Importer Certification Statement

Form
OMB Co. No.: 0920-0199
Expiration date: xx/xx/2027

Centers for Disease Control and Prevention

Import Permit Program

Importer Certification Statement (42 CFR 71.54(f))

This form should accompany noninfectious material intended for importation into the United States in accordance with 42 CFR 71.54(f). ¹

Importer Information Date

Name Organization/Company Address

Airway/Invoice Number

This shipment contains [insert description of material and purpose(s) for importation (e.g., human urine for drug testing)]:

The material described above is not known or suspected to contain an infectious biological agent because (choose all that apply²):

• The material or source has been tested in accordance with standard scientifically accepted practices and found to be noninfectious.

• The material is a diagnostic specimen that is not known or suspected to contain an infectious biological agent based on known medical history, symptoms, and individual circumstances of the source, human or animal and endemic local conditions.

• The material contains a microorganism that is non-pathogenic to humans.

• The material consists only of nucleic acids that are not capable of producing infectious forms of any infectious biological agent.

• The material is an environmental sample for diagnostic testing that is not known or suspected to contain an infectious biological agent based upon endemic local conditions.

• The material was rendered non-infectious using commonly accepted scientific methods. Any infectious biological agent has been neutralized or inactivated.

• The material contains a vector that is infectious to humans but incapable of causing a communicable disease in humans.

I understand that additional information may be requested regarding the description and declaration(s) provided above.

I certify that, to the best of my knowledge and belief, all of the information on, attached, or otherwise submitted in support of this Importer Certification Statement, is true, correct, complete, and made in good faith. I understand that any violations of regulations under 42 U.S.C. 264, including those relating to the importation of infectious biological agents under 42 C.F.R. § 71.54, can result in criminal penalties under 42 U.S.C. § 271, 18 U.S.C. §§ 3559, 3571, and 42 CFR § 71.2). I further understand that any false statement made by me in connection with this form may subject me to criminal penalties pursuant to 18 U.S.C. § 1001.

Signature of Importer Name (Type/Print)

1 This form may only be used to import noninfectious materials under 42 CFR 71.54. This form may not be used to import the following: bat or nonhuman primate specimens or products, as stated in 42 CFR 71.54(f)(2-4); animal products regulated under 42 CFR 71.52, 71.53, 71.56, and 71.63.

2 If none of the statements apply to the material being imported, refer to the CDC Import Permit Program website for additional information or to apply for a permit. https://www.cdc.gov/orr/ipp/

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Public reporting burden of this collection of information is estimated to average 10 minutes 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 30333; ATTN: PRA 0920-0199