Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)

Forms and Documents

Document Name	Status
Form 0920-0576 Administrative Review Form	Unchanged
Form APHIS/CDC FORM 3 Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure Form and Instruction	Unchanged
Form 0920-0576 Records Form	Unchanged
Form APHIS/CDC Form 2 Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) Form and Instruction	Unchanged
Form 0920-0576 Training Form	Unchanged
Form 0920-0576 Incident Response Plan Form	Unchanged
Form 0920-0576 Request Regarding a Restricted Experiment Form	Unchanged
Form 0920-0576 Biosafety Plan Form	Unchanged
Form 0920-0576 Security Plan Form	Unchanged
Form 0920-0576 Request for Expedited Review Form	Unchanged
Form 0920-0576 Documentation of Self-Inspection Form	Unchanged
Form 0920-0576 Amendment to a Certificate of Registration Form	Unchanged
Form APHIS/CDC FORM 1 Application for Registration (APHIS/CDC Form 1) Form	Unchanged
Form 0920-0576 Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) Form	Unchanged
Form 4A Reporting the Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen (Form 4) Form and Instruction	Modified
Form 0920-0576 Request for Exclusions Form	Unchanged
0920-0576-Form4 Non-SubChangeRequest_220321.docx Justification for No Material/Nonsubstantive Change	2022-03-21
Non-substantive change request_2021-08-13.docx Justification for No Material/Nonsubstantive Change	2021-09-10
0920-0576-Form1 Non-SubChangeRequest-210630.docx Justification for No Material/Nonsubstantive Change	2021-07-07
0920-0576-Non-substantive change request_2021-02-24v2.docx Justification for No Material/Nonsubstantive Change	2021-03-05
0920-0576-Non-substantive change request_2021-01-25.docx Justification for No Material/Nonsubstantive Change	2021-01-29
Attachment 3 - System of Record Notice.PDF Supplementary Document	2020-07-20
Attachment 2 - 60-DayFRN-CDC-2020-0034-0001.pdf Supplementary Document	2020-07-20
Attachment 1 - CDC Select Agent Regulations.pdf Supplementary Document	2020-07-20
Supporting Statement B.docx Supporting Statement B	2020-07-20
0920-0576-2020REv-Supporting Statement A ICROv1200713 final.docx Supporting Statement A	2020-07-20

IC Document Collections

IC ID	Document Title	Status
217521	Administrative Review Form	Unchanged
217520	Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure Form and Instruction	Unchanged
217519	Records Form	Unchanged
217518	Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) Form and Instruction	Unchanged
217517	Training Form	Unchanged
217516	Incident Response Plan Form	Unchanged
217515	Request Regarding a Restricted Experiment Form	Unchanged
217514	Biosafety Plan Form	Unchanged
217512	Security Plan Form	Unchanged
217511	Request for Expedited Review Form	Unchanged
217510	Documentation of Self-Inspection Form	Unchanged
217509	Amendment to a Certificate of Registration Form	Unchanged
217508	Application for Registration (APHIS/CDC Form 1) Form	Unchanged
217507	Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) Form	Unchanged
217505	Reporting the Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen (Form 4) Form and Instruction	Modified
217504	Request for Exclusions Form	Unchanged

ICR Details

OMB Control No: 0920-0576	ICR Reference No: 202203-0920-007
Status: Active	Previous ICR Reference No: 202109-0920-003
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0576-21IA
Title: Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)
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 without change	Conclusion Date: 03/22/2022
	Date Received in OIRA: 03/22/2022
Terms of Clearance: Previous terms continue: USDA and CDC will carefully monitor the usage of this system and update this package accordingly.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2024	01/31/2024	01/31/2024
Responses	4,453	0	4,453
Time Burden (Hours)	4,467	0	4,467
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Disease Control and Prevention collects information under 42CFR Part 73, with the purpose of ensuring select agents or toxins are managed appropriately to prevent any threats to human health or safety. This request for nonmaterial/non-substantive changes clarifies the meaning/intent of questions on a few forms.

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Authorizing Statute(s): PL: Pub.L. 107 - 188 Subtitle A Name of Law: Public Health Security and Bioterrorism Preparedness and Response Act of 2002
  

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 18980	04/03/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 43844	07/20/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 16

IC Title	Form No.	Form Name
Administrative Review	0920-0576	Administrative Review
Amendment to a Certificate of Registration	0920-0576	Amendment to Registration
Application for Registration (APHIS/CDC Form 1)	APHIS/CDC FORM 1	Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins
Biosafety Plan	0920-0576	Biosafety Plan
Documentation of Self-Inspection	0920-0576	Documentation of self-inspection
Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure	APHIS/CDC FORM 3	INCIDENT FORM TO REPORT POTENTIAL THEFT, LOSS, RELEASE, OR OCCUPATIONAL EXPOSURE
Incident Response Plan	0920-0576	Incident Response Plan
Records	0920-0576	Records
Reporting the Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen (Form 4)	4A	Reporting the Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen
Request Regarding a Restricted Experiment	0920-0576	Request Regarding Restricted Experiment
Request for Exclusions	0920-0576	Request for Exclusions
Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5)	0920-0576	Request for Exemption
Request for Expedited Review	0920-0576	Request for Expedited Review
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2)	APHIS/CDC Form 2	Request to Transfer Select Agents and Toxins
Security Plan	0920-0576	Secuity Plan
Training	0920-0576	Training

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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	4,453	4,453	0	0	0	0
Annual Time Burden (Hours)	4,467	4,467	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $19,896,009

Does this IC contain surveys, censuses, or employ statistical methods? No

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.     Yes

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.     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? 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: 03/22/2022

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