This information collection is approved through August 1998. We continue to have concerns with the burden and possible lack of practical utility of this ICR (see previous terms of clearance). This approval is therefore based upon the following understandings: 1) NRC has informed OMB that it is reviewing the issue of compatibility of the QM rule for the Agreement States as part of NRC's overall review of its Agreement State Adequacy and Compatibility Program. During this review, NRC does not expect to enforce a compatibility requirement on the 10 (of the 29) Agreement States, representing approximately 2000 licensees, that have not adopted the QM rule. Therefore, this approval covers only NRC licensees and the 19 Agreement States that have already adopted the requirements outlined in this ICR. 2) In our discussions, NRC has agreed to initiate reform of this program. Specific steps include, but are not limited to: A) a recognition of the different risks involved in different nuclear specialties, such as the differences between diagnostic and therapeutic nuclear medicine. Consistent with NRC's DSI #7, (Option 3), NRC should work to relieve the burden from licensees that are involved only in low-risk activities. B) an effort to reduce reporting frequency, such as by going from annual QM plan reviews to a review every 2 to 3 years. OMB will expect a written progress report on the status of NRC reforms of this information collection at the time of its next renewal. Of course, areas for improvement are by no means limited to the two examples above, and we encourage NRC to explore other areas of reform. If for any reason NRC decides it is unwise to proceed in the two areas listed above, its reasoning should be outlined in the progress report. In conversations with OMB, NRC has indicated a desire to do everything possible to improve the information collection during the 18-month approval period. NRC has been informed that OMB review of this ICR at the next renewal will focus upon the progress NRC has made towards burden reduction, consistent with the requirements of the Paperwork Reduction Act that information collections have practical utility and minimize the burden on respondents.
Inventory as of this Action
Requested
Previously Approved
10/31/1998
10/31/1998
03/31/1997
2,919
0
3,825
34,743
0
51,778
0
0
0
NRC requires licensees to implement a quality management program to provide high confidence that by-product material or radiation from by-product material will be administered as directed by an authorized user physician. Records and reports are required for certain errors in the administration of limited diagnostic and therapeutic quantities of by-product material by material use licensees.
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.
Quality Management Program and Misadministrations -- 10 CFR 35.32 and 35.33