alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
N OTE : This disposition is nonprecedential. 

# United States **Court of Appeals**  **for the Federal Circuit**

______________________ ENDOTACH LLC, Plaintiff

- Appellant

v.
COOK MEDICAL LLC, Defendant

- Appellee

______________________
2018

- 1347

______________________ Appeal from the United States District Court for the Southern District of Indiana in No. 1:13

- cv

- 01135

- RLM

MJD, Senior Judge Robert L. Miller , Jr.

______________________
JUDGMENT

______________________
J ONATHAN T AD S UDER , Friedman, Suder & Cooke, Fort Worth, TX, argued for plaintiff

- appellant. Also represented by G LENN S CHUYLER O RMAN , B RETT M ICHAEL P INKUS

.

D OMINIC P. Z ANFARDINO , Brinks Gilson & Lione, Chicago, IL, argued for defendant

- appellee. Also repr esented by J EFFRY M. N ICHOLS , J ASON W AYNE S CHIGELONE

.

______________________T HIS C AUSE ha ving been heard and considered, it is

O RDERED and A DJUDGED :

P ER C URIAM (D YK , R EYNA , and H UGHES , Circuit Judges ).
AFFIRMED. See Fed . Cir. R. 36.

E NTERED BY O RDER OF THE C OURT

October 9, 2018 /s/ Peter R. Marksteiner Date Peter R. Marksteiner Clerk of Court
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Home                 > Browse by Title > Materials Prepared in Connection with the Study of Employment, Growth, and Price Levels for Consideration by the Joint Economic Committee, Congress of the United States

              																								United States. Congress. Joint Economic Committee, 1956-					 and 	Eighty-Sixth Congress, 1959-1961.						"Study Paper No. 21 : Postwar Movement of Prices and Wages in Manufacturing Industries, and Supplemental Technical Material to the Staff Report" in *Materials Prepared in Connection with the Study of Employment, Growth, and Price Levels for Consideration by the Joint Economic Committee, Congress of the United States*			(January 30, 1960).						https://fraser.stlouisfed.org/title/1244/item/3649, accessed on September 26, 2024.	    

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#### § 50.20 General requirements for informed consent.

Except as provided in §§ 50.22, 50.23, and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

[46 FR 8951, Jan. 27, 1981, as amended at 64 FR 10942, Mar. 8, 1999; 88 FR 88248, Dec. 21, 2023]
§ 357.850 Labeling of deodorant drug products for internal use. ( a ) *Statement of identity.* The labeling of the product contains the established name of the drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or ileostomy deodorant.”
( b ) *Indications.* The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. ( 1 ) *For products containing bismuth subgallate identified in § 357.810(a) .* “An aid to reduce odor from a colostomy or ileostomy.”
( 2 ) *For products containing chlorophyllin copper complex identified in § 357.810(b) .* ( i ) “An aid to reduce odor from a colostomy or ileostomy.”
( ii ) “An aid to reduce fecal odor due to incontinence.”
( c ) *Warnings.* The labeling of the product contains the following warnings under the heading “Warnings”: ( 1 ) *For products containing chlorophyllin copper complex identified in § 357.810(b) .* ( i ) “If cramps or diarrhea occurs, reduce the dosage. If symptoms persist, consult your doctor.”
( ii ) The warning required by § 330.1(g) of this chapter concerning overdose is not required on products containing chlorophyllin copper complex identified in § 357.810(b).
( 2 ) [Reserved]
( d ) *Directions.* The labeling of the product contains the following information under the heading “Directions.” ( 1 ) *For products containing bismuth subgallate identified in § 357.810(a) .* Adults and children 12 years of age and over: Oral dosage is 200 to 400 milligrams up to 4 times daily. Children under 12 years of age: consult a doctor.
( 2 ) *For products containing chlorophyllin copper complex identified in § 357.810(b) .* Adults and children 12 years of age and over: Oral dosage is 100 to 200 milligrams daily in divided doses as required. If odor is not controlled, take up to an additional 100 milligrams daily in divided doses as required. The smallest effective dose should be used. Do not exceed 300 milligrams daily. Children under 12 years of age: consult a doctor.
§ 530.25 Orders prohibiting extralabel uses for drugs in food-producing animals. ( a ) FDA may issue an order prohibiting extralabel use of an approved new animal or human drug in food-producing animals if the agency finds, after providing an opportunity for public comment, that: ( 1 ) An acceptable analytical method required under § 530.22 has not been developed, submitted, and found to be acceptable by FDA or that such method cannot be established; or
( 2 ) The extralabel use in animals presents a risk to the public health.
( b ) After making a determination that the analytical method required under § 530.22 has not been developed and submitted, or that such method cannot be established, or that an extralabel use in animals of a particular human drug or animal drug presents a risk to the public health, FDA will publish in the Federal Register, with a 90-day delayed effective date, an order of prohibition for an extralabel use of a drug in food-producing animals. Such order shall state that an acceptable analytical method required under § 530.22 has not been developed, submitted, and found to be acceptable by FDA; that such method cannot be established; or that the extralabel use in animals presents a risk to the public health; and shall: ( 1 ) Specify the nature and extent of the order of prohibition and the reasons for the prohibition;
( 2 ) Request public comments; and
( 3 ) Provide a period of not less than 60 days for comments.
( c ) The order of prohibition will become effective 90 days after date of publication of the order unless FDA publishes a notice in the Federal Register prior to that date, that revokes the order of prohibition, modifies it, or extends the period of public comment.
( d ) The agency may publish an order of prohibition with a shorter comment period and/or delayed effective date than specified in paragraph (b) of this section in exceptional circumstances (e.g., where there is immediate risk to the public health), provided that the order of prohibition states that the comment period and/or effective date have been abbreviated because there are exceptional circumstances, and the order of prohibition sets forth the agency's rationale for taking such action.
( e ) If FDA publishes a notice in the Federal Register modifying an order of prohibition, the agency will specify in the modified order of prohibition the nature and extent of the modified prohibition, the reasons for it, and the agency's response to any comments on the original order of prohibition.
( f ) A current listing of drugs prohibited for extralabel use in animals will be codified in § 530.41.
( g ) After the submission of appropriate information (i.e., adequate data, an acceptable method, approval of a new animal drug application for the prohibited extralabel use, or information demonstrating that the prohibition was based on incorrect data), FDA may, by publication of an appropriate notice in the Federal Register, remove a drug from the list of human and animal drugs prohibited for extralabel use in animals, or may modify a prohibition.
( h ) FDA may prohibit extralabel use of a drug in food-producing animals without establishing a safe level.
#### § 520.1696 Penicillin.
§ 522.1610 Oleate sodium. ( a ) *Specifications.* Each milliliter of solution contains 50 milligrams (mg) of sodium oleate.
( b ) *Sponsor.* See No. 037990 in § 510.600(c) of this chapter.
( c ) *Conditions of use in horses* — ( 1 ) *Amount.* Administer by parenteral injection depending on the area of response desired. An injection of 1 milliliter (mL) will produce a response of approximately 15 square centimeters. Do not inject more than 2 mL per injection site. Regardless of the number of injection sites, the total volume used should not exceed 10 mL.
( 2 ) *Indications for use.* It is used in horses to stimulate infiltration of cellular blood components that subsequently differentiate into fibrous and/or fibrocartilagenous tissue.
( 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.
[41 FR 27034, July 1, 1976, as amended at 50 FR 40966, Oct. 8, 1985; 79 FR 16192, Mar. 25, 2014]
<PAGE>

                                                                  EXHIBIT 99 (a)



                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 Quarterly Report of Northland Cable Properties Seven
Limited Partnership (the "Partnership") on Form 10Q for the period ended June
30, 2002 as filed with the Securities and Exchange Commission on the date hereof
(the "Form 10-Q"), I, John Whetzell, Chief Executive Officer of Northland
Communications Corporation, the General Partner, 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 Form 10-Q fully complies with the requirements of Section 13
              (a) or (15(d) of the Securities Exchange Act of 1934 (15 U.S.C.
              78m or 78(d)); and

        (2)   The information contained in the Form 10-Q fairly presents in all
              material respects, the financial condition and results of
              operations of the Company.

Dated: August 14, 2002





                                            BY:  /s/ JOHN S. WHETZELL
                                                ---------------------------
                                                     John S. Whetzell
                                                     (Chief Executive Officer)
§ 320.34 Requirements for batch testing and certification by the Food and Drug Administration. ( a ) If the Commissioner determines that individual batch testing by the Food and Drug Administration is necessary to assure that all batches of the same drug product meet an appropriate in vitro test, he shall include in the bioequivalence requirement a requirement for manufacturers to submit samples of each batch to the Food and Drug Administration and to withhold distribution of the batch until notified by the Food and Drug Administration that the batch may be introduced into interstate commerce.
( b ) The Commissioner will ordinarily terminate a requirement for a manufacturer to submit samples for batch testing on a finding that the manufacturer has produced four consecutive batches that were tested by the Food and Drug Administration and found to meet the bioequivalence requirement, unless the public health requires that batch testing be extended to additional batches.
[42 FR 1635, Jan. 7, 1977. Redesignated at 57 FR 18001, Apr. 28, 1992]
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.

§ 314.90 Waivers. ( a ) An applicant may ask the Food and Drug Administration to waive under this section any requirement that applies to the applicant under §§ 314.50 through 314.81. An applicant may ask FDA to waive under § 314.126(c) any criteria of an adequate and well-controlled study described in § 314.126(b). A waiver request under this section is required to be submitted with supporting documentation in an NDA, or in an amendment or supplement to an NDA. The waiver request is required to contain one of the following: ( 1 ) An explanation why the applicant's compliance with the requirement is unnecessary or cannot be achieved;
( 2 ) A description of an alternative submission that satisfies the purpose of the requirement; or
( 3 ) Other information justifying a waiver.
( b ) FDA may grant a waiver if it finds one of the following: ( 1 ) The applicant's compliance with the requirement is unnecessary for the agency to evaluate the NDA or compliance cannot be achieved;
( 2 ) The applicant's alternative submission satisfies the requirement; or
( 3 ) The applicant's submission otherwise justifies a waiver.
( c ) If FDA grants the applicant's waiver request with respect to a requirement under §§ 314.50 through 314.81, the waived requirement will not constitute a basis for refusal to approve an NDA under § 314.125.
[50 FR 7493, Feb. 22, 1985, as amended at 50 FR 21238, May 23, 1985; 67 FR 9586, Mar. 4, 2002; 81 FR 69649, Oct. 6, 2016]
§ 573.485 Fumonisin esterase. The food additive fumonisin esterase may be safely used to degrade fumonisins in swine and poultry feed in accordance with the following prescribed conditions: ( a ) Fumonisin esterase, a carboxylesterase, is produced by a nontoxigenic and nonpathogenic yeast, *Komagataella phaffii,* genetically engineered to express the fumonisin esterase gene from the bacterium *Sphingopyxis* sp. Hydrolyzed fumonisin and two tricarballylic acid molecules are the reaction products of fumonisin hydrolysis by this 493 amino acid fumonisin esterase enzyme.
( b ) The additive shall meet the following specifications: ( 1 ) The fermentation media for the *Komagataella phaffii* shall not contain methanol.
( 2 ) Viable genetically engineered *Komagataella phaffii* shall not be present.
( 3 ) One unit of fumonisin esterase activity is defined as the amount of enzymatic activity required to release one micromole of tricarballylic acid (CAS 99-14-9) per minute from 100 micromolar fumonisin B1 in 20 millimolar Tris-hydrochloride buffer (pH 8.0) containing 0.1 milligram per milliliter of bovine serum albumin at 30 °C.
( c ) The additive is incorporated at a minimum of 15 units of fumonisin esterase activity per kilogram of complete feed: ( 1 ) Complete swine feeds cannot contain more than 10 parts per million of total fumonisins.
( 2 ) Complete feed for poultry being raised for slaughter cannot contain more than 50 parts per million of total fumonisins.
( 3 ) Complete feed for breeding poultry and hens laying eggs for human consumption cannot contain more than 15 parts per million of total fumonisins.
( d ) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act: ( 1 ) The label and labeling of the additive, any feed premix, and complete feed shall contain the common or usual name of the additive's source, dried *Komagataella phaffii* fermentation product.
( 2 ) The label and labeling of the additive and any feed premix shall also contain: ( i ) Adequate directions for use including a statement that the additive must be uniformly applied and thoroughly mixed into complete feeds;
( ii ) A guarantee for the minimum amount of fumonisin esterase activity, expressed in accordance with paragraph (b)(3) of this section, and the unit of weight being consistent with the inclusion rate stated in the directions for use;
( iii ) Appropriate warning and safety precaution statements concerning the additive as a respiratory sensitizer;
( iv ) A cautionary statement concerning the maximum fumonisin content as established in paragraph (c) of this section.
[87 FR 47344, Aug. 3, 2022, as amended at 87 FR 52682, Aug. 29, 2022]
**EXHIBIT 32.2****CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER**     Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002     I, John P. Saldarelli, Treasurer and Chief Financial Officer(Principal Financial Officer) of American Property Investors,Inc., the General Partner of American Real Estate Partners, L.P.(the “Registrant”), certify that to the best of myknowledge, based upon a review of the American Real EstatePartners, L.P. quarterly report on Form 10-Q for the periodended June 30, 2005 of the Registrant (the“Report”):          (1) The Report fully complies with the requirements of    Section 13(a) or 15(d) of the Securities Exchange Act of    1934, as amended; and           (2) The information contained in the Report fairly    presents, in all material respects, the financial condition and    results of operations of the Registrant.     /s/ John P. Saldarelli           John P. Saldarelli     Treasurer and Chief Financial Officer     American Property Investors, Inc.,     the General Partner of     American Real Estate Partners, L.P.Date: August 9, 2005
56
V 

118TH CONGRESS 

1ST SESSION H. R. 738 

For the relief of Mykhaylo Gnatyuk and Melnik Gnatyuk. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 1, 2023 

Mr. DAVIS of Illinois introduced the following bill; which was referred to the 

Committee on the Judiciary 

A BILL 

For the relief of Mykhaylo Gnatyuk and Melnik Gnatyuk. 

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

3 SECTION 1. PERMANENT RESIDENT STATUS FOR 

4 MYKHAYLO GNATYUK AND MELNIK 

5 GNATYUK. 

6 (a) IN GENERAL.—Notwithstanding subsections (a) 

7 and (b) of section 201 of the Immigration and Nationality 

8 Act, Mykhaylo Gnatyuk and Melnik Gnatyuk shall each 

9 be eligible for issuance of an immigrant visa or for adjust10 ment of status to that of an alien lawfully admitted for 

11 permanent residence upon filing an application for 

12 issuance of an immigrant visa under section 204 of such 


pbinns on DSKJLVW7X2PROD with $$_JOB
2 

•HR 738 IH

1 Act or for adjustment of status to lawful permanent resi2 dent. 

3 (b) ADJUSTMENT OF STATUS.—If Mykhaylo Gnatyuk 

4 or Melnik Gnatyuk enters the United States before the 

5 filing deadline specified in subsection (c), he or she shall 

6 be considered to have entered and remained lawfully and 

7 shall, if otherwise eligible, be eligible for adjustment of 

8 status under section 245 of the Immigration and Nation9 ality Act as of the date of the enactment of this Act. 

10 (c) DEADLINE FOR APPLICATION AND PAYMENT OF

11 FEES.—Subsections (a) and (b) shall apply only if the ap12 plication for issuance of an immigrant visa or the applica13 tion for adjustment of status is filed with appropriate fees 

14 within 2 years after the date of the enactment of this Act. 

15 (d) REDUCTION OF IMMIGRANT VISA NUMBER.— 

16 Upon the granting of an immigrant visa or permanent res17 idence to Mykhaylo Gnatyuk and Melnik Gnatyuk, the 

18 Secretary of State shall instruct the proper officer to re19 duce by 2, during the current or next following fiscal year, 

20 the total number of immigrant visas that are made avail21 able to natives of the country of the aliens’ birth under 

22 section 203(a) of the Immigration and Nationality Act or, 

23 if applicable, the total number of immigrant visas that are 

24 made available to natives of the country of the aliens’ birth 

25 under section 202(e) of such Act. 


pbinns on DSKJLVW7X2PROD with $$_JOB
3 

•HR 738 IH

1 (e) DENIAL OF PREFERENTIAL IMMIGRATION

2 TREATMENT FOR CERTAIN RELATIVES.—The natural 

3 parents, brothers, and sisters of Mykhaylo Gnatyuk and 

4 Melnik Gnatyuk shall not, by virtue of such relationship, 

5 be accorded any right, privilege, or status under the Immi6 gration and Nationality Act. 

Æ 


pbinns on DSKJLVW7X2PROD with $$_JOB
18400 VON KARMAN AVENUE, SUITE 800 IRVINE, CALIFORNIA 92612-0514

TELEPHONE (949) 760-1121 / FAX (949) 720-0182

Direct Dial Number: (949) 224-6247

Direct Facsimile Number: (949) 224-6407

E-Mail Address: pfraidenburgh@buchalter.com

June 11, 2015

SUBMITTED ELECTRONICALLY (VIA REGULATIONS.GOV)

Mr. Dan Ngo

Office of Rulemaking

Aircraft and Airport Rules Division

Federal Aviation Administration

Re: Request for Amendment to Exemption No. 11581 on Behalf of Mountain High 

Aviation, LLC (Regulatory Docket No. FAA-2014-0874)

Dear Mr. Ngo:

This is a request for an amendment to the existing Section 333 Exemption No. 11581 to 

add additional aircraft to the exemption-holder’s authorized commercial operations. On May 14, 

2015, the FAA granted this Petition for Exemption to conduct commercial operations using small 

unmanned aircraft systems. The Petitioner now seeks an amendment to its exemption 

authorizing the operation of the DJI Phantom 3 aircraft as documented in the confidential and 

proprietary operations manuals submitted in support of this amendment request.

Thank you for your prompt attention to this matter. Please do not hesitate to contact me 

if you should have any questions.

Best regards,

BUCHALTER NEMER

A Professional Corporation

By

Paul J. Fraidenburgh

Counsel for Mountain High Aviation, LLC

Los Angeles • Irvine • San Francisco • Scottsdale

BN 18469061v1
EXHIBIT 32



EXHIBIT 32  SECTION 906 CERTIFICATIONS



Each of the undersigned hereby certifies, in accordance with 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, in his capacity as an
officer of Provena Foods Inc. (the Company), that, to his knowledge, the Quarterly Report of the Company on Form 10-Q for the period ended March 31, 2004, fully complies with the requirements of Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 and that the information contained in such report fairly presents, in all material respects, the financial condition and results of operation of the Company.



Date: April 29, 2004



/s/ Theodore L. ArenaTheodore L. Arena, Chief Executive Officer/s/ Thomas J. MulroneyThomas J. Mulroney, Chief Financial Officer