alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
§ 310.547 Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria. ( a ) Quinine and quinine salts have been used OTC for the treatment and/or prevention of malaria, a serious and potentially life-threatening disease. Quinine is no longer the drug of choice for the treatment and/or prevention of most types of malaria. In addition, there are serious and complicating aspects of the disease itself and some potentially serious and life-threatening risks associated with the use of quinine at doses employed for the treatment of malaria. There is a lack of adequate data to establish general recognition of the safety of quinine drug products for OTC use in the treatment and/or prevention of malaria. Therefore, quinine or quinine salts cannot be safely and effectively used for the treatment and/or prevention of malaria except under the care and supervision of a doctor.
( b ) Any OTC drug product containing quinine or quinine salts that is labeled, represented, or promoted for the treatment and/or prevention of malaria is regarded as a new drug within the meaning of section 201(p) of 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 malaria 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 April 20, 1998, 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.
[63 FR 13528, Mar. 20, 1998]
[No. 40535-7-I.

Division One.

December 29, 1997.]

#### David White, et al., *Appellants,*v. The City of Blaine, et al., *Respondents.*

Appeal from a judgment of the Superior Court for What-com County, No. 94-2-02021-4, David A. Nichols, J., entered March 18, 1996. *Affirmed*by unpublished opinion per Baker, C.J., concurred in by Kennedy and Coleman, JJ.
July 7, 2015

Mr. Wayne Lee

5618 Powell Grove Drive

Midlothian, VA 23112

Dear Mr. Lee:

This letter is to inform you that we are unable to process your request for an exemption from 

Title 14, Code of Federal Regulations (14 CFR). It explains why we can not process your 

request and what you should do in the next 30 days.

Why We Can Not Process Your Request

We entered your June 26th 2015, exemption request into the public docket (No. FAA-2015-

2477), but we are unable to process your request any further. The information you sent does

not comply with the requirements of § 11.81 (copy enclosed). For us to consider the request 

any further, you must send us all of the following:

 The specific section or sections of 14 CFR from which you seek relief, the extent of the 

relief you seek, and the reason you seek relief.

 The reasons why granting the request would be in the public interest; that is, how it would 

benefit the public as a whole.

 The reasons why the exemption would not adversely affect safety or how the exemption 

would provide a level of safety at least equal to that provided by the rule from which you 

seek an exemption.

 Any additional information, views, or arguments available to support your request.

What You Should Do

If you want us to process your request any further, you must send the information described 

earlier to reach us within 30 days. Please note that § 11.63(d) requires you to send your 

petition for exemption at least 120 days before the proposed effective date of the exemption.
2

If We Do Not Hear From You

If we do not hear from you within 30 days, we will close the docket without notifying you 

further. If you have any questions or require additional time, you may call (202) 267-9677.

Sincerely,

Brittany Newton

Program Analyst, Airmen and 

 Airspace Rules Division

Enclosure
[Federal Register Volume 75, Number 37 (Thursday, February 25, 2010)]
[Notices]
[Page 8731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3760]



[[Page 8731]]

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

DEPARTMENT OF THE INTERIOR

Office of the Secretary


Privacy Act of 1974, as Amended; Revisions to the Existing System 
of Records

AGENCY: Office of the Secretary.

ACTION: Proposed revisions to an existing system of records.

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

SUMMARY: The Department of the Interior (DOI) is issuing public notice 
of its intent to amend a Department-wide Privacy Act System of Records 
Notice in its inventory of records systems subject to the Privacy Act 
of 1974 (5 U.S.C. 552a). DOI-71, ``Electronic FOIA Tracking System and 
FOIA Case Files--Interior,'' is being amended to include a centralized 
Office of the Solicitor FOIA (Freedom of Information Act) database and 
related files, as well as add their system owner and system location to 
the existing notice.

SYSTEM LOCATION:
    The additional system location is in the Office of the Solicitor 
network in the Department of the Interior (DOI), Washington, DC 20240.

SYSTEM MANAGER AND ADDRESS:
    The additional system manager is the Office of the Solicitor FOIA 
Officer, Office of the Solicitor, U.S. Department of the Interior, 1849 
C Street, NW., MS-6429 MIB, Washington, DC 20240, who has overall 
responsibility for the policies and procedures used to operate this 
system.

DATES: This amendment shall be effective on publication in the Federal 
Register (February 25, 2010). Additional information regarding this 
amendment may be obtained from the Departmental Privacy Office, 1849 C 
Street, NW., Mail Stop 7456, Washington, DC 20240, telephone (202) 208-
1605.

    Dated: February 5, 2010.
Linda S. Thomas,
Privacy Act Specialist, Departmental Privacy Office.
[FR Doc. 2010-3760 Filed 2-24-10; 8:45 am]
BILLING CODE 4310-RK-P
IN THE SUPREME COURT OF THE STATE OF MONTANA

No. DA 21-0584

STATE OF MONTANA,

Plaintiff and Appellee,

v.

MICHAEL JACOB DUNNE,

Defendant and Appellant.

ORDER

Upon consideration of Appellant’s motion for extension of time, 

and good cause appearing,

IT IS HEREBY ORDERED that Appellant is granted an extension 

of time to and including June 1, 2022, within which to prepare, file, and 

serve Appellant’s opening brief on appeal.

Electronically signed by:

Mike McGrath

Chief Justice, Montana Supreme Court

April 25 2022

04/25/2022

Case Number: DA 21-0584
Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### National Institutes of Health

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

*Name of Committee:*                         Center for Inherited Disease Research Access Committee.                    

*Date:*                         March 12, 2010.                    

*Time:*                         12:30 p.m. to 2 p.m.                    

*Agenda:*                         To review and evaluate grant applications.                     

*Place:*                         National Institutes of Health, 5635 Fishers Lane, Suite 4076, Bethesda, MD 20892 (Telephone Conference Call).                    

*Contact Person:*                         Camilla E. Day, PhD, Scientific Review Officer, CIDR, National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4075, Bethesda, MD 20892, 301-402-8837,                         *camilla.day@nih.gov.*

(Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS)

Dated: February 18, 2010.

Jennifer Spaeth,

Director, Office of Federal Advisory Committee Policy.

[FR Doc. 2010-3913 Filed 2-25-10; 8:45 am]

BILLING CODE 4140-01-P
###### 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.

#### § 314.170 Adulteration and misbranding of an approved drug.

All drugs, including those the Food and Drug Administration approves under section 505 of the act and this part, are subject to the adulteration and misbranding provisions in sections 501, 502, and 503 of the act. FDA is authorized to regulate approved new drugs by regulations issued through informal rulemaking under sections 501, 502, and 503 of the act.

[50 FR 7493, Feb. 22, 1985. Redesignated at 57 FR 17983, Apr. 28, 1992, and amended at 64 FR 402, Jan. 5, 1999]
### TEXAS COURT OF APPEALS, THIRD DISTRICT, AT AUSTIN

JUDGMENT RENDERED AU GUST 18, 2015

NO. 03

- 14

- 00380

- CR

Michael Stuart Burton, Appellant

v.

The State of Texas, Appellee

APPEAL FROM 264TH DISTRICT COURT OF BELL COUNTY

BEFORE JUSTICES PURYEAR, PE M BERTON, AND FIELD

AFFIRMED

-- OPINION BY JUSTICE PEMBERTON

This is an appeal from the judgment of conviction signed by the district court. Having reviewed

the record and the parties’ arguments, the Court holds that there was no reversible error in the

district court’s judgment of conviction . Therefore, the Court affirms the district court’s

judgment of conviction

. Because appellant is indigent and unable to pay costs , no adjudication

of costs is made.
<TABLE> <S> <C>

<ARTICLE> 5

<S>                             <C>
<PERIOD-TYPE>                   YEAR
<FISCAL-YEAR-END>                          DEC-31-1996
<PERIOD-START>                             JAN-01-1996
<PERIOD-END>                               DEC-31-1996
<CASH>                                         551,202
<SECURITIES>                                         0
<RECEIVABLES>                                   20,606
<ALLOWANCES>                                         0
<INVENTORY>                                     58,319
<CURRENT-ASSETS>                               641,740
<PP&E>                                       6,052,734
<DEPRECIATION>                               2,738,663
<TOTAL-ASSETS>                               3,986,972
<CURRENT-LIABILITIES>                          412,162
<BONDS>                                      3,181,870
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                             0
<OTHER-SE>                                     392,940
<TOTAL-LIABILITY-AND-EQUITY>                 3,986,972
<SALES>                                              0
<TOTAL-REVENUES>                             3,599,830
<CGS>                                                0
<TOTAL-COSTS>                                1,115,668
<OTHER-EXPENSES>                             1,241,218
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                             244,594
<INCOME-PRETAX>                              1,006,899
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                          1,006,899
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                 1,006,899
<EPS-PRIMARY>                                   211.22
<EPS-DILUTED>                                   211.22


</TABLE>
What are Long-Term Care Hospitals?

Revised August 2017

Most people who need inpatient hospital services are admitted to an 

“acute‐care” hospital for a relatively short stay. But some people may need a 

longer hospital stay. 

Long-term care hospitals (LTCHs) are certified as acute‐care hospitals, but 

LTCHs focus on patients who, on average, stay more than 25 days. Many 

of the patients in LTCHs are transferred there from an intensive or critical 

care unit. LTCHs specialize in treating patients who may have more than 

one serious condition, but who may improve with time and care, and return 

home. LTCHs generally give services like respiratory therapy, head trauma 

treatment, and pain management. 

I’ve heard a lot about “long-term care.” Is this the kind 

of care that LTCHs give? 

No. Long-term care usually refers to care that’s basically custodial, like help 

with feeding or dressing, even if there’s some health care given. Medicare 

doesn’t cover this kind of care, which can be given in your own home or in 

various kinds of facilities, like assisted living facilities. LTCHs are hospitals 

that give inpatient services to people who need a much longer stay to get well.

Do I pay more in a LTCH than in an acute-care hospital? 

Generally, no. Under Medicare, you’re only responsible for one deductible 

for any benefit period. A benefit period begins the day you’re admitted to a 

hospital or skilled nursing facility (SNF), and ends when you haven’t gotten 

any inpatient care in a hospital or SNF for 60 days in a row. This applies 

whether you’re in an acute care hospital or a LTCH.

You don’t have to pay a second deductible for your care in a LTCH if:

• You’re transferred to a LTCH directly from an acute‐care hospital.

• You’re admitted to a LTCH within 60 days of being discharged from an 

inpatient hospital stay.
2

Do I pay more in a LTCH than in an acute‐care hospital? 

(continued)

On the other hand, if you’re admitted directly to the LTCH more than 60 days after 

any previous hospital stay, you would pay the same deductibles and coinsurance as 

you would if you were being admitted to an acute‐care hospital.

Note: If you have Original Medicare and a Medicare Supplement Insurance 

(Medigap) policy, some of your deductible or coinsurance costs may be covered. 

If you have a Medicare Advantage Plan (like an HMO or PPO), you may 

have different ways to pay for care, so you should contact your plan for more 

information.

For more information about Medicare, visit Medicare.gov, or call 

1-800-MEDICARE (1-800-633-4227). TTY users can call 1-877-486-2048.

You have the right to get the information in this product in an alternate format. 

You also have the right to file a complaint if you feel you’ve been discriminated 

against. Visit CMS.gov/about-cms/agency-information/aboutwebsite/

cmsnondiscriminationnotice.html, or call 1-800-MEDICARE for more 

information.

CMS Product No. 11347
# Fourth Cou rt of Appeals San Antonio, Texas

December 22, 2022

No. 04

- 22

- 00261

- CR

Jose Manuel VILLAGRAN, Appellant

v.

The STATE of Texas, Appellee

From the 437th Judicial District Court

, Bexar County, Texas

Trial Court No. 2021CR3653B Honorable Melisa C. Skinner , Judge Presiding



### O R D E R

Appe llant’ s brief was originally due November 14 , 202 2

. We granted a ppellant’s first motion for extension of time

, extending the deadline for filing the brief to December 14 , 20 22

. On December 22

, 2022

, appellant filed a motion requesting an additional extension of time to file the brief until January 1 3 , 20 23 , for a total extension of 60 days

. After consideration, we GRANT the motion and ORDER appellant to file his brief by January 13, 2023

. Further requests for extension of time will be dis favored.

_________________________________ Beth Watkins , Justice

IN WITNESS WHEREOF, I have hereunto set my hand and affixed t he seal of the said court on this 22nd day of December, 2022

.

___________________________________ MICHAEL A. CRUZ

, Clerk of Court
# L_2018279EN.01003501.xml

| 9.11.2018 | EN | Official Journal of the European Union | L 279/35 |
| --- | --- | --- | --- |

9.11.2018

EN

Official Journal of the European Union

L 279/35

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1686

of 8 November 2018

on the minimum selling price for skimmed milk powder for the 27th partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),

Having regard to Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage (2), and in particular Article 32 thereof,

Whereas:

| (1) | Commission Implementing Regulation (EU) 2016/2080 (3) has opened the sale of skimmed milk powder by a tendering procedure. |
| --- | --- |

(1)

Commission Implementing Regulation (EU) 2016/2080 (3) has opened the sale of skimmed milk powder by a tendering procedure.

| (2) | In the light of the tenders received for the 27th partial invitation to tender, a minimum selling price should be fixed. |
| --- | --- |

(2)

In the light of the tenders received for the 27th partial invitation to tender, a minimum selling price should be fixed.

| (3) | The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets, |
| --- | --- |

(3)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

For the 27th partial invitation to tender for the selling of skimmed milk powder within the tendering procedure opened by Implementing Regulation (EU) 2016/2080, in respect of which the period during which tenders were to be submitted ended on 6 November 2018, the minimum selling price shall be 125,10 EUR/100 kg.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 November 2018.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General

Directorate-General for Agriculture and Rural Development

---

(1)  
  OJ L 347, 20.12.2013, p. 671.

1

(2)  
  OJ L 206, 30.7.2016, p. 71.

2

(3)  Commission Implementing Regulation (EU) 2016/2080 of 25 November 2016 opening the sale of skimmed milk powder by a tendering procedure (OJ L 321, 29.11.2016, p. 45).

3

---
Office of Management and Budget (OMB) and Office of Science and Technology Policy (OSTP) 

Comments on the Interagency Science Consultation Draft IRIS Assessment of tert-Butanol (dated 

September 2014)

Date: November 21, 2014

November 20, 2014

Interagency Review (Step 3) of EPA IRIS Toxicological Review of tert-Butanol

Dear EPA IRIS:

Thank you for the opportunity to provide comments on the draft Toxicological Review of tert-Butanol. 

We have comments on both the Preamble and the dose-response assessment.

Preamble Comments

As noted in the comments on the Preamble for ETBE and RDX, there are statements in the Preamble 

that amount to policy positions or decisions rather than scientific ones. Those comments are not 

reproduced here, but should be considered as part of this record. 

• For consistency with RDX and ETBE, the page numbers should be lower case Roman numerals

(the Preamble begins in lower case Roman numerals, but then switches to Arabic numerals).

Primary Comments

• Confusion regarding α2μ-globulin:

o p.ES-1, lines 30-32: “Mode of action analysis determined that male rat kidney effects 

were not mediated by α2u-globulin, and these effects are concluded to be relevant for 

human health hazard assessment.”

o p.ES-2, lines 16-18: “Mode of action analysis determined that male rat kidney effects 

were not mediated by α2u-globulin, and these effects are concluded to be relevant for 

human health hazard assessment.”

o p.ES-5, lines 17-20: “Because the available data supports the occurrence of at least two 

of the subsequent steps in the pathological sequence, these data are sufficient to 

conclude that α2u-globulin nephropathy is occurring in the kidney of male rats following 

tert-butanol exposure. Thus, the noncancer lesions associated with α2u-globulin 

nephropathy are not considered relevant to humans.”

• Table 2-6: please demarcate which rows (candidate values) are based off of a subchronic 

inhalation study or route-to-route extrapolation from a chronic drinking water study.

Comments on Charge to the SAB

• Follow-up to question 3e: Has EPA presented sufficient justification for deriving an oral slope 

factor and an inhalation unit risk when the cancer descriptor of “suggestive evidence” was 

concluded?
DISMISS and Opinion Filed August 27, 2019 

# S

In The 

## Court of Appeals Fifth District of Texas at Dallas
No. 05-19-00259-CV GLORIA VALICHKOFSKY BEY, Appellant V. CHURCHILL PROPERTIES, LLC, AND MISTY POSEY, Appellees On Appeal from the 298th Judicial District Court Dallas County, Texas Trial Court Cause No. DC-18-07116 

### MEMORANDUM OPINION Before Chief Justice Burns, Jus tice Molberg, and Justice Nowell Opinion by Chief Justice Burns Appellant’s brief in this case is overdue. On July 1, 2019, we ordered appellant’s brief filed by July 31, 2019. When it wa s not filed, we notified app ellant by postcard dated August 8, 2019 and directed her to file a brief and an extension motion w ithin ten days. We cautioned appellant that failure to file a brief and an extension motion would result in the dismissal of this appeal without further notice. To date, appellant has not filed her brief nor has she corresponded with the Court regarding t he status of this appeal. Accordingly, we dism iss this appeal. T EX
. R. A PP
. P. 38.8(a)(1); 42.3(b), (c).

190259F.P05 /Robert D. Burns, III/ ROBERT D. BURNS, III CHIEF JUSTICE–2– 

# S

Court of Appeals Fifth District of Texas at Dallas JUDGMENT
GLORIA VALICHKOFSKY BEY, Appellant
No. 05-19-00259-CV V. CHURCHILL PROPERTIES, LLC, AND MISTY POSEY, Appellees On Appeal from the 298th Judicial District Court, Dallas County, Texas Trial Court Cause No. DC-18-07116. Opinion delivered by Chief Justice Burns, Justices Molberg and Now ell participating.

In accordance with this Court’s opinion of this date, the appe al is DISMISSED

. Judgment entered August 27, 2019