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

Forms and Documents

Document Name	Status
Administrative Review Form	Unchanged
Notification of Potential Theft, Loss, or Release Form	Modified
Records Form	Unchanged
Request to Transfer Select Agents and Toxins Form	Modified
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 Form	Modified
Request for Exemption Form	Unchanged
Report of Identification of a Select Agent or Toxin Form	Modified
Request for Exclusions Form	Unchanged
Non-substantive change request_2016-12-01.docx Justification for No Material/Nonsubstantive Change	2016-12-01
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
217521	Administrative Review Form	Unchanged
217520	Notification of Potential Theft, Loss, or Release Form	Modified
217519	Records Form	Unchanged
217518	Request to Transfer Select Agents and Toxins Form	Modified
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 Form	Modified
217507	Request for Exemption Form	Unchanged
217505	Report of Identification of a Select Agent or Toxin Form	Modified
217504	Request for Exclusions Form	Unchanged

ICR Details

OMB Control No: 0920-0576	ICR Reference No: 201609-0920-014
Status: Historical Active	Previous ICR Reference No: 201507-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No: 16BEV
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: 12/05/2016
	Date Received in OIRA: 12/05/2016
Terms of Clearance:

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

---

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 change is to add drop-down lists to the pdf-fillable format of several forms.

---

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

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

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

---

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

IC Title	Form No.	Form Name
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	none	Request to Transfer Select Agents and Toxins
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
Notification of Potential Theft, Loss, or Release	none	Notification of Theft, Loss, or Release
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
Training	none	Training
Records	none	Records
Administrative Review	none	Administrative Review

---

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	5,322	0	0	0	0
Annual Time Burden (Hours)	8,528	8,528	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:

---

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

---

Common Form ICR:  No

---

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: 12/05/2016

---