alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
[Federal Register Volume 89, Number 176 (Wednesday, September 11, 2024)]
[Notices]
[Pages 73661-73662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20556]


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

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; OPZELURA (ruxolitinib)

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 OPZELURA (ruxolitinib), approved 
September 21, 2021, 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#fcbf9d88948e8592d2b09999bc9a989dd294948fd29b938a"><span class="__cf_email__" data-cfemail="014260756973786f2f4d6464416765602f6969722f666e77">[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 OPZELURA (ruxolitinib) 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 OPZELURA (ruxolitinib), go to the ``Drugs@FDA'' 
website at https://www.accessdata.fda.gov/scripts/cder/daf/.


[[Page 73662]]


    Dated: September 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20556 Filed 9-10-24; 8:45 am]
BILLING CODE 4164-01-P


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<PAGE>   1
                                                                      EXHIBIT 23

INDEPENDENT AUDITORS' CONSENT

We consent to the incorporation by reference in Registration Statement Nos.
333-40697, 333-34677, 33-65412, 33-97512, 33-65414 and 33-88114 of Pacific
Sunwear of California, Inc. on Form S-8 of our report dated March 12, 1998,
appearing in the Annual Report on Form 10-K of Pacific Sunwear of California,
Inc. for the year ended February 1, 1998.


/s/ DELOITTE & TOUCHE LLP

Costa Mesa, California
April 9, 1998
**Exhibit 31.2**

Certification of Principal Accounting OfficerPursuant to Rule 13a-14(a) or Rule 15d-14(a)of the Securities Exchange Act of 1934,as amended

I, Stephen Peary, ChiefFinancial Officer of FP Technology, Inc. (the “Company”), certify that:

       1. I have reviewed this Quarterly report on Form 10-QSB of theCompany;

       2. Based on my knowledge, this report does not contain anyuntrue statement of a material fact or omit to state a material fact necessaryto make the statements made, in light of the circumstances under which suchstatements were made, not misleading with respect to the period covered by thisreport;

       3. Based on my knowledge, the financial statements, and otherfinancial information included in this report, fairly present in all material respectsthe financial condition, results of operations and cash flows of the registrantas of, and for, the periods presented in this report;

       4. As the registrant’s certifying officer, I am responsiblefor establishing and maintaining disclosure controls and procedures (as definedin Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and I have:

       a) designed such disclosure controls andprocedures, or caused such disclosure controls and procedures to be designedunder our supervision, to ensure that material information relating to theregistrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which thisreport is being prepared;

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

       c) disclosed in this report any change in the registrant’sinternal control over financial reporting that occurred during the periodcovered by this report that has materially affected, or is reasonably likely tomaterially affect, the registrant’s internal control over financial reporting.

       5. As the registrant’s certifying officer, I have disclosed,based on my most recent evaluation of internal control over financialreporting, to the registrant’s auditors and the audit committee of registrant’sboard of directors (or persons performing the equivalent function):

       a) all significant deficiencies and material weaknesses in thedesign or operation of internal  controlover financial reporting which are reasonably likely to adversely affect theregistrant’s  ability to record, process,summarize and report financial information; and

       b) any fraud, whether or not material, that involvesmanagement or other employees who have a significant role in the registrant’sinternal control over financial reporting.
| Date: November 14, 2006 |   | /s/ Stephen Peary                       |
|-------------------------|--------|-----------------------------------------|
|                    |   | Stephen Peary, Chief  Financial Officer |

 

23

----
<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
FIRSTCITY LIQUIDATING TRUST MARCH 31, 1998 FORM 10-Q FINANCIAL STATEMENTS AND IS
QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FIRSTCITY LIQUIDATING TRUST MARCH
31, 1998 FORM 10-Q.
</LEGEND>
<MULTIPLIER> 1,000
       
<S>                             <C>
<PERIOD-TYPE>                   3-MOS
<FISCAL-YEAR-END>                          DEC-31-1998
<PERIOD-START>                             JAN-01-1998
<PERIOD-END>                               MAR-31-1998
<CASH>                                          32,911
<SECURITIES>                                         0
<RECEIVABLES>                                        0
<ALLOWANCES>                                         0
<INVENTORY>                                     66,134
<CURRENT-ASSETS>                                     0
<PP&E>                                               0
<DEPRECIATION>                                       0
<TOTAL-ASSETS>                                  99,045
<CURRENT-LIABILITIES>                            1,945
<BONDS>                                              0
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                             0
<OTHER-SE>                                      97,100
<TOTAL-LIABILITY-AND-EQUITY>                    99,045
<SALES>                                         24,766
<TOTAL-REVENUES>                                24,951
<CGS>                                                0
<TOTAL-COSTS>                                        0
<OTHER-EXPENSES>                                 1,925
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                                 23,026
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                             23,026
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                    23,026
<EPS-PRIMARY>                                        0
<EPS-DILUTED>                                        0
        

</TABLE>
Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Federal Mine Safety and Health Review Commission

# TIME AND DATE: 

2 p.m., Thursday, September 19, 2024.

# PLACE: 

The United States Department of Labor Auditorium, Frances Perkins Building, 200 Constitution Avenue NW, Washington, DC 20210.

# STATUS: 

Open.

# MATTERS TO BE CONSIDERED: 

                        The Commission will hear oral argument in the matter of                         *Geneva Rock Products, Inc.,*                         Docket No. WEST 2022-0097. (Issues include whether the Judge abused his discretion when he ordered a stay of the case for an indefinite duration because of a pending criminal matter.)                    

Any person attending this oral argument who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d).

# CONTACT PERSON FOR MORE INFORMATION: 

Emogene Johnson (202) 434-9935/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.

*Phone Number for Listening to Meeting:*                         1 (866) 236-7472, Passcode: 678-100.                    

(Authority: 5 U.S.C. 552b)

Dated: September 9, 2024.

Sarah L. Stewart,

Deputy General Counsel.

[FR Doc. 2024-20792 Filed 9-10-24; 11:15 am]

BILLING CODE 6735-01-P
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


     I,  David  Goldman,  Acting  Chief Financial Officer of Orbit International
Corp.,  certify,  pursuant  to  18  U.S.C.   1350,  as  enacted  by  906  of the
Sarbanes-Oxley  Act  of  2002,  that:

     (1)     The Annual Report on Form 10-K for the year ended December 31, 2010
(the  "Annual  Report") which this statement accompanies fully complies with the
requirements  of  Section  13(a)  or  15(d)  of  the  Exchange  Act;  and

     (2)     information  contained in the Annual Report fairly presents, in all
material  respects,  the  financial condition and results of operations of Orbit
International  Corp.

Dated: March 31, 2011
                                   /s/ David Goldman
                                   -----------------
                                   David Goldman
                                   Acting Chief Financial Officer

A  signed  original  of this written statement required by Section 906, or other
document  authenticating, acknowledging or otherwise adopting the signature that
appears  in  typed  form within the electronic version of this written statement
required by Section 906, has been provided to Orbit International Corp. and will
be  retained  by  Orbit  International Corp. and furnished to the Securities and
Exchange  Commission  or  its  staff  upon  request.
EXHIBIT 10.17
-------------



                  SENIOR CONVERTIBLE PROMISSORY NOTE



Date:                 December 10, 1999 (Evidenced by receipt of wired
funds to the account of Ampersand Medical Corporation)

Borrower:             Ampersand Medical Corporation

Lender:               Azimuth Corporation

Type:                 Senior Convertible Promissory Note, senior to all
currently outstanding debt.

Principle:            $50,000.00

Term:                 75 days from date.

Interest Rate:        12% per annum, payable on the due date of the note

Conversion:           At the option of the noteholder, the principle
amount of the note and any accrued interest due thereon may be converted
into shares of common stock of the Company at a conversion rate of $0.20
per share. Such conversion election may be made at any time during the 75-
day term of the note.

Penalty Provision:    If the Company fails to pay the note and accrued
interest in full on the due date, the Company shall be deemed to be in
default on the note. The Company shall have a thirty-day cure period to
remedy such default. Immediately following such default, the following
adjustments shall be made to the terms of the note: (1) the interest rate
on the unpaid principle amount of the note shall increase from 12% to 15%,
and (2) the noteholders option to convert the principle amount of the note
and any accrued interest due thereon into shares of common stock of the
Company shall be adjusted to reflect a conversion rate of $0.10 per share.
Al the conclusion of the 30-day cure period, the note and any accrued
interest thereon shall become immediately due and payable in full.

Other Conditions:     Ampersand will issue Azimuth Corporation a warrant
to purchase 50,000 shares of common stock at a strike price equal to $0.33
per share or 85% of the market price of Ampersand common stock as quoted on
the OTC Bulletin Board on December 10, 1999.


For Ampersand Medical Corporation




--------------------  ----------
Leonard R. Prange     Date
President
**EXHIBIT 32.2**

**CERTIFICATIONOF**

**CHIEFFINANCIAL OFFICER**

**PURSUANTTO 18 U.S.C. SECTION 1350,**

**ASADOPTED PURSUANT TO**

**SECTION906 OF THE SARBANES-OXLEY ACT OF 2002**

 

I, Christian S. Schade, certify, pursuant to 18 U.S.C.Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of2002, that the Annual Report of Medarex, Inc. on Form 10-K/A for the year endedDecember 31, 2005 fully complies with the requirements of Section 13(a) or15(d) of the Securities Exchange Act of 1934 and that information contained insuch Annual Report of Medarex, Inc. on Form 10-K/A fairly presents in allmaterial respects the financial condition and results of operations of Medarex,Inc.
| Date: February 9, 2007  | By:        | /s/ CHRISTIAN  S. SCHADE                          |
|------------------------------|------------|--------------------------------------------------------|
|                         | **Name:**  |  **Christian S. Schade**                          |
|                         | **Title:** | **Senior  Vice President and Chief Financial Officer** |

 

Signed originals of these written statements requiredby Section 906, or other documents authenticating, acknowledging or otherwiseadopting the signatures that appear in typed form within the electronic versionof these written statements required by Section 906, have been provided toMedarex, Inc. and will be retained by Medarex, Inc. and furnished to theSecurities and Exchange Commission or its staff upon request.

This Certification is being furnished pursuant to Rule15(d) and shall not be deemed “filed” for purposes of Section 18 of theExchange Act (15 U.S.C. 78r), or otherwise subject to the liability of thatsection. This Certification shall not be deemed to be incorporated by referenceinto any filing under the Securities Act or the Exchange Act, except to theextent that the Company specifically incorporates it by reference.

 

----
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 (the “report”)
of MEDITE Cancer Diagnostics, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2013, I, Robert F.
McCullough, Jr., the Chief Financial Officer of the Company, do hereby certify, pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002, 18 U.S.C. Section 1350, that to the best of my knowledge:



(1)       the
report 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 report fairly presents, in all material respects, the financial condition and results of operations
of the Company.



|Date:  May 08, 2015 | /s/ Robert McCullough Jr.
|------------------- | -------------------------
|                    | Robert McCullough Jr.    
|                    | Chief Financial Officer
<TABLE> <S> <C>

<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS OF USCS INTERNATIONAL, INC. AS OF
SEPTEMBER 30, 1998 FOR THE NINE MONTHS THEN ENDED AND IS QUALIFIED IN ITS
ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
       
<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1998
<PERIOD-START>                             JAN-01-1998
<PERIOD-END>                               SEP-30-1998
<CASH>                                          16,630
<SECURITIES>                                         0
<RECEIVABLES>                                   96,097
<ALLOWANCES>                                         0
<INVENTORY>                                      6,957
<CURRENT-ASSETS>                               134,633
<PP&E>                                         213,570
<DEPRECIATION>                                 108,249
<TOTAL-ASSETS>                                 272,779
<CURRENT-LIABILITIES>                           81,917
<BONDS>                                          2,451<F1>
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                         1,171
<OTHER-SE>                                     147,791<F2>
<TOTAL-LIABILITY-AND-EQUITY>                   272,779
<SALES>                                              0
<TOTAL-REVENUES>                               246,565
<CGS>                                                0
<TOTAL-COSTS>                                  146,010
<OTHER-EXPENSES>                                75,349<F3>
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                 250
<INCOME-PRETAX>                                 24,956
<INCOME-TAX>                                    11,838
<INCOME-CONTINUING>                             13,118
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                    13,118
<EPS-PRIMARY>                                      .56
<EPS-DILUTED>                                      .54
<FN>
<F1>CONSISTS OF NOTES PAYABLE
<F2>CONSISTS OF ADDITIONAL PAID-IN CAPITAL, RETAINED EARNINGS, TREASURY STOCK AND
FOREIGN CURRENCY TRANSLATION ADJUSTMENTS
<F3>CONSISTS OF RESEARCH AND DEVELOPMENT AND SELLING, GENERAL AND ADMINISTRATIVE
EXPENSES
</FN>
        

</TABLE>
### C OURT OF 

### A PPEALS FOR THE



### F IRST 

### D ISTRICT OF 

### T EXAS AT 

### H OUSTON



### O RDER ON 

### M OTION

Cause number: 01

- 1 8

- 0 0 376

- C R

Style: Oscar Axcel D uron

v

. The State of Texas

Date motion filed: November 19 , 201 8

Type of motion: Second M otion to Exten d Time to File Appellant ’s Brief

Party filing motion: Appellant

Document to be filed: Appellant ’s brief

Is appeal accelerated? No

If motion to extend time:

Original due date: August 1 7 , 201 8

Number of previous extensions granted: Current Due date: October 16, 2018

Date Requested: December 6 , 201 8

Ordered that motion is:

 Granted in part and dismissed as moot in part

If document is to be filed, document due: December 6 , 201 8

 T he Court will not grant additional motions to extend time absent extraordinary circumstances

.

 Denied

 Dismissed ( e.g. , want of jurisdiction, moot )

 Other: _____________________________________

Judge ’ s signature:

___

/s/ Terry Jennings

________  Acting individually Acting for the Court

Panel consists of

____________________________________________

Date: __ November 27, 2018

_____
COURT OF APPEALS

EIGHTH DISTRICT OF TEXAS

EL PASO, TEXAS

IN RE: VCC, LLC D/B/A VCC

GENERAL CONTRACTING AND

CONSTRUCTION MANAGEMENT,

RELATOR. §

§

§

§ No. 08

- 14

- 00154

- CV

ORIGINAL PROCEEDING

ON PETITION FOR WRIT OF

MANDAMUS

J U D G M E N T

The Court has considered this cause on the Relators’ petition for writ of mandamus

against the Honorable Marcos Lizarraga, Judge of the 168th District Court of El Paso County,

Texas, and concludes Relators’ petition for writ of mandamus should be denied. We therefore

deny the petition for writ of mandamus, in accordance with the opinion of this Court.

IT IS SO ORDERED THIS 12TH DAY OF SEPTEMBER, 2014.

YVONNE T. RODRIGUEZ, Justice

Before McClure, C.J., Rodriguez, J., and Barajas, Senior Judge

Barajas, Senior Judge (Sitting by Assignment) (Not Participating)
<TABLE> <S> <C>


<ARTICLE> 5
<MULTIPLIER> 1000
       
<S>                                           <C>
<PERIOD-TYPE>                                 6-MOS
<FISCAL-YEAR-END>                             DEC-27-1997
<PERIOD-START>                                DEC-29-1996
<PERIOD-END>                                  JUN-28-1997
<CASH>                                           1,133
<SECURITIES>                                         0
<RECEIVABLES>                                   38,028
<ALLOWANCES>                                       530
<INVENTORY>                                     51,847
<CURRENT-ASSETS>                                99,336
<PP&E>                                          83,029
<DEPRECIATION>                                   5,613
<TOTAL-ASSETS>                                 204,251
<CURRENT-LIABILITIES>                          111,763
<BONDS>                                              0
<PREFERRED-MANDATORY>                            5,500
<PREFERRED>                                          0
<COMMON>                                             1
<OTHER-SE>                                      54,685
<TOTAL-LIABILITY-AND-EQUITY>                   204,251
<SALES>                                        115,487
<TOTAL-REVENUES>                               115,487
<CGS>                                          115,995
<TOTAL-COSTS>                                  126,576
<OTHER-EXPENSES>                                     0
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                              11,724
<INCOME-PRETAX>                                (22,044)
<INCOME-TAX>                                       247
<INCOME-CONTINUING>                            (22,291)
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                   (22,484)
<EPS-PRIMARY>                                   (30.23)
<EPS-DILUTED>                                   (30.23)
        


</TABLE>