alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
§ 310.546 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps. ( a ) Quinine sulfate alone or in combination with vitamin E has been present in over-the-counter (OTC) drug products for the treatment and/or prevention of nocturnal leg muscle cramps, *i.e.*, a condition of localized pain in the lower extremities usually occurring in middle life and beyond with no regular pattern concerning time or severity. There is a lack of adequate data to establish general recognition of the safety and effectiveness of quinine sulfate, vitamin E, or any other ingredients for OTC use in the treatment and/or prevention of nocturnal leg muscle cramps. In the doses used to treat or prevent this condition, quinine sulfate has caused adverse events such as transient visual and auditory disturbances, dizziness, fever, nausea, vomiting, and diarrhea. Quinine sulfate may cause unpredictable serious and life-threatening hypersensitivity reactions requiring medical intervention and hospitalization; fatalities have been reported. The risk associated with use of quinine sulfate, in the absence of evidence of its effectiveness, outweighs any potential benefit in treating and/or preventing this benign, self-limiting condition. Based upon the adverse benefit-to-risk ratio, any drug product containing quinine or quinine sulfate cannot be considered generally recognized as safe for the treatment and/or prevention of nocturnal leg muscle cramps.
( b ) Any OTC drug product that is labeled, represented, or promoted for the treatment and/or prevention of nocturnal leg muscle cramps is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the act.
( c ) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC use for the treatment and/or prevention of nocturnal leg muscle cramps is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter.
( d ) After February 22, 1995, any such OTC drug product initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action.
[59 FR 43252, Aug. 22, 1994]
§ 71.6 Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice. ( a ) *Extension of time for studying petitions.* If the Commissioner determines that additional time is needed to study and investigate the petition, he shall by written notice to the petitioner extend the 90-day period for not more than 180 days after the filing of the petition.
( b ) *Substantive amendments.* After a petition has been filed, the petitioner may submit additional information or data in support thereof. In such cases, if the Commissioner determines that the additional information or data amounts to a substantive amendment, the petition as amended will be given a new filing date, and the time limitation will begin to run anew. If nonclinical laboratory studies are involved, additional information and data submitted in support of filed petitions shall include, with respect to each nonclinical laboratory study contained in the petition, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. If clinical investigations involving human subjects are involved, additional information or data submitted in support of filed petitions shall include statements regarding each such clinical investigation from which the information or data are derived, that it either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in accordance with § 56.104 or § 56.105, and that it was conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter.
( c ) *Withdrawal of petitions without prejudice.* ( 1 ) In some cases the Commissioner may notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or the regulation requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal will be without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew from the date of refiling.
( 2 ) At any time before the order provided for in § 71.20 has been forwarded to the Federal Register for publication the petitioner may withdraw the petition without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew.
[42 FR 15636, Mar. 22, 1977, as amended at 43 FR 60021, Dec. 22, 1978; 46 FR 8952, Jan. 27, 1981; 50 FR 7491, Feb. 22, 1985]
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 Hemispherx Biopharma, Inc. (the “Company”) on Form 10-K for the fiscal year ended December 31, 2010 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Charles T. Bernhardt, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:





(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/ Charles T. BernhardtCharles T. Bernhardt CPAChief Financial OfficerMarch 28, 2011
§ 522.2075 Robenacoxib. ( a ) *Specifications.* Each milliliter of solution contains 20 milligrams (mg) robenacoxib.
( b ) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.
( c ) *Conditions of use* — ( 1 ) *Dogs* — ( i ) *Amount.* Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a maximum of 3 days. After the initial subcutaneous dose, subsequent doses can be given by subcutaneous injection or as the oral tablet in dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose per day. See § 520.2075(c)(1) of this chapter.
( ii ) *Indications for use.* For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs at least 4 months of age for a maximum of 3 days.
( iii ) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
( 2 ) *Cats* — ( i ) *Amount.* Administer 0.91 mg per pound (2 mg/kg) by subcutaneous injection, once daily, for a maximum of 3 days.
( ii ) *Indications for use.* For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats at least 4 months of age for a maximum of 3 days.
( iii ) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[80 FR 61297, Oct. 13, 2015, as amended at 82 FR 12170, Mar. 1, 2017]
# C_2015398EN.01004502.xml

| 30.11.2015 | EN | Official Journal of the European Union | C 398/45 |
| --- | --- | --- | --- |

30.11.2015

EN

Official Journal of the European Union

C 398/45

---

Judgment of the General Court of 7 October 2015 — Atlantic Multipower Germany v OHIM — Nutrichem Diät + Pharma (NOxtreme)

(Case T-186/14) (1)

1

((Community trade mark - Invalidity proceedings - Community word mark NOxtreme - Earlier Community and national figurative marks X-TREME - Relative grounds for refusal - Likelihood of confusion - Article 8(1)(b) of Regulation No 207/2009 - Genuine use of the earlier mark - Article 43(2) and (3) of Regulation No 207/2009 - Article 15(2) of Regulation No 207/2009))

(2015/C 398/57)

Language of the case: German

Parties

Parties

Applicant: Atlantic Multipower Germany GmbH & Co. OHG (Hambourg, Allemagne) (represented by: W. Berlit, lawyer)

Applicant:

Defendant: Office for Harmonisation in the Internal Market (Trade Marks and Designs) (represented by: A. Schifko, acting as agent)

Defendant:

The other party to the proceedings before the Board of Appeal of OHIM, intervener before the General Court: Nutrichem Diät + Pharma GmbH (Roth, Germany) (represented by: D. Jochim and R. Egerer, lawyers)

The other party to the proceedings before the Board of Appeal of OHIM, intervener before the General Court:

Re:

Re:

Action brought against the decision of the Fourth Board of Appeal of OHIM of 29 January 2014 (case R 764/2013-4), relating to invalidity proceedings between Atlantic Multipower Germany GmbH & Co. OHG and Nutrichem Diät + Pharma GmbH.

Operative part of the judgment

Operative part of the judgment

The Court:

| 1) | Dismisses the action; |
| --- | --- |

1)

Dismisses the action;

| 2) | Orders Atlantic Multipower Germany GmbH & Co. OHG to pay the costs. |
| --- | --- |

2)

Orders Atlantic Multipower Germany GmbH & Co. OHG to pay the costs.

---

(1)  OJ C 142, 12.5.2014.

1

---
# C_2016392EN.01002901.xml

| 24.10.2016 | EN | Official Journal of the European Union | C 392/29 |
| --- | --- | --- | --- |

24.10.2016

EN

Official Journal of the European Union

C 392/29

---

Judgment of the General Court of 9 September 2016 — Tri Ocean Energy v Council

(Case T-719/14) (1)

1

((Common foreign and security policy - Restrictive measures taken against Syria - Freezing of funds - Error of assessment))

(2016/C 392/35)

Language of the case: English

Parties

Parties

Applicant: Tri Ocean Energy (Cairo, Egypt) (represented by: B. Kennelly, Barrister, P. Saini QC, and N. Sheikh, Solicitor)

Applicant:

Defendant: Council of the European Union (represented by: B. Driessen and A. Vitro, acting as Agents)

Defendant:

Re:

Re:

Action under Article 263 TFEU for the annulment of Council Implementing Decision 2014/678/CFSP of 26 September 2014 implementing Decision 2013/255/CFSP concerning restrictive measures against Syria (OJ 2014 L 283, p. 59) and of Council Implementing Regulation (EU) No 1013/2014 of 26 September 2014 implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria (OJ 2014 L 283, p. 9), in so far as those measures concern the applicant.

Operative part of the judgment

Operative part of the judgment

The Court:

| 1. | Annuls Council Implementing Decision 2014/678/CFSP of 26 September 2014 implementing Decision 2013/255/CFSP concerning restrictive measures against Syria, and Council Implementing Regulation (EU) No 1013/2014 of 26 September 2014 implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria in so far as they apply to Tri Ocean Energy; |
| --- | --- |

1.

Annuls Council Implementing Decision 2014/678/CFSP of 26 September 2014 implementing Decision 2013/255/CFSP concerning restrictive measures against Syria, and Council Implementing Regulation (EU) No 1013/2014 of 26 September 2014 implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria in so far as they apply to Tri Ocean Energy;

| 2. | Orders the Council of the European Union to bear its own costs and to pay the costs incurred by Tri Ocean Energy. |
| --- | --- |

2.

Orders the Council of the European Union to bear its own costs and to pay the costs incurred by Tri Ocean Energy.

---

(1)  OJ C 448, 15.12.2014

1

---
<PAGE>
 
                                                                    EXHIBIT 23.1

                         Consent of Ernst & Young LLP


We consent to the incorporation by reference in the Registration Statement 
(Form, S-8 No. 33-80927) pertaining to the 1993 Stock Option Plan, 1995 Employee
Stock Purchase Plan and the 1995 Non-Employee Director Stock Option Plan of our
report dated April 3, 1997, with respect to the consolidated financial
statements and schedule of Summit Medical Systems, Inc. for the three years
ended December 31, 1996, included in its Annual Report (Form 10-K/A) filed with
the Securities and Exchange Commission.


                                                       /s/ Ernst & Young LLP

Minneapolis, Minnesota
April 25, 1997
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.1 Scope. ( a ) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in commercial distribution.
( b ) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required in § 807.87.
( c ) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
( d ) Guidance documents referenced in this part are available on the Internet at *http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm .*
[52 FR 16122, May 1, 1987, as amended at 67 FR 58329, Sept. 16, 2002; 78 FR 18233, Mar. 26, 2013; 79 FR 50552, Aug. 25, 2014]
PUBLIC LAW 115–314—DEC. 13, 2018 132 STAT. 4431 

LEGISLATIVE HISTORY—S. 3442: 

CONGRESSIONAL RECORD, Vol. 164 (2018): 

Nov. 15, considered and passed Senate. 

Nov. 29, considered and passed House. 

Æ 

Public Law 115–314 

115th Congress 

An Act 

To designate the facility of the United States Postal Service located at 105 Duff 

Street in Macon, Missouri, as the ‘‘Arla W. Harrell Post Office’’. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. ARLA W. HARRELL POST OFFICE. 

(a) DESIGNATION.—The facility of the United States Postal 

Service located at 105 Duff Street in Macon, Missouri, shall be 

known and designated as the ‘‘Arla W. Harrell Post Office’’. 

(b) REFERENCES.—Any reference in a law, map, regulation, 

document, paper, or other record of the United States to the facility 

referred to in subsection (a) shall be deemed to be a reference 

to the ‘‘Arla W. Harrell Post Office’’. 

Approved December 13, 2018. 

Dec. 13, 2018 

[S. 3442] 


dkrause on DSKBC28HB2PROD with PUBLAWS
§ 501.18 Misbranding of animal food. ( a ) Among representations in the labeling of a food which render such food misbranded is a false or misleading representation with respect to another food or a drug, device, or cosmetic.
( b ) The labeling of a food which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such food in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling.
( c ) Among representations in the labeling of a food which render such food misbranded is any representation that expresses or implies a geographical origin of the food or any ingredient of the food except when such representation is either: ( 1 ) A truthful representation of geographical origin.
( 2 ) A trademark or trade name provided that as applied to the article in question its use is not deceptively misdescriptive. A trademark or trade name comprised in whole or in part of geographical words shall not be considered deceptively misdescriptive if it: ( i ) Has been so long and exclusively used by a manufacturer or distributor that it is generally understood by the consumer to mean the product of a particular manufacturer or distributor; or
( ii ) Is so arbitrary or fanciful that it is not generally understood by the consumer to suggest geographic origin.
( 3 ) A part of the name required by applicable Federal law or regulation.
( 4 ) A name whose market significance is generally understood by the consumer to connote a particular class, kind, type, or style of food rather than to indicate geographical origin.
NASA LogoNTRSNTRS - NASA Technical Reports ServerSearchmore_vertCollectionsAboutNewsHelpLogin Back to ResultsN+2 Advanced Low NOx Combustor Technology Final ReportIn accordance with NASAs technology goals for future subsonic vehicles, this contract identified and developed new combustor concepts toward meeting N+2 generation (2020) LTO (landing and take-off) NOx emissions reduction goal of 75 from the standard adopted at Committee on Aviation Environmental Protection 6 (CAEP6). Based on flame tube emissions, operability, and autoignition testing, one concept was down selected for sector testing at NASA. The N+2 combustor sector successfully demonstrated 75 reduction for LTO NOx (vs. CAEP6) and cruise NOx (vs. 2005 B777-200 reference) while maintaining 99.9 cruise efficiency and no increase in CO and HC emissions.The program also developed enabling technologies for the combustion system including ceramic matrix composites (CMC) liner materials, active combustion control concepts, and laser ignition for improved altitude relight.Document ID20170002700Acquisition SourceGlenn Research CenterDocument TypeContractor Report (CR)AuthorsHerbon, John*(General Electric Aviation Cincinnati, OH, United States)*Aicholtz, John*(General Electric Aviation Cincinnati, OH, United States)*Hsieh, Shih-Yang*(General Electric Aviation Cincinnati, OH, United States)*Viars, Philip*(General Electric Aviation Cincinnati, OH, United States)*Birmaher, Shai*(General Electric Aviation Cincinnati, OH, United States)*Brown, Dan*(General Electric Aviation Cincinnati, OH, United States)*Patel, Nayan*(General Electric Aviation Cincinnati, OH, United States)*Carper, Doug*(General Electric Aviation Cincinnati, OH, United States)*Cooper, Clay*(General Electric Aviation Cincinnati, OH, United States)*Fitzgerald, Russell*(General Electric Aviation Cincinnati, OH, United States)*Date AcquiredMarch 30, 2017Publication DateMarch 1, 2017Subject CategoryAircraft Propulsion And PowerReport/Patent NumberGRC-E-DAA-TN35615E-19298NASA/CR-2017-219410Funding Number(s)CONTRACT_GRANT: NNC10CA10CWBS: WBS 338881.02.26.03.01.01.01Distribution LimitsPublicCopyrightPublic Use Permitted.KeywordseraemissionsNOxAvailable DownloadsNameType20170002700.pdfSTIcloud_downloadcontent_copyvisibilityRelated RecordsThere are no records associated with this record.visibility_offNo Preview Available
 No Fear Act | Freedom of Information Act | Office of the Inspector General | Agency Financial ReportsNASA Web Privacy Policy and Important Notices | NASA Guidelines for Quality of InformationDisclaimers, Copyright, Terms of Use | Accessibility | NASA OCIO | USA.gov | NASA.govContact Us | Site MapSTI LogoNASA Official: JoAnne R. Calhoun Site Curator: STI Compliance and Distribution Services Last Modified: September 12, 2024
# C_2017277EN.01003001.xml

| 21.8.2017 | EN | Official Journal of the European Union | C 277/30 |
| --- | --- | --- | --- |

21.8.2017

EN

Official Journal of the European Union

C 277/30

---

Judgment of the General Court of 11 July 2017 — Viraj Profiles v Council

(Case T-67/14) (1)

1

((Dumping - Imports of certain stainless steel wires originating in India - Determination of the cost of production - Selling, General and Administrative costs - Obligation to state reasons - Injury - Causal link - Complaint - Opening of the investigation - Manifest error of assessment))

(2017/C 277/43)

Language of the case: English

Parties

Parties

Applicant: Viraj Profiles Ltd (Maharashtra, India) (represented by: V. Akritidis and Y. Melin, lawyers)

Applicant:

Defendant: Council of the European Union (represented: initially by B. Driessen, and subsequently by H. Marcos Fraile, acting as Agents, assisted by R. Bierwagen, C. Hipp and D. Reich, lawyers)

Defendant:

Intervener in support of the defendant: European Commission (represented by: J.-F. Brakeland and A. Stobiecka-Kuik, acting as Agents)

Intervener in support of the defendant:

Re:

Re:

Action pursuant to Article 263 TFEU for annulment of Council Implementing Regulation (EU) No 1106/2013 of 5 November 2013 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of certain stainless steel wires originating in India (OJ 2013 L 298, p. 1), in so far as it concerns the applicant.

Operative part of the judgment

Operative part of the judgment

The Court:

| 1. | Annuls Council Implementing Regulation (EU) No 1106/2013 of 5 November 2013 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of certain stainless steel wires originating in India, as far as it relates to Viraj Profiles Ltd; |
| --- | --- |

1.

Annuls Council Implementing Regulation (EU) No 1106/2013 of 5 November 2013 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of certain stainless steel wires originating in India, as far as it relates to Viraj Profiles Ltd;

| 2. | Orders the Council of the European Union to bear its own costs and to pay the costs incurred by Viraj Profiles; |
| --- | --- |

2.

Orders the Council of the European Union to bear its own costs and to pay the costs incurred by Viraj Profiles;

| 3. | Orders the European Commission to bear its own costs. |
| --- | --- |

3.

Orders the European Commission to bear its own costs.

---

(1)  OJ C 112, 14.4.2014.

1

---
#### § 352.71 Light source (solar simulator).

A solar simulator used for determining the SPF of a sunscreen drug product should be filtered so that it provides a continuous emission spectrum from 290 to 400 nanometers similar to sunlight at sea level from the sun at a zenith angle of 10° it has less than 1 percent of its total energy output contributed by nonsolar wavelengths shorter than 290 nanometers; and it has not more than 5 percent of its total energy output contributed by wavelengths longer than 400 nanometers. In addition, a solar simulator should have no significant time-related fluctuations in radiation emissions after an appropriate warmup time, and it should have good beam uniformity (within 10 percent) in the exposure plane. To ensure that the solar simulator delivers the appropriate spectrum of UV radiation, it must be measured periodically with an accurately-calibrated spectroradiometer system or equivalent instrument.
§ 251.21 Consequences for violations. ( a ) An article that is imported or offered for import into the United States in violation of section 804 of the Federal Food, Drug, and Cosmetic Act or this part is subject to refusal under section 801 of the Federal Food, Drug, and Cosmetic Act.
( b ) The importation of a prescription drug in violation of section 804 of the Federal Food, Drug, and Cosmetic Act; the falsification of any record required to be maintained or provided to FDA under section 804; or any other violation of this part is a prohibited act under section 301(aa) of the Federal Food, Drug, and Cosmetic Act.