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

Forms and Documents

Document Name	Status
Form 0920-0576 Application for Registration Form and Instruction	Modified
Form 0920-0576 Request for Exemption/Exclusion Form and Instruction	New
Form 0920-0576 Report of Identification of Select Agent or Toxin Form and Instruction	New
Form 0920-0576 Notification of Theft, Loss or Release Form and Instruction	New
Form 0920-0576 Request to Transer Select Agent or Toxin Form and Instruction	New
Attachment 2A-Response to Sheets on Proposed Data Collections.htm Supplementary Document	2008-07-08
Attachment 2A- comment from Sheets.ProposedDataCollection.doc Supplementary Document	2008-07-08
Attachment 2A-Upham comment and response to Federal Register Notice 0920-0576.htm Supplementary Document	2008-07-08
Attachment 2A-Response to Demmin comments 16May08.pdf - Adobe Acrobat Standard (UNCLASSIFIED).txt Supplementary Document	2008-07-08
Attachment 2A-CDC form comments.Demmin. 16May08.pdf Supplementary Document	2008-07-08
Attachment 2A-Response to Cook comments on OMB Control No. 0920-0576-1.htm Supplementary Document	2008-07-08
Attachment 2A-WU Comments from Cook.pdf Supplementary Document	2008-07-08
Attachment 2-60Day FRN.pdf Supplementary Document	2008-07-07
Attachment 5-Revisions to APHIS-CDC Forms.doc Supplementary Document	2008-07-07
Attachment 3-APHIS-CDC Form 5.pdf Supplementary Document	2008-07-07
Attachment 3-APHIS-CDC Form 4.pdf Supplementary Document	2008-07-07
Attachment 3-APHIS-CDC Form 3.pdf Supplementary Document	2008-07-07
Attachment 3-APHIS-CDC Form 2.pdf Supplementary Document	2008-07-07
Attachment 3-APHIS-CDC Form 1.pdf Supplementary Document	2008-07-07
CDC Select Agent Program Supporting Statement 7-16 08.doc Supporting Statement A	2008-07-16

IC Document Collections

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

ICR Details

OMB Control No: 0920-0576	ICR Reference No: 200808-0920-002
Status: Historical Active	Previous ICR Reference No: 200601-0920-003
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 with change	Conclusion Date: 12/07/2008
	Date Received in OIRA: 08/06/2008
Terms of Clearance: The text indicates the estimated cost to the government as: $13,376,078.00. The burden summary must reflect that estimate. Costs to respondent are estimated at $295,585.47. This amount should be noted in the burden summary.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	36 Months From Approved	03/31/2009
Responses	6,167	0	5,324
Time Burden (Hours)	9,657	0	7,785
Cost Burden (Dollars)	0	0	0

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Abstract: CDC is requesting three-year approval to continue data collection and reporting on 5 forms as required under the Final Rule 42 CFR Part 73. The data collection forms include Registration Application for entities, Requests to Transfer, Report theft, loss or Identification of Select Agents or Toxins, and Request for Exemption. Additional data collection is done through reports and reviews.

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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:
	73 FR 14252	03/18/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 39702	07/10/2008
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Application for Registration	0920-0576	Application for Registration
Request to Transer Select Agent or Toxin	0920-0576	Request to Transfer Select Agent or Toxin
Notification of Theft, Loss or Release	0920-0576	Notification of Theft, Loss, or Release
Report of Identification of Select Agent or Toxin	0920-0576	Report of Identification of Select Agent or Toxin
Request for Exemption/Exclusion	0920-0576	Request for Exemption/Exclusion
Request for Expedited Review
Documentation of Self-Inspection
Documentation of Training
Adminstrative Review
Ensure secure recordkeeping system
Amendment to Registration Application
Inspections

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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	6,167	5,324	0	0	843	0
Annual Time Burden (Hours)	9,657	7,785	0	0	1,872	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:

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Annual Cost to Federal Government: $13,276,078

Does this IC contain surveys, censuses, or employ statistical methods? No

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 08/06/2008

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