APHIS/CDC Form 4A Reporting the Identification of a Select Agent or Toxin

REPORTING THE IDENTIFICATION OF A SELECT AGENT OR
TOXIN FROM A CLINICAL/DIAGNOSTIC SPECIMEN
(APHIS/CDC FORM 4A)

FORM APPROVED
OMB NO. 0920-0576
EXP DATE: 01/31/2024

Detailed instructions are available at http://www.selectagents.gov/form4.html. This report must be submitted to either
DASAT or DSAT.

Animal and Plant Health Inspection Service
Division of Agricultural Select Agents and Toxins
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
FAX: (301) 734-3652
E-mail: [email protected]

Centers for Disease Control and Prevention
Division of Select Agents and Toxins
1600 Clifton Road NE, Mailstop H21-4
Atlanta, GA 30329
FAX: (404) 471-8469
E-mail: [email protected]

Submit completed form only once by either eFSAP, e-mail, or fax
PART 1 – REPORT OF IDENTIFICATION
SECTION A – REFERENCE LABORATORY INFORMATION
1. Name of individual completing Sections A and B (First, MI, Last):
2. E-mail address:

3. Telephone #:

4. Entity name or Name of Clinical/Diagnostic Laboratory:
5. Responsible Official or Laboratory Supervisor name (First, MI, Last):

6. E-mail address:

8. Address (NOT a post office address):

9. City:

7. Telephone #:
10. State:

11. Zip Code:

{Select}
SECTION B – SELECT AGENT OR TOXIN IDENTIFIED FROM CLINICAL/DIAGNOSTIC SPECIMEN(S)
4. Type of notification to APHIS or CDC:
1. Select Agent or Toxin Identified:
2. Date identified:
3. Date of Immediate Notification for Tier 1
agents or N/A for non-Tier 1 agent to APHIS or CDC:  E-mail  Fax  Telephone
{Select}
 eFSAP  N/A
5. # of samples received:

7. Zip code for case/patient/sample origin:

6. Sample type received:
{Select}

8. Type of test performed:
 Biochemical
 Culture
 DFA/IFA
 ELISA/EIA/RIA

Immunochemistry
Mass Spectrometry (e.g., MALDI)
Microscopy
Mouse Bioassay










PCR
Sequencing
Other: ______________________________

9. Dispositions of select agent or toxin listed by entity (complete all that apply):
 Transferred (Provide entity name and date of transfer. Entity:
Date:
)
 Destroyed (Provide destruction method and date. Method:
Date:
)
 Retained (Provide name of Principal Investigator retaining sample. Name:
)
10. Were any of the samples containing a select agent or toxin handled outside of primary containment which may have led to an unintentional release and/or exposure to
the select agent or toxin?
No
 Yes (If Yes, you are required under 7 CFR §331.19, 9 CFR §121.19, and 42 CFR §73.19 to complete and submit an APHIS/CDC Form 3)
11. Has the sender(s) (i.e., sample provider(s)) of the specimen(s) been notified of the identification of the select agent or toxin?  No
Yes
Date of Notification: _______________ NOTE: Please request completed and signed Part 2 from each facility that was in possession of the specimen(s).
12. Was your entity the source of the sample(s)?

No

Yes

13. Is the sample provider located outside the United States?  No

(If Yes, skip to #22 if you have any additional comments.)
 Yes If Yes, provide country: ___________________________________________
{Select}

14. Sample Provider Entity Name:
15. Address (NOT a post office address):
19: Sample Provider Point of Contact (First, MI, Last):

16. City:

17. State:

{Select}

20. Sample Provider E-mail Address:

18. Zip Code:

21. Sample Provider Contact Number:

22. Comments / Notes:
I hereby certify that the information contained in Part 1 of 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 7 CFR Part 331, 9 CFR Part 121, or 42 CFR Part 73 may result in
Civil or criminal penalties, including imprisonment.
Signature of Responsible Official/Laboratory Supervisor:

Date Signed:

_

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).