Form
OMB
Control No. 0920-XXXX
Expiration Date: XX/XX/XXXX
Application For Registration as an Importer of Nonhuman Primates*
Organizational Name: Telephone No.:
Address:
Person Responsible for Requested Record Keeping and Reporting
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Animal Holding Facilities:
Attach sketch of facility indicating rooms or area where newly acquired nonhuman primates are held and the relationship of these rooms or areas to offices, laboratories and other animal rooms in the same building.
Air handling procedures in rooms or areas where newly acquired primates are held:
Air
pressure in holding rooms
is higher than
same as
lower than adjacent corridors and other immediately adjoining
areas.
Is
exhaust air filtered?
Yes
No If yes, specify the type of filtration:
Usual number of animals per cage in the quarantine area:
Prosimians: Old World Species: New World Species: Great Apes:
Waste disposal procedures for animal feces:
Waste disposal procedures for liquid waste (provide a description of how potentially contaminated liquid waste is treated/disinfected):
Waste disposal procedures for animal carcasses:
Have you developed standard operating procedures for:
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*If applicable
Are newly acquired nonhuman primates held in rooms or areas with dedicated air-handling systems? Yes No
Are all animals that died during the quarantine period necropsied? Yes No
Is entry to the area where newly acquired nonhuman primates to only those personnel who are essential to its operation? Yes No
Is a veterinarian retained to provide or supervise case of nonhuman primates? Yes No
Name: Telephone No.:
Address:
Personnel Health Program
Are all employees given a pre-employment tuberculin test? Yes No
Routine interval between tuberculin tests of employees after employment:
Number or months: or Not Done
Do you have a respiratory control program, as required by OSHA 29 CFR 1910.134 Respiratory Protection – Standards. Yes No
Are workers fit-tested and trained annually? Yes No
Is an occupational health clinic or physician retained to supervise health care programs? Yes No
Name: Telephone No.:
Address:
Assurance Statement
As a condition of registration I, (we) assure the Director, Centers for Disease Control and Prevention that I (we) will import live nonhuman primates into the United States only for bona fide scientific, educational, or exhibition purposes. I (we) shall not subsequently sell, resell, or otherwise distribute the nonhuman primates to any other person or organization without clear evidence that these animals will be used solely for bona fide scientific, educational, or exhibition purposes. I (we) understand that “nonhuman primates” are defined as all nonhuman primates of the Order Primates including but not limited to animals commonly known as monkeys, chimpanzees, orangutans, gorillas, gibbons, apes, baboons, marmosets, tamarins, lemurs, and lorises.
Signature of Person Completing this Form: Date:
Registration Form for NHP Importation (Part 2 – Standard Operating Procedures)
Importer’s Contact Information |
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Date of Application: __ __ / __ __ / __ __ __ __ M M D D Y Y Y Y |
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Name: Institution: |
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Address: State abbr. County Zip Code |
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Email: Phone Number ( ) - |
Standard Operating Procedures |
In sections 1-6, please include the elements of your standard operating procedures (SOPs) that address each regulatory requirement for importing nonhuman primates. You may copy and paste applicable sections of your SOPs or reference the SOP (name AND page number/section) that addresses each element in the spaces provided. Please attach copies of your SOPs. |
Section 1: Documentation |
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Regulation 42 CFR §71.53 (h) |
Standard Operating Procedure Meeting Regulation |
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An importer must maintain these records in an organized manner, either electronically or in a central location that is at or in close proximity to the NHP facility to allow HHS/CDC to easily inspect the records during HHS/CDC site visits during regular business hours or within one hour of such visits. If records are maintained electronically, they must be time-dated in a manner than cannot be altered, and redundant back-up copies must be made in a manner that protects against loss. |
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i. Communicate to the recipients of NHPs, in writing, the restrictions and definitions of permitted purposes; and |
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ii. Obtain written certifications from the intended recipient that the NHPs will be used and distributed only for permitted purposes. |
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Section 2: Worker Protection Plan and Personal Protective Equipment |
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Regulation 42 CFR §71.53 (i) |
Standard Operating Procedure Meeting Regulation |
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Note: In addition to complying with the requirements of this section, an importer must comply with all relevant federal and state requirements relating to occupational health and safety. |
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Section 3: Crating, Caging, and Transport |
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Regulation 42 CFR §71.53 (j) |
Standard Operating Procedure Meeting Regulation |
Equipment standards for crating, caging, and transporting live NHPs must be in accordance with USDA Animal Welfare regulation standards (9 CFR parts 1, 2, and 3) and International Air Transport Association standards. Additionally, importers must establish, implement, maintain, and adhere to SOPs that ensure the items listed below are met. Describe the elements of your SOPs that will ensure the following: |
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Section 4: Ground Transport Vehicles |
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Regulation 42 CFR §71.53 (k) |
Standard Operating Procedure Meeting Regulation |
An importer must establish, implement, maintain, and adhere to SOPs for ground transport vehicles transporting NHPs that meet the following requirements. Provide a description of ground transport vehicles you intend to use for transportation of imported NHPs under CDC-mandated quarantine. You may also attach diagrams or photographs. |
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Section 5: Quarantine Facilities |
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Regulation 42 CFR §71.53 (l) |
Standard Operating Procedure Meeting Regulation |
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An importer must maintain a quarantine facility for holding a cohort during the required quarantine period. NHPs must be quarantined for 31 days after arrival at the importer's quarantine facility. HHS/CDC may extend the quarantine period if an importer or HHS/CDC finds or suspects that an NHP is infected with, or has been exposed to, a zoonotic disease, or if an importer or HHS/CDC finds a need for additional diagnostic testing. |
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A. Please verify that any cohort with positive or suspicious TST reaction will remain in quarantine and receive at least five additional TSTs (each administered at least two weeks apart) following removal of the last affected NHP. B. The validity of TB test results may be compromised if during quarantine an NHP contracts a viral illness, including measles; is treated with steroids; or is immunized. Please provide a written procedure for ensuring such occurrence(s) will be documented and the affected NHPs will be held until they have recovered from the illness or are no longer on treatment, and for a recommended time after recovery (to be determined in consultation with HHS/CDC, depending on the illness or treatment in question) before TB tests are performed. C. An importer must retain records of all TSTs performed during the lifetime of each NHP at the facility housing the NHP until the NHP is transferred to another facility. These records must accompany the NHP during moves to other facilities.
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Section 6: Health Reporting for NHPs |
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Regulation 42 CFR §71.53 (m) |
Standard Operating Procedure Meeting Regulation |
An importer must notify HHS/CDC of the events listed in this section (Section 6) by telephone, text, or email. Please provide elements of your SOPs that ensure the following: |
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Public reporting burden of this collection of information is estimated to average 2 hours 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-XXXX.
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Laughlin, Mark E. (CDC/DDID/NCEZID/DFWED) |
File Modified | 0000-00-00 |
File Created | 2022-05-17 |