Import Permit Applications (42 CFR 71.54)

Forms and Documents

Document	Type	Status	Availability
Form 0920-0199 Application for Permit to Import Infectious Biological Agents into the United States	Form	Unchanged	Repair queued
Form 0920-0199 Permit to Import Human Remains	Form and Instruction	New	Available
Form 0920-0199 Guidance Document for Completing Application for Permit to Import or Transport Live Bats (71.54)	Form	Unchanged	Available
Form 0920-0199 Susequent Transfer - Application for Permit to Import Infectious Biological Agents into the United States	Form	Unchanged	Repair queued
Form 0920-0199 Guidance Document for Completing the Application for Permit to Import Biological Agents into the United States	Form	Unchanged	Repair queued
Form 0920-0199 Application for Permit to Import or Transport Live Bats (71.54)	Form	Unchanged	Repair queued
0920-0199_NonSubChange_HumanRemainsImportForm200423.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-04-24	Available
SATRN PIA_signed.pdf	Supplementary Document	Uploaded 2018-03-20	Available
0920-0199-SSB.docx	Supporting Statement B	Uploaded 2018-03-13	Available
0920-0199-SSA_200428clean.docx	Supporting Statement A	Uploaded 2020-04-28	Available
Attachment 6-Determination of Applicability of Human Subjects Regulations.doc	Supplementary Document	Uploaded 2018-03-13	Repair queued
Att4-DraftSORN.docx	Supplementary Document	Uploaded 2018-03-13	Repair queued
Att2-60DayFRN.pdf	Supplementary Document	Uploaded 2018-03-13	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6654	Application for Permit to Import Infectious Biological Agents into the United States	Form	Unchanged
241509	Permit to Import Human Remains	Form and Instruction	New
230767	Guidance Document for Completing Application for Permit to Import or Transport Live Bats (71.54)	Form	Unchanged
230766	Susequent Transfer - Application for Permit to Import Infectious Biological Agents into the United States	Form	Unchanged
230765	Guidance Document for Completing the Application for Permit to Import Biological Agents into the United States	Form	Unchanged
195480	Application for Permit to Import or Transport Live Bats (71.54)	Form	Unchanged

ICR Details

OMB Control No: 0920-0199	ICR Reference No: 202004-0920-018
Status: Historical Active	Previous ICR Reference No: 201803-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0199-20NJ
Title: Import Permit Applications (42 CFR 71.54)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/29/2020
	Date Received in OIRA: 04/27/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2021	04/30/2021	04/30/2021
Responses	4,500	0	4,400
Time Burden (Hours)	1,355	0	1,322
Cost Burden (Dollars)	0	0	0

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Abstract: CDC requests Office of Management and Budget approval to collect information for three years. CDC revised the Application for Permit to Import Biological Agents, Infectious Substances and Vectors of Human Disease into the U.S. to remove questions that are duplicative or not required to process the import permit request and added questions requesting biosafety officer's contact information and verifying biosafety measures for any subsequent transfers listed on the import permit application of infectious biological agent infectious substance, and/or vector once in the U.S. CDC revised the Application for Permit to Import or Transport Live Bats to add a question about what protective measures will be used. This Change Request is associated with the COVID-19 Emergency Response. We are adding an additional form (Application Permit For Importation of Human Remains) that will be used by facilities that will bury/cremate the imported cadaver and educational facilities to request a permit for the importation and subsequent transfers throughout the U.S. of human remains or body parts that contains biological agents, infectious substances, or vectors of human disease. The CDC/IPP will review the application for permits to ensure that the imported human remains have appropriate biosafety measures in place to protect the public from exposure to blood and other body fluids during transportation, inspection, and/or storage of human remains that may be infected with SARS-CoV-2.

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

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 44795	09/26/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 10484	03/09/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Application for Permit to Import Infectious Biological Agents into the United States	0920-0199	Application for Permit to Import Infectious Biological Agents into the United States
Application for Permit to Import or Transport Live Bats (71.54)	0920-0199	Application for Permit to Import or Transfer Live Bats
Guidance Document for Completing the Application for Permit to Import Biological Agents into the United States	0920-0199	Application for Permit to Import Infectious Biological Agents into the United States
Susequent Transfer - Application for Permit to Import Infectious Biological Agents into the United States	0920-0199	Sebsequent Transfer - Application for Permit to Import Infectious Biological Agents into the United States
Guidance Document for Completing Application for Permit to Import or Transport Live Bats (71.54)	0920-0199	Guidance for Completing the Application for Permit to Import or Transfer Live Bats
Permit to Import Human Remains	0920-0199	Permit to Import Human Remains

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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	4,500	4,400	0	100	0	0
Annual Time Burden (Hours)	1,355	1,322	0	33	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: No

Burden Reduction Due to:

Short Statement: A form was added to the collection but this Change Request falls under Emergency review because it is related to COVID-19.

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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

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.     No

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? Yes

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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: 04/27/2020

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