[Federal Register Volume 63, Number 87 (Wednesday, May 6, 1998)]
[Notices]
[Pages 25098-25099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11981]
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NUCLEAR REGULATORY COMMISSION
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: U. S. Nuclear Regulatory Commission (NRC).
ACTION: Notice of pending NRC action to submit an information
collection request to OMB and solicitation of public comment.
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SUMMARY: The NRC is preparing a submittal to OMB for review of
continued approval of information collections under the provisions of
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
Information pertaining to the requirement to be submitted:
1. The 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:
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 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.
4. Who is 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.
5. An estimate of the number of respondents: 5276 (for both
reporting and recordkeeping)
6. The number of hours needed annually to complete the requirement
or
[[Page 25099]]
request: 34,743 hours for applicable licensees (Reporting: 24,400 hr/
yr, and Recordkeeping: 10,343 hrs/yr).
7. 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 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.
The NRC is currently revising 10 CFR Part 35, including 10 CFR
35.32 and 33. NRC sought early input and will continue to seek input on
the rulemaking through Federal Register notices, open meetings, public
workshops, and by putting documents on the internet. The proposed rule
will be published for comment for 75 days, and NRC plans to hold three
public meetings during the formal comment period to facilitate public
comment.
Submit, by July 6, 1998, comments that address the following
questions:
1. Is the proposed collection of information necessary for the NRC
to properly perform its functions? Does the information have practical
utility?
2. Is the burden estimate 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 information collection be minimized,
including the use of automated collection techniques or other forms of
information technology?
A copy of the draft 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 about the information collection
requirements may be directed to the NRC Clearance Officer, Brenda Jo.
Shelton, U.S. Nuclear Regulatory Commission, T-6 F33, Washington, DC,
20555-0001, or by telephone at 301-415-7233, or by Internet electronic
mail at [email protected].
Dated at Rockville, Maryland, this 21st day of April 1998.
For the Nuclear Regulatory Commission.
Brenda Jo. Shelton,
NRC Clearance Officer, Office of the Chief Information Officer.
[FR Doc. 98-11981 Filed 5-5-98; 8:45 am]
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