alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
#### § 290.2 Exemption from prescription requirements.

The prescription-dispensing requirements of section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act are not necessary for the protection of the public health with respect to a compound, mixture, or preparation containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams that also includes one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by codeine alone.

[67 FR 4907, Feb. 1, 2002]
§ 348.50 Labeling of external analgesic drug products. ( a ) *Statement of identity.* The labeling of the product contains the established name of the drug, if any, and identifies the product as follows: ( 1 ) *For products containing any ingredient identified in § 348.10(a) .* “Male genital desensitizer.”
( 2 ) [Reserved]
( b ) *Indications.* The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section. 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 any ingredient identified in § 348.10(a) .* ( i ) “Helps in the prevention of premature ejaculation.”
( ii ) “For temporary male genital desensitization, helping to slow the onset of ejaculation.”
( iii ) “Helps in temporarily” (select one of the following: “retarding the onset of,” “slowing the onset of,” or “prolonging the time until”) followed by “ejaculation.”
( iv ) “For reducing oversensitivity in the male in advance of intercourse.”
( 2 ) [Reserved]
( c ) *Warnings.* The labeling of the product contains the following warnings under the heading “Warnings”: ( 1 ) *For products containing any ingredient identified in § 348.10(a) .* ( i ) “Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor.”
( ii ) “Avoid contact with the eyes.”
( iii ) “If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.”
( 2 ) [Reserved]
( d ) *Directions.* The labeling of the product contains the following information under the heading “Directions”: ( 1 ) *For products containing any ingredient identified in § 348.10(a)* — ( i ) *For products containing benzocaine identified in § 348.10(a)(1) .* “Apply a small amount to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.”
( ii ) *For products containing lidocaine identified in § 348.10(a)(2) .* “Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.”
( 2 ) [Reserved]
( e ) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section.
#### James B. Sunbury et al. *v.*United States Rubber Company

Baldwin, O’Sullivan, Wynne, Daly and Phillips, Js.

*597Argued June 16

decided July 19, 1955

*James M. Lynch,*with whom, on the brief, was *Morton H. Engelman,*for the appellant (defendant).

*Daniel Baker,*with whom was *Sydney C. Kweskin,*for the appellees (plaintiffs).

Phillips, J.

This is an appeal by the defendant from a judgment of the Superior Court sustaining a finding and award by the workmen’s compensation commissioner in favor of the plaintiffs as dependents of the deceased employee, their eighteen-year-old son. The finding that the plaintiffs were dependents of the deceased is one of fact and is conclusive unless the subordinate facts which the commissioner has found fail legally or logically to support it. *Northrop*v. *Merritt-Chapman & Scott Corporation,*106 Conn. 233, 234, 137 A. 724. The finding of dependency was amply justified by subordinate facts in the finding which were not even attacked in the motion to correct. The essentials of dependency — reliance upon the deceased’s contribu*598tions and expectation of their continuance — were fully satisfied. *Tsoukalas*v. *Bolton Mfg. Co.,*130 Conn. 658, 661, 37 A.2d 357.

There is no merit to the claim that changed conditions of fact after the injury have deprived the plaintiffs of their rights. The determination of dependency was made in accordance with the fact at the time of the injury, as provided by statute. Greneral Statutes § 7429.

The decedent was injured in June, 1950, and died in October, 1950. He was the oldest of the plaintiffs’ six children. The record shows that the plaintiffs have been engaged in a continuous struggle to provide the bare necessities of life for their family. The humane purposes of the Workmen’s Compensation Act have not been served by this protracted litigation over what were obviously questions of fact for the commissioner.

There is no error.

In this opinion the other judges concurred.
#### § 225.120 Buildings and grounds.

Buildings used for production of medicated feed shall provide adequate space for equipment, processing, and orderly receipt and storage of medicated feed. Areas shall include access for routine maintenance and cleaning of equipment. Buildings and grounds shall be constructed and maintained in a manner to minimize vermin and pest infestation.
§ 344.50 Labeling of earwax removal aid drug products. ( a ) *Statement of identity.* The labeling of the product contains the established name of the drug, if any, and identifies the product as an “earwax removal aid.”
( b ) *Indication.* The labeling of the product states, under the heading “Indication,” the following: “For occasional use as an aid to” (which may be followed by: “soften, loosen, and”) “remove excessive earwax.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of 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.
( c ) *Warnings.* The labeling of the product contains the following warnings under the heading “Warnings”: ( 1 ) “Do not use if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; consult a doctor.”
( 2 ) “Do not use if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor.”
( 3 ) “Do not use for more than 4 days; if excessive earwax remains after use of this product, consult a doctor.”
( 4 ) “Avoid contact with the eyes.”
( d ) *Directions.* The labeling of the product contains the following statement under the heading “Directions”: FOR USE IN THE EAR ONLY. Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Children under 12 years of age: consult a doctor.
[51 FR 28660, Aug. 8, 1986; 52 FR 7830, Mar. 13, 1987; 65 FR 48905, Aug. 10, 2000]
Office of the Secretary 

Office of State and Local 

Government Coordination & 

Preparedness 

Washington, DC 20531 

ODP Information Bulletin 

No. 186, August 17, 2005 

TO: All State Administrative Agency Heads 

 All State Administrative Agency Points of Contact 

 Eligible Transit Agency CEOs 

 

FROM: Matt A. Mayer 

 Acting Executive Director 

SUBJECT: Prevention and Response to Suicide Bombing Incidents (PRSBI) 

In light of the heightened concerns about possible attacks on transit assets here in the United States, 

the Office of State and Local Government Coordination and Preparedness (SLGCP) encourages all 

urban area and transit system partners to consider sending key safety and security personnel to 

SLGCP’s “Prevention and Response to Suicide Bombing Incidents (PRSBI)” course offered 

through the Energetic Materials Research and Testing Center (http://www.emrtc.nmt.edu/), an 

element of SLGCP’s National Domestic Preparedness Consortium.

This course provides training on the suicide bombing threat, including familiarization with improvised 

explosive devices (IED) and explosive materials typically used in suicide bombings. It also addresses 

actions that individual emergency responders can take to assist in preventing or deterring suicide 

bombings, as well as techniques, tactics, and procedures that support an effective and safe response to a 

suicide bombing. Course objectives include: 

3⁄4 Providing participants with the skills and knowledge necessary to identify and report pre-attack 

indicators, and to participate in an integrated response to a suicide bombing using safe and 

effective techniques, tactics, and procedures; and, 

3⁄4 Providing participants with the skills and knowledge necessary to prevent and/or deter suicide 

bombings, and to plan for and direct the repose to these incidents. 

Because of the relevance of this course to the current security situation for transit systems, States are 

instructed to give preference to transit personnel when scheduling this course. Transit systems interested 

in sending key personnel to this course should contact the designated Training Point-of-Contact (POC) 

for their State. A copy of the current POC list is attached. 

For more information on the PRSBI course, the authorized use of grant funds for IED prevention and 

detection, or to request assistance with problems encountered in the expenditure of grant funds, please 

contact your SLGCP Preparedness Officer, or the SLGCP Helpline at (800) 368-6498 or 

askcsid@dhs.gov.
NUCLEAR MODERNIZATION 

Importance of the Nuclear Triad

The Triad Has Stood the Test of Time

For more than six decades, the U.S. has emphasized the need for a nuclear 

force that credibly deters adversaries, assures allies and partners, and would 

achieve U.S. objectives should deterrence fail. Since the 1960s, these 

objectives have been met by the U.S. nuclear triad through forces operating at 

sea, on land, and in the air. Today’s nuclear triad consists of: 

♦ 14 ballistic missile submarines (SSBNs) armed with 240 submarine-launched ballistic missiles

♦ 400 land-based intercontinental ballistic missiles (ICBMs)

♦ 60 nuclear-capable heavy bomber aircraft capable of delivering gravity bombs and cruise missiles

These strategic forces are enabled by a secure nuclear command and control system and supplemented by a small 

number of non-strategic nuclear forces that provide an ability to forward-deploy forces in Europe and globally. 

Complementary Attributes for Robust Deterrence

Each leg of the triad provides unique and complementary attributes. Collectively, the triad seeks to ensure that no 

adversary believes it could launched a strategic attack that eliminates the United States’ ability to respond and inflict 

unacceptable damage—for any reason, under any circumstances.

Eliminating a leg of the triad would weaken the combined strength of the force and simplify adversary attack planning. 

For example, without U.S. ICBMs an adversary could potentially destroy all U.S. strategic nuclear forces by attacking 

fewer than ten targets—rather than hundreds of targets dispersed over several thousand square miles. Also, the 

triad’s diversity enables mitigation of risk if a particular leg of the triad is degraded or unavailable. 

Most of the systems that compose the triad are operating well beyond their original design lives—they must be 

modernized or they will be lost. With foreign nuclear threats growing, the importance of the triad endures. 

ICBMs are responsive

ICBMs are deployed in hundreds 

of silos and can be launched and 

reach targets within minutes, 

creating a nearly insurmountable

targeting problem for adversaries.

SSBNs are survivable

A portion of the SSBN fleet is

always on patrol, making them 

very difficult to track and 

therefore highly survivable.

Bombers are visible

Bombers are a clear and visible 

signal of U.S. intent and resolve 

during a crisis and provide a 

variety of deployment and yield 

options when placed on alert.

“The nuclear triad has kept the 

peace since nuclear weapons 

were introduced and has 

sustained the test of time.” 

– General Mark Milley, 

Chief of Staff of the Army

“Based on the collection of potential threats and adversaries that exist in the world, the Joint Chiefs affirmed the 

necessity to maintain a triad and to modernize the weapon systems, the indications and warning, and the 

command and control associated with that triad...We believe the triad is foundational to deterrence. It's not 

about how we view the triad; it's how our potential adversaries view the triad.”

– General Paul Selva, Vice Chairman of the Joint Chiefs of Staff
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FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

EXCEPTIONAL CHILD CENTER, INC.;

INCLUSION, INC.; TOMORROW’S

HOPE SATELLITE SERVICES, INC.;

WDB, INC.; LIVING INDEPENDENTLY

FOR EVERYONE, INC.,

Plaintiffs-Appellees,

v.

RICHARD ARMSTRONG; LESLIE

CLEMENT,

Defendants-Appellants.

No. 12-35382

D.C. No.

1:09-cv-00634-

BLW

ORDER

On Remand From The United States Supreme Court

Filed May 14, 2015

Before: Richard C. Tallman and Carlos T. Bea, Circuit

Judges, and Stephen Joseph Murphy,

*

 District Judge.

* The Honorable Stephen Joseph Murphy III, United States District

Judge for the Eastern District of Michigan, sitting by designation.
2 EXCEPTIONAL CHILD CTR. V. ARMSTRONG

ORDER

The original decision entered by this court, reported at

567 F. App’x 496, was reversed by the Supreme Court of the

United States. The Court held that the Supremacy Clause

does not provide an implied private right of action and that

Medicaid providers do not otherwise have the ability to

proceed in equity for enforcement of § 30(A) of the Medicaid

Act. See Armstrong v. Exceptional Child Ctr., Inc., 135 S. Ct.

1378 (2015). Accordingly, the Supreme Court has now

specifically addressed the question our court had previously

addressed, and the opinion upon which we relied, Indep.

Living Ctr. of S. Cal. v. Shewry, 543 F.3d 1050 (9th Cir.

2008), is no longer valid and is overruled. See Miller v.

Gammie, 335 F.3d 889, 893 (9th Cir. 2003) (en banc). In

accordance with the Supreme Court’s opinion, we vacate the

district court’s injunction, and remand with direction to the

district court to dismiss the Complaint for failure to establish

a claim over which we have subject matter jurisdiction under

Federal Rule of Civil Procedure 12(b)(1).

REVERSED and REMANDED.
Editorial Note on Part 316
Editorial Note: Nomenclature changes to part 316 appear at 69 FR 13717, Mar. 24, 2004.

§ 316.25 Refusal to grant orphan-drug designation. ( a ) FDA will refuse to grant a request for orphan-drug designation if any of the following reasons apply: ( 1 ) The drug is not intended for a rare disease or condition because: ( i ) There is insufficient evidence to support the estimate that the drug is intended for treatment of a disease or condition in fewer than 200,000 people in the United States, or that the drug is intended for use in prevention or in diagnosis in fewer than 200,000 people annually in the United States; or
( ii ) Where the drug is intended for prevention, diagnosis, or treatment of a disease or condition affecting 200,000 or more people in the United States, the sponsor has failed to demonstrate that there is no reasonable expectation that development and production costs will be recovered from sales of the drug for such disease or condition in the United States. A sponsor's failure to comply with § 316.21 shall constitute a failure to make the demonstration required in this paragraph.
( 2 ) There is insufficient information about the drug, or the disease or condition for which it is intended, to establish a medically plausible basis for expecting the drug to be effective in the prevention, diagnosis, or treatment of that disease or condition.
( 3 ) The drug is otherwise the same drug as an already approved drug for the same rare disease or condition and the sponsor has not submitted a medically plausible hypothesis for the possible clinical superiority of the subsequent drug.
( b ) FDA may refuse to grant a request for orphan-drug designation if the request for designation contains an untrue statement of material fact or omits material information or if the request is otherwise ineligible under this part.
[57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35133, June 12, 2013]
#### UNITED STATES of America, Plaintiff-Appellee, v. Raymond Robert ZOCCOLA, Defendant-Appellant.

No. 75-1200.

United States Court of Appeals, Ninth Circuit.

Feb. 13, 1975.

Rehearing Denied July 31, 1975.

*234William M. Coffey, Milwaukee, Wis., for defendant-appellant.

William C. Smitherman, U. S. Atty., Tucson, Ariz., for plaintiff-appellee.

OPINION

CHAMBERS, Circuit Judge:

Zoccola has been convicted in the district of Arizona of trafficking in heroin. On his trial, he was represented by a Wisconsin lawyer. The case was not in forma pauperis prior to conviction.

On appeal the district court approved a transcript at government expense under the Criminal Justice Act and appointed John Lindberg as Zoccola’s attorney for the appeal, also under the Criminal Justice Act. I take judicial notice of what I know personally: that Mr. Lind-berg is an outstanding attorney in the criminal field.

Now as the deadline for the appellant to file his brief arrives, Mr. Zoccola presents to the court S. Jeffrey Minker, of Tucson, another lawyer, to be substituted for the appeal. This might delay the appeal. I assume that Mr. Minker is quite competent.

Of course, ordinarily a man is entitled to an attorney of his own choice. The district court has denied the substitution none the less, and on application here I deny it without prejudice to further consideration on reapplication.

Here is what motivates the district court: Mr. Minker will be paid by a Miss Pat Mokma, described by Mr. Minker as Mr. Zoccola’s “girl friend.” She will pay Mr. Minker by giving him title to a vintage Cadillac admittedly worth $2,000 to $2,500. The district court is concerned about the government paying for the transcript in such circumstances after the defendant had represented to the court that he could not arrange to pay for either a lawyer or the transcript.

It is requested that the district court hold a further hearing and inquire into:

1. The history of any financial transactions between Miss Mokma and Mr. Zoccola.

2. What is a reasonable fee for Mr. Minker to charge for the appeal. Here the fee may be reasonable, but certainly the court can consider the reasonableness of the fee in deciding whether the government should pay for the transcript.

3. Did Mr. Zoccola know Miss Mokma and about her Cadillac at the time he represented to the court that he could not get private counsel.

Counsel has indicated Miss Mokma will pay for the transcript if this court says so. On the present record, I am not prepared to say so, although I think so. But if the district court still refuses after a further hearing, which at all events I desire, to permit the substitution, I will further consider the substitution matter.

Meanwhile, counsel are reminded that appellant’s opening brief is due here March 3, 1975, and this deadline must be *235met. I do not see how Mr. Minker could meet it when he says he has not yet opened a file on the case.

This court may have to consider revoking Mr. Zoccola’s bail if the deadline is not met.
Exhibit 15.5




[BDO Auditores S.L.P. Letterhead]




March 21, 2016





Securities and Exchange Commission


100 F Street N.E.


Washington, D.C. 20549





We have been furnished with a copy of the response to Item 16F of Form 20-F of Ellomay Capital Limited for the event that occurred on November 3, 2015, related to Ellomay Spain, S.L., Rodriguez I Parque Solar, S.L. and Rodriguez II Parque Solar, S.L. We agree with the statements made in response to that Item insofar as they relate to our Firm.





Very truly yours,





/s/ BDO Auditores S.L.P.


BDO Auditores S.L.P.
#### § 26.78 Agreements with other countries.

Except where there is written agreement between the parties, obligations contained in mutual recognition agreements concluded by either party with a party not a party to the agreement from which this part is derived (a third party) shall have no force and effect with regard to the other party in terms of acceptance of the results of conformity assessment procedures in the third party.
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 June 30, 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: July 29, 2004



/s/ Theodore L. ArenaTheodore L. Arena, Chief Executive Officer




/s/ Thomas J. MulroneyThomas J. Mulroney, Chief Financial Officer