This information collection is approved under 5 CFR 1320. When submitting a request to revise or extend this collection, the NRC should ensure the following: I) That each of the record-keeping and reporting requirements contained in 10 CFR 35 have practical utility, as required by 5 CFR 1320.5 (d)(1)(iii). In determining whether these requirements have practical utility, the NRC should consider any new information regarding: a) the risks posed by the medical use of reactor byproduct materials, b) the burden imposed by the information collection requirements, c) and the costs and efficacy of alternative strategies for assuring safe use of these materials--including reliance on existing professional standards and state and federal medical and pharmaceutical laws. II) That requirements for record-keeping and reporting are the least burdensome necessary, as is required by 5 CFR 1320.5(d)(1) (i). In ensuring that its approach is the least burdensome necessary, the NRC should consider: a) whether alernatives, including the use of a third-party accrediting organization, would achieve the same purpose in a less burdensome way, b) whether records and reports related to the radiation safety program and its management would be sufficient to ensure safety without requiring retention of program records and written procedures, c) and whether the retention period for records can be shortened without damaging the NRC's ability to fulfill its purpose in these regulations. III) That the reporting threshold for a "medical event" ensures that all such reports have practical utility. The NRC should examine any new information regarding the risks posed by variation from the prescribed doses and examine whether a different threshold would better satisfy the requirements that information collected have practical utility (5 CFR 1320.5 (d)(1) (iii)) and is the least burdensome necessary (5 CFR 1320.5 (d)(1) (i)). In making the above determinations, the NRC should consult with licensees or relevant stakeholders, as well as with agreement states responsible for regulating the medical use of reactor byproduct materials.
Inventory as of this Action
Requested
Previously Approved
09/30/2004
09/30/2004
10/31/2002
214,402
0
6,676,254
889,754
0
1,294,681
16,000
0
0
10 CFR 35 is being completely revised to be more performance oriented. Part 35 contains requirements for licensees to administer byproduct material to humans for medical use. The information in the required reports, and records is used by NRC to ensure that the health and safety of the public is pro- tected and that the licensees' possession and use of byproduct material is in compliance with the license and regulatory requirements.
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.
10 CFR Part 35, Medical Use of Byproduct Material