[Federal Register Volume 59, Number 195 (Tuesday, October 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25032]
[[Page Unknown]]
[Federal Register: October 11, 1994]
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NUCLEAR REGULATORY COMMISSION
Documents Containing Reporting or Recordkeeping Requirements:
Office of Management and Budget Review
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of the Office of Management and Budget review of
information collection.
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SUMMARY: The Nuclear Regulatory Commission (NRC) has recently submitted
to the Office of Management and Budget (OMB) for review the following
proposal for the collection of information under the provisions of the
Paperwork Reduction Act (44 U.S.C. Chapter 35).
1. Type of submission, new, revision, or extension: Revision.
2. The title of the information collection: 10 CFR Parts 30, 32,
and 35--Preparation, Transfer for Commercial Distribution, and Use of
Byproduct Material for Medical Use.
3. The form number if applicable: Not applicable.
4. How often the collection is required: On occasion.
5. Who will be required or asked to report: Manufacturers of
radioactive drugs, independent nuclear pharmacies, and medical use
licensees.
6. An estimate of the total number of responses: 16 additional
responses (307 responses required and 291 responses eliminated).
7. An estimate of the total number of hours needed to complete the
requirement or request: A reduction of 408 hours (an increase of 43
hours for recordkeeping and a reduction of 451 hours for reporting).
The estimated 307 responses average 0.6 hour per response versus the
291 responses eliminated that average 2.2 hours per response.
8. An indication whether Section 3504(h), Public Law 96-511
applies: Applicable.
9. Abstract: In response to a petition for rulemaking submitted by
the American College of Nuclear Physicians and the Society of Nuclear
Medicine, the NRC is amending its regulations for the medical use of
byproduct material. This rule is necessary to provide greater
flexibility by eliminating current regulatory restrictions and allowing
properly qualified nuclear pharmacists and authorized users who are
physicians greater discretion in preparing radioactive drugs containing
byproduct material for medical use. This rule will also allow the use
of byproduct material in both research involving human subjects and the
medical use of radiolabeled biologics. In addition, this rule also
contains other miscellaneous and conforming amendments necessary to
clarify or update the current regulations.
Copies of the submittal may be inspected or obtained for a fee from
the NRC Public Document Room 2120 L Street NW (Lower Level),
Washington, DC.
Comments and questions can be directed by mail to the OMB reviewer:
Troy Hillier, Office of Information and Regulatory Affairs, (3150-0001,
-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 J. Shelton, (301) 415-7233.
Dated at Rockville, Maryland, this 29th day of September 1994.
For the Nuclear Regulatory Commission.
Gerald F. Cranford,
Designated Senior Official for Information Resources Management.
[FR Doc. 94-25032 Filed 10-7-94; 8:45 am]
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