Requirements for the Importation of Nonhuman Primates into the United States

Forms and Documents

Document Name	Status
Form 7510A Importer Registration and New Importer Registration - Nonhuman Primates Form and Instruction	Modified
Form 75.10A Nonhuman Primate Importer Application for Registration as an Importer of Nonhuman Primates (New Importer) Form	New
Form 75.10 Nonhuman Primate Importer Recordkeeping and reporting Form	New
Form 71.53 Documentation of Non-infectiousness Form and Instruction	New
Form 71.53 Importer/Filer Form and Instruction	New
Form 71.53(v) (No Form) Filovirus Diagnostic Specimen Submission Form and Instruction	Modified
Form 71.53(n) (no form) Recordkeeping and Reporting Requirements for importing Nonhuman Primates Form and Instruction	Modified
Form 71.53(g)(1)(iii) Documentation and Standard Operating Procedures (No Form) Form and Instruction	Modified
Attachment A5 - 49 CFR part 1520.11(b).pdf Supplementary Document	2014-06-19
Attachment A2 - 42 CFR part 71 Foreign Quarantine.pdf Supplementary Document	2014-06-19
Attachment A1 - Section 361 Public Health Service Act (42 USC 264).pdf Supplementary Document	2014-06-19
0920-0263 Revision ITDS Supptg Stmt B.docx Supporting Statement B	2014-06-19
0920-0263 Revision ITDS SUPPTG STMT A.docx Supporting Statement A	2014-06-19
Attachment 3 Special Permit Procedure.pdf Supplementary Document	2013-02-21

IC Document Collections

IC ID	Document Title	Status
6722	Importer Registration and New Importer Registration - Nonhuman Primates Form and Instruction	Modified
212043	Nonhuman Primate Importer Application for Registration as an Importer of Nonhuman Primates (New Importer) Form	New
212042	Nonhuman Primate Importer Recordkeeping and reporting Form	New
212007	Documentation of Non-infectiousness Form and Instruction	New
212006	Importer/Filer Form and Instruction	New
206055	Filovirus Diagnostic Specimen Submission Form and Instruction	Modified
206054	Quarantine Release Other-Data Elements	Unchanged
206053	Recordkeeping and Reporting Requirements for importing Nonhuman Primates Form and Instruction	Modified
206052	Documentation and Standard Operating Procedures (No Form) Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0263	ICR Reference No: 201406-0920-013
Status: Historical Active	Previous ICR Reference No: 201303-0920-003
Agency/Subagency: HHS/CDC	Agency Tracking No: 18894
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: 09/15/2014
	Date Received in OIRA: 06/24/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	36 Months From Approved	04/30/2016
Responses	5,187	0	476
Time Burden (Hours)	943	0	145
Cost Burden (Dollars)	0	0	0

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Abstract: CDC is submitting this revision to obtain authority to collect electronic information from importers/filters on nonhuman primate products over which CDC has authority, notably those found in 42 CFR part 71,. This request is consistent with requirements of the Security an Accountability for Every (SAFE) Port Act that states that all agencies that require documentation for clearing or licensing the importation and exportation of cargo participate in the International Trade Data System (ITDS) , and is also consistent with CDC authorities under Section 361 of the Public Health Service Act (PHSA) (42 U.S.C. 264).

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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: US Code: 42 USC 71 Name of Law: The Public Health and Welfare

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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:
	79 FR 15129	03/18/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 33924	06/13/2014
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Importer Registration and New Importer Registration - Nonhuman Primates	7510A	Application for Registration as an Importer of Nonhuman Primates
Documentation and Standard Operating Procedures (No Form)	71.53(g)(1)(iii)	Attachment E - CDC PGA Message Set Requested Data of Live Nonhuman Prima...
Recordkeeping and Reporting Requirements for importing Nonhuman Primates	71.53(n) (no form)	Recordkeeping and reporting requirements for importing Nonhuman primates
Quarantine Release
Filovirus Diagnostic Specimen Submission	71.53(v) (No Form)	Filovirus Diagnostic Specimen Submission Form for Non-human Primate Materials
Importer/Filer	71.53	CDC Partner Government Agency Message Set for Importing Nonhuman Primates
Nonhuman Primate Importer Application for Registration as an Importer of Nonhuman Primates (New Importer)	75.10A	Attachment C - CDC 75.10A Application for Registration as an Importer of...
Documentation of Non-infectiousness	71.53	Documentation of Non - Infectionusness
Nonhuman Primate Importer Recordkeeping and reporting	75.10	Attachment E - CDC PGA Message Set Requested Data of Live Nonhuman Prima...

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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	5,187	476	0	4,711	0	0
Annual Time Burden (Hours)	943	145	0	798	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: CDC is requesting the following changes based on the upcoming implementation of ITDS and ACE, which allows NHP importers/filers to voluntarily submit data concerning CDC-regulated imports electronically to CBP for clearance. These estimates are based on operational observation by Quarantine Staff at US ports of entry. • 150 submissions of CDC PGA Message Set importing Live Nonhuman Primates, resulting in 38 additional requested burden hours • 2280 submissions of CDC PGA Message Set data for importations of Nonhuman Primate products, resulting in an additional 570 requested burden hours • 2280 submissions of documentation indicating that Nonhuman Primate products have been rendered noninfectious, resulting in an additional 190 hours of requested burden. These submissions can be accomplished via the Document Imagining System. CDC retains the right to collect these in hard copy. The following change is a correction to clarify the public burden associated with providing the required statements and documentation that an NHP product has been rendered non-infectious. • 2280 submissions of documentation indicating that Nonhuman Primate products have been rendered noninfectious, resulting in an additional 190 hours of requested burden. These submissions can be accomplished via the Document Imagining System. CDC retains the right to collect these in hard copy. The estimates provided in this information collection request assume that every commercial importer of NHP covered by CDC's regulations will file a data entry using ITDS and ACE. However, CDC is maintaining its authority to collect hard copies of required documentation, as currently authorized by the Office of Management and Budget, because the use of ITDS/ACE will not be required for imports entering the United States until a later date. CDC will accept both hard copy and electronic filing of import-related documentation until the use of ACE is required for cargo entering the United States.

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Annual Cost to Federal Government: $433,788

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? 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: 06/24/2014

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