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 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.
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
NRC Form 483- Final Supporting Statement 2008.doc
Registration Certificate-In Vitro Testing with ByProduct Material Under General License