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
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