Import Permit Applications (42 CFR 71.54)

Forms and Documents

Document Name	Status
Application for Permit to Import Infectious Biological Agents into the United States Form and Instruction	Modified
Application for Permit to Import Infectious Human Remains into the United States Form and Instruction	Unchanged
Application for Permit to Import Infectious Biological Agents into the United States-SUBSEQUENT TRANSFERS Form and Instruction	Unchanged
Application for Permit to Import or Transport Live Bats (71.54) Form and Instruction	Unchanged
0920-1099-NonSubChangeRequest-220608.docx Justification for No Material/Nonsubstantive Change	2022-06-10
Att 3-Import Permit SORN_2020-0827.pdf Supplementary Document	2021-03-12
Att 2a_0920-0199 60d FRN_10212020.pdf Supplementary Document	2021-03-12
Att 1c_42 CFR 71.55, Importation of Human Remains.pdf Supplementary Document	2021-03-12
Att 1a_Public Health Service Act.pdf Supplementary Document	2021-03-12
Supporting Statement B_02242021.docx Supporting Statement B	2021-03-12
Supporting Statement A_03122021.docx Supporting Statement A	2021-03-12

IC Document Collections

IC ID	Document Title	Status
6654	Application for Permit to Import Infectious Biological Agents into the United States Form and Instruction	Modified
241509	Application for Permit to Import Infectious Human Remains into the United States Form and Instruction	Unchanged
230766	Application for Permit to Import Infectious Biological Agents into the United States-SUBSEQUENT TRANSFERS Form and Instruction	Unchanged
195480	Application for Permit to Import or Transport Live Bats (71.54) Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-0199	ICR Reference No: 202206-0920-007
Status: Received in OIRA	Previous ICR Reference No: 202101-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0199
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	Date Submitted to OIRA: 06/13/2022

	Requested	Previously Approved
Expiration Date	08/31/2024	08/31/2024
Responses	2,483	2,483
Time Burden (Hours)	764	764
Cost Burden (Dollars)	29,228	29,228

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Abstract: This information collection supports Section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264) and prevents the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. This is a request for nonmaterial/non-substantive changes to reflect the changes in the published 6th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL) and will not affect the burden in completing the form.

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Authorizing Statute(s): US Code: 42 USC CFR Part 71.55 Name of Law: Importation of Human Remains
   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:
	85 FR 66987	10/21/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 14120	03/12/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Application for Permit to Import Infectious Biological Agents into the United States	n/a	Application for Permit to Import Infectious Biological Agents into the United States
Application for Permit to Import Infectious Biological Agents into the United States-SUBSEQUENT TRANSFERS	n/a	Application for Permit to Import Infectious Biological Agents into the United States
Application for Permit to Import Infectious Human Remains into the United States	n/a	Application for Permit to Import Infectious Human Remains into the United States
Application for Permit to Import or Transport Live Bats (71.54)	n/a	Application for Permit to Import or Transfer Live Bats

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ICR Summary of Burden

	Total Request	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	2,483	2,483	0	0	0	0
Annual Time Burden (Hours)	764	764	0	0	0	0
Annual Cost Burden (Dollars)	29,228	29,228	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: No

Burden Reduction Due to:

Short Statement: The Import Permit Program implemented a new electronic data collection system that is more efficient and reduces the need to consult guidance documents. There is also an adjustment to the estimated number of respondents requesting permits to import live bats.

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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? No

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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: 06/13/2022

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