In accordance
with 5 CFR 1320, the collection is approved for 3 years.
Inventory as of this Action
Requested
Previously Approved
02/28/2014
36 Months From Approved
02/28/2011
246,581
0
261,394
1,173,785
0
1,025,958
74,597
0
79,079
10 CFR Part 35 contains NRC's
requirements and provisions for the medical use of byproduct
material and for issuance of specific licenses authorizing the
medical use of this material. These requirements and provisions
provide for the radiation safety of workers, the general public,
patients, and human research subjects. 10 CFR Part 35 contains
mandatory requirements that apply to NRC licensees authorized to
adminster byproduct material or radiation there from to humans for
medical use. The information in the required reports and records is
used by the NRC to ensure that public health and safety is
protected, and that the possession and use of byproduct material is
in compliance with the license and regulatory
requirements.
Although the overall burden has
increased by 147,827 hours from 1,025,958 (259,513 NRC Licensees +
766,445 Agreement States) to 1,173,785 hours (NRC Licensees 156,536
hrs + Agreement States 1,017,245 hrs), the number of responses
decreased by 14,813 responses from 261,394 responses (55,629 NRC
Licensees + 205,765 Agreement States) to 246,581 responses (32,880
NRC Licensees + 213,701 Agreement States). The burden calculations
were affected by (1) a correction for medical event reporting based
on the actual number of medical events reported per year, (2) an
increase in the number of Agreement States, and (3) a shift in the
distribution of medical uses by the remaining NRC licensees.
Approximately 38 medical events are reported each year by both NRC
and Agreement State licensees instead of the previously estimated
164. This correction resulted in a burden reduction of 995 hours
(327 hours for NRC licensees and 668 hours for the Agreement State
licensees). Three states (Pennsylvania, Virginia and New Jersey)
entered into agreements with NRC since 2007. NRC now has fewer
licensees then in 2007 and the Agreement States have more. This
accounts for a marked decrease in burden for NRC licensees and a
marked increased shift in burden to the Agreement States. NRC
calculates the burden for Agreement State medical use licensees
based on the ratio of NRC licensees to Agreement State licensees,
ratio of remaining medical use licensees to NRC licensees, and
distribution of the types of medical uses retained by NRC medical
licensees. The result is an estimated decrease in the total number
of NRC and Agreement State medical use licensees from 8,751 to
8,610 and a shift in the types of medical uses retained by NRC
licensees to those medical uses with larger calculated record
keeping burdens. For example, NRC lost approximately one third of
its medical use licensees but approximately one half of its
brachytherapy, gamma sterotactic radiosurgery and remote
afterloader use licensees which because of lower patient loads have
fewer record keeping burdens. At this time, NRC cannot determine
whether the resulting calculations for the Agreement State licensee
are less or more accurate.
$77,100
No
No
No
No
No
Uncollected
Gwendolyn Davis
3014158165
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.
Final 10CFR35 SS 110510.docx
10 CFR 35, Medical Use of Byproduct Material