10 CFR 35, Medical Use of Byproduct Material

ICR 202006-3150-004

OMB: 3150-0010

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-06-30
Supplementary Document
2020-06-30
IC Document Collections
IC ID
Document
Title
Status
42721
Modified
ICR Details
3150-0010 202006-3150-004
Received in OIRA 201807-3150-002
NRC
10 CFR 35, Medical Use of Byproduct Material
Extension without change of a currently approved collection   No
Regular 07/08/2020
  Requested Previously Approved
36 Months From Approved 01/31/2021
299,266 284,249
1,166,694 1,104,583
122,066 110,480

10 CFR part 35, ‘‘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 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

  85 FR 11125 02/26/2020
85 FR 41070 07/08/2020
No

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

  Total Request 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 299,266 284,249 0 0 15,017 0
Annual Time Burden (Hours) 1,166,694 1,104,583 0 0 62,111 0
Annual Cost Burden (Dollars) 122,066 110,480 0 0 11,586 0
No
No
The burden for Part 35 increased from 1,104,583 hours to 1,166,694 hours, an increase of 62,111 hours. 58,244 hours of this increase is an increase in recordkeeping burden. The number of estimated respondents decreased slightly from 7,121 to 7,021. Data on the number of NRC licensees is extracted from the Web-Based Licensing system (WBL). NRC staff queried the database to determine the total number of NRC licensees as well as the number of licensees holding licenses authorizing materials used for specific medical purposes. The data were used to estimate respondents on the NRC licensee burden tables. NRC staff anticipates that the number of licensees will remain stable over the course of the clearance period. The NRC does not have data on the number of licensee’s subject to Part 35 who operate in Agreement States; therefore, the number of these licensees must be estimated. Annually, the Agreement States provide the NRC with an estimate of the total number of radioactive materials licensees within their states. In the last survey, 7.2 times more licensees in Agreement States as there were in states regulated by the NRC. This is an increase from the previous renewal, in which the ratio was 6.4. Since the last renewal, Wyoming and Vermont became Agreement States (AS). There are now 39 AS compared to 37 in the last renewal. In states regulated by the NRC, data is available on both the number of licensees and the particular applications of the material for which they are licensed. As a result, the NRC can determine the specific requirements in the CFR and the specific information collections applicable to each of the licensees regulated by the agency. For AS, the NRC staff only knows the total number of licensees in each state - the specific applications of the material for they are licensed is unknown. As a result of the estimation method, the number of licensees in AS may show some variability over time, particularly when states newly join the AS program. Furthermore, when an NRC regulated state becomes an AS, the majority of them no longer report their licensing data in the NRC WBL system. Instead, NRC staff must estimate, the number of licensees in AS that are subject to each information collection requirement. Further, the method used to estimate respondents assumes that all types of licensees and applications of materials are equally distributed across states, and that the distribution is similar in Agreement States when compared to non-Agreement states. The NRC staff believes that the current method strikes the best balance between accuracy in estimation and burden upon licensees. The current estimation method is the most accurate available without burdening the AS with an annual, comprehensive survey of the specific types of licensees in each Agreement State. In addition, there was an increase in the overall hourly fee rate from $265/hr. to $278/hr.

$83,400
No
    No
    No
No
No
No
No
Said Daibes-Figueroa 301 415-6865

  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.
07/08/2020


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