ML20127C251
| ML20127C251 | |
| Person / Time | |
|---|---|
| Issue date: | 09/19/1991 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Hayward M SMALL BUSINESS ADMINISTRATION |
| Shared Package | |
| ML19341F879 | List: |
| References | |
| FRN-57FR41376, RULE-PR-35 AC65-2-057, AC65-2-39, AC65-2-57, NUDOCS 9203130335 | |
| Download: ML20127C251 (12) | |
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.g Mr. Mark 5. Naywsrd 'fer Advocacy i
Acttne Chief Counsel 11.5. Small lustuns Administretten 409 Third Street SW Wuhington, DC M1g Dear Mr. Nayward to yevr letter addressed to thateman Selin, dated August 15,'
I as n plyt 1991. en d Cesatssion's flul rule en Quality Mantement Progran and The et,1ective of the final rule la to Misadelaistattens(faclosure1).
4 gre that, after physicians have detetsthed dat trutae goe to great lengths is aveld any intrusten er interfare their patients.
The issue of %e %4ct of this twls on medical care i attention from the ag ucy d ile the rule was being developed. The nie-writt% team teek outreerdinary measures to interact with the professinal pcist'es and assectattens affected Iftensees, and the State regulators to discuss nose as well as olher significant issues. These interactius tukth
. place in several ev61(c workshops (incleurs it,L Street W. Washington, DC.
available in ne htC Pubitt DMusent Rees, 2110 Ovrt% the workshop's, partittpants free ses11 censunity hospitals and privat practee licensus indicated Oat there would set be e 4tgatftcant ecuenic imenct if certain proposed Paquirements for diapnestic adstnistrations are we e intnated these high-cost olistnated, la:H en that recommendation,ne final rule sleest esclusively en etnie w b uefit requirements, and focusedthese sintaus requirem theraHvita due, a dess range dere the result of errors seuld be
- igetfIcast.
These lesses identified in reve letter wre also raised earlier den our proposed rule was puh11thed for pubits comments in Jan I an enclosing a copy of the proposed rule (inclesvre 3) and the final rule (taclosure 4) for your reedy refemace
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.i M. Hayward Please let me know if ',1 can be of further assistance.
- Tweerely,
- .. a.u..: y Jtoe: M. T4ylor Executive Otractor for Operations Inclosures:
Your tetter to Chairman sella 1.2. List of Public Workshops 3.
Proposed Rule 4.
Final Rule cet Mrs. Patricia Saiki Administrater, U.S. Small Susiness Administration e*
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ENCLDSURE 8 Remarks on the SNM/ACNP Letter 4
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REMAX5 ON THE ACNP $M LETTER 1.
What is the basis for 13 million nuclear medicine precedures?
(p.1) a.
We use 7.1 million diagnutic precedures, refer to the NCAP Commentsry, Table 2.1 en page 3.
b.
We feel that 13 million is inflated.
What l's the basis for 9 nisadministrations7 (p.1) 2.
Consider the following:
(does, not include diagnostic) a.
Free November 19M to December IM8 (8 years), there,were M misadministrations.
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b.
During IN9 end itM (t ye,ars), there were 39 misadministrations.
c.
Frea IMI to 1984 (6 years), il misedninistrations involved 77 patients.
d.
In 1900, I sisadminiftraties involved il petfeats.
e.
In 1990,'1 aisedninistraties involved I patients, f.
For the ten year period, ending December 1990, there were 127 (M + 39) sisedninistrattens involving M + 39 + (M-fl) + 21-1 + (1-1) = M + 39 + lt + 10 + 1 IM patients Since 101C Ifconses facilities constitute 1/3 (2000/4000) of all facilities nattenwide, the b r of patient aisadministrattens is:
IN x 3 e 600 patients
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For the ten year period, ending December 1990, the average number is 60 patient aisadministrations per year; and the average rate of eccurrence 13 00.0 natient ainadministratians 00033; m80.000 patient seatnistrattens and the average rate (per facility) is
- 60. nattant aisadminis, rations nar waar 54.4 pattents per fact tty per year 1.1 patient m'isadministration per facility, where.
- so.000 nattants nar year = 54.8 patients, per facility per year.
D,300.tcensee factitttes 3.
What is the basis for sere fatalitiest (p.1)
Cen 1 der the following events that resulted 1,n one er mer' deatg.
s a.
Alverside teletherapy everexposures.'
3 b.
Overdose of Au-Itt.
c.
Administritten of p-3t in the wrong chemical fors.*
4.
'This papemerk terden is excessive'.
(p.1) tet's cespares e. tN eroposed, rule vs. final mio, and
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- b. current poquirements vs. flaal rule.
- Also, refer to the FIgl for the final rule p. 34110, public consent nei,3 4
a and the response.
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'NRC ignored the majority of comments dich eppesed the (proposed) rule'.
(p.1)
NRC accepted the majority of comments. Refer to FRN for the Final Rule pp. 34107-34109: Pilot Program, itses 5 - 15; AAPM, ACMP, ACR, AES and ASTRO, itses ! - 8: Agreesent States, items 1-4; and ACMUI, items 1 - 12.
6.
'The rule as an unnecessary intrusion into thogractice of medicine,'
(p.1)
The Final Rule is asi an intrusion. The authorized user physician decides what te de and states that in the Written Directive. The QM Rule's objective is to have the ' delivery system' shinister the byproduct material as directed. Refer to i 35.38 (a). Also, refer to FRN p. 3410s, public cessent no. 1, and the response.
7.
'The transcripts free each of the meetings... reflect almost unaniscus appetitiontothe(proposed] rule.' (p.1)
The werd proposed is tapertant. One purpose of the referenced meetings l
was to discuss with each relevant group:
a.
d et was wrong with the proposed rule, and b.-
howshouldtheproposedruldhe' repaired?
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Pilot Program
'The erivinal project was to include 14 participants.
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.but the MC was unstle to convince more t'han 44 to join.
This clearly does not represent a statistically valid sample,' (p.!)
For an acevrete description, refer to FM for the Final Rule p. 34107 and NUREG/CR 5798. We believe we did get a statistically and f
technically valid sample. Consider the propertional representation of:
4.
MC Regions, b.
. Agreement States, e
c.
class of licensee, d.
type of facility.
e.
e4se of' faciltty. -and f.*
fact 11ty location.
9.
'These modifications were never adopted by NRC.' (p.!).
Refer ta F181 for the final Role pp. 3418T 34108 describing the Pilot Program. ife adopted,most of the soggested modificatfans.
10.
- entities ashich feend the herdens sucessive and unneces:ary inslede.* (p.8)
'JCAle' Disagree. Refer to Flut p. 34100 and meeting transcript.,
... Agreement statas' Asfer to letter free CACPO.
... ACWl'
- RefertoJensary1991Tr$nscript. The ACMUI did act make this statement.
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'These entitles w'ere tsacerned that the P4perwerk burden could not be 1
compensated...' (p.2)
We disagree.
These entities, i.e., JCAH0, Agreement 5tates, and ACMV!,
d!d not sake such statements.
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12.
'The NRC clales to he've delsted dittnestic components ' (p.2)
Of agnostic components won deleted. Refer to the FM for the Final Avle, p. 34110, public comments no. 3 and no. 4, and the responses.
13.
'However, this modification has not signtficantly reduced the paperwork '
burden.'
(p.1)
The Pnposed Rule affects 7.2 etllion pacedures.
The Final Rule affects 180,000 procedures.
Thus, there is,a reduction. Refer to FM p. 34110, response to public comment no. 3.
14.
'the radiatten dose thresholds... would not result in any detectable detereintstic bielegic effects to patients.* (p.2) a.
Dese Thresholds were chosen to be at'the level.where non stochastic effects would be'seen.
b.
Refer to NCRp Commentary p. 39 Summary.
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The reporting thresholds were derived with assistance free upM, c.
ACMp, ACR, AE5 and ASTRO.
h 15.
' item 35.33 (e) directs physicians to maintain records en each patient.'
(p.8)
This ites applied to ' Records and Reports of Otagnostic Events or Misadministrations' in the Ar.adtied rule.
It is not in the final rule.
16.
'The average facility services 150,000 patients per yur.' (p.7)
We de not agree. Consider:
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100.000 patients per year /3,300 licensee fact 11 ties
= 54.4 patients per facility per yeart b.
13,000,000(sic]patientsperyear/6,000Itcenseefacilities 0
= 2.147 patients per facility per year.
17.
'This rule would' require three forms to be filed for each patient.' (p.8) ints is act correct. Ceapare i 35.23(a) en p.1447 of the FRN for the assessed rule to I St.3t(d) en p. 34132 of the FRN for the final rule.
Also, edsinistered deses'are currently required by I 38.13.
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'this cannet be semputertaed either since, according to the rule. the directives 1 erst he written.*
(p.1)
We disagne. Under the final rule, written directives are required for therape'utic athsinistrations; refer to l 35.32(a)(1), p. 34121 ef the FRN. These directives can be ' written' via a computer display screen or printed out. One wedd read either the screen er the printed page.
19.
'The cost from this tule to codi'ctne would be Stel million in the first year and apprestaately 3188 million each subsequent year.' (p.3)
No basis for uma cast ambers was prov'ided, as cespared to the imC's -
CIS package. ife believe these nubers are too high boccuse 13 et111en diagnostic adsteistrattens were incorrectly used, as compared te 180,000 therapeutic administrations.
20.
'leC does not have the resources to analyse the econesics of health care adequately *. (p.3)
We have the services of three etenestats (two with Mes) in the Regelattens Develht_ treach and any other desired assistance can be obtained by setside centract. Neuever, it should be noted that the one-time implementing cost of $1.4 elllion and annual operating cost of e
51 million, as estimated la the regulatory tapact analysis, are far below the amounts estimated by AtalP-SIM.
1 a
'A som realistic ocenamic asusseent shecid be based on the assumption that ne licensee serrently has a tpq program which fully satisfies the NRC's new reeutrements.'
We believe it is facerrect to start from aere, refer to huREG/rR 5794,
- p. 47. Also, consider the existence of QA progress by $Wt, AAPM, ACR, and JCAHO.
' Forty procedures are required by the istC's implementing guidance in RegulatorySuideS.22[ sic].*
(p.3) i Procedures in Regulatory Guide 8.33 are not required. The final rule
provides the requirements. Only shoot 35 of the 3,300 licensees i
tapacted by the final nie would need all procedens, f.e., for telptherapy, brachytherapy,gammastercetacticradiosurgery,And, I
t'herapeutie rad 1opharmacentIcals including I-lll and 1-131.
e 23.
- !t is unrealistic that a progree of this nature cov1d be developed by I
any facility in ene persee-eeek.'- (p.3)
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l tie believe it is not unrealistic. Consider that a facility could use-l the entsting ACA QA progree as an example and the statements in L
NURtt/CA-lfst, pp. vit and 47. Alse.,a facility could use Regulatory-1 Guide 8.33 as an example.
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- The rule is an issse of ceapatibility with the Agressent States, whose costs are approximately tne same as the NRC's.'
(p.3) i We disagres, some Agreement states already have imposed aest of these QM requirements by adding Ifconse conditions f?r their licensees, e.g.
NY. Also, Agreteent $tates costs, e.g., salaries and travel, are less than NRCs.
l 25.
'The NRC is incorrect in its opinion that the pledge of confidentieltty t
d6es not apply.'
(p.3) i There is re probles with confidont1alIty because the sisadmin1:tratien reports given to the NRC de asi contain 'the patients name er other informatten that could lead to identificatten of the patient,' refer to FRN p. 341216 35.33(a)(t).
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JUL. 01 '92 o98 38 CD0
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't EXECUTIVE OFRCE OF THE PRESCENT 3
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OFOCE Cf* MANAGFMENT AND SvoOgT
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Mr. James Taylor Executive Director for operations Hucledy bejulatory Commission L
Washingt0n DC 20555
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Deer % Taylor (A, Dscember 24, 1991, the Nuclear Regulatory Commission (NRC) cubmitted to the Of fice of Langement and Budget (OMB) an information ecliection request (ICA) for review.under the Paterwork Reduction Act (FRA).
This ICR would authorise the.NRC to require that medical practitioners engaged in therapies using
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radioactive material maintain records as evidence of a quality management program, submit copies of quality management programs to the NRC, and report to the NRC Vhen misadministrations occur.
1 i
In a letter dated January 24, 1992, OMB asked NRC to address numerous issues that arose during our review of the ICR.
OMB was concerned that the burden imposed on the regulated community by 1
these reporting and recordkeeping requirements was not justified by the limited practical utility of the requirements.-
The NRC responded to.0MB in a letter dated March.23, 1992',
stating that the NRC had already discussed with~the regulated.
community the issues raised by OMB, and had incorporated their suggestions into the final rule to the extent that it was apprcpriate.
The NRC reiterated its position that.these requirements are necessary in-order to protect the--health and safety of the public.
-Afte rfurther review'of the ICR's supporting statement, the
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NRC's letter of. March 23 and its attachnents, and other materials which OMB has-received during..its. review, I have concludedEthat
-the limited practical-utility of the' requirements im, posed on-the regulat.ed community do not justify their. burden. - I am therefore disapproving this ICR.
In order to= approve the ICR,-0MB would have had to de+, ermine.that the-practical utility-derived trom the-requirements in the -ICR outweighsc4 the burdens imposed by those-requirements.
In this-instance, we_could not make that; finding.
Practica11'O lity of.the Information Collection Request.
OMB strongly supports:the NRC's goal of.taking measures to protect human health andLthe environment, as directed-by the q
Atomic Energy Act.
However, 0MB believen that the reporting land l
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JUL O! '92 09:29 CIC p,og i
i recordkeeping requirementc containod ir. this ICR would not contributo to that goal.
The practical utility of the reporting and recordkeeping I
requirements in thio ICR may be measured by the degree to which they ancist in any action which further protects human health and the environment.
Therefore, in order to dotormine whether or not they have any practical utility, it is necessary to determine the degrou to which they contribute to the NRC's ability to provido additional protection of public health above the current level of protection.
Currently, most facilities implomont quality management (QM) programa to meet standards establishod by professional accreditation organizations.
In fact, according to the NRC, 90%
of all covered facilition already have a program that is oquivalont to the requiremento in this ICR and the aonociated rule.
Notwithstanding these programs, howevor, misadministrations do still occur.
The ICR and the annociated rulo 10 premised on the bellot that candating these programo for all covered facilition would further misadministrations, and in so doing provide additional protection for public health.
The information that the NRC has provided to OMB with the ICR does not support those accumptionu.
First, it is far from evident that the ICR will actually reduce minadministrations.
The NRC has not prosented OMB with any evidence that orrors reported to the NRC tended to occur at the 10% of facilities without QM programs and would have been provented had such programs boon in place.
Moreover, when compared to the error rates in other medical specialtion, the error rates in the uso of byproduct materials appear to be extremely low.
In our letter of January 24, 1992, we cited reveral journal articles which identified error rates in the administration of medications in hospitale which woro novoral orders of magnitude higher than the orror ratos cited by the NRC.8 In addition to those studies, a Harvard University study of advorno ovonts and negligence in hospitals which van recontly completed strongly supports our earlier conclusion.'
Given that the lovel of errors in
'In the January 24, 1992 lottor from James B. MacRae, Jr. of OMB to James Taylor of the NRC, OMB oited several journal articion which ontimated medication error raten in hospitals of between 0.5% and 18%.
7According to.the results of that etudy thoro were 2.672 million patients released from_New York Stato hospitals in 1984.
Of those patients, almost 99,000 (3.7% of all discharges) sufforod advorno ovonts (the study defined an "advorce event" as "an injury that was caused by medical management (rather than the undorlying-diconce) and that prolonged the hospitalization,
Jut. 01 '92 09 09 tre; p. 5,9 i
j l procedures using byproduct materiala is already extronaly low (particularly when compared to other medical proceduros) and is in fact approaching the limits of human error, it appears to be unlikely that the NRC program would significantly increase the public's overall health and safety by reducing the incidence of misadministrations.8 The NRC states that since the rate of misadministration rose significantly from 1989 to 1990, it is possible to reduce the rato of misadministrations from their most recent lovel.
Even if the NRC is correct that the increase from 1989 to 1990 means that it is possible to further reduco misadministrations, the NRC has not shown that this ICR is likely to yield such reductions.
The NRC has not presented any evidence that the riso in misadministrations botveen 1989 and 1990 was the result of any specific type of failurn that the requirements in this ICR would address.
Second, even if the ICR would significantly reduce misadministrations (which is unlikely for the above reasons), the additional protection afforded to public health and environmont would be marginal.
The NRC cites statistics which indicate that there are approximately 60 misadministrations of byproduct materials cach year, representing approximately 0.03% of 200,000 covered procedures.
Of the 60 annual misadministrations, few appear to have resultod in permanent injury.'
In fact, a produced a disability at the tino of discharge, or both") during their hospitalization; over 27,000 (27.6% of all advarse events) were due to negligence (the study defined " negligence" as " care that fell below the standard expected of physicians in their community"),
of those patients who suffered adverse events, approximately 13,450 (13.5% of all adverse events) died as a result of the adverse event.
of the adverse events which resulted in the death of a patient, approximately 6,900 (51% of adverse events which resulted in death) resulted from negligence.
(New EnglaMd Journal of Medicine.
Incidence of Adverso Effects and Negligence in Hospitalized patients: Results of the Harvard Medical Practice Study I.
February 7, 1991. Vol 324 No 6 page 370 - 376.)
80n pago 21 of a brief filed on March 6, 1992 with the U.S.
Court of Appeals for the D.C.
Circuit by the NRC in the caso American Collece of Nuclear _ Physicians and Society of Nuclear Medicino v. United States Ngq11ar Regulatory Cpmmission and United states of America (civil No. 91-1431) the NRC conceded that "it cannot be said with cortainty~that the QM rulo will reduce misadministrations."
'Maen discussing the need for this program, the NRC'most frequently cites the 1975 Riverside incident in which several patients were overexposed due to the incorrect calibration of a
-cobalt 60 machine, and some of the patients may have died as a
AL 01 '92 69840 CDO P.6/9 substantialpercentageofthemisadministrationsprobably resulted in no permanent adverse offects to the patient.
In sum, tho information that the NRC has provided to OMB, and the other information that OMB has received, does not support a conclusion that the reporting and recordkoeping requirements in the rule will contribute to the achievement of the goal of reducing misadministrations, and thereby providing additional protection to public nealth.
Accordingly, these requiremonto have little if any practical utility.
Burden Imposed on Medical Practitioners OMB is unable to determino with confidence the magnitude of the burden imposed on the regulated community by these recordkeeping and reporting requiremento.
According to HRC estimatos, the final rule would impose an annual burden of almost result of that mistake.
However, the NRC subsequently promulgated rules in 1979 that require frequent calibration of equipment by qualified experts.
Since the NRC has already taken steps to reduce the frequency of this type of error, it is unclear how the proposed measures would yield any further reduction in such risks.
Although the NRC asserted that there were one or two other misadministrations which resulted in significant injury or death, the NRC novar provided to OMB any background about other misadministrations.
'The NRC does not distinguish between that various levels of injury which patients have suffered as a result of misadministrations, simply stating that any exposure to radiation greater,than a certain percentage above the prescribed level is assumed to be harmful. -However, there are various level of injury which one could sustain from a misadministration, some more serious than others.
A Harvard University study (see footnoto 2) on the rate of abnormal events in hospitals, injuries were categorized as (1) Minimal impairment, recovery 1 month or less, (2) Moderate impairment,-recovery 1 to.6 months, (3)
Moderate impairment, recovery 6 months or more, (4) Permanent impairment, less than 50%, (5) Permanent impairment, greater than-50%, (6) Death, or (7) Could not reasonably judge impairment.
The NRC made no attempt to categorize the adverso offects caused by byproduct misadministrations by level of severity or any other measure.
OMB staff did review-the misadministrations listed in the Federal Reaister notice at 56 FR 34104 with Dr. Terrence Bevin, President of the American College of Nuclear Physicians.
He estimated, based on the limited data, that as few as 4 of the 66 misadministration might have resulted in any significant adverse effect.
Ju. ci '92 on.u tro
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-S-20,000 hourn on the regulated community.'
According to the professional annociation the burden could cantly roach 200,000 hourn -- a f actor of ten timeu larger than outinated by tho NRC.'
i The NRC has a clear conception of what is required by the ICR, and has calculated the burdon based on how long it believoa that it would take someone with an equally clear understanding of the ICR to meet its requiremento.
The protonsional associations, however, do not shara this conception of the ICR.8 Instead they face substantial uncertainty about what the NRC oxpecto the regulated community to do, and what each individual NRC inspector expects to find when inspecting a regulated party.
Given this uncertainty, the regulated individuals and facilities are likely to be overly cautious -- and assume a greater paporwork burden --
because they cannot continue to operate without an NRC license.'
OMB suggestod in January that the NRC and the regulated community moot to clarif*/ the requiremonto of thin ICR."
OMB felt that such largo discrepancios in burden hour estimate could only be explained if the regulated community interpreted the ICR as imposing requirements which the NRC never intended to impose.
However, since the NRC's choso not to meet with the professional
' March 23, 1992 letter from James Taylor to Jamon B. MacRae, Jr., onclosure 3.
' November 5, 1992 letter from Kristen Morris to Ronald Minck.
'During separato discussions between OMB and the NRC and between OMB and the profossional associations, OMB realitod that the NRC and the professional Associations do not even agree on what reporting and recordkenping requirements the regulated communi%y will have to comply with under tha final rule and the ICR subhitted to CMS for review.
If the two parties cannot even agree on what is required by the rule and the ICR, then they cortainly will not be able to agroo on the burdon they impose on the regulated community.
This led OMB to nuggest that the NRC mont with representatives of the regulated community.
'In addition to the paperwork burden borno by the regulated community in meeting the rule's requirements, they will also boar the costo of NRC's administration of this rule through fees imposed on the reporting community when NRC conducts its inspections.
See 10 CFR 170 and 10 CPR 171 and-56 FR 31472, at which the NRC revised its fee schedule for licenses and inspections to recover approximately 100% of its costs as required by the Omnibus Dudget Reconciliation Act of 1990.
- January 24, 1992 letter from James D. MacRae, Jr. to James Taylor, page 6.
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SuL m '92 ov 42 tro p,o,9 associations, there As no additional information that would allow us to improve our estimates."
Accordingly, OHB can only conclude that the ICR's true burden houro lies sonowhero between the NRC's and the professional association's cotimates.
An explained above, the available evidence indicates that the reporting and recordkoeping requirements will have little if any practical utility furthering the goal of reducing injurica from misadministrations.
Thorofore, any significant burden is unreasonable, whether that burden amounts to 20,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> (as the NRC estimaten) or 200,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> (as the professional association estimates).
Thus, 1 conclude that this information collection request in not "necessary for the proper performance of the functions of the agency" and that the information collection will not "have practical utility for the agency."
- 44. U.S.C.
3504(c)(2), 3508; ann 5 C.F.R.
13 2 0. 4 (b), (c).
conclusion currently, thero is a growing concern about the ever increasing coots of medical care.
Doctoro can always run more testo, perform more procedures, take additional steps, and even perform more paperwork in an effort to reduce health risks.
However, it is generally recognized that there are diminishing returns -- and that the medical community cannot conduct every test or take every possible precaution to prevent an adverso effect.
As part of controlling the costs of medical care, society expects that the medical community will only incur those conto which have a reasonable likelihood of benefiting their patients.
In this regard, the relevant question is not whether the ICR would be more cost-effective than the other steps that the NRC could take-to reduce the risks associated with the medical use of byproduct materials.
The relevant question la whether the ICR is cost-effective in an absolute sense -- rather than relative --
conse.
Whila this program may be more cost-effective than any other stop the NRC could take, the program is not cost-effective in an absolute sense, because the practical utility (if any) that the program will yield does not $ustify the significant burdon the program will inpose.
To the extent that the NRC imposes costs on the regulated community to conduct programs that are n21 cost-effective, it will divert resources from programs that Ars cost-effective and, as such, would result in greater improvements,
in public health and safety.
Thus, the NRC should review its d
actions in the context of this larger framoWork of the costs and risk management needs of the health care system as a whole.
HMarch 23, 1992 letter from James Taylor to James B. MacRae, Jr., page 2.
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. Ja. 01 '92 038.82 tro Pa9'9
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For the reasons set forth above, OMB belinves that the reporting and recordXceping requirements in this ICR have little if any practical utility.
Therefore, the significant burdens imposed on the regulated community are unreasonable and I an disapproving thio ICR under the authority of the PRA.
Sin
- rely, W
be,e. ;;M s 5. MacRae, Jr.
Acting Administrator and Deputy Administrator Office of Information and Regulatory Affairs r
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e va -. - ~
e m.-~
,-r, s
.-m-,--,
a
-, - - -