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. 0579-0213 OMB NO. 0920-0576 EXP DATE XX/XX/XXXX

INSTRUCTIONS

Read guidance instructions at www.selectagents.gov before completing this form. Answer all items completely and type or print in ink. The form must be signed and submitted to either APHIS or CDC by email attachment, fax, or mail:

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 E-mail: [email protected]

C Accession Number: (For Program use ONLY) enters for Disease Control and Prevention Division of Select Agents and Toxins 1600 Clifton Road NE, Mailstop A46 Atlanta, GA 30333 FAX: (404) 718-2096 Email: [email protected]

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: First: MI: Last:					2. Email address:			3. Telephone #:
4. Registered Entity (APHIS or CDC Registration #: __________________________)  Clinical or Diagnostic Laboratory [non-registered entity (NRE)] (NRE # (provided by APHIS or CDC): ____________________________)						9. Entity name:
5. Responsible Official or Laboratory Supervisor name: First: MI: Last:						10. Address (NOT a post office address):
6. Telephone #:	7. Fax #:		8. Email 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:							2. Date identified:
3. Case/patient/sample ID #(s):		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. 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 XX/XX/XXXX

SECTION C – SAMPLE PROVIDER INFORMATION
1. Name of individual completing Sections C and D: First: MI: Last:					2. Email address:				3. Telephone #:
4. Registered Entity (APHIS or CDC Registration #: __________________________) Clinical or Diagnostic Laboratory [non-registered entity (NRE)] (NRE # (provided by APHIS or CDC): ____________________________)						9. Entity name:
5. Responsible Official or Laboratory Supervisor name: First: MI: Last:						10. Address (NOT a post office address):
6. Telephone #:	7. Fax #:	8. Email address:				11. City:				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 identification:				7. Select agent or toxin identified by Reference Laboratory:
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. 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: _______________________________

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0579-0213. The time required to complete this information collection 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.