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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form NRC Form 483 Registration Certificate-In Vitro Testing with ByProduct Material Under General License	Form	Modified	Available
Final Form 483 SS Rev 121611.docx	Supporting Statement A	Uploaded 2011-12-22	Available

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 3150-0038	ICR Reference No: 201112-3150-001
Status: Historical Active	Previous ICR Reference No: 200810-3150-002
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: 01/22/2012
	Date Received in OIRA: 12/22/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2015	36 Months From Approved	01/31/2012
Responses	87	0	85
Time Burden (Hours)	13	0	12
Cost Burden (Dollars)	0	0	0

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Abstract: Section 31.11 of 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 tests not involving the internal or external administration of the byproduct material or the radiation there from 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:
	76 FR 52698	08/23/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 77560	12/13/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

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

table that charts list 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	87	85	0	0	2	0
Annual Time Burden (Hours)	13	12	0	0	1	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 estimate has increased slightly by 0.44 burden hours from 12.43 burden hours to 13 burden hours. The NRC Form 483 is expected to remain steady during the next 3 years. The total hourly burden has not significantly changed from the previously reported to the OMB in 2008. The number of registration certificates submitted by NRC licensees has decreased by 8 from 15 certificates to 7 certificates, a reduction of approximately one hour (8 certificates x 8 minutes x 1 hour/60 minutes = 1.07 hours). However, the number of registration certificates submitted by Agreement State licensees has increased by 10 from 70 certificates to 80, an increase of 1.3 hours (10 certificates x 8 minutes x 1 hour/60 minutes = 1.33 hours). In addition, the recordkeeping burden has increased by 0.04 from 1.13 to 1.17 hours. As a result, the overall change in burden is an increase of 0.3 hours (1.33 hours + 0.04 hours - 1.07hours). All estimates are based on the most recent three years of data. Due to additional states becoming Agreement States, there are fewer NRC licensees and more Agreement State licensees. The NRC continues to receive approximately the same number of registration certificates per year; however, more are being submitted by Agreement State licensees and fewer are being submitted by NRC licensees than in the past. The estimated burden cost since the last OMB approval of this package has increased by 35 from $238 to $273/hour, due to an increase in the hourly fee rate.

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Annual Cost to Federal Government: $628

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: 12/22/2011

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