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