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

Forms and Documents

Document Name	Status
Application for Registration Form	Removed
Administrative Review Form	New
Notification of Potential Theft, Loss, or Release Form	New
Records Form	New
Request to Transfer Select Agents and Toxins Form	New
Training Form	New
Incident Response Plan Form	New
Request Regarding a Restricted Experiment Form	New
Biosafety Plan Form	New
Security Plan Form	New
Request for Expedited Review Form	New
Documentation of Self-Inspection Form	New
Amendment to a Certificate of Registration Form	New
Application for Registration Form	New
Request for Exemption Form	New
Report of Identification of a Select Agent or Toxin Form	New
Request for Exclusions Form	New
Report of Identification of Select Agent or Toxin Form	Removed
Notification of Theft, Loss or Release Form	Removed
Request to Transer Select Agent or Toxin Form	Removed
Supporting Statement B.doc Supporting Statement B	2015-07-23
Supporting Statement A.doc Supporting Statement A	2015-07-23
Attachment 4 - System of Record Notice.PDF Supplementary Document	2015-07-16
Attachment 3 - Public Comments.docx Supplementary Document	2015-07-16
Attachment 2 - 60-day Federal Register 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
7036	Application for Registration Form	Removed
217521	Administrative Review Form	New
217520	Notification of Potential Theft, Loss, or Release Form	New
217519	Records Form	New
217518	Request to Transfer Select Agents and Toxins Form	New
217517	Training Form	New
217516	Incident Response Plan Form	New
217515	Request Regarding a Restricted Experiment Form	New
217514	Biosafety Plan Form	New
217512	Security Plan Form	New
217511	Request for Expedited Review Form	New
217510	Documentation of Self-Inspection Form	New
217509	Amendment to a Certificate of Registration Form	New
217508	Application for Registration Form	New
217507	Request for Exemption Form	New
217505	Report of Identification of a Select Agent or Toxin Form	New
217504	Request for Exclusions Form	New
186031	Inspections Instruction	Removed
186030	Amendment to Registration Application Instruction	Removed
186028	Adminstrative Review Instruction	Removed
186026	Request for Exclusion/Restricted Instruction	Removed
186025	Request for Expedited Review Instruction	Removed
186024	Request for Exemption Instruction	Removed
186023	Report of Identification of Select Agent or Toxin Form	Removed
186022	Notification of Theft, Loss or Release Form	Removed
186021	Request to Transer Select Agent or Toxin Form	Removed

ICR Details

OMB Control No: 0920-0576	ICR Reference No: 201507-0920-006
Status: Historical Active	Previous ICR Reference No: 201412-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 19723
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: 12/15/2015
	Date Received in OIRA: 07/28/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved	12/31/2015
Responses	5,322	0	6,370
Time Burden (Hours)	8,528	0	8,923
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Disease Control and Prevention is requesting a revision to forms used to collect 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.

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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:
	80 FR 18242	04/03/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 44130	07/24/2015
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Incident Response Plan	none	Incident Response Plan
Request to Transfer Select Agents and Toxins	none	Request to Transfer Select Agents and Toxins
Training	none	Training
Records	none	Records
Notification of Potential Theft, Loss, or Release	none	Notification of Theft, Loss, or Release
Administrative Review	none	Administrative Review
Notification of Theft, Loss or Release	none	Report of Theft, Loss or Release of Select Agents and Toxins (APHIS/CDC Form 3)
Report of Identification of Select Agent or Toxin	none, none, none	Reporting the Identification ,   4B ,   4C
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
Request for Exemption
Request for Expedited Review
Request for Exclusion/Restricted
Adminstrative Review
Amendment to Registration Application
Inspections
Request to Transer Select Agent or Toxin	none	Request to Transfer
Application for Registration	none	Application for Registration
Request for Exclusions	none	Request for Exclusions
Report of Identification of a Select Agent or Toxin	none	Report of Identification of a Select Agent or Toxin
Request for Exemption	none	Request for Exemption
Application for Registration	none	Application for Registration
Amendment to a Certificate of Registration	none	Amendment to Registration
Security Plan	none	Secuity Plan
Biosafety Plan	none	Biosafety 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	5,322	6,370	0	-728	-320	0
Annual Time Burden (Hours)	8,528	8,923	0	85	-480	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: Miscellaneous Actions

Short Statement: The requested revisions involve changes to some forms and a reduction in burden and respondents due to a decrease in the number of respondents now involved in this program.

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Annual Cost to Federal Government: $15,694,401

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? 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: 07/28/2015

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