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	Unchanged
Training Guidance Form and Instruction	Unchanged
Incident Response Plan Template Form and Instruction	Unchanged
Incident Response Plan Guidance Form and Instruction	Unchanged
Request Regarding a Restricted Experiment Guidance Form and Instruction	Unchanged
BioSafety Plan Template Form and Instruction	Unchanged
BioiSafety Plan Guidance Form and Instruction	Unchanged
Security Plan Template Form and Instruction	Unchanged
Security Plan - Guidance Form and Instruction	Unchanged
Request for Exclusion - Guidance Form and Instruction	Unchanged
Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance Form and Instruction	Unchanged
Form 0920-0576 Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance Form and Instruction	Modified
Form APHIS/CDC FORM 4C Att 4C_Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C Form and Instruction	Unchanged
Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance Form and Instruction	Unchanged
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance Form and Instruction	Unchanged
Application for Registration (APHIS/CDC Form 1) - Guidance Form and Instruction	Unchanged
Form APHIS/CDC FORM 4B Report of Identification of a Select Agent or Toxin from a Proficiency Test Form and Instruction	Unchanged
Administrative Review Form	Unchanged
Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure Form and Instruction	Unchanged
Records Form	Unchanged
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) Form	Unchanged
Training Form	Unchanged
Incident Response Plan Form	Unchanged
Request Regarding a Restricted Experiment Form	Unchanged
Biosafety Plan Form	Unchanged
Security Plan Form	Unchanged
Request for Expedited Review Form	Unchanged
Documentation of Self-Inspection Form	Unchanged
Amendment to a Certificate of Registration Form	Unchanged
Application for Registration (APHIS/CDC Form 1) Form	Unchanged
Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) Form	Unchanged
Form 0920-0576 Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen Form and Instruction	Modified
Request for Exclusions Form	Unchanged
0920-0576-Non-substantive change request 27APR2018.docx Justification for No Material/Nonsubstantive Change	2018-04-27
Att6 - SORN-EFSAP.DOC Supplementary Document	2017-12-18
Att5 - SORN-NSAR.PDF Supplementary Document	2017-12-18
NonSubChangeRequest.docx Justification for No Material/Nonsubstantive Change	2017-12-18
Att2a-60-DayComments.pdf Supplementary Document	2017-08-03
Att2-60-Day.pdf Supplementary Document	2017-08-03
0920-0576-SSB 06JUL2017.DOCX Supporting Statement B	2017-08-03
0920-0576 SSA 06JUL2017.doc Supporting Statement A	2017-08-03
Attachment 4 - System of Record Notice.PDF Supplementary Document	2015-07-16
Attachment 1 - CDC Select Agent Regulations.pdf Supplementary Document	2015-07-16

IC Document Collections

IC ID	Document Title	Status
227819	Inventory of Select Agents Guidance Form and Instruction	Unchanged
227818	Training Guidance Form and Instruction	Unchanged
227817	Incident Response Plan Template Form and Instruction	Unchanged
227816	Incident Response Plan Guidance Form and Instruction	Unchanged
227815	Request Regarding a Restricted Experiment Guidance Form and Instruction	Unchanged
227814	BioSafety Plan Template Form and Instruction	Unchanged
227813	BioiSafety Plan Guidance Form and Instruction	Unchanged
227811	Security Plan Template Form and Instruction	Unchanged
227809	Security Plan - Guidance Form and Instruction	Unchanged
227807	Request for Exclusion - Guidance Form and Instruction	Unchanged
227806	Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance Form and Instruction	Unchanged
227783	Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance Form and Instruction	Modified
227782	Att 4C_Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C Form and Instruction	Unchanged
227779	Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance Form and Instruction	Unchanged
227769	Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance Form and Instruction	Unchanged
227767	Application for Registration (APHIS/CDC Form 1) - Guidance Form and Instruction	Unchanged
227499	Report of Identification of a Select Agent or Toxin from a Proficiency Test Form and Instruction	Unchanged
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	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	Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen Form and Instruction	Modified
217504	Request for Exclusions Form	Unchanged

ICR Details

OMB Control No: 0920-0576	ICR Reference No: 201804-0920-015
Status: Active	Previous ICR Reference No: 201712-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0576 18ACH
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: 05/03/2018
	Date Received in OIRA: 05/01/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	10/31/2020	10/31/2020
Responses	7,869	0	7,869
Time Burden (Hours)	8,347	0	8,407
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 Non-Substantive Change Request is to modify APHIS/CDC Form 4A to clarify the meaning/intent of the question for the select agent or toxin identified as Botulinum neurotoxins. The revised Form 4A will result in a decrease in 60 Burden Hours for regulated entities.

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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:
	81 FR 96456	12/30/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 36144	08/03/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 33

IC Title	Form No.	Form Name
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)	none	Request for Exemption
Application for Registration (APHIS/CDC Form 1)	APHIS/CDC FORM 1, none	Application for Registration ,   Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins
Amendment to a Certificate of Registration	none	Amendment to Registration
Security Plan	none	Secuity Plan
Biosafety Plan	none	Biosafety Plan
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 ,   Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report (APHIS/CDC Form 4C)
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
Inventory of Select Agents Guidance	NA	Guidance document for the completion of Inventory Records of Select Agents
Application for Registration (APHIS/CDC Form 1) - Guidance	NA	Guidance Document for the completion of APHIS/CDC Form 1
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 Exclusion - Guidance	NA	Guidance Document for Exclusion of Select Agents and Toxins
Security Plan - Guidance	NA	Guidance Document for the completion of Security Plan
Security Plan Template	NA	Security Plan Template
BioiSafety Plan Guidance	NA	Guidance Documnet for the completion of BioSafety Plan
BioSafety Plan Template	NA	BioSafety Plan Template
Request Regarding a Restricted Experiment Guidance	NA	Guidance Document for the completion of Restricted Experiment Request
Incident Response Plan Guidance	NA	Guidance Document for the completion of Incident Response Plan
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance	NA	Guidance Document for the completion of APHIS/CDC Form 2
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
Incident Response Plan Template	NA	Incident Response Plan Template
Training Guidance	NA	Guidance Document for the completion of Training
Request for Exclusions	none	Request for Exclusions
Training	none	Training
Records	none	Records
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2)	APHIS/CDC FORM 2, none	Request to Transfer Select Agents and Toxins ,   REQUEST FOR TRANSFER SELECT AGENTS AND TOXINS
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: PROFICIENCY TESTING REPORT ,   REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN FROM A PROFICIENCY TEST (APHIS/CDC FORM 4B)
Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure	NA, APHIS/CDC FORM 3	Incident Notification and Reporting APHIS/CDC Form 3 (Theft/Loss/Release) ,   INCIDENT FORM TO REPORT POTENTIAL THEFT, LOSS, RELEASE, OR OCCUPATIONAL EXPOSURE
Administrative Review	none	Administrative Review
Documentation of Self-Inspection	none	Documentation of self-inspection
Request for Expedited Review	none	Request for Expedited Review
Request Regarding a Restricted Experiment	none	Request Regarding Restricted Experiment
Incident Response Plan	none	Incident Response Plan

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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	7,869	7,869	0	0	0	0
Annual Time Burden (Hours)	8,347	8,407	0	-60	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: Yes

Burden Reduction Due to: Cutting Redundancy

Short Statement: This Non-Substantive Change Request includes a revised Form 4A that will reduce 120 forms for approximately 8 entities, resulting in a reduction of 60 Burden Hours.

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Annual Cost to Federal Government: $20,210,121

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.     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? Uncollected

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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: 05/01/2018

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