10 CFR 35, Medical Use of Byproduct Material

ICR 201402-3150-001

OMB: 3150-0010

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2014-02-10
Supplementary Document
2014-07-24
Supporting Statement A
2014-07-24
IC Document Collections
IC ID
Document
Title
Status
42721
Modified
ICR Details
3150-0010 201402-3150-001
Historical Active 201011-3150-006
NRC
10 CFR 35, Medical Use of Byproduct Material
Extension without change of a currently approved collection   No
Regular
Approved with change 07/24/2014
Retrieve Notice of Action (NOA) 02/12/2014
The agency is reminded to consult on the ICR package prior to submission for review per 5 CFR 1320.8(d)(1).
  Inventory as of this Action Requested Previously Approved
07/31/2017 36 Months From Approved 07/31/2014
240,145 0 246,581
1,066,031 0 1,173,785
109,726 0 74,597

Part 35 of Title 10 of the Code of Federal Regulations (10 CFR), "Medical Use of Byproduct Material," 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. Part 35 contains mandatory requirements that apply to NRC licensees authorized to administer byproduct material or radiation therefrom to humans for medical use. These requirements also provide voluntary provisions for specialty boards to apply to have their certification processes recognized by the NRC so that their board certified individuals can use the certifications as proof of training and experience.

PL: Pub.L. 83 - 703 1-311 Name of Law: Atomic Energy Act
  
None

Not associated with rulemaking

  78 FR 67203 11/08/2013
79 FR 6933 02/05/2014
No

1
IC Title Form No. Form Name
10 CFR 35, Medical Use of Byproduct Material

  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 240,145 246,581 0 0 -6,436 0
Annual Time Burden (Hours) 1,066,031 1,173,785 0 0 -107,754 0
Annual Cost Burden (Dollars) 109,726 74,597 0 0 35,129 0
No
No
The overall burden has decreased by 107,754 hours from 1,173,785 hours (NRC Licensees 156,538 hrs + Agreement States 1,017,247 hrs) to 1,066,031 hours (NRC Licensees 144,203 hrs + Agreement States 921,826 hrs + specialty certifying entities 2 hrs), the number of responses decreased by 6,439 responses from 246,581 responses (32,880 NRC Licensees + 213,701 Agreement States) to 240,145 ((NRC: 31,431 + 1,035 recordkeepers = 32,466) + (Agreement States: 201,053 + 6,624 recordkeepers + 2 specialty certification entity = 207,679)). The burden calculations were affected by (1) a reduction in the number of NRC medical use licensees and Agreement State licensees, (2) a shift in the distribution of medical uses by the NRC licensees that may not reflect the same distribution of Agreement State medical use licensees, (3) use of the WBL data base which provides more detailed information for some medical uses, and (4) consolidation of multiple NRC licenses into a single medical use license the WBL data base. The requirements for the reporting burden notifications have been moved from the NRC and Agreement States reporting tables (Table 1 and Table 4) to the third-party disclosure tables (Table 3 and Table 6). NRC calculates the burden for Agreement State medical use licensees based on the ratio of NRC licensees to Agreement State licensees, and distribution of the types of medical uses authorized by NRC medical use licensees. While the total number of NRC and Agreement State licensees decreased from 2010 to 2013, the decrease in the number of Agreement State medical use licensees may not have been proportional to the decrease in the total number of NRC medical use licensees from 1,148 to 1,035. NRC estimates the number of NRC and Agreement State medical use licensees decreased from 8,610 to 7,659. Further, the types of medical uses retained by NRC licensees may not reflect the Agreement State licensees' distribution of these medical uses. In addition, there was a decrease in the overall hourly fee rate from $274/hr to $272/hr.

$81,600
No
No
No
No
No
Uncollected
Donna Howe 301 415-7848

  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.
02/12/2014


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