№ lp_2_1_00781
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Regulatory guidance and structured application text outlining statutory and scientific requirements for sponsors seeking orphan-drug designation in the United States under 21 CFR Part 316.
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
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
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.
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:
2024
Region / City:
Not specified
Topic:
Professional designation examination
Document Type:
Examination paper
Organ / Institution:
PPRA
Author:
Not specified
Target Audience:
Candidates sitting for the professional designation examination
Period of Validity:
February 2024
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2025
Region / City:
European Union
Topic:
Medical Devices
Document Type:
Application Form
Authoring Organization:
Medical Device Coordination Group (MDCG)
Target Audience:
Conformity assessment bodies
Period of Validity:
Ongoing
Approval Date:
January 2025
Amendment Date:
N/A
Year:
2017
Region / City:
European Union
Theme:
Medical Device Regulation
Document Type:
Regulatory Document
Organization / Institution:
Medical Device Coordination Group (MDCG)
Target Audience:
National Authorities, Notified Bodies, Conformity Assessment Bodies
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2026
Organization:
Texas Department of Insurance
Document Type:
Amendment Proposal Form
Related Manual:
2026 Valuation Manual, VM-20
Sections:
9.F.3, 9.F.4, Appendix 2
Author:
Rachel Hemphill
Date Received:
10/28/25
Notes:
2025-15 VM-20, Section 9.F.3 and 9.F.4
Year:
2013
Region / City:
Washington, D.C.
Topic:
Foreign-Trade Zones (FTZ) Application
Document Type:
Instruction Sheet
Agency / Institution:
U.S. Department of Commerce, International Trade Administration
Author:
FTZ Staff
Target Audience:
Corporations and grantees applying for FTZ designation
Period of Action:
N/A
Approval Date:
March 2013
Amendment Date:
N/A
Note:
Year
Region / City:
King County
Topic:
Legal case assignment, court procedures
Document type:
Court form
Organization / Institution:
King County Superior Court
Author:
King County Superior Court
Target audience:
Attorneys, individuals filing cases in King County
Year:
2023
Region / City:
King County
Subject:
Family Law
Document Type:
Court Form
Institution:
King County Superior Court
Author:
King County Superior Court
Target Audience:
Legal professionals, individuals filing family law cases
Period of Validity:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Region / City:
King County
Topic:
Legal Forms, Probate, Guardianship
Document Type:
Court Form
Agency / Institution:
King County Superior Court
Author:
King County Superior Court
Target Audience:
Attorneys, Individuals filing cases
Document type:
Request form
Program:
Local Business Enterprise (LBE)
Issuing organization:
Port Authority of New York & New Jersey
Department:
Office of Diversity, Equity, & Inclusion and Government & Community Relations
Geographic scope:
Newark, Elizabeth, and municipalities in Essex, Union, and Hudson counties
Defined zones:
Zone 1, Zone 1A, Zone 2
Eligibility criteria:
Principal place of business or significant business presence
Associated project:
AirTrain Newark Replacement Program
Certification references:
MBE, WBE, MWBE, SDVOB, ACDBE
Submission requirements:
Supporting documentation, signature, date
Intended respondents:
Contractors and subcontractors seeking LBE participation credit
Administrative status fields:
Approved, Needs More Information, Denied
Note:
Year
Theme:
Trauma Care, Health Services
Document Type:
Application
Organization / Institution:
Kentucky Cabinet for Health and Family Services
Author:
Kentucky Trauma Advisory Committee
Target Audience:
Healthcare Facilities, Trauma Centers
Year:
20xx
Region / city:
Ontario
Theme:
Legal Proceedings
Document Type:
Practice Direction
Organization / Institution:
Ontario Court of Justice
Author:
Ontario Court of Justice
Target Audience:
Legal professionals, Accused individuals
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2018
Region / City:
Philadelphia
Subject:
Information Technology, Project Management
Document Type:
Course Description
Organization / Institution:
Community College of Philadelphia
Author:
Barbara Anne Hearn
Target Audience:
Students pursuing a career in IT Project Management
Period of Validity:
Fall 2019 and onward
Approval Date:
November 28, 2018 (updated February 13, 2019)
Date of Changes:
February 13, 2019
Year:
2026
Region / City:
United States
Topic:
Education / Federal Student Aid
Document Type:
Instructional Guide
Organization:
U.S. Department of Education
Author:
U.S. Department of Education
Target Audience:
Postsecondary educational institutions, state grant agencies, institutional third-party servicers, FFELP guaranty agencies, and related entities
Period of Validity:
Ongoing
Approval Date:
N/A
Date of Changes:
N/A
Year:
2023
Region / City:
EU
Subject:
Medical Devices
Document Type:
Regulatory Document
Author:
Medical Device Coordination Group (MDCG)
Target Audience:
National Authorities, Conformity Assessment Bodies, Medical Device Manufacturers
Applicable Period:
N/A
Approval Date:
N/A
Date of Amendments:
N/A