 (Tex. 2004)(orig. proceeding). The 

burden is on relator to show it is entitled to mandamus relief. See In re Ford Motor Company, 165 

S.W.3d 315, 317 (Tex. 2005)(orig. proceeding); Walker v. Packer, 827 S.W.2d 833, 837 (Tex. 

1992)(orig. proceeding). After reviewing the mandamus petition and record, and the response 

filed by the Real Party in Interest, we conclude that Relators have failed to show that they are
- 2 -

entitled to mandamus relief. Accordingly, we deny the petition for writ of mandamus.

August 21, 2019

YVONNE T. RODRIGUEZ, Justice

Before McClure, C.J., Rodriguez, and Palafox, JJ.
# Euroopa Liidu L 30/2020

| | ISSN 1977-0650 |
| --- | --- |
| Euroopa Liidu
  Teataja | L 30 |
| | |
| Eestikeelne väljaanne | Õigusaktid | 63. aastakäik3. veebruar 2020 |

ISSN 1977-0650

Euroopa Liidu

Teataja

L 30

Eestikeelne väljaanne

Õigusaktid

63. aastakäik3. veebruar 2020

---

| Sisukord | | Parandused | Lehekülg |
| --- | --- | --- | --- |
| | * | Nõukogu 24. oktoobri 2019. aasta otsuse (EL) 2019/1815 (millega nimetatakse ametisse kaks Sloveenia Vabariigi esitatud Regioonide Komitee liiget ja kolm asendusliiget) parandus ( ELT L 278, 30.10.2019 ) | 1 |

Sisukord

Parandused

Lehekülg

*

Nõukogu 24. oktoobri 2019. aasta otsuse (EL) 2019/1815 (millega nimetatakse ametisse kaks Sloveenia Vabariigi esitatud Regioonide Komitee liiget ja kolm asendusliiget) parandus ( ELT L 278, 30.10.2019 )

( ELT L 278, 30.10.2019 )

1

| ET | Aktid, mille peakiri on trükitud harilikus trükikirjas, käsitlevad põllumajandusküsimuste igapäevast korraldust ning nende kehtivusaeg on üldjuhul piiratud.
  Kõigi ülejäänud aktide pealkirjad on trükitud poolpaksus kirjas ja nende ette on märgitud tärn. |
| --- | --- |

ET

Aktid, mille peakiri on trükitud harilikus trükikirjas, käsitlevad põllumajandusküsimuste igapäevast korraldust ning nende kehtivusaeg on üldjuhul piiratud.

Kõigi ülejäänud aktide pealkirjad on trükitud poolpaksus kirjas ja nende ette on märgitud tärn.

---

Parandused

| 3.2.2020 | ET | Euroopa Liidu Teataja | L 30/1 |
| --- | --- | --- | --- |

3.2.2020

ET

Euroopa Liidu Teataja

L 30/1

---

Nõukogu 24. oktoobri 2019. aasta otsuse (EL) 2019/1815 (millega nimetatakse ametisse kaks Sloveenia Vabariigi esitatud Regioonide Komitee liiget ja kolm asendusliiget) parandus

(
  Euroopa Liidu Teataja L 278, 30. oktoober 2019
  )

Leheküljel 12 artikli 1 punkti b esimeses taandes

asendatakse

| „— | Aleksander Saša ARESNOVIČ, župan Mestne občine Maribor,“ |
| --- | --- |

„—

Aleksander Saša ARESNOVIČ, župan Mestne občine Maribor,“

župan Mestne občine Maribor,

järgmisega:

| „— | Aleksander Saša ARSENOVIČ, župan Mestne občine Maribor,“. |
| --- | --- |

„—

Aleksander Saša ARSENOVIČ, župan Mestne občine Maribor,“.

župan Mestne občine Maribor,

---
---

---

Exhibit 10.2

CONSENT OF
INDEPENDENT ACCOUNTANTS

We hereby consent to the
incorporation by reference in the Registration Statements, on Form S-8 (file No.
333-12456) and on Form F-3 (file No. 333-114153), of Elbit Vision Systems Ltd., of our
report dated July 14, 2005, relating to the consolidated financial statements, which
appears in this form 20-F.

/s/ KESSELMAN & KESSELMAN, certified public accountants
Tel-Aviv, Israel
July 14, 2005
Haifa, Israel
July 14, 2005



---

---
#### UNITED STATES of America, Plaintiff—Appellee, v. Juan Manuel AGUILAR-MIRANDA, Defendant—Appellant.

No. 02-50157.

D.C. No. CR-01-02161-1-JTM.

United States Court of Appeals, Ninth Circuit.

Submitted Jan. 16, 2003.*

Decided Feb. 6, 2003.

*845Before HALL, KOZINSKI and RAWLINSON, Circuit Judges.

*

 This panel unanimously finds this case suitable for decision without oral argument. See Fed. R.App. P. 34(a)(2).

MEMORANDUM**

The prosecutor’s closing arguments did not constitute “clear or obvious” error seriously affecting the trial’s fairness or integrity. *See United States v. Blueford,*312 F.3d 962, 974 (9th Cir.2002). Additionally, we presume that the jury followed the district court’s curative instruction concerning the limited purpose of the hearsay statement. *See Mancuso v. Olivarez,*292 F.3d 939, 952 (9th Cir.2002). Aguilar-Miranda’s argument that 21 U.S.C. §§ 841 and 960 are unconstitutional under *Harris v. United States,*536 U.S. 545, 122 S.Ct. 2406, 153 L.Ed.2d 524 (2002), is foreclosed by our recent ruling in *United States v. Hernandez,*314 F.3d 430, 437-38 (9th Cir. 2002).

AFFIRMED.

**

 This disposition is not appropriate for publication and may not be cited to or by the courts of this circuit except as provided by Ninth Circuit Rule 36-3.
WITHDRAWN 7/16/15

IN THE

TENTH COURT OF APPEALS

No. 10-15-00119-CR

MAXEY KENNETH LOVELL,

Appellant

v.

THE STATE OF TEXAS,

Appellee

From the 272nd District Court

Brazos County, Texas

Trial Court No. 14-02819-CRF-272

ORDER

The appellant’s brief is overdue in this appeal. 

This appeal is abated to the trial court to conduct any necessary hearings within 

21 days from the date of this Order pursuant to Texas Rule of Appellate Procedure 

38.8(b)(2) and (3). TEX. R. APP. P. 38.8(b)(2), (3).

The supplemental clerk’s and reporter’s records required by the rule, if any, are 

ordered to be filed within 28 days of the date of this Order. See id.

PER CURIAM
Lovell v. State Page 2

Before Chief Justice Gray,

Justice Davis, and

Justice Scoggins

Appeal abated

Order issued and filed July 9, 2015
#### FAULKNER ADVERTISING ASSOCIATES, INCORPORATED Plaintiff-Appellant, v. NISSAN MOTOR CORPORATION IN U.S.A. Defendant-Appellee.

No. 89-1548.

United States Court of Appeals, Fourth Circuit.

Sept. 27, 1990.

Robert Gene Levy, Frank, Bernstein, Conaway & Goldman, Baltimore, Md. (Berryl A. Speert, Harry J. Katrichis, A. David Demiray, on brief), for plaintiff-appellant.

John J. Hanson, Gibson, Dunn & Crutch-er, Los Angeles, Cal. (Peter Sullivan, Robert W. Denton, Gibson, Dunn & Crutcher, Los Angeles, Cal., Lewis A. Noonberg, H. Mark Stichel, Piper & Marbury, Baltimore, Md., on brief), for defendant-appellee.

ON PETITION FOR REHEARING WITH SUGGESTION FOR REHEARING IN BANC

The appellee’s petition for rehearing and suggestion for rehearing in banc were submitted to the Court. A majority of judges having voted in a requested poll of the Court to grant rehearing in banc,

IT IS ORDERED that the rehearing in banc is granted.

IT IS FURTHER ORDERED that this case shall be calendared for argument at the February, 1991 session of Court. Within ten days of the date of this order four additional copies of appellant’s briefs, five additional copies of appellees briefs, four additional copies of appellant’s reply brief shall be filed and appellee will file ten additional copies of the joint appendix.