alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
§ 310.100 New drug status opinions; statement of policy. ( a ) Over the years since 1938 the Food and Drug Administration has given informal advice to inquirers as to the new drug status of preparations. These drugs have sometimes been identified only by general statements of composition. Generally, such informal opinions were incorporated in letters that did not explicitly relate all of the necessary conditions and qualifications such as the quantitative formula for the drug and the conditions under which it was prescribed, recommended, or suggested. This has contributed to misunderstanding and misinterpretation of such opinions.
( b ) These informal opinions that an article is “not a new drug” or “no longer a new drug” require reexamination under the Kefauver-Harris Act (Public Law 87-781; 76 Stat. 788-89). In particular, when approval of a new drug application is withdrawn under provisions of section 505(e) of the Federal Food, Drug, and Cosmetic Act, a drug generally recognized as safe may become a “new drug” within the meaning of section 201(p) of said act as amended by the Kefauver-Harris Act on October 10, 1962. This is of special importance by reason of proposed actions to withdraw approval of new drug applications for lack of substantial evidence of effectiveness as a result of reports of the National Academy of Sciences—National Research Council on its review of drug effectiveness; for example, see the notice published in the Federal Register of January 23, 1968 (33 FR 818), regarding rutin, quercetin, et al.
( c ) Any marketed drug is a “new drug” if any labeling change made after October 9, 1962, recommends or suggests new conditions of use under which the drug is not generally recognized as safe and effective by qualified experts. Undisclosed or unreported side effects as well as the emergence of new knowledge presenting questions with respect to the safety or effectiveness of a drug may result in its becoming a “new drug” even though it was previously considered “not a new drug.” Any previously given informal advice that an article is “not a new drug” does not apply to such an article if it has been changed in formulation, manufacture control, or labeling in a way that may significantly affect the safety of the drug.
( d ) For these reasons, all opinions previously given by the Food and Drug Administration to the effect that an article is “not a new drug” or is “no longer a new drug” are hereby revoked. This does not mean that all articles that were the subjects of such prior opinions will be regarded as new drugs. The prior opinions will be replaced by opinions of the Food and Drug Administration that are qualified and current on when an article is “not a new drug,” as set forth in this subchapter.
[39 FR 11680, Mar. 29, 1974]
§ 520.2130 Spinosad. ( a ) *Specifications.* Each chewable tablet contains 140, 270, 560, 810, or 1620 milligrams (mg) spinosad.
( b ) *Sponsor.* See No. 058198 in § 510.600 of this chapter.
( c ) *Special considerations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
( d ) *Conditions of use* — ( 1 ) *Dogs* — ( i ) *Amount.* Administer tablets once a month at a recommended minimum dosage of 13.5 mg per pound (30 mg per kilogram) of body weight.
( ii ) *Indications for use.* To kill fleas and for the prevention and treatment of flea infestations (*Ctenocephalides felis*) for 1 month on dogs and puppies 14 weeks of age and older and 3.3 pounds of body weight or greater.
( 2 ) *Cats* — ( i ) *Amount.* Administer tablets once a month at a minimum dosage of 22.5 mg per pound (50 mg per kilogram) of body weight.
( ii ) *Indications for use.* To kill fleas and for the prevention and treatment of flea infestations (*C. felis*) for 1 month on cats and kittens 14 weeks of age and older and 2 pounds of body weight or greater.
[77 FR 60623, Oct. 4, 2012, as amended at 81 FR 48702, July 26, 2016; 87 FR 10968, Feb. 28, 2022]
<TABLE> <S> <C>

<ARTICLE> 5
<RESTATED> 
<MULTIPLIER> 1,000
       
<S>                             <C>                     <C>
<PERIOD-TYPE>                   6-MOS                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1997             DEC-31-1997
<PERIOD-START>                             JAN-01-1997             JAN-01-1997
<PERIOD-END>                               JUN-30-1997             SEP-30-1997
<CASH>                                           1,461                   2,270
<SECURITIES>                                    21,414                  21,644
<RECEIVABLES>                                   21,723                  15,055
<ALLOWANCES>                                       705                     707
<INVENTORY>                                     14,725                  12,911
<CURRENT-ASSETS>                                62,679                  58,089
<PP&E>                                          26,211                  27,927
<DEPRECIATION>                                   8,687                   9,738
<TOTAL-ASSETS>                                  80,233                  76,358
<CURRENT-LIABILITIES>                           20,441                  20,146
<BONDS>                                              0                       0
<PREFERRED-MANDATORY>                                0                       0
<PREFERRED>                                          0                       0
<COMMON>                                            16                      16
<OTHER-SE>                                      53,754                  48,321
<TOTAL-LIABILITY-AND-EQUITY>                    80,223                  76,358
<SALES>                                         67,275                  95,285
<TOTAL-REVENUES>                                67,275                  95,285
<CGS>                                           61,731                  88,401
<TOTAL-COSTS>                                   61,731                  88,401
<OTHER-EXPENSES>                                 4,926                  14,170
<LOSS-PROVISION>                                 (189)                   (189)
<INTEREST-EXPENSE>                                 260                     389
<INCOME-PRETAX>                                    793                 (7,074)
<INCOME-TAX>                                         1                 (2,430)
<INCOME-CONTINUING>                                792                 (4,644)
<DISCONTINUED>                                       0                       0
<EXTRAORDINARY>                                      0                       0
<CHANGES>                                            0                       0
<NET-INCOME>                                       792                 (4,644)
<EPS-PRIMARY>                                      .13                  (0.73)
<EPS-DILUTED>                                      .12                  (0.73)
        

</TABLE>
§ 520.445 Chlortetracycline and sulfamethazine powder. ( a ) *Specifications.* Each pound of soluble powder contains chlortetracycline bisulfate equivalent to 102.4 grams (g) of chlortetracycline hydrochloride and sulfamethazine bisulfate equivalent to 102.4 g of sulfamethazine.
( b ) *Sponsor.* See No. 016592 in § 510.600(c) of this chapter.
( c ) *Related tolerances.* See §§ 556.150 and 556.670 of this chapter.
( d ) *Conditions of use in swine.* Administer in drinking water as follows: ( 1 ) *Amount.* 250 milligrams (mg) of chlortetracycline and 250 mg of sulfamethazine per gallon.
( 2 ) *Indications for use.* For the prevention and treatment of bacterial enteritis; as an aid in the reduction of the incidence of cervical abscesses; and as an aid in the maintenance of weight gains in the presence of bacterial enteritis and atrophic rhinitis.
( 3 ) *Limitations.* Use as the sole source of chlortetracycline and sulfonamide. Not to be used for more than 28 consecutive days. Withdraw 15 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[76 FR 49649, Aug. 11, 2011, as amended at 81 FR 17607, Mar. 30, 2016; 81 FR 94989, Dec. 27, 2016]
§ 211.122 Materials examination and usage criteria. ( a ) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials; such written procedures shall be followed. Labeling and packaging materials shall be representatively sampled, and examined or tested upon receipt and before use in packaging or labeling of a drug product.
( b ) Any labeling or packaging materials meeting appropriate written specifications may be approved and released for use. Any labeling or packaging materials that do not meet such specifications shall be rejected to prevent their use in operations for which they are unsuitable.
( c ) Records shall be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination or testing, and whether accepted or rejected.
( d ) Labels and other labeling materials for each different drug product, strength, dosage form, or quantity of contents shall be stored separately with suitable identification. Access to the storage area shall be limited to authorized personnel.
( e ) Obsolete and outdated labels, labeling, and other packaging materials shall be destroyed.
( f ) Use of gang-printed labeling for different drug products, or different strengths or net contents of the same drug product, is prohibited unless the labeling from gang-printed sheets is adequately differentiated by size, shape, or color.
( g ) If cut labeling is used for immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons, packaging and labeling operations shall include one of the following special control procedures: ( 1 ) Dedication of labeling and packaging lines to each different strength of each different drug product;
( 2 ) Use of appropriate electronic or electromechanical equipment to conduct a 100-percent examination for correct labeling during or after completion of finishing operations; or
( 3 ) Use of visual inspection to conduct a 100-percent examination for correct labeling during or after completion of finishing operations for hand-applied labeling. Such examination shall be performed by one person and independently verified by a second person.
( 4 ) Use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment.
( h ) Printing devices on, or associated with, manufacturing lines used to imprint labeling upon the drug product unit label or case shall be monitored to assure that all imprinting conforms to the print specified in the batch production record.
[43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41353, Aug. 3, 1993; 77 FR 16163, Mar. 20, 2012]
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 amended Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of Amerityre Corporation (the "Company") on Form 10-K/A for the year ended June 30, 2011, as filed with the Securities and  Exchange Commission on the date hereof (the "Report"), I, Timothy L. Ryan, Chief Executive and 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 the best of my knowledge and belief:





(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/ Timothy L. Ryan


Timothy L. Ryan


Chief Executive and Financial Officer


(Principal Executive and Financial Officer)


September 21, 2012
§ 520.314 Cefadroxil. ( a ) *Specifications.* ( 1 ) Each tablet contains 50, 100, or 200 milligrams (mg) or 1 gram of cefadroxil.
( 2 ) Each milliliter of suspension constituted from powder contains 50 mg of cefadroxil.
( b ) *Sponsor.* See No. 042791 in § 510.600(c) of this chapter.
( c ) *Conditions of use in dogs and cats* — ( 1 ) *Amount* — ( i ) *Dogs.* Administer 10 mg per pound (/lb) body weight twice daily orally.
( ii ) *Cats.* Administer 10 mg/lb body weight once daily orally.
( 2 ) *Indications for use* — ( i ) *Dogs.* For the treatment of skin and soft tissue infections including cellulitis, pyoderma, dermatitis, wound infections, and abscesses due to susceptible strains of *Staphylococcus aureus.* For the treatment of genitourinary tract infections (cystitis) due to susceptible strains of *Escherichia coli*, *Proteus mirabilis*, and *S. aureus.*
( ii ) *Cats.* For the treatment of skin and soft tissue infections including abscesses, wound infections, cellulitis, and dermatitis caused by susceptible strains of *Pasteurella multocida*, *S. aureus*, *Staphylococcus epidermidis*, and *Streptococcus* spp.
( 3 ) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[75 FR 10165, Mar. 5, 2010, as amended at 87 FR 76421, Dec. 14, 2022]
II 

Calendar No. 139 

109TH CONGRESS 

1ST SESSION S. 1017 

[Report No. 109–90] 

To reauthorize grants for the water resources research and technology 

institutes established under the Water Resources Research Act of 1984. 

IN THE SENATE OF THE UNITED STATES 

MAY 12, 2005 

Mr. CHAFEE (for himself, Mr. INHOFE, Mr. JEFFORDS, Mrs. CLINTON, Mr. 

LAUTENBERG, Mr. VITTER, Mr. BAUCUS, Ms. MURKOWSKI, Mr. CRAPO, 

Mr. ENZI, and Mr. CORZINE) introduced the following bill; which was 

read twice and referred to the Committee on Environment and Public 

Works 

JUNE 27, 2005 

Reported by Mr. INHOFE, with amendments 

[Insert the part printed in italic] 

A BILL

To reauthorize grants for the water resources research and 

technology institutes established under the Water Resources Research Act of 1984.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
2

•S 1017 RS

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Water Resources Re3 search Act Amendments of 2005’’. 

4 SEC. 2. WATER RESOURCES RESEARCH. 

5 (a) AUTHORIZATION OF APPROPRIATIONS.—Section 

6 104(f) of the Water Resources Research Act of 1984 (42 

7 U.S.C. 10303(f)) is amended— 

8 (1) in the subsection header, by striking ‘‘IN

9 GENERAL’’; 

10 (2) by striking paragraph (1) and inserting the 

11 following: 

12 ‘‘(1) IN GENERAL.—There is authorized to be 

13 appropriated to carry out this section, to remain 

14 available until expended— 

15 ‘‘(A) $12,000,000 for each of fiscal years 

16 2006 through 2008; and 

17 ‘‘(B) $13,000,000 for each of fiscal years 

18 2009 and 2010.’’; and 

19 (3) in paragraph (2), by striking ‘‘(2) Any’’ and 

20 inserting the following: 

21 ‘‘(2) FAILURE TO OBLIGATE FUNDS.—Any’’. 

22 (b) ADDITIONAL APPROPRIATIONS WHERE RE23 SEARCH FOCUSED ON WATER PROBLEMS OF INTERSTATE

24 NATURE.—Section 104(g) of the Water Resources Re25 search Act of 1984 (42 U.S.C. 10303(g)) is amended— 
3

•S 1017 RS

1 (1) by redesignating paragraph (2) as para2 graph (4); and 

3 (2) in paragraph (1)— 

4 (A) in the first sentence— 

5 (i) by striking ‘‘(1) There’’ and insert6 ing the following: 

7 ‘‘(1) IN GENERAL.—There’’; and 

8 (ii) by striking ‘‘$3,000,000 for fiscal 

9 year 2001, $4,000,000 for each of fiscal 

10 years 2002 and 2003, and $6,000,000 for 

11 each of fiscal years 2004 and 2005’’ and 

12 inserting ‘‘$6,000,000 for each of fiscal 

13 years 2006 through 2008 and $7,000,000 

14 for each of fiscal years 2009 and 2010’’; 

15 (B) in the second sentence, by striking 

16 ‘‘Such’’ and inserting the following: 

17 ‘‘(2) NON-FEDERAL MATCHING FUNDS.—The’’; 

18 and 

19 (C) in the third sentence, by striking 

20 ‘‘Funds’’ and inserting the following: 

21 ‘‘(3) AVAILABILITY OF FUNDS.—Funds’’. 
Calendar No. 139 

109TH CONGRESS 

1ST SESSION S. 1017 

[Report No. 109–90] 

A BILL

To reauthorize grants for the water resources re1984. under the Water Resources Research Act of search and technology institutes established 

JUNE 27, 2005 

Reported with amendments
Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We hereby consent to the incorporation by reference in the Registration Statement on Form S-8 (No. 333-136211) of Wayside Technology Group, Inc. (the "Company"), pertaining to the Company's 2006 Stock-Based Compensation Plan, and in the Registration Statement on Form S-8 (No. 333-72249) of the Company pertaining to the Company's  1986 Stock Option Plan, the Company's 1995 Stock Plan and the Company's 1995 Non-Employee Director Plan, of our report dated March 10, 2008, relating to the consolidated financial statements and financial statement schedule of the Company, which appear in the Annual Report (Form 10-K) of the Company for the year ended December 31, 2007.



Edison, New Jersey

March 12, 2008



/s/  Amper, Politziner & Mattia, P.C.
OFFICE OF THE ATTORNEY GENERAL OF TEXAS 

AUSTIN 

GROVER SELLERS 

ATTORNEY GENERAL 

Honoxabls Ikmm D. Eok 

County Auditor 

Fsyette Gouoty 

LaCSrangs, T6xas 

Dear Slrr. 
- 

i 

:’ 

. lXanorable 

‘_’ 

The warden or other pweox, Ocauuduotin 

l x o o utlahall o n <B allowed therefor 

the 

twtmty-f f vs 

dollas to bs aid by the oounty la whiabjw%g- : 

aent of axeout frm was rendered, and the aa%alesioaers court o? 8udh county #ball approve auoh 

aookut IS& order It paid out of thu @mm11 funds 

of the county, upon the oortitlo0te of.ths distrlat 

alsk of thq oouutg, ahavbg tha!.aaturn by 'the 

w0r geor t3 the ,ded*arrant, h with l x o o utior o n

sent6no endo ~r ed th6r 00n.a 

:
Exhibit
15.1




Board of
Directors and Partners of


Icahn
Enterprises L.P.





We have
reviewed, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the unaudited consolidated interim financial
statements of Icahn Enterprises L.P. and Subsidiaries as of September 30, 2009,
and for the three-month and nine-month periods ended September 30, 2009 and
2008, as indicated in our report dated August 5, 2009; because we did not
perform an audit, we expressed no opinion on that information.





We are
aware that our report referred to above, which is included in your Quarterly
Report on Form 10-Q for the quarter ended September 30, 2009 is incorporated by
reference in Registration Statements on Forms S-3 (File No. 333-158705, File No.
333-143930 and File No. 333-126069) and Form S-4 (File No.
333-143929).





We also
are aware that the aforementioned report, pursuant to Rule 436(c) under the
Securities Act of 1933, is not considered a part of the Registration Statement
prepared or certified by an accountant within the meaning of Sections 7 and 11
of that Act.








/s/ GRANT
THORNTON LLP





New York,
New York


November
4, 2009
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Home                 > Browse by Title > Implications of Automation and Other Technological Developments: A Selected Annotated Bibliography (1963)

              																	United States. Bureau of Labor Statistics. 						*Implications of Automation and Other Technological Developments: A Selected Annotated Bibliography (1963) : Bulletin of the United States Bureau of Labor Statistics, No. 1319-1*,												Washington, D.C: 								G.P.O., 										December 1963,									https://fraser.stlouisfed.org/title/4746,			accessed on September 26, 2024.						    

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# EUR-Lex - 31994D0564 - EN

Avis juridique important

*|*

# 31994D0564

**94/564/EC: Commission Decision of 27 July 1994 amending Decision 92/469/EEC authorizing methods for grading pig carcases in Denmark (Only the Danish text is authentic) **

*
Official Journal L 215 , 20/08/1994 P. 0025 - 0025 *

COMMISSION DECISION of 27 July 1994 amending Decision 92/469/EEC authorizing methods for grading pig carcases in Denmark (Only the Danish text is authentic) (94/564/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 3220/84 of 13 November 1984 determining the Community scale for grading pig carcases (1), as last amended by Regulation (EC) No 3513/93 (2), and in particular Article 5 (2) thereof,

Wheread the Commission, by Decision 92/469/EEC (3), has authorized methods for grading pig carcases in Denmark;

Whereas the amendments concerning the standard presentation of pig carcases introduced by Regulation (EC) No 3513/93 to Regulation (EEC) No 3220/84 as from 1 July 1994 allow to delete, as from the same date, the derogation from the standard presentation provided for in Article 3 of Decision 92/469/EEC;

Whereas the measures provided for in this Decision are in accordance with the opinion of the Management Committee for Pigmeat,

HAS ADOPTED THIS DECISION:

Article 1

Decision 92/469/EEC is hereby amended as follows:

1. Article 3 is deleted;

2. Article 4 becomes Article 3, Article 5 becomes Article 4 and Article 6 becomes Article 5.

Article 2

This Decision is addressed to the Kingdom of Denmark.

It shall apply with effect from 1 July 1994.

Done at Brussels, 27 July 1994.

For the Commission

René STEICHEN

Member of the Commission

(1) OJ No L 301, 20. 11. 1984, p. 1.

(2) OJ No L 320, 22. 12. 1993, p. 5.

(3) OJ No L 265, 11. 9. 1992, p. 39.