Select Agent Distribution Activity; Request for Select Agent

Forms and Documents

Document Name	Status
Form Attachment D Select Agent Distribution Activity; Request for Select Agent Form and Instruction	Modified
Attachment E SADAFlowDiagram.pdf Supplementary Document	2007-11-27
Attachment C 0920-0591 60d FRN.pdf Supplementary Document	2007-11-27
Attachment B.doc Supplementary Document	2007-11-27
Attachment A 42 USC 264.mht Supplementary Document	2007-11-27
List of Attachments.doc Supplementary Document	2007-11-27
0920-0591 Supporting Statement (2).doc Supporting Statement A	2007-11-27

IC Document Collections

IC ID	Document Title	Status
7054	Select Agent Distribution Activity; Request for Select Agent Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0591	ICR Reference No: 200712-0920-001
Status: Historical Active	Previous ICR Reference No: 200403-0920-010
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Select Agent Distribution Activity; Request for Select Agent
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/21/2008
	Date Received in OIRA: 12/10/2007
Terms of Clearance: CDC is reminded to maintain current approvals for collection activities the Agency reasonably believes will continue.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved
Responses	900	0	0
Time Burden (Hours)	450	0	0
Cost Burden (Dollars)	47,700	0	0

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Abstract: CDC is requesting OMB approval to reinstate without change, OMB Control No. 0920-0591: Select Agent Distribution Activity: Request for Select Agent. The purpose of this project is to provide a systematic and consistent mechanism to review requests that come to CDC for Select Agents. The Select Agent Distribution Activity (SADA) will use the information to evaluate the appropriateness of requests for Select Agents.

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Authorizing Statute(s): PL: Pub.L. 107 - 188 319D 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:
	72 FR 55774	10/01/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 66176	11/27/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Select Agent Distribution Activity; Request for Select Agent	Attachment D	Select Agent Distribution Activity Application

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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	900	0	0	900	0	0
Annual Time Burden (Hours)	450	0	0	450	0	0
Annual Cost Burden (Dollars)	47,700	0	0	47,700	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: No

Burden Reduction Due to:

Short Statement: This is a reinstatement of a previously approved clearance.

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Annual Cost to Federal Government: $53,354

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: 12/07/2007

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