Import Permit Applications (42 CFR 71.54)

Forms and Documents

Document	Type	Status	Availability
Importation of Infectious Biological Agents, Infectious Substances, and Vectors into the US	Form	Modified	Available
Application for Permit to Import or Transport Live Bats (71.54)	Form	Modified	Available
Supporting Statement B_OMB 0920-0199_2013-11-25.docx	Supporting Statement B	Uploaded 2013-12-12	Available
Determination of Applicabilty of Human Subjects Regulations.pdf	Supplementary Document	Uploaded 2013-12-12	Available
Attachment 4_Draft_SORN.docx	Supplementary Document	Uploaded 2013-12-12	Repair queued
Attachment 3_Public Comments.docx	Supplementary Document	Uploaded 2013-12-12	Repair queued
Attachment 2_60-Day FRN.pdf	Supplementary Document	Uploaded 2013-12-12	Available
Attachment 6-Application for Permit to Import or Transport Live Bats.pdf	Supplementary Document	Uploaded 2013-12-12	Available
Attachment 5-Application for Permit to Import Biological Agents and Vectors of Human Disease into the United States.pdf	Supplementary Document	Uploaded 2013-12-12	Repair queued
Attachment 7-Summary of Changes.docx	Supplementary Document	Uploaded 2013-12-12	Available
Supporting Statement A_OMB 0920-0199_2013-12-09.docx	Supporting Statement A	Uploaded 2013-12-12	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6654	Importation of Infectious Biological Agents, Infectious Substances, and Vectors into the US	Form	Modified
195480	Application for Permit to Import or Transport Live Bats (71.54)	Form	Modified

ICR Details

OMB Control No: 0920-0199	ICR Reference No: 201312-0920-005
Status: Historical Active	Previous ICR Reference No: 201012-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 21107
Title: Import Permit Applications (42 CFR 71.54)
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: 01/23/2014
	Date Received in OIRA: 12/19/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	36 Months From Approved	01/31/2014
Responses	1,635	0	2,010
Time Burden (Hours)	545	0	670
Cost Burden (Dollars)	0	0	0

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Abstract: The Application for Permit to Import Biological Agents and Vectors of Human Disease into the US form is used by laboratory facilities, such as those operated by government agencies, universities, and research institutions to request a permit for the importation of biological agents, infectious substances, or vectors of human disease. The form requests applicant and sender contact information; description of material for importation; facility isolation and containment information; and personnel qualifications.

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Authorizing Statute(s): US Code: 42 USC CFR Part 71.54 Name of Law: FOREIGN QUARANTINE - Subpart F--Importations
   US Code: 42 USC 264 Name of Law: PHSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0920-AA37	Final or interim final rulemaking	78 FR 7674	02/04/2013

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 55259	09/10/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 75921	12/13/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Importation of Infectious Biological Agents, Infectious Substances, and Vectors into the US	none	Application for Permit to Import Biological Agents or Vectors of Human Disease into the US
Application for Permit to Import or Transport Live Bats (71.54)	none	Application for Permit to Import or Transfer Live Bats

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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	1,635	2,010	0	-375	0	0
Annual Time Burden (Hours)	545	670	0	-125	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The reduction in burden is due to revised estimates of respondents based on past experience. CDC requests form revisions to include information on where the imported material will be stored at the recipient facility and who is responsible for the location; verification that the permittee has implemented biosafety measures commensurate with the hazard posed by the infectious biological agent, infectious substance, and/or vector to be imported, and the level of risk given its intended use; and a secondary contact information for the permittee. The additional data elements do not affect the burden. We also request a title change to Import Permit Applications (42 CFR 71.54).

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Annual Cost to Federal Government: $1,335,495

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? 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: 12/19/2013

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