alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 880
Editorial Note: Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.

§ 880.5270 Neonatal eye pad. ( a ) *Identification.* A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.
( 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 § 880.9. If the device is not labeled or otherwise represented as sterile, it 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 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]
Editorial Note on Part 866
Editorial Note: Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.

§ 866.5560 Lactic dehydrogenase immunological test system. ( a ) *Identification.* A lactic dehydrogenase immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the activity of the lactic dehydrogenase enzyme in serum. Increased levels of lactic dehydrogenase are found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood-forming organs). However, the diagnostic usefulness of this device is limited because of the many conditions known to cause increased lactic dehydrogenase levels.
( 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 § 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]
Editorial Note on Part 184
Editorial Note: Nomenclature changes to part 184 appear at 66 FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 69 FR 13717, Mar. 24, 2004; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005; and 81 FR 49897, July 29, 2016.

§ 184.1984 Zein. ( a ) Zein (CAS Reg. No. 9010-66-6) is one of the components of corn gluten. It is produced commercially by extraction from corn gluten with alkaline aqueous isopropyl alcohol containing sodium hydroxide. The extract is then cooled, which causes the zein to precipitate.
( b ) The ingredient must be of a purity suitable for its intended use.
( c ) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: ( 1 ) The ingredient is used as a surface-finishing agent as defined in § 170.3(o)(30) of this chapter.
( 2 ) The ingredient is used in food at levels not to exceed current good manufacturing practice.
( d ) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
[50 FR 8999, Mar. 6, 1985, as amended at 73 FR 8608, Feb. 14, 2008]
**Exhibit32.1**

 

**CERTIFICATIONOF PERIODIC REPORT**

 

I, William W. Hunt, President and Chief Executive Officer of PennTreaty American Corporation, certify, pursuant to Section 906 of theSarbanes-Oxley Act of 2002, 18 U.S.C.Section 1350, that:

 

(1) the Quarterly Report on Form 10-Q of the Company for the quarterlyperiod ended September 30, 2003 (the “Report’’) fully complies with therequirements of Section 13(a) or 15(d) of the Securities Exchange Act of1934 (15 U.S.C. 78m or 78o(d)); and

 

(2) the information contained in the Report fairly presents, in allmaterial respects, the financial condition and results of operations of theCompany.

 
| Date:  November 11, 2003 | /s/ William W. Hunt                    |   |
|------------------------------------|----------------------------------------|--------|
|                               | William W. Hunt                        |
|                               | President and Chief  Executive Officer |

 

1

----
EXHIBIT 32.2

                  CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
                       ARMANINO FOODS OF DISTINCTION, INC.
                       PURSUANT TO 18 U.S.C. SECTION 1350


     I hereby certify that, to the best of my knowledge, the Quarterly Report
on Form 10-QSB of Armanino Foods of Distinction, Inc. for the period ending
June 30, 2004:

     (1) 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 aspects, the financial condition and results of operations of
Armanino Foods of Distinction, Inc.





/s/ Edmond J. Pera
Edmond J. Pera
Chief Operating Officer
(Principal Financial Officer)
August 9, 2004


A signed original of this written statement required by Section 906 of the
Sarbanes-Oxley Act of 2002 has been provided to Armanino Foods of Distinction,
Inc. and will be retained by Armanino Foods of Distinction, Inc. and furnished
to the Securities and Exchange Commission upon request.
Exhibit 31.2



CERTIFICATION OF PRINCIPAL FINANCIAL
OFFICER

PURSUANT TO

SECTION 13(a) OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934

AS ADOPTED PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT
OF 2002



I, Lawrence A. Kenyon, certify that:



| | 1. | I have reviewed this Amendment No. 1 to the Annual Report
on Form 10-K of Oncobiologics, Inc. (the “registrant”); and
| | -- | ---------------------------------------------------------------------------------------------------------------------



| | 2. | Based on my knowledge, this report does not contain any
untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this report.
| | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Date: January 29, 2018



|/s/ Lawrence A. Kenyon  | 
|----------------------- | 
|Lawrence A. Kenyon      | 
|Chief Financial Officer |
[Federal Register Volume 75, Number 46 (Wednesday, March 10, 2010)]
[Notices]
[Page 11185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4992]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Centers for Medicare & Medicaid Services; Delegation of Authority

    Notice is hereby given that I have delegated to the Administrator, 
Centers for Medicare & Medicaid Services (CMS), or his or her 
successor, the authorities currently vested in the Secretary under 
section 1135 [42 U.S.C. 1320b-5] of Title XI of the Social Security 
Act, and as may hereafter be amended, to temporarily waive or modify 
requirements during certain emergencies or disasters that are related 
to Medicare, Medicaid, and the Children's Health Insurance Programs as 
they pertain to the mission of CMS.
    The authorities under section 1135 [42 U.S.C. 1320b-5] of the 
Social Security Act, and as may hereafter be amended, may be re-
delegated.

Limitations

    1. The authority to make the initial decision to invoke the waiver 
authorities under section 1135 [42 U.S.C. 1320b-5] upon the occurrence 
of the two conditions precedent specified in section 1135(g) [42 U.S.C. 
1320b-5(g)] is excluded from this delegation and is reserved by me.
    2. The following authorities under section 1135 [42 U.S.C. 1320b-5] 
of the Social Security Act, and as may hereafter be amended, are 
excluded from this delegation of authority:

--Section 1135(b)(7) pertaining to sanctions and penalties that arise 
from noncompliance with certain requirements of regulations promulgated 
under section 264(c) of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) [42 U.S.C. 1320d-2 note]. The 
authority to waive the HIPAA regulations at 45 of the Code of Federal 
Regulations, Part 164 will continue to be held by me.
--Section 1135(d) to provide a certification and advance written notice 
to Congress at least two days before exercising the authority with 
respect to an emergency area is reserved by me.
--Section 1135(f) to report to Congress regarding the approaches used 
to accomplish the purposes described in section 1135(a) [42 U.S.C. 
1320b-5] of the Social Security Act, including an evaluation of such 
approaches and recommendations for improved approaches should the need 
for such emergency authority arise in the future is reserved by me.

    3. The authorities under section 1135 [42 U.S.C. 1320b-5] shall be 
exercised under the Department's policy on regulations and the existing 
delegation of authority to approve and issue regulations.
    I hereby affirm and ratify any actions taken by the Administrator, 
CMS, or his or her subordinates, which involved the exercise of the 
authorities under section 1135 [42 U.S.C. 1320b-5] delegated herein 
prior to the effective date of this delegation of authority.
    This delegation of authority is effective immediately.

    Authority:  44 U.S.C. 3101.

Kathleen Sebelius,
Secretary.
[FR Doc. 2010-4992 Filed 3-9-10; 8:45 am]
BILLING CODE 4120-01-P
I 

118TH CONGRESS 

1ST SESSION H. R. 75 

To repeal the authority of the Food and Drug Administration to require 

that drugs be dispensed only upon prescription, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 9, 2023 

Mr. BIGGS introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL 

To repeal the authority of the Food and Drug Administration 

to require that drugs be dispensed only upon prescription, and for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Prescription Freedom 

5 Act of 2023’’. 

6 SEC. 2. REPEAL OF FDA AUTHORITY TO REQUIRE PRE7 SCRIPTIONS. 

8 (a) REPEAL.—Effective as of the date that is 6 

9 months after the date of enactment of this Act, subsection 


kjohnson on DSK79L0C42PROD with BILLS
2 

•HR 75 IH

1 (b) of section 503 of the Federal Food, Drug, and Cos2 metic Act (21 U.S.C. 353) is repealed. 

3 (b) REFERENCES.—Beginning on the effective date 

4 described in subsection (a), any reference in a Federal 

5 statute, regulation, or guidance— 

6 (1) to prescribing, a prescription, a prescription 

7 drug, or a drug subject to section 503(b) of the Fed8 eral Food, Drug, and Cosmetic Act is deemed to be 

9 a reference to prescribing, a prescription, or a pre10 scription drug, respectively, under applicable State 

11 law; and 

12 (2) to any requirement or provision of section 

13 503(b) of the Federal Food, Drug, and Cosmetic Act 

14 is deemed to be a reference to the corresponding re15 quirement or provision, if any, in applicable State 

16 law, as determined by the Federal official or officials 

17 responsible for administering the respective Federal 

18 statute, regulation, or guidance. 

19 (c) EXCEPTION.—Notwithstanding subsections (a) 

20 and (b), the Secretary of Health and Human Services may 

21 continue to exercise the authority vested by subsection (b) 

22 of section 503 of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 353), as in effect on the day before the 

24 effective date described in subsection (a), with respect to 


kjohnson on DSK79L0C42PROD with BILLS
3 

•HR 75 IH

1 any drug that is intended for use in terminating a preg2 nancy. 

Æ 


kjohnson on DSK79L0C42PROD with BILLS
Editorial Note on Part 872
Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

§ 872.5571 Auto titration device for oral appliances. ( a ) *Identification.* An auto-titration device for oral appliances is a prescription home use device that determines a target position to be used for a final oral appliance for the reduction of snoring and mild to moderate obstructive sleep apnea.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) Clinical performance testing must evaluate the following: ( i ) Performance characteristics of the algorithm; and
( ii ) All adverse events.
( 2 ) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following: ( i ) Validation of the closed loop algorithm;
( ii ) Mechanical integrity over the expected use life;
( iii ) Characterization of maximum force, distance, and speed of device movement; and
( iv ) Movement accuracy of intraoral components.
( 3 ) Performance testing must demonstrate the wireless compatibility, electrical safety, and electromagnetic compatibility of the device in its intended use environment.
( 4 ) Software verification, validation, and hazard analysis must be performed.
( 5 ) The patient-contacting components of the device must be demonstrated to be biocompatible.
( 6 ) Performance data must validate the reprocessing instructions for any reusable components.
( 7 ) Patient labeling must include: ( i ) Information on device use, including placement of sensors and mouthpieces;
( ii ) A description of all alarms; and
( iii ) Instructions for reprocessing any reusable components.
( 8 ) A human factors assessment must evaluate simulated use of the device in a home use setting.
[84 FR 5000, Feb. 20, 2019]
Editorial Note on Part 874
Editorial Note: Nomenclature changes to part 874 appear at 73 FR 35341, June 23, 2008.

§ 874.3450 Partial ossicular replacement prosthesis. ( a ) *Identification.* A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.
( b ) *Classification.* Class II.
Editorial Note on Part 868
Editorial Note: Nomenclature changes to part 868 appear at 73 FR 35341, June 23, 2008.

§ 868.5590 Scavenging mask. ( a ) *Identification.* A scavenging mask is a device positioned over a patient's nose to deliver anesthetic or analgesic gases to the upper airway and to remove excess and exhaled gas. It is usually used during dentistry.
( 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 § 868.9.
[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]
# C_2015398EN.01004801.xml

| 30.11.2015 | EN | Official Journal of the European Union | C 398/48 |
| --- | --- | --- | --- |

30.11.2015

EN

Official Journal of the European Union

C 398/48

---

Judgment of the General Court of 7 October 2015 — CBM v OHIM — Aeronautica Militare (TRECOLORE)

(Case T-228/14) (1)

1

((Community trade mark - Opposition proceedings - Application for Community figurative mark TRECOLORE - Earlier Community and national word and figurative marks FRECCE TRICOLORI - Relative ground for refusal - Likelihood of confusion - Article 8(1)(b) of Regulation (EC) No 207/2009))

(2015/C 398/60)

Language of the case: English

Parties

Parties

Applicant: CBM Creative Brands Marken GmbH (Zurich, Switzerland) (represented by: U. Lüken, M. Grundmann and N. Kerger, lawyers)

Applicant:

Defendant: Office for Harmonisation in the Internal Market (Trade Marks and Designs) (represented by: A. Folliard-Monguiral, acting as Agent)

Defendant:

Other party to the proceedings before the Board of Appeal of OHIM: Aeronautica Militare — Stato Maggiore (Rome, Italy)

Other party to the proceedings before the Board of Appeal of OHIM:

Re:

Re:

Action brought against the decision of the First Board of Appeal of OHIM of 29 January 2014 (Case R 594/2013-1), relating to opposition proceedings between Aeronautica Militare — Stato Maggiore and CBM Creative Brands Marken GmbH.

Operative part of the judgment

Operative part of the judgment

The Court:

| 1. | Dismisses the action; |
| --- | --- |

1.

Dismisses the action;

| 2. | Orders CBM Creative Brands Marken GmbH to pay the costs. |
| --- | --- |

2.

Orders CBM Creative Brands Marken GmbH to pay the costs.

---

(1)  OJ C 245, 28.7.2014.

1

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Home                 > Browse by Title > Conflicting Official Views on Monetary Policy: April 1956

              																	United States. Congress. Joint Committee on the Economic Report. Subcommittee on Economic Stabilization, [1954]-1956					 and 	Eighty-Fourth Congress, 1955-1957. 						*Conflicting Official Views on Monetary Policy: April 1956 : Hearing Before the Subcommittee on Economic Stabilization of the Joint Committee on the Economic Report, Congress of the United States, Eighty-Fourth Congress, Second Session, June 12, 1956*,												Washington: 								Government Printing Office, 										1956-06-12,									https://fraser.stlouisfed.org/title/1209,			accessed on September 22, 2024.						    

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Editorial Note on Part 874
Editorial Note: Nomenclature changes to part 874 appear at 73 FR 35341, June 23, 2008.

§ 874.4680 Bronchoscope (flexible or rigid) and accessories. ( a ) *Identification.* A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.
( b ) *Classification.* Class II.
Editorial Note on Part 872
Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

§ 872.3060 Noble metal alloy. ( a ) *Identification.* A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.
( b ) *Classification.* Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
[69 FR 51766, Aug. 23, 2004]
Editorial Note on Part 886
Editorial Note: Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.

§ 886.5842 Spectacle frame. ( a ) *Identification.* A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.
( 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 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]
Editorial Note on Part 882
Editorial Note: Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008.

§ 882.4560 Stereotaxic instrument. ( a ) *Identification.* A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
( b ) *Classification.* Class II (performance standards).
Docket No: FAA-2015-0492 Dir ID: 2014-NM-232-AD
Exhibit 35.1

SERVICER COMPLIANCE STATEMENT

In connection with the Annual Report on Form 10-K of Santander Drive Auto Receivables Trust 2015-4 for the fiscal year ended December 31, 2017, (the Report), the undersigned, a duly authorized officer of Santander Consumer USA Inc. (the Servicer), does hereby certify and
represent that:



| | 1. | A review of the activities and performance of the Servicer under the Sale and Servicing Agreement, dated as of August 26, 2015, among Santander Drive Auto Receivables LLC, Santander Consumer USA Inc., Santander
Drive Auto Receivables Trust 2015-4 and Wells Fargo Bank, National Association (the Agreement) during the period that is the subject of the Report has been made under my supervision.
| | -- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 2. | To the best of my knowledge, based on such review, the Servicer has fulfilled all of its obligations under the Agreement in all material respects throughout the period that is the subject of the Report.
| | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



SANTANDER CONSUMER USA INC.By:

/s/ Sandra M. BroderickName:

Sandra M. BroderickTitle:

EVP Head of OperationsDate:

March 30, 2018By:

/s/ Andrew KangName:

Andrew KangTitle:

Executive Vice President Capital Markets and TreasurerDate:

March 30, 2018