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.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
12/31/2010
12/31/2010
12/31/2010
259,332
0
259,332
987,764
0
987,764
79,079
0
79,079
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.
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.
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:
(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;
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.
10CFR35PRssMedicalEvent071008.doc
10 CFR 35, Medical Use of Byproduct Material