alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
§ 814.47 Temporary suspension of approval of a PMA. ( a ) *Scope.* ( 1 ) This section describes the procedures that FDA will follow in exercising its authority under section 515(e)(3) of the act (21 U.S.C. 360e(e)(3)). This authority applies to the original PMA, as well as any PMA supplement(s), for a medical device.
( 2 ) FDA will issue an order temporarily suspending approval of a PMA if FDA determines that there is a reasonable probability that continued distribution of the device would cause serious, adverse health consequences or death.
( b ) *Regulatory hearing.* ( 1 ) If FDA believes that there is a reasonable probability that the continued distribution of a device subject to an approved PMA would cause serious, adverse health consequences or death, FDA may initiate and conduct a regulatory hearing to determine whether to issue an order temporarily suspending approval of the PMA.
( 2 ) Any regulatory hearing to determine whether to issue an order temporarily suspending approval of a PMA shall be initiated and conducted by FDA pursuant to part 16 of this chapter. If FDA believes that immediate action to remove a dangerous device from the market is necessary to protect the public health, the agency may, in accordance with § 16.60(h) of this chapter, waive, suspend, or modify any part 16 procedure pursuant to § 10.19 of this chapter.
( 3 ) FDA shall deem the PMA holder's failure to request a hearing within the timeframe specified by FDA in the notice of opportunity for hearing to be a waiver.
( c ) *Temporary suspension order.* If the PMA holder does not request a regulatory hearing or if, after the hearing, and after consideration of the administrative record of the hearing, FDA determines that there is a reasonable probability that the continued distribution of a device under an approved PMA would cause serious, adverse health consequences or death, the agency shall, under the authority of section 515(e)(3) of the act, issue an order to the PMA holder temporarily suspending approval of the PMA.
( d ) *Permanent withdrawal of approval of the PMA.* If FDA issues an order temporarily suspending approval of a PMA, the agency shall proceed expeditiously, but within 60 days, to hold a hearing on whether to permanently withdraw approval of the PMA in accordance with section 515(e)(1) of the act and the procedures set out in § 814.46.
[61 FR 15190, Apr. 5, 1996]
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.1118 Biotinidase test system. ( a ) *Identification.* The biotinidase test system is an in vitro diagnostic device intended to measure the activity of the enzyme biotinidase in blood. Measurements of biotinidase are used in the treatment and diagnosis of biotinidase deficiency, an inborn error of metabolism in infants, characterized by the inability to utilize dietary protein bound vitamin or to recycle endogenous biotin. The deficiency may result in irreversible neurological impairment.
( b ) *Classification.* Class II (special controls). The special control is sale, distribution, and use in accordance with the prescription device requirements in § 801.109 of this chapter.
[65 FR 16521, Mar. 29, 2000]
Editorial Note on Part 864
Editorial Note: Nomenclature changes to part 864 appear at 73 FR 35341, June 23, 2008.

§ 864.9125 Vacuum-assisted blood collection system. ( a ) *Identification.* A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.
( b ) *Classification.* Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
[45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]
§ 601.50 Confidentiality of data and information in an investigational new drug notice for a biological product. ( a ) The existence of an IND notice for a biological product will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged.
( b ) The availability for public disclosure of all data and information in an IND file for a biological product shall be handled in accordance with the provisions established in § 601.51.
( c ) Notwithstanding the provisions of § 601.51, the Food and Drug Administration shall disclose upon request to an individual on whom an investigational biological product has been used a copy of any adverse reaction report relating to such use.
[39 FR 44656, Dec. 24, 1974]
### Section 487A

(b) REGULATORY IMPROVEMENT AND STREAMLINING EXPERI - MENTS.

— (1) IN GENERAL.

—The Secretary may continue any experi - mental sites in existence on the date of enactment of the High - er Education Amendments of 1998. Any activities approved by the Sec retary prior to such date that are inconsistent with this section shall be discontinued not later than June 30, 1999. (2) REPORT.

—The Secretary shall review and evaluate the experience of institutions participating as experimental sites during the period o f 1993 through 1998 under this section (as such section was in effect on the day before the date of enact - ment of the Higher Education Amendments of 1998), and shall submit a report based on this review and evaluation to the Committee on Labor and Human Re sources of the Senate and the Committee on Education and the Workforce of the House of Representatives not later than 6 months after the enactment of the Higher Education Amendments of 1998. Such report shall include

— (A) a list of participating institutio ns and the specific statutory or regulatory waivers granted to each institution; (B) the findings and conclusions reached regarding each of the experiments conducted; and (C) recommendations for amendments to improve and streamline this Act, based on the r esults of the experi - ment. (3) SELECTION.

— (A) IN GENERAL.

—Upon the submission of the report required by paragraph (2), the Secretary is authorized to select a limited number of additional institutions for vol - untary participation as experimental sites to provide rec - omme ndations to the Secretary on the impact and effec - tiveness of proposed regulations or new management ini - tiatives. (B) CONSULTATION.

—Prior to approving any additional experimental sites, the Secretary shall consult with the Committee on Lab or and Human Resources of the Senate and the Committee on Education and the Workforce of the House of Representatives and shall provide to such Com - mittees

— (i) a list of institutions proposed for participation in the experiment and the specific statutory or regu - latory waivers proposed to be granted to each institu - tion; (ii) a statement of the objectives to be achieved through the experiment; and (iii) an identification of the period of time over which the experiment is to be conducted. (C) WAIVERS.

— The S ecretary is authorized to waive, for any institution participating as an experimental site under subparagraph (A), any requirements in this title, or regulations prescribed under this title, that will bias the results of the experiment, except that the Sec retary shall not waive any provisions with respect to aw ard rules, grant and loan maximum a ward amounts, and need analy - sis requirements.
<PAGE>

                                                                    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 of Evergreen Solar, Inc. (the "Company") on
Form 10-K for the year ended December 31, 2004 as filed with the Securities and
Exchange Commission on the date hereof (the "Report"), I, Richard G. Chleboski,
Chief Financial 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 to 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 result of operations of the Company.

/s/ Richard G. Chleboski
-------------------------------
Richard G. Chleboski
Chief Financial Officer
March 10, 2005
Opinion issued May 17, 2022.

In The

Court of Appeals 

For The 

First District of Texas 

————————————

NO. 01-21-00125-CV

———————————

STEVE NICANDROS, LUIS GIUSTI, TYLER NELSON, AND FRONTERA 

RESOURCES CORPORATION, Appellants

V.

ZAZA MAMULAISHVILA, INDIVIDUALLY AND DERIVATIVELY ON 

BEHALF OF FRONTERA RESOURCES CORPORATION, Appellee

On Appeal from the 281st District Court

Harris County, Texas

Trial Court Case No. 2021-03816

MEMORANDUM OPINION

Appellants Steve Nicandros, Luis Giusti, Tyler Nelson, and Frontera

Resources Corporation filed a voluntary motion to dismiss their accelerated appeal 
2

of the trial court’s order denying their motion to compel arbitration.

1

In their

motion, Appellants state that on March 4, 2022, the trial court issued a final 

judgment in the underlying case rendering their interlocutory appeal moot. See 

Hernandez v. Ebrom, 289 S.W.3d 316, 319 (Tex. 2009) (“Appeals of some 

interlocutory orders become moot because the orders have been rendered moot by 

subsequent orders.”). No opinion has issued in this interlocutory appeal. See TEX.

R. APP. P. 42.1(c).

We grant Appellants’ motion and dismiss this interlocutory appeal, with 

costs taxed against the party incurring same. See TEX. R. APP. P. 42.1(a)(1), 

43.2(f).

PER CURIAM

Panel consists of Justices Landau, Hightower, and Rivas-Molloy.

1 See TEX. CIV. PRAC. & REM. CODE § 51.016.
#### § 520.1044 Gentamicin sulfate oral dosage forms.
Exhibit 3.1



Certificate of Amendment to Articles of Incorporation

For Nevada Profit Corporations

(Pursuant to NRS 78.385 and 78.390
 After Issuance of Stock)



1. Name of corporation: GlycoGenesys,
Inc.



2. The articles have been amended as follows (provide article
numbers, if available):



Article Fourth of the Articles of Incorporation is
hereby amended by inserting the following section at the end of Article Fourth:



1-For-6 REVERSE STOCK SPLIT OF COMMON STOCK



At the close of business on the date of the filing of the Certificate of Amendment with respect to the Articles of Incorporation, as amended, each six outstanding shares of Common Stock shall be combined into one
share of Common Stock (the Reverse Stock Split) without any action by the holders of such shares; provided, however, that upon such combination, (SEE ANNEX A)



3. The vote by which the stockholders holding shares in the corporation entitling them to exercise at least a majority of the voting power,
or such greater proportion of the voting power as may be required in the case of a vote by classes or series, or as may be required by the provisions of the articles of incorporation have voted in favor of the amendment is: NONE-NRS 78-207.



|                                        |  |                                                                
|--------------------------------------- |  | ---------------------------------------------------------------
|4. Effective date of filing (optional): |  |                                                                
|                                        |  | (must not be later than 90 days after the certificate is filed)



|                                 |  |                             
|-------------------------------- |  | ----------------------------
|5. Officer Signature (required): |  | /s/ John W. Burns, Secretary



---

ANNEX A



the corporation shall not issue fractional shares or pay cash in respect thereof, but shall instead issue to each
stockholder the aggregate number of shares resulting from the Reverse Stock Split rounded up to the next higher whole number of shares based upon the preceding calculation. Following the Reverse Stock Split, each holder of a certificate or
certificates representing shares of Common Stock of the Corporation, upon surrender thereof, shall receive a certificate or certificates representing the number of shares such stockholders is entitled to receive following the Reverse Stock Split.
Pending such surrender of Stock of the Corporation shall be deemed for all purposes, as a result of the Reverse Stock Split and without any action on the part of the holders thereof, to evidence only the right to receive one or more certificates
representing shares of Common Stock in accordance with the terms and conditions hereof.



Pursuant to the provisions of Nevada Revised Statutes 78.207, the authorized outstanding shares of the Corporation are correspondingly reduced to 38,333,333 shares and the authorized shares of Common Stock of the
Corporation are correspondingly reduced to 33,333,333 shares.
§ 582.2906 Tricalcium silicate. ( a ) *Product.* Tricalcium silicate.
( b ) *Tolerance.* 2 percent.
( c ) *Limitations, restrictions, or explanation.* This substance is generally recognized as safe when used in table salt in accordance with good manufacturing or feeding practice.
<PAGE>   1

PRESS RELEASE

                    FRONTIER FINANCIAL CORPORATION COMPLETES
                         MERGER WITH THE BANK OF SUMNER

Everett, Washington - December 21, 1998. Frontier Financial Corporation,
(NASDAQ, FTBK) today announced that its merger with Valley Bancorporation,
headquartered in Sumner, Washington and whose principal subsidiary is the Bank
of Sumner, has been completed with an effective date of December 21, 1998.

        As part of this transaction, the Bank of Sumner was merged into Frontier
Bank, the subsidiary of Frontier Financial Corporation, assuming the name of
Frontier Bank. The merger will result in the addition of four Frontier Bank
branch offices located in Sumner, Orting, Puyallup and Buckley, Washington.
These offices will continue to offer financial services to meet the needs of
consumers, professionals and small-to-medium size businesses with a continued
"high touch" philosophy of customer service. Following the transaction, Frontier
Bank will have assets exceeding $1.1 billion and 23 offices located in Skagit,
Snohomish, King and Pierce counties. .

        Linda Dryden, President and CEO of the Bank of Sumner, will join
Frontier Bank as Senior Vice President and Manager of the Pierce County offices.
All other officers and employees of the Bank of Sumner will stay on with
Frontier and continue to provide the personal service that the Bank of Sumner
has been providing since its inception in 1975.

        The shareholders of Valley Bancorporation will receive .8625 shares of
Frontier Financial Corporation stock for each share of Valley Bancorporation
stock. The merger will be accounted for as a pooling of interests, and is
expected to be accretive to income in 1999.

        Information herein contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, which can be
identified by words such as "may", "expected", "anticipate", "estimate",
"continue" or comparable words. In addition, all statements other than
statements of historical facts that address activities that Frontier expects or
anticipates will or may occur in the future are forward-looking statements.
Readers are encouraged to read the SEC reports of Frontier particularly its Form
10-K for the Fiscal Year Ended December 31, 1997, for meaningful cautionary
language discussing why actual results may vary materially from those
anticipated by management.
FIRST DISTRICT COURT OF APPEAL

STATE OF FLORIDA

_____________________________

No. 1D18-3104

_____________________________

LEE SHIVER,

Appellant,

v.

STATE OF FLORIDA,

Appellee.

_____________________________

On appeal from the Circuit Court for Suwannee County.

David W. Fina, Judge.

February 12, 2019

PER CURIAM.

AFFIRMED.

B.L. THOMAS, C.J., and BILBREY and JAY, JJ., concur.

_____________________________

Not final until disposition of any timely and 

authorized motion under Fla. R. App. P. 9.330 or 

9.331.

_____________________________
2

Lee Shiver, pro se, Appellant.

Ashley B. Moody, Attorney General, and Holly N. Simcox, 

Assistant Attorney General, Tallahassee, for Appellee.
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.1185 Compound S (11-deoxycortisol) test system. ( a ) *Identification.* A compound S (11-dioxycortisol) test system is a device intended to measure the level of compound S (11-dioxycortisol) in plasma. Compound S is a steroid intermediate in the biosynthesis of the adrenal hormone cortisol. Measurements of compound S are used in the diagnosis and treatment of certain adrenal and pituitary gland disorders resulting in clinical symptoms of masculinization and hypertension.
( b ) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]
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Home                 > Browse by Title > Health Care Costs and Their Effects on the Economy

              																	United States. Congress. Joint Economic Committee, 1956-					 and 	Ninety-Eighth Congress, 1983-1985. 						*Health Care Costs and Their Effects on the Economy : Hearings Before the Joint Economic Committee, Congress of the United States, Ninety-Eighth Congress, Second Session, April 12 and August 29, 1984*,												Washington: 								U.S. Government Printing Office, 										April 12 and August 29, 1984,									https://fraser.stlouisfed.org/title/889,			accessed on September 10, 2024.						    

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### IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT

No. 12

- 31270 Summary Calendar

UNITED STATES OF AMERICA , Plaintiff

- Appellee

v.
DARRYL MOORE , Defendant

- Appellant

Appeal from the United States District Court for the Eastern District of Louisiana USDC No. 2:10

- CR

- 331

- 1

Before DAVIS, SOUTHWICK and HIGGINSON, Circuit Judges. PER CURIAM: * The attorney appointed to represent Darryl Moore has moved for leave
to withdraw and has filed a brief in accordance with Anders v. California , 386 U.S. 738 (1967), and United States v. Flores , 632 F.3d 229 (5th Cir. 2011).
Moore has filed a response. We have reviewed counsel’s brief and t he relevant portions of the record reflected therein , as well as Moore’s response . We concur with counsel’s assessment that the appeal presents no nonfrivolous issue for

* 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 Fifth Circuit 

### FILED March 11, 2014 Lyle W. Cayce Clerk Case: 12-31270 Document: 00512557613 Page: 1 Date Filed: 03/11/2014No. 12

- 31270

appellate review. Accordingly, counsel’s motion for leave to withdraw is GRANTED, co unsel is excused from further responsibilities herein, and the
APPEAL IS DISMISSED. See 5 TH C IR

. R . 42.2.

2 Case: 12-31270 Document: 00512557613 Page: 2 Date Filed: 03/11/2014
Editorial Note on Part 864
Editorial Note: Nomenclature changes to part 864 appear at 73 FR 35341, June 23, 2008.

§ 864.6550 Occult blood test. ( a ) *Identification.* An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
( b ) *Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
[45 FR 60606, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]
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.

§ 314.99 Other responsibilities of an applicant of an ANDA. ( a ) An applicant must comply with the requirements of § 314.65 regarding withdrawal by the applicant of an unapproved ANDA and § 314.72 regarding a change in ownership of an ANDA.
( b ) An applicant may ask FDA to waive under this section any requirement that applies to the applicant under §§ 314.92 through 314.99. The applicant must comply with the requirements for a waiver under § 314.90. If FDA grants the applicant's waiver request with respect to a requirement under §§ 314.92 through 314.99, the waived requirement will not constitute a basis for refusal to approve an ANDA under § 314.127.
81 FR 69653, Oct. 6, 2016]
#### THE CHICAGO, ST. PAUL, MINNEAPOLIS AND OMAHA RAILWAY COMPANY v. THE UNITED STATES.

[Not reported in C. CIS. R.;

217 U. S. R., 180.]

*On the claimant's appeal.*

The claimant, a land-grant road, seeks to recover $40,000 under a contract for carrying the mails. The Court of Claims reduces the amount to $3,389.33 on the authority of *Astoria <& Columbia River Railway Company*v. *The United States*(41 C. Cls. B., 284) holding that the power reserved to Congress in the land-grant Act was over the property and not alone over the company which owned it, and that it attaches to all the uses of the property.

*612The decision of the court below is affirmed on the same ground.

Mr. Justice McKenna

delivered the opinion of the Supreme Court April 4, 1910.