10 CFR 35, Medical Use of Byproduct Material

Forms and Documents

Document Name	Status
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: 200708-3150-003
Status: Historical Active	Previous ICR Reference No: 200410-3150-001
Agency/Subagency: NRC	Agency Tracking No:
Title: 10 CFR 35, Medical Use of Byproduct Material
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/04/2007
	Date Received in OIRA: 08/15/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2010	36 Months From Approved	12/31/2007
Responses	259,332	0	244,086
Time Burden (Hours)	987,764	0	1,113,217
Cost Burden (Dollars)	79,079	0	67,000

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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 68 STAT 919 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	259,332	244,086	0	15,246	0	0
Annual Time Burden (Hours)	987,764	1,113,217	0	-125,453	0	0
Annual Cost Burden (Dollars)	79,079	67,000	0	12,079	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: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: The burden reduction is attributable to two causes: (1)the loss of a one-time burden associated with the submission of preceptor statements in accordance with the amended 35.14(a); and (2) one-time activities that specialty boards are required to undertake, in order to become recognized by the NRC as entities capable of certifying licensees' training to effectively carry out duties under Part 35. In addition, Subpart J contained training and experience requirements and associated reporting requirements that were effective during the last reporting period. However, the Subpart J training and experience and any associated reporting expired as of October 24, 2005.

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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)? Uncollected

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: 08/15/2007

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