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
NRC Form 483- Final Supporting Statement 2008.doc Supporting Statement A	2008-10-16

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: 200810-3150-002
Status: Historical Active	Previous ICR Reference No: 200509-3150-006
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/15/2009
	Date Received in OIRA: 10/16/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2012	36 Months From Approved	01/31/2009
Responses	85	0	364
Time Burden (Hours)	12	0	42
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:
	73 FR 39339	07/09/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 61173	10/15/2008
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	85	364	0	-279	0	0
Annual Time Burden (Hours)	12	42	0	-30	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The overall hourly burden estimate for NRC Form 483 is expected to decrease during the next 3 years. The expected decrease in estimated hourly burden is primarily due to results obtained from a NRC internal review and study based on available NRC Form 483 submissions to the agency and a sample of annual NRC Form 483 returns provided by 6 Agreement States. The internal review/study and samples showed that the estimated number of registration certificates that NRC is expecting to receive annually will drop from 104 to 15 and the annual registration certificates received by the Agreement States will drop from 260 to 70. Therefore, the total hourly burden has decreased by 29.6 hours, from 42 hours submitted in the previous renewal package to OMB in 2005 to 12.4 hours. The total cost for this package has decreased by $5,323 from $8,274 in 2005 to $2,951 in 2008. However, the estimated burden cost since the last OMB approval of this package has increased from $197 to $238/hour, due to an increase in the hourly fee rate.

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Annual Cost to Federal Government: $1,190

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 10/16/2008

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