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This document serves as a registration form for research involving select agents, outlining federal regulations and requirements for the use, transfer, and disposal of hazardous agents.
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How to fill out form 8 - research
How to fill out FORM 8 - RESEARCH INVOLVING SELECT AGENTS
01
Obtain FORM 8 from the relevant regulatory agency's website.
02
Read the instructions thoroughly to understand the requirements.
03
Fill out the research project's title and principal investigator's information.
04
Provide detailed information about the select agents involved in the research.
05
Outline the purpose and objectives of the research.
06
Describe the facilities and security measures in place for handling select agents.
07
Include any necessary approvals from institutional biosafety committees.
08
Review the completed form for accuracy and completeness.
09
Submit the form according to the agency's submission guidelines.
Who needs FORM 8 - RESEARCH INVOLVING SELECT AGENTS?
01
Researchers conducting studies involving select agents.
02
Institutions planning to work with select agents in their research.
03
Laboratories requiring compliance with federal regulations on select agents.
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What is a select agent in research?
A select agent is a biological agent or toxin that has the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant product.
What are select agents in NIH?
Select agents are hazardous biological agents and toxins that have been identified by HHS or the U.S. Department of Agriculture (USDA) as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products.
What is tier 1 select agent?
Tier 1 Select agents and toxins – A subset of select agents and toxins have been designated as Tier 1 because these biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public
What are the Category A select agents?
These category A select agents are variola major virus (smallpox), Bacillus anthracis (anthrax), Yersinia pestis (plague), Clostridium botulinum toxin (botulism), Francisella tularensis (tularemia), and the viral hemorrhagic fever agents Arenaviridae (Lassa fever, Junin-Argentine hemorrhagic fever, and Venezuelan
What viruses are classified as bioweapon tier 1 select agents?
The list of Tier 1 select agents and toxins includes: Bacillus anthracis. Bacillus cereus Biovar anthracis. Botulinum neurotoxins. Botulinum neurotoxin producing species of Clostridium. Burkholderia mallei. Burkholderia pseudomallei. Ebolavirus. Foot-and-mouth disease virus.
What are Tier 1 select agents?
Tier 1 Select agents and toxins – A subset of select agents and toxins have been designated as Tier 1 because these biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public
Is mpox a select agent?
Monkeypox virus is a select agent. If monkeypox virus clade undetermined or Clade I is identified in a clinical or diagnostic specimen, the material is a select agent and the select agent and toxin regulations apply; however, an exemption may apply.
Is Veev a select agent?
Because it can affect both animals and humans, VEEV is listed as an overlap select agent in § 121.4(b) of the regulations and therefore is subject to regulation by both APHIS and CDC.
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What is FORM 8 - RESEARCH INVOLVING SELECT AGENTS?
FORM 8 is a regulatory document required by the U.S. government for research activities that involve select agents and toxins that pose a significant risk to public health and safety.
Who is required to file FORM 8 - RESEARCH INVOLVING SELECT AGENTS?
Researchers, institutions, and organizations that plan to work with select agents and toxins are required to file FORM 8 with the appropriate regulatory authorities.
How to fill out FORM 8 - RESEARCH INVOLVING SELECT AGENTS?
To fill out FORM 8, provide detailed information about the research project, including the type of select agents being used, the purpose of the research, and safety protocols. Follow the guidelines provided by the regulatory authority.
What is the purpose of FORM 8 - RESEARCH INVOLVING SELECT AGENTS?
The purpose of FORM 8 is to ensure that research involving select agents is conducted safely and responsibly, minimizing risks to public health and safety while allowing for scientific advancement.
What information must be reported on FORM 8 - RESEARCH INVOLVING SELECT AGENTS?
FORM 8 requires reporting information such as the name and location of the institution, details about the select agents to be used, the principal investigator's contact information, and the safety measures in place to handle these agents.
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