[Federal Register Volume 61, Number 195 (Monday, October 7, 1996)]
[Notices]
[Pages 52470-52471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25627]
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NUCLEAR REGULATORY COMMISSION
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: U. S. Nuclear Regulatory Commission (NRC).
ACTION: Notice of pending NRC action to submit an information
collection request to OMB and solicitation of public comment.
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SUMMARY: The NRC is preparing a submittal to OMB for review of
continued approval of information collections under the provisions of
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
Information pertaining to the requirement to be submitted:
1. The title of the information collection: 10 CFR 35.32 and 35.33
``Quality Management Program and Misadministrations''.
2. Current OMB approval number: 3150-0171.
3. How often the collection is required: For quality management
program (QMP):
Reporting: One time submittal of a quality management program (QMP)
for each existing and new licensee, when the QMP is modified, or when
new modalities (uses) are added to an existing license.
Ten Agreement States, who should have adopted the rule by January
1995, have not done so. Therefore, this estimate includes the one-time
burden for the development of QMPs by these ten Agreement State
licensees.
Recordkeeping: Records of written directives, administered dose or
dosage, annual review, and recordable events, for 3 years.
For Misadministrations:
Reporting: Whenever a misadministration occurs.
Recordkeeping: Records of misadministrations for 5 years.
4. Who is required or asked to report: NRC Part 35 licensees who
use byproduct material in limited diagnostic and therapeutic ranges and
similar type of licensees regulated by Agreement States.
5. The number of respondents: 6300 licensees.
6. The number of hours needed annually to complete the requirement
or request: 34,743 hours for applicable licensees (24,400 hrs/yr for
reporting and 10,343 hrs/yr for recordkeeping).
7. Abstract: In the medical use of byproduct material, there have
been instances where byproduct material was not administered as
intended or was administered to a wrong individual, which resulted in
unnecessary exposures or inadequate diagnostic or therapeutic
procedures. The most frequent causes of these incidents were:
insufficient supervision, deficient procedures, failure to follow
procedures, and inattention to detail. In an effort to reduce the
frequency of such events, the NRC requires licensees to implement a
quality management program (Sec. 35.32) to provide high confidence that
byproduct material or radiation from byproduct material will be
administered as directed by an authorized user physician.
Collection of this information enables the NRC to ascertain whether
misadministrations are properly identified, evaluated, and investigated
by the licensee and that corrective action is taken. Additionally, NRC
has a responsibility to inform the medical community of generic issues
identified
[[Page 52471]]
in the NRC review of misadministrations.
Submit, by December 6, 1996, comments that address the following
questions:
1. Is the proposed collection of information necessary for the NRC
to properly perform its functions? Does the information have practical
utility?
2. Is the burden estimate accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the information collection be minimized,
including the use of automated collection techniques or other forms of
information technology?
A copy of the draft supporting statement may be viewed free of
charge at the NRC Public Document Room, 2120 L Street NW, (lower
level), Washington, DC. Members of the public who are in the
Washington, DC, area can access this document via modem on the Public
Document Room Bulletin Board (NRC's Advanced Copy Document Library),
NRC subsystem at FedWorld, 703-321-3339. Members of the public who are
located outside of the Washington, DC, area can dial FedWorld, 1-800-
303-9672, or use the FedWorld Internet address: fedworld.gov (Telnet).
The document will be available on the bulletin board for 30 days after
the signature date of this notice. If assistance is needed in accessing
the document, please contact the FedWorld help desk at 703-487-4608.
Additional assistance in locating the document is available from
the NRC Public Document Room, nationally at 1-800-397-4209, or within
the Washington, DC, area at 202-634-3273.
Comments and questions about the information collection
requirements may be directed to the NRC Clearance Officer, Brenda Jo.
Shelton, U.S. Nuclear Regulatory Commission, T-6 F33, Washington, DC,
20555-0001, or by telephone at (301) 415-7233, or by Internet
electronic mail at [email protected].
Dated at Rockville, Maryland, this 18th day of October, 1996.
For the Nuclear Regulatory Commission.
Gerald F. Cranford,
Designated Senior Official for Information Resources Management.
[FR Doc. 96-25627 Filed 10-04-96; 8:45 am]
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