Viruses, Serums, Toxins, and Analogous Products; Records and Reports

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form APHIS 2081 Adverse Event Report Follow-up Information	Form	Modified	Available
Form APHIS 2080 Adverse Event Report	Form	Modified	Repair queued
Form APHIS 2081 Adverse Event Report Follow-up Information	Form	New	Available
Form APHIS 2080 Adverse Event Report	Form	New	Available
Form APHIS 2081 Adverse Event Report Follow-up Information	Form	New	Repair queued
Form APHIS 2080 Adverse Event Report	Form	New	Repair queued
2015 ss Adverse Event.docx	Supporting Statement A	Uploaded 2015-09-11	Available
2015 79.xls	Supplementary Document	Uploaded 2015-09-08	Available
2015 71 split.xls	Supplementary Document	Uploaded 2015-09-08	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
2387	Business	Form	Modified	Adverse Event Report Follow-up Information
2387	Business	Form	Modified	Adverse Event Report
218105	State	Form	New	Adverse Event Report Follow-up Information
218105	State	Form	New	Adverse Event Report
218104	Individuals	Form	New	Adverse Event Report Follow-up Information
218104	Individuals	Form	New	Adverse Event Report

ICR Details

OMB Control No: 0579-0209	ICR Reference No: 201504-0579-002
Status: Historical Inactive	Previous ICR Reference No: 200210-0579-003
Agency/Subagency: USDA/APHIS	Agency Tracking No:
Title: Viruses, Serums, Toxins, and Analogous Products; Records and Reports
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 03/25/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/14/2015
Terms of Clearance: OMB is withholding approval at this time. Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In addition, the agency must enter the correct burden estimates.

table that charts list comparision

	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: APHIS is amending the Virus-Serum-Toxin Act regulations for records and reports. APHIS will be requiring veterinary biologics licensees and permittees to record and submit reports to the Animal and Plant Health Inspection Service concerning adverse events associated with the use of biological products that they produce or distribute.

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

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0579-AE11	Proposed rulemaking	80 FR 53475	09/04/2015

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 53475	09/04/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Business	APHIS 2081, APHIS 2080	Adverse Event Report ,   Adverse Event Report Follow-up Information
Individuals	APHIS 2080, APHIS 2081	Adverse Event Report ,   Adverse Event Report Follow-up Information
State	APHIS 2080, APHIS 2081	Adverse Event Report ,   Adverse Event Report Follow-up Information

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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 reinstatement of a proposed rule; withdrawal and reproposal resulting in in 5, 280 burden hours.

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Annual Cost to Federal Government: $436,164

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: 09/14/2015

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