ML20198J830
| ML20198J830 | |
| Person / Time | |
|---|---|
| Issue date: | 09/20/1996 |
| From: | Treby S NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| To: | Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-067, AF70-1-67, NUDOCS 9801140222 | |
| Download: ML20198J830 (15) | |
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- peog'e UNITED STATES NUCLEAR REGULATORY COMMISSION p
! }., WAsHINoioN. D.C, 20556-4001 g September 20, 1996 OFFICE OF THE GENrRAL counsel MEMORANDUM TO: David Morrison, Director '
Office of Nuclear Reactor rch . . .
FROM: Stuart A. Treby " gd Assistant General ounsel for Rulemaking and Fuel Cycle
SUBJECT:
NO LEGAL OBJECTION TO RULEMAKING PLAN FOR AMENDMENT OF 10 CFR PART 35 TO PROVIDE A GENERAL LICENSE FOR PHYSICIANS TO USE CAPSULES CONTAINING ONE MICROCURIE OF DIAGNOSTIC .
We have reviewed the rulemaking plan concerning the resolution of PRM 35-12. We recommend the addition of the following two paragraphs as a separate section entitled "OGC 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 one micro-Curie of carbon-14 urea. OGC has reviewed the rulemaking plan, including the proposed approach of a " direct final rule." No significant impediments to promulgation of a " direct final rule" drafted along the lines discussed in the plan is anticipated. OGC has not identified any environmental or Paper Work Reduction Act issues that would present significant difficulties in pursuing the proposed course of action. However, in developing actual rule language, consideration should be given to the issue whether any general license conditions (such as those in former 10 CFR 35.31, "Generallicense for medical use of certain quantities of byproduct material) are appropriate.
Since the proposed direct final rulemaking plan would address resolution of PRM 35-12, the staff will need to assure 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 associaud with the rulemaking on l'n a separate federal register notice, and informing the petitioner of the,C6mmission's decision. The detailed procedures for responding to the rulemaking petition cre contained in Part 11 of the Regulations Handbook (NUREG/BR-0053, Rev. 3).
CONTACT: Marjorie Rothschild, OGC 415-1333
-9901140222-900109 PDR PR 30 62FR32552 PDR
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' Marjorie Rothschild has discussed our preliminary comments on the draft rulemaking plan (included in the attached mark-up) with RES and NMSS staff and agreed that a memorandum would be transraitted formally conveying these comments.
OGC would have no legal objection to the rulemaking plan subject to the inclusion of the -
above language and revisions consistent with our other comments. However, we wou!d like -
to review the Commission paper that will accompany this package prior,to its being ,_..
forwarded to the Commission. OGC believes that all rulemaking plans should be forwarded to the Commission as negative consent papers rather than as informational papers.
Attachment:
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10 CFR PART 35 -f8v 94k w4 m<u-aU.. Q MEDICAL USE OF CAPSULES CONTAINING ONE MICR0 CURIE lF CARBON-14 (PRM-35-12) 0%A ky acrc 0 %*PPW49 '*>nvJ;;
Backarot...d oGd) '-#T On October 6,1994, the Comission 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 comercial 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 inflamatory 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 comonly cau ed 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 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 laboratory. If "C-CO, more than twice background is present in the breath sample, then the patient must be infected with H. pylori.
Currently',C.the receive Thistest must'be supplied requirement makes the only toprohibitively test facilities licensed expansive to for the great majority of doctors.
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Current Reaulations 10.CFR 30.14, " Exempt Concentratiors.",-states that the. exemption does not I apply to the tronsfer of byproduct natorial contained in any food, baverage,-
cosmetic,' drug, or other, commodity (r product designed for ingestion or ,
inhalation by,;or. application to, a 3uman being.
10 CFR 30.18. " Exempt quantities," atr forth the provisions for exempt
. quantities,-which for "C is 100 pC1. Since the rule language of 5 30.18(a) -
. states:1"... any person is exempt ... from the regulations in parts 30 through 34,=36 and 39 of this chapter ...," it is clear t1at, due to the absence of -
.Part 35 in the rule language, medical use is.not exempt under this regulation. ;
10 CFR-Part 32.72, " Manufacturers, preparation, or transfer for commercial: >
distribution of radioactive drugs containing byproduct material'for medical H , use under Part 35." provides the provisions for commercial distribution of radioactive drugs containing byproduct. material for use by persons authorized pursuant to Part-35. The _ regulations currently permit Part 32 licensees to commercially distribute capsule containing one micro-Curie'(pC1) of "C-urea to-persons authorized in Part-35.
10 CFR Part 35,'" Medical Use of Byproduct Material" currently permits the-D medical use of radioactive drugs containing pproduct material ((including .
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= capsulescontaining one micro-Curie (pC1) of C-urea)) for medical use by any / 4
[ physician, who is an " authorized user" under $35.100, or an individual working
- under the supervision of the authorized user.
' :10 CFR 35.100 "Use of- unsealed byproduct materials for uptake, dilution, and L excretion studies" provides the conditions for use of unsealed byproduct
- material for uptake, dilution, and excretion studies. Capsulescontaining one i micro-Curie ( C1) of "C-urea for in vivo diagnostic testing are currently regulated under 535.100 as an excretion te t.
Ast, 10 CFR 35. 0, " Training for uptake dilu on and excretion studies.", provides the traini g and experience reefirements physicians must meet to be e authorited users fo he medical use of 35.100' materials. These provisions requir4% ysician ob: UT4 certified c.ia of the boards listed .in W /
135.100(a , e.g.:4NucearmedicinebytheAmericanBoardofNuc1carMedicine; or'(2) 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 JMe Pequ4ee('20 hours technioues of supervised clinical Leomplete& a six month training program in nuclear medicine.
applicable experience; toorthe use of prepared (3) successfully radi Reculatory Issue ,
p ?Should NRC. amend its regulations to permit physicians who are not " authorized users"i(i.o 'do not meet NRC's training and experience requirements for the 1 x Emedical' use of- 535.100 materials)' to receive and use capsules containing one
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3 Safety Analysis A safety analysis, conducted by an NRC contractor, concluded that the use of these capsules results in insignificant exposures, as depicted below: ,
Scenario Maxiirs Exposed Routine Exposure Inditidual Worker administering Full-time worker, less than 0.7 mres/yr.
"C-urea breath tests 8,000 patient /yr Routine exposure of Patient tests negative 0.38 arem/ capsule patients from "C- Patient tests positive 0.18 ares / capsule urea breath tests.
Release of 150 Ci of Member of public Less than 0.0002 arem "CO, into administra- in the adminstra-tion area tion area Rupture of a capsule Skin (100 cm') exposed 5.8 mrad skin dose causing skin contami- for one hour prior to 0.029 mres (CEDE) nation of worker or washing; 0.075 Ci skin patient absorption Pathways to the Environment Q (environmental report, conducted by an NRC contrM concluded that the impacts associated with any releases of "C to the surrounding environient are Q ' expected to be very small and the expected risks are minimal. .
% he 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 toJ he huge inventory of about 240-million curies in the world's oceans and oceanVfloor4 The "C released into the atmosphere /
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-cccurring "C.
Since the current world inventory of naturally-occurring "C results in an average dose to the public of about 1.25 arem/ rear, releases of 0.6 curies of "C from breath tests would result in a averagc annual dose of 2 X 10" arem.
In a total population of about 260 million people in the U.S., the collective annual dose would:be about 0.051 person-rem. The doses from normal use of breath tests are aho below any Federal (NRC and EPA) regulatory li.mits, and Act for routire exposures tdfmember of the public, or 4 mrem / year EPA limitare belo for public drinking water. Impacts associated with any releases of "C to /
surrounding environmental me4 Ware expected to be very small due to the fact /
that the concentration of CO, released is very low and would be mixed into the atmosphere:immediately, l
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Collective Exposures to Members of the Public The small iner femkh ases in doses from naturally-occurring "C are of little significance < human health and the environment. Potential long-term impacts from wide-spr (5,730 year radiological half-life) f> pad om breath releases testsof_was the long-lived considered "C to be insignificant. Assuming that the te '.ing in the U.S. would incrcoe over a period af time to an average of =ill.icn 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
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from naturally occurring "C of over 300,000 person-rem, and about 78,000,000 person-rem from all naturally occurring radiation. Clearly, an increase of a few person-rcm 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 (dh,s k - L u p & x Alternative 3 - Grant the petition, Amend regulations to permit a physician to receive and '
, us,e such capsules under a ge ral license.
Y Alternative 1 - Deny the Detitionttc, -tAA C4ACLc4 Q g 4QQq
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This alternative would maintain the status quo by continuing"to permit the medical use of capsules containing one micro-Curio (pci) of C-urea only by physicians who are authorized users to use 535.100 materials. g g Any physician could apply to become an authorized user. However, NRC expects 3 few physicians would apply for a Part 35 specific license for the soler #
such capsules because- of the associated costs of obtaining and maintaining a specific Part 35 license. Therefore, since physicians who are not authorized users'would not be able to receive and use such capsules, their patients would require referrals to ph diagnostic test.lk a ;.ysicians , M who 73 are4 authorized eqm J users h ,,tu to undergo 4% 7the /
This a'ternative is the status quo and serves as the base case from which the other alternatives are evaluated. '
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Alternative 2 -Grant the petition.
Exempt the use of the capsules from reculation .
This alternative would permit anyone to receive and use capsules containing one microcurie "C urea.
NRC regulations regarding exempt concentrations (i.c.; 130.14) state that the cx:. ptica does not apply to 'he transfer of byproduct material contained in >
any drug or product designed for ingestion or inhalation by a human being.
The medical use of byproduct material is regulated in Part 35. Part 35 limits the use of radioactive drugs containing byproduct material to authorized users. If the use of capsules containing one micro-Curie ( C1) of "C-urea were to be regulated as an exempt material, any aerson, under NRC regulations, would be permitted to give such capsules to anotier person, including children and pregnant women, regardless of a medical benefit. The NRC believes that the use of capsules containing one micro-Curie (pci) of "C-urea should be limited to physicians to ensure there is an associated medical benefit for the use of the byproduct material contained in such capsules. Therefore, this approach is not deemed feasible and is not recommended. Also, even though the l
FDA may lin.it the distribution of such capsules to physicians, the NRC regulations should be explicit, by specifically stating in its regulations, that only physicians, or individuals under the supervision of the physician, i could administer radioactive drugs containing byproduct material to humans.
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One way to sol e the above concern is to limit the receipt nd use to a physician, in luding those who are not authorized users, but excmpt them from NRC licensing requirements. However, this would not entirely resolve the problem with 41: appre: W because 10 CFR 150.15(a)(6) specifies that persons (
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who manufacture or distribute materials or devices to persons exempt from regulations must be' licensed by the NRC. Therefore, if this alternative were to be adopted, manufacturers or distributors located in Agreement States who intend to manufacture or distribute such capsules would need an NRC manufacturer and distribution license in addition to their Agreement State possessior, license.
Therefore, this approach is not recommended.
Alternative 3 - Grant the petition.
Amend reaalations to permit anY Dh_Ysician to receive and use such capsules und . A ceneral license.
This alternative would permit hysicians, including physicians who are not
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authorized users, to receive and use capsules contain %; cnc micrecuria "r/
ur fer -adien1 u m under c gencral enseGithnoassociatedregistration~]
tificate to be submitted hysici The concept of a general licenst r me ical use-is not n . Pr or o 1987, Part 35 regulations permitted the medical use of certain radioactive drugs under a general license. However, g.g*
.the general license was deleted from Part 35 because of the low-level of use .
at that time. #
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6 This alternative is preferred relative to the base case (Alternative 1) for the following reasons: .
- Health and Safety As noted earlier, a detailed safety analysis was performed which ar.alyzed 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
-concluded that:
- 1. the potential impacts are so small that they are well within normal.
variation in natural background radiation;
- 2. the impacts are below all regulatory limits, including 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.
Furthermore, and most importantly, the NRC concludes that relative to Alternative the public health 1 (the andbase case),
safety. The radiological Alternativeimpact 3 poses noworkers, to the additional risk to /[
patients, and the general public would be the same regardless of wh, ether /
the nhysician is or it act 5"the"ized user ;i.e., the radiation dose is not-(
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affected by the(medical specialtvlof the physicians). Therefore,' .the NRC g i.pmaintainsthatitisnotnecessaryforaphysiciantomeetthetrainingand
'M% experience requirements in 35.910, if the physician's medical use ofbyproduct material is lim
% #cd a because the radiological risk associated with such use of capsules is gk M.
insignificant.
. p4 Lt k u a M % U Q & AP W W g k ** i -Avoided Costs g Ql.1 nder Alternative 1 (the base case), physicians who are not authorized users would have to refer patients to authorized users to undergo the _ g 4dleacD diagnostic test. These referrals [could be avoided under Alternative 3 A44M0 m 4 -J. , since physicians who are not authorized users could perform the test pM8/J directly. Patients would realize savings in reduced travel expenses and personal time. 'In addition, certain medical costs associated with the referral, such as completion of new paperwork, reviewing the patients health history, maintaining a second set of records, etc. could be ieliminated.
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-Other Considerations
, Alternative 3 avoids the problem discussed in Alternative 2 regarding /
10 CFR 150.15(a)(6) which would required" Agreement States licensees V (i.e.manufact.urers and distributors) to obtain an NRC license to.
manufacture #or distribute exempt meterial;
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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 proceeding with a direct final rule amending Part 35 in conformance with Alternative 3.
Preliminar, Regulatory Analysis for Alternative 3 Benefits - Cost Savinas 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 saving 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 provjding 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 lieu of performing endoscopy, at an average cost of
$1000/ test ($500 million + $900 cest 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 unregul.ated 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 Part 35.100 regulation (status quo) versus releasing the test to all physicians (NRC licensed and non-licensed alike). Implicit in Tri-Med's benefit calculation is the presumption tha' none of these C-14 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 physiciant or clinics holding a specific license under NRC Part 35 regulation.
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-NRC's benefits analysis focuses on the'i cremental benefits of- the- or) petition. Our analysis looks solely at 1anges relative to the base case or
--status quo. In this analysis, the c rison is between regulated and unregulated Carbon-14 urea breath' test , not unregulated C-urea breath tests and endoscopies or other noninvasive sts such as serological tests for igg
, antibodies to H pylori antigens.- Fu her, although the NRC acknowledges the-possibility that the breath test may be more widely used if unregulated, for the purposes cf this regulatory ana sis, the NRC conservatively assumes that -
tl+ same number of breath tests _(i. .. 600,000 tests) will- be administered
- egardless of the level of NRC regt atoryconpl. The NRC's view is j i . predicated on the belief that each >hysiciar(s primary motivation is to' 'v .
provide the best possible care to bwWpatients. If the breath test is 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
, J practice where patients are frequently referred to laboratories and j s'ecialists for a wide array of tests and procedures. In the NRC's analysis,
- tie benefits of adopting the petition accrue as a result of reduced patient cost and redur i health care cost resulting from the elimination of the need u for referrals from a physician who is not an authorized user (e.g.:
l gastrointestinal specialists). There would also be some regulatory savings because the NRC would not have to expend resources reviewinr new applications for specific medical use licenses. .However, these saving wt. 'd 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.
I NRC's benefit calculation is based on the assumation that a significant..
portion of the 600,000 patients would receive t1e Carbon 14 breath test from
! physicians who are.not authorized users (e.g., gastrointestinal specialists) instead of authorized users (e.g., nuclear medicine medical speciali.st). The E actual savings attributable to Alternative 3 is dependent on the number of L tests ultimately administered by physicians who are not authorized users
- thereby eliminating the need for a referral.
p The annual savings could be as high as approximately $20 million if there was a complete shift of the administratior, of the tests from physicians who-are i
authorized users (i.e, base case) ta physicians who are not authorized users.
4-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)
- Assuming round- trip of 20 miles 9 $0.25/ mile, and personal- time of C 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 p
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,_j._ m Health Care Savings (a'verted administrative expenses) .
(Administrative costs incurred with medical referral):
Assuming $19.00 (administrative cost / patient). Based on the differentia 1' 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 sedical records, etc. The patient who is referred to an authorized user (e.g., nuclear medicine specialist) for the "C-urea breath test would most likely be a new patient for the -
authorized user.
600,000 patients / year 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.
These annual savings (benefits) are converted to a net present value based on a present value factor of 10.59-(7% real discount rate over a 20-year period).
If 600,000, 400,000, or 200,000 tests are performed each year by physici.ans who are not authorized users, present value savings are approximately 5230 million, $150 milljon, and $80 million (over a 20 year period), respectively.
[omments from the Advisory Committee on the Medical Uses of IsotoDes (ACMUI)
This petition was discussed with the ACHUI at the October 1995 meeting.- The ACMUI indicated that it endorsed the wida 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 (
- Wrs) l The"Noticeofreceiptofpefitionforrulemak " was publis for public comment in the Federal Reaitter on December . 1994 (59 FR 31 . A total of /
315 public coment lettersA313 supportin and-2opposingfwerer)eceived. /
The two lettere opposing the petition made the following two comments:
~ (1) The product should not receive an exempt status because the uncontrolled distribuths nd application of this product could lead to significant risk to the public; and
10 (2) Medical uses should be restricted to short-lived isotopes because of disposal problems presented by long-lived isotopes. g krinWh% be %eong The staff disagrees with both connents. ,
- 1) As shown in the " Safety Anal sis" sectio this report the radiation [
ose to workers, patients, and i e public very low. /
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+(2) As discussed in the ' Pathways to the Environment
- section of this report, /-
p48 the impacts associated with any releases of "C tt, the surrounding environment Also, as 9*ib d are discussed expectedintothebe" Collective very small and thetoexpected Exposures Members risks of the are minimal.
Public" section of h t tr o l this report, "The small increases in doses from naturally-occurring "C are of V 16:yl md little significance to human health and the environment. Potential long-term Gohpes impacts fror wide-spread releases of the long-lived "C (5,730 year radiologicas half-life) from breath tests was considered to be insignificant.
Basis for the Recommended Alternative (1) Relative the status quo (Alternative 1), the recome.,ded alternative poses no incremental radiological rist s and no incremental health, safety, or environmental impacts.
(2) The preliminary cost /Paefit analysis indicates that, if Alternative 3 were adopted, the affer,ted patient population would realize significant cost savings. ,
(3)Thepetitionhksbee'nendorsedbytheACMVI. -
(4) The majority of public comment letters supported the petition and the two opposing corwents have been addressed, g a e H Basis for the Recommendation for a Direct Final Rule pr p k.+ n. puNihgugr%%
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f(l) The direct final rule (versus a propose ule/ final rule) is recommended. / I TS 1RC does not expect significant Sth comments because this rulc would Q( ' expand the availability of the diagnostic test, thereby resulting in 5
significant cost savings, whereas the public health and safety risks as well M ,e as the environmental impacts remain unaffected.
- 2) h M oppo3 ng comments received in response to the ' Notice of receipt of petition for rulemaking" will be addressed in the direct final rule, av j (3) In accordance with usual procedures, the staff will prepare a companion" MDs f proposed rule, to be published at the same time as the direct final rule, in M"tr the event any significant opposing comments are received. ~c dd (4) The use of the direct final rule would resolve this petition in a time pe pepq co&a.e asnAs S frame consistent with the FD), so that the product is made available as soon
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as practical. To the extent possible, the staff intends to ND#
close to the time when FDA approvethis radioactive drug as hew Drug Approvaublish ,
(NDA). Af CAqj '
Aareement State Implementation
%p Part ~,:i (except for definitions, quality management regulations, and misadministration reporting requirements) is not an item of compatibility.
Therefore, a general license for medical use in Part 35 would no;; be an item of compatibility.
Assessment of likely Impacts on NRC and Aareement State Licensees This rulemaking would nct result in any additional regulatory burden to NRC medical use licensees. Authorized users would continue to be authorized to receive and use this product for medical use.
$ bGQ hed Supportina Documents
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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 St4(f and Staff from Supportina Offices P
Staff Level Workina 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 ADM - Mlle Lesar David L. Meyer
,Steerina GMoos/Workina 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 elctronic bulletin board at FedWorld ,
and will also be published in the Federal Reaister.
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- , , i 12 EDO or Commission Issuance. '
Because the amendment represents a significant policy issue (i.e. permitting the " medical use" of a drug containing byproduct material by physicians who-arenot"authorizedusers"),itisrecommendedthattheCommissionissuethe i rule.
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e-13 Schedule Weeks from the date ED0/ Cons approves the Rulemaking plan Direct Final Rule (DFR)*:
Send DFR to office for conc 2 weeks **
Send DFR to EDO 6 weeks Send DFR to Comm 8 weeks Receive Comm approval 10 weeks Publish in FR; submit Itrs to 13 weeks Congress /GA0 'non-major rule)
- Includenq a companion proposed rule.
- Assuming RES staff will start work on DFR after sending the rulemaking plan to Agreement States for review.
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