[Federal Register Volume 61, Number 250 (Friday, December 27, 1996)]
[Notices]
[Pages 68308-68309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32948]


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NUCLEAR REGULATORY COMMISSION

Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

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

ACTION: Notice of the OMB review of information collection and 
solicitation of public comment.

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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). 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.
    1. Type of submission, new, revision, or extension: 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:
    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.

[[Page 68309]]

    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.
    5. Who will be 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.
    6. An estimate of the number of responses: Approximately 2,919 per 
year.
    7. The estimated number of annual respondents: 6300
    8. An estimate of the total 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).
    9. An indication of whether section 3507(d), Pub. L. 104-13 
applies: Not Applicable
    10. 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 in the NRC review of misadministrations.
    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. 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 should be directed to the OMB reviewer by 
January 27, 1997: Edward Michlovich, 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 (202) 395-3084. The 
NRC Clearance Officer is Brenda Jo. Shelton, (301) 415-7233.

    Dated at Rockville, Maryland, this 20th day of December 1996.

    For the Nuclear Regulatory Commission.
Gerald F. Cranford,
Designated Senior Official for Information Resources Management.
[FR Doc. 96-32948 Filed 12-26-96; 8:45 am]
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