[Federal Register Volume 59, Number 231 (Friday, December 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29654]
[[Page Unknown]]
[Federal Register: December 2, 1994]
VOL. 59, NO. 231
Friday, December 2, 1994
NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
[Docket No. PRM-35-12]
Tri-Med Specialties, Inc.; Filing of Petition for Rulemaking
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of receipt of petition for rulemaking.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is publishing for
public comment a notice of receipt of a petition for rulemaking, dated
August 23, 1994, that was filed with the Commission by Tri-Med
Specialties, Inc. The petition was assigned Docket No. PRM-35-12 on
October 6, 1994. The petitioner requests that the Commission amend its
regulations to permit licensed pharmaceutical manufacturers to
commercially distribute, under general licensing and/or exemption,
capsules containing one micro-curie of carbon-14 (C14) for
administration to humans for in vivo diagnostic testing.
DATES: Submit comments by February 15, 1995. Comments received after
this date will be considered if it is practical to do so, but assurance
of consideration cannot be given except as to comments received on or
before this date.
ADDRESSES: Submit comments to the Secretary, U.S. Nuclear Regulatory
Commission, Attention: Docketing and Service Branch, Washington DC
20555. For a copy of the petition, write to the Rules Review Section,
Rules Review and Directives Branch, Division of Freedom of Information
and Publications Services, Office of Administration, U.S. Nuclear
Regulatory Commission, Washington, DC 20555.
FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rules Review
Section, Rules Review and Directives Branch, Division of Freedom of
Information and Publications Services, Office of Administration, U.S.
Nuclear Regulatory Commission, Washington, DC 20555. Telephone: 301-
415-7163 or toll free: 1-800-368-5642.
SUPPLEMENTARY INFORMATION:
Petitioner
Tri-Med Specialties, Inc., headquartered in Overland Park, Kansas,
maintains a licensed pharmaceutical manufacturing site in
Charlottesville, Virginia. The petitioner also is licensed by the NRC
(#45-25215-01) to perform research using C14. This research involves
manufacture of capsules containing 1 micro-curie (Ci) of C14-
urea and production of diagnostic breath test kits. The test kits are
currently transferred only to facilities licensed by the Food and Drug
Administration (FDA) (IND#42294) and the NRC.
Petitioner's Request
Tri-Med Specialties requests that the NRC amend its regulations to
allow for the general licensing and/or exemption for the commercial
distribution by licensed pharmaceutical manufacturers of a capsule
containing 1 Ci of C14-urea for in vivo diagnostic testing.
The petitioner states that the capsules would be used to test for the
presence of Helicobacter pylori, a bacterium that causes peptic ulcers
in the stomach. According to the petitioner, the capsules would be
distributed separately or as part of a diagnostic kit that contains
supplies to perform the test. The petitioner suggests the maximum
number of capsules allowed in inventory at an unlicensed facility at
any time be 150 (150 Ci).
Grounds for Request
The petitioner states that recent medical research has found peptic
ulcers are commonly caused by the H.pylori bacterium that lives in the
stomach of most ulcer sufferers. According to the petitioner, in the
past, doctors used the endoscopy and biopsy procedure to detect the
stomach ulcers. This procedure was uncomfortable and expensive at a
cost of $1000. The petitioner states that by using a C14-urea tracer,
H.pylori can be detected noninvasively by having the patient swallow a
capsule with 30 milliliters of water. C14-urea is broken down by
H.pylori to form labeled CO2, which is expired in the breath. The
petitioner asserts that the C14-urea test could be performed by most
doctors for less than $100 cost to the patient.
Public Impact
The petitioner notes that the risks from the C14-urea test would be
very low because the 1 Ci of C14-urea consumed by the patient
is rapidly excreted as urea in the urine or CO2 in the breath. The
petitioner states that the radiation dose received by the patient would
be 0.3 millirem (an amount equal to background radiation received in 24
hours). The risk for persons administering the test would be
immeasurably low and risk to the public would be close to zero.
The petitioner indicates that the Commission's regulations
currently contain provisions for a general license whereby physicians
and veterinarians can receive, use, and dispose of byproduct material
for in vitro clinical or laboratory testing without applying for a
specific license. According to the petitioner, these recipients are
required only to be registered with the NRC. The petitioner further
asserts that the Commission's regulations permit other general licenses
that have a greater likelihood of affecting the public than the
proposed C14-urea test.
Benefits of the Test
The petitioner states that under the current regulations, the test
is 95-percent accurate and quite inexpensive because of its simplicity.
The test would permit doctors to determine easily whether or not ulcer
patients have been cured of their infection. The benefits to the
public, according to the petitioner, would be a curative therapy for
ulcers that can be made available to all people, thus saving the United
States an estimated $500 million per annum over conventional therapy.
Conclusion
The petitioner states that the test may be supplied currently only
to facilities licensed to receive C14. According to the petitioner,
this requirement makes the test prohibitively expensive for the great
majority of doctors. The petitioner states that the test is currently
being studied at four sites under a Notice of Claimed Investigational
Exemption for a New Drug (IND) application accepted by the FDA and is
also being used at other sites under approved research protocols. The
petitioner states that all of these sites are using the test under the
petitioner's IND and are also licensed by the NRC to administer C14 to
patients for diagnostic testing. The petitioner states that more than
200 tests have been performed at these additional sites and that no
adverse events from the tests performed as of this date have been
reported. Therefore, the petitioner believes that licensed
pharmaceutical manufacturers should be permitted to distribute the
capsule containing 1 Ci of C14-urea for in vivo diagnostic
testing.
Additional Documents
The petition includes additional justification and support for the
requested amendment not included in this Federal Register notice.
Members of the public interested in filing comments on PRM-35-12 can
obtain a copy of the petition and supporting documentation by writing
to the address noted above.
Dated at Rockville, Maryland, this 28th day of November, 1994.
For the Nuclear Regulatory Commission.
John C. Hoyle
Acting Secretary of the Commission.
[FR Doc. 94-29654 Filed 12-1-94; 8:45 am]
BILLING CODE 7590-01-P