Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling

Forms and Documents

Document Name	Status
Form APHIS 2015 Business Form	New
2016 ss 2.docx Supporting Statement A	2016-10-31
2015 71.xls Supplementary Document	2016-10-13
2016 79 new.xls Supplementary Document	2016-09-26

IC Document Collections

IC ID	Document Title	Status
223701	Foreign Federal Government	New
223700	Business Form	New

ICR Details

OMB Control No: 0579-0460	ICR Reference No: 201609-0579-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: USDA/APHIS	Agency Tracking No:
Title: Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling
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: Approved without change	Conclusion Date: 02/06/2017
	Date Received in OIRA: 10/31/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	36 Months From Approved
Responses	1,700	0	0
Time Burden (Hours)	180	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this information collection is to help APHIS ensure that biological products used in the United States are pure, safe, potent, and effective.

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Authorizing Statute(s): US Code: 21 USC 151-159 Name of Law: Virus-Serum-Toxin Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0579-AD19	Final or interim final rulemaking	81 FR 59427	08/30/2016

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 59725	10/02/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 59427	08/30/2016
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
Foreign Federal Government
Business	APHIS 2015	Transmittal of Labels and Circulars or Outlines

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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	1,700	0	0	1,700	0	0
Annual Time Burden (Hours)	180	0	0	180	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: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This is a new information collection resulting in 180 total burden hours.

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Annual Cost to Federal Government: $4,426

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: 10/31/2016

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