Fillable FORM APPROVED OMB NO.: SECTION A ENTITY INFORMATION (Department of Health and Human Services)

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FORM APPROVED OMB NO.: SECTION A ENTITY INFORMATION (Department of Health and Human Services)

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The FORM APPROVED OMB NO.: SECTION A ENTITY INFORMATION (Department of Health and Human Services) form is 6 pages long and contains:

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  • 100 check-boxes
  • 93 other fields

Country of origin: US
File type: PDF

U.S.A. forms for Department of Health and Human Services

BROWSE DEPARTMENT OF HEALTH AND HUMAN SERVICES (DC) FORMS

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1. Name of Entity:
2. Entity Registration/ NRE Number
3. Physical Address (NOT a post office box):
4. City:
5. State:
6. Zip Code:
7. Name of Responsible Official or Laboratory Supervisor:
8. Name of Principal Investigator:
10. Fax Number:
11. Email address:
1. Date and Time
of Incident:
2. Date of Immediate
Notification:
3. Type of Immediate Notification :
4. Location of Incident (bldg., room, equipment, etc.):
Email
Fax
Telephone
eFSAP
MM/DD/YY
MM/DD/YY
5. Name of Select Agent or Toxin:
6. Strain designation of Select Agent or Toxin:
7. Quantity
(Unit (vial, plates, etc.)
Additional Select Agents or Toxins listed in attached document
INCIDENT NOTIFICATION AND REPORTING APHIS/CDC FORM 3
(THEFT/LOSS/RELEASE)
FORM APPROVED OMB NO.
0920-0576
EXP DATE 10/31/2020
INSTRUCTIONS
Answer all items completely and type or print in ink. Detailed instructions are available at http://www.selectagents.gov/form3.html. This report must
be signed and submitted to either APHIS or CDC:
Animal and Plant Health Inspection Service Centers for Disease Control and Prevention
Agriculture Select Agent Services Division of Select Agents and Toxins
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07 1600 Clifton Road NE, MailstopA-46
Riverdale, MD 20737 Atlanta, GA 30329
FAX: (301) 734-3652 FAX: (404) 471-8375
Email: AgSAS@aphis.usda.gov
Email: form3@cdc.gov
Submit completed form only once by either eFSAP, email, or mail.
SECTION A – ENTITY INFORMATION
B
(Select)
1. Type of Theft: 2. Has Local Law Enforcement been
Notified:
(If yes, complete sections C3-C5)
3. Local Law Enforcement Agency:
4. Local Law Enforcement Agent Name:
First
5. Local Law Enforcement Contact Information (phone/email):
6. Has the FBI been Notified:
(If yes, fill out #s C7-8):
7. FBI Agent Name: (First M. Last) 8. FBI Agent Contact Information (phone/email):
9. Was the stolen BSAT material recovered: 10. Was there a potential exposure: (If yes, go to section E- Q: 5-11)
Yes
No
No
Yes
Yes
No
Yes
No
Unsure
Forced Entry
Insider/Insider-
assisted access
Unauthorized access
MI
Last
First
MI
Last
Phone
E-mail
Certification: I hereby certify that the information contained on this form is true and correct to the best of my knowledge. I understand that if I knowingly
provide a false statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that
violations of the select agent regulations may result in civil or criminal penalties, including imprisonment. 7 CFR Part 331, 9 CFR Part 121, 42 CFR Part 73.
Signature of Respondent: Title:
Typed or printed name of Respondent:
Date:
-
8. Type of Incident:
(After completing Section B. Go to Section C)
•
(After completing Section B. Go to Section D)
•
(After completing Section B. Go to Section E)
•
9. Severity of the incident:
10. What Biosafety Level did the incident occur?
11. Is this incident associated with an APHIS/CDC Form 2 (Transfer):
(Fill out Appendix B, if incident occurred during transfer.)
No
APHIS/CDC Form 2 transfer #:
12. Is this incident associated with an APHIS/CDC Form 4 (Identification):
APHIS/CDC Form 4 clinical ID#:
Yes
No
Yes
None
Negligible
Low
Moderate
High
Theft
Loss
Release/ Potential Exposure
ACL4
ACL3
ACL2
ABSL4
ABSL3
ABSL2
NIHBL2
NIHBL3
NIHBL4
NIHBL2N
NIHBL3N
PPQ Agent
NIHBL4-LS
BSL3 Ag
BSL4
BSL3
BSL2
NIHBL4N
NIHBL2-LS
NIHBL3-LS
Phone
E-mail
SECTION C – REPORT OF THEFT
click to sign
signature
click to edit
1. Type of Loss:
Inventory/Recordkeeping error
Sample lost/discarded at entity
Sample lost in transit
(Go to Appendix B to enter add’l info)
Other:
2. Has Local Law Enforcement been
Notified: (If yes, fill out #s D3-D5)
Yes
No
3. Local Law Enforcement Agency:
4. Local Law Enforcement Agent Name:
First
MI
Last
5. Local Law Enforcement Contact Information (phone/email):
Phone
E-mail
6. Was the FBI Notified:
7. FBI Agent Name:
(If yes, fill out #s D7-D8)
Yes
First
No
Last
8. FBI Agent Contact Information (phone/email):
Phone
MI
E-mail
9. Was the lost BSAT material
10. How long was the BSAT
11. Give the date of the last
12. Was there a potential exposure:
found?
material missing?
inventory/audit performed, which
(If yes, complete Section E- Q: 5-11)
Yes
No
Duration of loss
(hrs/days):
Date recovered:
meets the FSAP regulatory
requirement:
Yes
No
Certification: I hereby certify that the information contained on this form is true and correct to the best of my knowledge. I understand that if I knowingly
provide a false statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that
violations of the select agent regulations may result in civil or criminal penalties, including imprisonment. 7 CFR Part 331, 9 CFR Part 121, 42 CFR Part 73.
Signature of Respondent:
Title:
Date:
Typed or printed name of Respondent:
SECTION D - REPORT OF LOSS
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signature
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1. Type of Potential Exposure/Release:
2. Was there a release outside containment barriers?
(choose all that apply)
(e.g., biosafety cabinet, leaking storage vial within
storage unit)
(e.g., laboratory)
(e.g., resulting in possible agricultural/environmental/
public health threat)
3. What PPE was worn at the time of the incident?
4. Did the release result in potential exposure(s)?
If yes, how many individuals/animals/plants
were exposed?
5. Did the release result in a laboratory acquired infection or
an infection/outbreak in agriculture or in the environment?
6.
Has medical surveillance been initiated?
7. Has prophylaxis or treatment been
provided?
8. Has an internal investigation been initiated to lessen the likelihood of recurrences of incident involving the select agents and toxins at this entity?
(If yes, please provide additional details.)
No
Yes
Release outside all containment barriers of the facility
Release beyond secondary containment
Release outside primary containment
No
Yes
Yes
No
Yes
No
Not currently known
Yes
No
Respiratory Protection
Other/None:
Body Protection
Head Protectors/Covers
Foot Protection (e.g., boots, shoe covers)
Hand Protection (e.g., gloves)
Eye/Face Protection (e.g., goggles, face shield)
Type:
(choose all that apply)
(choose all that apply)
Animal bite/scratch
PPE failure
Spill
Needle stick/Sharps
Decontamination failure
Inactivation failure
Unintended Animal Infection
Unintended Plant Pathogen Release
Work performed on an open bench
Other:
Package damaged in transit (fill out Appendix B)
Equipment/mechanical failure
9. Other than a potential for occupational illness, what other hazards have been identified as a result of this incident?
10. Provide a brief summary of how the laboratory and work surfaces were decontaminated after the incident.
11. Provide a brief summary of the medical surveillance conducted (do not provide names or confidential information).
Certification: I hereby certify that the information contained on this form is true and correct to the best of my knowledge. I understand that if I knowingly
provide a false statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that
violations of the select agent regulations may result in civil or criminal penalties, including imprisonment. 7 CFR Part 331, 9 CFR Part 121, 42 CFR Part
73.
Signature of Respondent:
Title:
Date:
Typed or printed name of Respondent:
SECTION E- REPORT OF RELEASE
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signature
click to edit
APPENDIX A
EVENTS TIMELINE
Provide a detailed summary of events, including a timeline of what occurred.
APPENDIX B
IF THE INCIDENT OCCURRED DURING TRANSFER, COMPLETE SECTIONS A AND B OF FORM 3 AND PROVIDE THE
FOLLOWING INFORMATION (INCLUDE A COPY OF THE RELEVANT APHIS/CDC FORM 2)
1. Transfer authorization number from APHIS/CDC Form 2:
2. Date Shipped
3. Name of Carrier
4. Airway bill number, bill of lading number, tracking number
5. Package Description
(size, shape, description of packageing including number and type of inner packages; attach additional sheets as necessary)
6. Package with select agents and toxins received by requestor:
If yes, date of receipt:
7. Package with select agents and toxins appears to have been opened or damaged
during shipment:
If yes, include explanation in box 5 above.
8. Sender was contacted regarding incident:
9. Carrier/courier was contacted regarding incident:
No
Yes
No
Yes
No
Yes
No
Yes
Certification: I hereby certify that the information contained on this form is true and correct to the best of my knowledge. I understand that if I knowingly
provide a false statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that
violations of the select agent regulations may result in civil or criminal penalties, including imprisonment. 7 CFR Part 331, 9 CFR Part 121, 42 CFR Part 73.
Public reporting burden:
Public reporting burden of providing this information is estimated to average 1 hour per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or
sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden
estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE,
MS D74, Atlanta, Georgia 30329; ATTN: PRA (0920-0576).
Signature of Respondent:
Title:
Date:
Typed or printed name of Respondent:
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signature
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FORM APPROVED OMB NO.: SECTION A ENTITY INFORMATION (Department of Health and Human Services)

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Completed 26 January 2021

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