Requirements for a Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States

Forms and Documents

Document Name	Status
Attachment 6 Data Elements.doc Supplementary Document	2008-04-24
Attachment 5_Public Comments.doc Supplementary Document	2008-04-24
Attachment 4_60 day FRN.pdf Supplementary Document	2008-04-24
Attachment 3_55 FR 15210.pdf Supplementary Document	2008-04-24
Attachment 2 42CFR71.53.pdf Supplementary Document	2008-04-24
Attachment 1 42 USC264.pdf Supplementary Document	2008-04-24
2008 Supporting Statement (3).doc Supporting Statement A	2008-04-24

IC Document Collections

IC ID	Document Title	Status
6722	Requirements for a Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States (Businesses - Limited) Instruction	Modified
184798	Requirements for Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States (organizations - extended) Instruction	New
184797	Requirements for Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States (Businesses - extended) Instruction	New

ICR Details

OMB Control No: 0920-0263	ICR Reference No: 200805-0920-003
Status: Historical Active	Previous ICR Reference No: 200603-0920-003
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Requirements for a Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/12/2008
	Date Received in OIRA: 05/06/2008
Terms of Clearance: Approved consistent with the following terms of clearance: CDC is currently revising the relevant regulations and shall submit a revised collection to OMB for approval prior to finalizing any regulatory changes which would affect information requirements related to this collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	36 Months From Approved	06/30/2008
Responses	100	0	100
Time Burden (Hours)	21	0	20
Cost Burden (Dollars)	0	0	0

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Abstract: Section 361 of the Public Health Service Act (42 USC 264) (Attachment 1) authorizes the Secretary of Health and Human Services to make regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States. Existing regulations governing quarantine activities (42 CFR 71.53) (Attachment 2) provide for the registration of importers of nonhuman primates by the Director, Centers for Disease Control and Prevention (CDC), contingent upon the importers meeting certain recordkeeping, reporting, and disease control requirements to be established by the Director. Those recordkeeping, reporting, and disease control requirements are approved under OMB Control No. 0920-0134 (Foreign Quarantine Regulations).

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

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:
	72 FR 68887	12/06/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 22155	04/24/2008
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Requirements for a Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States (Businesses - Limited)
Requirements for Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States (Businesses - extended)
Requirements for Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States (organizations - extended)

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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	100	100	0	0	0	0
Annual Time Burden (Hours)	21	20	0	1	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: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The slight increase in burden is due to rounding.

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Annual Cost to Federal Government: $5,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 05/06/2008

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