alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 201
Editorial Note: Nomenclature changes to part 201 appear at 69 FR 13717, Mar. 24, 2004.

§ 201.300 Notice to manufacturers, packers, and distributors of glandular preparations. ( a ) Under date of December 4, 1941, in a notice to manufacturers of glandular preparations, the Food and Drug Administration expressed the opinion that preparations of inert glandular materials intended for medicinal use should, in view of the requirement of section 201(n) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1041; 21 U.S.C. 321(n)), be labeled with a statement of the material fact that there is no scientific evidence that the articles contain any therapeutic or physiologically active constituents. Numerous preparations of such inert glandular materials were subsequently marketed with disclaimers of the type suggested. The term *inert glandular materials* means preparations incapable of exerting an action or effect of some significant or measurable benefit in one way or another, i.e., in the diagnosis, cure, mitigation, treatment, or prevention of disease, or in affecting the structure or any function of the body.
( b ) Manufacturers have heretofore taken advantage of § 201.100 permitting omission of directions for use when the label bears the prescription legend. Section 201.100(c) requires that the labeling of the drug, which may include brochures readily available to licensed practitioners, bear information as to the use of the drug by practitioners licensed by law to administer it. Obviously, information adequate for the use of an inert glandular preparation is not available to practitioners licensed by law.
( c ) The Department of Health and Human Services is of the opinion that inert glandular materials may not be exempted from the requirements of section 502(f)(1) of the act that they bear adequate directions for use; and, accordingly, that their labeling must include among other things, representations as to the conditions for which such articles are intended to be used or as to the structure or function of the human body that they are intended to affect. Since any such representations offering these articles for use as drugs would be false or misleading, such articles will be considered to be misbranded if they are distributed for use as drugs.
( d ) The amended regulations provide also that in the case of drugs intended for parenteral administration there shall be no exemption from the requirement that their labelings bear adequate directions for use. Such inert glandular materials for parenteral use are therefore subject to the same comment as applies to those intended for oral administration.
§ 205.6 Minimum qualifications. ( a ) The State licensing authority shall consider, at a minimum, the following factors in reviewing the qualifications of persons who engage in wholesale distribution of prescription drugs within the State: ( 1 ) Any convictions of the applicant under any Federal, State, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;
( 2 ) Any felony convictions of the applicant under Federal, State, or local laws;
( 3 ) The applicant's past experience in the manufacture or distribution of prescription drugs, including controlled substances;
( 4 ) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;
( 5 ) Suspension or revocation by Federal, State, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;
( 6 ) Compliance with licensing requirements under previously granted licenses, if any;
( 7 ) Compliance with requirements to maintain and/or make available to the State licensing authority or to Federal, State, or local law enforcement officials those records required under this section; and
( 8 ) Any other factors or qualifications the State licensing authority considers relevant to and consistent with the public health and safety.
( b ) The State licensing authority shall have the right to deny a license to an applicant if it determines that the granting of such a license would not be in the public interest.
Order filed June 4 , 2013.

In The 

## Fourteenth Court of Appeals

____________ NO. 14

- 13

- 00397

- CV

____________ BENEDICT EMESOWUM , Appellant

V.

CHRISTMAS EVE MORGAN , Appellee

On Appeal from the Co unty Civil C our t at Law No

. 1

Harris County, Texas Trial Court Cause No. 1024921



### ORDER
On May 6, 2013, appellant filed a notice of appeal from the trial court’s final judgment signed April 29, 2013. Appellant also filed a request to proceed on appeal as a pauper without the advance payment of costs. See Tex. R. App. P. 20.1. The County Clerk of Harris County filed a contest to the affidavit on May 7, 2013.
Id. 20.1(e). The County Clerk also moved for an extension of time to conduct a hearing on the contest. Id. 20.1( i). The order granting an extension until M ay 21, 2013, that is included in our record is not signed by the trial court. The trial court’s2

docket reflects that on May 9, 2013, an order for extension of time was “granted and signed.” In addition, the docket reflects that on May 23, 2013, appellant f iled a request for a rehearing of the denial of his claim of indigence and included an affidavit containing additional information. These are not included in our record. Accordingly, we issue the following order:
We order the County Clerk of Harris County to file a supplemental clerk’s record without the advance payment of costs containing the following:
(1) the order granting an extension of time to conduct a hearing on the contest to appellant’s claim of indigence, signed on or about May 9, 2013; (2) app ellant’s request for rehearing of the order sustaining the contest to his claim of indigence filed on or about May 23, 2013; and (3) appellant’s affidavit of indigence filed on or about May 23, 2013. The supplemental clerk’s record shall be filed with the clerk of this court
within three days of the date of this order. See Tex. R. App. P. 20.1(j)(3).

PER CURIAM
UNPUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

No. 99-7703

CHAUNCEY E. ORR,

Petitioner - Appellant,

versus

MICHAEL MOORE, Director of South Carolina

Department of Corrections; CHARLES M. CONDON,

Attorney General of the State of South

Carolina,

Respondents - Appellees.

Appeal from the United States District Court for the District of

South Carolina, at Florence. G. Ross Anderson, Jr., District Judge.

(CA-98-208-4-13BD)

Submitted: March 23, 2000 Decided: March 30, 2000

Before LUTTIG, WILLIAMS, and MICHAEL, Circuit Judges.

Dismissed by unpublished per curiam opinion.

Chauncey E. Orr, Appellant Pro Se. Donald John Zelenka, Chief

Deputy Attorney General, Columbia, South Carolina, for Appellees.

Unpublished opinions are not binding precedent in this circuit.

See Local Rule 36(c).
2

PER CURIAM:

Chauncey E. Orr seeks to appeal the district court’s order

denying relief on his petition filed under 28 U.S.C.A. § 2254 (West

1994 & Supp. 1999). We dismiss the appeal for lack of jurisdiction

because Orr’s notice of appeal was not timely filed.

Parties are accorded thirty days after entry of the district

court’s final judgment or order to note an appeal, see Fed. R. App.

P. 4(b)(1), unless the district court extends the appeal period

under Fed. R. App. P. 4(a)(5) or reopens the appeal period under

Fed. R. App. P. 4(a)(6). This appeal period is “mandatory and

jurisdictional.” Browder v. Director, Dep’t of Corrections, 434

U.S. 257, 264 (1978) (quoting United States v. Robinson, 361 U.S.

220, 229 (1960)).

The district court’s order was entered on the docket on March

10, 1999. Orr’s notice of appeal was filed on November 29, 1999.

Because Orr failed to file a timely notice of appeal or to obtain

an extension or reopening of the appeal period, we deny a certificate of appealability and dismiss the appeal. We dispense with

oral argument because the facts and legal contentions are adequately presented in the materials before the court and argument would

not aid the decisional process.

DISMISSED
<PAGE>
               CONSENT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS



         We have issued our report dated February 25, 2000, accompanying the
consolidated financial statements included in Form 10-KSB of USABancShares.com,
Inc. for the year ended December 31, 1999. We hereby consent to the
incorporation by reference of said report in the Registration Statement of
USABancShares.com, Inc. on Forms S-8 (File No. 333-84135, effective July 30,
1999, and File No. 333-68955, effective December 15, 1998).

GRANT THORNTON LLP


Philadelphia, Pennsylvania
March 24, 2000
§ 507.33 Hazard analysis. ( a ) ( 1 ) You must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control; and
( 2 ) The hazard analysis must be written regardless of its outcome.
( b ) The hazard identification must consider: ( 1 ) Known or reasonably foreseeable hazards that include: ( i ) Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other pathogens;
( ii ) Chemical hazards, including radiological hazards, substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and nutrient deficiencies or toxicities (such as inadequate thiamine in cat food, excessive vitamin D in dog food, and excessive copper in food for sheep); and
( iii ) Physical hazards (such as stones, glass, and metal fragments); and
( 2 ) Known or reasonably foreseeable hazards that may be present in the animal food for any of the following reasons: ( i ) The hazard occurs naturally;
( ii ) The hazard may be unintentionally introduced; or
( iii ) The hazard may be intentionally introduced for purposes of economic gain.
( c ) ( 1 ) The hazard analysis must include an evaluation of the hazards identified in paragraph (b) of this section to assess the severity of the illness or injury to humans or animals if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls.
( 2 ) The hazard evaluation required by paragraph (c)(1) of this section must include an evaluation of environmental pathogens whenever an animal food is exposed to the environment prior to packaging and the packaged animal food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.
( d ) The hazard evaluation must consider the effect of the following on the safety of the finished animal food for the intended animal: ( 1 ) The formulation of the animal food;
( 2 ) The condition, function, and design of the facility and equipment;
( 3 ) Raw materials and other ingredients;
( 4 ) Transportation practices;
( 5 ) Manufacturing/processing procedures;
( 6 ) Packaging activities and labeling activities;
( 7 ) Storage and distribution;
( 8 ) Intended or reasonably foreseeable use;
( 9 ) Sanitation, including employee hygiene; and
( 10 ) Any other relevant factors such as the temporal (*e.g.,* weather-related) nature of some hazards (*e.g.,* levels of some natural toxins).
[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3717, Jan. 22, 2016]
38732.

#### McCRAY v. THE FIRST NATIONAL BANK *et al.*Executors.

Decided April 13, 1961.

*507
      *Walter V. Beasley, J. N. Johnson,*for plaintiff in error.

*Paul L. Lindsay, Jr., Emmett O. Dobbs, Jr.,*contra.

Jordan Judge.

*Code Ann.*§§ 113-1210.1,1210.'2,1210.3 (Ga. L. 1952, p. 87) provide as follows: “In all cases when the only qualified and acting executor of the estate of a decedent dies testate himself, any person or persons having an interest in the estate of *508such first decedent shall have the right to apply to the court of ordinary having-jurisdiction of the administration of such first estate for the *<*appointment -of an administrator de bonis non with-the will annexed of such first testator.” *(Code Ann.*■§- 113-1210.1). ■

'“■Upon the hearing of said application, after the issuance- and publication of citation as in other cases of applications for letters of administration, the ordinary- shall inquire into the circumstances of the -case and determine whether the -interest of such first estate and the persons interested therein will be best served-by the appointment of an administrator de bonis non with will annexéd or by-permitting the executor appointed under the will of- such deceased-executor-to be or become, as the case may be, -e executor- of such first estate by operation, of law.” *(Code*§113-1210.2). ' . • - - • -

"bhould' the ordinary find that the interest of such .first estate and of. the persons- interested therein will be best served by the granting-of said application-the same-shall be granted, otherwise said application shall'be denied.” *(Code Ann.*§ 113-1210.3). ■

Under the rulings of the Supreme Court and of th-is court in *Myers v. Gann,*95 Ga. 383 (22 S. E. 611) and *Roe v. Pitts,*82 Ga. App. 770 (2) (62 S. E. 2d 387), the-petitioner, as the sole- beneficiary under the will of-Harold Plennie -Miner who was a ■ beneficiary under the will of Mrs. J.- P. Miner, has an interest in.the estate of Mrs. J. P. Miner and is a competent party to be-named as administratrix of that estate.- Accordingly, she is a person “halving- an interest- in the estate of -such first decedent” within the purview of *Code Ann.*§ 113-1210.1 as quoted -above and was entitled under that-Code section to apply to the Court' of Ordinary of Fulton County for letters of administration de bonis non-with the will-annexed on the estate of Mrs. J. P.. Miner; There is no merit- to the defendant’s contention that the above cited Code sections refer only to those persons who are beneficiaries under the will of the first decedent. Accordingly, .thé plaintiff’s petition stated a cause of action and the trial'court erred in dismissing-the appeal from the court of ordinary since under. *Code*§ 6-501 the plaintiff was entitled to a de novo trial in the superior court on .the issues therein pre*509sentedv See *Roe v. Pitts,*supra; (1); *Goodman v. Little,*213 Ga. 178, 179 (97 S. E. 2d 567).

*Judgment reversed.*

*Townsend, P. Carlisle, and ■Frankum, JJ., concur.*
#### CHARLES HALPERN, RESPONDENT, v. THE EQUITABLE LIFE ASSURANCE SOCIETY OF THE U. S., APPELLANT.

Submitted February 17, 1939

Decided April 21, 1939.

For the respondent, *Aaron Heller.*

For the appellant, *Collins & Corbin.*

Per Curiam.

The judgment under review herein should be affirmed, for the reasons expressed in the opinion delivered by Mr. Justice Trenchard in the Supreme Court.

*For affirmance*— The Chancellor, Chief Justice, Case, Bodine, Donges, Heher, Porter, Hetfield, Dear, Wells, WolfsKeil, Bafferty, Hague, JJ. 13.

*For reversal*— None.
§ 347.1 Scope. ( a ) An over-the-counter skin protectant drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.
( b ) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
§ 200.51 Aqueous-based drug products for oral inhalation. ( a ) All aqueous-based drug products for oral inhalation must be manufactured to be sterile.
( b ) Manufacturers must also comply with the requirements in § 211.113(b) of this chapter.
[65 FR 34089, May 26, 2000]
UNPUBLISHED UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT No. 01-7552

MICHAEL R. CARTER, Petitioner - Appellant, versus RONALD J. ANGELONE, Respondent - Appellee.Appeal from the United States District Court for the Western District of Virginia, at Roanoke. Jackson L. Kiser, Senior District Judge. (CA-00-862) Submitted: February 27, 2002 Decided: March 18, 2002 Before LUTTIG, KING, and GREGORY, Circuit Judges. Dismissed by unpublished per curiam opinion. Michael Morchower, MORCHOWER, LUXTON & WHALEY, Richmond, Virginia; Christopher Campbell Booberg, THORSEN, MARCHANT & SCHER, L.L.P.,Richmond, Virginia, for Appellant. Thomas Drummond Bagwell, Assistant Attorney General, Richmond, Virginia, for Appellee. Unpublished opinions are not binding precedent in this circuit. See Local Rule 36(c).2 PER CURIAM: Michael R. Carter seeks to appeal the district court’s order denying relief on his petition filed under 28 U.S.C.A. § 2254 (West 1994 & Supp. 2001). We have reviewed the record and the district court’s opinion and find no reversible error. Accordingly, we deny a certificate of appealability and dismiss the appeal on the reasoning of the district court. See Carter v. Angelone , No. CA00-862 (W.D. Va. Aug. 10, 2001). We dispense with oral argument because the facts and legal contentions are adequately presented in the materials before the court and argument would not aid the decisional process.

DISMISSED
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§ 1316.58 Summary of testimony; affidavits. ( a ) The presiding officer may direct that summaries of the direct testimony of witnesses be prepared in writing and served on all parties in advance of the hearing. Witnesses will not be permitted to read summaries of their testimony into the record and all witnesses shall be available for cross-examination. Each witness shall, before proceeding to testify, be sworn or make affirmation.
( b ) Affidavits submitted at the prehearing conference or pursuant to § 1316.57 with good cause may be examined by all parties and opposing affidavits may be submitted to the presiding officer within a period of time fixed by him. Affidavits admitted into evidence shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to statements made therein.
[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]
COURT OF APPEALS

	SECOND DISTRICT OF TEXAS

	FORT WORTH

	NO. 2-03-127-CR

FERNANDO VASQUEZ	APPELLANT

	V.

THE STATE OF TEXAS	STATE

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

	FROM CRIMINAL DISTRICT COURT NO. 3 OF TARRANT COUNTY

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

	MEMORANDUM OPINION1

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

	Fernando Vasquez has appealed from the trial court’s judgment revoking his probation and sentencing him to three years’ confinement for felony driving while intoxicated.  We will affirm.

	During the two-year pendency of this appeal, appellant has been represented by three different attorneys (two appointed and one retained), all of whom have moved to withdraw and two of whom have filed briefs explaining why they believe the appeal is frivolous.  This appeal is not subject to the requirements of Anders v. California2 because appellant’s most recent attorney was retained.3

	We allowed retained counsel to withdraw after he informed appellant of his conclusion that the appeal lacked merit.4  We also asked appellant to advise the court by April 19, 2005 whether he wished to file a pro se brief and informed him that, if he did not respond, the appeal would be considered without briefs.5  No response has been filed; therefore, we will consider the appeal without briefs.6

	We have reviewed the record for fundamental error and find none.7  The indictment conferred jurisdiction on the trial court and provided appellant with sufficient notice to prepare a defense.8  Appellant knowingly and voluntarily pleaded true to two of the three allegations in the State’s petition to revoke his probation, and the punishment assessed is within the statutory range.9 Therefore, we affirm the trial court’s judgment.

								PER CURIAM

PANEL F:	CAYCE, C.J.; DAUPHINOT and HOLMAN, JJ.

DO NOT PUBLISH	

Tex. R. App. P. 47.2(b)

DELIVERED: May 12, 2005