[Federal Register Volume 63, Number 158 (Monday, August 17, 1998)]
[Notices]
[Pages 43960-43961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22085]
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NUCLEAR REGULATORY COMMISSION
Documents Containing Reporting or Recordkeeping Requirements:
Office of Management and Budget (OMB) Review
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).
1. Type of submission, new, revision, or extension: Revision.
2. The title of the information collection:
--10 CFR Part 35, Medical Use of Byproduct Material
--NRC Form 313 Application for Material License, and Supplemental
Forms, NRC Form 313A, Training and Experience, and NRC Form 313B,
Preceptor Statement
3. The form number if applicable: NRC Form 313, 313A and 313B.
4. How often the collection is required: Reports of medical events;
[[Page 43961]]
doses to an embryo/fetus or nursing child, or leaking sources are
reportable on occurrence. An organization desiring to become a
certifying entity must tender an application upon intent.
5. Who will be required or asked to report: Physicians and medical
institutions holding an NRC license authorizing the administration of
byproduct material or radiation therefrom to humans for medical use.
6. An estimate of the number of responses: 93,966 (26,850 NRC
licensees, 67,116 Agreement State licensees). In addition, 4 new
organizations are expected to apply to become certifying entities and
35 will be required to submit modified procedures.
7. The estimated number of annual respondents: 1,902 NRC licensees
and 4,755 Agreement State licensees.
8. An estimate of the total number of hours needed annually to
complete the requirement or request: Part 35: 877,807 hours (251,192
hours for NRC licensees, 626,381 hours for Agreement State licensees,
and 234 hours for certifying organizations) (an average of 132 hours
per licensee). In addition, there is a one-time burden of 2,956 hours
for certifying organizations to submit new or modified procedures. NRC
Form 313: 68 additional hours (48 hours for NRC licensees and 20 hours
for Agreement State licensees).
9. An indication of whether Section 3507(d), Pub. L. 104-13
applies: Applicable
10. Abstract: 10 CFR Part 35, ``Medical Use of Byproduct
Material,'' is being restructured into a risk-informed performance-
based regulation. The proposed rule contains mandatory requirements
that apply to NRC licensees authorized to administer byproduct material
or radiation therefrom to humans for medical use. In addition,
requirements are being added for organizations desiring to be
recognized by NRC as certifying organizations.
The information in the required reports and records is used by the
NRC to ensure that public health and safety is protected, and that the
possession and use of byproduct material is in compliance with the
license and regulatory requirements.
Submit, by September 16, 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 submittal may be viewed free of charge at the NRC
Public Document Room, 2120 L Street, NW (lower level), Washington, DC.
The proposed rule indicated in ``The title of the information
collection'' is or has been published in the Federal Register within
several days of the publication date of this Federal Register Notice.
Instructions for accessing the electronic OMB clearance package for the
rulemaking have been appended to the electronic rulemaking. Members of
the public may access the electronic OMB clearance package by following
the directions for electronic access provided in the preamble to the
titled rulemaking.
Comments and questions should be directed to the OMB reviewer by
September 16, 1998:
Erik Godwin, Office of Information and Regulatory Affairs (3150-0010,
and -0120), 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 11th day of August 1998.
For the Nuclear Regulatory Commission.
Beth St. Mary,
Acting NRC Clearance Officer, Office of the Chief Information Officer.
[FR Doc. 98-22085 Filed 8-14-98; 8:45 am]
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