[Federal Register Volume 66, Number 184 (Friday, September 21, 2001)]
[Notices]
[Pages 48719-48720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23613]
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NUCLEAR REGULATORY COMMISSION
Agency Information Collection Activities: Submission for the
Office of Management and Budget (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.
Information pertaining to the requirement to be submitted:
1. Type of submission, new, revision, or extension: Extension.
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: None.
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 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.
6. An estimate of the number of responses: 6300 (for both reporting
and recordkeeping).
7. The number of annual respondents: 6300 (for both reporting and
recordkeeping).
8. 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).
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
[[Page 48720]]
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
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 requirements 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 sections 35.32 and 35.33
under 3150-0171.
A copy of the final supporting statement may be viewed free of
charge at the NRC Public Document Room, One White Flint North, 11555
Rockville Pike, Room O-1 F23, 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 should be directed to the OMB reviewer
listed below by October 22, 2001. Comments received after this date
will be considered if it is practical to do so, but assurance of
consideration cannot be given to comments received after this date.
Bryon Allen, 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) 395-3087.
The NRC Clearance Officer is Brenda Jo. Shelton, 301-415-7233.
Dated at Rockville, Maryland, this 17th day of September 2001.
For the Nuclear Regulatory Commission.
Brenda Jo. Shelton,
NRC Clearance Officer, Office of the Chief Information Officer.
[FR Doc. 01-23613 Filed 9-20-01; 8:45 am]
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