Guidance Document for the completion of APHIS/CDC Form 5

Form Approved
OMB Control No. 0920-0576
Exp. Date xx/xx/2020
Guidance Document: Completing the Request for Exemption of
Select Agents and Toxins for an Investigational Product
Please review this guidance document in its entirety before completing and submitting your
request for investigational product exemption to Federal Select Agent Program.
An entity may apply for an exemption from the requirements of 9 CFR Part 121 or 42 CFR
Part 73 in order to use an investigational product that is, bears, or contains select agents or
toxins. This exemption request (APHIS/CDC Form 5) should be sent to either Federal Select
Agent Program for consideration.

Table of Contents
SECTION 1 – INVESTIGATIONAL PRODUCT EXEMPTION ............................................................................... 2
BLOCK 1, ENTITY NAME ......................................................................................................................................... 2
BLOCK 2, ENTITY REGISTRATION NUMBER.............................................................................................................. 2
BLOCKS 3-6, ENTITY ADDRESS .............................................................................................................................. 2
BLOCK 7, APPLICANT NAME ................................................................................................................................... 2
BLOCK 8, TITLE ..................................................................................................................................................... 2
BLOCK 9, TELEPHONE NUMBER ............................................................................................................................. 3
BLOCK 10, FAX NUMBER ....................................................................................................................................... 3
BLOCK 11, EMAIL ADDRESS ................................................................................................................................... 3
BLOCK 12, FDA IND/INAD/IDE NUMBER .............................................................................................................. 3
BLOCK 13, FDA PRODUCT NAME ........................................................................................................................... 3
BLOCK 14, PHASE I APPROVAL .............................................................................................................................. 3
BLOCK 15, FDA CENTER AND IND/INAD/IDE APPLICATION DATE........................................................................... 3
BLOCK 16, USDA VETERINARIAN PRODUCT CODE NUMBER ................................................................................... 3
BLOCK 17, USDA VETERINARIAN PRODUCT NAME ................................................................................................. 3
BLOCK 18, TESTED AND APPROVED FOR FIELD TRIALS ........................................................................................... 3
BLOCK 19, INVESTIGATIONAL PRODUCT.................................................................................................................. 4
BLOCK 20, FEDERAL ACT AUTHORIZATION ............................................................................................................. 4
BLOCK 21, EXEMPTION JUSTIFICATION ................................................................................................................... 4
SIGNATURE OF INVESTIGATIONAL PRODUCT EXEMPTION APPLICANT .................................................... 4
SIGNATURE OF INVESTIGATIONAL PRODUCT EXEMPTION APPLICANT (REQUIRED) ................................................. 4
DATE SIGNED........................................................................................................................................................ 4

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)

Updated: 11/01/2012

Request for Exemption of Select Agents and Toxins for
an Investigational Product Guidance Document

Page 1 of 4

Section 1 – Investigational Product Exemption
For exemption requests that involve the investigational product that is, bears, or contains
select agents or toxins, APHIS or CDC will confirm that the Food and Drug Administration
(FDA) has accepted or approved, under the authority of the Food, Drug, and Cosmetics Act
(21 U.S.C. 301 et. seq.), an Investigational New Drug application (IND), Investigational New
Animal Drug (INAD) application or an Investigational Device Exemption (IDE) application for
a clinical trial involving the use of an investigational product that is, bears, or contains a select
agent or toxin.

Block 1, Entity Name


Please provide the complete name of your entity (corporation, partnership, sole
proprietorship, etc.) under which the business conducts its operations (e.g., Animal
and Plant Health Inspection Service instead of APHIS).



Please do not abbreviate the organization name.

Block 2, Entity Registration Number


For entities registered with APHIS or CDC, please enter the registration number
exactly as it appears on your entity’s current certificate of registration. The registration
number is a 13 digit number which begins with an A or C and is not the entity
application number (e.g. A00000000-0000 or C00000000-0000).



Non-registered entities should leave this field blank.

Blocks 3-6, Entity Address


For entities registered with APHIS or CDC, please provide your entity’s complete
address, exactly as it appears on your current certificate of registration.



For non-registered entities, please provide the complete physical address of your
entity and not a P.O. Box address.



Zip Code – please provide only the five digit zip code.

Block 7, Applicant Name


Please provide the full name of the applicant (i.e., the individual completing the form
on behalf of the entity (e.g., Responsible Official or Facility Director).
o For the purposes of completing the Exemption Request form, the term “full name”
refers to an individual's first name, middle initial(s), and last name or surname,
without use of nicknames.

Block 8, Title


Please provide the title of the individual listed in Block 7 (i.e., Responsible Official,
Facility Director, Laboratory Supervisor).
o For the purposes of the APHIS/CDC Form 5, the term “Facility or Laboratory
Director” refers to the person with overall responsibility for the operation of the
laboratory and who ensures that quality standardized testing methods provide
accurate and reliable results.
o “Responsible Official” is the individual designated by a registered entity as the
responsible official.

Updated: 11/01/2012

Request for Exemption of Select Agents and Toxins for
an Investigational Product Guidance Document

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o “Laboratory Supervisor” refers to the individual who is responsible for the
supervision of a laboratory department and its procedures.

Block 9, Telephone Number


Please provide the direct dial 10-digit telephone number for the Applicant listed in
Block 7; include an extension, if required.

Block 10, Fax Number


Please provide the 10-digit facsimile number for the Applicant listed in Block 7.

Block 11, Email Address


Please provide the email address for the Applicant listed in Block 7.



Please print or type clearly; and ensure that you include the email domain (e.g., .org,
.gov, .edu, .com, .net).

Block 12, FDA IND/INAD/IDE Number


Please provide the Investigational New Drug Application (IND), Investigational New
Animal Drug file (INAD), or Investigational Device Exemption number (IDE) that was
provided by U.S. Food and Drug Administration (FDA).

Block 13, FDA Product Name


Please provide the product name that bears or contains the select agent or toxin that
was listed on the application for IND, INAD or IDE.

Block 14, Phase I Approval


Please indicate whether this product has been approved for Phase I clinical trials by
FDA.

Block 15, FDA Center and IND/INAD/IDE Application Date



Please indicate the date when the IND/INAD/IDE application submitted to FDA.
Please provide the name of the FDA center (e.g., Center for Biologics Evaluation and
Research (CBER), Center for Drug Evaluation and Research (CDER), Center for
Devices and Radiological Health (CDRH), or Center for Veterinary Medicine (CVM))
where the application for the IND, INAD, or IDE was submitted and the review office
name.

Block 16, USDA Veterinarian Product Code Number


Please provide the product code number that was provided by U.S. Department of
Agriculture (USDA).

Block 17, USDA Veterinarian Product Name


Please provide the product name that bears or contains the select agent or toxin that
was listed on the application submitted to USDA.

Block 18, Tested and Approved for Field Trials


Please indicate whether this product has been tested and approved for field trials by
USDA.

Updated: 11/01/2012

Request for Exemption of Select Agents and Toxins for
an Investigational Product Guidance Document

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Block 19, Investigational Product


Please list the select agent or toxin contained in the investigational product and any
characteristics of the agent (e.g., Bacillus anthracis (Ames strain)).

Block 20, Federal Act Authorization


Please indicate the Federal Act(s) that authorizes investigational use of this product
(e.g., Federal Food, Drug, and Cosmetic Act, Section 351 of the Public Health Service
Act pertaining to biological products, Act commonly known as the Virus-Serum-Toxin
Act, or Federal Insecticide, Fungicide, and Rodenticide Act).

Block 21, Exemption Justification


Provide a detailed justification to request an exemption for the use of an investigational
product that is, bears, or contains select agents or toxins (e.g., human clinical trials).

Signature of Investigational Product Exemption Applicant
IMPORTANT NOTE: By signing and submitting the completed Request for Exemption of
Select Agents and Toxins for Investigational Product to APHIS or CDC, the applicant is
certifying that the information contained on the form is true and correct to the best of their
knowledge. Additionally, the applicant is acknowledging that any false statement made in the
signed/submitted application may subject them to criminal penalties pursuant to 18 U.S.C.
1001. The applicant is also acknowledging that violations of 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 toxins, the
applicant is also authorizing FDA to confirm for APHIS or CDC the existence and status of
the IND, INAD, or IDE, and is agreeing 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 (REQUIRED)


The Applicant listed in Section 1, Block 7 must sign the completed exemption request
form.

Date Signed


Please enter the date the Applicant signs the completed form.

Updated: 11/01/2012

Request for Exemption of Select Agents and Toxins for
an Investigational Product Guidance Document

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