Requirements for the Importation of Nonhuman Primates into the United States

Forms and Documents

Document Name	Status
Form 75.10A Application for Importer Registration (Reregistration) - Nonhuman Primates Form	Modified
Documentation and Standard Operating Procedures - Registered Importer Form and Instruction	New
Form 75.10A Application for Registration as New Importer of Nonhuman Primates Form	Modified
Form 75.1 Recordkeeping and reporting Requirements for Importing Live Nonhuman Primates Form and Instruction	Modified
Form 71.53 Importer/Filer Documentation of Non-infectiousness Form and Instruction	Modified
Form 71.53 Importer/Filer of Nonhuman Primate Products Form and Instruction	Modified
Recordkeeping and Reporting Requirements for importing Nonhuman Primates Form and Instruction	Modified
Attachment 2C - Public Comment.pdf Supplementary Document	2017-05-17
Attachment 9 CDC Non Research Determination.pdf Supplementary Document	2017-05-15
Attachment 6 Requirements for Importers of Nonhuman Primates.pdf Supplementary Document	2017-05-15
Attachment 5 Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples Final Rule.pdf Supplementary Document	2017-05-15
Attachment 4 Special Permit Procedure.pdf Supplementary Document	2017-05-15
Attachment 3 42 CFR 71.53.pdf Supplementary Document	2017-05-15
Attachment 2B - Public Comment.pdf Supplementary Document	2017-05-15
Attachment 2 60-day FRN.pdf Supplementary Document	2017-05-15
Attachment 1 USCODE-2009-title42-chap6A-subchapII-partG.pdf Supplementary Document	2017-05-15
0920-0263 Revision_Sup_Sta_B 04262017.docx Supporting Statement B	2017-05-15
0920-0263 Revision_Sup_Sta_A 04262017_OMB CLEAN.docx Supporting Statement A	2017-08-09

IC Document Collections

IC ID	Document Title	Status
6722	Application for Importer Registration (Reregistration) - Nonhuman Primates Form	Modified
226836	Documentation and Standard Operating Procedures - Registered Importer Form and Instruction	New
212043	Application for Registration as New Importer of Nonhuman Primates Form	Modified
212042	Recordkeeping and reporting Requirements for Importing Live Nonhuman Primates Form and Instruction	Modified
212007	Importer/Filer Documentation of Non-infectiousness Form and Instruction	Modified
212006	Importer/Filer of Nonhuman Primate Products Form and Instruction	Modified
206055	Filovirus Diagnostic Specimen Submission Instruction	Modified
206054	Quarantine Release Instruction	Modified
206053	Recordkeeping and Reporting Requirements for importing Nonhuman Primates Form and Instruction	Modified
206052	Documentation and Standard Operating Procedures - New Importer Instruction	Modified

ICR Details

OMB Control No: 0920-0263	ICR Reference No: 201705-0920-008
Status: Historical Active	Previous ICR Reference No: 201611-0920-007
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 with change	Conclusion Date: 08/15/2017
	Date Received in OIRA: 06/02/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2020	36 Months From Approved	09/30/2017
Responses	5,124	0	5,187
Time Burden (Hours)	921	0	943
Cost Burden (Dollars)	41,004	0	0

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Abstract: This information collection continues 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.

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Authorizing Statute(s): US Code: 42 USC 264 Name of Law: Regulations to Control Communicable Diseases
   US Code: 19 USC 1411 Name of Law: Tariff Act of 1930 (As amended by the Safe Port Act of 2006)
   EO: EO 13659 Name/Subject of EO: Streamlining the Export/Import Process for America's Businesses
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 12962	03/08/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 25290	06/01/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Application for Importer Registration (Reregistration) - Nonhuman Primates	75.10A	Application for Registration as an Importer of Nonhuman Primates
Documentation and Standard Operating Procedures - New Importer
Recordkeeping and Reporting Requirements for importing Nonhuman Primates	none	42 CFR 71.53
Quarantine Release
Filovirus Diagnostic Specimen Submission
Importer/Filer of Nonhuman Primate Products	71.53	CDC Requested Data of Regulated Imports: Nonhuman Primate Products
Application for Registration as New Importer of Nonhuman Primates	75.10A	Application for Registration as an Importer of Nonhuman Primates
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
Documentation and Standard Operating Procedures - Registered Importer	none	42 CFR 71.53

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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	5,124	5,187	0	-63	0	0
Annual Time Burden (Hours)	921	943	0	-22	0	0
Annual Cost Burden (Dollars)	41,004	0	0	41,004	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: This revision adjusts the burden based on the number of registered importers and the number of filovirus samples processed by CDC. A new IC separates new registrants from reregistrants.

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Annual Cost to Federal Government: $123,150

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

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? Uncollected

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Common Form ICR:  No

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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: 06/02/2017

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