alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
[Federal Register Volume 89, Number 12 (Thursday, January 18, 2024)]
[Notices]
[Pages 3408-3409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00886]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2727]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Institutional Review Board Waiver or 
Alteration of Informed Consent for Minimal Risk Clinical Investigations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that a collection of information entitled ``Institutional

[[Page 3409]]

Review Board Waiver or Alteration of Informed Consent for Minimal Risk 
Clinical Investigations'' has been approved by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
<a href="/cdn-cgi/l/email-protection#29797b687a5d484f4f694f4d480741415a074e465f"><span class="__cf_email__" data-cfemail="653537243611040303250301044b0d0d164b020a13">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: On November 27, 2023, the Agency submitted a 
proposed collection of information entitled ``Institutional Review 
Board Waiver or Alteration of Informed Consent for Minimal Risk 
Clinical Investigations'' to OMB for review and clearance under 44 
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0130. 
The approval expires on December 31, 2026. A copy of the supporting 
statement for this information collection is available on the internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: January 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00886 Filed 1-17-24; 8:45 am]
BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
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##### Table of Contents



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) November 8, 2007
 LEINER HEALTH PRODUCTS INC.
  DELAWARE
    
    333-33121
    
    95-3431709(State or other jurisdiction of
    
    (Commission File Number)
    
    (IRS Employer Identificationincorporation or organization)
    
    
    
    Number)901 East 233rd Street, Carson, California
    
    
    
    90745(Address of principal executive offices)
    
    
    
    (Zip Code)
 (310) 835-8400
 N/A  (Former name or former address, if changed since last report)
  o
    
    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)o
    
    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)o
    
    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))o
    
    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))




---



TABLE OF CONTENTS  Item 8.01 Other EventsSIGNATURE    Table of Contents  
 Item 8.01 Other Events.
      - 2 -




---



##### Table of Contents



SIGNATURE
  Leiner Health Products Inc.By:\s\ Robert K. ReynoldsRobert K. Reynolds
President and Chief Operating Officer
  - 3 -
**Exhibit 31.2 — Chief Financial Officer Certification (Section 302)****CERTIFICATION OF CHIEF FINANCIAL OFFICER**Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002**CERTIFICATION**I, Wilbert Knol, certify that: 1. I have reviewed this amendment to quarterly report on Form10-QSB/A of Playlogic Entertainment, Inc.;  2. Based on my knowledge, this amendment to quarterly reportdoes not contain any untrue statement of a material fact oromit to state a material fact necessary to make thestatements made, in light of the circumstances under whichsuch statements were made, not misleading with respect tothe period covered by this amendment to quarterly report;  3. Based on my knowledge, the financial statements, and otherfinancial information included in this amendment toquarterly report, fairly present in all material respectsthe financial condition, results of operations and cashflows of the registrant as of, and for, the periodspresented in this amendment to quarterly report;  4. The registrant’s other certifying officers and I areresponsible for establishing and maintaining disclosurecontrols and procedures (as defined in Exchange Act Rules13a-15(e) and 15d-15(e)) for the registrant and have: a. Designed such disclosure controls and procedures, or causedsuch disclosure controls and procedures to be designedunder our supervision, to ensure that material informationrelating to the registrant, including its consolidatedsubsidiaries, is made known to us by others within thoseentities, particularly during the period in which thisreport is being prepared;  b. Evaluated the effectiveness of the registrant’s disclosurecontrols and procedures and presented in this amendment toquarterly report our conclusions about the effectiveness ofthe disclosure controls and procedures, as of the end ofthe period covered by this report based on such evaluation;and  c. Disclosed in this report any change in the registrant’sinternal control over financial reporting that occurredduring the registrant’s most recent fiscal quarter (theregistrant’s fourth fiscal quarter in the case of an annualreport) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internalcontrol 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 financialreporting, to the registrant’s auditors and to the audit committee ofthe registrant’s board of directors (or persons fulfilling theequivalent function): a. All significant deficiencies and material weaknesses in thedesign or operation of internal control over financialreporting which are reasonably likely to adversely affectthe registrant’s ability to record, process, summarize andreport financial information; and  b. any fraud, whether or not material, that involvesmanagement or other employees who have a significant rolein the registrant’s internal control over financialreporting.Dated:December 21, 2006     By: /s/ Wilbert Knol   Wilbert Knol  Interim Chief Financial Officer
----

            COMMISSION DECISION         

of 23 October 2006         

authorising the placing on the market of lycopene from Blakeslea trispora as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2006) 4973)

(Only the Spanish text is authentic)

(2006/721/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the Europeån Community,

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

Whereas:

HAS ADOPTED THIS DECISION:

Article 1

Lycopene from Blakeslea trispora as specified in Annex I, may be placed on the market in the Community as a novel food ingredient for use in foods as specified in Annex II.

Article 2

The designation ‘lycopene’ shall be displayed in the list of ingredients of foodstuffs containing it or, if there is no list of ingredients, on the labelling of the product as such.

Article 3

Vitatene Antibiotics SAU shall submit to the Commission, at the end of three years following the adoption of this Decision, data as to the groups of foods with lycopene from Blakeslea trispora that have been placed on the market in the EU and the corresponding use levels of this lycopene.

Article 4

This Decision is addressed to Vitatene Antibiotics SAU, Avd. de Antibioticos, 59-61, 24080 Leon, Spain.

Done at Brussels, 23 October 2006.

For the Commission

Markos KYPRIANOU            

Member of the Commission

----

(1)OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(2)OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003.

----

ANNEX I

SPECIFICATIONS OF LYCOPENE FROM BLAKESLEA TRISPORA

Definition

Obtained by extraction and crystallisation from a fungal fermentation of Blakeslea trispora, the product is supplied as a 5 % or 20 % lycopene suspension in high oleic acid sunflower oil containing 1 % α-tocopherol of the lycopene level. The lycopene from Blakeslea trispora consists of ≥ 90 % all-trans isomer and 1 % to 5 % of cis-isomeres.

Specifications

Chemical name Lycopene

C.A.S. number 502-65-8 (all trans lycopene)

Chemical formula C40H56

Structural formula

Formula weight 536,85

Assay Not less than 95 %

Purity

Mycotxins:

Microbiology:

----

ANNEX II

USES OF LYCOPENE FROM BLAKESLEA TRISPORA

----
```

[Congressional Record Volume 158, Number 127 (Wednesday, September 19, 2012)]
[Extensions of Remarks]
[Pages E1551-E1552]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

                       A TRIBUTE TO BRETT BUNNELL

                                 ______
                                 

                            HON. TOM LATHAM

                                of iowa

                    in the house of representatives

                     Wednesday, September 19, 2012

  Mr. LATHAM. Mr. Speaker, I rise today to recognize and congratulate 
Brett Bunnell of Norwalk, Iowa for being awarded the Girl Scout Gold 
Award.
  The Gold Award is the highest award that a high school-aged Girl 
Scout can earn. This is a prestigious honor as fewer than 6 percent of 
eligible Girl Scouts attain the Gold Award in a given year.
  To earn a Gold Award, a Girl Scout must complete a minimum of 80 
hours towards a community project that is both memorable and lasting. 
For her project, Brett worked to update rooms in her church by 
installing blinds and redecorating. The work ethic Brett has shown to 
earn her Gold Award speaks volumes about her commitment to serving a 
cause greater than herself and assisting her community.

[[Page E1552]]

  Mr. Speaker, the example set by this young woman and her supportive 
family demonstrates the rewards of hard work, dedication and 
perseverance. I am honored to represent Brett and her family in the 
United States Congress. I know that all of my colleagues in the House 
will join me in congratulating her on obtaining the Gold Award, and I 
wish her continued success in her future education and career.

                          ____________________
```
Document Headings

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

                    See the                                          Document Drafting Handbook                                        for more details.                  

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

###### National Institutes of Health

Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

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

*Name of Committee:*                         National Institute on Aging Special Emphasis Panel; Brain Cell Atlas of AD/ADRD.                    

*Date:*                         February 12, 2024.                    

*Time:*                         11:00 a.m. to 3:00 p.m.                    

*Agenda:*                         To review and evaluate grant applications.                    

*Place:*                         National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Virtual Meeting).                    

*Contact Person:*                         Sandhya Sanghi, Ph.D., Scientific Research Officer, 7201 Wisconsin Avenue (2N230), NIA/SRB, Bethesda, MD 20814, (301) 496-2879,                         *sandhya.sanghi@nih.gov.*

(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)

Dated: January 10, 2024.

Miguelina Perez, 

Program Analyst, Office of Federal Advisory Committee Policy.

[FR Doc. 2024-00665 Filed 1-12-24; 8:45 am]

BILLING CODE 4140-01-P
Exhibit 32

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 Bernard, Allan & Edwards, Inc.
on Form 10-QSB for the period ending March 31, 2003, as filed with the
Securities and Exchange  Commission  on the date  hereof  (the "Report"),
I, Michael McLaughlin, CEO/CFO of the Company, 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 and belief:

 (1) the Report 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 Report fairly presents, in all
material respects, the financial condition and result of operations
of the Company.

/s/    Michael McLaughlin
Michael McLaughlin
CEO/CFO
(Principal Executive and Financial Officer)

January 9, 2004

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 has been  provided to the Company and will be
retained  by the  Company and furnished to the Securities and Exchange
Commission or its staff upon request.
Exhibit 99.3


Certification of Chief Accounting Officer

                            CERTIFICATION PURSUANT TO
                  SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
                            (18 U.S.C. SECTION 1350)


     In  connection  with the  Annual  Report  of  Century  Casinos,  Inc.  (the
"Company") on Form 10-K for the period ended December 31, 2002 as filed with the
Securities  and  Exchange  Commission  on the date  hereof (the  "Report"),  the
undersigned certifies pursuant to 18 U.S.C. 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:

(1)  The Report fully complies with the  requirements  of Section 13(a) or 15(d)
     of the Securities Exchange Act of 1934, as amended; and

(2)  The information  contained in the Report fairly  presents,  in all material
     aspects, the financial condition and results of operations of the Company.





     Date:  March 11, 2003

     /s/ Larry Hannappel
     -----------------
     Larry Hannappel
     Chief Accounting Officer
```

[Congressional Record Volume 158, Number 128 (Thursday, September 20, 2012)]
[House]
[Page H6233]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

           By Ms. FUDGE:
        H.R. 6461.
        Congress has the power to enact this legislation pursuant 
     to the following:
       Article I, Section 8, Clause 1
       The Congress shall have Power to lay and collect Taxes, 
     Duties, Imposts and Excises, to pay the Debts and provide for 
     the common Defence and general Welfare of the United States; 
     but all Duties, Imposts and Excises shall be uniform 
     throughout the United States.
```
##### Table of Contents



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
 WASHINGTON, D.C. 20549
 FORM 8-K
 CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 May 23, 2007
 Pacific Sunwear of California, Inc.
  California
(State or Other
Jurisdiction of
Incorporation or
Organization)
    
    0-21296
(Commission File Number)
    
    95-3759463
(I.R.S. Employer Identification No.)3450 East Miraloma Avenue 
Anaheim, California
(Address of Principal Executive Offices)
    
    92806-2101
(Zip Code)
 (714) 414-4000
 Not applicable
   o
 o
 o
 o




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TABLE OF CONTENTS  Item 7.01 Regulation FD Disclosure.Item 9.01 Financial Statements and Exhibits.SIGNATUREEXHIBIT INDEXEXHIBIT 99.1    Table of Contents  
 Item 7.01 Regulation FD Disclosure.
  
 Item 9.01 Financial Statements and Exhibits.
 (d)Exhibits
 99.1
    
    Press Release, dated May 23, 2007, issued by Pacific Sunwear of California, Inc.




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##### Table of Contents



SIGNATURE
  Pacific Sunwear of California, Inc.(Registrant)By:
    /s/  GERALD M. CHANEYDate: May 23, 2007
    
    Name:
    Gerald M. ChaneyTitle:
    Senior Vice President, Chief Financial Officer




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##### Table of Contents



EXHIBIT INDEX
 ExhibitNumber
    
    Description99.1
    
    Press Release, dated May 23, 2007, issued by Pacific Sunwear of California, Inc.
----

| 1. | The Report fully complies with the requirements of Section 13(a) or 15(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 of the Company. |
|----|------------------------------------------------------------------------------------------------------------------------------------------------------|

| Date:  May 23, 2011  | By:    | /s/ John MacDonald             |
|-------------------------------------|--------|--------------------------------|
|                                |   | John MacDonald                 |
|                                |   | Chief Financial Officer        |
|                                |   | (Principal Accounting Officer) |
*Pursuant to 5TH CIR. 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 5TH CIR. R. 47.5.4.

United States Court of Appeals

Fifth Circuit

FILED

July 23, 2007

Charles R. Fulbruge III

Clerk

IN THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

No. 06-41326

Summary Calendar

UNITED STATES OF AMERICA,

Plaintiff-Appellee,

versus

JOSE ROSENDO GARZA,

Defendant-Appellant.

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

Appeal from the United States District Court

for the Southern District of Texas

USDC No. 5:05-CR-2401-ALL

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

Before JONES, Chief Judge, and JOLLY and OWEN, Circuit Judges.

PER CURIAM:*

Jose Rosendo Garza appeals his sentence following his guiltyplea conviction for possession with intent to distribute more than

50 grams of methamphetamine. He argues that the district court

erred in denying him a minor-role adjustment to his offense level

under U.S.S.G. § 3B1.2(b). Garza asserts that he was a minor

participant because he was a courier and had limited knowledge of

the conspiracy and drugs transported. 
2

As Garza did not preserve this issue in the district court, we

review for plain error. See United States v. Washington, 480 F.3d

309, 313 (5th Cir. 2007). Pursuant to § 3B1.2 (b), a district

court may decrease a defendant’s offense level by two levels if the

defendant was a minor participant. An adjustment for a minor role

applies to a defendant “who is less culpable that most other

participants, but whose role could not be described as minimal.”

§ 3B1.2, comment. (n.5). The district court did not plainly err in

denying Garza a minor-role adjustment. Accordingly, Garza’s

sentence is affirmed. 

Although Garza’s sentence is affirmed, there is a clerical

error in the record. The indictment and plea agreement charged

Garza with possession with intent to distribute more than 50 grams

of methamphetamine, whereas the judgment reflected that Garza was

convicted of possession with intent to distribute more than 50

kilograms of methamphetamine. Accordingly, this matter is remanded

to the district court for correction of the clerical error in the

judgment pursuant to FED. R. CRIM. P. 36. 

AFFIRMED; REMANDED FOR CORRECTION OF CLERICAL ERROR IN

JUDGMENT