[Federal Register Volume 66, Number 124 (Wednesday, June 27, 2001)]
[Notices]
[Pages 34274-34275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16097]
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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 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.
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. The estimated number of annual respondents: 6300 (for both
reporting and recordkeeping).
6. The 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).
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 (Sec. 35.33) 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.
Revisions to 10 CFR 35.32 and 35.33 are being made as part of a
complete revision of 10 CFR Part 35 to incorporate specific
improvements in NRC's regulations governing the medical use of
byproduct material. A final rule revising Part 35 was affirmed by the
Commission on October 23, 2000 and was submitted, along with its
associated clearance package, to the Office of Management and Budget
(OMB). A notice was published in the Federal Register on March 16,
2001, announcing a 30-day public comment period on the submittal. It is
anticipated that the effective date of the final rule revising Part 35,
including the revisions to Sections 35.32 and 35.33, will be March
2002, and the OMB clearance for Sections 35.32 and 35.33 will be then
be included under the OMB clearance for Part 35 (3150-0010).
Currently, the OMB clearances for Sections 35.32 and 35.33 are due
to expire October 31, 2001. In view of the fact that these parts will
shortly thereafter be covered under OMB clearance 3150-0010, the
Commission is seeking a 1-year clearance extension for the information
collection requirments in these sections to allow sufficient time for
OMB to complete its review of the NRC clearance package for the
revision to Part 35, for NRC to publish the final rule, and for the
rule to become effective. Because the final Part 35 and its OMB
clearance will be in place in a short time period, the burden hour
estimates in this extension package are not being revised from those
contained in the previous OMB approval for
[[Page 34275]]
Sections 35.32 and 35.33 under 3150-0171.
Submit, by August 27, 2001, 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, One White Flint North, 11555
Rockville Pike, Room O-1F23, Rockville, MD 20852. OMB clearance
requests are available at the NRC worldwide web site: http://www.nrc.gov/NRC/PUBLIC/OMB/index.html. 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 E6, Washington, DC
20555-0001, by telephone at (301) 415-7233, or by Internet electronic
mail at [email protected].
Dated at Rockville, Maryland, this 21st day of June 2001.
For the Nuclear Regulatory Commission.
Beth St. Mary,
Acting NRC Clearance Officer, Office of the Chief Information Officer.
[FR Doc. 01-16097 Filed 6-26-01; 8:45 am]
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