[Federal Register Volume 65, Number 79 (Monday, April 24, 2000)]
[Proposed Rules]
[Page 21673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10147]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 32

[Docket No. PRM-32-05]


Metabolic Solutions: Denial of Petition for Rulemaking

AGENCY: U.S. Nuclear Regulatory Commission.


ACTION: Denial of petition for rulemaking.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is denying a 
petition for rulemaking (PRM-32-05) submitted by Metabolic Solutions. 
The petitioner requested that the NRC extend the regulatory 
distribution exemption for 1 microcurie of carbon-14 (C-14) urea to 
include a product being developed by its company. The product is the 
Erythromycin Breath Test (EBT) which uses a 111-kilobequerel (kBq) (3-
microcurie) dose of C-14 erythromycin.

ADDRESSES: Submit comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001. Attention: Rulemakings and 
Adjudications Staff.
    Deliver comments to 11555 Rockville Pike, Rockville, Maryland, 
between 7:30 a.m. and 4:15 p.m. on Federal workdays.
    You may also provide comments via the NRC's interactive rulemaking 
website (http://ruleforum.llnl.gov). This site provides the capability 
to upload comments as files (any format), if your web browser supports 
that function. For information about the interactive rulemaking 
website, contact Ms. Carol Gallagher (301) 415-5905 (e-mail: 
[email protected]).
    Copies of any comments received may be examined at the NRC Public 
Document Room, 2120 L Street, NW (Lower Level), Washington, DC.

FOR FURTHER INFORMATION, CONTACT: James Smith, telephone (301) 415-
6459, e-mail: [email protected], of the Office of Nuclear Material Safety 
and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001.

      
      

SUPPLEMENTARY INFORMATION:

The Petition

    On May 4, 1999 (64 FR 23796), NRC noticed receipt and requested 
comment on the PRM filed by Metabolic Solutions Inc. The comment period 
closed on July 20, 1999. Notice of receipt of the Metabolic Solutions 
PRM resulted in the NRC receiving comment letters from two medical 
universities in support of the petition.
    The C-14 EBT measures the activity, in-vivo, of an important liver 
enzyme that is the most abundant drug-metabolizing enzyme in the body. 
This test is currently used to determine the safety of new drugs during 
clinical trials; as such, it is used only as a research tool. The 
petitioner states that the doses associated with this test are 
comparable to the doses for the C-14 urea test which is exempt from the 
requirement for licensing pursuant to 10 CFR 30.21 (a).

Public Comments on the Petition

    The notice of receipt of the PRM invited interested persons to 
submit comments. The two public comments received in response to the 
notice, from the University of Nebraska Medical Center and Johns 
Hopkins Medical Institutions, were in support of the petition. The two 
comments generally noted the low doses associated with the test and the 
possible economic benefit in reducing the expense of clinical trials 
through elimination of the need for a byproduct materials license.

Reasons for Denial

    A denial is consistent with the Commission's previous decision on 
the C-14 urea tests to require that research be performed under a 
specific license (62 FR 63634), since this product is to be used only 
in research use. The doses are not the limiting factor for extending 
the distribution exemption to this test. The previous decision was 
based upon restrictions of such use under the common rule entitled 
``Federal Policy for the Protection of Human Subjects; Notices and 
Rules'' (56 FR 28002). Although the NRC did not adopt the common rule, 
our intention is to follow the essential requirements of the rule, 
which have been adopted into 10 CFR 35.6, ``Provisions for Research 
Involving Human Subjects.'' Specifically, 10 CFR 35.6 requires a 
licensee that conducts research involving human research subjects to 
obtain informed consent and obtain approval by an Institutional Review 
Board. Because the common rule did not allow for exemptions for 
research involving minimal risk, the Commission determined that such 
research use should not be exempt from 10 CFR 35.6.

    Dated at Rockville, Maryland, this 5th day of April, 2000.

    For the U.S. Nuclear Regulatory Commission.
William D. Travers
Executive Director for Operations.
[FR Doc. 00-10147 Filed 4-21-00; 8:45 am]
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