alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Notices]
[Page 10865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4888]


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DEPARTMENT OF THE TREASURY

Internal Revenue Service


Open Meeting of the Area 6 Taxpayer Advocacy Panel (Including the 
States of Arizona, Colorado, Idaho, Montana, New Mexico, North Dakota, 
Oregon, South Dakota, Utah, Washington, and Wyoming)

AGENCY: Internal Revenue Service (IRS), Treasury.

ACTION: Notice of meeting.

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SUMMARY: An open meeting of the Area 6 Taxpayer Advocacy Panel will be 
conducted. The Taxpayer Advocacy Panel is soliciting public comment, 
ideas, and suggestions on improving customer service at the Internal 
Revenue Service.

DATES: The meeting will be held Tuesday, April 6, 2010.

FOR FURTHER INFORMATION CONTACT: Janice Spinks at 1-888-912-1227 or 
206-220-6098.

SUPPLEMENTARY INFORMATION: Notice is hereby given pursuant to Section 
10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) 
that an open meeting of the Area 6 Taxpayer Advocacy Panel will be held 
Tuesday, April 6, 2010, at 1 p.m. Pacific Time via telephone 
conference. The public is invited to make oral comments or submit 
written statements for consideration. Due to limited conference lines, 
notification of intent to participate must be made with Janice Spinks. 
For more information, please contact Ms. Spinks at 1-888-912-1227 or 
206-220-6098, or write TAP Office, 915 2nd Avenue, MS W-406, Seattle, 
WA 98174 or post comments to the Web site: http://www.improveirs.org.
    The agenda will include various IRS issues.

    Dated: March 3, 2010.
Shawn F. Collins,
Acting Director, Taxpayer Advocacy Panel.
[FR Doc. 2010-4888 Filed 3-8-10; 8:45 am]
BILLING CODE 4830-01-P
§ 701.20 Detergent substances, other than soap, intended for use in cleansing the body. ( a ) In its definition of the term *cosmetic,* the Federal Food, Drug, and Cosmetic Act specifically excludes soap. The term *soap* is nowhere defined in the act. In administering the act, the Food and Drug Administration interprets the term “soap” to apply only to articles that meet the following conditions: ( 1 ) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and
( 2 ) The product is labeled, sold, and represented only as soap.
( b ) Products intended for cleansing the human body and which are not “soap” as set out in paragraph (a) of this section are “cosmetics,” and accordingly they are subject to the requirements of the act and the regulations thereunder. For example, such a product in bar form is subject to the requirement, among others, that it shall bear a label containing an accurate statement of the weight of the bar in avoirdupois pounds and ounces, this statement to be prominently and conspicuously displayed so as to be likely to be read under the customary conditions of purchase and use.
Editorial Note on Part 870
Editorial Note: Nomenclature changes to part 870 appear at 73 FR 35341, June 23, 2008.

§ 870.2345 Electrocardiograph software for over-the-counter use. ( a ) *Identification.* An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) Clinical performance testing under anticipated conditions of use must demonstrate the following: ( i ) The ability to obtain an electrocardiograph of sufficient quality for display and analysis; and
( ii ) The performance characteristics of the detection algorithm as reported by sensitivity and either specificity or positive predictive value.
( 2 ) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs.
( 3 ) Non-clinical performance testing must validate detection algorithm performance using a previously adjudicated data set.
( 4 ) Human factors and usability testing must demonstrate the following: ( i ) The user can correctly use the device based solely on reading the device labeling; and
( ii ) The user can correctly interpret the device output and understand when to seek medical care.
( 5 ) Labeling must include: ( i ) Hardware platform and operating system requirements;
( ii ) Situations in which the device may not operate at an expected performance level;
( iii ) A summary of the clinical performance testing conducted with the device;
( iv ) A description of what the device measures and outputs to the user; and
( v ) Guidance on interpretation of any results.
[86 FR 2549, Jan. 18, 2022]
UNITED STATES
                SECURITIES AND EXCHANGE COMMISSION
                      Washington, DC 20549

                            FORM 8-K

                         CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of
1934


Date of Report (Date of earliest event reported): September 3, 2002


                      CONCEPTS DIRECT, INC.
____________________________________________________________________
      (Exact name of registrant as specified in its charter)


      Delaware                    0-20680          52-1781893
 _________________________     ______________    _______________
(State or other jurisdiction  (Commission File   (IRS Employer
     of incorporation)             Number)     Identification No.)

                 2950 Colorful Avenue, Longmont, CO
                      _____________________________
                  (Address of principal executive offices

                                80504
                          ____________________
                             (Zip Code)

  Registrant's telephone number, including area code: (303) 772-9171

Item 5. Other Events and Regulation FD Disclosure.

On September 3, 2002, Concepts Direct, Inc. (the "Company")
announced the election of Zaid H. Haddad, the Company's
Controller, as Chief Financial Officer, Secretary and Treasurer.
On September 3, 2002, Cody S. McGarraugh, formerly Vice President
- Finance, Chief Financial Officer, Secretary and Treasurer of the
Company, resigned from the Company to pursue other interests.

A copy of the press release dated September 3, 2002 announcing the
foregoing is filed as an exhibit to this Current Report on Form
8-K.

Item 7. Financial Statements and Exhibits.

Exhibit                 Description

99.1                    Concepts Direct, Inc. Press Release *

*    Exhibit filed herewith.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned hereunto duly authorized.

                                         CONCEPTS DIRECT, INC.


Date: September 3, 2002                 /s/Phillip A. Wiland___________
					Phillip A. Wiland
					Chief Executive Officer
					and President
**Exhibit 32**

 

# **CERTIFICATION**

# ** **

The undersigned certify pursuant to 18 U.S.C. § 1350, that:

 

(1)           Theaccompanying Quarterly Report on Form 10-Q for the period ended July 31,2008 fully complies with the requirements of Section 13(a) or 15(d) ofthe Securities Exchange Act of 1934; and

 

(2)           The informationcontained in the accompanying Report fairly presents, in all material respects,the financial condition and results of operations of the Company.

 

 
| Date:  | September 15, 2008 |                    | /s/ Rodney A. Young     |
|--------|-------------------------|-------------------------|-------------------------|
|   |                    | President and           |
|   |                    | Chief Executive Officer |
|   |                    |                    |
|   |                    |                    |
| Date:  | September 15, 2008 |                    | /s/ William J. Kullback |
|   | Chief Financial Officer |

 

----
<PAGE>   1

                                                                    EXHIBIT 23.1

                       CONSENT OF INDEPENDENT ACCOUNTANTS

     We hereby consent to the use in this Registration Statement on Form S-1 of
our report dated May 19, 1999 except for the last paragraph of Note 8 which is
as of June 22, 1999, relating to the financial statements and financial
statement schedules of Vixel Corporation which appear in such Registration
Statement. We also consent to the reference to us under the heading "Experts"
and "Selected Financial Data" in such Prospectus. However, it should be noted
that PricewaterhouseCoopers LLP has not prepared or certified "Selected
Financial Data" in such Registration Statement.

/s/ PricewaterhouseCoopers LLP
---------------------------------------------------------
PricewaterhouseCoopers LLP
Seattle,Washington
June 22, 1999
Editorial Note on Part 866
Editorial Note: Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.

§ 866.3940 West Nile virus serological reagents. ( a ) *Identification.* West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.
( b ) *Classification.* Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus.” See § 866.1(e) for the availability of this guidance document.
[68 FR 61745, Oct. 30, 2003]
#### § 822.21 What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?

You must receive our approval in writing before making changes in your plan that will affect the nature or validity of the data collected in accordance with the plan. To obtain our approval, you must submit the request to make the proposed change and revised postmarket surveillance plan to the applicable address listed in § 822.8. You may reference information already submitted in accordance with § 822.14. In your cover letter, you must identify your submission as a supplement and cite the unique document number that we assigned in our acknowledgment letter for your original submission, specifically identify the changes to the plan, and identify the reasons and justification for making the changes. You must report changes in your plan that will not affect the nature or validity of the data collected in accordance with the plan in the next interim report required by your approval order.

[87 FR 17950, Mar. 29, 2022]
EXHIBIT 32.a



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 of American Affordable Housing II Limited Partnership (the "Partnership") on Form 10-Q for the period ended September 30, 2004 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, John P. Manning, Principal Executive Officer of the general partner of the general partner of the Partnership's general partner, C&M Management Inc., certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge, after due inquiry:



|(1) | The Report fully complies with the requirements of section 13(a)-15 or 15(d)-15 of the Securities and Exchange Act of 1934; and                        
|--- | -------------------------------------------------------------------------------------------------------------------------------------------------------
|    |                                                                                                                                                        
|(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Partnership.



|                  |     |                            
|----------------- | --- | ---------------------------
|Date:             |     |                            
|November 19, 2004 | By: | /s/ John P. Manning        
|                  |     |                            
|                  |     | John P. Manning            
|                  |     | Principal Executive Officer

A signed original of this written statement required by Section 906, or other

document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to the Fund and will be retained by the Fund and furnished to the Securities and Exchange Commission or its staff upon request.
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.

§ 860.230 Accepting a De Novo request. ( a ) The acceptance of a De Novo request means that FDA has made a threshold determination that the De Novo request contains the information necessary to permit a substantive review. Within 15 days after a De Novo request is received by FDA, FDA will notify the requester whether the De Novo request has been accepted.
( b ) If FDA does not find that any of the reasons in paragraph (c)(1) of this section for refusing to accept the De Novo request apply or FDA fails to complete the acceptance review within 15 days, FDA will accept the De Novo request for review and will notify the requester. The notice will include the De Novo request reference number and the date FDA accepted the De Novo request. The date of acceptance is the date that an accepted De Novo request was received by FDA.
( c ) ( 1 ) FDA may refuse to accept a De Novo request if any of the following applies: ( i ) The requester has an open or pending premarket submission or reclassification petition for the device;
( ii ) The De Novo request is incomplete because it does not on its face contain all the information required under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act or does not contain each of the items required under this part, or a justification for omission of any item;
( iii ) The De Novo request is not formatted as required under § 860.210;
( iv ) The De Novo request is for multiple devices and those devices are of more than one type; or
( v ) The requester has not responded to, or has failed to provide a rationale for not responding to, deficiencies identified by FDA in previous submissions for the same device, including those submissions described in § 860.220(a)(3).
( 2 ) If FDA refuses to accept a De Novo request, FDA will notify the requester of the reasons for the refusal. The notice will identify the deficiencies in the De Novo request that prevent accepting and will include the De Novo request reference number.
( 3 ) If FDA refuses to accept a De Novo request, the requester may submit the additional information necessary to comply with the requirements of section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act and this part. The additional information must include the De Novo request reference number of the original submission. If the De Novo request is subsequently accepted, the date of acceptance is the date FDA receives the additional information.
* Pursuant to 5 TH C IR . R. 47.5, the court has determined

that this opinion should not be published and is not precedent except under the limited circumstances set forth in 5 TH C IR . R. 47.5.4. IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT

No. 97-41118 Conference Calendar

UNITED STATES OF AMERICA, Plaintiff-Appellee,

versus RAMIRO MANUEL BAZALDUA-LANDEROS, Defendant-Appellant.

- - - - - - - - - - Appeal from the United States District Court for the Southern District of Texas USDC No. M-97-CR-62-1

- - - - - - - - - - August 19, 1998 Before KING, HIGGINBOTHAM, and JONES, Circuit Judges.
PER CURIAM: * Court-appointed counsel for Ramiro Manuel Bazaldua-Landeros has filed a brief as required by Anders v. California , 386 U.S.738 (1967). Our independent review of the brief, BazalduaLanderos’s response, and the record discloses no nonfrivolous issue. Accordingly, counsel is excused from further responsibilities herein, and the APPEAL IS DISMISSED. See 5 TH C IR . R. 42.2.
§ 520.154c Bacitracin zinc soluble powder. ( a ) *Specifications.* Each pound contains the equivalent of not less than 5 grams of bacitracin.
( b ) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.
( c ) *Related tolerances.* See § 556.70 of this chapter.
( d ) *Conditions of use* — ( 1 ) *Broiler chickens* — ( i ) *Amount.* 100 milligrams per gallon in drinking water. ( A ) *Indications for use.* Prevention of necrotic enteritis caused by *Clostridium perfringens* susceptible to bacitracin zinc.
( B ) *Limitations.* Prepare a fresh solution daily.
( ii ) *Amount.* 200 to 400 milligrams per gallon in drinking water. ( A ) *Indications for use.* Control of necrotic enteritis caused by *Clostridium perfringens* susceptible to bacitracin zinc.
( B ) *Limitations.* Prepare a fresh solution daily.
( 2 ) *Growing quail* — ( i ) *Amount.* 500 milligrams per gallon in drinking water for 5 days followed by 165 milligrams per gallon in drinking water for 10 days.
( ii ) *Indications for use.* Control of ulcerative enteritis caused by *Clostridium* spp. Susceptible to bacitracin zinc.
( iii ) *Limitations.* Prepare a fresh solution daily.
[57 FR 37322, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28818, May 20, 2014]
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 on Form 10-Q of Biopure Corporation for the quarter ended April 30, 2008, I, Zafiris G. Zafirelis, Chief Executive Officer,
hereby certify, to the best of my knowledge, pursuant to 18 U.S.C. 1350, as adopted pursuant to 906 of the Sarbanes-Oxley Act of 2002, that:

1. the Form 10-Q for the period ended April 30, 2008, fully 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 Form 10-Q for the period ended April 30, 2008 fairly presents, in all material respects, the financial condition
and results of operations of Biopure Corporation.



|                                
|--------------------------------
|/s/ Zafiris G. Zafirelis        
|Zafiris G. Zafirelis            
|Chairman of the Board, President
|And Chief Executive Officer     

June 16, 2008



31
#### Palmer S. Willard *v.*Hart Seed Company et al.

King, C. J., Alcorn, House, Cotter and Thim, Js.

Argued January 9

decided January 9, 1969

*John B. Willard,*for the appellant (plaintiff).

*602
      *Edward 8. Downes,*Jr.,.for the appellees (defendants).

Per Curiam.

The commissioner’s award decided the question of compensability in favor of the claimant and stated that further proceedings were necessary to determine the specific amount of compensation. The claimant, instead of pursuing a further hearing as to the amount of compensation, appealed to the Superior Court, which rendered judgment dismissing the appeal. We find no error in that judgment.

There is no error.
[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Rules and Regulations]
[Page 10413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4923]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2009-N-0436]


New Animal Drug Applications; Confirmation of Effective Date

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Direct final rule; confirmation of effective date.

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SUMMARY:  The Food and Drug Administration (FDA) is confirming the 
effective date of March 8, 2010, for the final rule that appeared in 
the Federal Register of October 23, 2009 (74 FR 54749). The direct 
final rule amends the regulations regarding new animal drug 
applications (NADAs). Specifically, this direct final rule is being 
issued to provide that NADAs shall be submitted in the described form, 
as appropriate for the particular submission. Currently, the regulation 
requires that all NADAs contain the same informational sections and 
does not explicitly provide the appropriate flexibility needed to 
address the development of all types of new animal drug products. This 
amendment will allow the agency to appropriately review safety and 
effectiveness data submitted to support the approval of new animal drug 
products. This document confirms the effective date of the direct final 
rule.

DATES: Effective date confirmed: March 8, 2010.

FOR FURTHER INFORMATION CONTACT:  Urvi Desai, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8297, e-mail: <a href="/cdn-cgi/l/email-protection#87f2f5f1eea9e3e2f4e6eec7e1e3e6a9efeff4a9e0e8f1"><span class="__cf_email__" data-cfemail="dda8afabb4f3b9b8aebcb49dbbb9bcf3b5b5aef3bab2ab">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 23, 2009 
(74 FR 54749), FDA solicited comments concerning the direct final rule 
for a 75-day period ending January 6, 2010. FDA stated that the 
effective date of the direct final rule would be on March 8, 2010, 60 
days after the end of the comment period, unless any significant 
adverse comment was submitted to FDA during the comment period. FDA did 
not receive any significant adverse comments.

    Authority: Therefore, under the Federal Food, Drug, and Cosmetic 
Act and under authority delegated to the Commissioner of Food and 
Drugs, 21 CFR part 514 is amended. Accordingly, the amendments 
issued thereby are effective.

    Dated: March 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4923 Filed 3-5-10; 8:45 am]
BILLING CODE 4160-01-S


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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.                  

###### Mississippi River Commission

# FOR FURTHER INFORMATION CONTACT:

 Mr. Stephen Gambrell, telephone 601-634-5766.

George T. Shepard,

Colonel, EN, Secretary, Mississippi River Commission.

[FR Doc. 2010-4809 Filed 3-3-10; 4:15 pm]

BILLING CODE 3720-58-P