ML20198J869
| ML20198J869 | |
| Person / Time | |
|---|---|
| Issue date: | 09/19/1996 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-068, AF70-1-68, NUDOCS 9801140231 | |
| Download: ML20198J869 (16) | |
Text
_ . - _ .- _ _ . . = .
l p.m u cc: Trottier S UNITED STA1 ES
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,j Jones g NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20666 4001 o,
% . . . . . y[ September 19, 1990 gg7()_/ l MEMORANDUM T0: David L. Morrison, Director Nb Office of Nuclear Regulatory Research
' f' ;
FROM: Carl J. Maperiello, Director [M [ '/, u, c 'tu ' - l Office of Nuclear Material Safety l
. and Safeguards l
SUBJECT:
RULEMAKING PLAN: 10 CFR PART 35 MEDICAL USE OF CAPSULES CONTAINING ONE MICR0 CURIE OF CARBON-14 (PRM-35-12)
I am responding to your Rulemaking Plan, received September 16, 1996, requesting Office concurrence on the rulemaking package for a direct final rule. The staff cone"rs with the rulemaking package subject to consideration of the attached comments provided as a markup of your doce-ent. The staff is available to meet with you to discuss the comments if necessary.
Attachment:
Markup of your Document
Contact:
Donna-Beth Howe, NMSS 415-7848 l
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9901140231 990109
' P DR - PH 30 62FR32552 PDR ev-,,,vu - ,-
- nwn / gses l NMLS M (w cw v e I
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RULEMAKING PLAN Lead Office: Office of Nuclear Regulatory Research Staff
Contact:
S. Jones, RES/RPHEB Concurrences:
D. Morrison, RES Date
[$ $ l fatte'ta $ 9Date ll1 0' C. Paperiplo, fpiS l
R. Bangart, OSP Date W. Olmstead, OGC Date D. Meyer, ADR Date Approval:
J. Taylor, EDO Date Attaclinent a
RULEMAKING PLAN 10 CFR PART 35 MEDICAL USE OF CAPSULES CONTAINING ONE MICR0 CURIE OF CARBON-14 (PRM-35-12)
Backaroud On October 6, 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 retrdations "to allow for the general licensing and/or exemption for the commercial distribution oy ifcensedp'harmaceuticalmanufacturersofacapsulecontainingonemicro-Curie g
( Ci) 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 s JAMA, July 6, 1994-Vol 272, x 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 comn.aly caused by a bacterium called H. pylori. This bacterium lives in the stomach of most ulcer sufferers. By treating ulcer patients with antibiotics, doctors can now cure mnst 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 .lon-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 laboratory. If "C-00, more than twice background is present in the breath sample, then the patient must be infected with H. pylori.
the test must be supplied only to facilities licensed to Currently',C receive . This requirement makes the test prohibitively expensive for the great majority of doctors.
I
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2 Current Reculations 10 CFR 30,14, " Exempt Concentrations.", states that the exemption does not apply to the transfer of byproduct material contained in-any food, beverage,
. cosmetic, drug, or other commodity or product destgr,ed for ingestion or inhalation by,' or application to, a human being.
10 CFR 30.18 " Exempt Quantities," sets forth the provisions for exempt quantities, which for "C is 100 C1. Since the rule language of 6 30.18(a)
- states: "
. . . any person is exempt ... from the regulations in parts 30 through 34, 36 and 39 of this chapter ...," it is clear that, due to the absr.nce of a-.n h e 4
+o Part 35 in the rule language, medical use is not exempt under this regulatten.
10 CFR Part 32.72, " Manufacturers, preparation, or transfer for commercial
~ distribution of radioactive drugs containing byproduct material for medical 8 use'under Part 35," provides the provisions *for commercial distribution of radioactive drugs containing byproduct material for use by persoas authorized '
pursuant to Part 35. The regu1 3 tions currently permit Part 32'ldcensees to X commercially distribute capsule:containing one micro-Curie ( Ci) of "C-urea to persons authorized in Part 35.
10 CFR Part 35, " Medical Use of Byproduct Material" currently permits the medical,use of radioactive drugs containing byproduct material (s' including g capsule 3containing one micro-Curie ( Ci). of ' C-urea)) for medical use by any physician, who is-an " authorized user" under 535.100, er an indWidual working under the supervision of the authorized user.
10 CFR 35.100 'Use of unsealed byproduct materials for uptake, dilution, and excration studies" provides the condites for use of unsealed byproduct :
material for uptake, dilution, and excretion studies. Capsule!containingone x micro-Curie ( Ci) of "C-urea for in vivo diagnostic testing are currently regtilated under 135.100 as an excretion test.
10 CFR 35.910. " Training for uptake 3 dilution 3and excretion studiess", provides u the training and experience requirements physicians must meet to be These provisj authorized userstofor v be:the medical use of $35.100 materials.(1) certified in one of t require physician 35.100(a),e.g.: Nuclest medicine by the American Board of Nuclear Medicine; or (2) .had.40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of classroom and laboratory training in-basic radioisotope handling. techniques applicable to the use of prepared radioparmaceuticals, and-requires-20 hours of supervised clinical experience; or (3) successfully completed a six month training' program in nuclear medicine.
~ Reaulator_v Issue Should NRC amend ~its regulations to permit physicians who are not " authorized users"-(i.e. do not meet NRC's training and experience requirements for the medical.use~of- 135.100 materials) to receive and use capsules containing one
- micro-Curie- (yCi) of "C-ureal - x L uc w wo uc T
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i Safety Analysis men"
- f A safety analysis, conducted by an NRC contractor, concluded that the use of these capsules results in insignificant exposures, as depicted below:3 j I
Scenario -Maximum Exposed _ Routine Exposure ,
Individual ;
Worker administering full-time worker, Less than 0.7 mrem /yr.
"C-urea breath tests 8,000 patient /yr
- Routine exposure of Patient tests negative 0.38 mrem / capsule
. patients from "C- Patient tests positive 0.18 mrem / capsule urea breath' tests Release of 150 pCi of Member of public less-than 0.0002 mrem I
"CO, into administra- in the adminstra-tion area tion area ;
Rupture of a capsule Skin (100 cm') exposed 5.8 mrad skip dosgs- !
for one hour prior to FJ causing skin contami- 0.029 mrem /CEDEJ nation of. worker or washing; 0.075 Ci skin patient- absorption Pathways to the Environment x
(environmentalreport,conductedbyanNRCcontractor,concludedthatthe impacts associated with any releases of "C to the surrounding envir:,nment are expected to be very small and the expe::ted risks are minimal.
The earth's atmosphere contains an inventory of naturally-occurring "C of about 3.8-n.illion 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 and ocean'? floor. -The "C released into the atmosphere would mix with the global inventory and expose the public and other biotic comronents of the environment to ' C intakes from inhalation, drinking water, and all possible food-pathways in the same manner as naturally-occurring "C.
'Since the current world inventory of naturally-occurring "C results in an average: dose to the public of 'about 1.25 mrem / year, releases of 0.6 curies of "C from breath tests would result in a" average annual dose of 2 X 10" mrem. x In' a' total population of about 260 million people in the 'U.S., the collective annual dose wculd be about 0.051 person-rem.. The doses from normal use of ~
breath tests are also below any Federal (NRC and EPA) regulatory limits, and 1 mrem / year required under the Clean Air
- Act arefor below the Ef; reporting level routine uxposures to member, o{of the public, or 4 mrem / year EPA limit v for public drinking water, impacts associated with any releases of "C to.
Tsurrounding: environmental media are expected to be very small due to the fact
'that the concentration of CO, released is very low- and would.be mixed into the tatmosphere immediately.
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Collective Exposures to Members of the Public The'small increases in doses from naturally-occurrino "C are of little siontficance to human health and the environment. Potential long-term impacts l from wide-spread releases of the long-lived "C (5.730 year radiological !
half-life) from breath tests was considered 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 per year for 50 years, the collective annual dose to the U.S. would be 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 78,600,000 ;
- person-rem from all naturally occurring radiation. Clearly, an increase of a few person-rem will not significantly change these exposures, and there would be no expected impact from the widespread use of the breath test on the entire '
U.S. population.
Alternatives Considered (includes Recommended Course of Action) _
The following three alternatives have been considered:
Alternative 1 - Deny the petition; ;
Alternative 2 - Grant the petition, Exempt the use of the capsules from regulation; and l Alternative 3 - Grant the petition, Amend regulations to permit any physician to receive and-use such capsules under a general license.
Alternative 1 - Deny the petition 1 This alternative would maintain the status quo by continuing to permit the medical use of capsules containing one micro-Curie ( C1) of "C-urea only by physicianswhoareauthorized.usd.touse 635.100 materials. x Any physician could apply to become an authorized user. However, NRC expects few-physicians would apply for a Part 35 pecific license for the sole use of such capsules'becruse of the associated costs of' obtaining and maintaining a specific Part 35-license. Therefore, since physicians who are not authorized t users would not be able-to receive and use such capsules, Ah ati x tgquire referrals to physicians who are authorized users,tV undergc' ent woul t'he
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diagnostictesy.
This; alternative is the' status quo and serves as the base case from which the 1
other alternatives;are evaluated.- ,
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Alternative 2 -Grant-the petition, f Exempt the ase of the capsules from regulatton i This alternative would permit anyone to receive and use capsules containinq
.one microcurie "C urea. w , u, a ecya w we n.m NRC regulations regarding exempt cpatentrations (i.e.;-630.14) state that the i exemption does not apply to the, transfer.of byproduct material contained in ;
any drug or product designed Jdr ingestion or inhalation by a human being.
-The medical use-of byprodu t material is regulated in Part 35. Part 35 limits l ;
j the use of radioactive d s containing byproduct material to authorized users. If' the use of ca sules containing one micro-Curie ( C1) of. "C-urea 1 were to be regulated i an exempt material, any person, und 9r NRC regulations, #^
would Le permitted t give such capsules to another personf ucluding-ch&44ren x^
and-pregnant-womenf egar41ess-of+ medical-benef4t. The NRC believes that '
the use of capsules containing one micro-Curie ( Ci) of "C-urea should be x limited to physicians to ensureAthers-is-an associated medical benefitthis for the i use of the byproduct material c ntained in such capules. Therefore, t
and is not recommended. M*, c"cn '5;;h the y**fDA-sey44mit-the-distrthat4a@reachisnotdeemedfeasib1 er euch-capsules,-.to-phys 4t4 ens, the NRC !
i regulations should.be explici , by specifically stating in its regulations, -
that only physicians, or ind iduals under the supervision of tite physician, could administer radioactive drugs e.ontaining byproduct material to humans. 4,_
a w m, , o e ma i o ., *,u we t n .p ou, u, One way to solve the above concern is to limit the receipt and use to a '
- physician, including those who are not authorized users, but exempt them fro NRClicensingrequirement[s.because problem 4th this approac 10 CFR 150.15(a)(6) .[.
e, who manufacture or distribute materials or devices.to persons exempt from ragulations must be. licensed by the NRC. Therefore, if this alternative were sw x.y c res : '
to be adopted, manufacturers or distributors located in Agreement States whu w e.<<+ -
as intend to manufacture or distribute such capsules would need an NRC manufacturer and distribution license in addition to their Agreement State p-possession license, s.o en<.we- ,
,herefore, this appreech is not recommended.
T 4
Alternative 3 - Grant the petition.
Amend reaulations to permit an_y physician to receive and use such capsules under a aeneral license.
.This. alternative would permit physicians, including-phys 4r.ians who are not authorized users, to receive and use capsules containing one microcurie "C urea for medical use under a gynpral license with no associated registration v certificatetobesubmntedbyJhysicians. The concept of a general license
'for medical use is not new. Prior to 1987, Part 35 regulations permitted the r
- medical use of-certain' radioactive drugs under a general license. However, v >
ithe general: license was' deleted from Part 35 because of the low level of use) at that time'.-
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This alternative is preferred relative to the ba + tase (Alternative 1) for }
the following reasons: j
- Health and Safety i As noted earlier, a detailed safety analysis was performed which analyzed !
public, worker, and patient. radiation safety hazards associated with ;
handling and administering the capsules from the point of distribution through waste disposal.
Using conservative analyses of the radiological impacts, the analysis j concluded that:
- 1. the_ potential impacts are so small that.they are'well within normal variation in natural background radiation; a u c a n t u "" * .-
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' 2.theimpactsarebelowallrepineryli=itd-cincluding levels that would ,
require reporting to the Environmental Protection Agency under the Clean Air Act; ,
- 3. individuals would not be expected to experience any radiation-related !
> risks; and
- 4. there do not appear to be any 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. ~nd a sn w u n.
furthermore,and.mostimportantly{theNRCconcludesthatrelativeto 1
Alternative 1 (the base case), Alternative 3 poses no. additional risk to f the public health and safety. Thp radiological impact to the workers, v.
M- patients, and the general gblicrwould be the same regardless of whether ,
the physician is or is not, authorized user (i.e., the radiation dose is not 3 >
affected by the medical specialty of the physicians). Therefore, the NRC maintains that it is not necessary for a physician to meet the training and experience requirements-in 35.910, if the physician's medical use of .
byproduct material is limited to these capsules. NRC takes +,his position k because thu radiological risk associated with such use of capsules is coa 5mmA insignificant.
-Avoided Costs g( g ,,% w new men ,
- Under7 Alternative-1 (the base case), physicians who are not3 authorized- ,
users would have.to refer patients to authorized users to undergo the 2: diagnostic test. These referrals, could be avoided under
- since physicians who are not- authorizedp users m the couldl"4Wo,r,61,tprna test x
- di r'ectly. Patients would realize _ savings in reduced travel expenses and personal time. . In addition, certain medical costs associated with ")e referral, such as completion of new paperwork, reviewing the patients-
~
-health-history, maintaining a second set of records, etc. could be
. . eliminated. ,
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-Other Considerations Alternative : a.c the problem discussed in Alternative 2 regarding ;
10 C R 150.lt(a)(6; ich would required Agreement States licensees x
(i.e manufacturer:; and distributors) to obtain an NRC license to
' manu acturer or disiribute exempt material;- ,
Alternative 3 imposes no paperwork costs and license fees on physicians who are not authorized users, and imposes no regulatory burden on the NRC.
Recommended Course of Action The staff recommends proceedinc with a direct final rule amending Part 35 in conformance with Alternative 3. ;
Preliminary Reculator_y Analysis for Alternative 3 Benefits - Cost Savinos in the letter dated August 23, 1994, the petitioner stated, i 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 saving over endosco.ny and biopsy ($1000).
In a ietter 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 de6 ermine easily whether or not ulcer patients have been cured of their infection. By providing the public with an inexpensive, easily accessible diagnostic test, more individuals would be accurately diagnosed and treated for their H. pylor 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_600,000 Carbon-14 urea breath tests / year, at an average cost of $100, in.!ieu of performing endoscopy, at an average cost of i
$1000/ test ($500 million + $900 cost differential / test of C-14 versus endoscopy --555,555 tests or approximately 600,000 tests), it assumes that the-lower cost and greater availability- 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 administerirg the test pursuant to 10
- CFR Part 35.100 regulation (status quo) versus releasing.the test to all abysicians (NRC licensed and non-licensed alike). Implicit in Tri-Med's aenefit calculation is tr.c presumption that none of these C-14 tests and c:rresponding savings would accrue if the petition were denied. In reality, Lunder the status quo, the test would be available and administered by
- physicians or clinics holdir.g a specific license under NRC Part 35 regulation.
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8 NRC's benefits analysis focuses on the incremental benefits of adopting the petition. Our analysis looks solely at changes relative to the base case or '
status quo. In this analysis, the comparison is between regulated and unregulated Carbon-14 urea breath tests, not unregulated C-urea breath testsG A and endoscopies or other noninvasive. tests such as serologicat-fest+ for49 anteodies-to-44-pylof+-ant 49 en# further, although the NRC acknowledges the possibility that the breath test may be more widely used if unregulated, for the purposes of this regulatory analysis, the NRC conservatively assumes that the same number of breath tests (i.e., 600,000 tests) will be administered regardless of the level of NRC-regulatory control. The NRC's view is predicated on the belief that each physicians' primary nativation is to provide the best possible care to their patients. If the breath test .s judged preferable to endoscopy, any' physician not authorized to use the. test will refer his or her patients to authorized users who could perform the test under existing NRC regulations. This appears fully consistent with standard medical practice where patients are frequently referred to 1Aaratories and x specialists for a wide array of tests and procedures.U nI 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 specialists). There would also bereviewing some regulatory savings new applications because the NRC would not have to expend resourceeHowever, these saving would be small for specific medical use licenses.
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 sould receive the Carbon 14 breath test fron physicians who are not authorizad users (e.g., gastrointestinal specialists) instead of authorized users (e.g., nuclear medicine medical specialist). The actual savings attributable to Alternative 3 is 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 atthorized 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 (averted travel expenses)
(Transportation and personal time incurred with medical referral) #m
' Assuming round trip of 20 miles @ $0.25/ mile, and personal time of 7 w m ??
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 $25.00/ hour) = $10.5 million/ year ,
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i Health Care Savings (averted administrative expenses) << w enu (Administrative costs incurred with medical referral): hn yac m, s Assuming $19.00 (administrative cost / patient). Based on 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 mcdicine specialist) for the "C-urea breath test would most likely be a new patient for tb authorized user.
600,000 patients /yecr x $19.00/ patient = $11.4 million/ year Total Savings:
$10.5 million/ year + $11.4 million/ year = $ 21.9 million/ year Alternatively, if under Alternative 3, only 200,000 or 400,000 of the 600,000 tests were performed by a physician who is not an authorized user the annual cost savings would approximate $7 million/ year and $15 million/ year, respectively.
cesenu w a Th e gnnual pavings f(benefiAs) ar conve ted t a net present vplue b seq on acw ms real disco nt rat over a 2 -jear pe io ).*s r*-vm a
re56nt v Tue fac)6r of 1A.59 (
600,000 400,00 , or 2 0,000 ests a e per ormed ach ar y ph ic an euhmN h are n autho ized up rs, p sent alue aving are pprq imatp y 23 L-_ '"'
mil ion, p3150 mit ion, ahd $80 11110 (ove a 20 year erio8), respectiv'9 ely. ~'""* Q '3 Comments from the Advisory Comittee on the Medical Uses of Isotopes (ACMUI)
This petition was discussed with the ACHUI 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 public The " Notice of receipt of petition for rulemaking" was published for public f' coment in the Federal Register on December 2, 1994 (59 FR 61831). A total of 315 public coment letters (313 supporting and 2 opposing) were received.
The two letters opposing the petition made the following two coments:
(1) The product should not rereive an exempt status because the uncontrolled distribution and application of this product could lead to significant risk to the public; and
9 10 (2) Medical uses should be restricted to short-lived isotopes because of disposal problems presented by long-lived isotopes.
The staff disagrees with both comments.
(1) As shown in the " Safety Analysis" section of this report the radiation dose to workers, patients, and the public are very low.
(2) As discussed in the " Pathways to the Environment" section of this report, 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 report, "The small increases in doses from naturally-occurring "C are of little significance to human health and the environmerd Potential long-term impacts from wide-spread releases of the long-lived "C (5,730 year radiological half-life) from breath tests was considered to be insignificant.
Basis for tha Recommended Alternative (1) RelativeYthe status quo (Alternative 1), the recommended alternative poses x no incremental radiological risks and no incremental health, safety, or environmental impacts.
(2) The preliminary cost / benefit analysis indicates that, if Alternative 3 were adopted, the effected patient population would realize significant cost savings.
(3) The petition has been endorsed by the ACMUI.
(4) The majority of public comment letters supported the petition and the two opposing comments have been addressed.
Basis for the Recommendation for a Direct Final Rule (1) The direct final rule (versus a proposed rule / final rule) is recommended.
The NRC does not expect significant negative comments because this rule would expand the availability of the diagnostic test, thereby resulting in significant cost savings, whereas the public health and safety risks as well x as the environmental impacts remainvunaffected.
m an a u mns w (2) The two opposing comments received in response to the " Notice of receipt of petition for rulemaking" will be addressed in the direct final rule.
(3) In accordance with usual procedures, the staff will prepare a companion proposed rule, to be publishad at the same time a the direct final rule, in the event any.significant opposing comments are received.
(4) The use of the direc final rule would resolve this petition in a time frame consistent with the FDA, so that the product is made available as soon V
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.as practical. To the extent possi j close to the time when FDAthis apprr 'e,ple, radioactive the drug staffDrug as New ;ntends to publish Approval .k thjt (NDA).- i Aaree Nnt State implementation-Part 35 (except for definitions, quality management. regulations, and nor$c" myce ?
misadministration reporting requirements) is not an item of compatibility. '
Therefore, a general license for medical use in Part 35 would not be an item of compatibility. l Assessment of likely impacts on NRC and Aareement State Licensees LThis'rulemaking would not result in any additional regulatory berden to NRC .
medical use licensees. Authorized users would continue to be authorized to 1
~
. receive.and use this product for medical use.
l
- Supportina Documents _
'i A regulatory anclysis and an envircnmental essessment will be provided 'or this rulemaking.
Resources j Resources to complete and implement this rule are included in the current .
budget.
Lead Office Staff and Staff from Supportina Offices ;
Staff Level Worktga Group Concurrina 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 AUM '--Mike Lesar David L. Meyer ,
Steerino Groups /Workina Group i
-There is no need for a-steering group for this rulemaking. The Working Group is identifled above.
Enh'anced Public Participation This rulemaking will be placed on the electronic bulletin board at FedWorld i and'will also be published in the Federal Reaister.. ;
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t EDO or Commission Issuance. t Because the amendment represents a significant policy issue (i'.e. permitting the " medical use" of a drug containing byproduct material by physicians who are not " authorized users"), it is recommended that the Commission issue ~the ,
rule, ,
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. 3 $$ i . r,.
l 13 5chedule Weeks from t5e date ED0/Comm '
approves the Rulemaking plan Direct final Rule (DFR)*:
Send DFR to office for conc 2 weeks **
Send DFR to EDO 6 weeks Send UFR to Comm 8 weeks Receive Comm approval 10 weeks Publish in FR; submit ltrs to 13 weeks Congress /GA0 (non-major rule)
- Including a companion proposed rule.
- Assuming RES staff will start work on DFR after serding the rulemaking plan to Agreement States for review.
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MEMORANDUM TO: David L. Morrison, Director
, Office of Nuclear Regulatory Research FROM: Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
Rulemaking Plan: 10 CFR Part 35 Medical Use of Capsules Containing one microcurie of Carbon-14 (PRM-35-12)
I am rcsponding to your Rulemaking Plan recieved September 16, 1996, requesting office concurrence on the rulemaking package for a direct final rule. The staff concurs with the rulemaking package subject to consideration of the attached comments provided as a markup of your document. The staff is available to met with you to discuss the comments if necessary.
Attachment:
Marked up Document
Contact:
Donna-Beth Howe, NMSS 415-7848 Distribution: (Closes IMNS5533)
NHSS r/f_ IMAB R/F IMNS Central File NRC File Center G:\D8H:c14dir.pkg A .,
0FC IMAB E JMASy f )6 I@k// / NMSS NMSS NAME- 'DBHowe Nker !Lka tbTr DACool CJPaperiello DATE 9/lR/96 [/[96 I/h96 9/ /96 9/ /96
.