View Information Collection Request (ICR) Package

OMB Control No: 3150-0010	ICR Reference No: 200807-3150-007
Status: Historical Inactive	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: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 10/29/2008
	Date Received in OIRA: 08/07/2008
Terms of Clearance: In accordance with 5 CFR 1320, OMB is withholding approval at this time. Prior to publication of the final rule, the agency must submit to OMB a summary of all comments related to the information collection contained in the proposed rule and the agency response. The agency should clearly indicate any changes made to the information collection as a result of these comments.

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

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.

Authorizing Statute(s): PL: Pub.L. 83 - 703 68 STAT 919 Name of Law: Atomic Energy Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
3150-AI26	Proposed rulemaking	73 FR 45635	08/06/2008

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

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

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

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: This proposed rule would amend 10 CFR 35.40 and 35.3045 to revise the criteria for defining medical events (ME) and clarify requirements for written directives (WD) for permanent implant brachytherapy. The proposed amendments would change the criteria for defining a ME for permanent implant brachytherapy from dose based to activity based, would add a requirement to report, as a ME, any administration requiring a WD if a WD was not prepared, would clarify requirements for WDs for permanent implant brachytherapy, and would make certain administrative and clarification changes. The change from dose based to activity based criteria for defining MEs in permanent implant brachytherapy is necessary because 1) currently there is no suitable clinically used dose metric available for judging the occurrences of MEs and 2) clinicians have better control over activity being implanted than dose resulting from the implant. Information that is required on a WD is crucial to insuring a patient receives the appropriate treatment. Changing from a dose based to an activity based criteria for defining a ME means the information required in a WD must reflect this change. Under both the current regulations and the proposed rule the WD must be completed after implantation. Requiring the Authorized User (AU) to sign and dated the WD before the patient leaves the post-treatment area would ensure that the information added to the WD has been reviewed and approved by the AU. This change would clarify the intent of the current regulations that the AU approves all required information on the WD and is an insignificant change for the medical licensee. The proposed changes in rule language in 10 CFR 35.3045 would impact information reporting burdens by changing the number of medical events that medical licensees are required to report to the NRC. NRC anticipates an increase of approximately 2 MEs reported for 35.3045(a), and a decrease of approximately 4 MEs reported for 35.3045(a)(2), thus resulting in a total reduction of 2 MEs annually.

Annual Cost to Federal Government: $0

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

Agency Contact: Edward Lohr 301 415-0253 eml1@nrc.gov

View ICR - OIRA Conclusion