[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.

-----------------------------------------------------------------------

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