№ lp_1_27383
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The document provides a template for applicants to prepare a report evaluating the similarity of their medicinal product with authorized orphan medicinal products in the EU under market exclusivity, as part of the regulatory procedure.
Year:
2022
Region / City:
European Union
Theme:
Orphan medicinal products, market exclusivity
Document type:
Template
Organization:
European Medicines Agency
Author:
CMDh
Target Audience:
Applicants for marketing authorization of orphan medicinal products
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2022
Document Type:
Exclusivity Agreement
Parties:
San Diego Community Power and [INSERT ENTITY NAME]
Organization:
San Diego Community Power
Legal Form (SDCP):
California joint powers authority
Project:
[INSERT PROJECT NAME]
Related Procurement:
San Diego Community Power 2024 Request for Offers for Renewable Energy and Energy Storage Projects
Subject Matter:
Exclusive good faith negotiations for a long-term renewable Power Purchase Agreement
Negotiation Period:
120 calendar days from execution by SDCP
Extension Period:
30 additional calendar days at SDCP’s discretion
Deposit Amount:
$3,000 per MW of proposed guaranteed capacity
Deposit Form:
Cash or irrevocable standby Letter of Credit
Governing Location:
San Diego, California
Referenced Officer:
Dr. Eric W. Washington, CFO
Year:
2017
Region / City:
International
Topic:
Expertise Call
Document Type:
Declaration
Organization:
ITER Organization
Author:
Undersigned party
Target Audience:
Potential candidates for expertise roles
Period of Validity:
November 2017 - December 2018
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2018
Region / City:
Australia
Theme:
Pharmaceutical application
Document Type:
Authority Required listing submission
Agency / Organization:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Orphan Australia Pty Ltd
Target Audience:
Healthcare professionals, regulatory authorities
Effective Period:
Not specified
Approval Date:
12 June 2012
Amendment Date:
Not specified
TABLE OF CHANGES – INSTRUCTIONS for Form I-600, Petition to Classify Orphan as an Immediate Relative
Year:
2022
Region / city:
United States
Topic:
Immigration, Adoption
Document Type:
Instruction Manual
Organization / Institution:
U.S. Citizenship and Immigration Services (USCIS)
Author:
USCIS
Target Audience:
Applicants for Form I-600, adoption agencies, immigration professionals
Period of validity:
Until changes are implemented or the form expires
Approval Date:
08/06/2022
Date of Amendments:
None indicated
Context:
Instructions for the filing of Form I-600 and related forms, outlining necessary documents, eligibility requirements, and procedural steps for adoption petitions.
Document Type:
Regulatory guidance and application template
Subject:
Orphan-drug designation request
Regulatory Framework:
Code of Federal Regulations Title 21 (2019)
Jurisdiction:
United States
Relevant Authority:
Food and Drug Administration
Applicable Regulation:
21 CFR Part 316
Referenced Guidance:
M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry
Module Reference:
Module 1.12.17
Intended Applicant:
Sponsor of a drug product
Scope:
Rare diseases or conditions affecting fewer than 200,000 persons in the United States or meeting cost-recovery criteria
Submission Requirements:
Completed, dated, and signed request in duplicate
Content Requirements:
Sponsor information, drug description, scientific rationale, regulatory status, prevalence documentation, references
Sections Included:
Title Page; Orphan-Drug Designation Request Statement; Information on the Sponsor; Description of Rare Disease and Proposed Use; Description of the Drug and Rationale; Statement Regarding Follow-On Drugs; Disease Subsets/Plausibility; Summary of Regulatory Status; References
Year:
2023
Region / City:
Oklahoma
Subject:
Orphan Well Site Testing, Plugging, Remediation, and Reclamation Program
Document Type:
Contract Document
Organization:
Oklahoma Corporation Commission (OCC)
Author:
Oklahoma Corporation Commission (OCC)
Target Audience:
Contractors, Project Managers, Subcontractors, Federal and State Agencies
Period of Action:
2023–2024 (and possible renewals)
Approval Date:
Not specified
Date of Changes:
Not specified
Scope:
Management of Orphan Well Site Testing, Plugging, Remediation, and Reclamation Program
Responsibilities:
Coordination of subcontractors, compliance with IIJA, preparation of monthly reports
Technological Requirements:
Website and database development for data tracking, GIS mapping
Additional Requirements:
Physical office in Oklahoma, insurance coverage, compliance with OCC procedures
Context:
Contract document detailing responsibilities and requirements for a Project Manager overseeing the Orphan Well Site Testing, Plugging, Remediation, and Reclamation Program for OCC.
Title:
Orphan High-Field Superconductivity in Non-Superconducting Uranium Ditelluride
Authors:
Corey E. Frank; Sylvia K. Lewin; Gicela Saucedo Salas; Peter Czajka; Ian M. Hayes; Hyeok Yoon; Tristin Metz; Johnpierre Paglione; John Singleton; Nicholas P. Butch
Affiliations:
NIST Center for Neutron Research, National Institute of Standards and Technology, Gaithersburg, MD, USA; Maryland Quantum Materials Center, Department of Physics, University of Maryland, College Park, MD, USA; Canadian Institute for Advanced Research, Toronto, Ontario, Canada; National High Magnetic Field Laboratory, Los Alamos National Laboratory, Los Alamos, NM, USA
Correspondence:
[email protected]
Field of Study:
Condensed Matter Physics
Research Topic:
High-field superconductivity in uranium ditelluride (UTe2)
Material Studied:
Uranium Ditelluride (UTe2) single crystals
Phenomenon Investigated:
Reentrant and orphan high-field superconductivity
Magnetic Field Range:
37 T – 52 T
Angular Range:
29°–42° between crystallographic b and c axes
Temperature Range:
Down to 110 mK
Type of Document:
Scientific research article
Experimental Context:
High magnetic field measurements and transport studies
Key Terms:
Spin-triplet superconductivity; metamagnetic transition; Kondo lattice effects; field-induced superconductivity
Year:
2026
Region / State:
West Virginia
Subject:
Oil and gas well regulation
Document type:
Legislative bill
Legislative body:
West Virginia Legislature
Authors:
Delegates Hansen, Petitto, Dean, Eldridge, Young
Target audience:
Lawmakers, regulatory agencies, oil and gas operators
Effective period:
Upon enactment
Date introduced:
February 10, 2026
Committees:
Energy and Public Works, Finance
Legal references:
§22-6A-1 et seq., §22-10-3(c), §22-10-7
Purpose:
Prevention and reclamation of orphaned oil and gas wells
Year:
2026
Region / city:
Hungary
Subject:
E-learning, Student Performance Evaluation
Document type:
Research Paper
Organization / institution:
Kodolányi János University, MY-X Research Team
Author:
Shagai Turtogtokh, László Pitlik, László Pitlik (Jr)
Target audience:
Educators, Researchers, Data Scientists
Period of validity:
Ongoing
Date of approval:
Not specified
Date of modifications:
Not specified
Keywords:
AI, anti-discrimination, optimization, automation, e-learning
Context:
This is a research paper analyzing student performance using Moodle log data, advanced data analytics, and AI tools to offer an objective, data-driven evaluation framework for educators.
Year:
2016
Region / city:
Geneva
Topic:
Development of UPOV denomination similarity search tool
Document type:
Meeting report
Organization:
International Union for the Protection of New Varieties of Plants (UPOV)
Author:
Working Group for the Development of a UPOV Denomination Similarity Search Tool
Target audience:
UPOV members, plant breeders, legal and technical experts
Period of validity:
N/A
Approval date:
February 4, 2016
Modification date:
N/A
Note:
Year
Theme:
Mathematics / Geometry
Document Type:
Educational Assignment
Target Audience:
Students
Subject:
Fluid machinery similarity and scaling calculations
Topic:
Pumps, turbines, and fans performance relationships
Document type:
Engineering problem set with solutions
Academic field:
Fluid Mechanics
Subfield:
Turbomachinery
Key concepts:
Flow coefficient, head coefficient, power coefficient, specific speed, dynamic similarity
Machines analyzed:
centrifugal pump, axial flow fan, Francis turbine, Kaplan turbine
Units used:
SI and US customary units
Content structure:
numbered calculation problems with given data and step-by-step solutions
Number of problems:
13
Physical quantities:
flow rate, head, rotational speed, power, efficiency, diameter, scale ratio
Year:
2021
Region:
United States, Arizona and California
Topic:
Election statistics and alleged voter fraud
Document type:
Research article / Analytical report
Author:
Roger W. Fuller
Date of publication:
May 15, 2021
Methodology:
Comparison of historical and current voter registration and turnout ratios
Data sources:
Arizona Secretary of State, Marin County records, census.gov, World Population Review
Key terms:
Election Froude Number, voter registration, turnout ratio, phantom ballots
Year:
2023
Region / city:
Global
Topic:
Freshwater fish life-history strategies
Document type:
Scientific Supplementary Information
Organization:
N/A
Author:
N/A
Target audience:
Researchers in ecology, environmental science
Period of validity:
N/A
Date of approval:
N/A
Date of amendments:
N/A
Context:
Supplementary information providing detailed figures, tables, and analyses on life-history strategies of freshwater fish species across global river basins, focusing on native versus non-native fish.
Year:
Not specified
Region / City:
Not specified
Subject:
Religious Education
Type of Document:
Lesson Plan
Author:
Not specified
Target Audience:
Children
Learning Objectives:
Explore similarities and differences among individuals and understand Christian beliefs about human creation in God’s image
Resources:
Mirrors, Lego, drawing materials, Bible
Biblical References:
Genesis 1:26, Genesis 11:1-9
Activities:
Reflection in pairs, discussion, building/drawing exercises, storytelling
Unit:
6
Topic:
Sense Relations – Identity and Similarity of Sense
Subject Area:
Linguistics / Semantics
Document Type:
Educational Textbook Unit
Concepts Discussed:
Synonymy, Sense, Predicate, Paraphrase
Language:
English
Content Elements:
Definitions, Examples, Practice Exercises, Feedback, Commentary
Key Terms:
synonymy, predicate, sense relations, paraphrase, cognitive meaning
Part of Course:
Semantics / Meaning in Language
Educational Level:
Linguistics Study Material