[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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