10 CFR 35, Medical Use of Byproduct Material

Forms and Documents

Document Name	Status
83-C Justification 2009 Part 35 [2].doc Justification for No Material/Nonsubstantive Change	2009-07-07
Narm Rule 83C for Part 35.doc Justification for No Material/Nonsubstantive Change	2009-02-26
Final10CFR35ss2007.wpd Supporting Statement A	2007-08-03

IC Document Collections

IC ID	Document Title	Status
42721	10 CFR 35, Medical Use of Byproduct Material	Modified

ICR Details

OMB Control No: 3150-0010	ICR Reference No: 200902-3150-003
Status: Historical Active	Previous ICR Reference No: 200708-3150-003
Agency/Subagency: NRC	Agency Tracking No:
Title: 10 CFR 35, Medical Use of Byproduct Material
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/02/2009
	Date Received in OIRA: 03/04/2009
Terms of Clearance: Agency submitted additional 83-C to clarify and correct procedural elements.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2010	12/31/2010	12/31/2010
Responses	261,394	0	259,332
Time Burden (Hours)	1,025,958	0	987,764
Cost Burden (Dollars)	79,079	0	79,079

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Abstract: 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. 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.

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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:
	72 FR 24626	05/03/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 44186	08/07/2007
Did the Agency receive public comments on this ICR? No

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

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

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ICR Summary 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	261,394	259,332	0	0	2,062	0
Annual Time Burden (Hours)	1,025,958	987,764	0	0	38,194	0
Annual Cost Burden (Dollars)	79,079	79,079	0	0	0	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 Nuclear Regulatory Commission (NRC) amended its regulations to include jurisdiction over discrete sources of radium-226, accelerator-produced radioactive materials, and discrete sources of naturally occurring radioactive material, as required by the Energy Policy Act of 2005 (EPAct), which was signed into law on August 8, 2005. This provides a regulatory framework by which to license and regulate byproduct material in accordance with the new, expanded definition. The amended regulations impacted numerous existing information collections. The NRC packaged all of the impacted information collections into one new information collection which OMB approved and assigned control number 3150-0203. The clearance affecting this 83-C is 10 CFR Part 35, “Medical Use of Byproduct Material,” which is currently covered under OMB Clearance 3150-0010. This regulation 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. The purpose of this 83-C is to transfer burden from OMB Clearance 3150-0203, “10 CFR Parts 20, 30, 31, 32, & 35, Requirements for Expanded Definition of Byproduct Material, Final Rule and NRC Forms 4, 5, 313, 314, & 664,” to OMB Clearance 3150-0010, “Medical Use of Byproduct Material,” which was contained in the final rule approved on 8/23/07. 10 CFR Part 35 regulations contain 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. Once the entire burden for 3150-0203 has been transferred to the correct clearances, we will submit an 83-D to discontinue 2150-0203. A total of 38,194 hours will be transferred to 3150-0010, resulting in a revised total burden of 1,025,958 hours.

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Annual Cost to Federal Government: $64,200

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 03/04/2009

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