alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
# C_2023179EN.01006001.xml

| 22.5.2023 | EN | Official Journal of the European Union | C 179/60 |
| --- | --- | --- | --- |

22.5.2023

EN

Official Journal of the European Union

C 179/60

---

Action brought on 10 March 2023 — Biogen Netherlands v Commission

(Case T-137/23)

(2023/C 179/85)

Language of the case: English

Parties

Applicant: Biogen Netherlands BV (Badhoevedorp, Netherlands) (represented by: C. Schoonderbeek, lawyer)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

| — | annul the decision of the European Commission of 12 December 2022 C(2022) 9544 (final) granting marketing authorisation under Regulation (EC) No 726/2004 (1) for ‘Dimethyl Fumarate Teva — dimethyl fumarate’, a medicinal product for human use; and |
| --- | --- |

—

annul the decision of the European Commission of 12 December 2022 C(2022) 9544 (final) granting marketing authorisation under Regulation (EC) No 726/2004 (1) for ‘Dimethyl Fumarate Teva — dimethyl fumarate’, a medicinal product for human use; and

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

—

order the Commission to pay the costs.

Pleas in law and main arguments

In support of the action, the applicant relies on two pleas in law.

| 1. | First plea in law, alleging failure to observe the system of Directive 2001/83/EC (2) in relation to the rules on regulatory data protection, including Article 6(1) of that Directive, and the obligations of generic applicants under Article 10(1) of that Directive. |
| --- | --- |

1.

First plea in law, alleging failure to observe the system of Directive 2001/83/EC (2) in relation to the rules on regulatory data protection, including Article 6(1) of that Directive, and the obligations of generic applicants under Article 10(1) of that Directive.

| 2. | Second plea in law, alleging failure to recognise the consequences of the Opinion of the Committee for Medicinal Products for Human Use of 11 November 2021 for the question whether the marketing authorisation for the medicinal product Fumaderm was capable of commencing a global marketing authorisation for the medicinal product Tecfidera in accordance with Article 6(1), second subparagraph, of Directive 2001/83/EC. |
| --- | --- |

2.

Second plea in law, alleging failure to recognise the consequences of the Opinion of the Committee for Medicinal Products for Human Use of 11 November 2021 for the question whether the marketing authorisation for the medicinal product Fumaderm was capable of commencing a global marketing authorisation for the medicinal product Tecfidera in accordance with Article 6(1), second subparagraph, of Directive 2001/83/EC.

---

(1)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004, L 136, p. 1).

(2)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001, L 311, p. 67).

---
[Federal Register Volume 70, Number 168 (Wednesday, August 31, 2005)]
[Notices]
[Page 51824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17345]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Committee on Vital and Health Statistics: Meeting

    Pursuant to the Federal Advisory Committee Act, the Department of 
Health and Human Services (HHS) announces the following advisory 
committee meeting.

    Name: National Committee on Vital and Health Statistics (NCVHS), 
Subcommittee on Standards and Security (SSS).
    Time and Date: September 21, 2005: 9 a.m.-5 p.m.; September 22, 
2005: 8:30 a.m.-12 p.m.
    Place: Hubert H. Humphrey Building, 200 Independence Avenue SW., 
Room 705A, Washington, DC 20201.
    Status: Open.
    Purpose: On the first day the Subcommittee will focus on two 
topics: introductory discussions of the issues surrounding matching 
patients with their records, and then continued explorations into 
issues around HIPAA Return on Investment (ROI). The second day open 
with an overview of the e-prescribing pilots required under Medicare 
Modernization Act (MMA) and will move to continued discussions on 
the secondary use of clinical data.
    Contact Person for More Information: Substantive program 
information as well as summaries of meetings and a roster of 
Committee members may be obtained from Maria Friedman, Health 
Insurance Specialist, Security and Standards Group, Centers for 
Medicare and Medicaid Services, MS: C5-24-04, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, telephone: 410-786-6333 or 
Marjorie S. Greenberg, Executive Secretary, NCVHS, National Center 
for Health Statistics, Centers for Disease Control and Prevention, 
Room 1100, Presidential Building, 3311 Toledo Road, Hyattsville, 
Maryland 20782, telephone: (301) 458-4245. Information also is 
available on the NCVHS home page of the HHS Web site: http://www.nevhs.hhs.gov/ where an agenda for the meeting will be posted 
when available.
    Should you require reasonable accommodation, please contact the 
CDC Office of Equal Employment Opportunity on (301) 458-3EEO (4336) 
as soon as possible.

    Dated: August 23, 2005.
James Scanlon,
Acting Deputy Assistant Secretary for Science and Data Policy, Office 
of the Assistant Secretary for Planning and Evaluation.
[FR Doc. 05-17345 Filed 8-30-05; 8:45 am]
BILLING CODE 4151-05-M
Exhibit 32.1

                            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 CharterMac (the "Company") on Form
10-K/A for the year ending December 31, 2003, as filed with the Securities and
Exchange Commission on the date hereof (the "Report"), I, Stuart J. Boesky,
Chief Executive 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:

(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.

By: /s/ Stuart J. Boesky
    --------------------
    Stuart J. Boesky
    Chief Executive Officer
    May 7, 2004
STATE v. EVANS

No. COA07-19.

Court of Appeals of North Carolina.

Filed June 19, 2007

Certification Date July 9, 2007.

Appeal from Lincoln (02CRS50598).

Case reported without published opinion. No error.
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.                  

###### Environmental Protection Agency

          - [FRL-7965-5] 

# AGENCY:

Environmental Protection Agency. 

# ACTION:

Notice of charter renewal. 

The Charter for the Environmental Protection Agency's (EPA) National Environmental Justice Advisory Council (NEJAC) will be renewed for an a one-year period, in accordance with the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. App. II § 9(c). The purpose of the NEJAC is to provide independent advice and recommendations to the Administrator on areas relating to environmental justice. 

EPA has determined that the NEJAC is in the public interest and supports the Agency in performing its duties and responsibilities. 

Inquiries may be directed to Charles Lee, NEJAC Designated Federal Officer, U.S. EPA, (mail code 2201A), 1200 Pennsylvania Avenue, NW, Washington, DC 20460. 

Dated: September 1, 2005. 

Barry E. Hill, 

Director, Office of Environmental Justice, Office of Enforcement and Compliance Assurance. 

[FR Doc. 05-17817 Filed 9-7-05; 8:45 am] 

BILLING CODE 6560-50-P
# C_2023127EN.01005501.xml

| 11.4.2023 | EN | Official Journal of the European Union | C 127/55 |
| --- | --- | --- | --- |

11.4.2023

EN

Official Journal of the European Union

C 127/55

---

Action brought on 20 February 2023 — Boshab v Council

(Case T-89/23)

(2023/C 127/67)

Language of the case: French

Parties

Applicant: Evariste Boshab (Kinshasa, Democratic Republic of the Congo) (represented by: T. Bontinck, P. De Wolf and A. Guillerme, lawyers)

Defendant: Council of the European Union

Form of order sought

The applicant claims that the Court should:

| — | annul Council Decision (CFSP) 2022/2412 of 8 December 2022, (1) in so far as the applicant remains at No 5 in the annex to that decision; |
| --- | --- |

—

annul Council Decision (CFSP) 2022/2412 of 8 December 2022, (1) in so far as the applicant remains at No 5 in the annex to that decision;

| — | annul Council Implementing Regulation (EU) 2022/2401 of 8 December 2022, (2) in so far as the applicant remains at No 5 in Annex I to that regulation; |
| --- | --- |

—

annul Council Implementing Regulation (EU) 2022/2401 of 8 December 2022, (2) in so far as the applicant remains at No 5 in Annex I to that regulation;

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

—

order the Council to pay the costs.

Pleas in law and main arguments

In support of the action, the applicant relies on two pleas in law, which are, in essence, identical or similar to those relied on in Case T-88/23, Kande Mupompa v Council.

---

(1)  Council Decision (CFSP) 2022/2412 of 8 December 2022 amending Decision 2010/788/CFSP concerning restrictive measures in view of the situation in the Democratic Republic of the Congo (OJ 2022 L 317, p. 122).

(2)  Council Implementing Regulation (EU) 2022/2401 of 8 December 2022 implementing Article 9 of Regulation (EC) No 1183/2005 concerning restrictive measures in view of the situation in the Democratic Republic of the Congo (OJ 2022 L 317, p. 32).

---
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<CASH>                                           1,315
<SECURITIES>                                         0
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1 Distr ict Judge of the Eastern District of Louisiana,

sitting by designation.

2 Pursuant to 5 TH C IR

. 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 5 TH C IR

. R. 47.5.4. UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

No. 99-21049

UNITED STATES OF AMERICA,

Plaintiff-Appellee,

versus

ALTON DANE HUDNALL,

Defendant-Appellant.

Appeal from the United States District Court

for the Southern District of Texas

(H-97-CR-262-3)

May 14, 2001

Before POLITZ and BARKSDALE, Circuit Judges, and FALLON, 1 District

Judge.

PER CURIAM: 2

Having considered the briefs and pertinent parts of the

record, and the arguments of counsel, the district court did not

abuse i ts discretion regarding the submission of the evidence at

issue nor did it clearly err in enhancing the sentence for abuse ofa position of trust pursuant to § 3B1.3 of the Sentencing

Guidelines.

AFFIRMED
# Commission Implementing Regulation (EU) No 1020/2014Show full title

Commission Implementing Regulation (EU) No 1020/2014 of 25 September 2014 entering a name in the register of protected designations            of origin and protected geographical indications (Българско розово масло (Bulgarsko rozovo maslo) (PGI))         

        - Previous
        - Next

U.K.

# Commission Implementing Regulation (EU) No 1020/2014                     

# of 25 September 2014

# entering a name in the register of protected designations of origin and protected geographical indications (Българско розово                        масло (Bulgarsko rozovo maslo) (PGI))                     

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality                           schemes for agricultural products and foodstuffs(1), and in particular Article 52(2) thereof,                        

Whereas:

(1)Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Bulgaria's application to register the name ‘Българско розово                              масло’ (Bulgarsko rozovo maslo), was published in the *Official Journal of the European Union* (2).

(2)As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name                              ‘Българско розово масло’ (Bulgarsko rozovo maslo) should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

# Article 1U.K.

The name ‘Българско розово масло’ (Bulgarsko rozovo maslo) (PGI) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 2.10 essential oils, as listed in Annex XI to Commission                     Implementing Regulation (EU) No 668/2014(3).                  

# Article 2U.K.

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

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

Done at Brussels, 25 September 2014.

*For the Commission,*                            

*On behalf of the President,*                            

Neven Mimica                            

*Member of the Commission*                            

1

OJ L 343, 14.12.2012, p. 1.                           

2

OJ C 122, 25.4.2014, p. 12.                           

3

Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU)                              No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).
# Commission Regulation (EU) No 1017/2014Show full title

Commission Regulation (EU) No 1017/2014 of 24 September 2014 establishing a prohibition of fishing for roundnose grenadier            in EU and international waters of VIII, IX, X, XII and XIV by vessels flying the flag of Ireland         

        - Previous
        - Next

U.K.

# Commission Regulation (EU) No 1017/2014                     

# of 24 September 2014

# establishing a prohibition of fishing for roundnose grenadier in EU and international waters of VIII, IX, X, XII and XIV by                        vessels flying the flag of Ireland                     

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring                           compliance with the rules of the common fisheries policy(1), and in particular Article 36(2) thereof,                        

Whereas:

(1)Council Regulation (EU) No 1262/2012(2) lays down quotas for 2014.

(2)According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation                              by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for                              2014.

(3)It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

## Article 1U.K.Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein                     for 2014 shall be deemed to be exhausted from the date set out in that Annex.                  

## Article 2U.K.Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in                     the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited                     to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.                  

## Article 3U.K.Entry into force

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

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

Done at Brussels, 24 September 2014.

*For the Commission,*                            

*On behalf of the President,*                            

Lowri Evans                            

*Director-General for Maritime Affairs and Fisheries*                            

## ANNEXU.K.

1

OJ L 343, 22.12.2009, p. 1.                           

2

Council Regulation (EU) No 1262/2012 of 20 December 2012 fixing for 2013 and 2014 the fishing opportunities for EU vessels                              for certain deep-sea fish stocks (OJ L 356, 22.12.2012, p. 22).
<TABLE> <S> <C>


<ARTICLE> 5

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<PERIOD-TYPE>                                 3-MOS
<FISCAL-YEAR-END>                          DEC-31-2000
<PERIOD-END>                               MAR-31-2000
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<SECURITIES>                                   697,245
<RECEIVABLES>                                  283,075
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                             4,856,707
<PP&E>                                       7,479,374
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<TOTAL-REVENUES>                               179,228
<CGS>                                            6,004
<TOTAL-COSTS>                                    6,004
<OTHER-EXPENSES>                               361,046
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                              (187,822)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                                  0
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                 (187,822)
<EPS-BASIC>                                    (.04)
<EPS-DILUTED>                                    (.05)


</TABLE>
IN RE A.H.

No. COA08-18.

Court of Appeals of North Carolina.

Filed May 6, 2008.

Certification Date May 27, 2008.

Appeal from Transylvania (01J46, 01J47, 07JA44).

Case reported without published opinion. Affirmed.
UN PUBLISHED
UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 18
- 1315

BURL ANDERSON HOWELL; ALICE ANNETTE HOWELL , Plaintiffs

- Appellants ,

v. GEORGE A. WOOD, County Manager for the Wayne County NC Department of Social Services (WCNCDSS) in his managerial capacity for injunctive relief; RESEE PHELPS, Income Maintenance Supervisor for WCNCDSS sued in her individual and official capacities for monetary and equitable relief; LOU JONES, Case Worker for WCNCDSS sued directly in her in dividual for same; EDWARD S. FELTMAN, State Hearing Officer for WCNCDSS in his individual capacity; MANDY COHEN, Secretary of North Carolina Department of Health and Human Services sued in her official capacity for declaratory relief , Defendants

- Appe llees

.

Appeal from the United States District Court for the Eastern District of North Carolina , at Raleigh

. Terrence W. Boyle , District Judge. ( 5:17

- cv
- 00093

- BO )

Submitted : July 17, 2018 Decided: July 20, 2018

Before WILKINSON, DUNCAN, and AGEE , Circuit Judges.

Affirmed by un published per curiam opinion

.
Burl Anderson Howell, Alice A. Howell, Appellants Pro Se. Scott Christopher Hart, SUMRELL, SUGG, CARMICHAEL, HICKS & HART, PA, New Bern, North Carolina,2 for Appellees.

Unpublished o pinions are not binding precedent in this circuit.3 PER CURIAM:
Burl Anderson Howell and Alice Annette Howell appeal the district court’s order s denying their motions, granting Defendants’ motions, and dismissing their 42 U.S.C. § 1983 (2012) complaint. We have reviewed the record and find no reversible error. Accordingly, we affirm for the reasons stated by the district court. See Howell v. Wood , No. 5:17

- cv
- 00093

- BO (E.D.N.C. Mar. 16, 2018; Dec. 21, 2017; filed Sept. 9, 2017, entered Sept. 11, 2017). 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.

AFFIRMED