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	New
Training Guidance Form and Instruction	New
Incident Response Plan Template Form and Instruction	New
Incident Response Plan Guidance Form and Instruction	New
Request Regarding a Restricted Experiment Guidance Form and Instruction	New
BioSafety Plan Template Form and Instruction	New
BioiSafety Plan Guidance Form and Instruction	New
Security Plan Template Form and Instruction	New
Security Plan - Guidance Form and Instruction	New
Request for Exclusion - Guidance Form and Instruction	New
Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance Form and Instruction	New
Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance Form and Instruction	New
Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C Form and Instruction	New
Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance Form and Instruction	New
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance Form and Instruction	New
Application for Registration (APHIS/CDC Form 1) - Guidance Form and Instruction	New
Report of Identification of a Select Agent or Toxin from a Proficiency Test Form and Instruction	New
Administrative Review Form	Modified
Report of Theft, Loss, or Release of Select Agent or Toxin (APHIS/CDC Form 3) Form and Instruction	Modified
Records Form	Modified
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) Form	Modified
Training Form	Modified
Incident Response Plan Form	Modified
Request Regarding a Restricted Experiment Form	Modified
Biosafety Plan Form	Modified
Security Plan Form	Modified
Request for Expedited Review Form	Modified
Documentation of Self-Inspection Form	Modified
Amendment to a Certificate of Registration Form	Modified
Application for Registration (APHIS/CDC Form 1) Form	Modified
Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) Form	Modified
Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen Form	Modified
Request for Exclusions Form	Modified
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	New
227818	Training Guidance Form and Instruction	New
227817	Incident Response Plan Template Form and Instruction	New
227816	Incident Response Plan Guidance Form and Instruction	New
227815	Request Regarding a Restricted Experiment Guidance Form and Instruction	New
227814	BioSafety Plan Template Form and Instruction	New
227813	BioiSafety Plan Guidance Form and Instruction	New
227811	Security Plan Template Form and Instruction	New
227809	Security Plan - Guidance Form and Instruction	New
227807	Request for Exclusion - Guidance Form and Instruction	New
227806	Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance Form and Instruction	New
227783	Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance Form and Instruction	New
227782	Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C Form and Instruction	New
227779	Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance Form and Instruction	New
227769	Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance Form and Instruction	New
227767	Application for Registration (APHIS/CDC Form 1) - Guidance Form and Instruction	New
227499	Report of Identification of a Select Agent or Toxin from a Proficiency Test Form and Instruction	New
217521	Administrative Review Form	Modified
217520	Report of Theft, Loss, or Release of Select Agent or Toxin (APHIS/CDC Form 3) Form and Instruction	Modified
217519	Records Form	Modified
217518	Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) Form	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	Modified
217504	Request for Exclusions Form	Modified

ICR Details

OMB Control No: 0920-0576	ICR Reference No: 201706-0920-009
Status: Historical Active	Previous ICR Reference No: 201701-0920-008
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/27/2017
	Date Received in OIRA: 08/07/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	36 Months From Approved	12/31/2018
Responses	7,869	0	5,322
Time Burden (Hours)	8,407	0	8,528
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 Revision request is to modify APHIS/CDC Form 3 CDC to clarify the intent and meaning of certain questions. In addition CDC has developed Guidance Documents for entities covered by the Federal Select Agent Program to use to assist in completion of APHIS/CDC 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:
	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
Request for Exclusions	none	Request for Exclusions
Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen	NA	REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN FROM A CLINICAL/DIAGNOSTIC SPECIMEN (APHIS/CDC FORM 4A)
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)	none	Application for Registration
Amendment to a Certificate of Registration	none	Amendment to Registration
Security Plan	none	Secuity Plan
Biosafety Plan	none	Biosafety Plan
Training	none	Training
Records	none	Records
Report of Theft, Loss, or Release of Select Agent or Toxin (APHIS/CDC Form 3)	NA	Incident Notification and Reporting APHIS/CDC Form 3 (Theft/Loss/Release)
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
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2)	none	Request to Transfer Select Agents and Toxins
Report of Identification of a Select Agent or Toxin from a Proficiency Test	NA	REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN FROM A PROFICIENCY TEST (APHIS/CDC FORM 4B)
Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C	NA	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	NA	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

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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	5,322	0	2,547	0	0
Annual Time Burden (Hours)	8,407	8,528	0	-121	0	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: Revision of 0920-0576 - Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73) involves both a reduction in Burden due to a decrease in number of Respondents, and time needed for completion of Forms, as well as an increase in Burden due to the addition of Guidance Documents.

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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: 08/07/2017

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