ML20198J766
| ML20198J766 | |
| Person / Time | |
|---|---|
| Issue date: | 09/30/1996 |
| From: | Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-065, AF70-1-65, NUDOCS 9801140207 | |
| Download: ML20198J766 (23) | |
Text
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'*** September 30, 1996 MEHORANDUH TO:
h- .. Bangart, Director
. he of State Programs FROM: / David L. Morrison, Director f^ Office of Nuclear Regulatory [e carch
SUBJECT:
REQUESTING AGREEMENT STATE INPUT ON DRAFT RULEMAKING PLAN (PART15)
Attached is a draft rulemaking plan, entitled " Medical Use of Capsules Containing One Microcurie of carbon-14." Please forward it promptly to the Agrer. ment States allowing 30 days for their input.
It is my understanding, based on a r.onversation between yourself and Tony Tse of my staff, that a 30-day comment period would be acceptable because the rulemaking plan is not complicated.
i Also note that:
(1) The draft rulemaking plan has been marked " pre-decisional - for limited distribution,"
(2) The Commission is be'.ng provided a copy of the draft rulemaking plan via an EDO memo (draft attached), and l
(3) The CRCPD Council Chair having responsibility for the Suggested State l
Regulations will be notified by Dr. Costanzi, the RES CRCPD point of contact.
l If you have any questions, please contact Sam Jones at 415-6198.
Attachments:
- 1. Draf t Rulemaking Plan
- 2. Draft Memo to Commission l
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's NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 61 e% ...../ September 30, 1996-MEMORANDUM 10: James M. Taylor Executive Director for Operations /
-FROM: David L. Morrison. Director .
Office of lear key latory R ear
SUBJECT:
DRAFl R6 MAKING PLAN (PART 35) TO BE FORWARDED TO COMMISS10i 5'OR INFORMATION In accordar.ce with the SRM - COMSECY-96-035 dateJ June 11, 1996, a copy of a draft rulemaking plan, entitled " Medical Use of Capsules Containing One Microcurie of Carbon-14," is attached for your transmittal to the Commission
.for information.
The draft rulemaking plan has been forwarded to the Agreement States for comment.
Attachment:
As stated S
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- .....d MEMORANDUM TO: Chairman Jackson Commissioner Rogers Commissioner Dicus Cornissioner Diaz Commissioner McGaffigan
- FROM:. 13 mas M. Taylor Execstive Director for Operations
SUBJECT:
DRAF RULEMAKING PLAN (PART 35) FORWARDED TO AGREEMENT STA745 FOR THEIR INPUT In accordance with the SRM - COMSECY-96-035 dated June 11, 1996, a copy of a-draft rulemaking plan, entitled " Medical Use of Capsules containing One Microcurie of Carbon-14," is' attached for your information. The draft rulemaking plan has been forwarded to the Agreement States for comment.
Also attached for your information are two wire service articles of September 19, 1996, reporting that Meretek, Inc. announced receipt of market clearance and approval by the FDA for their breath test for detecting H. pylori' infections using non-radioactive carbon ("C).
After consider comments from .the Agreement States, I will forward the final rulemaking plan to the Commission for approval.
Attachment:
As stated cc: .0GC OCA OIP SECY
Contact:
Sam Jones, RES 415-6198-
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PRE DECISIONAL FOR LIMITED DISTRIBUTION RULEMAKING PLAN 10 CFR PART 35 MEDICAL USE OF CAPSULES CONTAINING ONE MICR0 CURIE OF CARBON-14 (PRM-35-12)
BACKGR01)E On October 0, 1994, the Commission docketed a petition for rulemaking (Docket No. PRM-35-12) from Tri-Med Specialties, Inc (Tri-Med). In a letter dated August 23, 1994, Tri-Med petitioned the NRC to amend its regulations "to allow for the general licensing and/or exemption for the commercial distribution by licensed p'harmaceutical manufacturers of a capsule containing one micro-Curie
( C1) of C-urea for in vivo diagnostic testing." The purpose of this diagnostic test is to detect the presence of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers.
" Peptic ulcer disease is a chronic inflammatory condition of the stomach and duodenum that affects as many as 10% of people in the United States at some time in their lives. The disease has relatively low mortality, but it results in substantial human suffering and high economic costs." (Source: Article included as an appendix to the petition, from JAMA, July 6,1994-Vol 272, No. 1, "H. pylori in Peptic Ulcer Disease-NIH Consensus Conference").
In the petition dated August 23, 1994, the petitioner stated the following:
Recent medical research has found that peptic ulcers are commonly caused by a bacterium called H. pylori. This bacterium lives in the stomach of most ulcer sufferers. By treating ulcer patients uith antibiotics, doctors can now cure most ulcer problems, it is therefore necessary to detect the presence of H. pylori bacteria in ulcer patients so that the new treatment can be given appropriately, in the past, this was done by a gastroenterologist who took biopsy samples of the stomach lining at endoscopy, a procedure which was uncomfortable and expensive ($1000).
With the new test H. pylori can be detected non-invasively using a "C-urea tracer. g'C-urea is broken down by H. pylori to form labeled CO, which is expired in the breath. To do the test, a doctor asks the patient to swallow the capsule with 30 mis of water.
After 15 minutes the patient blows 2 liters of breath into a collection bag (a Mylar balloon) which is mailed to a testing
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! PRE DECISIONAL FOR LIMITED DISTRIBUTIOlJ 1aboratory. If 'C-00, more than twice background is present in the 8
breath sample, then the patient must be infected with H. pylori.
Current Reaulations 10 CFR Part 32. " Specific Domestic Licenses To Manufacture or Transfer Cert..n items Containing Byproduct Materials," l 32.72, " Manufacture, Preparation, or Transfer for Commercial Distribution of Radioactive Drugs Containing Byaroduct Material for Medical Use under Pa *t 35," provides for commercial distri)ution of radioactive drugs containing byproduct material for use by persons authorized pursuant to Part 35. Thus, the regulations currently would permit Part 32 licensees to commercially distribute capsules containing 1 Ci of "C-urea to persons authorized to possess and use radioactive drugs containing-byproduct material under i 35.100.
REGULATORY ISSUE The NRC regulations set forth radiation safety requirements, including requirements for the training and experience of authorized user physicians as defined by Part 35, to assure the safe possession and use of radioactive drugs containing byproduct material. The ragulatory issue is whether the "C-urea capsules present a sufficiently small radiation risk that they can be safely possessed and administered by physicians who are not subject to these requirements.
Safety Analysis Based on a safety analysis conducted by an NRC contractor, the staff has concluded that the moutcal use of these capsules results in insignificant exposures as depicted below:
P".E DEC S!ONAL FOR L!M'TED-GGTWOUT;ON
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PP DECISIONAL - FOR LIMITED DISTRIBUTION Scenario Maximum Exposed Routine Exposure Individual Worker administering Full time worker, 8,000 Less than 0.7 mrem /yr "C-urea breath tests patients /yr Routine exposure of Patient tssts negative 0.38 mrem / capsule patients from "C-urea breath tests Patient tests positive 0.18 mrem / capsule Release of 150 pCi of Member of public in the Less than 0.0002 mrem "CO, into administration administration area area Rupture of a capsule Skin (100 cm') exposed 5.8 mrad skin dose causing skin contamit- for one hour prior to 0.075 Ci skin ation of worker or washing absorption 0.029 mrem patient CEDE Pathways to the Environment Based on an environmental report prepared by an NRC contractor, the staff concluded that the impacts associated with any releases of "C to the surrounding environment are expected to be very small and the expected risks are minimal.
The earth's atmosphere contains an inventory of naturally occurring "C of about 3.8 million curies (equivalent to the activity in 3.8 trillion breath tests), which is in addition to the huge inventory of about 240 million curies in the world's oceans. The "C released into the atmosphere from the use of this test would mix with the global inventory and expose the public and other biotic components of the environment to "C intakes from inhalation, drinking water, and all possible food pathways in the same manner as naturally occurring "C. The current world inventory of naturally occurring "C results in an average dose to the public of about 1.25 mrem / year, and the release of 0.6 curies of "C from the total of 600,000 tests assumed to be administered annually (see the REGULATORY ANALYSIS section below) would result in an additional average annual dose of 2 X 10" mrem. This is far below the EPA reporting level of 1 mrem / year required under the Clean Air Act for routine exposures to a member of the public, or the 4 mrem / year EPA limit for public drirking water, in a total population of about 260 million people in the U.S.,
the collective annual dose from the breath tests would be about 0.051 person-rem. In addition, the doses from normal use of breath tests, or from any accidental release of "C to the environment also are expected '.o be very
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i PRE DEC!SIONAL FOR LIMITED DISTRIBUTION small because the concentration of CO, released is very low and it would mix immediately with the atmosphere.
Collective Exomuros to Members of the Public The small doses from naturally occurring "C are of little significance to human health and the environment. Potential long-term impacts from widespread releases of the long-lived "C (5,730-year radiological half-life) from breath tests were .oncluded to be insignificant. Assuming that the testing in the U.S. would increase over a period of time to an average of a million tests )er year for 50 years, the collective annual dose to the U.S. population would se about 5 person-rem over the next 50 years. This dose is very small when compared to the annual collective dose to the U.S. population from naturally occurring "C of over 300,000 person-rem, and about 78,000,000 person-rem from all naturally occurring radiation. Clearly, an ir. crease of a few person-rem will not significantly change these exposures, and thus inere is no expected impact from the widespreaa use of the breath test on the entire U.S.
population.
AllERNATIVES CONSIDERED AND RECOMMENDED COURSE Of ACTION The following three alternatives have been considtred:
Alternative 1 - Deny the petition, Alternative 2 - Grant the petition via an exemption to permit physicians who are not " authorized users" to receive and use capsules containing 1 Ci of "C-urea.
Alternative 3 - Grant the petition via a general license to permit physicians who are not " authorized users" to receive and use capsules containing 1 Ci of "C-urea.
Alternatiuh Deny the N.ition This alternative would maintain the status quo. Only physicians who are authorized users under Part 35 would be allowed to possess and administer the "C-urea test. Any physician could apply to besome an authorized user.
llowever, the NRC expects few physicians would apply for a Part 35 license for the sole purpose of using such capsules because of the requirement for training and experience and the associated costs of obtaining 6,;d maintaining a Part 35 license. Alternatively, physicians who are not authorized users could refer their patients to physicians who are authorized users to undergo PRE-DEGtslONAL - FOR-LIM;TEO OtSTRtBUTieft---
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i PRE DECISIONAL - FOR LIMITED DISTRIBUTION the diagnostic test, but this would add expense, inconvenience, and delay to an otherwise straight-forward procedure.
This citernative serves as the base case from which the other alternatives are evaluated.
Alternative 2 - Grant the petition via an exemption to permit physicians who are not " authorized users" to receive and use capsules containing 1 Ci of "C-urea This alternative would permit the receipt and medical use of capsules containing 1 pCi "C-urea by physicians who are , A authorized users.
However, manufacture and distribution of exempt materials can only be made by NRC licensees; Agreement States licensees who intend to manufacture or
. distribute such capsules would need to obtain an NRC manufacture and
-distribution license in addition to their Agreement State license (10 CFR 150.15(a)(6)). Therefore, this alternative is not recommended.
Alternative 3 - Grant the petition via a general license to permit physicians who are not " authorized users" to receive and use capsules containing 1 pCi of "C-urea This alternative would permit physicians who are not authorized users to receive and use ca Ci "C-urea for medical use under a general license.' psules containing 1 This alternative is preferred over the base case (Alternative 1) for the following reasons:
o Health and Safety As noted earlier, a detailed safety inalysis was performed that analyzed public, worker, and patient radiation safety hazards associated with
' The concept of a general license for medical use is not new. Prior to 1987, Part 35 regulations permitted the medical use of certain radioactive drugs under a general license to physicians who were registered. Registration certificates would not be necessary for "C because, as discussed in the SAFETY ANALYSIS section . radiation safety concerns associated with the use of these -
capsules are' insignificant. The general license was deleted from Part 35 because '
of- the-low level of use.
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PRE DECISIONAL FOR LIMITED DISTRIBUTION- t handling and administering the capsules from the point of distribution ;
through waste disposal. Besed upon the conservative analyses of the ,
radiological impacts, there do not appear to be any safety or technical.
reasons why the capsules, breath test materials, counting fluids and vials, and urine from patients cannot be treated as if they were not-radioactive. Further, the radiological impact to the workers, patients, and the general public would be the same regardless of whether the physician is or is not an authorized user. Therefore, the NRC maintains that it is not necessary for a physician to meet the tra.ning and experience requirements in i 35.910 if the physician's medical use of-byproduct material is limited to these capsules. The NRC takes this position because the radiological risk associated with such use of '
capsules is considered insigniffcant.
o Avoided Costs' Under Alternative 1 (the base case), physicians who are not authorized Lusers would have to refer patients to authorized users to undergo the '
diagnostic test. These referrals could be avoided under Alternative 3 since physicians who are not authorized users could administer the test directly. Patients would realize savings in reduced travel expenses and personal time. In addition, certain medi,al. costs associated with the -
referral,-such as completion of new paperwork, reviewing the patient's
' health history, maintaining a second set:of records, etc., could be eliminated.
o Other Considerations Alternative 3 avoids the problem discussed in Alternative 2 regarding 10 CFR 150.15(a)(6), which would require Agreement States licensees (i.e., manufacturers and distributors) to obtain an NRC license to
-manufacture er distribute exempt material.
Alternative 3 inposes no paperwork costs and license fees on physicians who are not authorized users, and it imposes no regulatory burden on the NRC.
Recommended Course of Action i
.The staff recommends proceeding with a direct final rule amending Part 35 in conformance.with Alternative 3..
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PRELIMINARY REGULATORY ANALYSIS FOR ALTERNATIVE 3 In the letter dated August 23,. 1994, the petitioner stated, If exempted, the C-14 breath test could be done by most doctors for less than $100 cost to the patient. This is a considerable savings over endoscopy and biopsy ($1000).
In a letter on November 30, 1994, the petitioner stated:
... The test is 95% 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. By providing the public with an inexpensive, easily accessible diagnottic test, more individuals would be accurately diagnosed and treated for their H. pylori infection. This would save the United States an estimated $500 million per annum over conventional therapy.
Tri-Med estimates annual benefits to be on the order of $500 million/ year.
This assumes approximately 500,000 "C-urea breath tests / year, at an average cost of $100, in lieu <of performing endoscopy at an average cost of
$1000/ test. It assumes that the lower cost and greater wailability of an unregulated breath test would result in a complete substitution for endoscopy.
Tri-Med's benefit analysis provides a measure of the total benefits associated with the test and does not focus on the incremental benefits of administering the test pursuant to 10 CFR 35.100 regulation (statu: quo) versus releasing the test to all physicians (NRC licensed and non licensed alike). Implicit in Tri-Med's estimated annual benefits is the presumption that none of these "C tests and corresponding savings would accrue if the petition were denied. In reality, under the status quo, the test would be available and administered by physicians or clinics holding a license under NRC's Part 35. Further, Tri-Med's estimate did not allow for the substitution of other non-invasive tests (e.g., serological test for igg antibodies to H. pylori antigens) for both endoscopy and "C-urea tests. In addition, wire service articles dated September 19,199f>, stated that the FDA has approved a non-radiological diagnostic breath test using "C for detecting the presence of H. pylori infections.
The staff's benefit analysis focuses on the incremental tunefits of granting relief based on the petition. The analysis looks solely at changes relative to the base case or status quo. In this analysis, the comparison is between regulated and unregulated "C-urea breath tests, not unregulated "C-urea
- Veath tests and endoscopies or other non-invasive tests. For the purposes of this regulatory analysis, the staff assumes that the same number of breath
. tests (i.e., 600,000 tests) will be administered regardless of the level of NRC regulatory. control . This view is predicated on the belief that each rn: DEC10:0NAL - refFtdMITED DISTRIBUTION 7
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O PRE-DECISIONAL. - FOR LIMITED DISTRIBUTION physician's primary motivation is to provide the best possible care to his or her patients. If the breath test is judged preferable to endoscopy, or other procedure, any physician not authorized to use the test will refer his or her patient to authorized users who could perform the test under existing NRC regulations. This appears fully consistent with standard medical practice, whereby patients are referred routinely to laboratories and specialists for a wide array of tests and procedures.
In the NRC's analysis,_the benefits of adopting the petition accrue as a result of reduced patient cost and reduced health care cost resulting from the elimination of the need for referrals from a physician who is not an authorized user (e.g., gastrointestinal specialist). There would also be some regulatory savings because the NRC would not have to expend resources reviewing new applications for specific medical _ use licenses. However, these
~ savings would be small because the NRC expects that few physicians who are not
- authorized users would apply for a specific NRC license for use of this one product.
NRC's benefit calculation is based on the assumption that a significant portion of the. 600,000 patients would receive the "C breath test from physicians who are not authorized users (e.g., gastrointestinal specialists) instead of authorized users (e'.g., nuclear medicine specialists). The actual savings attributable to Alternative 3 would be dependent on the number of tests ultimately administered by physicians who are not authorized users, thereby eliminating the need for a referral.
The annual savings could be as high as approximately $20 million if there was a complete shift of the administration of the tests from physicians who are authorized users (i.e., base case) to physicians who are not authorized users.
The basis for this estimate is as follows.
Assuming Alternative 3 eliminates the need for 600,000 referrals, patient savings in averted travel expenses (transportation and personal time incurred with medical referral) would be:
Assuming round trip of 20 miles 0 $0.25/ mile, and personal time of 0.5/ hours / trip valued at $25.00/ hour 600,000 trips / year x (20 miles / trip x $0.25/ mile + 0.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / trip x
$75.00/ hour) - $10.5 million/ year PRE-DECisl0NAL FOP. LIM:TCO 0:0Tm0UT;ON 8
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PRE-DECISIONAL - FOR LIMITED DISTRIBUTION Health Care Savings in averted administrative expenses (administrative costs incurred with medical referral) would be:
/
600,000 patients / year x $19.00/ patient = $11.4 million/ year Assuming $19.00 (administrative cost / patient) as the differential between the cost of an office visit to a general family practice physician by an established patient ($45.90), and the cost to a new patient ($64.90 per visit) for completion of new patient paperwork, reviewing health history, maintaining medical records, etc. The patient who is referred to an authorized user ;e.g., nuclear medicine specialist) for the "C-urea breath tes', would most likely be a new patient for the authorized user.
Total Savings:
$10.5 million/ year + $11.4 million/ year = $ 21.9 million/ year Alternatively, if only 200,000 or 400,000 of the 600,000 tests were p e formed by a physician who is not an authorized user, the annual cost savings would be approximately $7 million/ year and $15 million/ year, respectively.
COMMENTS FROM THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES (ACHUI)
This petition was discussed with the ACMUI at the October 1995 meeting. The ACMUI indicated that it endorsed the wide availability of this diagnostic test and that the radioactive drug could be used under a general license or an exemption, whichever the NRC thought to be procedurally easier.
COMMENTS FROM THE PUBllC The " Notice of receipt of petition for rulemaking" was published for public '
comment in the Federal Reaister on December 2, 1994 (59 FR 61831). A total of 315 public comment letters, 313 supporting (mostly form letters) and 2 opposing letters, were received.
The two letters opoosing the petition made the following two comments:
'(1) The product should not receive an exempt status because the uncontrolled distribution and application of this product could lead to significant risk to the public, and (2). Medical uses should be restricted to short-lived isotopes because of disposal problems presented by long-lived isotopes.
""E DEC!C!ON ^.L FOR LM TED 0:0TnlCUT;GN 9
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i PRE DECISIONAL - FOR LIMITED DISTRIBUTION The staff disagrees with both comments.
(1) As shown in the " SAFETY ANALYSIS" section of this plan, the radiation dose tc, workers, patients, and the public is very low.
(2) As discussed in the " Pathways to the Environment" section of this plan, the impacts associated with any releases of "C to the surrounding ,
environment are expected to be very small and the expected risks are minimal. Also, as discussed in the " Collective Exposures to Members of the Public" section of this plan, the small doses from naturally occurring "C are nf little significance to human health and the environment. Potential long-term impacts from widespread releases of the long-lived "C (5,730-year radiological half-life) from breath tests were concluded to be insignificant.
BASES FOR THE RECOMMENDATION (1) Relative to the status quo (Alternative 1), the recommended alternative poses no significant radiological risks and no significant health, safety, or environmental impacts.
(2) The preliminary cost / benefit analysis indicates that, if Alternative 3 were adopted, the affected patient population could realize significant cost savings.
(3) The petition has been endorsed by the ACMUI.
(4) The majority of public comment letter s supported the petition and the two opposing comments have been addressed.
BASES FOR THE RECOMMENDATION FOR A DIRECT FINAL RULE (1) Proceeding via a direct final rule (versus a proposed rule / final rule) is recommended. The staff dcas not expect significant adverse comments because this rule would only make use of this diagnostic test more convenient and less expensive. The health and envircnmental impacts remain insignificant. >
(2) The overwhelming majority of the public comments in response to the
" Notice of Receipt of the Petition" were favorable. The two opposing comments received in response to the " Notice of receipt of petition for rulemaking" will be addressed in the direct final rule.
PRE DEC:0 ONAL FOn UM;TED 0;STn;;UT;CN 10
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PRE DECISIONAL - FOR LIMITED DISTRIBUTION ,
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-(3) The staff will' prepare a companion proposed rule,' to be published ut the same time as the direct final rule, in the event any significant opp.;;ng comments are received.
(4) The use of the direct final rule could resolve this petition in a time frame consistent Mith FDA approval expected early next year, so that the product'would be made available as soon as practical. To the extent possible, the staff intends to publish this rule close to the time when FDA approves this radioactive drug as a New Drug Appraval (NDA).
AGREEMENT STATE IMPLEMENTATION A general license for medical use in Part 35 would be a Division 3 item of
~ compatibility for tha Agreement States. Division 3 regulations are appropriate for the Agreement States to adopt, but do not require any degree of uniformity between NRC and Agreement State rules.
0GC LEGAL SUFFICIENCY ANALYSIS DEMONSTRATING THAT NO KNOWN BASIS EXISTS FOR LEGAL OBJECTION The proposed rulemaking would amend 10 CFR Part 35 to provide a general license.for physicians (including those who are not " authorized users") to receive and use for diagnostic medical use capsules containing 1 Ci "C-urea.
0GC has taviewed the rulemaking plan, including the proposed approach of a
" direct- final rule." No significial impediments to promulgation of a " direct final rule" drafted along the lines discussed in the plan are anticipated.
0GC has not identified any environmental or Paperwork Reduction Act issues that would-present significant difficulties in pursuing the proposed course of action._ However, in developing the actual rule language, consideration should be given to the istue of whether any general license conditions (such as those in former 10 CFR 35.31, " General License fur Medical Use of Certain Quantities of Byproduct Material") are appropriate.
Since the proposed direct final rulemaking plan would address the resolution of PRM-35-12, the staff will need to ensure that appropriate procedural actions are taken to close the actions associated with that petition. These actions include specifically granting or denying the petition for rulemaking, either in the Federal Register notice associated with the rulemaking or in a separate Federal Register notice,- and informing the petitioner of the Commission's decision. The detailed procedures for responding to the rulemaking petition are contained in Part 11 of the Regulations Handbook (NUREG/BR-0053, Rev. 3).
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?RE DECISIONAL - FOR LIMITED DISTRIBUTION ASSESSMENT OF LIKELY IMPACTS ON NRC AND AGREEMENT STATE LICENSEES
.This rulemaking would not result in any additional regulatory burden to NRC medical use use receive and licensees. Authorized this product users use.
for medical would continue to be authorized to SUPPORTING DOCUMENTS A regulatory analysis and an environmental assessment will be provided for this rulemaking.
RESOURCES Resources to complete and implement this rule are included in the current
. budget.
LEAD OFFICE STAFF AND STAFF FROM SUPPORTING OFFICES '
Staff-level Workina Grogg Concurrino Official RES - Sam Jones Bill M. Morris NMSS - Donna-Beth Howe Donald A. Cool OGC - Marjorie Rothschild Stuart A. Treby OSP - Lloyd Bolling Richard L. Bangart ADM - Mike Lesar David L. Meyer STEERING GROUPS / WORKING GROUP There is no need for a steering group for this rulemaking. The Working Group is identified above.
ENHANCED PUBLIC PARTICIPATION This rulemaking will be placed on the electronic bulletin board at FedWorld and will also be published in the Federal Reaister.
Int-DEC:0 OMAL - T0n L M;TCO DISTRIBUTION 12
F PRE-DECISIONAL - FOR LIMITED DISTRIBUTION EDO OR COMMISSION ISSUANCE Because the amendment represents a significant policy issue (i.e., permitting the " medical use" of a radioactive drug containing byproduct material by physicians who are not authorized users"), it is recommended that the Commission issue the rule.
SCHEDULE Direct Final Rule (DFR)*: Weeks from the date ED0/Comm anoroves the Rulemakino plan Send DFR to office for concurrence 2 weeks **
Send DFR to EDO 6 weeks Send DFR to Commission 8 weeks Receive Commission approval 10 weeks Publish in Federal Reaister; 13 weeks submit letters to Congress /GA0 (non-major rule)
- Including a companion proposed rule.
- Assuming RES staff will start work on DFR after sending the rulemaking plan to Agreement States for review.
P9E DECISIONAL FOP. L!MlTEO DISTillOUTlON 13
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\g W MEMORANDUM 10: Chairman Jackson Commissioner Rogers Commissioner Dicus .-
Commissioner Diaz
-Commissioner McGaffigan FROM:
James M. Taylor Executive Director _for Operations
SUBJECT:
DRAFT RULEMAKING PLAN (PART 35) FORWARDED TO AGREEMENT STATES FOR THEIR INPUT In accordance with the SRM - COMSECY-96-035 dated June 11, 1996, a copy of a draf t rulemaking plan, entitled " Medical Use of Capsules Containing One Microcurie of Carbon-14," is attached for your information. The draft rulemaking plan has been forwarded to the Agreement States for comment.
Also attached for your information are two wire service articles of September 19, 1996, reporting that Heretek, Inc. announced receipt of market clearance and approval by the FDA for their breath test for detecting H. pylori infections using non-radioactive carbon ("C).
After consider comments from the Agreement States, I will forward the final rulemaking plan to the Commission for approval. .
Attachment:
As stated cc: OGC OCA OlP SECY
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Page 3 2ND STORY of Level 1 printed in TULL format.
Copyright 1996 PR Newswire Association, I n,c .
PR Newswire September 19, 1996, Thursday SECTION: Financial News A
DISTRIBUTION: TO BUSINESS EDITOR 1.ND MEDICAL EDITOR LENGTH: 1068 words J HEADLINE:
Heretek Breath Test Receives FDA Approval for Detecting Ulcer-Causing Bacterium; Non-Radioactive heretek UBT(TM) Breath Test Offers First Non-Invasive, Technology for Direct Detection of Active H. pylori Infection in Patients with Peptic Ulcer Disease DATELINE: NASHVILLE, Tenn., Sept. 19 BODY:
Today, Heretek, Inc. announced receipt of market clearance and approval for their innovative diagnostic breath test for detection of the ulcer-causing The bactarium, Helicobacter pylori, by the Food and Drug Administration (FDA).
MERETEK UBT(TM) Breath Test for H. pylori is the first and only breath test for diagnosis of H. pylori cleared and approved in the United States utilizing patented non-radioactive technology.
The MERETEK UBT Breath Test for H.
pylori provides a uniquely simple, non- invasive, accurate and cost effective means for direct detectiogcan of an active infection of the H. pylori bacterium so appropriate treatment In a multi-center study be prescribed and an ulcer can be cured. the published earlier this year in the American Journal of Gastroenterology, HERETEK UBT Breath Test detected the presence or absence of H. pylori with 95 percent accuracy.
A Long-Awaited Diagnostic Alternative pyloci infection Until now, the only way to accurate . diagnose active H.
has been endoscopy with stomach biopsy -- a costly, invasive and uncomfortable procedure that involves sedating the patient, inserting a tube into Blood the tests stomach and removing a sample of the stomach lining for analys.s. requiring are designed to detect antibodias to the bacterium and are invasive, a needle puncture.
These tests can't always reliably determine if a patient is actively infected. Antibodies remain in the blood after a previous exposure or infection for many months and can-be detectable via blood test, even if an infection is-not present in the stomach.
In striking contrast, accura *.e diagnosis with the MERETEK.UBT Breath Test is easily achieved at a fraction of the cost of endoscopy with stomach biopsy.
Now-a patient can be reliably diagnosed for H. pylori without this invasive procedure. President and CEO of Meretek, Inc., "This According to Claudia Hitchcock, decision by the FDA is a momentous milestone for our company and paves the way for the introduction of this breakthrough tr ahnology through our first available to product. We have initiated our plans to take the product ,(
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I Page 4 PR Newmire, SeptemNr 19, 1996 physicians later this fall. We are excited by the FDA's clearance of our in the disease management cpplicmtion. This test provides the missing piece model for ulcer disease. People can now be easily tested and treated, which reductions for this dinease."
will ultimately provide the predicted cost This simple, painless procedure can be performed,with Meretek's 30 minutesUDTto Breath Test Collection Kit in the doctor's office and takes about complete. The patient drinks a new non-radioactive diagnostic drug, Pranactin(TM) solution, and then exhales also breath c*mples into a specially-contains the components to send the designed collection device. The kit breath samples to Heretek for analysis, with results promptly provided to the physician.
Heretek har established a centralized testing facility in research facility, will Nashville, TN, which, along with its Houston, TX, The company provide this service t- physicians and healthcare providers.
enticipates expansion of its facility as well as license opportunities for those clinical settings who may wish to perform the analysis on-sito.
Patented, Non-Radioactive Breath Test Technology Unlike another manufacturer's breath test which is still in the pylori is entirely the MERETEK UBT Breath Test for H.
investigational stage,Meretek's diagnostic Pranactin drug uses carbon 13 (13 C) non-radioactive. non-radioactive compound to determine enriched urea, a naturally occurring, the presence or absence of an active infection.
Easy on the Patient M.D., President of Gastrointestinal Associates, said Bergeln F. Overholt, "The MERETEK UBT Dreath Test provides a long-awaited P.C., in Knoxville, TN, in a means for detecting H. pylori infection accurately The andavailability cost effectively, of this manner that's safe and painless for the patient. pylori significant medical advancement for diagnosis of patients with H.
community because of the
-inf ection has been anticipated within the medica:
increasing awareness of the risks associated with this pathogen." pylori in peptic The groundbreaking discovery of the causal role of H.in how ulcers are diagnosed and ulcer disease is causing a paradigm shift treated. Peptic ulcer disease -- a condition characterized by chronic inflammation and painful sores in the lining of the stomach or An part of the 10 estimated small intestine -- afflicts millions of Americans every year. some percent of the American population is affected by peptic ulcer disease atand an e point in their lives, infected by this bacterium. infection is "Accurata detection of the presence or absence of this Graham, M.D., Professor of critical to su mossful therapy," said David Y. Baylor college Medicine and Mo ecular Virology, chief of Digestive Diseases atand head of Castroentero of Medicine, Houston, TX, we now achieve a Houston. With the approval of the MERETEK is UBT Breath safe for the Test, patient and easy to conclusive dingnosis with technology that use.* and coo of Meretek, Inc., "Today's As stated by Kerry Bush, Vice President environment demands medically sound patient care which must be cost effective.
proper diagnostic assessment results Indiscriminate use suffering of antibiotics and higher without medical costs.
This test is the only in. greater patient detection of alternative to' endoscopy / biopsy procedures for reliable direct the presence or absence of active H. pylori infection." non-invasive, Meretek in principally engaged in the dewelopment of simple, The f, non-radioactive breath tests that result in a better quality of life.
Page 5 1
l PR Newswne. Septemt - 19, 1996 company holde exclusive licenses to patents xnvolving non-radioactive breath test technologies. Heretek is headquartered in Nr.shville, TN, with research and development facilities in Houston, TX. Customers can call 1-888-MERETEK (1-888-637-3835) for more information about the HERETEK UBT Breath Test for H.
pylori.
SOURCE Meretek
/For interviews and additional information, see contact /
CONTACTS. Karen Barzilay, ext. 237, or Lisa Waters, ext. 246, both of BBK, 617-630-4477 LANGUAGE: ENGLISH LOAD-DATE: September 20, 1996
Pue6 i ,
I 3RD STORY of Level 1 printed-in FULL format.
Copyright 1996 Reuters, Limited Reuters tiorth American Wire September 19, 1996, Thursday, BC cycle LENGTH: 134 words PEADLINE: U.S. okays brceth test for ulcer-causing bacteria DATELINE: WASHINGTON BODY:
A brnith test for the bacteria that cause peptic :lleers was approved Thursday -
by the U.S. Food and Drug Administration, the test's maker said.
The test, manufactured by Nashville, Tennessee-based Meretek, involves drinking the diagnostic drug Prar. actin and exhaling into a collection device, which is then sent to the company's labort..ories for analysis.
The test detects the presence or absence of Helicobacter pylori, the bacteria shown to cause peptic cleers, no that patients can be appropriately treated.
Other tests for the presence of the bacteria have involved endoscopy with stomach biopsy, which involves sevating the patient, placing a tune into the stomach and taking a sample of the stomach lining for analysis, the company said.
There arc also blood tests for the bacteria.REUTER LANGUAGE: ENGLISH ,
LOAD-DATE: September 20, 1996
\ ..
MEMORANDUM 10: Chairman Jat. on Comissioner Rogers Commissioner Dicus Comissioner Diaz Commissioner McGaffisan FROM: James M. Taylor Executive Director for Operations
SUBJECT:
DRAFT RULEMAKING PLAN (PART 35) FORWARDED TO AGREEMENT STATES FOR THEIR INPUT In accordance with the SRM - CONSECY-96-035 dated June 11, 1996, a copy of a draft rulemaking plan, entitled " Medical Use of Capsules Containing The draftOne Microcurie of Carbon-14," is attached for your information.
rulemaking plan has been forwarded to the Agreement States for comment.
Also attached for your information are two wire service articles of September 19, 1996, reporting that Meretek, Inc. announced receipt of market clearance and approval by the FDA for their breath test for detecting H. pylori infections using non-radioactive carbon ("C).
Af ter consider comments from the Agreement States, I will forward the final rulemaking plan to the Commission for approval.
Attachment:
As stated cc: OGC OCA OIP SECY
Contact:
Sam Jones, RES 415-6198 Distribution: R8angart, OSP CTrottier/RPHEB rf File Center LBolling, OSP CPaperiellt, NMSS STreby, OGC DBHowe, NMSS MRothschild, OGC ATse
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ETE: 9/18/96 OFFICE: EDO NAME: JTaylor DATE: 9/ /96 0FFICIAL REC 0'RD COPY RES FILE CODE NO.: 3A-3
MEMORANDUM TO: Chairman Jackson Commissioner Rogers Commissioner Dicus /
Commissioner Diaz /
Commissioner McGaffigan f
/
-FROM: James M. Taylor Executive Director for Operati is/
2
SUBJECT:
DRAFT RULEMAKING PLAN (PART 5) FORWARDED TO AGREEMENT STATES FOR THEIR INPUT In accordance with the SRM - COMSECY- -035 dated June 11, 1996, a copy oi a draft rulemaking plan, entitled " Medical Use of Capsules Containing One MicrocurieofCarbon-14,"isattapfedforyourinformation. The draft rulemaking plan has been forwar (d to the Agreement States for comment.
Af ter consider comments fro /the Agreement States, I will forward the final rulemaking plan to the Co ssion for approval.
Attachment:
As state cc: OGC OCA OlP SECY Distribution:
CTrottier/RPHEB rf File Center CPaperiello, NHSS DBHowe, NMSS RBangart, OSP LBolling, OSP STreby,-OGC MRothschild, OGC ATse DOCUMENT NAME: g:\ jones \agr-sts.rev
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l MEMORANDUM T0: James M. Taylor __
Executive Director for Operations FROM: David L. Morrison, Director Office of Nuclear Regulatory Research
SUBJECT:
DRAFT RULEMAKING PLAN-(PART 35) TO BE FORWARDED TO
-COMMISSION FOR INFORMATION In accordance with the SRM - COMSECY-96-035 dated June 11, 1996, a copy of a draft rulemaking plan, entitled " Medical Use of Capsules Containing One Microcurie of Car]on-14," is attached for your transmittal to the Commission for information.
The draft rulemaking plan has been forwarded to the Agreement States for comment..
Attachment:
As stated Distribution:
- CTrottier/RPMEB rf File Center LRiani CGallagher NCostanzi-0Mendiola '
ATse DOCUMENT NAME: g:\ jones \agr-sts.rev *""****4*"* ' *"" ' * * "" """
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0 9/ 96 9/ (/96 DATE: 9/C)/96 9/ 24 /96 ,_ ,
0FFICIAL RECORD COPY ,
RES FILE CODE NO.: V, >
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