alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 864
Editorial Note: Nomenclature changes to part 864 appear at 73 FR 35341, June 23, 2008.

§ 864.9115 Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions. ( a ) *Identification.* A container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) The intended use of the device must specify: ( i ) The Red Blood Cell components that can be processed and stored including acceptable anticoagulants and additive solutions;
( ii ) The hold time after Red Blood Cell component collection;
( iii ) The processing capacity (volume) of the device; and
( iv ) The storage temperature and dating period of processed Red Blood Cell components.
( 2 ) Studies must demonstrate that the device is biocompatible and include detailed documentation of the biocompatibility evaluation.
( 3 ) Performance testing and nonclinical studies must include a detailed study of leached materials extracted under conditions similar to clinical usage of the device, and a toxicologic risk assessment of those extracted or leached materials.
( 4 ) Performance testing must support sterility of the device and include sterilization validation, endotoxin testing, and container closure integrity evaluation.
( 5 ) Nonclinical and clinical studies must include evaluation of red blood cell quality throughout the duration of storage based on in vitro and in vivo studies, including hemolysis and red blood cell survival and recovery.
( 6 ) Performance studies must include: ( i ) Detailed documentation of functional and mechanical testing, including evaluation of oxygen and, if applicable, carbon dioxide levels during Red Blood Cell components storage; and
( ii ) Detailed documentation of device shelf-life testing demonstrating continued sterility, package integrity, and functionality over the identified shelf life.
( 7 ) The labeling must include a contraindication against processing Red Blood Cell components collected from donors with hemoglobin S.
[88 FR 77199, Nov. 9, 2023]
§ 524.1445 Miconazole, polymixin B, and prednisolone suspension. ( a ) *Specifications.* Each milliliter of suspension contains 23 milligrams (mg) miconazole nitrate, 0.5293 mg polymixin B sulfate, and 5 mg prednisolone acetate.
( b ) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.
( c ) *Conditions of use in dogs* — ( 1 ) *Amount.* Instill five drops in the ear canal twice daily for 7 consecutive days.
( 2 ) *Indications for use.* For the treatment of canine otitis externa associated with susceptible strains of yeast (*Malassezia pachydermatis*) and bacteria (*Staphylococcus pseudintermedius*).
( 3 ) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[ 75 FR 4693, Jan. 29, 2010, as amended at 77 FR 46613, Aug. 6, 2012; 81 FR 48703, July 26, 2016]
I 

118TH CONGRESS 

2D SESSION H. R. 7529 

To amend the Chesapeake Bay Initiative Act of 1998 to reauthorize the 

Chesapeake Bay Gateways and Watertrails Network. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 5, 2024 

Mr. SARBANES (for himself, Mr. SCOTT of Virginia, and Mr. WITTMAN) introduced the following bill; which was referred to the Committee on Natural 

Resources 

A BILL 

To amend the Chesapeake Bay Initiative Act of 1998 to 

reauthorize the Chesapeake Bay Gateways and 

Watertrails Network. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Chesapeake Bay Gate5 ways and Watertrails Network Reauthorization Act of 

6 2024’’. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
2 

•HR 7529 IH

1 SEC. 2. REAUTHORIZATION OF CHESEAPEAKE BAY GATE2 WAYS AND WATERTRAILS NETWORK. 

3 Section 502(c) of the Chesapeake Bay Initiative Act 

4 of 1998 (54 U.S.C. 320101 note; title V of Public Law 

5 105–312) is amended— 

6 (1) by striking ‘‘$3,000,000’’ and inserting 

7 ‘‘$6,000,000’’; and 

8 (2) by striking ‘‘2025’’ and inserting ‘‘2030’’. 

Æ 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
# C_2014135EN.01005302.xml

| 5.5.2014 | EN | Official Journal of the European Union | C 135/53 |
| --- | --- | --- | --- |

5.5.2014

EN

Official Journal of the European Union

C 135/53

---

Action brought on 24 February 2014 — Albis Plastic v OHIM — IQAP Masterbatch Group (ALCOLOR)

(Case T-132/14)

2014/C 135/69

Language in which the application was lodged: German

Parties

Parties

Applicant: Albis Plastic GmbH (Hamburg, Germany) (represented by: C. Klawitter, lawyer)

Applicant:

Defendant: Office for Harmonisation in the Internal Market (Trade Marks and Designs)

Defendant:

Other party to the proceedings before the Board of Appeal: IQAP Masterbatch Group, SL (Masíes de Roda, Spain)

Other party to the proceedings before the Board of Appeal:

Form of order sought

Form of order sought

The applicant claims that the Court should:

| — | annul the decision of the Second Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 3 December 2013 in Case R 1015/2012-2; |
| --- | --- |

—

annul the decision of the Second Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 3 December 2013 in Case R 1015/2012-2;

| — | order the defendant to pay the costs. |
| --- | --- |

—

order the defendant to pay the costs.

Pleas in law and main arguments

Pleas in law and main arguments

Registered Community trade mark in respect of which a declaration of invalidity has been sought: Word mark ‘ALCOLOR’ for goods and services in Class 1 — Community trade mark No 3 073 889

Registered Community trade mark in respect of which a declaration of invalidity has been sought:

Proprietor of the Community trade mark: Applicant

Proprietor of the Community trade mark:

Applicant for the declaration of invalidity of the Community trade mark: IQAP Masterbatch Group, SL

Applicant for the declaration of invalidity of the Community trade mark:

Grounds for the application for a declaration of invalidity: National figurative mark containing the word element ‘ALCOLOR’ for goods in Class 2, and company name ‘ALCOLOR’ used in Spain the course of trade for ‘dyestuffs’

Grounds for the application for a declaration of invalidity:

Decision of the Cancellation Division: Rejection of the application for a declaration of invalidity

Decision of the Cancellation Division:

Decision of the Board of Appeal: Allowed the appeal and remitted the case to the Cancellation Division

Decision of the Board of Appeal:

Pleas in law: Infringement of Article 53(1) of Regulation No 207/2009 and its implementing provisions

Pleas in law:

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

§ 862.3200 Clinical toxicology calibrator. ( a ) *Identification.* A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)
( b ) *Classification.* Class II (special controls). 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.
[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]
[Federal Register Volume 75, Number 42 (Thursday, March 4, 2010)]
[Notices]
[Pages 9867-9868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4600]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

International Trade Administration


University of Pittsburgh, et al.; Notice of Consolidated Decision 
on Applications for Duty-Free Entry of Electron Microscopes

    This is a decision consolidated pursuant to Section 6(c) of the 
Educational, Scientific, and Cultural Materials Importation Act of 1966 
(Pub. L. 89-651, as amended by Public Law 106-36; 80 Stat. 897; 15 CFR 
part 301). Related records can be viewed between 8:30 a.m. and 5 p.m. 
in Room 3720, U.S. Department of Commerce, 14th and

[[Page 9868]]

Constitution Avenue., NW. Washington, DC.
    Docket Number: 09-069. Applicant: University of Pittsburgh, 
Pittsburgh, PA 15260. Instrument: Electron Microscope.
    Manufacturer: JEOL, Ltd., Japan. Intended Use: See notice at 75 FR 
3895, January 25, 2010.
    Docket Number: 09-070. Applicant: Haverford College, Haverford, PA 
19041. Instrument: JEM-1400 Electron Microscope.
    Manufacturer: JEOL Ltd., Japan. Intended Use: See notice at 75 FR 
3895, January 25, 2010.
    Comments: None received. Decision: Approved. No instrument of 
equivalent scientific value to the foreign instrument, for such 
purposes as these instruments are intended to be used, was being 
manufactured in the United States at the time the instruments were 
ordered. Reasons: Each foreign instrument is an electron microscope and 
is intended for research or scientific educational uses requiring an 
electron microscope. We know of no electron microscope, or any other 
instrument suited to these purposes, which was being manufactured in 
the United States at the time of order of each instrument.

    Dated: February 26, 2010.
Christopher Cassel,
Director, Subsidies Enforcement Office, Import Administration.
[FR Doc. 2010-4600 Filed 3-3-10; 8:45 am]
BILLING CODE 3510-DS-P
§ 876.5010 Biliary catheter and accessories. ( a ) *Identification.* A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.
( b ) *Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]
|   |
|---|
|   |  |
| 1 | I have reviewed this report on Form 10-K and all reports on Form 10-D required to be filed in respect of the period covered by this report on Form 10-K of Ally Auto Receivables Trust 2015-1 (the “Exchange Act periodic reports”); |

|   |
|---|
|   |  |
| 2 | Based on my knowledge, the Exchange Act periodic reports, taken as a whole, do not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |

|   |
|---|
|   |  |
| 3 | Based on my knowledge, all of the distribution, servicing and other information required to be provided under Form 10-D for the period covered by this report is included in the Exchange Act periodic reports; |

|   |
|---|
|   |  |
| 4 | Based on my knowledge and the servicer compliance statement required in this report under Item 1123 of Regulation AB, and except as disclosed in the Exchange Act periodic reports, the servicer has fulfilled its obligations under the servicing agreement in all material respects; and |

|   |
|---|
|   |  |
| 5 | All of the reports on assessment of compliance with servicing criteria for asset-backed securities and their related attestation reports on assessment of compliance with servicing criteria for asset-backed securities required to be included in this report in accordance with Item 1122 of Regulation AB and Exchange Act Rules 13a-18 and 15d-18 have been included as an exhibit to this report, except as otherwise disclosed in this report. Any material instances of noncompliance described in such reports have been disclosed in this report on Form 10-K. |

|                                                               |
|---------------------------------------------------------------|
|                                                               |  |
| /s/ Ryan C. Farris                                            |   |
|                                                          |
| Ryan C. Farris                                                |
| President, Ally Auto Assets LLC, as Depositor                 |
| (Senior Officer in charge of securitization of the depositor) |
# C_2019073EN.01000201.xml

| 26.2.2019 | EN | Official Journal of the European Union | C 73/2 |
| --- | --- | --- | --- |

26.2.2019

EN

Official Journal of the European Union

C 73/2

---

COUNCIL DECISION

of 18 February 2019

extending the term of office of the Chairperson of a Board of Appeal of the European Union Intellectual Property Office

(2019/C 73/03)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (1), and in particular Article 166(3) thereof,

Whereas on 20 November 2018, the Management Board of the European Union Intellectual Property Office decided to propose to the Council of the European Union the extension of the term of office of Mr Gordon HUMPHREYS as Chairperson of a Board of Appeal of the European Union Intellectual Property Office for a period of five years, as from 1 September 2019,

HAS ADOPTED THIS DECISION:

Article 1

The term of office of Mr Gordon HUMPHREYS as Chairperson of a Board of Appeal of the European Union Intellectual Property Office is hereby extended from 1 September 2019 to 31 August 2024.

Article 2

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

Done at Brussels, 18 February 2019.

For the Council

The President

N. BĂDĂLĂU

---

(1)  OJ L 154, 16.6.2017, p. 1.

1

---
<PAGE>

                                                                    Exhibit 99.5

             REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the board of directors
of EverQ GmbH, Thalheim (Germany)

We have audited the accompanying balance sheet of EverQ GmbH, Thalheim
(Germany), as of December 31, 2006, and the related income statement, statement
of changes in equity and cash flow statement for the period from December 20 to
December 31, 2006, as well as the notes to these financial statements. These
financial statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audit.

We conducted our audit in accordance with standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provide a reasonable
basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of EverQ GmbH, Thalheim (Germany),
at December 31, 2006, and the results of its operations and its cash flows for
the period from December 20 to December 31, 2006, in conformity with accounting
principles generally accepted in Germany.

Accounting principles generally accepted in Germany vary in certain significant
respects from accounting principles generally accepted in the United States of
America. Information relating to the nature and effect of such differences is
presented in Note 6 to the financial statements.

As discussed in the notes, the financial statements referred to above do not
constitute annual statutory financial statements of EverQ GmbH, Thalheim
(Germany), pursuant to German commercial law. Hence, these financial statements
do not present the results of the Company's operations and its cash flows for
the Company's fiscal year and do not include comparative financial information.

/s/ PricewaterhouseCoopers AG
PricewaterhouseCoopers AG

Leipzig, Germany
February 27, 2007
Exhibit 23.2
 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
  1.
    
    Registration Statement (Form S-8 No. 333-13405) pertaining to the Amended and Restated
Equity Participation Plan of Ambassadors International, Inc.,2.
    
    Registration Statement (Form S-8 No. 333-81023) pertaining to the Amended and Restated
Equity Participation Plan of Ambassadors International, Inc.,3.
    
    Registration Statement (Form S-8 No. 333-104280) pertaining to the Amended and Restated
Equity Participation Plan of Ambassadors International, Inc.,4.
    
    Registration Statement (Form S-8 No. 333-129404) pertaining to the Amended and Restated
Equity Participation Plan of Ambassadors International, Inc.,5.
    
    Registration Statement (Form S-8 No. 333-143958) pertaining to the Amended and Restated
Equity Participation Plan of Ambassadors International, Inc.,6.
    
    Registration Statement (Form S-3/A No. 333-144999) of Ambassadors International, Inc.
pertaining to the registration of 1,734,002 shares of common stock to be issued upon
conversion of the 3.75% Convertible Notes due 2027.
 /s/ ERNST & YOUNG
<TABLE> <S> <C>

<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONDENSED CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS INCLUDED IN THE COMPANY'S
QUARTERLY REPORT ON FORM 10-QSB FOR THE QUARTERLY PERIOD ENDED MARCH 31, 1998
AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
       
<S>                             <C>
<PERIOD-TYPE>                   3-MOS
<FISCAL-YEAR-END>                          DEC-31-1998
<PERIOD-START>                             JAN-01-1998
<PERIOD-END>                               MAR-31-1998
<CASH>                                           81286
<SECURITIES>                                         0
<RECEIVABLES>                                     2241
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                                135814
<PP&E>                                         1397067
<DEPRECIATION>                                  498972
<TOTAL-ASSETS>                                 1102745
<CURRENT-LIABILITIES>                          4040648
<BONDS>                                         131746
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                          9824
<OTHER-SE>                                   (3079473)
<TOTAL-LIABILITY-AND-EQUITY>                   1102745
<SALES>                                           1855
<TOTAL-REVENUES>                                  1855
<CGS>                                           379516
<TOTAL-COSTS>                                   379516
<OTHER-EXPENSES>                                     0
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                               69176
<INCOME-PRETAX>                              (2884844)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                          (2884844)
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                 (2884844)
<EPS-PRIMARY>                                    (.30)
<EPS-DILUTED>                                    (.30)
        

</TABLE>
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EXHIBIT 99.4

REPORT OF INDEPENDENT ACCOUNTANTS

To the Partners of GWF Power Systems L.P.:

In our  opinion,  the  balance  sheets  and the  related  statements  of income,
partners'  equity,  and cash  flows of GWF Power  Systems  L.P.  (not  presented
separately  herein)  present  fairly,  in all material  respects,  the financial
position at December 31, 1998 and 1999,  and the results of its  operations  and
its cash flows for the three years in the period ended  December  31,  1999,  in
conformity with accounting  principles  generally accepted in the United States.
These  financial   statements  are  the   responsibility  of  the  Partnership's
management;  our  responsibility  is to express  an  opinion on these  financial
statements  based on our audits.  We conducted our audits of these statements in
accordance  with auditing  standards  generally  accepted in the United  States,
which require that we plan and perform the audit to obtain reasonable  assurance
about whether the financial  statements  are free of material  misstatement.  An
audit includes examining,  on a test basis,  evidence supporting the amounts and
disclosures in the financial  statements,  assessing the  accounting  principles
used and  significant  estimates made by management,  and evaluating the overall
financial  statement  presentation.   We  believe  that  our  audits  provide  a
reasonable basis for the opinion expressed above.

San Fransisco, California                         /s/ PricewaterhouseCoopers LLP
March 3, 2000