UCSD Shipping Permits
USDA permits
MIT cheat sheet for permitting biological materials
Permits and Field work
Duke Permits and Procedures for Field work
Guidelines for Shipping/Receiving Biological Materials
Permit to Import or Transport Etiologic Hosts or Vectors of Human Disease | Required for importation, interstate and intrastate transport of human pathogens. Expedites the package through customs.
Contact: Centers for Disease Control and Prevention at 404-718-2093. | Materials such as blood, bodily fluid, animals, etc that come from areas of endemic infection should be permitted.
Takes 2 weeks to process, expires after movement of material occurs,
Examples of materials for permit: blood, serum or plasma from different countries unless verified to be virus free, dengue, |
https://www.aphis.usda.gov/aphis/resources/permits
Apply for ePermit access and authenticate. You may need to authenticate in person.
Fill out online questionnaire according to permit type and submit,. You can check status https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/sa_permits_notifications_and_petitions/sa_check_status
sample of status check
17-209-102m University of California/Irvine
Reg article: African Malaria Mosquito
Movements to: CA
Interstate
Received: 28-JUL-2017
Status: Pending
Tech review: 09-AUG-2017
State notify: Pending
CA Interstate
FDA and EPA would be for live mosquitoes. The constructs should go through IBC and EHS locally, IATA...etc.
As of January 2017 the FDA defines GMO Mosquitoes as;
1. Examples of New Animal Drugs a. Products intended to reduce the virus/pathogen load within a mosquito, including reduction in virus/pathogen replication and spread within the mosquito and/or reduction in virus/pathogen transmissibility from mosquitoes to humans. b. Products intended to prevent mosquito-borne disease in humans or animals. (FDA)
It recommends approvals from both agencies (FDA and EPA) to assure due diligence.
2. Example of Pesticide Products a. Products intended to reduce the population of mosquitoes (for example, by killing them at some point in their life cycle, or by interfering with their reproduction or development)5 . (EPA)
UCI IRB does not have specific guidance for GMO mosquitoes, however it would expect documentation of community consent prior to any release.
Pre Award SOPs
Purpose: To have consistent workflow for starting and managing awards pre and post.
Definitions
KC – Kuali Coeus - workflow program
PI - Principal Investigator
WIKI – website for documentation and information
LOI - Letter of Intent
LOS – Letter of support
COI - Conflict of Interest
F&A – Facilities and Administration AKA overhead (OH)
MMG – Microbiology and Molecular Genetics
MBB – Microbiology and Biochemistry
Workflow
1. Receive documents from sponsor or PI and verify managing Department MMG 7473 or MBB 8039
2. Create folder in share drive or wiki (copy original documents)
3. Create/Draft Documents
- a) Justification
- b) Supply list*
- c) Equipment list*
- d) Salary and benefits sheet
- e) Budget
- f) LOI – Letter of intent
- g) LOS – Letter of support
4. Provide documents to Deans office Joseph Garrido (j.garrido@uci.edu) 949-824-7413 (MMG & MBB)
- a. Deans office creates KC document (add you as aggregator)
- b. Respond to questions in KC
- c. Attach draft documents in KC
- d. Complete budget estimate attach to KC document and calculate F&A
5. Notify department and provide copies
6. Post award MMG is Kimberly Smith Lyons smithkl@uci.edu for NIH and grants
7. Post award MBB is Kathleen Gustafson for NIH and grants
8. Post Award Endowments Sentelle Eubanks sentelle@uci.edu
As approvals and permits are received, please email to UCI-Malaria-Initiative@uci.edu
Meeting Planning SOP in progress
You can email your approved documents to: UCI-Malaria-Initiative@uci.edu