alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-13

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron Rippke

Director

SUBJECT: Revised Scope of Eligibility for Studies Requiring Single-Tier Summaries

I. PURPOSE

The purpose of this notice is to announce a change in the scope of eligibility for licensing 

studies requiring an Individual Study Summary (ISS) under APHIS Rule 2011-0049 

(Single Label Claim for Veterinary Biological Products) and 9CFR 112.5(b).

II. BACKGROUND

CVB Notice 16-15 announced the implementation of APHIS Rule 2011-0049 and 

referred readers to the Single Tier Label Claim (STLC) Industry Guidance page of the 

CVB website for detailed guidance on preparing and submitting standardized summaries 

of efficacy and safety data. The website includes a page focusing on the scope of studies

requiring a single tier summary. The scope focused on the types of studies requiring a 

summary, regardless when the studies were conducted.

Concerns have arisen regarding the regulatory burden to licensees and permittees 

associated with locating old studies and formatting data to current standards. The scope 

of studies requiring a single tier summary is being amended to lessen the burden. 

III. POLICY

The scope of studies has been amended to state that only those eligible studies submitted 

on, or after, January 1, 2007, are required to have a full single tier summary. This 

submission date applies regardless of the actual license date of the product(s) to which 

the study applies. The types of studies (e.g., pivotal efficacy, safety) requiring a 

summary, and the types of products included under the single tier rule, have not changed.

Studies submitted prior to 2007 are exempt from the requirement for a full single tier

summary. Instead, a placeholder statement will be posted to productdata.aphis.usda.gov 

to clarify that the licensing study was conducted prior to 2007. Licensees and permittees 

are welcome to submit full single tier summaries voluntarily for studies submitted prior 

to 2007. If full summaries are submitted, however, they must meet all requirements for 

format and content of single tier summaries.

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary 

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(515) 337-6100
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-13

Page 2

 An Equal Opportunity Provider and Employer

IV. IMPLEMENTATION/ APPLICABILITY

This revised policy is effective immediately. Licensees and permittees are strongly 

encouraged to review updated detailed instructions on the Single Tier Label Claim 

(STLC) Industry Guidance page of the CVB website, particularly the scope of studies

page and the example of a placeholder statement for studies pre-dating 2007 (Example 17

in the list of example study summaries).
**GLOSSARY CONTINUED**

***AQUATIC ANIMAL HEALTH SERVICES***

means the combination of governmental and non-governmental individuals and organisations that perform activities to implement the standards of the *Aquatic Code*~~in the territory~~. ~~The Aquatic Animal Health Services are under the overall control and direction of the *Competent Authority*. Private sector organisations, *veterinarians*or *aquatic animal health professionals*are normally accredited or approved by the *Competent Authority*to deliver the delegated functions.~~

***AQUATIC ANIMAL HEALTH SERVICES (CLEAN VERSION)***

means the combination of governmental and non-governmental individuals and organisations that perform activities to implement the standards of the *Aquatic Code*.

***COMPETENT AUTHORITY***

means ~~the~~a*~~Veterinary Authority~~*~~or other~~ Governmental Authority of a Member Country having the responsibility ~~and competence for ensuring or supervising the implementation of *aquatic animal* health and welfare measures, international health certification and other~~in the whole or part of the territory for the implementation of certain standards ~~and recommendations in~~of the *Aquatic Code*~~in the whole territory~~.

***COMPETENT AUTHORITY (CLEAN VERSION)***

means a Governmental Authority of a Member Country having the responsibility in the whole or part of the territory for the implementation of certain standards of the *Aquatic Code*.

***VETERINARY AUTHORITY***

means the Governmental Authority of a Member Country~~, comprising *veterinarians*, other professionals and paraprofessionals,~~ having the primary responsibility ~~and competence for ensuring or supervising~~in the whole territory for coordinating the implementation of *~~aquatic animal~~*~~health and welfare measures, international *aquatic animal* health certification and other~~the standards ~~and recommendations in~~of the *Aquatic Code*by *Competent Authorities*~~in the whole *territory*~~.~~The *Veterinary Authority* is a *Competent Authority*.~~

***VETERINARY AUTHORITY (CLEAN VERSION)***

means the Governmental Authority of a Member Country having the primary responsibility in the whole territory for coordinating the implementation of the standards of the *Aquatic Code* by *Competent Authorities*. 

___________________________
**Exhibit32**

 

 

**CERTIFICATIONSOF CEO AND CFO PURSUANT TO**

**18 U.S.C.SECTION 1350,**

**AS ADOPTEDPURSUANT TO**

**SECTION 906 OFTHE SARBANES-OXLEY ACT OF 2002**

 

Inconnection with the Quarterly Report on Form 10-Q of Dendrite International,Inc. (the “Company”) for the quarterly period ended March 31, 2004 as filedwith the Securities and Exchange Commission on the date hereof (the “Report”),John E. Bailye, as Chief Executive Officer of the Company, and Kathleen E.Donovan, as Chief Financial Officer, each hereby certifies, pursuant to 18U.S.C. (section) 1350, as adopted pursuant to (section) 906 of theSarbanes-Oxley Act of 2002, that, to the best of his or her knowledge:

 

(1)The Report fully complies with the requirements of section 13(a) or 15(d) ofthe Securities Exchange Act of 1934; and

 

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

 

 
| /s/  John E. Bailye     |                                                |   |
|-------------------------|-----------------------------------------------------|--------|
| Name:                   | John  E. Bailye                                     |
| Title:                  | Chairman  of the Board and  Chief Executive Officer |
| Date:                   | May  7, 2004                                        |
|                    |                                                |
|                    |                                                |
| /s/ Kathleen E. Donovan |                                                |   |
| Name:                   | Kathleen  E. Donovan                                |
| Title:                  | Senior  Vice President and  Chief Financial Officer |
| Date:                   | May 7, 2004                                         |
|                         |                                                     |        |  |

 

----
How to request IAV‐S Repository Isolates

The repository contains over 5000 viruses and individual IAV‐S repository isolates are not listed in the

catalog. Customers will need to search for isolates of interest (see below) and provide a list to the

diagnostic virology lab before submitting a reagent request. Please note that there have been recent

changes to the USDA repository:

 Viruses with a collection date of July 2022 or later will need to be propagated. There will be a

2‐week delay in orders (barring any propagation issues).

 Due to virus isolates in the USDA IAV‐S Repository no longer being supported by the USDA

Surveillance program, the price per isolate will be $197, effective June 1, 2023.

Once you have selected your isolates:

1. To confirm isolate availability, email nvsl.dvl.comm@usda.gov the list of isolates (specify 1 or 2

vials) before submitting the request.

2. After the list is finalized, email nvsl_concerns@usda.gov and include your:

a. shipping permit

b. completed VS Form 4‐9 (the reagent code number for repository isolates is SIV‐REP and

the reagent name is the barcode ID).

Below is the link to the request form and ordering instructions:

USDA APHIS | Reagents and Proficiency Testing Available from the NVSL

Options to search for repository isolates:

1. Octoflu

https://flu‐crew.org/octoflushow/

Octoflu is a user‐friendly platform to search viruses in the repository/USDA surveillance program. It also

breaks down the lineage of the internal genes, if sequenced.

Click on the Data tab and filter for preferred characteristics. There is an option to select viruses that

have had WGS (select true).

Manuscript providing examples: https://pubmed.ncbi.nlm.nih.gov/34913720/

2. GenBank

USDA Swine Surveillance Influenza A virus isolates can be identified in GenBank by their eight digit

barcode designations in the virus name, e.g. A/swine/North Carolina/A02431994/2019(H1N2). The
           

                                

                               

          

   

                                 

                             

     

How to request IAV‐S Repository Isolates

information in GenBank will usually list USDA Swine Surveillance, or similar, in the author, journal or

Consortium field. Many of the available isolates will have H and N sequenced, but some will

have full genome sequencing completed.

3. USDA Surveillance Report “representative viruses”

There are also quarterly reports available to the public under the IAV‐S surveillance tab that provide a

list of the representative strains in the US (see table 4 in the quarterly report)

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal‐disease‐information/swine‐disease‐

information/influenza‐a‐virus

FY22 Q4 example:
Exhibit 31.1 (c)
CERTIFICATIONS

I, Dean A Goodson certify that:

1. I have reviewed this annual report on Form 10-KSB of Edd Helms Group, Inc.:

2.  Based on my  knowledge,  this  annual  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; and


Date:    February 2, 2006


/s/ Dean A. Goodson
-----------------------
By:   Dean A. Goodson
Chief Financial Officer
#### Almeida v. Tanaka

16249

01/14/94

Affirmed
Adulto

Cuerpos en 

forma de bala 

de 3

/4 a 11/2

pulgadas de 

largo

Negro brilloso con 

manchas blancas 

dispersas en la parte 

posterior

Huevos Larva(s) Pupa

Antenas bien largas de 

11

/2 a 21/2 veces el largo de 

su cuerpo con distintivas 

rayas blancas y negras 

Seis patas 

negras o que 

pueden parecer 

azuladas

CICLO DE VIDA

Huevos

ESCARABAJO ASIÁTICO DE 

CUERNOS LARGOS

*Tamaño real del 

agujero de salida
FÍJESE EN LO SIGUIENTE

• Escarabajos adultos en el verano y 

principios de otoño

• Agujeros redondos con diámetro 

de al menos tres octavos de pulgada

• Hoyos en la corteza hechos por 

el escarabo hembra en los que 

deposita los huevos

• Acumulación de material parecido 

al aserrín (excrementos del insecto) 

alrededor de la base del árbol o de 

las ramas

• Muerte regresiva en el follaje del 

árbol o cambio en el color de las 

hojas fuera de temporada 

• Exudación de savia por los hoyos, 

especialmente en los arces

ElDAÑO QUE CAUSA

El escarabajo asiático de cuernos largos afecta el fl ujo del 

agua y los nutrientes en el árbol, desde las raíces hasta su 

frondoso follaje. Una vez que dichas vías se afecten lo 

sufi ciente, el árbol infestado morirá.

LO QUE USTED PUEDE HACER

• No mueva la leña cruda, pues podría estar moviendo una 

plaga.

• La detección temprana es importante; aprenda sobre el 

insecto y el daño que causa.

• Inspeccione los árboles con regularidad y reporte todo 

signo o señal en PlagasHambrientas.com o llamando al 

1-866-702-9938.

Agujeros redondos

Hoyos en la corteza

Muerte regresiva

Material parecido al aserrín

BACK

Para obtener más información, visite: 

Departamento de Agricultura de los Estados Unidos

Servicio de Inspección Sanitaria de Animales y Plantas

El Departamento de Agricultura de EEUU es un proveedor y empleador que ofrece igualdad de 

oportunidades. Material del programa núm. 2125-ALB-S Publicado en septiembre de 2012

PLAGASHAMBRIENTAS.COM
# C_2019139EN.01005901.xml

| 15.4.2019 | EN | Official Journal of the European Union | C 139/59 |
| --- | --- | --- | --- |

15.4.2019

EN

Official Journal of the European Union

C 139/59

---

Order of the President of the General Court of 5 February 2019 — Trifolio-M and Others v EFSA

(Case T-675/18 R)

(Application for interim measures - Plant protection products - Procedure for reviewing the approval of the active substance azadirachtin - Rejection of the request for confidential treatment - No prima facie case)

(2019/C 139/61)

Language of the case: English

Parties

Applicants: Trifolio-M GmbH (Lahnau, Germany), Oxon Italia SpA (Milan, Italy), Mitsui AgriScience International SA (Brussels, Belgium) (represented by: C. Mereu and S. Englebert, lawyers)

Defendant: European Food Safety Authority (represented by: D. Detken and S. Gabbi, acting as Agents, assisted by S. Raes, lawyer)

Re:

Application pursuant to Articles 278 and 279 TFEU seeking the suspension of the operation of the decision of the Executive Director of the European Food Safety Authority on the requests for confidentiality made in relation to the conclusions on the Peer Review of the pesticide risk assessment of the active substance Azadirachtin of 11 September 2018 (EFSA/LA/DEC/19777743/2018).

Operative part of the order

| 1. | The application for interim measures is dismissed. |
| --- | --- |

1.

The application for interim measures is dismissed.

| 2. | The order of 20 November 2018, Trifolio-M and Others v EFSA, (T-675/18 R) is cancelled. |
| --- | --- |

2.

The order of 20 November 2018, Trifolio-M and Others v EFSA, (T-675/18 R) is cancelled.

| 3. | Each party shall bear its own costs. |
| --- | --- |

3.

Each party shall bear its own costs.

---
May 25, 2023

Need Training Assistance with Mobile Information Management (MIM)? 

Did you know MIM Network Associates are available to assist you with day to day training needs in addition to

scheduled formal training sessions? If you use MIM and need some training assistance, have a question, or you just 

want to explore MIM capabilities, please email or call a network associate. 

To reach the first available MIM Network Associate, email:

mim.training.network@usda.gov

 *State assistance only

MIM Training Network Coordinator:

Kristen Higgins

Kristen.m.higgins@usda.gov 

Last Name First Name Duty Station Phone 1 Phone 2

Boswell Alyson Richmond, VA 540-241-8189 (C)

Brown Kathleen Los Fresnos, TX 512-720-1749 (C) 956-264-9804 (O)

Brown Roberta Sutton, MA 508-254-8367 (C) 508-363-2290 (O)

Croft Doug Sutton, MA 508-363-2299 508-889-5176

Elizondo Greg Harlingen, TX 956-605-8260 (C) 512-383-2400 (O)

Leidorf Yvette Helena, MT 406-437-9457 (O) 406- 422-3468 (C)

Lizardi Mabany Sanford, FL 352-316-8034 (C)

Massengill Rose Jefferson City, 573-658-9850 (C) 573-658-9846 (O)

Moody Megan Tulare, CA 559-331-1545 (C)

*Odom Rick Charlottesville, 804-692-0600

Robinson Tracey Fort Collins, CO 701-426-7391 (C) 701-355-330 (O)

Shere Matt Spokane, WA 360-688-0965 (C)

Smithson Jacob Montgomery, AL 615-864-5062 (C)

Taillon David Reno, NV 916-203-3230 (C) 916-854-3934

White Roberta Pickerington, OH 614-314-6244 (C) 614-856-4735 (O)

Yvette Leidorf

Helena, MT

Roberta Brown

Sutton, MA

Tracey Robinson

Fort Collins, CO

Rick Odom*

Charlottesville, VA

Greg Elizondo

Harlingen, TX

Dave Taillon

Reno, NV

Roberta White

Pickerington, OH

Megan Moody

Tulare, CA

Kathleen Brown

Los Fresnos, TX

Jacob Smithson

Montgomery, AL

Doug Croft

Sutton, MA

Mabany Lizardi

Sanford, FL

Alyson Boswell

Richmond, VA

Rose Massengill

Jefferson City, MO

Matt Shere

Spokane, WA
EXHIBIT 32.1

GENAERA CORPORATION

CERTIFICATION OF

CHIEF EXECUTIVE 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 Quarterly Report of Genaera Corporation (the Company) on Form 10-Q for the period ended
March 31, 2006 as filed with the Securities and Exchange Commission on the date hereof (the Report), I, John L. Armstrong, Jr., President and Chief Executive Officer 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:



| | (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.
| | --- | ----------------------------------------------------------------------------------------------------------------------------------------------------



|                                     
|-------------------------------------
|/s/ John L. Armstrong, Jr.           
|John L. Armstrong, Jr.               
|President and Chief Executive Officer
|May 10, 2006
#### State v. Silk

22970

10/27/2000

Vacated and Remanded
#### Child Support Enforcement Agency v. Roe

22278

01/23/2001

Affirmed
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 Commerce

###### Foreign-Trade Zones Board

          - [S-233-2023]

An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Eastern Distribution Center, Inc., grantee of FTZ 24, requesting subzone status for the facility of GMA Accessories DBA Capelli New York (Capelli), located in Pittston, Pennsylvania. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on December 8, 2023.

The proposed subzone (28.08 acres) is located at 901 Sathers Drive, Pittston, Pennsylvania. No authorization for production activity has been requested at this time. The proposed subzone would be subject to the existing activation limit of FTZ 24.

In accordance with the FTZ Board's regulations, Juanita Chen of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.

                    Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary and sent to:                     *ftz@trade.gov.*                     The closing period for their receipt is January 23, 2024. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to February 7, 2024.                

                    A copy of the application will be available for public inspection in the “Online FTZ Information Section” section of the FTZ Board's website, which is accessible via                     *www.trade.gov/​ftz.*

                    For further information, contact Juanita Chen at                     *juanita.chen@trade.gov.*

Dated: December 11, 2023.

Elizabeth Whiteman,

Executive Secretary.

[FR Doc. 2023-27483 Filed 12-13-23; 8:45 am]

BILLING CODE 3510-DS-P