Select Agent Distribution Activity: Request for Select Agent

Forms and Documents

Document Name	Status
Select Agent Distribution Activity Application Form	Modified
Sup_StaA_.doc Supporting Statement A	2014-04-22
Att A 1 public law 107-188.pdf Supplementary Document	2014-04-22
Attachment_A-_Section_361_PHS_Act[1].docm Supplementary Document	2014-04-22
Attach B 60 day.pdf Supplementary Document	2014-04-22
Sup_Sta_B_0920-0591.docx Supporting Statement B	2014-04-22

IC Document Collections

IC ID	Document Title	Status
7054	Select Agent Distribution Activity Application Form	Modified

ICR Details

OMB Control No: 0920-0591	ICR Reference No: 201404-0920-008
Status: Historical Active	Previous ICR Reference No: 201106-0920-010
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Select Agent Distribution Activity: Request for Select Agent
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/28/2014
	Date Received in OIRA: 04/24/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	36 Months From Approved	07/31/2014
Responses	900	0	900
Time Burden (Hours)	450	0	450
Cost Burden (Dollars)	0	0	47,700

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Abstract: CDC is requesting a 3-year extension of data collection entitled 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
   US Code: 42 USC 361 Name of Law: Public Health Safety Act
  

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:
	79 FR 10525	02/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 20206	04/11/2014
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 Application	none	SADA 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	900	0	0	0	0
Annual Time Burden (Hours)	450	450	0	0	0	0
Annual Cost Burden (Dollars)	0	47,700	0	-47,700	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: $23,850

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]? 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: 04/24/2014

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