10 CFR 35, Medical Use of Byproduct Material

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
2014-02424 Final.pdf	Supplementary Document	Uploaded 2014-02-10	Available
Copy of Part_35_tables_for_final_(2).xlsx	Supplementary Document	Uploaded 2014-07-24	Available
10_CFR_Part_35_Final_SS (2).docx	Supporting Statement A	Uploaded 2014-07-24	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: 201402-3150-001
Status: Historical Active	Previous ICR Reference No: 201011-3150-006
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 with change	Conclusion Date: 07/24/2014
	Date Received in OIRA: 02/12/2014
Terms of Clearance: The agency is reminded to consult on the ICR package prior to submission for review per 5 CFR 1320.8(d)(1).

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	36 Months From Approved	07/31/2014
Responses	240,145	0	246,581
Time Burden (Hours)	1,066,031	0	1,173,785
Cost Burden (Dollars)	109,726	0	74,597

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Abstract: 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.

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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:
	78 FR 67203	11/08/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 6933	02/05/2014
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	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

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 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.

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Annual Cost to Federal Government: $81,600

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 02/12/2014

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