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

Forms and Documents

Document Name	Status
Inventory of Select Agents Guidance Form and Instruction	Removed
Training Guidance Form and Instruction	Removed
Incident Response Plan Template Form and Instruction	Removed
Incident Response Plan Guidance Form and Instruction	Removed
Request Regarding a Restricted Experiment Guidance Form and Instruction	Removed
BioSafety Plan Template Form and Instruction	Removed
BioiSafety Plan Guidance Form and Instruction	Removed
Security Plan Template Form and Instruction	Removed
Security Plan - Guidance Form and Instruction	Removed
Request for Exclusion - Guidance Form and Instruction	Removed
Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance Form and Instruction	Removed
Form 0920-0576 Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance Form and Instruction	Removed
Att 4C_Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C Form and Instruction	Removed
Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance Form and Instruction	Removed
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance Form and Instruction	Removed
Application for Registration (APHIS/CDC Form 1) - Guidance Form and Instruction	Removed
Report of Identification of a Select Agent or Toxin from a Proficiency Test Form and Instruction	Removed
Form 0920-0576 Administrative Review Form	Modified
Form APHIS/CDC FORM 3 Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure Form and Instruction	Modified
Form 0920-0576 Records Form	Modified
Form APHIS/CDC FORM 2 Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) Form and Instruction	Modified
Form 0920-0576 Training Form	Modified
Form 0920-0576 Incident Response Plan Form	Modified
Form 0920-0576 Request Regarding a Restricted Experiment Form	Modified
Form 0920-0576 Biosafety Plan Form	Modified
Form 0920-0576 Security Plan Form	Modified
Form 0920-0576 Request for Expedited Review Form	Modified
Form 0920-0576 Documentation of Self-Inspection Form	Modified
Form 0920-0576 Amendment to a Certificate of Registration Form	Modified
Form APHIS/CDC FORM 1 Application for Registration (APHIS/CDC Form 1) Form	Modified
Form 0920-0576 Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) Form	Modified
Form 0920-0576 Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen Form and Instruction	Modified
Form 0920-0576 Request for Exclusions Form	Modified
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
227819	Inventory of Select Agents Guidance Form and Instruction	Removed
227818	Training Guidance Form and Instruction	Removed
227817	Incident Response Plan Template Form and Instruction	Removed
227816	Incident Response Plan Guidance Form and Instruction	Removed
227815	Request Regarding a Restricted Experiment Guidance Form and Instruction	Removed
227814	BioSafety Plan Template Form and Instruction	Removed
227813	BioiSafety Plan Guidance Form and Instruction	Removed
227811	Security Plan Template Form and Instruction	Removed
227809	Security Plan - Guidance Form and Instruction	Removed
227807	Request for Exclusion - Guidance Form and Instruction	Removed
227806	Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance Form and Instruction	Removed
227783	Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance Form and Instruction	Removed
227782	Att 4C_Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C Form and Instruction	Removed
227779	Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance Form and Instruction	Removed
227769	Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance Form and Instruction	Removed
227767	Application for Registration (APHIS/CDC Form 1) - Guidance Form and Instruction	Removed
227499	Report of Identification of a Select Agent or Toxin from a Proficiency Test Form and Instruction	Removed
217521	Administrative Review Form	Modified
217520	Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure Form and Instruction	Modified
217519	Records Form	Modified
217518	Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) Form and Instruction	Modified
217517	Training Form	Modified
217516	Incident Response Plan Form	Modified
217515	Request Regarding a Restricted Experiment Form	Modified
217514	Biosafety Plan Form	Modified
217512	Security Plan Form	Modified
217511	Request for Expedited Review Form	Modified
217510	Documentation of Self-Inspection Form	Modified
217509	Amendment to a Certificate of Registration Form	Modified
217508	Application for Registration (APHIS/CDC Form 1) Form	Modified
217507	Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) Form	Modified
217505	Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen Form and Instruction	Modified
217504	Request for Exclusions Form	Modified

ICR Details

OMB Control No: 0920-0576	ICR Reference No: 202006-0920-017
Status: Received in OIRA	Previous ICR Reference No: 201804-0920-015
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0576
Title: Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/21/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2021
Responses	4,453	7,869
Time Burden (Hours)	4,467	8,347
Cost Burden (Dollars)	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. The requested revisions to the data collection are primarily changes to the forms to clarify instructions, correct editorial errors from previous submission, and reformat the structure of the forms based on the day-to-day processing of these 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
Att 4C_Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C	NA, APHIS/CDC FORM 4C	Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report (APHIS/CDC Form 4C) ,   Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report
Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance	NA	Guidance Document for the completion of APHIS/CDC Form 3
Request for Exclusion - Guidance	NA	Guidance Document for Exclusion of Select Agents and Toxins
Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance	0920-0576	Guidance Document for the Completion of APHIS/CDC Form 4
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance	NA	Guidance Document for the completion of APHIS/CDC Form 2
Application for Registration (APHIS/CDC Form 1) - Guidance	NA	Guidance Document for the completion of APHIS/CDC Form 1
Report of Identification of a Select Agent or Toxin from a Proficiency Test	NA, APHIS/CDC FORM 4B	REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN FROM A PROFICIENCY TEST (APHIS/CDC FORM 4B) ,   REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN: PROFICIENCY TESTING REPORT
Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance	NA	Guidance Document for the completion of APHIS/CDC Form 5
Request for Exclusions	0920-0576	Request for Exclusions
Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen	0920-0576	APHIS/CDC FORM 4A - REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN FROM A CLINICAL/DIAGNOSTIC SPECIMEN
Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5)	0920-0576	Request for Exemption
Application for Registration (APHIS/CDC Form 1)	APHIS/CDC FORM 1	Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins
Amendment to a Certificate of Registration	0920-0576	Amendment to Registration
Request Regarding a Restricted Experiment	0920-0576	Request Regarding Restricted Experiment
Incident Response Plan	0920-0576	Incident Response Plan
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2)	APHIS/CDC FORM 2	REQUEST FOR TRANSFER SELECT AGENTS AND TOXINS
Inventory of Select Agents Guidance	NA	Guidance document for the completion of Inventory Records of Select Agents
Training Guidance	NA	Guidance Document for the completion of Training
Incident Response Plan Template	NA	Incident Response Plan Template
Incident Response Plan Guidance	NA	Guidance Document for the completion of Incident Response Plan
Request Regarding a Restricted Experiment Guidance	NA	Guidance Document for the completion of Restricted Experiment Request
BioSafety Plan Template	NA	BioSafety Plan Template
BioiSafety Plan Guidance	NA	Guidance Documnet for the completion of BioSafety Plan
Security Plan Template	NA	Security Plan Template
Security Plan - Guidance	NA	Guidance Document for the completion of Security Plan
Security Plan	0920-0576	Secuity Plan
Biosafety Plan	0920-0576	Biosafety Plan
Training	0920-0576	Training
Records	0920-0576	Records
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
Administrative Review	0920-0576	Administrative Review
Documentation of Self-Inspection	0920-0576	Documentation of self-inspection
Request for Expedited Review	0920-0576	Request for Expedited Review

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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	4,453	7,869	0	-72	-3,344	0
Annual Time Burden (Hours)	4,467	8,347	0	-2,205	-1,675	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: Yes

Burden Reduction Due to: Using Information Technology

Short Statement: The estimate of respondents has decreased and the burden decreased because of IT implementation.

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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: 07/21/2020

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