Requirements for the Importation of Nonhuman Primates into the United States

Forms and Documents

Document Name	Status
Form CDC 75.10 Application for Importer Registration (Re-registration) - Nonhuman Primates Form and Instruction	Modified
Form CDC 75.10 Application for Registration as New Importer of Nonhuman Primates Form and Instruction	Modified
Form 75.1 Recordkeeping and reporting Requirements for Importing Live Nonhuman Primates Form and Instruction	Removed
Form 71.53 Importer/Filer Documentation of Non-infectiousness Form and Instruction	Removed
Form 71.53 Importer/Filer of Nonhuman Primate Products Form and Instruction	Removed
Filovirus Diagnostic Specimen Submission Form and Instruction	Modified
Attachment 10 CDC Non Research Determination.pdf Supplementary Document	2020-07-27
Attachment 9 QARS PIA.pdf Supplementary Document	2020-07-27
Attachment 6 Requirements for Importers of Nonhuman Primates.pdf Supplementary Document	2020-07-27
Attachment 5 Establishment of User Fees.PDF Supplementary Document	2020-07-27
Attachment 4 Special Permit Procedure.pdf Supplementary Document	2020-07-27
Attachment 2 Published 60 Day FRN.pdf Supplementary Document	2020-07-27
Attachment 3 42 CFR 71.53.pdf Supplementary Document	2020-07-27
Attachment 1 USCODE-2009-title42-chap6A-subchapII-partG.pdf Supplementary Document	2020-07-27
0920-0263 Revision SSB_07272020.docx Supporting Statement B	2020-07-27
0920-0263 Revision SSA_07272020.docx Supporting Statement A	2020-07-27

IC Document Collections

IC ID	Document Title	Status
6722	Application for Importer Registration (Re-registration) - Nonhuman Primates Form and Instruction	Modified
242786	Statements, including necropsy reports, about the nonhuman primates upon their release from CDC quarantine Instruction	New
242784	Statements regarding the health of the nonhuman primates during travel and CDC quarantine Instruction	New
226836	Documentation and Standard Operating Procedures - Registered Importer Instruction	Modified
212043	Application for Registration as New Importer of Nonhuman Primates Form and Instruction	Modified
212042	Recordkeeping and reporting Requirements for Importing Live Nonhuman Primates Form and Instruction	Removed
212007	Importer/Filer Documentation of Non-infectiousness Form and Instruction	Removed
212006	Importer/Filer of Nonhuman Primate Products Form and Instruction	Removed
206055	Filovirus Diagnostic Specimen Submission Form and Instruction	Modified
206054	Quarantine Release Instruction	Modified
206053	Recordkeeping and Reporting Requirements: Notification of shipment arrival Instruction	Modified
206052	Documentation and Standard Operating Procedures - New Importer Instruction	Modified

ICR Details

OMB Control No: 0920-0263	ICR Reference No: 202007-0920-010
Status: Active	Previous ICR Reference No: 201705-0920-008
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0263
Title: Requirements for the Importation of Nonhuman Primates into the United States
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/28/2020
	Date Received in OIRA: 08/14/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2023	36 Months From Approved	09/30/2020
Responses	651	0	5,124
Time Burden (Hours)	184	0	921
Cost Burden (Dollars)	8,772	0	41,004

---

Abstract: The goal of this information collection is to continue regulatory oversight of nonhuman primate importers through registration, reregistration, evaluation of standard operating procedures, receiving pre-shipment notification, reviewing requests for releasing shipments from CDC quarantine, and overseeing filovirus testing of nonhuman primates when required.

---

Authorizing Statute(s): US Code: 42 USC 264 Name of Law: Regulations to Control Communicable Diseases
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 66899	12/06/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 49373	08/13/2020
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Statements regarding the health of the nonhuman primates during travel and CDC quarantine
Statements, including necropsy reports, about the nonhuman primates upon their release from CDC quarantine
Importer/Filer of Nonhuman Primate Products	71.53	CDC Requested Data of Regulated Imports: Nonhuman Primate Products
Importer/Filer Documentation of Non-infectiousness	71.53	Documentation of Non-infectiousness
Recordkeeping and reporting Requirements for Importing Live Nonhuman Primates	75.1	CDC Requested Data on Regulated Imports - Live Nonhuman Primates
Application for Importer Registration (Re-registration) - Nonhuman Primates	CDC 75.10	Application for Registration as an Importer of Nonhuman Primates
Documentation and Standard Operating Procedures - New Importer
Recordkeeping and Reporting Requirements: Notification of shipment arrival
Quarantine Release
Filovirus Diagnostic Specimen Submission	n/a	Ebola Diagnostic Specimen Submission Form for quarantined non-human primates
Application for Registration as New Importer of Nonhuman Primates	CDC 75.10	Application for Registration as an Importer of Nonhuman Primates
Documentation and Standard Operating Procedures - Registered Importer

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	651	5,124	0	-4,473	0	0
Annual Time Burden (Hours)	184	921	0	-737	0	0
Annual Cost Burden (Dollars)	8,772	41,004	0	-32,232	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Based on the number of registered importers and number of filovirus samples processed by CDC, CDC is adjusting downward the number of burden hours for four of the information collections.

---

Annual Cost to Federal Government: $136,267

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 08/14/2020

---