alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
§ 573.685 Natamycin. The food additive natamycin (CAS No. 7681-93-8) may be safely used in broiler chicken feeds in accordance with the following specifications: ( a ) The additive is a stereoisomer of 22-[(3-amino-3,6,dideoxy-β-D-mannopyranosyl)oxy]-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatricyclo[22.3.1.05,7] octacosa-8,14,16,18,20-pentaene-25-carboxylic acid with the empirical formula C33H47NO13.
( b ) The additive shall conform to U.S.P. specifications.
( c ) The additive (as part of a premix composed of calcium carbonate, natamycin, and lactose) is used for retarding the growth of *Aspergillus parasiticus* in broiler chicken feeds for up to 14 days after the addition of natamycin.
( d ) Each pound (454 grams (g)) of the premix shall contain 434 (g) of calcium carbonate, 10 g of natamycin activity, and 10 g of lactose. The premix shall be mixed into broiler chicken feed at the rate of 1 pound (0.454 kilograms (kg)) per ton (908 kg) of feed to provide natamycin at a level of 11 parts per million (ppm). The premix shall be thoroughly mixed into the dry components of the broiler chicken feed before adding the liquid components. Broiler feeds to which the natamycin premix is added shall be used within 4 weeks of addition of the premix.
( e ) To assure the safe use of the additive, the label or labeling of the additive shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, the following: ( 1 ) The name and CAS number of the additive, and its purpose.
( 2 ) A listing of ingredients consisting of calcium carbonate, the additive, and lactose and their proportions in the premix as prescribed under paragraph (d) of this section.
( 3 ) Adequate directions for use to ensure a broiler chicken feed that is in compliance with the limitations prescribed in paragraph (d) of this section.
( 4 ) An appropriate cautionary statement: “Caution: Store in a tightly-closed, light-resistant container in a cool, dry place.”
( 5 ) An expiration date of 1 year from the date of manufacture.
( 6 ) A contact address and telephone number for reporting adverse reactions experienced by users, or to request a copy of the Material Safety Data Sheet for natamycin.
[69 FR 19321, Apr. 13, 2004]
Editorial Note on Part 878
Editorial Note: Nomenclature changes to part 878 appear at 73 FR 35341, June 23, 2008.

§ 878.4165 Wound autofluorescence imaging device. ( a ) *Identification.* A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.
( 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.
[83 FR 52968, Oct. 19, 2018]
§ 529.1186 Isoflurane. ( a ) *Specifications.* The drug is a clear, colorless, stable liquid.
( b ) *Sponsors.* See Nos. 017033, 054771, and 065085 in § 510.600(c) of this chapter.
( c ) *Conditions of use.* Administer by inhalation: ( 1 ) *Amount* — ( i ) *Horses:* For induction of surgical anesthesia: 3 to 5 percent isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen).
( ii ) *Dogs:* For induction of surgical anesthesia: 2 to 2.5 percent isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen).
( 2 ) *Indications for use.* For induction and maintenance of general anesthesia in horses and dogs.
( 3 ) *Limitations.* Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[51 FR 594, Jan. 7, 1986, as amended at 54 FR 23472, June 1, 1989; 58 FR 17346, Apr. 2, 1993; 59 FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, 1995; 63 FR 8122, Feb. 18, 1998; 63 FR 24106, May 1, 1998; 66 FR 17510, Apr. 2, 2001; 71 FR 43967, Aug. 3, 2006; 74 FR 68530, Dec. 28, 2009; 76 FR 16533, Mar. 24, 2011; 78 FR 14669, Mar. 7, 2013; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, Apr. 8, 2015; 87 FR 58963, Sept. 29, 2022; 89 FR 14411, Feb. 27, 2024; 89 FR 42360, May 15, 2024]
Editorial Note on Part 886
Editorial Note: Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.

§ 886.4155 Scleral plug. ( a ) *Identification.* A scleral plug is a prescription device intended to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. These plugs prevent intraocular fluid and pressure loss when instruments are withdrawn from the eye. Scleral plugs include a head portion remaining above the sclera, which can be gripped for insertion and removal, and a shaft that fits inside the scleral incision. Scleral plugs are removed before completing the surgery.
( b ) *Classification.* Class II (special controls). The special controls for the scleral plug are as follows: ( 1 ) 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 if the material is a surgical grade stainless steel with or without a gold, silver, or titanium coating. The special controls for the surgical grade stainless steel scleral plug (with or without a gold, silver, or titanium coating) are: ( i ) The device must be demonstrated to be sterile during the labeled shelf life;
( ii ) The device must be demonstrated to be biocompatible; and
( iii ) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.
( 2 ) The device is not exempt from premarket notification procedures if it is composed of a material other than surgical grade stainless steel (with or without a gold, silver, or titanium coating). The special controls for scleral plugs made of other materials are: ( i ) The device must be demonstrated to be sterile during the labeled shelf life;
( ii ) The device must be demonstrated to be biocompatible;
( iii ) Characterization of the device materials must be performed;
( iv ) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device;
( v ) Performance data must demonstrate adequately low levels of the extractables or residues from manufacturing (or processing) of the device; and
( vi ) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.
[78 FR 68715, Nov. 15, 2013]
<PAGE>
                                                                    EXHIBIT 31.1


                                  CERTIFICATION


I, Zafiris G. Zafirelis, certify that:

1.   I have reviewed this quarterly report on Form 10-Q of Biopure Corporation;

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;

3.   Based on my knowledge, the financial statements, and other financial
     information included in this report, fairly present in all material
     respects the financial condition, results of operations and cash flows of
     the registrant as of, and for, the periods presented in this report;

4.   The registrant's other certifying officer(s) and I are responsible for
     establishing and maintaining disclosure controls and procedures (as defined
     in Exchange Act Rules 13a- 15(e) and 15d-15(e)) for the registrant and
     have:

     (a) Designed such disclosure controls and procedures, or caused such
     disclosure controls and procedures to be designed under our supervision, to
     ensure that material information relating to the registrant, including its
     consolidated subsidiaries, is made known to us by others within those
     entities, particularly during the period in which this report is being
     prepared;

     (b) Evaluated the effectiveness of the registrant's disclosure controls and
     procedures and presented in this report our conclusions about the
     effectiveness of the disclosure controls and procedures, as of the end of
     the period covered by this report based on such evaluation; and

     (c) Disclosed in this report any change in the registrant's internal
     control over financial reporting that occurred during the registrant's most
     recent fiscal quarter (the registrant's fourth fiscal quarter in the case
     of an annual report) that has materially affected, or is reasonably likely
     to materially affect, the registrant's internal control over financial
     reporting; and

5.   The registrant's other certifying officer(s) and I have disclosed, based on
     our most recent evaluation of internal control over financial reporting, to
     the registrant's auditors and the audit committee of the registrant's board
     of directors (or persons performing the equivalent functions):

     (a) All significant deficiencies and material weaknesses in the design or
     operation of internal control over financial reporting which are reasonably
     likely to adversely affect the registrant's ability to record, process,
     summarize and report financial information; and

     (b) Any fraud, whether or not material, that involves management or other
     employees who have a significant role in the registrant's internal control
     over financial reporting.

Date: September 13, 2004

/s/ Zafiris G. Zafirelis
----------------------
Zafiris G. Zafirelis
President and Chief Executive Officer
[Federal Register Volume 75, Number 46 (Wednesday, March 10, 2010)]
[Notices]
[Pages 11134-11135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5085]


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

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration

RIN 0648-XU98


North Pacific Fishery Management Council; Public Meeting

AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and 
Atmospheric Administration (NOAA), Commerce.

[[Page 11135]]


ACTION: Notice of a public meeting of the North Pacific Fishery 
Management Council's Crab Plan Team (CPT).

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

SUMMARY: The Crab Plan Team will meet in Seattle, WA.

DATES: The meeting will be held March 29 - April 1, 2010, from 9 a.m. 
to 5 p.m.

ADDRESSES: The meeting will be held at the Alaska Fishery Science 
Center, 7600 Sand Point Way N.E. Bldg 4, Seattle, WA 98115.
    Council address: North Pacific Fishery Management Council, 605 W. 
4th Avenue, Suite 306, Anchorage, AK 99501-2252.

FOR FURTHER INFORMATION CONTACT: Diana Stram; telephone: (907) 271-
2809.

SUPPLEMENTARY INFORMATION: The Plan Team will address the following 
issues: Review Essential Fish Habitat (EFH) designations by species; 
review time series revision and strata; review net selectivity results 
and model sensitivity; review preliminary draft Crab Annual Catch 
Limits (ACLs)and rebuilding for Bristol Bay Red King Crab, snow crab, 
Tanner crab, Norton Sound Red King Crab, Pribilof Island Red King Crab, 
Pribilof Island Blue King Crab, Saint Matthew Blue King Crab, Aleutian 
Island Golden King Crab. The Agenda is subject to change, and the 
latest version will be posted at http://www.alaskafisheries.noaa.gov/npfmc/
    Although non-emergency issues not contained in this agenda may come 
before this group for discussion, in accordance with the Magnuson-
Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 
those issues may not be the subject of formal action during this 
meeting. Actions will be restricted to those issues specifically 
identified in this notice and any issues arising after publication of 
this notice that require emergency action under Section 305(c) of the 
Magnuson-Stevens Act, provided the public has been notified of the 
Council's intent to take final action to address the emergency.

Special Accommodations

    This meeting is physically accessible to people with disabilities. 
Requests for sign language interpretation or other auxiliary aids 
should be directed to Gail Bendixen at (907) 271-2809 at least 7 
working days prior to the meeting date.

    Dated: March 5, 2010.
William D. Chappell,
Acting Director, Office of Sustainable Fisheries, National Marine 
Fisheries Service.
[FR Doc. 2010-5085 Filed 3-9-10; 8:45 am]
BILLING CODE 3510-22-S
Editorial Note on Part 872
Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

§ 872.3150 Articulator. ( a ) *Identification.* An articulator is a mechanical device intended to simulate movements of a patient's upper and lower jaws. Plaster casts of the patient's teeth and gums are placed in the device to reproduce the occlusion (bite) and articulation of the patient's jaws. An articulator is intended to fit dentures or provide orthodontic treatment.
( 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 § 872.9. If the device is not labeled or otherwise represented as sterile, the device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exceptions of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001]
#### § 1.1014-0 Table of contents.

This section lists the captions contained in §§ 1.1014-1 through 1.1014-10.

## § 1.1014-1 Basis of property acquired from a decedent.

(a) General rule.

(b) Scope and application.

(c) Property to which section 1014 does not apply.

(d) Applicability date.

## § 1.1014-2 Property acquired from a decedent.

(a) In general.

(b) Property acquired from a decedent dying after December 31, 1953.

(1) In general.

(2) Rules for the application of paragraph (b)(1) of this section.

(3) Exceptions to application of this paragraph.

(c) Special basis rules with respect to certain property acquired from a decedent.

(1) Stock or securities of a foreign personal holding company.

(2) Spouse's interest in community property of decedent dying after October 21, 1942, and on or before December 31, 1947.

## § 1.1014-3 Other basis rules.

(a) Fair market value.

(b) Property acquired from a decedent dying before March 1, 1913.

(c) Reinvestments by a fiduciary.

(d) Reinvestments of property transferred during life.

(e) Alternate valuation dates.

## § 1.1014-4 Uniformity of basis; adjustment to basis.

(a) In general.

(b) Multiple interests.

(c) Records.

(d) Effective/applicability date.

## § 1.1014-5 Gain or loss.

(a) Sale or other disposition of a life interest, remainder interest, or other interest in property acquired from a decedent.

(b) Sale or other disposition of certain term interests.

(1) In general.

(2) Effective/applicability date.

(c) Sale or other disposition of a term interest in a tax-exempt trust.

(1) In general.

(2) Tax-exempt trust defined.

(3) Taxable beneficiary defined.

(4) Effective/applicability date.

(d) Illustrations.

## § 1.1014-6 Special rule for adjustments to basis where property is acquired from a decedent prior to his death.

(a) In general.

(b) Multiple interests in property described in section 1014(b)(9) and acquired from a decedent prior to his death.

(c) Adjustments for deductions allowed prior to the decedent's death.

## § 1.1014-7 Example applying rules §§ 1.1014-4 through 1.1014-6 to case involving multiple interests.

## § 1.1014-8 Bequest, devise, or inheritance of a remainder interest.

## § 1.1014-9 Special rule with respect to DISC stock.

(a) In general.

(b) Portion of property acquired from decedent before his death included in decedent's gross estate.

(1) In general.

(2) Example.

(c) Estate tax valuation date.

(d) Examples.

## § 1.1014-10 Basis of property acquired from a decedent must be consistent with property's Federal estate tax value.

(a) Consistent basis requirement.

(1) General rule.

(2) Initial basis in consistent basis property and effect of basis adjustments.

(3) Duration of consistent basis requirement.

(b) Final value and reported value.

(1) Final value.

(2) Reported value if no final value yet determined.

(3) Special rules.

(c) Consistent basis property.

(1) Property subject to the consistent basis requirement.

(2) Property excepted from or not subject to the consistent basis requirement.

(d) Definitions.

(e) Examples.

(f) Applicability date.

[T.D. 9991, 89 FR 76375, Sept. 17, 2024]
Editorial Note on Part 870
Editorial Note: Nomenclature changes to part 870 appear at 73 FR 35341, June 23, 2008.

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode. ( a ) *Temporary pacemaker electrode* — ( 1 ) *Identification.* A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an *external* pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.
( 2 ) *Classification.* Class II (performance standards).
( b ) *Permanent pacemaker electrode* — ( 1 ) *Identification.* A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.
( 2 ) *Classification.* Class III (premarket approval).
( c ) *Date PMA or notice of completion of PDP is required.* A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 77 FR 39927, July 6, 2012]
**EXHIBIT 32**

 

**CERTIFICATION OF CHIEF EXECUTIVE OFFICERAND CHIEF FINANCIAL OFFICER**

**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 AmendmentNo. 2 to EMRISE Corporation’s (the “Company”) Quarterly Report on Form 10-Q forthe period ended June 30, 2009 (the “Report”), the undersigned herebycertify in their capacities as Chief Executive Officer and Chief FinancialOfficer of the Company, respectively, pursuant to 18 U.S.C. section 1350,as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002,that:

 

1.             the Report fully complies with the requirements of Section 13(a) or15(d) of the Securities Exchange Act of 1934, as amended; and

 

2.             the information contained in the Report fairly presents,in all material respects, the financial condition and results of operations ofthe Company.

 
| Dated: April 15, 2010 | By:    | /s/ CARMINE T. OLIVA                                  |
|----------------------------|--------|-------------------------------------------------------|
|                       |   | Carmine T. Oliva                                      |
|                       |   | Chief Executive Officer (principal executive officer) |
|                       |   |                                                  |
|                       |   |                                                  |
| Dated: April 15, 2010 | By:    | /s/ D. JOHN DONOVAN                                   |
|                       |   | D. John Donovan                                       |
|                       |   | Chief Financial Officer (principal financial officer) |

 

*A signed original of this writtenstatement required by Section 906, or other document authenticating,acknowledging, or otherwise adopting the signatures that appear in typed formwithin the electronic version of this written statement required by Section906, has been provided to the Company and will be retained by the Company andfurnished to the Securities and Exchange Commission or its staff upon request.*

 

----
IN THE SUPREME COURT OF PENNSYLVANIA

EASTERN DISTRICT

PAUL SINCLAIR AND KELLY WELLS

SINCLAIR,

Petitioners

v.

FIRST GLOBAL EXPRESS, INC. AND

YAKOV R. MELNIK,

Respondents :

:

:

:

:

:

:

:

:

:

:

:

: No. 401 EAL 2017

Petition for Allowance of Appeal from the Order of the Superior Court

ORDER

PER CURIAM

AND NOW , this 17th day of January, 2018

, the Petition for Allowance of Appeal

is DENIED

.
TS- EMLA50 /60/70/80

Attachment #3
Pt. 1, Sec. B
CA S

Inventory Expert Service Report and Chemical Structure of the New Chemical Substance
This attachment gives the CAS Inventory Expert Service (IES) Report on the new chemical substance. The chemical structure of the compound is also provided.,(62UGHU1XPEHU

5HJLVWU\1XPEHU
&$,QGH[1DPH