Fillable FORM APPROVED: Submit completed form only once by (Department of Health and Human Services)

Fill Online, Printable, Fillable, Blank FORM APPROVED: Submit completed form only once by (Department of Health and Human Services) Form

Use Fill to complete blank online DEPARTMENT OF HEALTH AND HUMAN SERVICES (DC) pdf forms for free. Once completed you can sign your fillable form or send for signing. All forms are printable and downloadable.

FORM APPROVED: Submit completed form only once by (Department of Health and Human Services)

On average this form takes 24 minutes to complete

The FORM APPROVED: Submit completed form only once by (Department of Health and Human Services) form is 2 pages long and contains:

  • 2 signatures
  • 10 check-boxes
  • 84 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

Related forms
Fill has a huge library of thousands of forms all set up to be filled in easily and signed.
Fill in your chosen form
Sign the form using our drawing tool
Send to someone else to fill in and sign.
find another form
 
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 10/31/2020
INSTRUCTIONS
Detailed instructions are available at http://www.selectagents.gov/form4.html. Answer all items completely and type or print
in black ink. This report must be signed and submitted to either APHIS or CDC:
Animal and Plant Health Inspection Service
Agriculture Select Agent Services
Centers for Disease Control and Prevention
Division of Select Agents and Toxins
Accession Number:
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
1600 Clifton Road NE, Mailstop A-46
Riverdale, MD 20737
Atlanta, GA 30329
FAX: (301) 734-3652
E-mail: AgSAS@aphis.usda.gov
FAX: (404) 471-8469
E-mail: CDCForm4@cdc.gov
(For Program Use ONLY)
Submit completed form only once by either e-mail, fax, or mail
SECTION A – REFERENCE LABORATORY INFORMATION
1. Name of individual completing Sections A and B:
First: MI: Last:
2. E-mail 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 (if same as field 1 then skip to field 9):
First: MI: Last:
10. Address (NOT a post office address):
6. E-mail address:
7. Telephone #:
8. Fax #:
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:
6. Case/patient origin (zip code):
7. Type of test performed (e.g., PCR, mouse bioassay, ELISA):
8.
Dispositions of select agent or toxin by entity listed in Block A9 (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:_____________________________________________________)
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 §331.19, 9 CFR §121.19, and 42 CFR §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 Yes N/A
NOTE: Please request completed and signed Sections C & D from each facility that was in possession of the specimen(s).
12. Sample Provider Entity Name:
13: Sample Provider Point of Contact:
First: MI: Last:
14. Sample Provider E-mail Address:
15. Sample Provider Contact
Number:
16. 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 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: _______________________________
Next Page
Next Page
click to sign
signature
click to edit
REPORTING THE IDENTIFICATION OF A SELECT AGENT OR
FORM APPROVED
OMB NO. 0579-021
3
TOXIN FROM A CLINICAL/DIAGNOSTIC SPECIMEN
OMB NO. 0920-0576
(APHIS/CDC FORM 4A)
EXP DATE 10/31/2020
INSTRUCTIONS
Detailed instructions are available at http://www.selectagents.gov/form4.html
. Answer all items completely and type or print in
black ink. This report must be signed and submitted to either APHIS or CDC:
Animal and Plant Health Inspection Service
Agriculture Select Agent Services
Centers for Disease Control and Prevention
Division of Select Agents and Toxins
Reference ID Number:
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
1600 Clifton Road NE, Mailstop A-46
Riverdale, MD 20737
Atlanta, GA 30329
FAX: (301) 734-3652
FAX: (404) 471-8469
E-mail: AgSAS@aphis.usda.gov E-mail: CDCForm4@cdc.gov
Submit completed form only once by either e-mail, fax, or mail
SECTION C – SAMPLE PROVIDER INFORMATION
1. Name of individual completing Sections C and D:
First: MI: Last:
2. E-mail 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 (if same as field 1 then skip to field 9):
First: MI: Last:
10. Address (NOT a post office address):
6. E-mail address: 7. Telephone #: 8. Fax #: 11. City:
12. State: 13. Zip Code:
SECTION D – SPECIMEN(S) CONTAINING SELECT AGENT OR TOXIN PROVIDED TO REFERENCE LABORATORY
1. Select Agent or Toxin Identified: 2. Date notified of select agent or toxin identification:
3. Case/patient/sample ID #(s): 4. # of samples shipped: 5. Sample type provided: 6. Case/patient/sample origin (zip code):
7. Date sample(s) shipped to Reference Laboratory: 8. Name of Reference Laboratory:
9. Disposition of any remaining select agent or toxin by entity listed in Block C9:
Destroyed (Provide destruction method and date. Method: __________________________ Date:_____________________)
Retained (Provide name of Principal Investigator retaining sample. Name:_____________________________________________________)
Not applicable, the entire specimen was transferred to the Reference Laboratory.
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. Was your entity the source of the sample(s)? No Yes (If Yes, skip to field 18)
12. 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.)
13. 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
NOTE: Please request completed and signed Sections C & D from each facility that was in possession of the specimen(s).
14. Sample Provider Entity Name:
15: Sample Provider Point of Contact:
First: MI: Last:
16. Sample Provider E-mail Address: 17. Sample Provider Contact Number:
18. 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 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).
Previous Page
Reset Form
Print
Save Data
CDC E-mail Form
APHIS E-mail Form
click to sign
signature
click to edit
Download
Save PDF to desktop
Email
Email completed PDF
Send for Signing
Email for others to sign
Print
Print document
Choose a Field
Click on a field and
select the person that should complete it
Want to add a signature?
You can add a signature field
and assign it to someone else
to sign
Choose a Field
Click on a field and
select the person that should complete it

FORM APPROVED: Submit completed form only once by (Department of Health and Human Services)

This document is locked as it has been sent for signing.

You have successfully completed this document.

Other parties need to complete fields in the document. You will recieve an email notification when the document has been completed by all parties.

This document has been signed by all parties.

Completed 26 January 2021

Message

View Audit Log
Print With Audit Log
Duplicate Document