alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
```

                                                                      EXHIBIT 32

                                ORTHOMETRIX, INC.
                          FORM 10-KSB DECEMBER 31, 2005

                            CERTIFICATION PURSUANT TO
                  SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

     In connection with the Annual Report of Orthometrix, Inc., (the "Company"),
on Form 10-KSB for the annual period ended December 31, 2005, as filed with the
Securities and Exchange Commission on the date hereof (the "Report"), the
undersigned, in the capacities and on the date indicated below, hereby certifies
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, that to his knowledge: (1) the Report fully complies
with the requirements of Section 13(a) or 15(d) of the Securities and 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: February 22, 2006                  /s/ Reynald G. Bonmati
                                         --------------------------------------
                                         Reynald G. Bonmati
                                         Chief Executive Officer

Date: February 22, 2006

                                         /s/ Neil H. Koenig
                                         ---------------------------------------
                                         Neil H. Koenig
                                         Chief Financial Officer
```
# C_2019302EN.01000201.xml

| 6.9.2019 | EN | Official Journal of the European Union | C 302/2 |
| --- | --- | --- | --- |

6.9.2019

EN

Official Journal of the European Union

C 302/2

---

COUNCIL DECISION

of 3 September 2019

adopting the Council’s position on draft amending budget No 1 of the European Union for the financial year 2019

(2019/C 302/02)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 314 thereof, in conjunction with the Treaty establishing the European Atomic Energy Community, and in particular Article 106a thereof,

Having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (1), and in particular Article 44 thereof,

Whereas:

| — | the Union’s budget for the financial year 2019 was definitively adopted on 12 December 2018 (2), |
| --- | --- |

—

the Union’s budget for the financial year 2019 was definitively adopted on 12 December 2018 (2),

| — | on 15 April 2019, the Commission submitted a proposal containing draft amending budget No 1 to the general budget for the financial year 2019, |
| --- | --- |

—

on 15 April 2019, the Commission submitted a proposal containing draft amending budget No 1 to the general budget for the financial year 2019,

HAS DECIDED AS FOLLOWS:

Sole Article

The Council’s position on draft amending budget No 1 of the European Union for the financial year 2019 was adopted on 3 September 2019.

The full text can be accessed for consultation or downloading on the Council’s website: http://www.consilium.europa.eu/

Done at Brussels, 3 September 2019.

For the Council

The President

T. TUPPURAINEN

---

(1)  OJ L 193, 30.7.2018, p. 1.

1

(2)  OJ L 67, 7.3.2019, p. 1.

2

---
IN THE SUPREME COURT OF THE STATE OF DELAWARE

JAMES ST. LOUIS,

Defendant Below,

Appellant,

v.

STATE OF DELAWARE,

Plaintiff Below,

Appellee.

§

§

§ No. 160, 2019

§

§ Court Below—Superior Court

§ of the State of Delaware

§ 

§ Cr. ID No. 0009015005 (S)

§

§

§

Submitted: June 13, 2019

Decided: June 18, 2019

ORDER

Following the denial of his motion to proceed in forma pauperis on May 28, 

2019, the appellant was directed to pay the Court’s filing fee by June 12, 2019, or 

else his appeal would be dismissed without further notice. The appellant has not 

paid the filing fee. The dismissal of this appeal is therefore deemed to be unopposed.

NOW, THEREFORE, IT IS ORDERED, under Supreme Court Rules 3(b)(2)

and 29(b), that this petition is DISMISSED.

BY THE COURT:

/s/ Karen L. Valihura

Justice
#### In re Application of Mary V. McCarthy for Admission to the Bar

*George D. Stoughton,*for the appellee (standing committee for Hartford County on recommendations for admission to the bar).

*Joseph D. Harbaugh,*for the appellant (the applicant).

Argued June 3

decided June 3, 1969

The motion by the Standing Committee for Hartford Connty on Recommendations for Admission to the Bar to dismiss the appeal from the Superior Court in Hartford County is granted.
###### Editorial Note on Part 314

#### Editorial Note:

Nomenclature changes to part 314 appear at 69 FR 13717, Mar. 24, 2004; 81 FR 69639, Oct. 6, 2016.

#### § 314.500 Scope.

This subpart applies to certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy).

[57 FR 58958, Dec. 11, 1992, as amended at 64 FR 402, Jan. 5, 1999]
§ 529.2464 Ticarcillin. ( a ) *Specifications.* Each vial contains ticarcillin disodium powder equivalent to 6 grams of ticarcillin for reconstitution with 25 milliliters of sterile water for injection or sterile physiological saline.
( b ) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.
( c ) *Conditions of use in horses* — ( 1 ) *Amount.* Administer 6 grams daily by intrauterine infusion for 3 consecutive days during estrus.
( 2 ) *Indications for use.* For the treatment of endometritis caused by beta-hemolytic streptococci.
( 3 ) *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.
[79 FR 10974, Feb. 27, 2014]
§ 582.1711 Silica aerogel. ( a ) *Product.* Silica aerogel as a finely powdered microcellular silica foam having a minimum silica content of 89.5 percent.
( b ) [Reserved]
( c ) *Limitations, restrictions, or explanation.* This substance is generally recognized as safe when used as a component of antifoaming agents in accordance with good manufacturing or feeding practice.
§ 26.14 Transmission of preapproval inspection reports. ( a ) A preliminary notification that an inspection may have to take place will be made as soon as possible.
( b ) Within 15-calendar days, the relevant authority will acknowledge receipt of the request and confirm its ability to carry out the inspection. In the European Community (EC), requests will be sent directly to the relevant authority, with a copy to the European Agency for the Evaluation of Medicinal Products (EMEA). If the authority receiving the request cannot carry out the inspection as requested, the requesting authority shall have the right to conduct the inspection.
( c ) Reports of preapproval inspections will be sent within 45-calendar days of the request that transmitted the appropriate information and detailed the precise issues to be addressed during the inspection. A shorter time may be necessary in exceptional cases and these will be described in the request.
‘PCOMM-NWE4LTHojVIRG4WIADEPARTMENTOFEM’IROJJMENTALQUALiTYS6eetaddress:629EastMã’Stt;RiêhñiUñd,Viiiii23219DouglasW.DomenechMailingaddress:P.O.Box1105,Richmond,Virginia23218DavidK.PaylorSecretaryofNaturalResourcesTDD(804)6984021Directorwww:deq.virginia:gov(8)69840001-800-592-5482lIAR04ZO11Ms.DianaEsher,DirectorAirProtectionDivision(3APOO)U.S.EnvironmentalProtectionAgency,Regionifi1650ArchStreetPhiladelphia,Pennsylvania19103-2029Reference:AmbientAirQualityStandards,NitrogenOxides,RevisionAlODearMs.Esher:Pursuanttotherequirementsof§110oftheCleanAirAct,weareofficiallyrequestingapprovalofarevisiontotheCommonwealthofVirginiaStateImplementationPlanapprovedandsubmittedundertheauthorityof*10.1-1185oftheCodeofVirginiaandinaccordancewiththerequirementsof40CFRPart51(RequirementsforPreparation,Adoption,andSubmittalofImplementationPlans).Thisrevisionconsistsofaregulation(9VAC5Chapter30)thatcontainstheambientairqualitystandardssetoutin40CFRPart50.Thisactionaddedanewprimary1-hourstandardfornitrogenoxides(NOx)measuredasnitrogendioxide(NO2)at100ppb.Inaddition,theListofappendicesto40CFRPart51wasupdatedunderdocumentsincorporatedbyreference,9VAC5-20-21.TheregulationamendmentswereadoptedbytheStateAirPollutionControlBoardonJune4,2010undertheauthorityof§10.1-1308oftheCodeofVirginia.Enclosedarethefollowing:1.Atruecopyoftheofficialregulation(RevisionAlO)whichwaspublishedintheVirginiaRegisteronJuly19,2010afterbeingdulyadoptedbytheStateAirPollutionControlBoardonJune4,2010,certifiedbytheOfficeoftheAttorneyGeneralaswithintheboard’sstatutoryauthorityonJune17,2010,andthusfullyenforceableunderVirginialaw,andsubmittedtotheVirginiaRegistraronbehalfoftheboardbytheDepartmentofEnvironmentalQualityasatrueandaccuratecopyofthedulyadoptedregulationonJune27,2010,providingtheevidencerequiredbySecti&i2.1(b)and(e)ofAppendix.Vöf4(Y’CFRPart51.2.Certificationofpublicparticipationactivitiesandconiplianqewithstateadministrativeprocedures.3.Publicparticipationrecord.Ifyouhaveanyquestionsorneedadditionalinformation,pleaseletusknow;Sinly,/DavidK.PaylorDKPkgsTEMPLATES\SIP-REO\RBGOOSIPNONATTNAREAS\2011\A1O-SIP.DOCEnclosures
§ 524.1005 Furazolidone powder. ( a ) *Specifications.* The product contains either 4 or 10 percent furazolidone in inert dispersing agent and propellant.
( b ) *Sponsors.* ( 1 ) See No. 051031 in § 510.600(c) of this chapter for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii), and (c)(3) of this section.
( 2 ) See No. 017135 for use of the 4 percent product as in paragraph (c)(2)(iv) of this section.
( c ) *Conditions of use* — ( 1 ) *Amount.* Hold container about 6 to 12 inches from the eye or affected area and apply only enough powder to impart a light yellow color.
( 2 ) *Indications of use* — ( i ) *Dogs.* For treatment or prevention of bacterial infection of superficial wounds, abrasions, lacerations, and pyogenic dermatitis.
( ii ) *Horses.* For treatment or prevention of bacterial infection of superficial wounds, abrasions, lacerations, and following firing (heat or electrocautery).
( iii ) [Reserved]
( iv ) *Horses and ponies.* For treatment or prevention of bacterial infection of superficial wounds, abrasions, and lacerations caused by *Staphylococcus aureus, Streptococcus spp.* and *Proteus spp.* sensitive to furazolidone.
( 3 ) *Limitations.* For topical application in horses, ponies, and dogs: Clean affected area thoroughly, apply drug once or twice daily, and repeat treatment as required. Use only as recommended by a veterinarian in treatment of puncture wounds, wounds requiring surgical debridement or suturing, those of a chronic nature involving proud flesh, generalized and chronic infections of the skin, and those skin conditions associated with intense itching. If redness, irritation, or swelling persists or increases, discontinue use and consult a veterinarian. Do not use in horses intended for human consumption.
[45 FR 49543, July 25, 1980, as amended at 50 FR 30153, July 24, 1985; 56 FR 50653, Oct. 8, 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, Nov. 2, 1995; 65 FR 41588, July 6, 2000; 79 FR 10969, Feb. 27, 2014; 82 FR 11508, Feb. 24, 2017]
#### § 21.75 Rights of legal guardians.

For the purposes of this part, the parent of any individual who is a minor or the legal guardian of any individual who has been declared to be incompetent due to physical or mental incapacity or age by a court of competent jurisdiction may act on behalf of the individual.
<PAGE>
                                                                    Exhibit 10.4

                       CONSENT OF INDEPENDENT ACCOUNTANTS

We hereby consent to the incorporation by reference in the Registration
Statements (Forms F-3 No. 333-12096, No. 333-13550 and No. 333-84510) of
Deutsche Telekom AG of our report dated April 30, 2001, relating to the
financial statements of DT-FT Italian Holding GmbH, which appears in this
Annual Report on Form 20-F/A.

June 26, 2003



PwC Deutsche Revision
Aktiengesellschaft
Wirtschaftspruefungsgesellschaft
Frankfurt am Main



(Laue)                                         (Kuetting)
Wirtschaftspruefer                             Wirtschaftspruefer
§ 522.1055 Gleptoferron. ( a ) *Specifications.* Each milliliter (mL) contains the equivalent of 200 milligrams of elemental iron as gleptoferron, a complex of ferric hydroxide and dextran glucoheptonic acid.
( b ) *Sponsors.* See No. 013744 in § 510.600(c) of this chapter.
( c ) *Conditions of use in swine* — ( 1 ) *Indications for use and amounts.* ( i ) Prevention of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection on or before 3 days of age.
( ii ) Treatment of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection as soon as signs of deficiency appear.
( 2 ) [Reserved]
[81 FR 59134, Aug. 29, 2016, as amended at 82 FR 11508, Feb. 24, 2017; 82 FR 21690, May 10, 2017]
# L_2019262EN.01006601.xml

| 15.10.2019 | EN | Official Journal of the European Union | L 262/66 |
| --- | --- | --- | --- |

15.10.2019

EN

Official Journal of the European Union

L 262/66

---

COUNCIL DECISION (CFSP) 2019/1722

of 14 October 2019

amending Decision (CFSP) 2018/1544 concerning restrictive measures against the proliferation and use of chemical weapons

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

Having regard to Council Decision (CFSP) 2018/1544 of 15 October 2018 concerning restrictive measures against the proliferation and use of chemical weapons (1),

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

| (1) | On 15 October 2018, the Council adopted Decision (CFSP) 2018/1544. |
| --- | --- |

(1)

On 15 October 2018, the Council adopted Decision (CFSP) 2018/1544.

| (2) | Decision (CFSP) 2018/1544 applies until 16 October 2019. On the basis of a review of that Decision, the restrictive measures set out therein should be extended until 16 October 2020. |
| --- | --- |

(2)

Decision (CFSP) 2018/1544 applies until 16 October 2019. On the basis of a review of that Decision, the restrictive measures set out therein should be extended until 16 October 2020.

| (3) | Decision (CFSP) 2018/1544 should therefore be amended accordingly, |
| --- | --- |

(3)

Decision (CFSP) 2018/1544 should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Article 8 of Decision (CFSP) 2018/1544 is replaced by the following:

‘
  Article 8

This Decision shall apply until 16 October 2020. This Decision shall be kept under constant review. It shall be renewed, or amended as appropriate, if the Council deems that its objectives have not been met.’.

Article 2

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

Done at Luxembourg, 14 October 2019.

For the Council

The President

F. MOGHERINI

---

(1)  
  OJ L 259, 16.10.2018, p. 25.

1

---
§ 582.1155 Bentonite. ( a ) *Product.* Bentonite.
( b ) *Conditions of use.* This substance is generally recognized as safe when used in accordance with good manufacturing or feeding practice.
#### People of the State of Illinois, Plaintiff-Appellee, v. Lawrence Butler, Defendant-Appellant.

Gen. No. 52,767. (Abstract of Decision.)

First District, Second Division.

April 22, 1969.

Gerald W. Getty, Public Defender of Cook County, of Chicago (John E. Hughes and James J. Doherty, Assistant Public Defenders, of counsel), for appellant;

Edward V. Hanrahan, State’s Attorney of Cook County, of Chicago (Elmer C. Kissane and Gerald T. Rohrer, Assistant State’s Attorneys, of counsel), for appellee.

Opinion by

JUSTICE McCORMICK.

Not to be published in full.
INITIAL REVIEW ENGINEERING REPORT PMN: 04-0144

ENGINEER: Arnold / AMO PV (kg/yr):

SUBMITTER:

USE:

OTHER USES:

MSDS: Label:

General Eqp.: Respirator: Health Effects: TLV/PEL (PMN or raw materials):INITIAL REVIEW ENGINEERING REPORT PMN: 04-0144

CRSS (12/08/2003): Chemical Category:

VP: S-H 2 O: MW: Phys State:

Consumer Use:

SAT (12/09/2003): Related cases: Ground Water: Health:

Eco: PBT:

OCCUPATIONAL EXPOSURE RATING:INITIAL REVIEW ENGINEERING REPORT PMN: 04-0144

ASSUMPTIONS:

POLLUTION PREVENTION CONSIDERATIONS:INITIAL REVIEW ENGINEERING REPORT PMN: 04-0144

Site/Location: Days/yr:

Process Description:

ENVIRONMENTAL RELEASES (Eqpt. cleaning, container residue, etc.):

WATER: from:

to: basis:

OCCUPATIONAL EXPOSURE Tot. # of workers: Days/yr:

Inhalation: Basis:

Dermal: contact with liquids: Basis:
Exhibit 23.4

CONSENT OF INDEPENDENT ACCOUNTANTS

We hereby consent to the use in this Registration  Statement on Form S-4 of PSEG
Energy Holdings Inc. of our report dated March 3, 2000 relating to the financial
statements  of GWF Power  Systems,  L.P.,  which  appears  in such  Registration
Statement.  We also consent to the reference to us under the headings  "Experts"
in such Registration Statement.

San Francisco, California                         /s/ PricewaterhouseCoopers LLP
August 31, 2000
* Pursuant to Local Rule 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 Local Rule 47.5.4.

IN THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

 

No. 96-30572

Summary Calendar

 

LIONELL J. DAVIS, 

Plaintiff-Appellant,

versus,

RICHARD L. STALDER; C. MARTIN LENSING, Warden;

C. DAVID RAGLAND; C. SCROPSHIRE, LT.,

Defendants-Appellees.

- - - - - - - - - -

Appeal from the United States District Court

for the Middle District of Louisiana

USDC No. 95-CV-2024

- - - - - - - - - -

October 3, 1996

Before DAVIS, EMILIO M. GARZA and STEWART, Circuit Judges.

PER CURIAM:*

Because Lionell J. Davis (#118554) makes no argument that

challenges the district court’s dismissal of his civil-rights

action, his motion for leave to proceed in forma pauperis (“IFP”)

on appeal is DENIED. See Carson v. Polley, 689 F.2d 562, 586

(5th Cir. 1982). Because only Davis signed the notice of appeal,

he is the only appellant moving for IFP. Carter v. Stalder, 60

F.3d 238, 239 (5th Cir. 1995). The appeal is DISMISSED. See 5th

Cir. R. 42.2. 
No. 96-30572

- 2 -

IFP DENIED; APPEAL DISMISSED.
```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7384 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                                H. R. 7384

    To amend the Federal Food, Drug, and Cosmetic Act to extend the 
   authority of the Secretary of Health and Human Services to issue 
  priority review vouchers to encourage treatments for rare pediatric 
                               diseases.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           February 15, 2024

 Mr. McCaul (for himself, Ms. Eshoo, Mr. Bilirakis, Ms. Barragan, Mrs. 
   Trahan, and Mr. Burgess) introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
    To amend the Federal Food, Drug, and Cosmetic Act to extend the 
   authority of the Secretary of Health and Human Services to issue 
  priority review vouchers to encourage treatments for rare pediatric 
                               diseases.

    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 ``Creating Hope Reauthorization Act of 
2024''.

SEC. 2. EXTENSION OF AUTHORITY TO ISSUE PRIORITY REVIEW VOUCHERS TO 
              ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES.

    Section 529(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360ff(b)(5)) is amended--
            (1) by striking ``September 30, 2024'' each place it 
        appears and inserting ``September 30, 2028''; and
            (2) in subparagraph (B), by striking ``September 30, 2026'' 
        and inserting ``September 30, 2030''.
                                 <all>
```
ORDER EXTENDING TIME TO FILE APPELLANT ’ S OPENING BRIEF 1 SUPREME COURT OF THE STATE OF MONTANA

CASE NO. DA 24

- 0 4 22

STEVEN CORRY STEPHENSON, as trustee of the Steven Corry Stephenson
Trust amended and reinstated September 20, 2000

,

Appellant

vs.

LONE PEAK PRESERVE, LLC,

Appellee.

ORDER EXTENDING TIME TO FILE APPELLANT’S OPENING BRIEF

On Appeal from the Montana Eighteenth Judicial District, Gallatin County

Cause No. DV 16

- 2021

- 0001297

- DK

Before Hon. John C. Brown

Appearances:

Michael L. Rabb (#13734)

THE RABB LAW FIRM, PLLC 3950 Valley Commons Drive, Suite 1

Bozeman, MT 59718 Telephone: (406) 404

- 1747 Facsimile: (406) 551

- 6847 service@therabblawfirm.com
Attorney for Appellant Kelsey Bunkers

CROWLEY FLECK PLLP

1915 S. 19 th Avenue

P.O. Box 10969

Bozeman, MT 59719

- 10969 Telephone: 406

- 556

- 1430 kbunkers@crowleyfleck.com
Attorney for Appellee 09/25/2024

Case Number: DA 24-0422ORDER EXTENDING TIME TO FILE APPELLANT ’ S OPENING BRIEF 2 Appell ant Steven Corry Stephenson having filed a n U nopposed Motion for Extension of

Time to File Appellant’s Opening Brief, and good cause appearing therefrom,

IT IS HEREBY OR D ERED that Appell ant ’s Motion is GRANTED. Appell ant ’s Opening

Brief shall be filed on or before October 29, 2024

.

Electronically signed by:

Bowen Greenwood Clerk of the Supreme Court September 25 2024
#### § 357.280 Professional labeling.

The labeling provided to health professionals (but not to the general public) may contain the following information for ingredients identified in § 357.210: *Indication.* “For visualization of biliary ducts during cholecystography.”

[54 FR 8321, Feb. 28, 1989]
§ 516.163 Change in ownership of an index file. ( a ) A holder may transfer ownership of a drug's index file to another person. ( 1 ) The former owner shall submit in writing to FDA a statement that all rights in the index file have been transferred, giving the name and address of the new owner and the date of the transfer. The former owner shall also certify that a complete copy of the following, to the extent that they exist at the time of the transfer of ownership, has been provided to the new owner: ( i ) The request for determination of eligibility;
( ii ) The request for addition to the index;
( iii ) Any modifications to the index listing;
( iv ) Any records and reports under § 516.165; and
( v ) All correspondence with FDA relevant to the indexed drug and its index listing.
( 2 ) The new owner shall submit the following information in writing to FDA: ( i ) The date that the change in ownership is effective;
( ii ) A statement that the new owner has a complete copy of all documents listed in paragraph (a)(1) of this section to the extent that they exist at the time of the transfer of ownership;
( iii ) A statement that the new owner understands and accepts the responsibilities of a holder of an indexed drug;
( iv ) The name and address of a new primary contact person or permanent-resident U.S. agent; and
( v ) A list of labeling changes associated with the change of ownership (e.g., a new trade name) as draft labeling, with complete final printed labeling to be submitted in the indexed drug annual report in accordance with §§ 516.161 and 516.165.
( b ) Upon receiving the necessary information to support a change of ownership of a drug's index file, FDA will update its publicly-available listing in accordance with § 516.157.