In accordance with 5 CFR 1320, the information collection is approved for three years.
Inventory as of this Action
Requested
Previously Approved
01/31/2015
36 Months From Approved
01/31/2012
87
0
85
13
0
12
0
0
0
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.
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.
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:
(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;
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.
Form NRC Form 483 Registration Certificate-In Vitro Testing with ByProduct Material Under General License
Final Form 483 SS Rev 121611.docx
Registration Certificate-In Vitro Testing with ByProduct Material Under General License