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

Forms and Documents

Document Name	Status
Supporting Statement B 09200576.doc Supporting Statement B	2011-10-14
Attachment 4 SORN2011.pdf Supplementary Document	2011-10-14
Attachment 15 Summary of Changes.doc Supplementary Document	2011-10-14
Supporting Statement A 101311.doc Supporting Statement A	2011-10-14

IC Document Collections

IC ID	Document Title	Status
7036	Application for Registration Instruction	Modified
186031	Inspections Instruction	Modified
186030	Amendment to Registration Application Instruction	Modified
186029	Ensure secure recordkeeping system Instruction	Removed
186028	Adminstrative Review Instruction	Modified
186027	Documentation of Training Instruction	Removed
186026	Request for Exclusion/Restricted Instruction	Modified
186025	Request for Expedited Review Instruction	Modified
186024	Request for Exemption Instruction	Modified
186023	Report of Identification of Select Agent or Toxin Instruction	Modified
186022	Notification of Theft, Loss or Release Instruction	Modified
186021	Request to Transer Select Agent or Toxin Instruction	Modified

ICR Details

OMB Control No: 0920-0576	ICR Reference No: 201110-0920-007
Status: Historical Active	Previous ICR Reference No: 200901-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No:
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: 10/19/2011
	Date Received in OIRA: 10/18/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2014	36 Months From Approved	12/31/2011
Responses	6,370	0	6,167
Time Burden (Hours)	8,878	0	9,657
Cost Burden (Dollars)	0	0	0

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Abstract: CDC is requesting continued OMB approval to collect information through the use of five separate forms. These forms are: 1) Application for Registration, 2) Request to Transfer Select Agent or Toxin, 3) Report of Theft, Loss, or Release of Select Agent and Toxin, 4) Report of Identification of Select Agent or Toxin, and 5) Request for Exemption. The Application for Registration (42 CFR 73.7(d)) will be used by entities to register with CDC. The Application for Registration requests facility information; a list of select agents or toxins in use, possession, or for transfer by the entity; characterization of the select agent or toxin; and laboratory information. The Request to Transfer Select Agent or Toxin form (42 CFR 73.16) will be used by entities requesting transfer of a select agent or toxin to their facility. The Report of Theft, Loss, or Release of Select Agent and Toxin form (42 CFR 73.19(a)(b)) must be completed by entities whenever there is theft, loss, or release of a select agent or toxin. The Report of Identification of Select Agent or Toxin form 42 CFR 73.5(a)(b) and 73.6(a)(b)) will be used by clinical and diagnostic laboratories to notify CDC that select agents or toxins identified as the result of diagnostic or proficiency testing have been disposed of in a proper manner. In addition, the form will be used by Federal law enforcement agencies to report the seizure and final disposition of select agents and toxins. The Request for Exemption form (42 CFR 73.5 (d)(e) and 73.6 (d)(e)) will be used by entities that are using an investigational product that are, bear, or contain select agents or toxins or in cases of public health emergency.

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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:
0920-AA09	Final or interim final rulemaking	70 FR 13294	03/18/2005

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 29754	05/23/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 62412	10/07/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Notification of Theft, Loss or Release
Report of Identification of Select Agent or Toxin
Request for Exemption
Request for Expedited Review
Request for Exclusion/Restricted
Application for Registration
Request to Transer Select Agent or Toxin
Adminstrative Review
Amendment to Registration Application
Inspections
Documentation of Training
Ensure secure recordkeeping system

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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	6,370	6,167	0	203	0	0
Annual Time Burden (Hours)	8,878	9,657	0	-779	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: Changing Forms

Short Statement: Revisions to the data collection instruments have been structured to reduce the previous annualized burden hours of 9,656.5 hours to 8,878 hours. Removing similar questions, enhanced clarification of the transfer process, improving surveillance methods for monitoring the reports of select agents and toxins identified by registered entities and improving process flow will result in a decrease of 778.5 hours burden hours upon the regulated community.

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Annual Cost to Federal Government: $15,573,024

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? 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: 10/18/2011

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