IBC# ______ Institutional Biosafety Committee Amendment# ______

IBC ApplicationIBC application and amendment form for research using biologicals, animals, toxins, pathogens and rDNA.

INSTRUCTIONS: ALWAYS download the latest version, and then save this form before completing it. DO NOT type into the gray shaded areas. Add lines to tables as needed. To check a box, point the cursor to the box and left click.Sign and submit only the first page to the IBC Office at 433 Bolivar St. RCB#206, New Orleans, LA 70112. EMAIL the completed application in WORD format to: IBCoffice@lsuhsc.edu. Paper submission will not be accepted.Personnel submitting in behalf of the PI must cc the PI on the email for IBC acceptance of the application.

********************This box is for IBC OFFICE use only********************

☐ This IBC application was approved by the LSUHSC-NO IBC. Annual re-approval will be required and routine inspections should be expected. You must submit an amendment prior to implementing any changes.

☐ This amendment was approved by the LSUHSC-NO IBC. Annual re-approval will be bound to the approved date of the application which this document amends.

Approval Signature: _______________________________ Date of IBC Approval: _____________Arnold H. Zea, Ph.D., IBC Chairman

As Principal Investigator of this project, I attest that the below information contained in this application is accurate and complete. I accept the responsibility for the safe conduct of work with this study at the Biological Safety Level practices and procedures assigned by the IBC. I will inform all personnel, who may be at risk of potential exposure of the conditions of this work. I assure that all personnel will receive adequate training to perform all activities safely and proficiently. I will not carry out the work described in the attached application until it has been approved by the IBC and all requirements have been met. Where applicable, I agree to comply with the NIH requirements pertaining to shipment and transfer of recombinant DNA materials. I acknowledge my responsibility for the conduct of this research in accordance with Section IV-B-7 of the NIH Guidelines: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html. I certify that I and all the individuals participating in this project 1) are listed in the COI Team Member Form and, where applicable, the associated IRB or IACUC application and 2) have a currently active annual COI disclosure. “Currently active” means the COI disclosure has been updated to reflect any COI acquired as a consequence of this specific research project.

Principal Investigator’s Signature: _____________________________________________ Date: ____________________Sign and submit only the original signature page to the IBC Office at 433 Bolivar St. RCB#206, New Orleans, LA 70112.

Date of submission

Check Type of Application If 5-year renewal, enter previous IBC#

If amendment, enter amendment #

☐Initial ☐Renewal ☐Amendment

PI Name DegreePosition DepartmentEmail address Telephone

Copy email IBC correspondence to the following personnel.Name EmailName Email

Project Title

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1. Other Required Institutional OversightLSUHSC-NO IACUC approval required? ☐ Approved ☐ Pending ☐ NO IACUC#LSUHSC-NO IRB approval required? ☐ Approved ☐ Pending ☐ NO IRB#List any non-LSUHSC-NO institutional oversight and approval date.

Institutional project #

List any non-LSUHSC-NO institutional oversight and approval date.

Institutional project #

2. Check ALL appropriate boxes for the use of any of the following items in this research project.☐ Human or non-human primate blood/body materials, cell lines, OPIM in a clinical setting☐ Human or non-human primate blood/body materials, cell lines, OPIM in a laboratory setting☐ Investigational New Drugs (INDs)☐ Infectious agents, bacteria, toxins, pathogens, carcinogens☐ “Select Agent” as listed on http://www.selectagents.gov/ ☐ “Dual Use Research of Concern” as listed on

http://osp.od.nih.gov/office-biotechnology-activities/biosecurity/dual-use-research-concern☐ Viruses, viral vectors, lentivirus or rDNA☐ Synthetic nucleic acid molecules☐ Animal or animal parts; breeding or cross breeding animals☐ Insects☐ Plants☐ Appendix A: Exposure requires special treatment BEYOND medical standard of care and established SOPs

3. Estimate the time frame of this project.Approximate Start date Duration

4. List all LSUHSC-NO campus locations where research activities will be conducted or materials stored.Building Room# Activities (clinic, procedures, cell work, processing specimens or materials, storage)

5. List non-LSUHSC-NO locations where research activities will be conducted. Name of Institution/Clinic Address: Street, City, Sate Activities (clinic, procedures, cell work,

processing specimens or materials, storage)

6. List all funding sources.Name of department, agency, organization, foundation, corporation

Grant #, if applicable.

Grant #, if applicable.

Dates of award period or pending?

Name of department, agency, Grant #, if applicable.

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organization, foundation, corporation

Dates of award period or pending?

7. If this project is or will be associated with a grant, a congruency check may be required for funding. List and provide a brief explanation for any discrepancies between what is described in the grant and this application.

☐ There is no association with a federal grant or any other organization that requires a congruency check.☐ There are no discrepancies between the grant and this IBC application. ☐ The following differences between the grant and this IBC application are explained below.

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8. Research materials and bio-agents used or stored in a LSUHSC-NO laboratory must be listed and managed in the EH&S On-Site Bioinventory. Provide the last update when your inventory was verified. Log into inventory On-Site database at http://chem-tracker2:1568/

Enter the last verification date (must be within one year of this application date) or enter “N/A” if not required to maintain a laboratory inventory subject to EH&S Policy and Procedures

If biological materials for this research protocol are not yet in PI possession, PI ensures that they will be listed in On Site as soon as they are received in the laboratory. For additional assistance (i.e., granting PI designate access to manage inventory, adding labs/materials, or login assistance) contact the Biosafety Officer at 504-568-6585.

9. List all participants in this project in either Table 9a or Table 9b according to level of contact with research materials or animals or with human subjects. Add rows to the tables as needed.The PI is responsible for ensuring that all research personnel participating in this project have completed all required institutional training. Training is necessary to ensure that individuals are aware of the potential hazards involved in handling these materials and use the proper precautions to protect themselves. Individuals who handle human blood and blood products, human body fluid and/or human tissue are required to complete Bloodborne Pathogen (BBP) Training- High Risk annually. It is also advisable that these individuals receive the Hep B vaccine series. All other LSUHSC personnel are required to complete Bloodborne Pathogen (BBP) Training- Low Risk every 5 years. Individuals working in a laboratory are also required to complete Laboratory Safety; investigators working with rDNA, must complete Institutional Biosafety in Research training via KDS on-line training.

9a. Personnel who will perform laboratory activities or handle research materials/samples. First & Last Name, Degree Role in Project/Activities Date of

current BBP training

Date of Lab or Bio Safety training

If not an LSUHSC-NO employee/student, list employer or institution and provide safety training documentation.

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9b. Personnel who will not perform laboratory activities but may have contact with research subjects or materials. First & Last Name, Degree Role in Project/Activities Date of current

BBP trainingIf not an LSUHSC-NO employee/ student, list employer or institution

10.

List research materials to be transported or shipped off campus or clinical site. Biological Materials Shipping training is required for all applicable personnel. [For LSUHSC personnel, go to EH&S On-line Training for Shipping Biological Materials at http://www.lsuhsc.edu/admin/pfm/ehs/train.aspx]

☐ No ☐ Yes No research samples/materials will be transported or shipped off campus or clinical site. ☐ No ☐ Yes Personnel from other institution/clinic (non-LSUHSC personnel) will collect, process, pack

and/or ship research samples following their institutional SOPs and training requirements.☐ No ☐ YesIf Yes, complete table

LSUHSC-NO personnel will pack and/or ship research samples.

Sample/Material Mode of transportation

If toxin or select agent, enter DOT division and UN classification

Enter “from” and “to” locations

Name of person who will pack and/or ship

IATA or EH&S Bio Shipping Training Date

11. If amending a previously approved IBC application, describe the changes requested and list all applicable item numbers that are changed in this amendment.

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12. In NON-TECHNICAL LANGUAGE, provide a brief explanation of the purpose(s) of this project. Define all acronyms. (In 200 words or less.)

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13. In NON-TECHNICAL LANGUAGE, briefly describe the experimental design and the laboratory work in sufficient detail for the IBC to assess the risks related to laboratory activities and the use of research materials (e.g., human biologicals, regulated materials, pathogens, toxins, animals, recombinant DNA, AAV, viral vectors, and any other cell work. Do not copy and paste IRB, IACUC or grant detailed project narratives).

[Type here]

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14. Bio Safety Level (BSL) – BSL number indicates the level of containment practices that will be used, regardless of Risk Group (RG) of the materials being used. Minimum standard description of BSL are provided as a guide.The PI is responsible for ensuring all personnel are trained to perform assigned duties and that all equipment to be used is operational and certified where required.

(Contact EH&S BSO if any equipment or laboratory requires evaluation or certification.)

BSL-1 Use of standard microbiological practices; work can be performed on an open lab bench or table; PPE (lab coats, gloves, eye protection) are worn as needed; frequent decontamination of surfaces; an available sink for hand washing. The lab space is sectioned to separate the working space and access is limited. Most RG1 materials can be used under BSL1 but when manipulated, BSL2 may be required. All work with human cells or viral vectors must be performed at a minimum of BSL2 even if the item is rated as RG1.

BSL-2 In addition to BSL-1 considerations, required PPE includes lab coats and gloves, eye protection and face shields as needed; all procedures that can cause infection from aerosols or splashes are performed within a biological safety cabinet. Decontamination of surfaces after using; an autoclave or an alternative method of decontamination is available for proper disposals. The laboratory has separate doors with access to the laboratory restricted when work is being conducted; sink and eyewash are readily available; biosafety signs on door.

BSL-3 In addition to BSL-2 considerations, lab personnel are under medical surveillance and might receive immunizations for microbes they work with; access to the laboratory is restricted and controlled at all times; appropriate PPE must be worn, and respirators might be required; all work with microbes must be performed within an appropriate biological safety cabinet; a hands-free sink and eyewash are available near the exit. Exhaust air cannot be recirculated, and the laboratory must have sustained directional airflow by drawing air into the laboratory from clean areas towards potentially contaminated areas. Entrance to the lab is through two sets of self-closing and locking doors.

In the table below, indicate the BSL containment level for each activity or use of research material. List the specific PPE to be used (e.g. double latex gloves, disposable lab coat, hair bonnet, shoe covers, mask, goggles) and identify any containment equipment that will be used (e.g., sharps container, biosafety cabinet, chemical fume hood, containment centrifuge, secured cabinets) or special procedures to be used to minimize exposure. (You may attached any specific lab SOPs to be used.)BLS# Activity/Research Material Specific PPE, containment, SOP

15. Describe method(s) to be used to inactivate agents or to decontaminate infectious materials, workspaces and supplies. Identify how and where research materials will be disposed.

[Type here]

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16. Research Materials - Research materials include animals, animal parts, human or non-human tissues or biological samples, experimental drugs, biologicals, toxins, pathogens, virus, viral vectors, recombinant or synthetic DNA molecules.Regulatory websites are listed for reference. (Alternatively, copy and paste the link into your web browser).NIH Guidelines Appendix B Risk Groups: https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.html#_APPENDIX_B._CLASSIFICATION ABAS https://my.absa.org/Riskgroups CAS Registry Number: http://www.cas.org/expertise/cascontent/registry/regsys.html EAR - CCL Database: Part 774 (In particular, see Category 1, pgs. 58 -73) http://www.access.gpo.gov/bis/ear/pdf/ccl1.pdfNIH Appendix B Risk Group classifications are used for those biological agents known to infect humans as well as selected animal agents that may pose theoretical risks if inoculated into humans. The BSL containment level is determined by risk of the agent as it is being used. (e.g., injecting a RG1 material into an animal host may require BSL2 procedures).Risk Group 1 Agents that are not associated with disease in healthy adult humans Risk Group 2 Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often availableRisk Group 3 Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low

community risk)Risk Group 4 Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and

high community risk)

List specific material(s) to be used, include strain where applicable

Identify type of material(e.g. human or non-human blood or cells/tissues, toxin, carcinogen, bacteria, pathogen, fungi, prions, parasites, virus, viral vector, lentivirus, AAV, rDNA)

Vendor or Source

Identify host and experiment type

mice/vivo, human fibroblast/vitro

Using under

BSL1,2,3

NIH Risk Group 1,2,3,4 (bio- agents only)

Chemical Abstract Service (CAS) Registry Number

Where applicable, submit the SDS or vector map with application or enter a direct web address to view the documents.

Example: pENN.AAV.CB7.CI.eGFP.WPRE.rBG

AAV vector UPenn Vector Core In vivo mice BSL1, 2 after injection

1 https://www.med.upenn.edu/gtp/vectorcore/BiosafetyInformation.shtml

Example: Ecoli Bacteria In house Ecoli /invitro 1 1

Add rows as needed

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17. Identify materials that may require review by the IRE that are on the CDC/USDA Select Agents and Toxin List or is listed as a Dual Use of Concern [research with an identifiable benefit but with the potential for misuse]. Indicate the maximum quantity that will be used and stored at any given time on this campus. Attach the required LSUHSC EH&S Toxin Form and indicate if Federal Select Agent Program registration will be required. Contact the EH&S BSO for assistance. IRE (Institutional Review Entity) approval will be required. Additional mitigation SOPs may be required.)

[Type here]

18. Identify any research material which is toxic or will produce toxins that have a mammalian lethal dose of 50% (LD50) and the value of the LD50 is ≤100 µg/kg of body weight for humans or animals used.

(This project may fall under NIH Guidelines Section III-B-1.)Toxin LD50 Value Maximum volume

per experiment in liters

Total volume in use and storage

Provide justification for required quantity.

Explain risks and identify what treatments or antidotes are available.

19. Identify any material that was prescreened or will be screened for pathogens or if the material has been intentionally infected or is suspected of being infected, partially with the use of human blood/tissues/cells. Also, indicate the associated pathogen, virus, etc.

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20. Identify any research material that will be diluted and describe the method. Indicate how they will be

aliquoted.

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21. Identify any live organisms, pathogens, viruses, microorganisms, genetically modified cells, etc. that will be cultured or concentrated and describe method. Indicate method of inactivation and method to verify inactivation if organism is inactivated prior to other

manipulations. Where culture volumes exceed 10L, indicate the maximum volume in liters that will be made, used and

stored. Provide justification for required volumes needed.

(If the research material is Risk Group 2 or more, this project may fall under NIH Guidelines Section III-D-6.)

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22. Identify any live organisms or hazardous materials (carcinogens, recombinant molecule, vectors, toxins, or pathogens) that will be introduced into live animals that will be returned to DOAC housing rooms. Describe procedure(s) used to minimize occupational exposure to DOAC personnel where there is any possibility that any of the research material could remain a viable hazard to personnel. (e.g., in animal secreta, excreta and/or soiled bedding).

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23. Identify the use of any Investigational New Drugs (INDs). (Copy table to list each IND separately.)

Name of IND and purpose.Does the IND involve rDNA and/or synthetic nucleic acids technology? If “yes”, complete all applicable sections of this application.If IND is manufactured elsewhere, report facility and contact information here.If IND is made on-site, describe IND laboratory practices and manufacturing process.Describe how IND is tested for sterility.

24. In event of an accidental exposure to personnel, Occupational Health standard of care and established LSUHSC SOPs will be followed. Identify any research material(s) that requires treatment beyond these established guidelines and complete Appendix A - Medical Information for Occupational Health Treatment for Exposure.

☐ Standard or established LSUHSC policies and procedures are appropriate.

☐ Appendix A details additional specific treatment required for the following exposures:

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25. Check the applicable sections of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Molecules for research using transgenic animals, viruses, viral vectors, lentivirus, rDNA, etc. and complete the remaining sections of this application where applicable. The NIH guidelines define recombinant and synthetic nucleic acids as:

i. Molecules that are constructed by joining nucleic acid molecules and can replicate in a living cell (i.e. recombinant nucleic acids);

ii. Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acids (i.e. synthetic nucleic acids).

iii. Molecules that result from the replication of those described in (i) or (ii) above.

For description of the classifications under the NIH Guidelines for rDNA, click link: [https://osp.od.nih.gov/wp-content/uploads/2013/06/NIH_Guidelines.pdf ] Additional web pages for information on classifying experiments involving whole animals:NIH Classification Table for Animal experiments: https://osp.od.nih.gov/wp-content/uploads/Animal_Activities_Table.pdf

NIH FAQs: http://osp.od.nih.gov/biotechnology/faqs-on-genetically-modified-transgenic-animals-and-the-use-of-recombinant-or-synthetic-nucleic-acid-molecules-in-animals/Projects under Section III A, B and C require additional approvals from NIH prior to starting.

Check applicable section(s)

Check applicable subpart

NIH Guidelines Sections (to identify sections and subparts, click link: https://osp.od.nih.gov/wp-content/uploads/2013/06/NIH_Guidelines.pdf

☐ ☐

Section III-A-1 The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally (see Section V-B, Footnotes and References of Sections I-IV), if such acquisition could compromise the ability to control disease agents in humans, veterinary medicine, or agriculture, will be reviewed by the RAC.

☐ Section III-B-1 or B-2

Experiments involving the cloning of toxin molecules with LD50 of less than 100 ng/kg of body weight

☐Section III-C-1 Experiments involving the deliberate transfer of recombinant or synthetic

nucleic acid molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid molecules, into one or more human research participants.

☐ ☐a ☐b ☐c ☐d

Section III-D-1 Experiments using Risk Group 2, Risk Group 3, Risk Group 4, or restricted agents as host-vector systems.

☐ ☐a ☐bSection III-D-2 Experiments in which DNA from Risk Group 2, Risk Group 3, or restricted

agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems.

☐☐a ☐b ☐c ☐d ☐e

Section III-D-3 Experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems.

☐☐a ☐b ☐c ☐c1 ☐c2

Section III-D-4 Experiments involving whole animals that cannot be done at BSL-1

☐ ☐a ☐b ☐c ☐d

Section III-D-5 Experiments involving whole plants; Experiments to genetically engineer plants by recombinant or synthetic nucleic acid molecule methods, to use such plants for other experimental purposes (e.g. response to stress), to propagate such plants, or to use plants together with microorganisms or insects containing recombinant or synthetic nucleic acid molecules that cannot be done at BSL-1.

☐ Section III-D-6 Experiments involving more than 10 liters of culture. (Also refer to Appendix K)

☐ ☐a ☐b ☐c ☐d

Section III-D-7 Experiments involving Influenza viruses.

☐ Section III-E-1 Experiments involving the formation of recombinant or synthetic nucleic acid molecules containing no more than 2/3 of the genome of any

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Check applicable section(s)

Check applicable subpart

NIH Guidelines Sections (to identify sections and subparts, click link: https://osp.od.nih.gov/wp-content/uploads/2013/06/NIH_Guidelines.pdf

eukaryotic virus (BSL-1 experiments only).

☐☐a ☐b ☐b1 ☐b2 ☐b3 ☐b4 ☐b5

Section III-E-2 Experiments involving recombinant DNA-modified whole plants, and /or experiments involving recombinant or synthetic nucleic acid molecule-modified organisms associated with whole plants, except those that fall under Section III-A, III-B, III-D, or III-F (BSL-1 experiments only).

☐Section III-E-3 Experiments involving transgenic rodents modified by the stable

introduction of recombinant or synthetic nucleic acid molecules into their genome, or nucleic acids derived therefrom, into the germ-line (transgenic rodents). (BSL-1 experiments only).

☐Section III-F-1 Experiments using synthetic nucleic acids that: (1) can neither replicate nor

generate nucleic acids that can replicate in any living cell, (2) are not designed to integrate into DNA, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of <100 ng/kg.

☐Section III-F-2 Recombinant/synthetic molecules are not in organisms, cells, or viruses, and

that have not been modified or manipulated to make cellular membrane penetration possible.

☐Section III-F-3 Recombinant/synthetic molecules that consist entirely of the exact

recombinant or synthetic nucleic acid sequence from a single source that exists in nature.

☐

Section III-F-4 Recombinant/synthetic molecules that consist entirely of DNA from a prokaryotic host including its indigenous plasmids, or viruses when propagated only in that host (or closely related strain of the same species), or when transferred to another host by well-established physiological means.

☐Section III-F-5 Recombinant/synthetic molecules that consist entirely of DNA from

eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).

☐

Section III-F-6 Those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. A list of such exchangers is prepared and periodically revised by the NIH Director and can be found in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

☐Section III-F-7 Those genomic DNA molecules that have acquired a transposable element,

provided the transposable element does not contain any recombinant and/or synthetic DNA.

☐Section III-F-8 Those exemptions as determined by the NIH Director to not present a

significant risk to health or the environment are listed in the appendices below. Also check all categories that apply:

☐ Appendix C-I Recombinant or synthetic nucleic acid molecules in tissue culture.

☐ Appendix C-II Escherichia coli K-12 host-vector systems.

☐ Appendix C-III Saccharomyces host-vector systems.

☐ Appendix C-IV Kluyveromyces host-vector systems.

☐ Appendix C-V Bacillus subtilis or Bacillus licheniformis host-vector systems.

☐ Appendix C-VI Extrachromosomal elements of gram positive organisms.

☐ Appendix C-VII The purchase or transfer of transgenic rodents (and subsequent use at BSL1)

☐ Appendix C-VIII Generation of BL1 transgenic rodents via breeding.

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26. Human Gene Transfer (HGT) – Study involves the transfer of rDNA, viral or synthetic nucleic acids or biological agents containing rDNA into human subjects. Consult Appendix M of the NIH Guidelines. Complete all applicable sections of this application. (Copy table to list each HGT separately.)

Identify and describe the primary HGT product.

Is vertical transmission of HGT product(s) from an individual to the offspring possible?

Is horizontal transmission of HGT product(s) to other persons or the environment possible?

Date of NIH/RAC approval. Attach a copy of your NIH approval letter(s) and your submission as per Appendix M-I - Requirements for Protocol Submission, Review, and Reporting – Human Gene Transfer Experiments

27. Animal Projects. Refer to NIH Table for Animal Experiments to help determine activities falling under the NIH rDNA Guidelines and compete all applicable questions.

27a. If using transgenic animals, provide the following information.Indicate if using “knock-outs” or “knock-ins”; provide gene names, function and sourceIdentify genes that are oncogenes. Identify genes that encodes a toxin or any other hazardous agent. Identify the toxin/agent.Identify any potential hazards with the transgenic animals to personnel, environment or other animals?If the majority of the work in this project is conducted under BSL1 containment, indicate time point(s) when BSL2 containment would be required. (e.g., for 72 hours after animal is injected with AAV, animal will be housed under ABLS2)

27b. Indicate method(s) to be use to make transgenic animals.

☐ Mating established strains only☐ Microinjection of gene constructs into pronuclear fertilized oocytes☐ Insertion of gene constructs into embryonic stem cells that are microinjected into oocyctes☐ Vector-mediated transfer of construct to embryonic stem cells for microinjection into oocyctes; identify

vector and at what titer (particles/ml) of vector will be used☐ Describe other method to be used:

28. Breeding of Rodents “Exempted” from NIH Guidelines: Breeding is exempted from NIH rDNA Guidelines under Section III-F-8 Appendix C-VIII for rodent breeding to be performed under BSL1 containment and falls under breeding schemes described in this section (18a). The subsequent use of the offspring in research experiments may or may NOT be exempted. (IACUC Breeding Application is required for rodents.)

For breeding and other animal activities that are NOT “exempted from NIH Guidelines,” complete the applicable sections that follows.

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28a. Identify rodent and source if breeding a rodent from one strain for colony maintenance or propagation.

Species Strain Source

28b. Identify rodents and source if breeding a genetically-modified (knock-in or knock-out) rodent from one established genetically-modified strain for propagation or colony maintenance.Species Strain Original parent -

strain 1 (genotype, phenotype)

Source of parent1 Original parent-strain 2 (genotype, phenotype)

Source of parent2

28c. Identify breeding scheme in table below if breeding rodents from two strains (generating a new strain) providing neither parental rodent contains the following genetic modifications: (i) incorporation of more than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses; or (ii) incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat (LTR); and (iii) the rodent that results from the breeding is NOT expected to contain more than one-half of an exogenous viral genome from a single family of viruses. If these criteria are not met, use the Table 20b.Species New Strain Parent Strain 1

(genotype, phenotype, source)

Parent Strain 2(genotype, phenotype, source)

Describe resulting genetically modified lines

29. Breeding of any animal NOT exempted from NIH Guidelines: Complete the table for any species crossbreeding genetically-modified strains where the resulting animal contains MORE than 1/2 of an exogenous viral genome from a single family of viruses. (IACUC Breeding Application is required for vertebrates.)

Indicate species breeding (mouse, pig, fly):

New Strain Parent Strain 1 genotype, phenotype, source

Parent Strain 2genotype, phenotype, source

Describe resulting genetically modified lines

BSL1,2,3

30. Breeding of any animal NOT exempted from NIH Guidelines: Complete table for inserting rDNA, creating and breeding new strain. (IACUC Breeding Application required for vertebrates.)

Indicate species breeding (mouse, pig, fly):

New Strain Genes/Sequences(e.g. Tg-GFP green fluorescent protein)

Species of origin (e.g. jellyfish)

Function of Gene: Insertion/Deletion(e.g. marker for insertion)

Describe any promoter, enhancer, or regulatory elements to be used.

BSL1,2,3

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31. rDNA - Provide detail information on the use of rDNA. Any viruses included here should also be listed in the viral vector sections. (Provide web address in Table 16 or attach vector map, SDS, or literature.)

Source Species of inserted DNA

Plasmid and/or Vector(s) (recombinant viruses) to be used

Host(s) to be used, include all intermediate hosts

Identify the gene or transcription product

Indicate if oncogenic, toxic or mutated gene. Describe potential harm in next table.

Example: human pcDNA3.1 E.coli, drosophila cells RalGDS1 none

*For vectors that the encoded gene is oncogenic, toxic or mutated gene, describe potential harm. Material Describe considerations and potential harm.

32. AAV–Adeno Associated Viral Vectors (Provide web address in Table 16 or attach vector map, SDS, or literature.)

AAV vector(s) Promoter and encoded gene

Made with: helper virus (V) or helper plasmid (P)

Produced in human (H) or Insect (I) cells?

If produced in human cells, has it been purified?

Indicate if encoded gene is oncogenic, toxic or mutated gene. *Describe potential harm

Example: pAAV EF1 alpha

EF1-NMNAT2 ☒V ☐P ☐N/A ☐H ☒ I ☐ N/A ☒Yes ☐ No none

☐ V ☐ P ☐ N/A ☐ H ☐ I ☐ N/A ☐ Yes ☐ No☐ V ☐ P ☐ N/A ☐ H ☐ I ☐ N/A ☐ Yes ☐ No

*For vectors that the encoded gene is oncogenic, toxic or mutated gene, describe potential harm. Material Describe considerations and potential harm.

33. Lentiviral Vectors (Provide web address in Table 16 or attach vector map, SDS, or literature.)Lentiviral vector (include plasmid to be packaged/shuttle package)

Indicate generation

Plasmids used and map

If 2nd generation, describe tests to confirm replication incompetence.

If TAT encoded on any system component, describe.

Will more than 10 liters of culture be used in one container?

Indicate if encoded gene is oncogenic, toxic or mutated gene.*

Example:psPAX2, pCMV-VSV-G, pLVTHM

2 psPAX2, map attached

Serial passage followed by p24 ELSIA

Packing plasmid encodes TAT

☐Yes ☒ No none

☐ Yes ☐ No☐ Yes ☐ No

*For vectors that the encoded gene is oncogenic, toxic or mutated gene, describe potential harm. Material Describe considerations and potential harm.

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34. Non-AAV and Non-Lentiviral Vectors (Provide web address in Table 16 or attach vector map, SDS, or literature.)

Non-AAV or Non-Lentiviral vectors

Describe tests to confirm replication incompetence

List use of helper viruses or packing/producer cell lines

List any essential genes that have been deleted, added or modified from the vector/packing system

Will you amplify or produce your own viral particle stock?

Will more than 10 liters of culture be used in one container?

Does the viral vectors have an expanded host range or increase tissue tropism compared to the wild-type virus?* (i.e. product is now potentially infectious in other organisms or cells not normally infected.)

Example:pSIREN-RetroQ (Clontech)

Extended S+/L-assay with PG4 cell line (Chen et al, Virology 2001)

Packing cell line- Phoneix- ECO HEK 293T cells

Deletion in 3’-LTR enhancer

☒Yes ☐No ☐Yes ☒No ☐Yes ☒ No

☐Yes ☐No ☐Yes ☐No ☐Yes ☐No☐Yes ☐No ☐Yes ☐No ☐Yes ☐No

*Provide explanation for vectors that have an expanded host range or increase tissue tropismMaterial Describe considerations and potential harm.

35. Provide any additional information specific to the recombinant work to assist the IBC assessment of risks that has not been covered in this application. Include discussion of any work that has the potential to change agent characteristics such as virulence, pathogenicity, or environmental stability. Where appropriate, explain what additional precautions will be taken.

[Type here]

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Institutional Biosafety Committee433 Bolivar St. Room 206New Orleans, LA 70112504-568-4970

Appendix A: Medical Information for Occupational Health Provider for Exposure from Materials Requiring Specific Treatment

Complete this form for each material. Describe any special drug and/or treatment plan required to mediate the exposure. Provide the information that can assist the health care provider in the medical evaluation and treatment. You may submit a copy of the Safety Data Sheet if the source/vendor provided one. Retain a copy of this factsheet with other safety documents in the laboratory. In the event of an exposure, this form should be brought with the individual seeking medical attention.

There are many resources available regarding genetic background and vectors online. Basic medical information for a variety of common pathogens can be found at http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php

Contact Information Name Office or Lab Telephone

Cell Phone or After Hours Telephone

Principal InvestigatorLab ManagerOther

IBC #:Identify material:Genetic BackgroundSpecies/StrainVectors/Plasmids/ToxinsInfection/Replication CompetencyHost Range/TransmissionDrug Susceptibility/ResistanceSource/VendorRisk GroupPublished or known medical precautions or treatmentProphylaxisVaccineTreatmentMedical SurveillanceAdditional information

List the Safety Data Sheets or any other information that is being submitted with this application.

[Type here]

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