In accordance with 5 CFR 1320, the information collection is approved for three years.
Inventory as of this Action
Requested
Previously Approved
02/28/2018
36 Months From Approved
02/28/2015
8
0
87
1
0
13
0
0
0
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.
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.
$753
No
No
No
No
No
Uncollected
Justin Vazquez 610 337-5257
No
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 OMB Supporting Statement for Form 483.docx
2014-25252.pdf
Registration Certificate-In Vitro Testing with ByProduct Material Under General License