NRC Form 483, Registration Certificate In-Vitro Testing with ByProduct Material Under General License, 10 CFR 31.11

Forms and Documents

Document Name	Status
Form NRC Form 483 Registration Certificate-In Vitro Testing with ByProduct Material Under General License Form	Modified
Final OMB Supporting Statement for Form 483.docx Supporting Statement A	2014-11-04
2014-25252.pdf Supplementary Document	2014-11-03

IC Document Collections

IC ID	Document Title	Status
33272	Registration Certificate-In Vitro Testing with ByProduct Material Under General License Form	Modified

ICR Details

OMB Control No: 3150-0038	ICR Reference No: 201410-3150-011
Status: Historical Active	Previous ICR Reference No: 201112-3150-001
Agency/Subagency: NRC	Agency Tracking No:
Title: NRC Form 483, Registration Certificate In-Vitro Testing with ByProduct Material Under General License, 10 CFR 31.11
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: 02/12/2015
	Date Received in OIRA: 11/06/2014
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved	02/28/2015
Responses	8	0	87
Time Burden (Hours)	1	0	13
Cost Burden (Dollars)	0	0	0

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Abstract: Section 31.11 of Title 10 of the Code of Federal Regulations (10 CFR), establishes a general license authorizing any physician, clinical laboratory, veterinarian in the practice of veterinary medicine, or hospital to possess certain small quantities of byproduct material for in vitro clinical or laboratory test not involving the internal or external administration of the byproduct material or the radiation therefrom to human beings or animals. Possession of byproduct material under 10 CFR 31.11 is not authorized until the physician, clinical laboratory, veterinarian in the practice of veterinary medicine, or hospital has filed NRC Form 483 and received from the Commission a validated copy of NRC Form 483 with a registration number.

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Authorizing Statute(s): PL: Pub.L. 83 - 703 1-311 Name of Law: Atomic Energy 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 42375	07/21/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 63441	10/23/2014
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
Registration Certificate-In Vitro Testing with ByProduct Material Under General License	NRC Form 483	Registration Certificate In-Vitro Testing with Byproduct Material Under General License

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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	8	87	0	0	-79	0
Annual Time Burden (Hours)	1	13	0	0	-12	0
Annual Cost Burden (Dollars)	0	0	0	0	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: The overall hourly burden has decreased by approximately 11.69 burden hours (from 12.87 burden hours to 1.18 burden hours), due to a correction in the method used to estimate burden. In the previous renewal, Agreement State burden was included. In the current submission, Agreement State burden has been removed because the Agreement States are not required by the NRC to implement 10 CFR 31.11 for compatibility purposes. The reduction in burden due to the removal of the Agreement State burden in the estimates. The number of registration certificates submitted by NRC licensees has increased by 1 from 7 certificates to 8 certificates, an increase of approximately 8 minutes (1 certificate x 8 minutes x 1 hour/60 minutes = 0.13 hours). The number of registration certificates submitted by Agreement State licensees is no longer counted in this estimate, therefore the number in this estimate decreased from 80 certificates to zero, a decrease of 10.7 hours (80 certificates x 8 minutes x 1 hour/60 minutes = 10.7 hours). In addition, the recordkeeping burden has decreased by 1.06 hours, from 1.17 hours to 0.11 hour. As a result, the overall change in burden is a decrease of approximately 11.6 hours (-10.7 hours - 1.06 hours + 0.13 hours = -11.63 hours). The estimated hourly burden cost for this package is $279/hour.

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Annual Cost to Federal Government: $753

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: 11/06/2014

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