[Federal Register Volume 60, Number 151 (Monday, August 7, 1995)]
[Notices]
[Page 40204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19500]



=======================================================================
-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION


Documents Containing Reporting or Recordkeeping Requirements: 
Notice of Pending Submittal to the Office of Management and Budget 
(OMB) for Review

AGENCY: Nuclear Regulatory Commission (NRC).

ACTION: Notice of pending NRC action to submit an information 
collection request to OMB, and solicitation of public comment.

-----------------------------------------------------------------------

SUMMARY: NRC is preparing a submittal to OMB for review and continued 
approval of information collection requirements currently approved by 
OMB under the provisions of the Paperwork Reduction Act of 1995 (44 
U.S.C. Chapter 35).
    1. 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: 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. Misadministrations are reported as they occur. 
Records of written directives, administered dose or dosage, an annual 
review of the QMP, and recordable events must be maintained in 
auditable form for 3 years and misadministrations for 5 years.
    4. Who will be required to report: 10 CFR Part 35 licensees and 
equivalent Agreement State licensees who use byproduct material in 
limited diagnostic and therapeutic ranges.
    5. An estimate of the annual number of respondents: 10 CFR 35.32: 
6300 licensees, 10 CFR 35.33: 75 licensees.
    6. An estimate of the total number of hours needed to complete the 
requirements or request: Approximately 41,821 hours (Reporting: 35,035 
hrs/yr, and Recordkeeping: 6,786 hrs/yr). The Commission is currently 
reviewing the compatibility requirements for the Agreement States. 
Relief from certain of these requirements would significantly reduce 
the burden associated with 10 CFR 35.32. If relief is granted to the 
Agreement States, the staff will submit a modification of the burden 
estimate that reflects the changes.
    7. Abstract: In the medical use of byproduct material, there have 
been instances where byproduct material was not administered as 
intended or administered to a wrong individual which resulted in 
unnecessary exposures or inadequate or incorrect diagnostic or 
therapeutic procedures. The most frequent causes of these incidents 
were: insufficient supervision, deficient procedures, failure to follow 
procedures, and inattention to detail. To reduce the frequency of such 
events, the NRC requires licensees to implement a quality management 
program (10 CFR 35.32) to provide high confidence that byproduct 
material or radiation from byproduct material will be administered as 
directed by an authorized user physician.
    Records and reports to NRC are required for certain errors in the 
administration of limited diagnostic and therapeutic quantities of 
byproduct material by medical use licensees. Section 35.33 clarifies 
these requirements to avoid confusion over whether certain events 
should be reported to NRC and to help ensure that the licensee is in 
compliance with the requirements. NRC has a responsibility to inform 
the medical community of generic issues identified in the NRC review of 
misadministrations.
    NRC has revised the definition for ``misadministration'' in 10 CFR 
35.2, ``Definitions.'' The revision considerably reduces the number of 
``errors'' that must be reported to the NRC or an Agreement State.
    Collection of this information will enable the NRC to ascertain 
whether misadministrations are investigated by the licensee and that 
corrective action is taken.
    Specific comments requested within 60 days:
    1. Is the proposed renewal of the collection of information 
necessary for NRC to properly perform its functions, including whether 
the information will have practical utility?
    2. Is the estimate of burden 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 collection of information be 
minimized, including the use of automated collection techniques?
    Members of the public may obtain, free of charge, a copy of the 
DRAFT OMB clearance submittal. This information can be obtained by 
Internet: SLM[email protected] or by calling Sally L. Merchant at (301) 415-
7874. The NRC anticipates that the OMB clearance submittal will be 
available for inspection in the NRC Public Document Room, 2120 L Street 
NW (Lower Level), Washington, DC, on August 18, 1995.
    Comments and questions should be directed to the NRC Clearance 
Officer, Brenda Jo. Shelton, U.S. Nuclear Regulatory Commission, T-6 F 
33, Washington, D.C., 20555-0001, (301) 415-7233.

    Dated at Rockville, Maryland, this 2nd day of August 1995.

    For the U.S. Nuclear Regulatory Commission.
Gerald F. Cranford,
Designated Senior Official for Information Resources Management.
[FR Doc. 95-19500 Filed 8-4-95; 8:45 am]
BILLING CODE 7590-01-P