[CPR] 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
Non-Applicants (Providing Statement that Material is Non-Infectious) Form and Instruction	New
Application for Permit to Import Infectious Human Remains into the United States Form and Instruction	Modified
Application for Permit to Import Infectious Biological Agents into the United States-SUBSEQUENT TRANSFERS Form and Instruction	Modified
Application for Permit to Import or Transport Live Bats (71.54) Form and Instruction	Modified
Attachment 5 - Non-Human Research Determination.pdf Supplementary Document	2024-07-15
Attachment 3 - Import Permit SORN_2020-0827.pdf Supplementary Document	2024-07-15
Attachment 2a - 2024-02173-0920-0199-60-DayFRRevision.pdf Supplementary Document	2024-07-15
Attachment 1a - Public Health Service Act.pdf Supplementary Document	2024-07-15
SSB-0920-0199-2024Rev_clean.docx Supporting Statement B	2024-07-15
SSA-0920-0199-Rev2024_clean_final.docx Supporting Statement A	2024-07-15

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
269439	Non-Applicants (Providing Statement that Material is Non-Infectious) Form and Instruction	New
241509	Application for Permit to Import Infectious Human Remains into the United States Form and Instruction	Modified
230766	Application for Permit to Import Infectious Biological Agents into the United States-SUBSEQUENT TRANSFERS Form and Instruction	Modified
195480	Application for Permit to Import or Transport Live Bats (71.54) Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0199	ICR Reference No: 202407-0920-001
Status: Received in OIRA	Previous ICR Reference No: 202206-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0199
Title: [CPR] 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	Date Submitted to OIRA: 07/16/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2024
Responses	8,956	2,483
Time Burden (Hours)	2,044	764
Cost Burden (Dollars)	0	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 form changes, addition of a form, and a total burden increase.

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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
   US Code: 42 USC CFR Part 71.55 Name of Law: Importation of Human Remains
  

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:
	89 FR 7712	02/05/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 57897	07/16/2024
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

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
Non-Applicants (Providing Statement that Material is Non-Infectious)	n/a	Importer Certification Statement

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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	8,956	2,483	0	6,473	0	0
Annual Time Burden (Hours)	2,044	764	0	1,280	0	0
Annual Cost Burden (Dollars)	0	29,228	0	-29,228	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 burden increase is due to an increase in respondents and addition of a new instrument.

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Annual Cost to Federal Government: $19,274,049

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: 07/16/2024

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