[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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