alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 866
Editorial Note: Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.

§ 866.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: ( a ) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;
( b ) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or
( c ) The device is an in vitro device that is intended: ( 1 ) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;
( 2 ) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;
( 3 ) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;
( 4 ) For assessing the risk of cardiovascular diseases;
( 5 ) For use in diabetes management;
( 6 ) For identifying or inferring the identity of a microorganism directly from clinical material;
( 7 ) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;
( 8 ) For noninvasive testing as defined in § 812.3(k) of this chapter; and
( 9 ) For near patient testing (point of care).
[65 FR 2311, Jan. 14, 2000]
EXHIBIT 10.9 (h)

                       ASSIGNMENT AND ASSUMPTION AGREEMENT

         THIS ASSIGNMENT AND ASSUMPTION AGREEMENT ("Agreement") is entered into
this 1st day of November 2002 by and between Ledger Technologies Pty Ltd,
(A.C.N. 085 887 921) of Bickhams Court East St. Kilda, Victoria 3183, Australia
("Assignor") and Cohero Group, Inc., of 253 5th Avenue 7th Floor, New York, NY
10016, ("Assignee").

         Pursuant to the terms of this Agreement, in exchange for the
satisfaction of $152,084 (USD) of oblications owed by Assignor to Assignee in
connection with the loan arrangements reached in February 2002, , Assignor
hereby assigns, conveys, transfers and delivers all of its right, title and
interest in and to $152,084 (USD) that remains of the certain Promissory Note
(Loan Agreement) dated November 8, 2000 (the "Loan") due from I.T. Technology,
Inc., a Delaware corporation (the "Obligor") to Assignor (the "Note Assignment")

         In connection with and limited to the Note Assignment, Assignee hereby
agrees to assume all of Assignor's obligations under that certain Loan Agreement
dated November 8, 2000 between the Assignor and the Obligor.

         IN WITNESS WHEREOF, Assignor, Assignee and the Obligor have duly
executed this Assignment and Assumption Agreement as of the date first above
written.


                                                   LEDGER TECHNOLOGIES PTY LTD

                                                   By: /s/Lisa Mochkin
                                                   Name: Lisa Mochkin
                                                   Title: Director


                                                   COHERO GROUP, INC.


                                                   By: /s/ Mendel Mochkin
                                                   Name: Mendel Mochkin
                                                   Title: Managing Director
                                    .
AGREED TO AND ACCEPTED
THIS 4th DAY OF NOVEMBER  2002

I.T. TECHNOLOGY, INC.

By: /s/ Yam-Hin Tan
Name: Yam-Hin Tan
Title: Chief Financial Officer
Editorial Note on Part 878
Editorial Note: Nomenclature changes to part 878 appear at 73 FR 35341, June 23, 2008.

§ 878.3800 External aesthetic restoration prosthesis. ( a ) *Identification.* An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.
( b ) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]
Editorial Note on Part 860
Editorial Note: Nomenclature changes to part 860 appear at 73 FR 35341, June 23, 2008, and at 86 FR 54846, Oct. 5, 2021.

§ 860.10 Implants and life-supporting or life-sustaining devices. ( a ) A classification panel will recommend classification into class III of any implant or life-supporting or life-sustaining device unless the panel determines that such classification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. If the panel recommends classification or reclassification of such a device into a class other than class III, it shall set forth in its recommendation the reasons for so doing and an identification of the risks to health, if any, presented by the device. In the case of such a device being recommended for classification or reclassification into class II, the panel shall describe the special controls that, in addition to general controls, the panel believes are necessary to provide reasonable assurance of safety and effectiveness of the device and how such controls provide such assurance.
( b ) The Commissioner will classify an implant or life-supporting or life-sustaining device into class III unless the Commissioner determines that such classification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. If the Commissioner proposes to classify or reclassify such a device into a class other than class III, the regulation or order effecting such classification or reclassification will be accompanied by a full statement of the reasons for so doing. A statement of the reasons for not classifying or retaining the device in class III may be in the form of concurrence with the reasons for the recommendation of the classification panel, together with supporting documentation and data satisfying the requirements of § 860.7 and an identification of the risks to health, if any, presented by the device. In the case of such a device being classified or reclassified into class II, the Commissioner shall describe the special controls that, in addition to general controls, the panel believes are necessary to provide reasonable assurance of safety and effectiveness of the device and how such controls provide such assurance.
[83 FR 64455, Dec. 17, 2018]
### Page 1 of 3 **Disposition Comments Docket No:**  

### FAA - 201 4 - 0258 These comments are in **Directorate ID:** 

### 201 3 -NM - 065 - AD response to an SNPRM Originating Office Tracking No.: 

### 2013 - 0051 **Next Step:** FRAN SNPRM 

### N o C omments/Only

Supportive Comments Received

– If this box is checked, no signatures are required. No 

### Has the reference d service information been revised since the NPRM was issued? I f ye s, list latest revision and attach a cop y. Note that changes beyond the scope of the previously published NPRM will require a new notice. Contact the Directorate focal point for guidance. Instructions: Summarize all comments **by issue** (not by commenter) and provide your recommended resolution of each issue. **All comments relating to the sam e issue should be discussed together.**  Do not list all of the issues from one commenter together. If changes to the AD are required based on the comments received, explain why and describe in detail what change(s) you recommend. Reference FAA - IR- M - 8040.1C Chapter 9. **ISSUE 1:** Select one o

f the following : If other, explain : Commenter(s): What change to the AD action is requested? Why is the change requested or how is it justified? Do we agree? If **YES,** we agree because Make the following changes to the AD: If **PARTIALLY AGREE** , we agree with because We disagree with because

Make the following changes to the AD: If **NO** , we don’t agree because **ISSUE 2**  **:** Select one of the following :

If other, explain : Commenter(s): What change to the AD action is requested? Why is the change requested or how is it justified? Do we agree? If **YES,** we agree because Make the following changes to the AD: If **PARTIALLY AGREE** , we agree w ith because We disagree with because Make the following changes to the AD:

### Page 2 of 3

If **NO** , we don’t agree because **For additional issues, do uble**  **- click**  **here**

### Page 3 of 3 **S ignature Section**  Signature indicates concurrence with this action. Originating Office Tracking No.: **ASE** Printed Name **: Date** 

**Branch Man ager**  **Date**
§ 861.34 Amendment or revocation of a standard. ( a ) The Food and Drug Administration will provide for periodic evaluation of performance standards to determine whether such standards should be changed to reflect new medical, scientific, or other technological data.
( b ) The Food and Drug Administration may, on its own initiative or upon petition of an interested party, amend or revoke by regulation a standard established under this part.
( c ) Any petition to amend or revoke a standard shall: ( 1 ) Identify the specific device and standard for which the amendment or revocation is sought; and
( 2 ) Be submitted in accordance with the requirements of § 10.30.
( d ) Proceedings to amend or revoke a performance standard shall be conducted in accordance with the rulemaking procedures of § 10.40. In addition, a notice of proposed rulemaking to amend or revoke a standard shall set forth proposed findings with respect to the degree of risk or illness to be eliminated or reduced and the benefit the public will derive from the proposed amendment or revocation.
§ 900.13 Revocation of accreditation and revocation of accreditation body approval. ( a ) *FDA action following revocation of accreditation.* If a facility's accreditation is revoked by an accreditation body, the agency may conduct an investigation into the reasons for the revocation. Following such investigation, the agency may determine that the facility's certificate shall no longer be in effect or the agency may take whatever other action or combination of actions will best protect the public health, including the establishment and implementation of a corrective plan of action that will permit the certificate to continue in effect while the facility seeks reaccreditation. A facility whose certificate is no longer in effect because it has lost its accreditation may not practice mammography.
( b ) *Withdrawal of FDA approval of an accreditation body.* ( 1 ) If FDA withdraws approval of an accreditation body under § 900.6, the certificates of facilities previously accredited by such body shall remain in effect for up to 1 year from the date of the withdrawal of approval, unless FDA determines, in order to protect human health or because the accreditation body fraudulently accredited facilities, that the certificates of some or all of the facilities should be revoked or suspended or that a shorter time period should be established for the certificates to remain in effect.
( 2 ) After 1 year from the date of withdrawal of approval of an accreditation body, or within any shorter period of time established by the agency, the affected facilities must obtain accreditation from another accreditation body, or from another entity designated by FDA.
# C_2014361EN.01002102.xml

| 13.10.2014 | EN | Official Journal of the European Union | C 361/21 |
| --- | --- | --- | --- |

13.10.2014

EN

Official Journal of the European Union

C 361/21

---

Action brought on 11 August 2014 — Almashreq Investment Fund v Council

(Case T-604/14)

2014/C 361/32

Language of the case: French

Parties

Parties

Applicant: Almashreq Investment Fund (Damascus, Syria) (represented by: E. Ruchat and C. Cornet d'Elzius, lawyers)

Applicant:

Defendant: Council of the European Union

Defendant:

Form of order sought

Form of order sought

The applicant claims that the Court should:

| — | declare the applicant’s action admissible and well-founded; |
| --- | --- |

—

declare the applicant’s action admissible and well-founded;

| — | in consequence, annul Decision 2014/309/CFSP of 28 May 2014 and its subsequent implementing measures, insofar as they concern the applicant; |
| --- | --- |

—

in consequence, annul Decision 2014/309/CFSP of 28 May 2014 and its subsequent implementing measures, insofar as they concern the applicant;

| — | order the Council of the European Union to pay the costs of the proceedings. |
| --- | --- |

—

order the Council of the European Union to pay the costs of the proceedings.

Pleas in law and main arguments

Pleas in law and main arguments

In support of the action, the applicant relies on three pleas in law which are in essence identical or similar to those relied on in Case T-432/11 Makhlouf v Council
   (1).

Makhlouf

Council

1

---

(1)  OJ C 290, p. 13.

1

---
§ 884.3650 Fallopian tube prosthesis. ( a ) *Identification.* A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.
( b ) *Classification.* Class II (performance standards).
Editorial Note on Part 886
Editorial Note: Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.

§ 886.1905 Nystagmus tape. ( a ) *Identification.* Nystagmus tape is a device that is a long, narrow strip of fabric or other flexible material on which a series of objects are printed. The device is intended to be moved across a patient's field of vision to elicit optokinetic nystagmus (abnormal and irregular eye movements) and to test for blindness.
( b ) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001]
UNITED STATES NAVY–MARINE CORPS

COURT OF CRIMINAL APPEALS

_________________________

No. 201600373

_________________________

UNITED STATES OF AMERICA

Appellee

v.

JOSE R. SALAZAR

Corporal (E-4), U.S. Marine Corps

Appellant

_________________________

Appeal from the United States Navy-Marine Corps Trial Judiciary

Military Judge: Colonel James K. Carberry, USMC.

Convening Authority: Commanding General, 1st Marine Division, 

Camp Pendleton, CA.

Staff Judge Advocate’s Recommendation: Lieutenant Colonel 

Matthew J. Stewart, USMC.

For Appellant: Commander Suzanne M. Lachelier, JAGC, USN.

For Appellee: Brian K. Keller, Esq.

_________________________

Decided 23 February 2017

_________________________

Before CAMPBELL, RUGH, and HUTCHISON, Appellate Military Judges

_________________________

After careful consideration of the record, submitted without assignment of 

error, we affirm the findings and sentence as approved by the convening 

authority. Art. 66(c), Uniform Code of Military Justice, 10 U.S.C. § 866(c). 

For the Court

R.H. TROIDL

Clerk of Court
```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7875 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                                H. R. 7875

   To direct the Secretary of State to designate MS-13 as a foreign 
            terrorist organization, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             April 5, 2024

Mr. Good of Virginia introduced the following bill; which was referred 
                   to the Committee on the Judiciary

_______________________________________________________________________

                                 A BILL

 
   To direct the Secretary of State to designate MS-13 as a foreign 
            terrorist organization, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Every Town A Border Town Act''.

SEC. 2. DESIGNATION OF MS-13 AS A FOREIGN TERRORIST ORGANIZATION.

    On the date of enactment of this Act, the Secretary of State shall 
designate Mara Salvatrucha (MS-13) (and any successor organization) as 
a foreign terrorist organization in accordance with section 219 of the 
Immigration and Nationality Act (8 U.S.C. 1189).

SEC. 3. MEMBERS OF MS-13 CONSIDERED TO HAVE ENGAGED IN TERRORIST 
              ACTIVITY.

    Section 212(a)(3)(B)(i) of the Immigration and Nationality Act (8 
U.S.C. 1182(a)(3)(B)(i)) is amended by adding at the end the following: 
``An alien who is a member, officer, official, representative, or 
spokesman of Mara Salvatrucha (MS-13) is considered, for the purposes 
of this Act, to have engaged in terrorist activity.''.
                                 <all>
```
<TABLE> <S> <C>


<ARTICLE> 5

<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM AVITAR'S
REPORT FOR THE NINE MONTHS ENDED JUNE 30, 1998 AND IS QUALIFIED IN ITS ENTIRETY
BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>

       
<S>                                     <C>
<PERIOD-TYPE>                           9-MOS
<FISCAL-YEAR-END>                       SEP-30-1998
<PERIOD-START>                          OCT-1-1997
<PERIOD-END>                            JUN-30-1998
<CASH>                                       26,248
<SECURITIES>                                      0
<RECEIVABLES>                               437,722
<ALLOWANCES>                                  3,200
<INVENTORY>                                 181,475
<CURRENT-ASSETS>                            772,450
<PP&E>                                      931,072
<DEPRECIATION>                              750,474
<TOTAL-ASSETS>                              967,733
<CURRENT-LIABILITIES>                     2,002,394
<BONDS>                                           0
<PREFERRED-MANDATORY>                             0
<PREFERRED>                                   7,072
<COMMON>                                    174,697
<OTHER-SE>                              (1,271,370)
<TOTAL-LIABILITY-AND-EQUITY>                967,733
<SALES>                                   1,560,299
<TOTAL-REVENUES>                          1,560,299
<CGS>                                     1,395,331
<TOTAL-COSTS>                             2,919,026
<OTHER-EXPENSES>                                  0
<LOSS-PROVISION>                                  0
<INTEREST-EXPENSE>                           94,173
<INCOME-PRETAX>                            (300,552)
<INCOME-TAX>                                      0
<INCOME-CONTINUING>                      (1,436,722)
<DISCONTINUED>                            1,136,170
<EXTRAORDINARY>                                   0
<CHANGES>                                         0
<NET-INCOME>                               (300,552)
<EPS-PRIMARY>                                  (.02)
<EPS-DILUTED>                                  (.02)
        


</TABLE>
Editorial Note on Part 888
Editorial Note: Nomenclature changes to part 888 appear at 73 FR 35341, June 23, 2008.

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. ( a ) *Identification.* A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).
( b ) *Classification.* Class II.
Editorial Note on Part 886
Editorial Note: Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.

§ 886.1760 Ophthalmic refractometer. ( a ) *Identification.* An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.
( b ) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38812, July 25, 2001]
**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 Quarterly Report onForm 10-Q of Ebix, Inc. (the “Company”) for the quarterly period ended March31, 2004, as filed with the Securities and Exchange Commission on the datehereof (the “Report”), I, Robin Raina, Chief Executive Officer of the Company,certify, pursuant to 18 U.S.C. 1350, as adopted pursuant to 906 of theSarbanes-Oxley Act of 2002, that:

 

1. The Report fully complieswith the requirements of section 13(a) or 15(d) of the Securities Exchange Actof 1934; and

 

2. The information contained inthe Report fairly presents, in all material respects, the financial conditionand results of operations of the Company.

 
| By:                      | /s/ Robin  Raina |   |
|--------------------------|------------------|--------|
|                     |             |
| Name:                    | Robin Raina      |   |
|                     |             |
| Chief  Executive Officer |             |
|                     |             |
| May 17, 2004             |             |
|                          |                  |        |  |

 

1

----