Fillable FORM APPROVED: REQUEST FOR EXEMPTION OF SELECT AGENTS (Department of Health and Human Services)

Fill Online, Printable, Fillable, Blank FORM APPROVED: REQUEST FOR EXEMPTION OF SELECT AGENTS (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: REQUEST FOR EXEMPTION OF SELECT AGENTS (Department of Health and Human Services)

On average this form takes 8 minutes to complete

The FORM APPROVED: REQUEST FOR EXEMPTION OF SELECT AGENTS (Department of Health and Human Services) form is 1 page long and contains:

  • 1 signature
  • 0 check-boxes
  • 26 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
 
REQUEST FOR EXEMPTION
OF SELECT AGENTS AND TOXINS FOR
AN INVESTIGATIONAL PRODUCT
(APHIS/CDC FORM 5)
FORM APPROVED
OMB NO. 0579-0213
OMB NO. 0920-0576
EXP DATE 10/31/2020
Read all instructions carefully before completing the form. Answer all items completely and type or print in ink. The form must
be signed and submitted to either APHIS or CDC:
Animal and Plant Health Inspection Service
Agriculture Select Agent Program
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
FAX: 301-734-3652
E-mail: AgSAS@aphis.usda.gov
Centers for Disease Control and Prevention
Division of Select Agents and Toxins
1600 Clifton Road NE, Mailstop A-46
Atlanta, GA 30329
FAX: 404-718-2096
E-mail: lrsat@cdc.gov
SECTION 1 – TO BE COMPLETED FOR INVESTIGATIONAL PRODUCT EXEMPTION
1. Entity name:
2. Entity registration number (if applicable):
3. Entity address (NOT a post office address):
4. City:
5. State:
6. Zip code:
7. Applicant
First: MI: Last:
8. Title:
9. Telephone #:
10. FAX #:
11.
E-mail address:
12. FDA IND/INAD/IDE number:
13. FDA product name:
14. This product has been approved for Phase I clinical trials
by FDA: No Yes
15. Date of the IND/INAD/IDE application submitted to FDA including the name of the FDA center and review office
FDA Center/Review Office: Date:
16. USDA veterinarian product code number:
17. USDA veterinarian product name:
18. This product has been tested and approved for field trials
by USDA: No Yes
19. Investigational product (Give select agent name and characterization):
20. Federal act that authorizes investigational use of this product:
21. Provide a detailed justification to request an exemption for the use of an investigational product that is, bears, or contains select agents or toxins
(attach additional sheets if necessary):
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 7 CFR
Part 331, 9 CFR Part 121, or 42 CFR Part 73 may result in civil or criminal penalties, including imprisonment. For exemption requests that involve the
investigational product that is, bears, or contains select agents or toxin, I authorize FDA to confirm for APHIS or CDC the existence and status of the IND,
INAD, or IDE, and agree that such confirmation will not violate FDA's information disclosure regulations, the Federal Food, Drug, and Cosmetic Act, or the
Trade Secrets Act (18 U.S.C. § 1905).
Signature of Investigational Product Exemption Applicant: ________________________________________________ Date: ________________
Public reporting burden: Public reporting burden of this collection of 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 D-74, Atlanta, Georgia 30329; ATTN: PRA (0920-0576).
APHIS/CDC FORM 5 (11/30/2018)
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: REQUEST FOR EXEMPTION OF SELECT AGENTS (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 19 July 2020

Message

View Audit Log
Print With Audit Log
Duplicate Document