10 CFR 35, Medical Use of Byproduct Material

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
NRC-2017-0013-0003 30-day FRN (1).pdf	Supplementary Document	Uploaded 2017-06-01	Available
Copy of 12-21-DBH-Copy of Copy of Copy of Copy of Part 35 tables for final Dec 8 2016 cell AND cost fixed RENEWALshirley final(1).xlsx	Supplementary Document	Uploaded 2017-06-01	Available
Part 35 Final Supporting Statement from Draft PDF to word March 21 2017.docx	Supporting Statement A	Uploaded 2017-06-01	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
42721	10 CFR 35, Medical Use of Byproduct Material		Modified

ICR Details

OMB Control No: 3150-0010	ICR Reference No: 201706-3150-001
Status: Historical Active	Previous ICR Reference No: 201402-3150-001
Agency/Subagency: NRC	Agency Tracking No:
Title: 10 CFR 35, Medical Use of Byproduct Material
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/28/2017
	Date Received in OIRA: 06/01/2017
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2020	36 Months From Approved	08/31/2017
Responses	276,359	0	240,145
Time Burden (Hours)	1,073,224	0	1,066,031
Cost Burden (Dollars)	106,974	0	109,726

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Abstract: 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 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.

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Authorizing Statute(s): PL: Pub.L. 83 - 703 1-311 Name of Law: Atomic Energy Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 8959	02/01/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 24750	05/30/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

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

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ICR Summary of Burden

table that charts list of burden

	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	276,359	240,145	0	0	36,214	0
Annual Time Burden (Hours)	1,073,224	1,066,031	0	0	7,193	0
Annual Cost Burden (Dollars)	106,974	109,726	0	0	-2,752	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The overall burden has increased by 7,193 hours from 1,066,031 hours (NRC Licensees 144,203 hrs. + Agreement States 921,826 hrs. + specialty certifying entities 2 hrs.) to 1,073,224 hours (NRC Licensees 145,195 hrs. + Agreement States 928,027 hrs. + specialty certifying entities 2 hrs.), the number of responses increased by 36,214 responses from 240,145 (32,466 NRC + 207,677 Agreement States + 2 specialty certification entities) to: 276,359 ((NRC: 36,313 + 962 record keepers = 37,275) + (Agreement States: 232,925 + 6,157 record keepers + 2 specialty certification entity = 239,084)). 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 and the use of materials within NRC license groups 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, but also consolidated multiple NRC licenses into a single medical use license in the data base and (4) NRC observed a number of shifts that reduced the burdens in many individual burden estimates and a few key shifts from low frequency and low burden uses to higher frequency leading to the total increased burdens. 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). The 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 2013 to 2016, 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 1,035 to 962. The NRC estimates the number of NRC and Agreement State medical use licensees decreased from 7,659 to 6,157. Further, the types of medical uses retained by NRC licensees may not reflect the Agreement State licensees’ distribution of these medical uses. The NRC regional inspectors and license reviewers also observed a shift in the uses of materials such as a marked reduction in generator elution’s and hospitalization of patients and shifts from low frequency and low burden uses to higher frequency and burden uses such as the shift from manual brachytherapy to high dose rate remote after loaders and other sophisticated therapy uses. In addition, there was a decrease in the overall hourly fee rate from $272/hr. to $265/hr.

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Annual Cost to Federal Government: $79,500

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 06/01/2017

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