Reporting the Identification

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

FORM APPROVED
OMB NO. 0579-0213
OMB NO. 0920-0576
EXP DATE 11/30/2015

INSTRUCTIONS
Detailed instructions are available at http://www.selectagents.gov/CDForm.html. Answer all items completely and type or print in
ink. This report must be signed and submitted to either APHIS or CDC:
Animal and Plant Health Inspection Service
Agricultural Select Agent Program
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
FAX: (301) 734-3652
Email: [email protected]

Centers for Disease Control and Prevention
Division of Select Agents and Toxins
1600 Clifton Road NE, Mailstop A-46
Atlanta, GA 30333
FAX: (404) 471-8469
Email: [email protected]

Accession Number:

(For Program Use ONLY)

Submit completed form only once by either email, fax, or mail
SECTION A – REFERENCE LABORATORY INFORMATION
1. Name of individual completing Sections A and B:
2. Email address:
First:
MI:
Last:
4. Registered Entity (APHIS or CDC Registration #: __________________________)
 Clinical or Diagnostic Laboratory [non-registered entity (NRE)]
(NRE # (provided by APHIS or CDC): ____________________________)
5. Responsible Official or Laboratory Supervisor name:
First:
MI:
Last:
6. Telephone #:

7. Fax #:

8. Email address:

3. Telephone #:

9. Entity name:

10. Address (NOT a post office address):
11. City:

12. State:

13. Zip Code:

SECTION B – SELECT AGENT OR TOXIN IDENTIFIED FROM CLINICAL/DIAGNOSTIC SPECIMEN(S)
1. Select Agent or Toxin Identified:
3. Case/patient/sample ID #(s):

2. Date identified:
4. # of samples received:

5. Sample type(s) received:

6. Case/patient origin (zip code):

7. Dispositions of select agent or toxin (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 person retaining sample. Name:_____________________________________________________)
8. 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 Part 331.19, 9 CFR Part 121.19, and 42 CFR Part 73.19 to complete and submit an APHIS/CDC Form 3)
9. Do you anticipate receiving additional samples/specimens for this case/patient that originate from the initial case (e.g. patient, environmental sample)?
 No
 Yes (If Yes, please refer to the guidance instructions at www.selectagents.gov for further directions.)
10. 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  N/A
NOTE: Please request completed and signed Sections C & D from each laboratory that was in possession of the specimen(s).
11. Sample Provider Entity Name:
12. Sample Provider Point of Contact:
13. Sample Provider Email Address:
14. Sample Provider Contact
(First, MI, and Last Name)
Number:

15. Comments / Notes:

I hereby certify that the information contained in Sections A and B 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 331, 9 CFR 121, or 42 CFR 73 may result in civil or
criminal penalties, including imprisonment.
Signature of Responsible Official/Laboratory Supervisor: ___________________________________________________

Date Signed: _______________________________

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

FORM APPROVED
OMB NO. 0579-0213
OMB NO. 0920-0576
EXP DATE 11/30/2015

INSTRUCTIONS
Detailed instructions are available at http://www.selectagents.gov/CDForm.html. Answer all items completely and type or print in
ink. This report must be signed and submitted to either APHIS or CDC:
Animal and Plant Health Inspection Service
Agricultural Select Agent Program
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
FAX: (301) 734-3652
Email: [email protected]

Centers for Disease Control and Prevention
Division of Select Agents and Toxins
1600 Clifton Road NE, Mailstop A-46
Atlanta, GA 30333
FAX: (404) 471-8469
Email: [email protected]

Submit completed form only once by either email, fax, or mail
SECTION C – SAMPLE PROVIDER INFORMATION
1. Name of individual completing Sections C and D:
2. Email address:
First:
MI:
Last:
4. Registered Entity (APHIS or CDC Registration #: __________________________)
Clinical or Diagnostic Laboratory [non-registered entity (NRE)]
(NRE # (provided by APHIS or CDC): ____________________________)
5. Responsible Official or Laboratory Supervisor name:
First:
MI:
Last:

9. Entity name:

6. Telephone #:

11. City:

7. Fax #:

8. Email address:

Reference ID Number:

3. Telephone #:

10. Address (NOT a post office address):
12. State:

13. Zip Code:

SECTION D – SPECIMEN(S) CONTAINING SELECT AGENT OR TOXIN PROVIDED TO REFERENCE LABORATORY
1. Date specimens(s) shipped to Reference Laboratory:

2. # of specimens provided:

3. Case/patient/sample ID #(s):

4. Sample type(s) provided:

5. Case/patient/sample origin (zip code):

6. Date notified by Reference Laboratory of select agent or toxin
7. Select agent or toxin identified by Reference Laboratory:
identification:
8. Dispositions of select agent or toxin (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 person retaining sample. Name:_____________________________________________________)
9. 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 Part 331.19, 9 CFR Part 121.19, and 42 CFR Part 73.19 to complete and submit an APHIS/CDC Form 3)
10.Do you anticipate receiving additional samples/specimens for this case/patient that originate from the initial case (e.g. patient, environmental sample)?
 No
 Yes (If Yes, please refer to the guidance instructions at www.selectagents.gov for further directions.)
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
NOTE: Please request completed and signed Sections C & D from each laboratory that was in possession of the specimen(s).
12. Sample Provider Entity Name:

13. Sample Provider Point of Contact:
(First, MI, and Last Name)

14. Sample Provider Email Address:

 Yes

 N/A

15. Sample Provider Contact
Number:

16. Comments / Notes:

I hereby certify that the information contained in Sections C and D 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 331, 9 CFR 121, or 42 CFR 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 30333; ATTN: PRA (0920-0576).