Biennial Publication of the Select Agent and Toxin List; Regulatory Amendments

Forms and Documents

Document Name	Status
Form APHIS/CDC Form 1 Biennial Publication of the Select Agent and Toxin List; Regulatory Amendments Form and Instruction	New
Form APHIS/CDC Form 4 Biennial Publication of the Select Agent and Toxin List; Regulatory Amendments Form and Instruction	New
2011 APHIS 71.xls Supplementary Document	2011-10-03
SS.doc Supporting Statement A	2011-10-03
2011 APHIS 79.xls Supplementary Document	2011-09-27

IC Document Collections

IC ID	Document Title	Status
199488	Biennial Publication of the Select Agent and Toxin List; Regulatory Amendments Form and Instruction	New
199486	Biennial Publication of the Select Agent and Toxin List; Regulatory Amendments Form and Instruction	New

ICR Details

OMB Control No: 0579-0389	ICR Reference No: 201109-0579-011
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: USDA/APHIS	Agency Tracking No:
Title: Biennial Publication of the Select Agent and Toxin List; Regulatory Amendments
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 02/15/2012
	Date Received in OIRA: 10/03/2011
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. When submitting a request for approval at the Final rule stage, the agency should request a revision of 0579-0213 and provide a thorough explanation of the program changes and adjustments to the collection that will occur as a result of the rulemaking. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this collection is to ensure that persons who possess, use, or transfer select agents and toxins register those agents with either APHIS or CDC and meet all security and safety requirements

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Authorizing Statute(s): US Code: 42 USC 262 (a)(2) Name of Law: Regulation of biological products
   EO: EO 13546 Name/Subject of EO: Optimizing the Security of Biological Select Agents and Toxins in the United States
   PL: Pub.L. 107 - 188 201 and 212 (a)(2) Name of Law: Public Health Security and Bioterrorism Preparedness and Response Act of 2002
   US Code: 7 USC 8401 (a)(2) Name of Law: Regulation of certain biological agents and toxins
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0579-AD09	Proposed rulemaking	76 FR 191	10/03/2011

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Biennial Publication of the Select Agent and Toxin List; Regulatory Amendments	APHIS/CDC Form 3, APHIS/CDC Form 4, APHIS/CDC Form 2, APHIS/CDC Form 1	Report of the Identification of a Select Agent or Toxin in a Clinical or Diagnostic Laboratory ,   Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins ,   Report of Transfer of Select Agents and Toxins ,   Report of Theft, Loss, or Release of Select Agents and Toxins
Biennial Publication of the Select Agent and Toxin List; Regulatory Amendments	APHIS/CDC Form 3, APHIS/CDC Form 4, APHIS/CDC Form 2, APHIS/CDC Form 1	Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins ,   Re[prt pf Transfer of Select Agents and Toxins ,   Report of Theft, Loss, or Release of Select Agents and Toxins ,   Report of the Identification of a Select Agent or Toxin in a Clinical or Diagnostic Laboratory

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection resulting in a program change of 10,947 burden hours.

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Annual Cost to Federal Government: $655,988

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: 10/03/2011

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