[Federal Register Volume 63, Number 158 (Monday, August 17, 1998)]
[Notices]
[Pages 43961-43962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22086]


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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: 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: New applicants for medical use licenses, who plan to use 
byproduct material in limited diagnostic and therapy quantities under 
Part 35, must develop a written QMP and submit a copy of it to NRC. 
When a new modality involving therapeutic quantities of byproduct 
material is added to an existing license, current licensees must submit 
QMP modifications.
    This ICR burden estimate is inflated by the one-time cost for the 
development and submission of QMPs for approximately 2000 Agreement 
States licensees in the ten Agreement States who have not adopted the 
rule and are not required to.
    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: 3,194.
    7. The estimated number of annual respondents: 6300 (for both 
reporting and recordkeeping).
    8. An estimate of the total number of hours needed annually to 
complete the requirement or request: 34,743 hours for applicable 
licensees (Reporting: 24,400 Hrs/yr, and Recordkeeping: 10,343 Hrs/yr, 
or an average of 5.5 hrs per licensee).
    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:

[[Page 43962]]

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 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.
    On May 6, 1998, an invitation to comment on the information 
collection requirements for 10 CFR 35.32 and 35.33 was published in the 
Federal Register (63 FR 25098). NRC received two responses. The NRC is 
evaluating the reporting and recordkeeping requirements associated with 
this clearance as part of NRC's efforts to revise 10 CFR Part 35, 
``Medical Use of Byproduct Material,'' in its entirety, The proposed 
rule is expected to be published for comment in August 1998. The 
comments received in response to the May 1998 Federal Register notice 
will be considered during development of the final rule.
    A copy of the final supporting statement may be viewed free of 
charge at the NRC Public Document Room, 2120 L Street, NW (lower 
level), Washington, DC. OMB clearance requests are available at the NRC 
worldwide web site (http://www.nrc.gov) under the FedWorld collection 
link on the home page tool bar. The document will be available on the 
NRC home page site for 60 days after the signature date of this notice.
    Comments and questions should be directed to the OMB reviewer by 
September 16, 1998: Erik Godwin, 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 5th day of August 1998.

    For the Nuclear Regulatory Commission.
Brenda Jo. Shelton,
NRC Clearance Officer, Office of the Chief Information Officer.
[FR Doc. 98-22086 Filed 8-14-98; 8:45 am]
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