95-31545. Documents Containing Reporting or Recordkeeping Requirements: Office of Management and Budget (OMB) Review

[Federal Register Volume 60, Number 250 (Friday, December 29, 1995)]
[Notices]
[Page 67370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31545]



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NUCLEAR REGULATORY COMMISSION

Documents Containing Reporting or Recordkeeping Requirements: 
Office of Management and Budget (OMB) Review

AGENCY: U. S. Nuclear Regulatory Commission (NRC).

ACTION: Notice of the OMB review of information collection and 
solicitation of public comment. The NRC hereby informs potential 
respondents that an agency may not conduct or sponsor, and that a 
person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number.

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SUMMARY: The NRC has recently submitted to OMB for review the following 
proposal for the collection of information under the provisions of the 
Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
    1. Type of submission: Revision.
    2. The title of the information collection: 10 CFR 35.32 and 35.33, 
``Quality Management Program and Misadministrations''.
    3. The form number if applicable: Not applicable.
    4. 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.
    5. Who will be required or asked to report: 10 CFR Part 35 
licensees and equivalent Agreement State licensees who use byproduct 
material in limited diagnostic and therapeutic ranges.
    6. An estimate of the number of responses: 3825.
    7. The estimated number of annual respondents: 6388.
    8. An estimate of the total number of hours needed annually to 
complete the requirement or request: Approximately 51,778 hours 
(reporting: 38,706 hrs/yr and recordkeeping: 13,072 hrs/yr).
    9. An indication of whether Section 3507(d), Pub. L. 104-13 
applies: applicable.
    10. 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.
    A copy of the submittal 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 
the submittal 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.
    Comments and questions should be directed to the OMB reviewer by 
January 29, 1996: Troy Hillier, Office of Information and Regulatory 
Affairs (3150-0171), NEOB-10202, Office of Management and Budget, 
Washington, DC 20503.
    Comments can also be submitted by telephone at [phone].
    The NRC Clearance Officer is Brenda Jo. Shelton, [phone].

    Dated at Rockville, Maryland, this 27th day of December 1995.

    For the Nuclear Regulatory Commission.
Gerald F. Cranford,
Designated Senior Official for Information Resources Management.
[FR Doc. 95-31545 Filed 12-28-95; 8:45 am]
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